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Primary packaging requirements for medical devices

Primary packaging requirements for medical devices, Total:500 items.

In the international standard classification, Primary packaging requirements for medical devices involves: Medical equipment, Sterilization and disinfection, Medical sciences and health care facilities in general, Packaging and distribution of goods in general, Cases. Boxes. Crates, Packaging materials and accessories, Sacks. Bags, Character sets and information coding, Graphical symbols, Pharmaceutics, Company organization and management, Wastes, Quality, Applications of information technology, Laboratory medicine, Hospital equipment, Sociology. Demography, First aid, Microbiology, Dentistry, Aircraft and space vehicles in general, Standardization. General rules.

国家药监局, Primary packaging requirements for medical devices

YY/T 1759-2020 Medical device soft primary packaging design and evaluation guide
YY/T 1630-2018 Basic requirements for unique identification of medical devices
YY/T 0698.2-2022 Packaging materials for terminally sterilized medical devices Part 2: Requirements and test methods for sterilization packaging materials
YY/T 0681.16-2019 Sterile medical device packaging test methods Part 16: Packaging system climate adaptability test
YY/T 1754.1-2020 Preclinical Animal Studies for Medical Devices Part 1: General Requirements
YY/T 0681.18-2020 Test methods for sterile medical device packaging - Part 18: Non-destructive testing of packaging leakage using vacuum attenuation method
YY/T 0681.1-2018 Sterile Medical Device Packaging Test Methods Part 1: Guidelines for Accelerated Aging Tests
YY/T 1833.2-2022 Artificial Intelligence Medical Device Quality Requirements and Evaluation Part 2: General Requirements for Data Sets
YY/T 1833.1-2022 Artificial Intelligence Medical Device Quality Requirements and Evaluation Part 1: Terminology
YY/T 0681.4-2021 Test methods for sterile medical device packaging Part 4: Determination of seal leakage of breathable packaging by dye solution penetration method
YY/T 0681.15-2019 Test methods for sterile medical device packaging - Part 15: Performance testing of transport containers and systems
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

Group Standards of the People's Republic of China, Primary packaging requirements for medical devices

T/CAMDI 015-2018 Good Manufacturing Practice for Primary Packaging of Sterile Medical Devices
T/CAMDI 009.10-2020 Cleanliness of primary package for sterile medical device - Part 10：limits of contamination
T/CAMDI 009.10-2023 Cleanliness of primary package for sterile medical device - Part 10：Limits of contamination
T/CAMDI 009-2018 Sterile Medical Device Package - Part 1： Test Methods for Particulate Matter
T/SHBX 005-2023 Sterilizable packaging films for medical devices
T/CAMDI 009.3-2023 Cleanliness of primary package for sterile medical device – Part 3：Test methods for estimating the total number of microorganisms
T/CAMDI 009.1-2020 Cleanliness of primary package for sterile medical device - Part 1：Test methods for particulate contamination - Gas elution method
T/CAMDI 009.2-2020 Cleanliness of Primary Packaging of Sterile Medical Devices Part 2: Particle Contamination Test Method Liquid Elution Method
T/CAMDI 033-2020 Guide for biological evaluation of packaging materials for medical devices
T/CAMDI 058-2020 Packaging for terminally sterilized medical devices—Guidance on the application of GB/T 19633.1 and GB/T 19633.2
T/CAMDI 039-2020 Special requirements for the production quality system of bioprinted medical devices
T/CAMDI 026-2019 Group standard for special requirements for customized medical device quality system
T/CAMDI 062-2021 Special requirements for 3D modeling software for additive manufacturing of personalized medical devices

German Institute for Standardization, Primary packaging requirements for medical devices

DIN 96042:2006 Medical instruments - Packaging - Technical specification
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 556-1:2002-03 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001 / Note: To be replaced by DIN EN 556-1 (2023-02).
DIN EN 556-1 Berichtigung 1:2006-12 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001, Corrigenda to DIN EN 556-1:2002-03; German version EN 556-1...
DIN EN 556-2:2023-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: requirements for aseptically processed medical devices; German and English version prEN 556-2:2023 / Note: Date of issue 2023-01-06*Intended as r...
DIN EN 556-2:2015-11 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2015 / Note: To be replaced by DIN EN 556-2 (2023-02).
DIN EN 556-1:2023-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German and English version prEN 556-1:2023 / Note: Date of issue 2023-01-06*Intended as r...
DIN EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2003
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 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2015
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 13532:2002-08 General requirements for in vitro diagnostic medical devices for self-testing; German version EN 13532:2002, German and English texts
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 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 15986:2011-05 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version EN 15986:2011, with CD-ROM
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 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 ISO 13485/A1:2019 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German and English version EN ISO 13485:2016/prA1:2019
DIN EN ISO 13485:2021-12 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016); German version EN ISO 13485:2016 + AC:2018 + A11:2021
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 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 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 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 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 868-4:2009 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 10993-2:2023-02 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022); German version EN ISO 10993-2:2022
DIN EN ISO 9626:2016-12 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016); German version EN ISO 9626:2016
DIN EN ISO 15223-1/A1:2019 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016); German and English version EN ISO 15223-1:2016/prA1:2019
DIN EN 868-3:2017-05 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; German version EN ...
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 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version EN 15986:2011, with CD-ROM
DIN EN ISO 15223-1:2020 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO/DIS 15223-1:2020); German and English version prEN ISO 15223-1:2020
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 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 868-8:2019 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
DIN EN 868-8:2019-03 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods; German version EN 868-8:2018
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 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 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

