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Medical Product Packaging Requirements

Medical Product Packaging Requirements, Total:496 items.

In the international standard classification, Medical Product Packaging Requirements involves: Cases. Boxes. Crates, Applications of information technology, Quality, Sterilization and disinfection, Medical equipment, Medical sciences and health care facilities in general, Products of the chemical industry, Pharmaceutics, Aids for disabled or handicapped persons, Domestic safety, Equipment for children, Protection against dangerous goods, Packaging and distribution of goods in general, Packaging materials and accessories, Processes in the food industry, Sacks. Bags, Materials and articles in contact with foodstuffs, Laboratory medicine, Domestic electrical appliances in general, Environmental protection, Freight distribution of goods, Wastes, Wood-based panels, Nuclear energy engineering, Electricity. Magnetism. Electrical and magnetic measurements, Electrical engineering in general, Equipment for entertainment, Microbiology, Hospital equipment, Vocabularies, Company organization and management, HEALTH CARE TECHNOLOGY, Plant and equipment for the food industry, Products of non-ferrous metals, Home textiles. Linen, Graphic technology, PAPER TECHNOLOGY, Tobacco, tobacco products and related equipment, Agricultural machines, implements and equipment, Metrology and measurement in general, Transformers. Reactors.

RU-GOST R, Medical Product Packaging Requirements

GOST 22972-1978 Medical packing cases. General technical requirements
GOST R 57305-2016 Health informatics. Requirements for international machine-readable coding of medicinal product package identifiers
GOST R ISO 15378-2014 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
GOST R 57298-2016 Radiopharmaceutical medicinal products. General requirements for organization of production of radiopharmaceuticals in medical organizations
GOST R 57765-2017 Medical equipment. Products prosthetic-orthopedic. General technical requirements
GOST R 57765-2021 Prosthetic-orthopedic products. General technical requirements
GOST R ISO 13022-2016 Medical products containing viable human cells. Application of risk management and requirements for processing practices
GOST R ISO 13408-1-2000 Aseptic processing of health care products. Part 1: General reguirements
GOST R ISO 13683-2000 Sterilization of health care products. Requirements for validation and routine control of moist heat sterilization in health care facilities
GOST 23170-1978 Packing for products of engineering industry. General requirements
GOST R 56988-2016 Inflatable equipment. Technical sewing products. Envelopes. Requirements for manufacture
GOST R 52770-2007 Medical products. Safety requirements. Methods of sanitation-chemical and toxicological tests
GOST R ISO 11140-1-2000 Sterilization of health care products. Chemical indicators. Part 1. General requirements
GOST R ISO 11140-1-2009 Sterilization of health care products. Chemical indicators. Part 1. General requirements
GOST ISO 11138-1-2012 Sterilization of health care products. Biological indicators. Part 1. Technical requirements
GOST R ISO 11138-1-2000 Sterilization of health care products. Biological indicators. Part 1. General requirements
GOST R ISO 17665-1-2016 Sterilization of health care products. Moist heat. Part 1. Requirements for development, validation and routine control of a sterilization process for medical device
GOST R ISO 11134-2000 Sterilization of health care products. Requirements for validation and routine control. Industrial moist heat sterilization
GOST R ISO 11137-1-2008 Sterilization of health care products. Radiation. Part 1. Requirements for development, validation and routine control of a sterilization process for medical devices
GOST R 50267.47-2004 Medical electrical equipment. Part 2. Particular requirements for the safety, including essential performance, of ambulatory electrocardiographic systems
GOST ISO 11137-1-2011 Sterilization of health care products. Radiation. Part 1. Requirements for development, validation and routine control of a sterilization process for medical devices

International Organization for Standardization (ISO), Medical Product Packaging Requirements

ISO/TS 16791:2020 Health informatics — Requirements for international machine-readable coding of medicinal product package identifiers
ISO/TS 19256:2016 Health informatics - Requirements for medicinal product dictionary systems for health care
ISO 14937:2000 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
ISO 13408-1:1998 Aseptic processing of health care products - Part 1: General requirements
ISO 13408-1:2008 Aseptic processing of health care products - Part 1: General requirements
ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO/TR 25257:2009 Health informatics - Business requirements for an international coding system for medicinal products
ISO/DIS 11135 Sterilization of health care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO 11137:1995 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization
ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11607-1:2006/Amd 1:2014 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems; Amendment 1
ISO 11607-1:2019/FDAmd 1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
ISO 11607-1:2019 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
ISO 13022:2012 Medical products containing viable human cells - Application of risk management and requirements for processing practices
ISO 11134:1994 Sterilization of health care products; requirements for validation and routine control; industrial moist heat sterilization
ISO 11137:1995/Amd 1:2001 Sterilization of health care products - Requirements for validation and routine control - Radiation sterilization; Amendment 1: Selection of terms for dose setting
ISO 11607-2:2006/Amd 1:2014 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
ISO 11607-2:2019/FDAmd 1 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
ISO 11607-2:2019 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1
ISO 25424:2018/Amd 1:2022 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices — Amendment
ISO 14937:2000/Cor 1:2003 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices; Technical Corrigendum 1
ISO 14708-6:2010 Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
ISO 11607-1:2019/Amd 1:2011 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1: Application of risk management
ISO 11607-2:2019/Amd 1:2011 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — Amendment 1: Application of risk management
ISO/TS 16791:2014 Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers
ISO/TS 22421:2021 Sterilization of health care products - Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
ISO 15378:2011 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
ISO 15378:2017 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
ISO 15378:2015 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 22441:2022 Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

