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Where are the second class medical devices used?

Where are the second class medical devices used?, Total:204 items.

In the international standard classification, Where are the second class medical devices used? involves: Medical equipment, Graphical symbols, Pharmaceutics, Sterilization and disinfection, Laboratory medicine, Quality, Kitchen equipment, Vocabularies, Applications of information technology, Microbiology, Hospital equipment, Products of non-ferrous metals, Packaging materials and accessories, Dentistry.

未注明发布机构, Where are the second class medical devices used?

DIN EN ISO 14971:2022 Medical devices – applying risk management to medical devices
DIN EN 980:2003 Graphic symbols for labeling medical devices
DIN EN 980:2001 Graphic symbols for labeling medical devices
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 3970-4:1990(1999) Sterilizing and disinfecting equipment for medical products — Part 4 : Specification for transportable steam sterilizers for unwrapped instruments and utensils
DIN EN 20594-1 Ber-1:1996 Tapered connections with a 6% (Luer) taper for syringes, cannulas and certain other medical devices – Part 1: General requirements (ISO 594-1: 1986)

Canadian Standards Association (CSA), Where are the second class medical devices used?

CAN/CSA-ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices (Second Edition)
CSA ISO/TR 24971:2021 Medical devices - Guidance on the application of ISO 14971 (Adopted ISO/TR 24971:2020, second edition, 2020-06)
CSA PLUS 14971-2007 The ISO 14971:2007 essentials — A practical handbook for implementing the ISO 14971 Standard for medical devices (Second Edition)
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 15225-CAN/CSA:2001 Nomenclature - Specification for a Nomenclature System for Medical Devices for the Purpose of Regulatory Data Exchange ISO 15225:2000

Shanghai Provincial Standard of the People's Republic of China, Where are the second class medical devices used?

DB31/T 1378-2022 Service Specifications for Class II Medical Device Registration

Danish Standards Foundation, Where are the second class medical devices used?

DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
DS/EN 540:1993 Clinical investigation of medical devices for human subjects
DS/EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
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/CEN/CR 13217:1998 Nomenclature system for medical devices for the purpose of regulatory data exchange - Rationale
DS/EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

Lithuanian Standards Office , Where are the second class medical devices used?

LST EN 15986-2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
LST EN 980-2008 Symbols for use in the labelling of medical devices
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 9626:2001/A1:2002 Stainless steel needle tubing for the manufacture of medical devices (ISO 9626:1991/AM 1:2001)
LST L ENV 13004-2002 Nomenclature system for medical devices for the purposes of regulatory data exchange - Recommendations for an interim system and rules for a future system

AENOR, Where are the second class medical devices used?

UNE-EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
UNE-EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing.
UNE-EN 14254:2004 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
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 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 13975:2003 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects
UNE-ENV 13004:2000 Nomenclature system for medical devices for the purposes of regulatory data exchange - Recommendations for an interim system and rules for a future system
UNE-EN ISO 18113-5:2012 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)
UNE-EN ISO 19001:2013 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013)

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Where are the second class medical devices used?

GB/Z 42217-2022 Medical device —Validation of software for medical device quality system
GB/T 42061-2022 Medical devices—Quality management systems—Requirements for regulatory purposes
GB 18282.5-2015 Chemical Indicators for Sterilization of Healthcare Products Part 5: Class II Indicators for Class BD Air Exclusion Tests
GB 18282.3-2009 Sterilization of health care products-Chemical indicators-Part3：Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
GB 18282.4-2009 Sterilization of health care products-Chemical indicators-Part 4:Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration

Association Francaise de Normalisation, Where are the second class medical devices used?