CZ-CSN, Primary packaging requirements for medical devices

CSN 36 4721-1983 X-ray primary collimators of medical apparatus Basic sizes Technical requirements

US-FCR, Primary packaging requirements for medical devices

FCR 21 CFR PART 821-2015 MEDICAL DEVICE TRACKING REQUIREMENTS
FCR 21 CFR PART 808-2015 EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS
FCR 21 CFR PART 808-2014 EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS
FCR 21 CFR PART 808-2013 EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS
FCR 40 CFR PART 157-2014 PACKAGING REQUIREMENTS FOR PESTICIDES AND DEVICES
FCR 40 CFR PART 157-2015 PACKAGING REQUIREMENTS FOR PESTICIDES AND DEVICES
FCR 40 CFR PART 157-2013 PACKAGING REQUIREMENTS FOR PESTICIDES AND DEVICES

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Primary packaging requirements for medical devices

GB/T 19633-2005 Packaging for terminally sterilized medical devices
GB/T 27949-2011 Hygienic requirements for medical items disinfection
GB 27949-2011 General Requirements for Disinfectants for Medical Devices
GB/T 19633.1-2015 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems
GB/T 19633.2-2015 Packaging for terminally sterilized medical devices.Part 2:Validation requirements for forming, sealing and assembly processes
GB/T 42061-2022 Medical devices—Quality management systems—Requirements for regulatory purposes
GB/T 16886.2-2000 Biological evaluation of medical devices--Part 2: Animal welfare requirements
GB/T 16886.2-2011 Biological evaluation of medical devices.Part 2: Animal welfare requirements
GB 18279-2023 Development, validation and routine control requirements for ethylene oxide medical device sterilization processes for healthcare product sterilization

Korean Agency for Technology and Standards (KATS), Primary packaging requirements for medical devices

KS T 5011-2020 Packaging—Complete, filled transport packages —Test methods for transport packaging of medical devices
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 11607-2:2021 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 11607-1:2018 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
KS P ISO 15223-1:2019 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
KS P ISO 13485:2018 Medical devices — Quality management systems — Requirements for regulatory purposes
KS P ISO 13485:2007 Medical devices－Quality management systems－Requirements for regulatory purposes
KS P ISO 13488:2002 Quality systems－Medical devices－Particular requirements for the application of ISO 9002
KS P ISO 14155-1-2007(2012) Clinical investigation of medical devices for human subjects－Part 1：General requirements
KS P ISO 10993-2-2010(2021) Biological evaluation of medical devices－Part 2：Animal welfare requirements
KS P ISO 10993-2-2010(2016) Biological evaluation of medical devices－Part 2：Animal welfare requirements
KS P ISO 10993-2:2010 Biological evaluation of medical devices-Part 2:Animal welfare requirements
KS P ISO 9626:2020 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods

Association Francaise de Normalisation, Primary packaging requirements for medical devices