British Standards Institution (BSI), Medical Product Packaging Requirements

PD ISO/TS 21560:2020 General requirements of tissue-engineered medical products
BS PD CEN/TR 15753:2008 Packaging — Package leaflets for medicinal products — Braille and other formats for visually impaired people
BS EN ISO 11138-1:2006 Sterilization of health care products - Biological indicators - General requirements
BS EN 868-4:2009 Packaging for terminally sterilized medical devices - Paper bags - Requirements and test methods
BS EN 15593:2008 Packaging - Management of hygiene in the production of packaging for foodstuffs - Requirements
BS EN 868-2:2009 Packaging for terminally sterilized medical devices - Sterilization wrap - Requirements and test methods
BS 7236:1989 Code of practice for non-reclosable packaging for solid dose units of medicinal products
BS EN 868-2:2017 Tracked Changes. Packaging for terminally sterilized medical devices. Sterilization wrap. Requirements and test methods
BS EN ISO 11607-2:2020+A11:2022 Packaging for terminally sterilized medical devices - Validation requirements for forming, sealing and assembly processes
BS EN 13795:2011 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment. General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
BS EN ISO 11137-1:2015 Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices
BS EN ISO 11137-1:2006+A1:2013 Sterilization of health care products - Radiation - Requirements for development, validation and routine control of a sterilization process for medical devices
BS EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
BS EN 868-4:2017 Tracked Changes. Packaging for terminally sterilized medical devices. Paper bags. Requirements and test methods
BS EN 868-9:2009 Packaging for terminally sterilized medical devices - Uncoated nonwoven materials of polyolefines - Requirements and test methods
BS EN 13795-1:2002+A1:2009 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Part 1: General requirements for manufacturers, processors and products
BS EN ISO 11135:2014 Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
BS EN 868-2:1999 Packaging materials and systems for medical devices which are to be sterilized - Sterilization wrap - Requirements and test methods
BS EN ISO 15378:2015 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
BS EN ISO 15378:2011 Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
BS EN 868-1:1997 Packaging materials and systems for medical devices which are to be sterilized - General requirements and test methods
BS EN 868-6:2009 Packaging for terminally sterilized medical devices - Paper for low temperature sterilization processes - Requirements and test methods
BS EN 862:2005 Packaging — Childresistant packaging — Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
BS EN 862:2006 Packaging. Child resistant packaging. Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
BS EN 868-4:1999 Packaging materials and systems for medical devices which are to be sterilized - Paper bags - Requirements and test methods
22/30422020 DC BS ISO 11607-2:2019/AMD1. Packaging for terminally sterilized medical devices - Validation requirements for forming, sealing and assembly processes
BS EN ISO 15378:2017 Tracked Changes. Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
16/30347647 DC BS EN ISO 15378. Primary packaging materials for medicinal products. Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
22/30427344 DC BS EN ISO 11607-1:2019 AMD1. Packaging for terminally sterilized medical devices - Part 1. Requirements for materials, sterile barrier systems and packaging systems
BS EN ISO 14160:2011 Sterilization of health care products. Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives. Requirements for characterization, development, validation and routine control of a sterilization proc
BS EN 868-7:1999 Packaging materials and systems for medical devices which are to be sterilized - Adhesive coated paper for the manufacture of heat sealable packs for medical use for sterilization by ethylene oxide or irradiation - Requirements and test methods
BS EN 14287:2004 Aluminium and aluminium alloys. Specific requirements on the chemical composition of products intended to be used for the manufacture of packaging and packaging components
BS EN 868-7:2009 Packaging for terminally sterilized medical devices - Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
BS EN 868-10:2009 Packaging for terminally sterilized medical devices - Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
BS EN 868-9:2000 Packaging materials and systems for medical devices which are to be sterilized - Uncoated nonwoven materials of polyolefines for use in the manufacture of heat sealable pouches, reels and lids - Requirements and test methods
BS EN 868-3:2009 Packaging for terminally sterilized medical devices - Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) Requirements and test methods
BS EN 1174-1:1996 Sterilization of medical devices - Estimation of the population of micro-organisms on product - Requirements
BS EN 13795-1:2002 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - General requirements for manufacturers, processors and products
BS EN 13795-1:2019 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment. General requirements for manufacturers, processors and products
BS EN 868-6:2017 Tracked Changes. Packaging for terminally sterilized medical devices. Paper for low temperature sterilization processes. Requirements and test methods
BS EN 868-5:2009 Packaging for terminally sterilized medical devices - Sealable pouches and reels of porous and plastic film construction - Requirements and test methods
BS EN 868-9:2018 Tracked Changes. Packaging for terminally sterilized medical devices. Uncoated nonwoven materials of polyolefines. Requirements and test methods
BS PAS 223:2011 Prerequisite programmes and design requirements for food safety in the manufacture and provision of food packaging
BS PD ISO/TS 16791:2014 Health informatics. Requirements for international machine-readable coding of medicinal product package identifiers
22/30409085 DC BS EN ISO 17665. Sterilization of health care products. Moist heat. Requirements for the development, validation and routine control of a sterilization process for medical devices
BS EN 868-10:2018 Tracked Changes. Packaging for terminally sterilized medical devices. Adhesive coated nonwoven materials of polyolefines. Requirements and test methods
BS PD ISO/TS 22421:2021 Sterilization of health care products. Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
BS EN 868-7:2017 Tracked Changes. Packaging for terminally sterilized medical devices. Adhesive coated paper for low temperature sterilization processes. Requirements and test methods
23/30424625 DC BS EN ISO 11135. Sterilization of health care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices

American National Standards Institute （ANSI), Medical Product Packaging Requirements

ANSI/AAMI/ISO 17665-1:2005 Sterilization of health care products - Moist heat - Requirements for development, validation and routine control of a sterilization process for medical devices
ANSI/AAMI/ISO 11607-1:2006 Packaging for teminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging
ANSI/AAMI/ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO/DIS 11135:2023 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
ANSI/AAMI/ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation and requirements for forming, sealing and assembly processes
ANSI/AAMI/ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ANSI/AAMI/ISO 11137-1AMD 1:2013 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 1
ANSI/AAMI/ISO 14937:2000 Sterilization of Health Care Products - General Requirements for Characteristics of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process

Korean Agency for Technology and Standards (KATS), Medical Product Packaging Requirements

KS P ISO TS 21560:2021 General requirements of tissue-engineered medical products
KS P ISO 13408-1:2010 Aseptic processing of health care products-Part 1:General requirements
KS P ISO 13408-1:2017 Aseptic processing of health care products－Part 1：General requirements
KS X ISO TR 25257:2014 Health informatics — Business requirements for an international coding system for medicinal products
KS X ISO TR 25257:2010 Health informatics-Business requirements for an international coding system for medicinal products
KS X ISO TR 25257:2016 Health informatics — Business requirements for an international coding system for medicinal products
KS P ISO 11607-1:2021 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
KS P ISO 11607-1:2018 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
KS P ISO 11607-2:2021 Packaging for terminally sterilized medical devices —Part 2: Validation requirements for forming, sealing and assembly processes
KS P ISO 11607-2:2018 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
KS P ISO 25424:2020 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
KS P ISO 13022:2018 Medical products containing viable human cells — Application of risk management and requirements for processing practices
KS P ISO 11137-1:2019 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
KS P ISO 17665-1:2019 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
KS P ISO 17665-1:2008 Sterilization of health care products-Moist heat-Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices
KS P ISO 11135:2018 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

