Class I medical device packaging

Class I medical device packaging, Total:330 items.

The international standard classification for "Class I medical device packaging" includes: Medical equipment in general , Medical equipment , Sterilization and disinfection , sterilized packaging , Packaging materials and accessories .

The Chinese standard classification for "Class I medical device packaging" includes: General and microsurgical devices , Medical apparatus and devices in general , Public medical equipment , Packaging material and container .

Group Standards of the People's Republic of China

T/ZGXX 0003-2019 Medical device cleaning agent
T/CAMDI 009.10-2024 Cleanliness of primary package for sterile medical device Part 10：Limits of contamination
T/SAMD 0005-2023 Technical Guidelines for Domestic Class I Medical Device Filing
T/CAMDI 009.10-2020 Cleanliness of primary package for sterile medical device - Part 10：limits of contamination
T/CAMDI 033-2020 Guide for biological evaluation of packaging materials for medical devices
T/SHBX 010-2023 Packaging Design Guidance for Robotically Assisted Surgical System
T/CAMDI 009.10-2023 Cleanliness of primary package for sterile medical device - Part 10：Limits of contamination
T/CAMDI 015-2018 Good Manufacturing Practice for Primary Packaging of Sterile 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/SHBX 005-2023 Sterilizable packaging films for medical devices
T/CAMDI 009-2018 Sterile Medical Device Package - Part 1： Test Methods for Particulate Matter

Professional Standard - Medicine

YY/T 0681.3-2010 Test methods for sterile medical device package—Part 3:Internal pressurization failure resistance of unrestrained packages
YY/T 1942-2024 Form and content of the unique device identifier
YY 91055-1999 Paint coating for medical devices. Classification and speciation
YY/T 1943-2024 UDI implementation and application in medical device package levels
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 0468-2015 Medical devices―Quality management―Medical device nomenclature data structure
YY/T 1879-2022 Creation and placement of unique device identifier
YY/T 0316-2016 Medical devices-Application of risk management to medical devices
YY/T 0316-2008 Medical devices - Application of risk management to medical devices
YY/T 91049-1999 Third class category expansion variety method for medical devices standard literature
YY/T 0316-2003 Medical devices -- Application of risk management to medical devices

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

GB/T 19633.1-2015 Packaging for terminally sterilized medical devices―Part 1:Requirements for materials, sterile barrier systems and packaging systems
GB/T 42062-2022 Medical devices—Application of risk management to medical devices
GB/Z 42217-2022 Medical device —Validation of software for medical device quality system
GB/T 19633-2005 Packaging for terminally sterilized medical devices
GB/T 19633.1-2024 Packaging for terminally sterilized medical devices—Part 1: Requirements for materials, sterile barrier systems and packaging systems

Professional Standard-Packaging

BB/T 0059-2012 Co-extrusion films for the vaccum thermoforming packaging of medical devices

Guangdong Provincial Standard of the People's Republic of China

DB4420/T 45-2024 Specifications for registration management of Class I medical device products
DB4403/T 277-2022 Medical device unique identification data interface specification
DB4403/T 218-2021 Implementation Specification for Unique Identification of Medical Devices

国家药监局

YY/T 0681.18-2020 Test methods for sterile medical device package—Part 18:Nondestructive detection of leaks in packages by vacuum decay method
YY/T 1630-2018 Fundamental requirements for unique device identifier
YY/T 1759-2020 Guide for design and evaluation of primary flexible packaging for medical devices
YY/T 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer
YY/T 0681.16-2019 Test methods for sterile medical device package—Part 16:Test for climatic stressing of packaging system
YY/T 1681-2019 Basic terms of unique device identification system

Professional Standard - Commodity Inspection

SN/T 3062.2-2011 Packing Materials for Terminally Sterilized Medical Devices for Import. Part 2: Paper Bags. Requirements and Test Methods
SN/T 3061-2011 Rules of the Inspection of Packaging for Import Terminally Sterilized Medical Devices