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 S99-015*NF EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates.
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 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 45502-2-1:2004 Dispositifs médicaux implantables actifs - Partie 2-1 : règles particulières pour les dispositifs médicaux implantables actifs destinés à traiter la bradyarythmie (stimulateurs cardiaques)
NF EN ISO 6717:2021 Dispositifs médicaux de diagnostic in vitro - Récipients à usage unique pour le prélèvement d'échantillons d'origine humaine autres que le sang
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 EN 13975:2003 Procédures d'échantillonnage utilisées pour l'acceptation des essais des dispositifs médicaux de diagnostic in vitro - Aspects statistiques
AFNOR SPEC S93-250:2022 Néonatalogie - Exigences relatives aux dispositifs médicaux destinés à l'administration de l'alimentation et des médicaments par voie entérale
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 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 S92-036*NF EN ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood
NF EN ISO 18113-5:2012 Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 5 : instruments de diagnostic in vitro pour auto-tests
NF S94-179*NF ISO 15309:2014 Implants for surgery - Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices
NF EN ISO 18113-4:2012 Dispositifs médicaux de diagnostic in vitro - Informations fournies par le fabricant (étiquetage) - Partie 4 : réactifs de diagnostic in vitro pour auto-tests
NF ISO 15309:2014 Implants chirurgicaux - Calorimétrie par balayage différentiel des polyéthercétones, polymères et composés pour l'utilisation dans les dispositifs médicaux implantables

Professional Standard - Medicine, Where are the second class medical devices used?

YY 0466-2003 Medical devices-Symbols to be used with medical device labels,labelling and information to be supplied
YY/T 1406.1-2016 Medical device software.Part 1:Guidance on the application of ISO 14971 to medical device software
YY/T 1406.1-2016/IEC/TR 80002-1 Medical Device Software Part 1: Guidelines for YY/T 0316 Applied to Medical Device Software
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 1914-2023 General requirements for medical devices and appliances used in human assisted reproductive technology
YY/T 1263-2015 Evaluation of materials of medical device subject to dry heat sterilization
YY/T 1264-2015 Evaluation of materials of medical device subject to ozone sterilization
YY/T 1265-2015 Evaluation of materials of medical device subject to moist heat sterilization
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 0995-2015 Medical devices for human assisted reproductive technology.Terminology and definitions
YY/T 0926-2014 Quantitative analysis of DEHP in PVC medical devices
YY/T 0466.2-2015 Medical devices.Symbols to be used with medical device labels, labelling,and information to be supplied.Part 2:Symbol development,selection and validation
YY/T 1769-2022 Medical devices for human assisted reproductive technology Artificial insemination catheters
YY/T 1266-2015 Evaluation of materials of medical device subject to hydrogen peroxide sterilization
YY/T 1267-2015 Evaluation of materials of medical device subject to ethylene oxide sterilization
YY/T 1912-2023 Biological evaluation and testing of medical devices for soft tissue regeneration
YY/T 1434-2016 Medical devices for human in vitro assisted reproductive technology.In vitro mouse embryo assay
YY/T 0468-2003 Nomenclature-Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange
YY/T 1852-2022 Determination of ammonium ions in the culture solution of medical devices for human assisted reproductive technology
YY/T 0466.1-2023 Symbols for medical devices used for information provided by manufacturers Part 1: General requirements
YY/T 0268-2001 Dentistry----Preclinical evaluation of biocompatibility of medical devices used in dentistry----Part 1:Evaluation and test methods selection

ZA-SANS, Where are the second class medical devices used?

SANS 1593:1994 Disinfectants based on glutaraldehyde for use on medical instruments

VN-TCVN, Where are the second class medical devices used?

TCVN 6916-2001 Medical devices.Symbols to be used with medical device labels, labelling and information to be supplied
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 7740-1-2007 Clinical investigation of medical devices for human subjects.Part 1: General requirements
TCVN 7740-2-2007 Clinical investigation of medical devices for human subjects.Part 2: Clinical investigation plans

International Organization for Standardization (ISO), Where are the second class medical devices used?