NF EN 868-2:2017 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2 : enveloppe de stérilisation - Exigences et méthodes d'essai
NF EN 556-1:2002 Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage STERILE - Partie 1 : exigences relatives aux dispositifs médicaux stérilisés au stade terminal
NF S98-107-2*NF EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2 : requirements for aseptically processed medical devices
NF EN 556-2:2015 Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage "STÉRILE" - Partie 2 : exigences pour les dispositifs médicaux soumis à un traitement aseptique
NF S98-107-1*NF EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 1 : requirements for terminally sterilized medical devices
NF S98-051-2*NF EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2 : sterilization wrap - Requirements and test methods
NF S98-107-2:2004 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2 : requirements for aseptically processed medical devices".
NF EN 868-4:2017 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 4 : sacs en papier - Exigences et méthodes d'essai
NF S98-051-4*NF EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4 : paper bags - Requirements and test methods
NF S98-052-1*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 S99-015*NF EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates.
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 S90-751:1990 MEDICO-SURGICAL EQUIPMENT. INTRA-OCULAR LENSES. GENERAL REQUIREMENTS FOR STERILIZATION,PACKAGING AND LABELLING.
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 X30-511:2015 Packaging for medical care waste - Additional and/or alternative characteristics and requirements for sharps containers
NF S90-445:1985 MEDICO-SURGICAL EQUIPMENT. IMPLANTS FOR SURGERY. ORTHOPAEDIC JOINT PROSTHESES. BASIC REQUIREMENTS.
NF S99-101/A11*NF EN ISO 13485/A11:2021 Medical devices - Quality management systems - Requirements for regulatory purposes
NF S99-101*NF EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
NF EN ISO 13485:2016 Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires
NF EN ISO 13485/A11:2021 Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires
NF EN 13532:2002 Exigences générales relatives aux dispositifs médicaux de diagnostic in vitro pour auto-test
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 EN 15986:2011 Symbole à utiliser pour l'étiquetage des dispositifs médicaux - Exigences relatives à l'étiquetage des dispositifs médicaux contenant des phtalates
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
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
FD S99-212*FD CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485:2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
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 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 50637:2017 Appareils électromédicaux - Exigences particulières de sécurité de base et de performances essentielles des lits médicaux pour enfants
NF S99-014-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1 : general requirements.
NF EN 45502-2-2:2008 Dispositifs médicaux implantables actifs - Partie 2-2 : exigences particulières pour les dispositifs médicaux implantables actifs destinés au traitement des tachyarythmies (y compris les défibrillateurs implantables)
NF S99-101:2012 Medical devices - Quality management systems - Requirements for regulatory purposes
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 S98-052-1:2009 Packaging for terminally sterilized medical devices - Part 1 : requirements for materials, sterile barrier systems and packaging systems.
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
XP S98-167*XP CEN ISO/TS 16775:2021 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
XP CEN ISO/TS 16775:2021 Emballages des dispositifs médicaux stérilisés au stade terminal - Lignes directrices relatives à l'application de l'ISO 11607-1 et l'ISO 11607-2
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 S98-051-4:2009 Packaging for terminally sterilized medical devices - Part 4 : paper bags - Requirements and test methods.
NF S93-004*NF EN ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
NF S98-051:1997 Packaging materials and systems for medical devices which are to be sterilized. Part 1 : general requirements and test methods.
NF EN ISO 14708-6:2022 Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 6 : Exigences particulières pour les dispositifs médicaux implantables actifs conçus pour traiter la tachyarythmie (y compris les défibrillateurs implantables)
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 868-3:2017 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 3 : papier utilisé dans la fabrication des sacs en papier (spécifiés dans l'EN 868-4) et dans la fabrication de sachets et gaines (spécifiés dans l'EN 868-5) - Exigence...
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 S98-051-2:2009 Packaging materials for terminally sterilized medical devices - Part 2 : sterilization wrap - Requirements and test methods.
NF EN ISO 10993-2:2022 Évaluation biologique des dispositifs médicaux - Partie 2 : Exigences relatives à la protection des animaux
NF S98-051-8*NF EN 868-8:2018 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 868-8:2018 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 8 : conteneurs réutilisables de stérilisation pour stérilisateurs à la vapeur d'eau conformes à l'EN 285 - Exigences et méthodes d'essai
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 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
FD CEN/TR 17223:2018 Document d'orientation sur la relation entre l'EN ISO 13485:2016 (Dispositifs médicaux - Systèmes de management de la qualité - Exigences à des fins réglementaires) et le Règlement européen relatif aux dispositifs médicaux ainsi que le Règle...

British Standards Institution (BSI), Primary packaging requirements for medical devices