Beijing Provincial Standard of the People's Republic of China

DB11/T 1032-2013 Medical waste disposable packing box

未注明发布机构

CAN/CSA-ISO 17664:2018 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
DIN 96057 E:2022-08 Medical instruments - Raspatory type Sedillot
CAN/CSA-ISO/TS 16775:2017 Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
DIN 58852 E:2020-06 Medical instruments - Probes
DIN EN ISO 14971:2022 Medical devices – applying risk management to medical devices
DIN 13173 E:2016-07 Medical instruments - Dressing forceps
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 96056 E:2022-08 Medical instruments - Bone raspatory
ANSI/AAMI/ISO 14971:2019 Medical devices— Application of risk management to medical devices
DIN 96056:2016-03 Medical instruments - Bone raspatory
DIN 58852 E:2014-02 Medical instruments - Probes
DIN 96056:2023-03 Medical instruments - Bone raspatory
DIN 96056 E:2015-09 Medical instruments - Bone raspatory
ANSI/AAMI/ISO 11607-1:2019 Packaging for terminally sterilized medical devices— Part 1: Requirements for materials, sterile barrier systems and packaging systems
YY 91049-1999 Expanded classification method for three-level categories of medical device standard documents
DIN 13119 E:2008-09 Medical instruments bowel scissors
DIN 58279 E:2019-09 Medical instruments - First aid box scissors
DIN EN ISO 14971 E:2018-08 Application of medical device risk management in medical devices (draft)
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
ANSI/AAMI/ISO 15225:2016 Medical devices—Quality management—Medical device nomenclature data structure

国家食品药品监督管理局

YY/T 1474-2016 Medical devices－Application of risk management to medical devices

Shanghai Provincial Standard of the People's Republic of China

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

German Institute for Standardization

DIN 96042:2006 Medical instruments - Packaging - Technical specification
DIN 58279:2006 Medical instruments - First aid box scissors
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 58846:2017-11 Medical instruments - Raspatories
DIN 58794:1982 Medical instruments; ear forceps
DIN 58852:2008 Medical instruments - Probes
DIN 58857:2019-12 Medical instruments - Directors
DIN 96056:2009 Medical instruments - Bone raspatory
DIN 58794:2010 Medical instruments - Ear forceps
DIN 58852:2014 Medical instruments - Probes
DIN 13119:2010 Medical instruments - Bowel scissors
DIN 13117:1980 Medical instruments; bone shears
DIN 58852:2021 Medical instruments - Probes
DIN 13119:1980 Medical instruments; bowel scissors
DIN 13117:2013 Medical instruments.Bone shears
DIN 58852:1976 Medical instruments; probes
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 556-1:2023-02 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 556-2:2015-11 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 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 ISO 14971:2022-04 Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019 + A11:2021
DIN EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
DIN EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
DIN 58263:1973 Medical instruments; mouth gag Heister's
DIN 13111:2006 Medical instruments - Bandage scissors
DIN 13173:2023-03 Medical instruments - Dressing forceps
DIN 13103:1973 Medical instruments; dissecting scalpels
DIN 58862:2010 Medical instruments - Bone curettes
DIN 13145:2010 Medical instruments - Mallet of plastic material
DIN 58846:1988 Medical instruments; raspatories
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

Korean Agency for Technology and Standards (KATS)

KS T 5011-2020 Packaging—Complete, filled transport packages —Test methods for transport packaging of medical devices
KS P ISO 11607-2007 Packaging for terminally sterilized medical devices
KS P ISO 15223-2007(2012) Medical devices－Symbols to be used with medical device labels, labelling and information to be supplied
KS P ISO 11607:2007 Packaging for terminally sterilized medical devices
KS P ISO 11607:2002 Packaging for terminally sterilized medical devices
KS P ISO 14971:2021 Medical devices — Application of risk management to medical devices
KS P ISO 14971:2018 Medical devices — Application of risk management to medical devices
KS A 1231-1994 PACKAGING AND PACKING OF MEDICAL SUPPLIES
KS P ISO 15223-2019 Medical devices－Symbols to be used with medical device labels, labelling and information to be supplied
KS P ISO 15225-2023 Medical devices — Quality management — Medical device nomenclature data structure
KS P ISO 15225-2014(2019) Medical devices — Quality management — Medical device nomenclature data structure