ISO 15223:2000 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied
ISO 17664-2:2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
ISO 15223:2000/Amd 2:2004 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied; Amendment 2
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 15223-1:2007/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 15223-2:2010 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
ISO 14155:2011 Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 15225:2000 Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange
ISO 14155:2011/cor 1:2011 Clinical investigation of medical devices for human subjects - Good clinical practice; Technical Corrigendum 1
ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood
ISO 15225:2000/Amd 1:2004 Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange; Amendment 1
ISO/TS 17665-3:2013 Sterilization of health care products - Moist heat - Part 3: Guidance on the designation of a medical device to a product family and processing category for steam sterilization
ISO 15309:2013 Implants for surgery.Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices

Japanese Industrial Standards Committee (JISC), Where are the second class medical devices used?

JIS T 0307:2004 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied

European Committee for Standardization (CEN), Where are the second class medical devices used?

CEN EN 980-2008 Symbols for use in the labelling of medical devices
EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
EN 980:2003 Graphical Symbols for Use in the Labelling of Medical Devices
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 980:1996/PRA2:1996 Graphical Symbols for Use in the Labelling of Medical Devices Amendment PRA2
CEN EN 13532-2002 General Requirements for in Vitro Diagnostic Medical Devices for Self-Testing
EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
EN ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
EN 980:1996/A1:1996 AMD A1 Graphical Symbols for Use in the Labelling of Medical Devices Includes Amendment A1:1999
EN ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)
EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
EN 12442-1:2000 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices - Part 1: Analysis and Management of Risk
EN 928:1995 In Vitro Diagnostic Systems - Guidance on the Application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for in Vitro Diagnostic Medical Devices
EN 12442-2:2000 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices - Part 2: Controls on Sourcing, Collection and Handling
EN ISO 7405:1997 Dentistry - Preclinical Evaluation of Biocompatibility of Medical Devices Used in Dentistry - Test Methods for Dental Materials ISO 7405: 1997
prEN ISO 18113-5:2021 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/DIS 18113-5:2021)
FprEN ISO 18113-5 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO/FDIS 18113-5:2022)
EN ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels@ labelling and information to be supplied - Part 1: General requirements
EN ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes Incorporating corrigendum June 2007 [Superseded: CEN EN 46003, CEN EN ISO 13488]

British Standards Institution (BSI), Where are the second class medical devices used?

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
BS ISO 15223-2:2010 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Symbol development, selection and validation
BS EN ISO 14155:2020 Clinical investigation of medical devices for human subjects. Good clinical practice
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)
PD 6630:1998 Nomenclature system for medical devices for the purpose of regulatory data exchange. Rationale
BS EN ISO 14708-5:2022 Implants for surgery. Active implantable medical devices - Circulatory support devices
BS EN ISO 9626:2016 Tracked Changes. Stainless steel needle tubing for the manufacture of medical devices. Requirements and test methods
18/30343606 DC BS EN ISO 14708-6. Implants for surgery. Active implantable medical devices. Part 6. Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
PD ISO/TS 17665-3:2013 Sterilization of health care products. Moist heat. Guidance on the designation of a medical device to a product family and processing category for steam sterilization
BS ISO 15309:2013 Implants for surgery. Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices
BS EN ISO 14708-7:2022 Implants for surgery. Active implantable medical devices - Particular requirements for cochlear and auditory brainstem implant systems
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 ISO 6717:2021 Tracked Changes. In vitro diagnostic medical devices. Single-use containers for the collection of specimens from humans other than blood

US-CFR-file, Where are the second class medical devices used?

CFR 21-803.21-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.21:Where can I find the reporting codes for adverse events that I use with medical device reports?
CFR 21-803.33-2013 Food and Drugs. Part803:Medical device reporting; (Eff. Until 8-14-15). Section803.33:If I am a user facility, what must I include when I submit an annual report?
CFR 21-803.32-2013 Food and Drugs. Part803:Medical device reporting; (Eff. Until 8-14-15). Section803.32:If I am a user facility, what information must I submit in my individual adverse event reports?
CFR 21-803.11-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.11:What form should I use to submit reports of individual adverse events and where do I obtain these forms?
CFR 21-803.10-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.10:Generally, what are the reporting requirements that apply to me??