KR-KS, Medical Product Packaging Requirements

KS P ISO TS 21560-2021 General requirements of tissue-engineered medical products
KS P ISO 11607-1-2021 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
KS P ISO 11607-1-2018 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
KS P ISO 11607-2-2021 Packaging for terminally sterilized medical devices —Part 2: Validation requirements for forming, sealing and assembly processes
KS P ISO 11607-2-2018 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
KS P ISO 25424-2020 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
KS P ISO 13022-2018 Medical products containing viable human cells — Application of risk management and requirements for processing practices
KS P ISO 11137-1-2019 Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
KS P ISO 17665-1-2019 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
KS P ISO 11135-2018 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

US-AAMI, Medical Product Packaging Requirements

ANSI/AAMI ST67-2003 Sterilization of medical devices - Requirements for products labeled "STERILE"
ANSI/AAMI/ISO 13022:2012 Medical products containing viable human cells.Application of risk management and requirements for processing practices

American Society for Testing and Materials (ASTM), Medical Product Packaging Requirements

ASTM F2097-05 Standard Guide for Design and Evaluation of Primary Packaging for Medical Products
ASTM F2097-01 Standard Guide for Design and Evaluation of Primary Packaging for Medical Products
ASTM F2097-20 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
ASTM F2097-08 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
ASTM F2097-14 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
ASTM F2097-16 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
ASTM F2097-23 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products
ASTM F2097-07 Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products

Danish Standards Foundation, Medical Product Packaging Requirements

DS/ISO/TS 22421:2021 Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
DS/EN 15593:2008 Packaging - Management of hygiene in the production of packaging for foodstuffs - Requirements
DS/EN 14375:2006 Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing
DS/EN 14375:2004 Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing
DS/EN 868-2:2009 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
DS/EN 868-4:2009 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
DS/EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
DS/EN ISO 15378:2012 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
DS/EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
DS/EN ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
DS/EN ISO 11137-1/A1:2013 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
DS/EN 862:2006 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
DS/EN ISO 14937:2009 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
DS/EN 868-6:2009 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
DS/EN 14287:2004 Aluminium and aluminium alloys - Specific requirements on the chemical composition of products intended to be used for the manufacture of packaging and packaging components
DS/EN 868-7:2009 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
DS/EN ISO 14160:2011 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr
DS/EN 868-9:2009 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
DS/EN 868-10:2009 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods

Professional Standard - Medicine, Medical Product Packaging Requirements

YY/T 0048-1991 Basic requirements for working drawings of medical device products
YY/T 0313-2014 Medical polymer products.Requirement for package and information supplied by manufacturer
YY/T 0567.1-2005 Aseptic processing of health care products - Part 1: General requirements
YY/T 0567.1-2013 Aseptic processing of health care products.Part 1:General requirements
YY/T 0698.1-2011 Packaging materials for terminal sterilized medical devices.Part 1:Co-extrusion plastic films used for vacuum forming packaging.Requirements and test methods
YY/T 0698.2-2009 Packaging materials for terminal sterilized medical devices.Part 2:Sterilization wrap.Requirements and test methods
YY/T 0698.4-2009 Packaging materials for terminally sterilized medical devices - Part 4: Requirements and test methods for paper bags
YY/T 1914-2023 General requirements for medical devices and appliances used in human assisted reproductive technology
YY/T 0698.7-2009 Packing materials for terminal sterilized medical devices.Part 7:Adhesive coated paper for the manufacture of sealable packs for medical use for sterilization by ethylene oxide or irradiation.Requirements and test methods
YY/T 0698.3-2009 Packaging materials for terminal sterilized medical devices.Part 3:Paper for use in the manufacture of paper bags(specified in YY/T 0698.4)and in the manufacture of pouches and reels(specified in YY/T 0698.5).Requirements and test methods
YY/T 0698.6-2009 Packaging materials for terminally sterilized medical devices-Part 6: Requirements and test methods for paper used in the production of sterile barrier systems for low-temperature sterilization processes or radiation sterilization
YY/T 0698.8-2009 Packaging materials for terminally sterilized medical devices—Part 8: Requirements and test methods for reusable sterilization containers for steam sterilizers

Professional Standard - Light Industry, Medical Product Packaging Requirements

QB/T 1685-2006 Requirements of packaging appearance for cosmetic products
QB/T 1685-1993 Packaging Appearance Requirements for Cosmetic Products