SCC

AAMI/ISO 11607:2000 Packaging for terminally sterilized medical devices
AAMI 11607:1997 Packaging for terminally sterilized medical devices
MIL MIL-C-42068-1989 CHEST, MEDICAL INSTRUMENT AND SUPPLY SET
DIN 58312 E:2008 Draft Document - Medical instruments - Rib contractor
NS-EN 868-2:2009 Packaging for terminally sterilized medical devices — Part 2: Sterilization wrap — Requirements and test methods
DIN 58263 E:2008 Draft Document - Medical instruments - Mouth gag type Heister
UNE-EN 868-2:2009 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
NS-EN 868-2:2017 Packaging for terminally sterilized medical devices — Part 2: Sterilization wrap — Requirements and test methods
DANSK DS/EN 868-2:2017 Packaging for terminally sterilized medical devices – Part 2: Sterilization wrap – Requirements and test methods
NS-EN 868-1:1997 Packaging materials and systems for medical devices which are to be sterilized — Part 1: General requirements and test methods
BS 3970-4:1990 Sterilizing and disinfecting equipment for medical products-Specification for transportable steam sterilizers for unwrapped instruments and utensils
CAN/CSA-ISO 14971:2007(C2012) Medical devices - Application of risk management to medical devices
CEI UNI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
AAMI/ISO 14971:2019 Medical devices - Application of risk management to medical devices
CAN/CSA-ISO 14971:2007(R2012) Medical Devices - Application of Risk Management to Medical Devices
DANSK DS/EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
NS-EN 556:1994+A1:1998 Sterilization of medical devices — Requirements for terminally-sterilized medical devices to be labelled "Sterile" (including amendment A1:1998)
DANSK DS/ISO 14971:2020 Medical devices – Application of risk management to medical devices
CAN/CSA-ISO 14971:2001(R2006) Medical Devices - Application of Risk Management to Medical Devices
ISO 14971:2019 Plus Redline Medical devices - Application of risk management to medical devices
BS EN ISO 11607-1:2009+A1:2014 Packaging for terminally sterilized medical devices-Requirements for materials, sterile barrier systems and packaging systems
BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices
CAN/CSA-ISO 14971:2001(C2006) Medical devices - Application of risk management to medical devices
DANSK DS/EN ISO 15225:2016 Medical devices – Quality management – Medical device nomenclature data structure
AAMI/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
CEI UNI EN/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
AAMI/ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
CSA ISO/TS 16775:2023 Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
DIN 58858 E:2020 Draft Document - Medical instruments - Director type KÃ¶nig
CEI EN 62366:2008 Medical devices - Application of usability engineering to medical devices
AENOR UNE-EN 62366:2009 Medical devices - Application of usability engineering to medical devices
DANSK DS/ISO/TS 16775:2021 Packaging for terminally sterilized medical devices – Guidance on the application of ISO 11607-1 and ISO 11607-2
NS-EN 868-4:2009 Packaging for terminally sterilized medical devices — Part 4: Paper bags — Requirements and test methods
DANSK DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
AENOR UNE-EN 62366/A1:2009 Medical devices - Application of usability engineering to medical devices
CEI EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
DANSK DS/EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
CSA ISO 17664-2:2023 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
AAMI/ISO 17664-2:2022 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
BS EN ISO 11607-2:2006+A1:2014 Packaging for terminally sterilized medical devices-Validation requirements for forming, sealing and assembly processes
DIN 96056:2016 Medical instruments - Bone raspatory
DANSK DS/ISO 17664-2:2021 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
DIN 58857:2019 Medical instruments - Directors
BS PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems
NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements
SN-CR 14060:2000 Medical device traceability
CAN/CSA-ISO 17664-2-2023 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
AAMI/ISO 17664-1:2022 Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices—Part 1: Critical and semi-critical medical devices
UNE-EN 868-1:1997 PACKAGING MATERIALS AND SYSTEMS FOR MEDICAL DEVICES WHICH ARE TO BE STERILIZED. PART 1: GENERAL REQUIREMENTS AND TEST METHODS.
DANSK DS/CEN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices – Guidance on the application of ISO 11607-1 and ISO 11607-2
UNE-EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
BS PD CEN ISO/TS 16775:2021 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
AAMI/ISO TIR16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
DIN EN 868-2 E:2015 Draft Document - Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods; German and English version prEN 868-2:2015
DANSK DS/ISO 17664-1:2021 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices
NS-EN 868-6:1999 Packaging materials and systems for medical devices which are to be sterilized — Part 6: Paper for the manufacture of packs for medical use for sterilization by ethylene oxide or irradiation — Requirements and test methods
NS-EN ISO 14971:2019 Medical devices — Application of risk management to medical devices (ISO 14971:2019)
CAN/CSA Z314-2023 Canadian medical device reprocessing in all health care settings, Includes Update No. 1 (2024)
NS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
NS-EN 556:1994 Sterilization of medical devices — Requirements for medical devices to be labelled "Sterile"
AENOR 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
AENOR UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN ISO 14971:2001 Medical devices - Application of risk management to medical devices. (ISO 14971:2000)
UNE-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
DANSK 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
NS-EN 556-2:2015 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 2: Requirements for aseptically processed medical devices
DANSK DS/EN ISO 17664-2:2024 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)
NS-EN ISO 17664-2:2023 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)
NS-EN 556-1:2001 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1: Requirements for terminally sterilized medical devices
NS-EN 556-2:2003 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 2: Requirements for aseptically processed medical devices
AAMI/ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
DANSK DS/EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
DIN EN 556-2 E:2014 Draft Document - Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2: Requirements for aseptically processed medical devices; German version prEN 556-2:2014
NS-EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
DANSK DS/EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
DIN 58318:2019 Medical instruments - Elevators Langenbeck's

