Technical requirements for non-medical device products

Technical requirements for non-medical device products, Total:331 items.

The international standard classification for "Technical requirements for non-medical device products" includes: Surgical instruments and materials , Sterilization and disinfection in general , Implants for surgery, prosthetics and orthotics , Sterilization and disinfection .

The Chinese standard classification for "Technical requirements for non-medical device products" includes: Medical apparatus and devices in general , Public medical equipment , General and microsurgical devices , Orthopedic devices , Extracorporeal circulation, artificial organ and prosthesis device , , Sanitation in general .

Professional Standard - Medicine

YY/T 0051-1991 Completeness of medical device drawings and their main design documents
YY/T 0468-2015 Medical devices―Quality management―Medical device nomenclature data structure
YY/T 1914-2023 Medical devices for human assisted reproductive technology―General requirements of apparatus products
YY/T 0615.2-2007 Requirements for medical devices to be designated“STERILE” - Part 2: Requirements for aseptically processed medical devices
YY/T 0048-1991 Basic requirements for working drawings of medical device products
YY/T 91050-1999 Editorial method for design documents of medical device product
YY/T 0615.1-2007 Requirements for medical devices to be designated STERILE - Part 1: Requirements for terminally sterilized medical devices
YY/T 0047-1991 Terminology of product drawings and design documents of medical devices
YY/T 0049-1991 Drawings and design document formats for medical devices

Henan Provincial Standard of the People's Republic of China

DB41/T 2656-2024 Product registration self-inspection system requirements for medical device manufacturers

国家食品药品监督管理局

YY/T 1570-2017 Tissue engineering medical device products—Terminology,classification and nomination of skin substitute
YY/T 1445-2016 Tissue engineering medical device products--Terminology
YY/T 0567.7-2016 Aseptic processing of health care products. Part 7: Alternative processes for medical devices and combination products
YY/T 1571-2017 Tissue engineering medical device products—Sodium hyaluronate

Group Standards of the People's Republic of China

T/SXS 128-2023 Medical device safety management requirements specification
T/DE 4-2021 Security technical requirements of medical blockchain
T/CASME 962-2023 Code of practice for the management of R&D and design of medical device products
T/GZBC 38-2020 Technical requirements for IoT of medical institution asset management
T/SAMD 0005-2023 Technical Guidelines for Domestic Class I Medical Device Filing
T/CCTAS 65-2023 Technical requirements on medical materials transportation using multi-rotor unmanned aircraft vehicle
T/CAMDI 039-2020 Special requirements for the production quality system of bioprinted medical devices

Sichuan Provincial Standard of the People's Republic of China

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

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
ANSI/AAMI/ISO 13485:2016(2019) Medical devices—Quality management systems— Requirements for regulatory purposes
YY 91050-1999 How to prepare medical device product design documents
ANSI/AAMI/ISO 14937:2009(2013) 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
DIN EN 13795 E:2013-04 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
DIN EN ISO 17664 E:2016-06 Disposal of Healthcare Products Information provided by medical device manufacturers for medical devices (draft)
DIN EN ISO 11135 E:2011-09 Requirements for the development, validation and routine control of ethylene oxide medical device sterilization processes for sterilization of healthcare products (draft)
DIN EN 556-2 E:2014-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
ANSI/AAMI/ISO 13408-7:2012(2018) Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
CAN/CSA-ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes
DIN EN ISO 17664-1 E:2021-02 Handling of Healthcare Products Information provided by medical device manufacturers for medical devices Part 1: Critical and semi-critical medical devices (draft)

国家质量监督检验检疫总局

SN/T 4445.2-2016 Technical requirements for the inspection of medical apparatus for import-Part 2: Patient monitor
SN/T 4508.2-2016 Technical requirements for the inspection of medical equipment on export - Part 2: Syringe for single use (with needles)
SN/T 4445.1-2016 Technical requirements for the inspection of medical apparatus for import-Part 1: Medical electrical equipment

Professional Standard - Agriculture

SN/T 4445.4-2023 Technical requirements for the inspection of medical equipment for importPart 4:Infusion pump
SN/T 4445.3-2018 Technical requirements for the inspection of imported medical devices Part3 : Anaesthetic equipment