German Institute for Standardization, Medical Product Packaging Requirements

DIN-Fachbericht CEN/TR 15753:2008 Packaging - Package leaflets for medicinal products - Braille and other formats for visually impaired people; German version CEN/TR 15753:2008
DIN 58765:2012 Production in optical engineering - Packaging - Requirements
DIN EN 15593:2008 Packaging - Management of hygiene in the production of packaging for foodstuffs - Requirements;English version of DIN EN 15593:2008-05
DIN EN 868-2:2017-05 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; German version EN 868-2:2017
DIN EN 15593:2008-05 Packaging - Management of hygiene in the production of packaging for foodstuffs - Requirements; German version EN 15593:2008
DIN EN 868-4:2017-05 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods; German version EN 868-4:2017
DIN EN ISO 11607-1/A11:2022-08 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019); German version EN ISO 11607-1:2020/A11:2022
DIN EN ISO 11607-1:2020-05 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019); German version EN ISO 11607-1:2020 / Note: To be amended by DIN EN ISO 11607-1/A1 (2022-08).
DIN EN ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements (ISO 11138-1:2006); English version of DIN EN ISO 11138-1:2006-09
DIN EN ISO 15378:2018-04 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017); German version EN ISO 15378:2017
DIN EN ISO 11607-2:2020-05 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019); German version EN ISO 11607-2:2020 / Note: To be amended by DIN EN ISO 11607-2/A1 (2022-08).
DIN EN ISO 11607-2/A11:2022-08 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019); German version EN ISO 11607-2:2020/A11:2022
DIN EN ISO 11137-1:2020-04 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd.1:2013 + Amd.2:2018); German version EN ISO 11137-1...
DIN EN 14287:2004 Aluminium and aluminium alloys - Specific requirements on the chemical composition of products intended to be used for the manufacture of packaging and packaging components; German version EN 14287:2004
DIN EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
DIN EN ISO 15378:2018 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
DIN EN ISO 11135:2023-05 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2023); German and English version prEN ISO 11135:2023 / Note: Date o...
DIN EN 45502-2-2:2008 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators); German version EN 45502-2-2:2008
DIN ISO 13022:2014 Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)
DIN EN 13795:2013 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels; German version
DIN EN 868-6:2017-05 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-6:2017
DIN EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
DIN ISO 13022:2014-06 Medical products containing viable human cells - Application of risk management and requirements for processing practices (ISO 13022:2012)
DIN EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; German version EN 868-2:2017
DIN EN ISO 11607-2:2017 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO/DIS 11607-2:2017); German and English version prEN ISO 11607-2:2017
DIN EN 14375 Corrigendum 1:2006 Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing Corrigendum 1 to English version of DIN EN 14375:2004-02
DIN EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006) English version of DIN EN ISO 11607-2:2006-07
DIN EN 14287:2004-09 Aluminium and aluminium alloys - Specific requirements on the chemical composition of products intended to be used for the manufacture of packaging and packaging components; German version EN 14287:2004
DIN EN 868-2:2009 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; English version of DIN EN 868-2:2009-09
DIN EN ISO 14160:2018 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr
DIN EN ISO 14937:2010-03 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009); German version EN ISO 14937:2009
DIN EN ISO 11607-1/A1:2022-08 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1 (ISO 11607-1:2019/DAM 1:2022); German and English version EN ISO 11607-1:2020/prA1:2022 / Note: Date o...
DIN EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods; German version EN 868-4:2017
DIN EN 868-10:2019-03 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods; German version EN 868-10:2018
DIN EN 13795:2011 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels; German version
DIN EN 868-9:2019 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
DIN EN 868-9:2019-03 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods; German version EN 868-9:2018
DIN EN 868-4:2009 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods; English version of DIN EN 868-4:2009-09
DIN EN 868-7:2017-05 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-7:2017
DIN EN ISO 11135:2023 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2023); German and English version prEN ISO 11135:2023
DIN EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006); English version of DIN EN ISO 11607-1:2009-09
DIN EN ISO 11607-2/A1:2022-08 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1 (ISO 11607-2:2019/DAM 1:2022); German and English version EN ISO 11607-2:2020/prA1:2022 / Note: Date of issu...
DIN EN 868-9:2009 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods; English version of DIN EN 868-9:2009-09
DIN EN 868-10:2009 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods; English version of DIN EN 868-10:2009-09
DIN EN ISO 13408-1:2011 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008); German version EN ISO 13408-1:2011
DIN EN 868-10:2019 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
DIN EN 13795-1:2009 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products(includes Amendment A1:2009); English version of DIN EN 13795-1:2009-1
DIN EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013); German version EN ISO 11137-1:2015
DIN EN ISO 11140-1:2015 Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014); German version EN ISO 11140-1:2014
DIN EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods; German version EN 868-6:2017
DIN EN ISO 11607-1:2014 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006 + Amd 1:2014); German version EN ISO 11607-1:2009 + A1:2014