BS EN 868-4:2009 Packaging for terminally sterilized medical devices - Paper bags - Requirements and test methods
BS EN 868-2:2009 Packaging for terminally sterilized medical devices - Sterilization wrap - Requirements and test methods
BS EN 556-2:2015 Tracked Changes. Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed medical devices
BS EN ISO 11607-2:2020+A11:2022 Packaging for terminally sterilized medical devices - Validation requirements for forming, sealing and assembly processes
BS EN 868-2:2017 Tracked Changes. Packaging for terminally sterilized medical devices. Sterilization wrap. Requirements and test methods
23/30457240 DC BS EN 556-2. Sterilization of medical devices. Requirements for medical devices to be designated ''STERILE" - Part 2. requirements for aseptically processed medical devices
23/30457243 DC BS EN 556-1. Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Part 1. Requirements for terminally sterilized medical devices
BS EN 868-4:2017 Tracked Changes. Packaging for terminally sterilized medical devices. Paper bags. Requirements and test methods
BS EN 556-2:2004 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices
BS EN 868-9:2009 Packaging for terminally sterilized medical devices - Uncoated nonwoven materials of polyolefines - 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 ISO 15223-1:2017 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
BS EN ISO 15223-1:2012 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
22/30422020 DC BS ISO 11607-2:2019/AMD1. Packaging for terminally sterilized medical devices - Validation requirements for forming, sealing and assembly processes
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 ISO 10993-2:2006 Biological evaluation of medical devices - Animal welfare requirements
BS EN ISO 10993-2:2022 Biological evaluation of medical devices - Animal welfare requirements
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
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 13795-3:2006+A1:2009 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment — Part 3: Performance requirements and performance levels
BS EN ISO 14708-6:2022 Implants for surgery. Active implantable medical devices - Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
BS PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices. General requirements
PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices. General requirements
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 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 868-6:2017 Tracked Changes. Packaging for terminally sterilized medical devices. Paper for low temperature sterilization processes. Requirements and test methods
BS PD CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
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 EN 868-8:2009 Packaging for terminally sterilized medical devices - Re-usable sterilization containers for steam sterilizers conforming to EN 285: Requirements and test methods
BS EN 868-8:2018 Tracked Changes. Packaging for terminally sterilized medical devices. Re-usable sterilization containers for steam sterilizers conforming to EN 285. Requirements and test methods
BS EN 868-10:2018 Tracked Changes. Packaging for terminally sterilized medical devices. Adhesive coated nonwoven materials of polyolefines. Requirements and test methods
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 868-7:2017 Tracked Changes. Packaging for terminally sterilized medical devices. Adhesive coated paper for low temperature sterilization processes. Requirements and test methods
PD CEN ISO/TS 16775:2021 Tracked Changes. Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
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

Lithuanian Standards Office , Primary packaging requirements for medical devices

LST EN 556-1-2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
LST EN 556-2-2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
LST EN 556-1-2002/AC-2006 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
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 EN 15986-2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
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 868-6-2009 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
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 868-7-2009 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
LST EN 868-9-2009 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
LST EN 45502-2-1-2004 Active implantable medical devices -- Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
LST EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
LST EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)
LST EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003+Cor.1:2009)
LST EN 868-10-2009 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
LST EN 868-8-2009 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods

AENOR, Primary packaging requirements for medical devices

UNE-EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
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 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
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 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
UNE-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)
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 868-7:2017 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
UNE-EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing.
UNE-EN 868-9:2009 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
UNE-EN 45502-2-1:2005 Active implantable medical devices -- Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
UNE-EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)
UNE-EN 868-10:2009 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
UNE-EN 868-8:2009 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods
UNE-EN ISO 9626:2017 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)
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)

未注明发布机构, Primary packaging requirements for medical devices

BS EN 556-1:2001(2006) Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1 : Requirements for terminally sterilized medical devices
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
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 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)
BS EN 45502-2-2:2008(2009) Active implantable medical devices — Part 2 - 2 : Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
BS EN ISO 13488:2001 Quality systems - Medical devices - Particular requirements for the application
DIN EN ISO 13485:2003 Medical devices quality management systems requirements for regulatory purposes
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
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
YY 0288-1996 Quality system. Medical devices. GB/T 19002—Special requirements for ISO 9002 applications

ES-UNE, Primary packaging requirements for medical devices

UNE-EN 556-1:2002/AC:2007 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
UNE-EN 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
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 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 13485:2018/A11:2022 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
UNE-EN ISO 13485:2018 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016). (Consolidated version)
UNE-EN 45502-2-2:2008 CORR:2009 Active implantable medical devices -- Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
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 ISO 14708-6:2023 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)
UNE-EN 868-9:2019 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
UNE-CEN ISO/TS 16775:2021 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 (ISO/TS 16775:2021) (Endorsed by Asociación Española de Normalización in January of 2022.)

European Committee for Standardization (CEN), Primary packaging requirements for medical devices

EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
EN 556-2:2003 Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2: Requirements for aseptically processed medical devices
EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
EN 868-4:2017 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
prEN 556-1991 Sterilization of medical devices; sterility assurance level for medical devices labelled "Sterile"; requirements
EN ISO 13485:2016/A11:2021 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
EN 556:1998 Sterilization of Medical Devices - Requirements for Terminally - Sterilized Medical Devices to Be Labelled "Sterile" Ratified European Text; Includes Amendment 1: 1994
prEN 46001-1992 Quality systems; medical devices; particular requirements for the application of EN 29001
prEN 46002-1991 Particular requirements for the application of EN 29002 for medical devices
EN ISO 13485:2016/AC:2018 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
EN ISO 13485:2000 Quality Systems - Medical Devices - Particular Requirements for the Application of EN ISO 9001 Revision of EN 46001:1996; Identical to ISO 13485:1996
EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (Incorporating corrigendum July 2012)
EN 868-1:1997 Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 1: General Requirements and Test Methods
EN ISO 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
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 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
EN 868-4:1999 Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 4: Paper Bags - Requirements and Test Methods
EN ISO 25424:2019/prA1:2021 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 1 (ISO 25424:2018/DAM 1:2021)
EN ISO 25424:2019/A1:2022 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 1 (ISO 25424:2018/Amd 1:2022)
CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
EN 868-6:2017 Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
EN ISO 15223-1:2021 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (Remains Current)
EN ISO 13488:2000 Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002 Revision of EN 46002: 1996; Identical to ISO 13488: 1996; Superseded by EN ISO 13485:2003
EN 46001:1993 Quality Systems - Medical Devices - Particular Requirements for the Application of EN 29001
EN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
EN ISO 25424:2019 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018)
EN 868-4:2009 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
EN 46002:1996 Quality Systems - Medical Devices - Particular Requirements for the Application of EN ISO 9002
EN 46003:1999 Quality Systems - Medical Devices - Particular Requirements for the Application of EN ISO 9003
CEN EN 13532-2002 General Requirements for in Vitro Diagnostic Medical Devices for Self-Testing
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 868-7:2017 Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
EN 868-2:2009 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
EN ISO 10993-2:1998 Biological Evaluation of Medical Devices - Part 2: Animal Welfare Requirements ISO 10993-2:1992
EN ISO 10993-2:2022 Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2022)
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 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 13718-1:2008 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
EN 868-9:2009 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - 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 ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
EN 1174-1:1996 Sterilization of Medical Devices - Estimation of the Population of Micro- Organisms on Product - Part 1: Requirements

CEN - European Committee for Standardization, Primary packaging requirements for medical devices

EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
EN 556-2:2015 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices"
PD CEN/TR 17223:2018 Guidance on the relationship between EN ISO 13485: 2016 (Medical devices - Quality management systems - Requirements for regulatory purposes) and European Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
EN 15424:2007 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development@ validation and routine control of a sterilization process for medical devices
EN 46002:1993 Quality Systems - Medical Devices - Particular Requirements for the Application of EN 29002
EN 46001:1996 Quality Systems - Medical Devices - Particular Requirements for the Application of EN ISO 9001

RU-GOST R, Primary packaging requirements for medical devices

GOST EN 556-1-2011 Sterilization of medical devices. Requirements for medical devices to be designated «sterile». Part 1. Requirements for terminally sterilized medical devices
GOST 22972-1978 Medical packing cases. General technical requirements
GOST R 57501-2017 Maintenance of medical devices. Requirements for governmental purchases
GOST R 57504-2017 Medical devices. Syringe pumps. Technical requirements for governmental purchases
GOST R ISO 20857-2016 Sterilization of medical devices. Dry heat. Requirements for development, validation and routine control of a sterilization process for medical devices
GOST R ISO 15223-1-2014 Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Part 1. General requirements
GOST ISO 13485-2017 Medical devices. Quality management systems. Requirements for regulatory purposes
GOST R 57506-2017 Medical devices. Implantable defibrillators and other active implantable medical devices intended to treat tachyarrhythmia. Technical requirements for governmental purchases
GOST R ISO 25424-2013 Sterilization of medical devices. Low temperature steam and formaldehyde. Requirements for development, validation and routine control of a sterilization process for medical devices
GOST R 57497-2017 Medical devices. Implantable active devices intended to circulatory support. Technical requirements for governmental purchases
GOST R 57495-2017 Medical devices. Implantable neurostimulators. Technical requirements for governmental purchases
GOST R 57492-2017 Medical devices. Implantable cardiac pacemakers. Technical requirements for governmental purchases
GOST R 57505-2017 Medical devices. Cochlear implant system. Technical requirements for governmental purchases
GOST R 57500-2017 Medical devices. Implantable infusion pumps. Technical requirements for governmental purchases
GOST R 57305-2016 Health informatics. Requirements for international machine-readable coding of medicinal product package identifiers
GOST ISO 13485-2011 Medical devices. Quality management systems. System requirements for regulatory purposes
GOST R EN 13718-1-2015 Medical vehicles and their equipment. Air Ambulances. Part 1. Requirements for medical devices used in air ambulances
GOST R 52770-2016 Medical devices. Safety requirements. Methods of sanitation-chemical and toxicological tests
GOST R 57493-2017 Medical devices. Protective garments for radiology department stuff. Technical requirements for governmental purchases
GOST R 57503-2017 Medical devices. Protective garments for radiology department patients. Technical requirements for governmental purchases
GOST R 57451-2017 Medical devices. Quality Management System. Requirements for competence and maintaining competence for audit organizations that audit medical device manufacturers for regulatory purposes
GOST R IEC 62359-2011 Medical equipment. General requirements for methods of determination of mechanical and thermal fields safe indices for medical ultrasonic diagnostic equipment