CEN - European Committee for Standardization, Where are the second class medical devices used?

EN 980:1996 Graphical Symbols for Use in the Labelling of Medical Devices
EN ISO 15225:2000 Nomenclature - Specification for a Nomenclature System for Medical Devices for the Purpose of Regulatory Data Exchange

Korean Agency for Technology and Standards (KATS), Where are the second class medical devices used?

KS P 4906-2006(2016) Stainless steel needle tubing for manufacture of medical devices
KS P ISO 7405:2020 Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
KS P ISO 9626:2020 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
KS X IEC TR 80001-2-3-2015(2020) Application of risk management for IT-networks incorporating medical devices — Part 2-3: Guidance for wireless networks
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 11135:2018 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

German Institute for Standardization, Where are the second class medical devices used?

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 17664-2:2023-09 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices (ISO 17664-2:2021); German and English version prEN ISO 17664-2:2023 / Note:...
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 15225:2005 Nomenclature - Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange (ISO 15225:2000 + Amd 1:2004); German version EN ISO 15225:2000 + A1:2004 + A2:2005
DIN EN ISO 15223-1:2013 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012); German version EN ISO 15223-1:2012, with CD-ROM
DIN 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); German version EN ISO 15223-1:2012, with CD-ROM
DIN EN 13975:2003-11 Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspects; German version EN 13975:2003, German and English texts
DIN 58849-2:2023-03 Medical instruments - Scalpel handles for detachable blades - Part 2: Handles
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 ISO 15223-1:2017 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03); German version EN ISO 15223-1:2016, with CD-ROM
DIN EN ISO 6717:2020 In vitro diagnostic medical devices - Single-use containers for the collection of specimens, other than blood, from humans (ISO/DIS 6717:2020); German and English version prEN ISO 6717:2020
DIN EN ISO 6717:2021-12 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021); German version EN ISO 6717:2021
DIN EN ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021); German version EN ISO 6717:2021
DIN EN ISO 19001:2013-07 In vitro diagnostic medical devices - Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology (ISO 19001:2013); German version EN ISO 19001:2013 / Note: DIN EN 12376 (1999-04) remains valid alongside this stan...
DIN ISO 15309:2021-12 Implants for surgery - Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices (ISO 15309:2013)

RU-GOST R, Where are the second class medical devices used?

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 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 15223-2-2013 Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Part 2. Symbol development, selection and validation
GOST R ISO 14155-2014 Clinical investigation. Good clinical practice
GOST R 59745-2021 Active implantable medical devices. Axial pumps for auxiliary blood circulation. General technical requirements
GOST ISO 11737-2-2011 Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the validation of a sterilization process
GOST R ISO 11737-2-2003 Sterilization of medical devices. Microbiological methods. Part 2. Tests of sterility performed in the validation of a sterilization process

GOSTR, Where are the second class medical devices used?

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 EN 14254-2010 In vitro diagnostic medical devices. Single-use receptacles for the collection of specimens, other than blood, from humans

Standard Association of Australia （SAA）, Where are the second class medical devices used?

AS ISO 14155.1:2004 Clinical investigations of medical devices for human subjects - General requirements

IT-UNI, Where are the second class medical devices used?

UNI ISO 18250-6:2021 Medical devices -- Connectors for reservoir delivery systems for healthcare applications - Part 6: Neural applications

IX-EU/EC, Where are the second class medical devices used?