Association Francaise de Normalisation, Medical Product Packaging Requirements

NF H00-202:1997 Packaging. Child-resistant packaging. Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products.
NF EN 868-2:2017 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2 : enveloppe de stérilisation - Exigences et méthodes d'essai
NF S98-052-1:2009 Packaging for terminally sterilized medical devices - Part 1 : requirements for materials, sterile barrier systems and packaging systems.
XP S98-224*XP ISO/TS 22421:2021 Sterilization of health care products - Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
XP ISO/TS 22421:2021 Stérilisation des produits de santé - Exigences communes applicables aux stérilisateurs utilisés pour la stérilisation terminale des dispositifs médicaux dans les établissements de santé
NF H60-200*NF EN 15593:2008 Packaging - Management of hygiene in the production of packaging for foodstuffs - Requirements.
NF H00-204*NF EN 14375:2016 Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing
NF S98-051-4:2009 Packaging for terminally sterilized medical devices - Part 4 : paper bags - Requirements and test methods.
NF X30-511:2015 Packaging for medical care waste - Additional and/or alternative characteristics and requirements for sharps containers
NF EN 82304-1:2017 Logiciels de santé - Partie 1 : exigences générales pour la sécurité des produits
NF S98-051-2*NF EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2 : sterilization wrap - Requirements and test methods
NF S98-051-2:2009 Packaging materials for terminally sterilized medical devices - Part 2 : sterilization wrap - Requirements and test methods.
NF S98-104*NF EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
NF EN ISO 20857:2013 Stérilisation des produits de santé - Chaleur sèche - Exigences pour l'élaboration, la validation et le contrôle de routine d'un processus de stérilisation pour dispositifs médicaux
NF EN 868-4:2017 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 4 : sacs en papier - Exigences et méthodes d'essai
NF S97-165/IN1:2013 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
NF S98-052-1*NF EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices - Part 1 : requirements for materials, sterile barrier systems and packaging systems
NF EN ISO 11607-1:2020 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1 : exigences relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage
NF S92-013:1996 In vitro diagnostic systems. Transport packages for medical and biological specimens. Requirements, tests.
NF S98-051-4*NF EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4 : paper bags - Requirements and test methods
NF S98-004-1:2006 Sterilization of health care products - Biological indicators - Part 1 : general requirements.
NF EN ISO 11135:2014 Stérilisation des produits de santé - Oxyde d'éthylène - Exigences de développement, de validation et de contrôle de routine d'un processus de stérilisation pour des dispositifs médicaux
NF EN ISO 15378:2018 Articles d'emballage primaire pour médicaments - Exigences particulières pour l'application de l'ISO 9001:2015 prenant en considération les Bonnes Pratiques de Fabrication (BPF)
NF S98-052-2:2006 Packaging for terminally sterilized medical devices - Part 2 : validation requirements for forming, sealing and assembly processes.
NF S98-051-9:2009 Packaging materials for terminally sterilized medical devices - Part 9 : uncoated nonwoven materials of polyolefines - Requirements and test methods.
NF S93-200*NF EN ISO 15378:2018 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
NF S98-052-1/A1:2014 Packaging for terminally sterilized medical devices - Part 1 : requirements for materials, sterile barrier systems and packaging systems - Amendment 1
NF S98-052-2*NF EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices - Part 2 : validation requirements for forming, sealing and assembly processes
NF EN ISO 11607-2:2020 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2 : exigences de validation pour les procédés de formage, scellage et assemblage
NF S98-103-1*NF EN ISO 11137-1:2016 Sterilization of health care products - Radiation - Part 1 : requirements for development, validation and routine control of a sterilization process for medical devices
NF S98-051:1997 Packaging materials and systems for medical devices which are to be sterilized. Part 1 : general requirements and test methods.
NF A50-426*NF EN 14287:2004 Aluminium and aluminium alloys - Specific requirements on the chemical composition of products intended to be used for the manufacture of packaging and packaging components.
NF EN ISO 11607-1/A11:2022 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1 : exigences relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage - Amendement A11
NF S98-051-6:2009 Packaging materials for terminally sterilized medical devices - Part 6 : paper for low temperature sterilization processes - Requirements and test methods.
NF S98-051-3:2009 Packaging for terminally sterilized medical devices - Part 3 : paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods.
NF H00-202*NF EN 862:2016 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
NF S98-051-7:2009 Packaging for terminally sterilized medical devices - Part 7 : adhesive coated paper for low temperature sterilization processes - Requirements and test methods.
NF EN 868-6:2017 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 6 : papier pour des procédés de stérilisation à basse température - Exigences et méthodes d'essai
NF S98-051-10:2009 Packaging for terminally sterilized medical devices - Part 10 : adhesive coated nonwoven materials of polyolefines - Requirements and test methods.
NF S98-052-2/A1:2014 Packaging for terminally sterilized medical devices - Part 2 : validation requirements for forming, sealing and assembly processes - Amendment 1
NF EN ISO 11607-2/A11:2022 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2 : exigences de validation pour les procédés de formage, scellage et assemblage - Amendement A11
NF EN ISO 25424/A1:2022 Stérilisation des produits de santé - Formaldéhyde et vapeur à faible température - Exigences pour le développement, la validation et le contrôle de routine d'un procédé de stérilisation pour dispositifs médicaux - Amendement 1
NF EN ISO 14937:2009 Stérilisation des produits de santé - Exigences générales pour la caractérisation d'un agent stérilisant et pour la mise au point, la validation et la vérification de routine d'un processus de stérilisation pour dispositifs médicaux
NF S98-103-1:2006 Sterilization of health care products - Radiation - Part 1 : requirements for development, validation and routine control of a sterilization process for medical devices.
NF H00-202:2006 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products.
NF S98-051-6*NF EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6 : paper for low temperature sterilization processes - Requirements and test methods
NF EN 14287:2004 Aluminium et alliages d'aluminium - Exigences spécifiques pour la composition chimique de produits destinés à la fabrication d'emballages et de composants d'emballage
NF C74-502-2-2*NF EN 45502-2-2:2008 Active implantable medical devices - Part 2-2 : particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
NF S98-051-9*NF EN 868-9:2018 Packaging for terminally sterilized medical devices - Part 9 : uncoated nonwoven materials of polyolefines - Requirements and test methods
NF S98-051-7*NF EN 868-7:2017 Packaging for terminally sterilized medical devices - Part 7 : adhesive coated paper for low temperature sterilization processes - Requirements and test methods
NF S97-165:2013 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
NF S98-051-5:2009 Packaging for terminally sterilized medical devices - Part 5 : sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods.
NF EN 868-7:2017 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 7 : papier enduit d'adhésif pour des procédés de stérilisation à basse température - Exigences et méthodes d'essai
NF EN ISO 11135/A1:2019 Stérilisation des produits de santé - Oxyde d'éthylène - Exigences de développement, de validation et de contrôle de routine d'un processus de stérilisation pour des dispositifs médicaux - AMENDEMENT 1 : révision de l'Annexe E, Libération ...
NF S98-051-8:2009 Packaging for terminally sterilized medical devices - Part 8 : re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods.
NF EN ISO 11137-1:2016 Stérilisation des produits de santé - Irradiation - Partie 1 : exigences relatives à la mise au point, à la validation et au contrôle de routine d'un procédé de stérilisation pour les dispositifs médicaux
NF S98-051-10*NF EN 868-10:2018 Packaging for terminally sterilized medical devices - Part 10 : adhesive coated nonwoven materials of polyolefines - Requirements and test methods
NF S98-101-1:2007 Sterilization of health care products - Ethylene oxide - Part 1 : requirements for development, validation and routine control of a sterilization process for medical devices.
NF S98-105*NF EN ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1 : requirements for the development, validation and routine control of a sterilization process for medical devices.
NF S98-103-1/A1:2013 Sterilization of health care products - Radiation - Part 1: requirements for development, validation and routine control of a sterilization process for medical devices
NF EN 868-9:2018 Matériaux et systèmes d'emballage pour les dispositifs médicaux stérilisés au stade terminal - Partie 9 : matériaux non tissés à base de polyoléfines, non enduits - Exigences et méthodes d'essai

European Committee for Standardization (CEN), Medical Product Packaging Requirements

EN ISO 13408-1:2011/A1:2013 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008/Amd 1:2013)
EN 868-4:2009 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
EN 868-2:2009 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
EN 15593:2008 Packaging - Management of hygiene in the production of packaging for foodstuffs - Requirements
CEN EN 15593-2008 Packaging — Management of hygiene in the production of packaging for foodstuffs — Requirements
EN ISO 13408-1:2011 Aseptic processing of health care products - Part 1: General requirements [Superseded: CEN EN 13824]
EN ISO 11137-1:2006/A1:2013 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006/Amd 1:2013)
EN ISO 11137-1:2015/A2:2019 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - Amendment 2: Revision to 4.3.4 and 11.2 (ISO 11137-1:2006/Amd 2:2018)
EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
EN 868-9:2009 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
EN 868-6:1999 Packaging Materials and Systems for Medical Devices Which are to Be Sterilized - Part 6: Paper for the Manufacture of Packs for Medical Use for Sterilization by Ethylene Oxide or Irradiation - Requirements and Test Methods
EN 13795:2011+A1:2013 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
prEN 868-6-1992 Packaging materials for sterilization of wrapped goods; part 6: paper for the manufacture of packs for medical use for sterilization by ethylene oxide of irradiation; requirements and tests
EN 868-6:2009 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
EN 1174-1:1996 Sterilization of Medical Devices - Estimation of the Population of Micro- Organisms on Product - Part 1: Requirements
EN ISO 15378:2011 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
prEN 868-7-1992 Packaging materials for sterilization of wrapped goods; part 7: adhesive coated paper for the manufacture of packs for medical use for sterilization by ethylene oxide or irradiation; requirements and tests
EN 862:2005 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for nonpharmaceutical products
EN 862:1997 Packaging - Child-Resistant Packaging - Requirements and Testing Procedures for Non-Reclosable Packages for Non-Pharmaceutical Products
EN 862:2001 Packaging - Child-Resistant Packaging - Requirements and Testing Procedures for Non-Reclosable Packages for Non-Pharmaceutical Products
EN 868-3:2009 Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
EN 868-2:1999 Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 2: Sterilization Wrap - Requirements and Test Methods
EN 13795:2011 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels (Incorporates A
EN 868-1:1997 Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 1: General Requirements and Test Methods
EN 868-7:2009 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
EN 868-7:1999 Packaging Materials and Systems for Medical Devices Which are to Be Sterilized - Part 7: Adhesive Coated Paper for the Manufacture of Heat Sealable Packs for Medical Use for Sterilization by Ethylene Oxide or Irradiation - Requirements and Test Methods
EN 868-4:1999 Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 4: Paper Bags - Requirements and Test Methods
prEN ISO 11137-1 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023)
EN ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements
EN ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
EN 868-3:1999 Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 3: Paper for Use in the Manufacture of Paper Bags (Specified in EN 864-4) and in the Manufacture of Pouches and Reels (Specified in EN 868-5) - Requirements and Test Me
EN 14287:2004 Aluminium and aluminium alloys - Specific requirements on the chemical composition of products intended to be used for the manufacture of packaging and packaging components
EN 862:2016 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for nonpharmaceutical products
EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
EN ISO 14708-6:2022 Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO 14708-6:2019)
EN ISO 11607-1:2020/prA1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1 (ISO 11607-1:2019/DAM 1:2022)
EN ISO/TS 16791:2015 Health informatics - Requirements for international machine-readable coding of medicinal product package identifiers
EN 868-5:2009 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
EN 868-7:2017 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
EN ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11137-1:2006;:1994 [Superseded: CEN EN 552]
EN 868-3:2017 Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
EN ISO 11607-2:2020/prA1 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1 (ISO 11607-2:2019/DAM 1:2022)
EN 868-9:2000 Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 9: Uncoated Nonwoven Materials of Polyolefines for Use in the Manufacture of Heat Sealable Pouches, Reels and Lids - Requirements and Test Methods