Danish Standards Foundation, Primary packaging requirements for medical devices

DS/EN 556-1/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices
DS/EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices
DS/EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices
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 556:1995 Sterilization of medical devices - Requirements for medical devices to be labelled "Sterile"
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 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
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 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
DS/EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes
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 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 25424:2011 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
DS/EN 46002:1993 Quality systems. Medical devices. Particular requirements for the application of EN 29002
DS/EN 46001:1993 Quality systems. Medical devices. Particular requirements for the application of EN 29001
DS/EN ISO 13485:2021 Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016)
DS/EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
DS/EN 868-9:2009 Packaging for terminally sterilized medical devices - Part 9: Uncoated nonwoven materials of polyolefines - Requirements and test methods
DS/EN 45502-2-1:2004 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (Cardiac pacemakers)
DS/EN ISO 13485/AC:2012 Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1
DS/ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices – Part 1: General requirements
DS/EN 868-10:2009 Packaging for terminally sterilized medical devices - Part 10: Adhesive coated nonwoven materials of polyolefines - Requirements and test methods
DS/EN 868-8:2009 Packaging for terminally sterilized medical devices - Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285 - Requirements and test methods

Professional Standard-Packaging, Primary packaging requirements for medical devices

BB/T 0059-2012 Co-extruded film for medical device blister packaging

Professional Standard - Medicine, Primary packaging requirements for medical devices

YY/T 0615.1-2007 Requirements for medical devices to be designated“STERILE”.part 1:Requirements for terminally sterilized medical devices
YY/T 0615.2-2007 Requirements for medical devices to be dwsignated“SIERILE”.Part 2:Requirements for aseptically processed medical devices
YY/T 0698.4-2009 Packaging materials for terminally sterilized medical devices - Part 4: Requirements and test methods for paper bags
YY/T 0698.2-2009 Packaging materials for terminal sterilized medical devices.Part 2:Sterilization wrap.Requirements and test methods
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 0681.11-2014 Test methods for sterile medical device package.Part 11:Determining integrity of seals for medical packaging by visual inspection
YY/T 0048-1991 Basic requirements for working drawings of medical device products
YY/T 0466.1-2009 Medical devices.Symbols to be used with medical device labels,labelling and information to be supplied.Part 1:General requirements
YY/T 0466.1-2016 Medical devices.Symbols to be used with medical device labels,labelling and information to be supplied.Part 1:General requirements
YY/T 1441-2016 General requirements of performance evaluation of in vitro diagnostic medical devices
YY 91056-1999 Evaluating requirements for corrosion test of electroplated metallic coatings of medical instruments
YY/T 0681.3-2010 Test methods for sterile medical device package.Part 3:Internal pressurization failure resistance of unrestrained packages
YY/T 1454-2016 General requirements for in vitro diagnostic medical devices for self-testing
YY/T 0287-2017 Medical devices.Quality management systems.Requirements for regulatory purposes
YY/T 0287-2003 Medical devices-Quality management systems-Requirements for regulatory purposes
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
YY/T 0681.10-2011 Test methods for sterile medical device package.Part 10:Test for microbial barrier ranking of porous package material
YY/T 1914-2023 General requirements for medical devices and appliances used in human assisted reproductive technology
YY/T 0288-1996 Quality system.Medical devices.Particular requirements for the application of GB/T 19002.ISO 9002
YY/T 1433-2016 Test method of hot seal strength(hot tack)of flexible webs of medical devices
YY/T 0681.1-2009 Test methods for sterile medical device package.Part 1:Test guide for accelerated aging
YY/T 0681.8-2011 Test methods for sterile medical device package.Part 8:Coating/adhesive weight determination
YY/T 0681.12-2014 Test methods for sterile medical device package.Part 12:Flex durability of flexible barrier films
YY/T 0681.4-2010 Test methods for sterile medical device package.Part 4 :Detecting seal leaks in porous packages by dye penetration
YY/T 0681.6-2011 Test methods of sterile medical device package.Part 6:Evaluation of chemical resistance of printed inks and coatings on flexible packaging materials
YY/T 0681.9-2011 Test methods for sterile medical device package.Part 9:Burst testing of flexible package seals using internal air pressurization weight restraining plates
YY/T 1833.3-2022 Artificial Intelligence Medical Device Quality Requirements and Evaluation Part 3: General Requirements for Data Labeling
YY/T 0681.12-2022 Test methods for sterile medical device packaging-part 12: rubbing resistance of soft barrier materials
YY/T 1473-2016 Guide to the development and inclusion of safety aspects in Standards for medical devices
YY/T 1276-2016 Requirements for the development, validation and routine control of dry heat sterilization process for medical devices
YY 1276-2016 Requirements for development, validation and routine control of dry heat sterilization process for medical devices