European Committee for Standardization (CEN)

EN ISO 14971:2019/A11:2021 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
EN ISO/TS 16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
EN 868-1:1997 Packaging Materials and Systems for Medical Devices Which Are to Be Sterilized - Part 1: General Requirements and Test Methods
EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
EN ISO 17664-1:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)

US-FCR

FCR 21 CFR PART 860-2015 MEDICAL DEVICE CLASSIFICATION PROCEDURES
FCR 21 CFR PART 860-2013 MEDICAL DEVICE CLASSIFICATION PROCEDURES

CZ-CSN

CSN 77 0126-1982 Packages for pharmaceutics General specifications
CSN 77 0125-1982 Packaging of pharmaceutics General specifications
CSN 85 0002-1983 Medical instruments. Marking, packaging, transport and storage

RO-ASRO

STAS 10719/1-1984 MEDICAL INSTRUMENTS Clasification and terminology
STAS 12902-1990 Human being medical instruments. Dental extracting forceps. General technical requirements for quality

GOST

GOST R 50444-2020 Medical instruments, apparatus and equipment. General technical requirements

American Society for Testing and Materials (ASTM)

ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM F1980-99e1 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
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

Standard Association of Australia （SAA）

AS ISO 14155.1:2004 Clinical investigations of medical devices for human subjects - General requirements
AS ISO 14971:2020 Medical devices — Application of risk management to medical devices

Danish Standards Foundation

Standardpakke Medicinsk udstyr 1-2009 Standards package - Medical devices - Basic standards
DS/EN ISO 14971:2013 Medical devices - Application of risk management to medical devices
DS/EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
DS/CEN/CR 14060:2001 Medical device traceability
DS/EN 868-2:2009 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
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 868-4:2009 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods

American National Standards Institute （ANSI)

AAMI TIR22:1998 Guidance for ANSI/AAMI/ISO 11607, Packaging for terminally sterilized medical devices, 1ed
ANSI/AAMI/ISO 17664-2:2022 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
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 17664-1:2022 Processing of health care products -Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices
ANSI/AAMI/IEC 62366/A1:2014 Medical devices - Application of usability engineering to medical devices - Amendment 1

Association Francaise de Normalisation

NF S90-751:1990 MEDICO-SURGICAL EQUIPMENT. INTRA-OCULAR LENSES. GENERAL REQUIREMENTS FOR STERILIZATION,PACKAGING AND LABELLING.
NF EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: sterilization envelope - Requirements and test methods
NF S99-211:2013 Medical devices - Application of risk management to medical devices
NF S99-211/A11*NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
NF EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
NF S98-116-2*NF ISO 17664-2:2021 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
NF S99-012:2010 Medical devices - Quality management - Medical device nomenclature data structure.
NF S98-051-2*NF EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2 : sterilization wrap - Requirements and test methods
XP CEN ISO/TS 16775:2021 Packaging for terminally sterilized medical devices - Guidelines for the application of ISO 11607-1 and ISO 11607-2
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
NF S99-401:1994 Dispositifs médicaux - Élastomère de silicone de qualité médicale
NF S98-136:2009 Sterilisation of medical devices - Risk management related to the preparation of sterile medical devices within health establishments.
NF X30-507:2018 Packaging for medical waste - Medical waste - Cardboard box with inner bag for infectious medical waste
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 EN 868-4:2017 Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 4 : sacs en papier - Exigences et méthodes d'essai

RU-GOST R

GOST 22972-1978 Medical packing cases. General technical requirements
GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
GOST R ISO 15225-2014 Medical devices. Quality management. Medical device nomenclature data structure

IX-EU/EC

MEDDEV 2.4/1 PART 2-2001 Guidelines for the Classification of Medical Devices Rev 8

GSO

BH GSO 2680:2022 Halal medical device – General requirements
GSO 2680:2021 Halal medical device – General requirements
BH GSO 2628:2022 Medical devices and supplies classification criteria
GSO 2628:2021 Medical devices and supplies classification criteria
BH GSO ASTM F2475:2023 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
GSO ASTM F2475:2022 Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
BH GSO ISO 14971:2017 Medical devices -- Application of risk management to medical devices
OS GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
BH GSO ISO 15225:2017 Medical devices -- Quality management -- Medical device nomenclature data structure
OS GSO IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
OS GSO ISO/TS 16775:2015 Packaging for terminally sterilized medical devices -- Guidance on the application of ISO 11607-1 and ISO 11607-2
GSO ISO 17664-2:2023 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
GSO ISO 15225:2016 Medical devices -- Quality management -- Medical device nomenclature data structure
BH GSO ISO 17664-2:2023 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
GSO IEC/TR 62354:2014 General testing procedures for medical electrical equipment
GSO ISO 15223-1:2020 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
OS GSO ISO 15223-1:2020 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
GSO ISO 11607-1:2021 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
BH GSO ISO 11607-1:2022 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems
GSO ISO/TR 19727:2021 Medical devices — Pump tube spallation test — General procedure
BH GSO ISO/TR 19727:2022 Medical devices — Pump tube spallation test — General procedure

KR-KS

KS P ISO 11607-2002 Packaging for terminally sterilized medical devices
KS P ISO 14971-2018 Medical devices — Application of risk management to medical devices
KS P ISO 14971-2021 Medical devices — Application of risk management to medical devices
KS P ISO 17664-2-2022 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
KS P ISO 17664-1-2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices

British Standards Institution (BSI)