Inner Mongolia Provincial Standard of the People's Republic of China, Medical Product Packaging Requirements

DB15/T 1174-2017 Pharmaceutical logistics refrigerated drug transport packaging requirements

PT-IPQ, Medical Product Packaging Requirements

NP EN 862-2000 Packaging Child-resistant packaging Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products

Lithuanian Standards Office , Medical Product Packaging Requirements

LST EN 15593-2008 Packaging - Management of hygiene in the production of packaging for foodstuffs - Requirements
LST EN 14375-2004 Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing
LST EN 14375-2004/AC-2006 Child-resistant non-reclosable packaging for pharmaceutical products - Requirements and testing
LST EN 868-2-2009 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
LST EN 868-4-2009 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
LST 1495-1997 Organization and quality. Control cleanroom technology for medical products. General requirements
LST EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
LST EN 862-2006 Packaging - Child-resistant packaging - Requirements and testing procedures for non-reclosable packages for non-pharmaceutical products
LST EN ISO 15378:2012 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP) (ISO 15378:2011)
LST EN ISO 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)
LST EN 868-6-2009 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
LST EN ISO 14937:2010 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
LST EN 14287-2004 Aluminium and aluminium alloys - Specific requirements on the chemical composition of products intended to be used for the manufacture of packaging and packaging components
LST EN 868-7-2009 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
LST EN ISO 14160:2011 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr
LST EN ISO 14160:2021 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr
LST EN 868-9-2009 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
LST EN ISO 13408-1:2015 Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013)
LST EN 868-10-2009 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods

AENOR, Medical Product Packaging Requirements

UNE-EN 15593:2008 Packaging - Management of hygiene in the production of packaging for foodstuffs - Requirements
UNE-EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
UNE-EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
UNE-EN ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
UNE-EN ISO 11607-1:2017 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014)
UNE-EN ISO 11607-2:2017 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006, including Amd 1:2014)
UNE-EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
UNE-EN ISO 14937:2010 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)
UNE-EN 868-7:2017 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
UNE-EN ISO 14160:2012 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr
UNE-EN 868-9:2009 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
UNE-EN 14287:2005 Aluminium and aluminium alloys. Specific requirements on the chemical composition of products intended to be used for the manufacture of packaging and packaging components.
UNE-EN 868-10:2009 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods

ES-UNE, Medical Product Packaging Requirements

UNE-EN 15593:2008 ERRATUM:2009 Packaging - Management of hygiene in the production of packaging for foodstuffs - Requirements
UNE-EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
UNE-EN ISO 11607-1:2020/A11:2022 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
UNE-EN ISO 15378:2018 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP) (ISO 15378:2017)
UNE-EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
UNE-EN ISO 11607-2:2020/A11:2022 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
UNE-EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
UNE-EN 868-10:2019 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
UNE-EN 868-9:2019 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods

国家食品药品监督管理局, Medical Product Packaging Requirements

YY/T 0507.1-2005 Sterile processing of medical products Part 1: General requirements

Canadian Standards Association (CSA), Medical Product Packaging Requirements

CSA ISO 14937-01-CAN/CSA:2001 Sterilization of Health Care Products - General Requirements for Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices First Edition; ISO 14937:2000
CSA Z11138-1-07-CAN/CSA-2007 St閞ilisation des produits de sant??Indicateurs biologiques ?Partie 1: Exigences g閚閞ales deuxi鑝e 閐ition
CSA Z11140-1-07-CAN/CSA-2007 St閞ilisation des produits de sant??Indicateurs chimiques ?Partie 1 : Exigences g閚閞ales deuxi鑝e 閐ition
CSA ISO 11137-98-CAN/CSA:1998 Sterilization of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilization ISO 11137: 1995
CAN/CSA-ISO 14937:2011 Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (Second Edition)
CSA ISO 11607-1:2021 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (Adopted ISO 11607-1:2019, second edition, 2019-02)
CSA ISO 14937-01-CAN/CSA:2001-b Sterilization of Health Care Products - General Requirements for Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices First Edition; ISO 14937:2000

Group Standards of the People's Republic of China, Medical Product Packaging Requirements

T/CAMMT 9-2018 Technical specification of green package of household electrical appliances
T/CASME 492-2023 General technical requirements for product packaging design
T/DGECA 002-2020 General requierments of package for agricultural products e-commerce
T/CPF 0053-2023 Technical requirements for evaluating carbon emission reductions of products—Packaging
T/CSX 005-2023 Variable QR code printing quality requirements for plastic packaging products
T/CADERM 6002-2021 Configuration requirements for equipment type and quantity of first aid medical rescue for large-scale ice and snow sport events
T/CADERM 6003-2021 Configuration requirements for equipment type and quantity of transport treatment of emergency medical rescue for large-scale ice and snow sporting events
T/CCAA 0022-2014 Food safety management system—Requirements for food packaging containers and artic1es product estab1ishments
T/CAAMM 2.4-2017 Tractor Products—Requirements for marking, packaging,transportation and storage—Part 4: parts
T/CAAMM 2.1-2017 Tractor Products—Requirements for marking, packaging, transportation and storage—Part 1：General requirements