Professional Standard - Commodity Inspection, Primary packaging requirements for medical devices

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 3061-2011 Operational Procedures for Sterilization Packaging Inspection of Imported Medical Devices
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

PL-PKN, Primary packaging requirements for medical devices

PN Z54058-1990 Medical instruments Needle holders Re?uirements and tests
PN Z54032-1989 Medical instruments Haemostatic forceps Re?uirements and tests
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 Z58022-1973 Medical instruments ynaecological curettes echnical requirements and tests
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 Z54094-1972 Medical and surgical instruments Forceps Technical requirements and tes?s

国家市场监督管理总局、中国国家标准化管理委员会, Primary packaging requirements for medical devices

GB 27949-2020 General requirements of disinfectant of medical instruments

VN-TCVN, Primary packaging requirements for medical devices

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 6916-1-2008 Medical devices.Symbols to be used with medical device labels, labelling and information to be supplied.Part 1: General requirements
TCVN 7391-2-2005 Biological evaluation of medical devices.Part 2: Animal welfare requirements
TCVN 7740-1-2007 Clinical investigation of medical devices for human subjects.Part 1: General requirements

GOSTR, Primary packaging requirements for medical devices

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 R EN 13532-2010 General requirements for in vitro diagnostic medical devices for self-testing
GOST R ISO 15223-1-2020 Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Part 1. General requirements
GOST R 58162-2018 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
GOST R ISO 10993-2-2009 Standardization in the Russian Federation. Medical devices. Biological evaluation of medical devices. Part 2. Animal welfare requirements

American National Standards Institute （ANSI), Primary packaging requirements 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 11607-2:2006 Packaging for terminally sterilized medical devices - Part 2: Validation and requirements for forming, sealing and assembly processes
AAMI/ISO TIR16775:2023 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
ANSI/AAMI/ISO 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare 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

KR-KS, Primary packaging requirements for medical devices

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 11607-2-2021 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 11607-1-2018 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
KS P ISO 15223-1-2019 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
KS P ISO 13485-2018 Medical devices — Quality management systems — Requirements for regulatory purposes
KS P ISO 13488-2002 Quality systems－Medical devices－Particular requirements for the application of ISO 9002
KS P ISO 9626-2020 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods

International Organization for Standardization (ISO), Primary packaging requirements for medical devices

ISO 14971:2000/Amd 1:2003 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements
ISO 14971:2019 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements
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 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 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
ISO 15223-1:2007 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
ISO 15223-1:2021 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 13485:1996 Quality systems - Medical devices - Particular requirements for the application of ISO 9001
ISO 13488:1996 Quality systems - Medical devices - Particular requirements for the application of ISO 9002
ISO 15223-1:2007/Amd 1:2008 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements; Amendment 1
ISO 25424:2018 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 25424:2009 Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 14708-6:2019 Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillato
ISO/TS 16791:2020 Health informatics — Requirements for international machine-readable coding of medicinal product package identifiers
ISO/TS 16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
ISO/TS 16775:2021 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
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 10993-2:2006 Biological evaluation of medical devices - Part 2: Animal welfare requirements
ISO 10993-2:1992 Biological evaluation of medical devices; part 2: animal welfare requirements
ISO 10993-2:2022 Biological evaluation of medical devices — Part 2: Animal welfare requirements
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 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices — Part 1: General requirements
ISO 18250-1:2018 Medical devices — Connectors for reservoir delivery systems for healthcare applications — Part 1: General requirements and common test methods
ISO 21474-1:2020 In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation
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

American Society for Testing and Materials (ASTM), Primary packaging requirements for medical devices

ASTM F1980-99e1 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
ASTM F2475-20 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
ASTM F2761-09 Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model
ASTM F2761-09(2013) Medical Devices and Medical Systems - Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) - Part 1: General requirements and conceptual model

Jiangsu Provincial Standard of the People's Republic of China, Primary packaging requirements for medical devices

DB32/T 3769-2020 Basic requirements for medical device network information security