海关总署

SN/T 5473.3-2022 Technical requirements for the inspection of export medical devices - Part 3: Infrared thermometer
SN/T 5473.1-2022 Technical requirements for the inspection of export medical devices - Part 1: Breathing machine
SN/T 5473.2-2022 Technical requirements for the inspection of export medical devices - Part 2: Patient monitor

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

GB 18279-2023 Sterilization of health-care products—Ethylene oxide—Requirements for the development,validation and routine control of a sterilization process for medical devices
GB 18278.1-2015 Sterilization of health care products―Moist heat―Part 1:Requirements for the development, validation and routine control of a sterilization process for medical devices
GB 27949-2011 General Requirements for Disinfectants for Medical Devices
GB/T 27949-2011 Hygienic requirements for medical items disinfection
GB 18279.1-2015 Sterilization of health care products―Ethylene oxide―Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices
GB 18280.1-2015 Sterilization of health care products―Radiation―Part 1:Requirements for development,validation and routine control of a sterilization process for medical devices

Inner Mongolia Provincial Standard of the People's Republic of China

DB15/T 2639-2022 Technical specifications for sampling of medical devices

国家市场监督管理总局、中国国家标准化管理委员会

GB 27949-2020 General requirements of disinfectant of medical instruments

Guangdong Provincial Standard of the People's Republic of China

DB4403/T 220-2021 Assignment Rules for Medical Device Product Identification
DB4420/T 45-2024 Specifications for registration management of Class I medical device products

国家药监局

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
YY/T 1654-2019 Tissue engineering medical device products—Alginate
YY/T 1464-2022 Sterilization of health care products-Low temperature steam and formaldehyde-Requirements for development,validation and routine control of a sterilization process for medical devices
YY/T 1630-2018 Fundamental requirements for unique device identifier
YY/T 1699-2020 Tissue engineering medical device products—Chitosan

Jiangsu Provincial Standard of the People's Republic of China

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

GOST

GOST R 55954-2018 Medical equipment. Lung ventilators. Technical requirements for governmental purchases
GOST R 50444-2020 Medical instruments, apparatus and equipment. General technical requirements
GOST ISO 14971-2021 Medical devices. Application of risk management to medical devices
GOST R 55953-2018 Medical equipment. Anesthetic and respiratory equipment. Technical requirements for governmental purchases
GOST R ISO 10993-13-2009 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST R 56312-2021 Medical electrical equipment. Digital fluorographs. Technical requirements for governmental purchases
GOST R 59767-2021 Medical devices. Risk management. Risk assessment in the desing and development of medical devices
GOST ISO 10993-23-2023 Medical devices. Biological evaluation of medical devices. Part 23. Irritant studies
GOST R ISO 10993-12-2009 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and control materials
GOST R ISO 10993-1-2009 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST ISO 10993-10-2023 Medical devices. Biological evaluation of medical devices. Part 10. Sensitization tests

American National Standards Institute （ANSI)

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
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
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

Association Francaise de Normalisation

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
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 Sterilization of healthcare products - Common requirements for sterilizers used for terminal sterilization of medical devices in healthcare settings
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 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 S98-107-2:2004 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2 : requirements for aseptically processed medical devices".
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 Sterilization of healthcare products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
NF EN ISO 11135:2014 Sterilization of healthcare products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices
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 S98-116-1*NF 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
NF S98-103-1*NF EN ISO 11137-1:2016 Sterilization of health care products - Radiation - Part 1 : requirements for development, validation and routine control of a sterilization process for medical devices
NF EN ISO 13408-7:2015 Aseptic processing of healthcare products - Part 7: alternative processes for medical devices and combination products
NF EN ISO 13485:2016 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 S99-101/A11*NF EN ISO 13485/A11:2021 Medical devices - Quality management systems - Requirements for regulatory purposes
NF EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
NF S90-445:1985 MEDICO-SURGICAL EQUIPMENT. IMPLANTS FOR SURGERY. ORTHOPAEDIC JOINT PROSTHESES. BASIC REQUIREMENTS.
NF EN ISO 13485/A11:2021 Medical devices - Quality management systems - Requirements for regulatory purposes
NF EN 15986:2011 Symbole à utiliser pour l'étiquetage des dispositifs médicaux - Exigences relatives à l'étiquetage des dispositifs médicaux contenant des phtalates