Professional Standard - Aviation, Medical Product Packaging Requirements

HB 7611.1-1998 General requirements for aircraft product transport packaging
HB 7611.5-1998 Aircraft product transport packaging test requirements
HB 7611.6-1998 Requirements for the use of aircraft product transportation packaging
HB 7611.4-1998 Preparation Requirements for Aircraft Product Transportation, Packaging, Storage and Transportation
HB 7611.2-1998 Aircraft product transport packaging structure and strength requirements
HB 20047-2011 Technical requirements for shipping packages of export products of the aviation industry

Professional Standard - Environmental Protection, Medical Product Packaging Requirements

HJ/T 209-2005 Technical requirement for environmental labeling products Packaging products
HJ 209-2017 Technical requirements for environmental labeling products Plastic packaging products
HJ/T 204-2005 Technical Requirement for Environmental Labeling Products–Fibrous Desiccant for Packaging

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Medical Product Packaging Requirements

GB/T 20367-2006 Sterilization of health care products. Requirement for validation and routine control of moist heat sterilization in health care facilities
GB/T 26544-2011 General requirements of aquatic products package for air transportation
GB/T 19633.1-2015 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
GB 18280-2000 Sterilization of health care products--Requirement for validation and routine control--Radiation sterilization
GB 18279-2023 Development, validation and routine control requirements for ethylene oxide medical device sterilization processes for healthcare product sterilization
GB/T 19633.2-2015 Packaging for terminally sterilized medical devices.Part 2:Validation requirements for forming, sealing and assembly processes
GB 18280.1-2015 Sterilization of health care products.Radiation.Part 1: Requirements for development,validation and routine control of a sterilization process for medical devices
GB 18278.1-2015 Damp heat for sterilization of healthcare products - Part 1: Requirements for development, validation and routine control of sterilization processes for medical devices
GB 18278-2000 Sterilization of health care products--Requirements for validation and routine control--Industrial moist heat sterilization
GB 18279.1-2015 Sterilization of health care products.Ethylene oxide.Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
GB/T 19974-2005 Sterilization of health care products.General requirement for characterization of a sterilization agent and the development,validation and routine control of a sterilization process for medical devices
GB/T 19974-2018 Sterilization of health care products.General requirement for characterization of a sterilization agent and the development, validation and routine control of a sterilization process for medical devices
GB 15269.3-2011 Cigars.Part 3:Technical requirements for packing,making,storage and transport
GB/T 19212.16-2005 Safety of power transformers ,power supply units and similar devices -- Part 16: Particular requirements for isolating transformers for the supply of medical locations
GB 19212.16-2005 Safety of power transformers,power supply units and similar devices.Part 16: Particular requirements for isolating transformers for supply of medical locations

ZA-SANS, Medical Product Packaging Requirements

SANS 50868-2:2003 Packaging materials and systems for medical devices which are to be sterilized Part 2: Sterilization wrap - Requirements and test methods
SANS 11607-1:2007 Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
SANS 11607-2:2007 Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
SANS 50868-1:2003 Packaging materials and systems for medical devices which are to be sterilized Part 1: General requirements and test methods
SANS 50868-4:2003 Packaging materials and systems for medical devices which are to be sterilized Part 4: Paper bags - Requirements and test methods
SANS 50868-7:2003 Packaging materials and systems for medical devices which are to be sterilized Part 7: Adhesive coated paper for the manufacture of heat sealable packs for medical use for sterilization by ethylene oxide or irradiation - Requirements and test methods
SANS 50868-6:2003 Packaging materials and systems for medical devices which are to be sterilized Part 6: Paper for the manufacture of packs for medical use for sterilization by ethylene oxide or irradiation - Requirements and test methods
SANS 289:2008 Labelling requirements for prepackaged products (prepackages) and general requirements for the sale of goods subject to legal metrology control
SANS 289:2006 Labelling requirements for prepackaged products (prepackages) and general requirements for the sale of goods subject to legal metrology control
SANS 11135-1:2008 Sterilization of health care products - Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

CZ-CSN, Medical Product Packaging Requirements

CSN 85 5202-1982 Resistance fo medical products to clima- ?ic effects. General technical require- ments
CSN 85 5204-1987 Products of medical engineering. Requi- rements for resistance during mechanical action and testing methods

Professional Standard - Forestry, Medical Product Packaging Requirements

LY/T 2717-2016 General specifications for packages of wood-based panels

Professional Standard - Nuclear Industry, Medical Product Packaging Requirements

EJ/T 1059-1998 General specifications for packaging of nuclear instrumentation products

工业和信息化部, Medical Product Packaging Requirements

SJ/T 11587-2016 Technical requirements for anti-static packaging of electronic products

Professional Standard - Commodity Inspection, Medical Product Packaging Requirements

SN/T 3062.2-2011 Pachaking materials for terminally sterilized medical devices for import.Part 2:Paper bags.Requirements and test methods
SN/T 3062.1-2011 Packing materials for terminally sterilized medical devices for import. Part 1:Validation requirements for forming,sealing and assembly processes
SN/T 3062.4-2011 Pachaking materials for terminally sterilized medical devices for import.Part 4:Requirements for materials and sterile barrier systems of importing medical device sterilization packaging

GOSTR, Medical Product Packaging Requirements

GOST R 52770-2020 Medical devices. Evaluation system of biological effects. Part 1. General requirements for biological safety
GOST ISO 11607-1-2018 Packaging for terminally sterilized medical devices. Part 1. Requirements for materials, sterile barrier systems and packaging systems
GOST ISO 11607-2-2018 Packaging for terminally sterilized medical devices. Part 2. Validation requirements for forming, sealing and assembly processes
GOST 19348-1982 Electrotechnical products for agricultural purposes. General technical requirements. Marking, packing, transportation and storage

VN-TCVN, Medical Product Packaging Requirements

TCVN 7394-1-2008 Packaging for terminally sterilized medical devices.Part 1: Requirements for materials, sterile barrier systems and packaging systems
TCVN 7394-2-2008 Packaging for terminally sterilized medical devices.Part 2: Validation requirements for forming, sealing and assembly processes
TCVN 7393-1-2009 Sterilization of health care products.Radiation.Part 1: Requirements for developement, validation and routine control of a sterilization process for medical devices.
TCVN 7392-1-2009 Sterilization of health care products.Ethylene oxide.Part 1: Requirements for developement validation and routine control of a sterilization process for medical devices.