BS EN 868-2:2017 Packaging for terminally sterilized medical devices. Sterilization wrap. Requirements and test methods
BS EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to medical devices
BS EN 62366-1:2015 Medical devices. Application of usability engineering to medical devices
BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
BS EN 868-4:2017 Packaging for terminally sterilized medical devices. Paper bags. Requirements and test methods
BS EN 868-4:2009 Packaging for terminally sterilized medical devices - Paper bags - Requirements and test methods
BS EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
BS EN ISO 11607-1:2020+A1:2023 Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems
BS PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering to medical devices
BS EN ISO 14971:2019+A11:2021 Medical devices - Application of risk management to medical devices
BS EN 1639:2004 Dentistry - Medical devices for dentistry - Instruments
BS EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
BS EN 556-1:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for terminally sterilized medical devices
BS EN 868-2:2009 Packaging for terminally sterilized medical devices - Sterilization wrap - Requirements and test methods
BS EN ISO 15225:2016 Medical devices. Quality management. Medical device nomenclature data structure
BS EN 556-2:2015 Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed medical devices
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 ISO 17664-2:2021 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Non-critical medical devices
PD CEN ISO/TS 16775:2021 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2
BS EN ISO 11607-2:2020+A1:2023 Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
24/30479649 DC BS EN 868-2 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
BS EN ISO 11607-2:2020+A11:2022 Packaging for terminally sterilized medical devices - Validation requirements for forming, sealing and assembly processes
BS EN 556-1:2001(2006) Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1 : Requirements for terminally sterilized medical devices
BS PD ISO/TR 19727:2017 Medical devices. Pump tube spallation test. General procedure

CEN - European Committee for Standardization

EN ISO 14971:2007 Medical devices - Application of risk management to medical devices
EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
EN ISO 14971:2000 Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

Japanese Industrial Standards Committee (JISC)

JIS T 14971:2003 Medical devices -- Application of risk management to medical devices
JIS T 14971:2012 Medical devices -- Application of risk management to medical devices

International Organization for Standardization (ISO)

ISO 14971:2019 Medical devices — Application of risk management to medical devices
ISO 14971:2000 Medical devices - Application of risk management to medical devices
ISO 15223-1:2021 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
ISO/TS 16775:2021 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
ISO/TS 16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
ISO/TR 19727:2017 Medical devices — Pump tube spallation test — General procedure

ZA-SANS

SANS 14971:2008 Medical devices - Application of risk management to medical devices
SANS 15223:2006 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied

TH-TISI

TIS 14971-2013 Medical devices.application of risk management to medical devices

International Electrotechnical Commission (IEC)

IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices

ES-UNE

UNE-EN ISO 14971:2020/A11:2022 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
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 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 ISO 17664-1:2022 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)

CENELEC - European Committee for Electrotechnical Standardization

EN 62366:2008 Medical devices - Application of usability engineering to medical devices

Canadian General Standards Board （CGSB)

CAN/CGSB-43.125-2016 Packaging of Category A and Category B infectious substances (Class 6.2) and clinical, (bio) medical or regulated medical waste

GOSTR

GOST R 58162-2018 Packaging for terminally sterilized medical devices. Guidance on the application of ISO 11607-1 and ISO 11607-2

US-AAMI

ANSI/AAMI/ISO TIR16775:2014 Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
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

DIN

DIN EN 868-2:1999 Packaging materials and systems for medical devices which are to be sterilized - Part 2: Sterilization wrap - Requirements and test methods
DIN EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

Lithuanian Standards Office

LST EN 868-2-2009 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
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 868-4-2009 Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
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

AENOR

UNE-EN 868-2:2017 Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
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

Canadian Standards Association (CSA)

CSA ISO 14971-07-CAN/CSA:2007 Medical Devices - Application of Risk Management to Medical Devices second edition
CSA Z314.23-2012 Sterilization by chemical agent of reusable medical devices in healthcare establishments (first edition)
CAN/CSA-ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices (Second Edition)