SCC

AENOR UNE-EN 556-1:2002 Sterilization of medical products. Requirements for medical devices to be designated "STERILE". Part 1: Requirements for sterilized medical devices in their terminal state.
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
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
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
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)
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)
DIN EN ISO 17664-2 E:2023 Draft Document - 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 176...
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
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
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
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
AAMI ST98:2022 Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
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
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 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
NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements
DIN EN 556-1 E:2023 Draft Document - 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
UNE-EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
UNE-EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed medical devices
NS-EN 556:1994 Sterilization of medical devices — Requirements for medical devices to be labelled "Sterile"
AAMI/ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.
NS-EN 1174-1:1996 Sterilization of medical devices — Estimation of the population of micro-organisms on product — Part 1: Requirements
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
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
AS/NZS 3551:1996 Technical management programs for medical devices
DANSK DS/EN ISO 17665:2024 Sterilization of health care products – Moist heat – Requirements for the development, validation and routine control of a sterilization process for medical devices
MIL MIL-C-42068-1989 CHEST, MEDICAL INSTRUMENT AND SUPPLY SET
CAN/CSA-ISO 17664-1-2023 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
BS EN ISO 17664:2017 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices
DANSK DS/EN ISO 17664:2017 Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017)
UNE-EN 1174-1:1996 STERILIZATION OF MEDICAL DEVICES. ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT. PART 1: REQUIREMENTS.
DANSK DS/ISO/TS 22421:2021 Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
DANSK DS/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)
NS-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)
AAMI/ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices
NS-EN ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017)
NS-EN ISO 17665:2024 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)
AAMI/ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
AENOR UNE-EN ISO 17664:2018 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017)
CEI UNI 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
BS PD ISO/TS 21560:2020 General requirements of tissue-engineered medical products
07/30164697 DC ISO 20857. Sterilization of health care products. Dry heat. Requirements for the development, validation and routine control of an industrial sterilization process for medical devices
MIL MIL-C-36020-1959 CASE, MEDICAL INSTRUMENT AND SUPPLY SET, NONRIGID, NO. 5, EMPTY
DIN EN ISO 17664 E:2016 Draft Document - Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO/DIS 17664:2016); German and English version prEN ISO 17664:2016
DIN EN ISO 20857 E:2012 Draft Document - 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); German version FprEN ISO 20857:2012
09/30205582 DC BS EN 15986. Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates
DANSK DS/EN ISO 13485:2016 Medical devices – Quality management systems – Requirements for regulatory purposes
CAN/CSA-ISO 13485:2003(R2013) Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes
DANSK DS/EN ISO 13485/AC:2018 Medical devices – Quality management systems – Requirements for regulatory purposes
AENOR UNE-EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing.
CAN/CSA-ISO 13485:2003(C2013) Medical devices - Quality management systems - Requirements for regulatory purposes
CEI UNI EN/ISO 13485:2017 Medical devices - Quality management systems - Requirements for regulatory purposes
MIL MIL-C-37183-1975 CASE, MEDICAL INSTRUMENT AND SUPPLY SET, NYLON, NON-RIGID, NO. 8
NS-EN 15986:2011 Symbol for use in the labelling of medical devices — Requirements for labelling of medical devices containing phthalates
CAN/CSA-Z11135-1-2009(R2014) Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
11/30244091 DC BS EN ISO 11135. Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
AAMI/ISO 14937:2000 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
DANSK DS/ISO 22441:2022 Sterilization of health care products – Low temperature vaporized hydrogen peroxide – Requirements for the development, validation and routine control of a sterilization process for medical devices
04/30048118 DC BS EN ISO 11135. Sterilization of health care products. Ethylene oxide. Requirements for development, validation and routine control of a sterilization process for medical devices
AAMI/ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
DANSK DS/EN ISO 11135-1:2007 Sterilization of health care products – Ethylene oxide – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
DIN EN ISO 17665 E:2022 Draft Document - Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 17665:2022); German and English version prEN ISO 17665:2022
DANSK DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
CEI UNI EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
AENOR UNE-EN 15986:2011 Symbol for use in the labeling of medical devices - Requirements for labeling of medical devices containing phthalates
NS-EN 556:1994+A1:1998 Sterilization of medical devices — Requirements for terminally-sterilized medical devices to be labelled "Sterile" (including amendment A1:1998)