未注明发布机构, Medical Product Packaging Requirements

DIN EN ISO 11607-1 Berichtigung 1:2016 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems
BS 3970-1:1990(1999) Sterilizing and disinfecting equipment for medical products — Part 1 : Specification for general requirements
DIN EN ISO 11607-1 A11:2022 Packaging for medical devices to be sterilized in the final packaging – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
DIN EN 868-1:1997 Packaging materials and systems for medical devices which are to be sterilized — Part 1: General requirements and test methods
DIN EN ISO 11607-1:2017 Packaging for medical devices to be sterilized in the final packaging – Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006 + Amd 1.:2014); German version EN ISO 11607-1:2017
DIN EN ISO 11607-2 A11:2022 Packaging for medical devices to be sterilized in final packaging – Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019); German version EN ISO 11607-2:2020/A11:2022
BS 3970-4:1990(1999) Sterilizing and disinfecting equipment for medical products — Part 4 : Specification for transportable steam sterilizers for unwrapped instruments and utensils

国家邮政局, Medical Product Packaging Requirements

YZ/T 0179-2021 Agricultural product delivery services and environmentally friendly packaging requirements

中华全国供销合作总社, Medical Product Packaging Requirements

GH/T 1279-2019 Packaging requirements for agricultural products from farmers’ professional cooperatives

Military Standard of the People's Republic of China-General Armament Department, Medical Product Packaging Requirements

GJB 1443-1992 Quality management requirements for product packaging, loading, unloading, transportation and storage

Japanese Industrial Standards Committee (JISC), Medical Product Packaging Requirements

JIS T 11140-1:2013 Sterilization of health care products.Chemical indicators.Part 1: General requirements
JIS T 0841-1:2009 Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems
JIS T 0841-1:2019 Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems
JIS T 0806-1:2022 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
JIS T 0841-2:2009 Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes
JIS T 0806-1:2010 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
JIS T 0816-1:2010 Sterilization of health care products-moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
JIS T 0806-1:2015 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

Professional Standard - Agriculture, Medical Product Packaging Requirements

GB 43284-2023 Limit excessive packaging of goods and require fresh edible agricultural products

国家药监局, Medical Product Packaging Requirements

YY/T 0698.2-2022 Packaging materials for terminally sterilized medical devices Part 2: Requirements and test methods for sterilization packaging materials
YY/T 1464-2022 Development, validation and routine control requirements for low-temperature steam formaldehyde medical device sterilization process for sterilization of healthcare products
YY 0970-2023 Sterilization of healthcare products Liquid chemical sterilants for single-use medical devices of animal origin Characterization, development, validation and routine control requirements for medical device sterilization processes

中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会, Medical Product Packaging Requirements

GB/T 34344-2017 General technical requirement of packaging materials for agricultural products logistics
GB/T 34343-2017 General technical requirement of packaging containers for agricultural products logistics

IX-EU/EC, Medical Product Packaging Requirements

92/27/EEC-1992 Council Directive on the Labelling of Medicinal Products for Human Use and on Package Leaflets
MEDDEV 2.5/2 PART 1-1999 GUIDELINES FOR REGULATORY AUDITING OF QUALITY SYSTEMS OF MEDICAL MANUFACTURERS PART 1: GENERAL REQUIREMENTS: 1998 (Rev. 2)

Professional Standard - Business, Medical Product Packaging Requirements

SB/T 229-2013 General specifications for food machinery.Technical requirements for product packing
SB/T 229-2007 General specification for food machinery- Technical requirments for product packing
SB 229-1985 General Technical Conditions of Food Machinery Product Packaging Technical Requirements

CEN - European Committee for Standardization, Medical Product Packaging Requirements

EN ISO 15378:2007 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2000@ with reference to Good Manufacturing Practice (GMP)
EN ISO 15378:2017 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015@ with reference to good manufacturing practice (GMP)
EN 868-5:2018 Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods

Guangxi Provincial Standard of the People's Republic of China, Medical Product Packaging Requirements

DB4502/T 0015-2022 Technical requirements for traceability of prepackaged Liuzhou snail powder products

Sichuan Provincial Standard of the People's Republic of China, Medical Product Packaging Requirements

DB51/T 1768.2-2018 General Technical Requirements for Textile Products for Public Use Part 2 For Non-medical Places

PL-PKN, Medical Product Packaging Requirements

PN-EN ISO 11607-1-2020-06 P Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
PN-EN ISO 11607-2-2020-06 P Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
PN O79701-1992 Glass consumer packages. Jars for food products. General requirements and methods of test

UNKNOWN, Medical Product Packaging Requirements

GB/T 18279.1-2015 Ethylene oxide for sterilization of healthcare products Part 1: Requirements for the development, validation and routine control of sterilization processes for medical devices

Professional Standard - Press and Publication, Medical Product Packaging Requirements

CY/T 256-2022 Production process control requirements for green printed food paper packaging printed matter

HU-MSZT, Medical Product Packaging Requirements

MSZ 10096-1962

Shandong Provincial Standard of the People's Republic of China, Medical Product Packaging Requirements

DB37/T 1862-2011 Technical requirements for environmentally friendly products in Shandong Province Natural color food packaging base paper

AT-ON, Medical Product Packaging Requirements

OENORM EN ISO 14160:2021 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr

CH-SNV, Medical Product Packaging Requirements

SN EN ISO 14160:2021 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr

IT-UNI, Medical Product Packaging Requirements

UNI EN ISO 14160:2021 Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization pr

Standard Association of Australia （SAA）, Medical Product Packaging Requirements

ISO 11607-1:2019/Amd 1:2023 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — AMENDMENT 1: Application of risk management
ISO 11607-2:2019/Amd 1:2023 Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes — AMENDMENT 1: Application of risk management

Anhui Provincial Standard of the People's Republic of China, Medical Product Packaging Requirements

DB34/T 2612-2016 Evaluation requirements for integrity measurement demonstration units of quantitative packaging commodity production enterprises

CENELEC - European Committee for Electrotechnical Standardization, Medical Product Packaging Requirements

EN 60601-2-17:1996/A1:1996 Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Remote-Controlled Automatically-Driven Gamma-Ray Afterloading Equipment