RO-ASRO, Primary packaging requirements for medical devices

STAS 12916-1991 Human use medical instruments. Retractors. General technical requirements for quality
STAS 12670-1988 Medical instruments SURGICAL SCISSORS General technical requirements for quality
STAS 12902-1990 Human being medical instruments. Dental extracting forceps. General technical requirements for quality

国家食品药品监督管理局, Primary packaging requirements for medical devices

YY 0989.6-2016 Surgical implants Active implantable medical devices Part 6: Specific requirements for active implantable medical devices (including implantable defibrillators) for the treatment of tachyarrhythmias
YY/T 1613-2018 Characteristics and control requirements of medical device irradiation sterilization process
YY/T 0681.14-2018 Test methods for sterile medical device packaging Part 14: Wet and dry microbial barrier tests on breathable packaging materials

Shanxi Provincial Standard of the People's Republic of China, Primary packaging requirements for medical devices

DB14/T 2253-2020 Basic requirements for entrusted storage and distribution services of medical devices

Standard Association of Australia （SAA）, Primary packaging requirements for medical devices

AS ISO 14155.1:2004 Clinical investigations of medical devices for human subjects - General requirements
AS ISO 13485:2017 Medical devices — Quality management systems — Requirements for regulatory processes
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

U.S. Environmental Protection Agency (U.S. EPA), Primary packaging requirements for medical devices

EPA 40 CFR PART 157-2010 PACKAGING REQUIREMENTS FOR PESTICIDES AND DEVICES

GB-REG, Primary packaging requirements for medical devices

REG 40 CFR PART 157-2011 PACKAGING REQUIREMENTS FOR PESTICIDES AND DEVICES

TH-TISI, Primary packaging requirements for medical devices

TIS 13485-2004 Medical devices.quality management systems.requirements for regulatory purposes
TIS 2395.2-2008 Biological evaluation of medical devices.part 2: animal welfare requirements

Canadian Standards Association (CSA), Primary packaging requirements for medical devices

CAN/CSA-ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes (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-10993.2-97-CAN/CSA:1997 Evaluation Biologique Des Dispositifs Medicaux - Partie 2: Exigences Concernant La Protection Des Animaux
CSA ISO 13485-03-CAN/CSA:2003 Dispositifs m閐icaux ?Syst鑝es de management de la qualit??Exigences ?des fins r間lementaires Deuxi鑝e Edition

Japanese Industrial Standards Committee (JISC), Primary packaging requirements for medical devices

JIS Q 13485:2005 Medical devices -- Quality management systems -- Requirements for regulatory purposes

ZA-SANS, Primary packaging requirements for medical devices

SANS 13485:2004 Medical devices - Quality management systems - Requirements for regulatory purposes
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

Tianjin Provincial Standard of the People's Republic of China, Primary packaging requirements for medical devices

DB12/T 1016-2020 General requirements for design and implementation of medical device traceability system

US-AAMI, Primary packaging requirements for medical devices

ANSI/AAMI/ISO 15223-1:2012 Medical devices.Symbols to be used with medical device labels, labeling, and information to be supplied.Part 1: General requirements
ANSI/AAMI/ISO TIR16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2

国家质量监督检验检疫总局, Primary packaging requirements for medical devices

SN/T 4445.1-2016 Technical requirements for inspection of imported medical devices Part 1: Medical electrical equipment
SN/T 4445.2-2016 Technical requirements for inspection of imported medical devices Part 2: Patient monitors
SN/T 4508.2-2016 Technical requirements for export medical device inspection Part 2: Disposable syringes (with needle)

American Society of Quality Control （ASQC), Primary packaging requirements for medical devices

ASQ FDA WRLDWID QUAL SYS REQMT-2008 The FDA and Worldwide Quality System Requirements Guidebook for Medical Devices (Second Edition)

海关总署, Primary packaging requirements for medical devices

SN/T 5473.1-2022 Technical Requirements for Inspection of Export Medical Devices Part 1: Ventilators
SN/T 5473.2-2022 Technical requirements for inspection of exported medical devices Part 2: Patient monitors
SN/T 5473.3-2022 Technical Requirements for Inspection of Export Medical Devices Part 3: Infrared Thermometer

Professional Standard - Agriculture, Primary packaging requirements for medical devices

SN/T 4445.4-2023
SN/T 4445.3-2018 Technical Requirements for Inspection of Imported Medical Devices Part 3: Anesthesia Equipment

PH-BPS, Primary packaging requirements for medical devices

PNS ISO 10993-2:2021 Biological evaluation of medical devices - Part 2: Animal welfare requirements

IT-UNI, Primary packaging requirements for medical devices

UNI ISO 18250-1:2021 Medical devices -- Connectors for reservoir delivery systems for healthcare applications - Part 1: General requirements and common test methods