GSO

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 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/TS 22421:2023 Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
BH GSO ISO/TS 22421:2023 Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
BH GSO 2680:2022 Halal medical device – General requirements
GSO 2680:2021 Halal medical device – General requirements
BH GSO ISO 11137-1:2015 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
OS GSO ISO 11137-1:2014 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
BH GSO ISO 13485:2017 Medical devices -- Quality management systems -- Requirements for regulatory purposes
GSO ISO 22441:2024 Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices
GSO ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes
BH GSO EN 13532:2022 General requirements for in vitro diagnostic medical devices for self-testing
GSO EN 13532:2021 General requirements for in vitro diagnostic medical devices for self-testing
OS GSO ISO 13485:2016 Medical devices -- Quality management systems -- Requirements for regulatory purposes

KR-KS

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
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 TS 21560-2021 General requirements of tissue-engineered medical products
KS P ISO 25424-2020 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices
KS P ISO 10993-13-2018 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices

British Standards Institution (BSI)

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 556-1:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for terminally sterilized medical devices
BS EN 556-2:2015 Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed 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
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
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
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
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
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 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 11137-1:2015 Sterilization of health care products. Radiation. Requirements for development, validation and routine control of a sterilization process for medical devices
19/30378069 DC BS ISO 17664-2. 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 556-2:2004 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE". Requirements for aseptically processed medical devices
BS EN ISO 11135:2014 Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices
BS EN 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
PD ISO/TS 21560:2020 General requirements of tissue-engineered medical products
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 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 14160:2011 Sterilization of health care products. Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives. Requirements for characterization, development, validation and routine control of a sterilization proc
24/30485888 DC BS EN ISO 11135 Sterilization of health care products - Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices

Danish Standards Foundation

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/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
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 556-1/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices
DS/EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices
DS/EN ISO 13485/AC:2012 Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1
DS/EN 556:1995 Sterilization of medical devices - Requirements for medical devices to be labelled "Sterile"
DS/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)
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
DS/EN ISO 11137-1/A1:2013 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
DS/EN ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
DS/EN 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

RU-GOST R

GOST R 57504-2017 Medical devices. Syringe pumps. Technical requirements for governmental purchases
GOST R 57765-2021 Prosthetic-orthopedic products. General technical requirements
GOST R 57765-2017 Medical equipment. Products prosthetic-orthopedic. General technical requirements
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 R 57500-2017 Medical devices. Implantable infusion pumps. Technical requirements for governmental purchases
GOST R 57505-2017 Medical devices. Cochlear implant system. Technical requirements for governmental purchases
GOST R 57492-2017 Medical devices. Implantable cardiac pacemakers. Technical requirements for governmental purchases
GOST R 57495-2017 Medical devices. Implantable neurostimulators. Technical requirements for governmental purchases
GOST 19126-2007 Medical metallic instruments. General specifications
GOST R 57497-2017 Medical devices. Implantable active devices intended to circulatory support. Technical requirements for governmental purchases
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 57506-2017 Medical devices. Implantable defibrillators and other active implantable medical devices intended to treat tachyarrhythmia. Technical requirements for governmental purchases
GOST R 15.013-2016 System of products development and launching into manufacture. Medical devices
GOST R 56316-2014 Medical electrical equipment. Medical electron accelerators. Technical requirements for governmental purchases
GOST R 57501-2017 Maintenance of medical devices. Requirements for governmental purchases
GOST ISO 11138-1-2012 Sterilization of health care products. Biological indicators. Part 1. Technical requirements
GOST R ISO 11138-1-2000 Sterilization of health care products. Biological indicators. Part 1. General requirements
GOST R 50325-2011 Medical products. Radiation sterilization. Dosimetric techniques
GOST R ISO 17665-1-2016 Sterilization of health care products. Moist heat. Part 1. Requirements for development, validation and routine control of a sterilization process for medical device
GOST R 57498-2017 Medical devices. X-Ray therapy apparatus with anode voltage from 10 to 300 kV. Technical requirements for governmental purchases
GOST R 56606-2015 Control technical condition and functioning of medical devices. The main provisions
GOST ISO 10993-13-2016 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST ISO 10993-13-2011 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST R 57502-2017 Medical equipment. Industrial production regulation
GOST 22972-1978 Medical packing cases. General technical requirements
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