MEDDEV 2.1/6-2012 GUIDELINES ON THE QUALIFICATION AND CLASSIFICATION OF STAND ALONE SOFTWARE USED IN HEALTHCARE WITHIN THE REGULATORY FRAMEWORK OF MEDICAL DEVICES
MEDDEV 2.1/3-2009 GUIDELINES RELATING TO THE APPLICATION OF: THE COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES (Rev 3)
MEDDEV 2.2/3-1998 GUIDELINES RELATING TO THE APPLICATION OF: THE COUNCIL DIRECTIVE 90/385 EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES "USE-BY DATE" (Rev. 3)
NO 722/2012-2012 COMMISSION REGULATION concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal o

Group Standards of the People's Republic of China, Where are the second class medical devices used?

T/CAS 404-2020 Household and similar disinfecting tableware cabinets that reach the level for disinfecting medical items
T/CSBM 0029-2022 Standard guide for in vivo assessment of implantable devices intended to repair or regenerate articular cartilage

American National Standards Institute （ANSI), Where are the second class medical devices used?

ANSI/AAMI/ISO 15223-2:2010 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 2: Symbol development, selection and validation

KR-KS, Where are the second class medical devices used?

KS P ISO 7405-2020 Dentistry — Evaluation of biocompatibility of medical devices used in dentistry
KS P ISO 9626-2020 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
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 11135-2018 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

ES-UNE, Where are the second class medical devices used?

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 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 ISO 6717:2022 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)

国家药监局, Where are the second class medical devices used?

YY/T 1718-2020 Medical device embryo transfer catheter for human in vitro assisted reproductive technology
YY/T 1695-2020 Method for detection of amino acids in culture fluids for medical devices used in human assisted reproductive technology
YY/T 1688-2021 Blastocyst cell staining and counting methods for medical devices used in human assisted reproductive technology
YY/T 1698-2020 Medical device for human in vitro assisted reproductive technology, assisted reproductive puncture and egg retrieval needle

American Society for Testing and Materials (ASTM), Where are the second class medical devices used?

ASTM F3487-20 Standard Guide for Assessing the Service Life of a Brush Part Intended to Clean a Medical Device
ASTM F3293-18 Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices
ASTM F2819-10(2015)e2 Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices
ASTM F3276-19 Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device
ASTM F3276-22 Standard Guide for Using a Force Tester to Evaluate the Performance of a Brush Part Designed to Clean the External Surface of a Medical Device
ASTM F2503-13 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
ASTM F3275-22 Standard Guide for Using a Force Tester to Evaluate Performance of a Brush Part Designed to Clean the Internal Channel of a Medical Device
ASTM F2633-19 Standard Specification for Wrought Seamless Nickel-Titanium Shape Memory Alloy Tube for Medical Devices and Surgical Implants

EU/EC - European Union/Commission Legislative Documents, Where are the second class medical devices used?

NO 207/2012-2012 COMMISSION REGULATION on electronic instructions for use of medical devices (Text with EEA relevance)
MEDDEV 2.13-1998 Commission communication on the application of transitional provision of Directive 93/42/EEC relating to medical devices (REV 1; (98/C 242/05))

UNKNOWN, Where are the second class medical devices used?

GB/T 18282.5-2015 Chemical Indicators for Sterilization of Healthcare Products Part 5: Class II Indicators for Class BD Air Exclusion Tests

国家食品药品监督管理局, Where are the second class medical devices used?

YY/T 1535-2017 Biological evaluation of medical devices for human in vitro assisted reproductive technology and human sperm survival test

CH-SNV, Where are the second class medical devices used?

SN EN ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)

AT-ON, Where are the second class medical devices used?

ONORM S 5225-1994 Radiation protection Containers, tables and safes for use in nuclear medicine - Requirements and Classification - Marking of conformity
ONORM S 5224-1997 Installations for nuclear medicine - Rules for construction and equipment

NZ-SNZ, Where are the second class medical devices used?

AS/NZS 4261:1994 Reusable Containers for the Collection of Sharp Items Used in Human and Animal Medical Applications (Amendment 1 December 1997)
AS/NZS 4478:1997 Guide to the Reprocessing of Reusable Containers for the Collection of Sharp Items Used in Human and Animal Clinical/Medical Applications