PL-PKN

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

RO-ASRO

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

DIN

DIN 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); German version EN ISO 17664-2:2023
DIN EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

German Institute for Standardization

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 17664-2:2024-04 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 version EN ISO 17664-2:2023
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 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); German and English version prEN ISO 17664-2:2023
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 96042:2006 Medical instruments - Packaging - Technical specification
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 ISO 17664-1:2021-11 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); German version EN ISO 17664-1:2021
DIN EN ISO 17665:2024 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665:2024)
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 11137-1:2020-04 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd.1:2013 + Amd.2:2018); German version EN ISO 11137-1...
DIN EN 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 13795:2013 Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels; German version
DIN EN ISO 11135:2023-05 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135:2023); German and English version prEN ISO 11135:2023 / Note: Date o...
DIN EN ISO 11135:2024-04 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11135.2:2024); German and English version prEN ISO 11135:2024

ES-UNE

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 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)
UNE-EN ISO 11137-1:2015 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013)
UNE-EN 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)

US-FCR

FCR 21 CFR PART 821-2015 MEDICAL DEVICE TRACKING REQUIREMENTS

AENOR

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 ISO 20857:2013 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
UNE-EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

Lithuanian Standards Office

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 1495-1997 Organization and quality. Control cleanroom technology for medical products. General requirements
LST EN 15986-2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

European Committee for Standardization (CEN)

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)
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 1174-1:1996 Sterilization of Medical Devices - Estimation of the Population of Micro- Organisms on Product - Part 1: Requirements
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)
prEN 556-1991 Sterilization of medical devices; sterility assurance level for medical devices labelled "Sterile"; requirements
prEN 46002-1991 Particular requirements for the application of EN 29002 for medical devices
prEN 46001-1992 Quality systems; medical devices; particular requirements for the application of EN 29001
EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
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 ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (Incorporating corrigendum July 2012)
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 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices

CEN - European Committee for Standardization

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"

CZ-CSN

CSN 85 6101 Z1-1997 Syringes for medical use . Technical requirements. Testing.
CSN 36 4721-1983 X-ray primary collimators of medical apparatus Basic sizes Technical requirements
CSN 85 5202-1982 Resistance fo medical products to clima- ?ic effects. General technical require- ments
CSN 85 5926-1984 Medical instruments. Surgical needles. Technical requirements and test methods

International Organization for Standardization (ISO)

ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
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 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/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 14937:2000/Cor 1:2003 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices; Technical Corrigendum 1
ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 14971:2000/Amd 1:2003 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements
ISO 13485:2003/Cor 1:2009 Medical devices - Quality management systems - Requirements for regulatory purposes; Technical Corrigendum 1

Korean Agency for Technology and Standards (KATS)

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
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 TS 21560:2021 General requirements of tissue-engineered medical products
KS P ISO 13485-2023 Medical devices — Quality management systems — Requirements for regulatory purposes
KS P ISO 14937-2023 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
KS P ISO 10993-13:2018 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
KS P ISO 25424:2020 Sterilization of health care products — Low temperature steam and formaldehyde — Requirements for development, validation and routine control of a sterilization process for medical devices

AT-ON

OENORM 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/FDIS 17664-1:2021)

CH-SNV

SN 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)

Japanese Industrial Standards Committee (JISC)

JIS T 0806-1:2022 Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices

VN-TCVN

TCVN 7393-1-2009 Sterilization of health care products.Radiation.Part 1: Requirements for developement, validation and routine control of a sterilization process for medical devices.
TCVN 5766-1993 Medical scalpels and knives.General technincal requirements and test methods

GOSTR

GOST R 58551-2019 Disposable medical devices from nonwovens materials. Surgery disposable clothes from nonwovens materials. Technical requirements for governmental purchases
GOST R EN 13532-2010 General requirements for in vitro diagnostic medical devices for self-testing

TH-TISI

TIS 2395.13-2008 Biological evaluation of medical devices.part 13: identification and quantification of degradation products from polymeric medical devices

Others: Technical requirements for non-medical device products,Technical requirements for medical device products,Technical requirements for medical device products,Technical Requirements for Class II Medical Devices,Technical requirements for Class III medical device products,Technical requirements for medical device inspection products