Class II medical device products

Class II medical device products, Total:200 items.

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

The Chinese standard classification for "Class II medical device products" includes: Public medical equipment , Medical apparatus and devices in general , Orthopedic devices , Extracorporeal circulation, artificial organ and prosthesis device .

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

Shanghai Provincial Standard of the People's Republic of China

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

Professional Standard - Medicine

YY/T 1435-2016 Tissue engineering medical device products―Standard guide for characterization of hydrogels
YY/T 1571-2017 Tissue engineering medical device products—Sodium hyaluronate
YY/T 1654-2019 Tissue engineering medical device products—Alginate
YY/T 0048-1991 Basic requirements for working drawings of medical device products
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 1600-2018 Product family and processing category for steam sterilization of medical devices
YY/T 91050-1999 Editorial method for design documents of medical device product
YY/T 0567.7-2016 Aseptic processing of health care products. Part 7: Alternative processes for medical devices and combination products
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
YY 91050-1999 How to prepare medical device product design documents
YY/T 1914-2023 Medical devices for human assisted reproductive technology―General requirements of apparatus products
YY/T 1699-2020 Tissue engineering medical device products—Chitosan
YY/T 0050-1991 Numbering principle for medical device drawings and design documents

Group Standards of the People's Republic of China

T/HNAFQ 015-2025 "Meiyu Famous Products" public brand certification standardizes the medical device manufacturing industry
T/CASME 962-2023 Code of practice for the management of R&D and design of medical device products
T/SAMD 0005-2023 Technical Guidelines for Domestic Class I Medical Device Filing

Henan Provincial Standard of the People's Republic of China

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

Ente Nazionale Italiano di Unificazione

UNI EN ISO 17664:2018 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
UNI 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
UNI 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
UNI EN ISO 13408-7:2015 Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products
UNI CEI EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
UNI EN ISO 14971:2008 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2004 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2002 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2012 Medical devices - Application of risk management to medical devices

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO 2628:2022 Medical devices and supplies classification criteria
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

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
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 S99-015*NF EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates.
NF EN ISO 13408-7:2015 Aseptic processing of healthcare products - Part 7: alternative processes for medical devices and combination products
XP ISO/TS 22421:2021 Sterilization of healthcare products - Common requirements for sterilizers used for terminal sterilization of medical devices in healthcare settings
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
NF S99-211:2013 Medical devices - Application of risk management to medical devices

Gosstandart of Russia

GOST ISO 14971-2021 Medical devices. Application of risk management to medical devices
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 15.013-2016 System of products development and launching into manufacture. Medical devices
GOST ISO 10993-23-2023 Medical devices. Biological evaluation of medical devices. Part 23. Irritant studies
GOST R 59767-2021 Medical devices. Risk management. Risk assessment in the desing and development of medical devices
GOST R ISO 10993-12-2009 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and control materials
GOST R 57502-2017 Medical equipment. Industrial production regulation
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 ISO 10993-13-2016 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST R ISO 10993-1-2009 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST R ISO 10993-4-2009 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST ISO 10993-10-2023 Medical devices. Biological evaluation of medical devices. Part 10. Sensitization tests
GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
GOST R ISO 10993-14-2009 Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics
GOST ISO 10993-9-2015 Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products
GOST R 71579-2024 Medical electrical equipment. Phototherapy devices. Technical condition control methods
GOST R ISO 10993.12-1999 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
GOST R ISO 10993-11-2009 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST ISO 10993-11-2021 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
GOST ISO 10993-12-2023 Medical devices. Biological evaluation of medical devices. Part 12. Selection and preparation of samples for research

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
ANSI/AAMI/ISO 13408-7:2012(2018) Aseptic processing of health care products — Part 7: Alternative processes for medical devices and combination products
ANSI/AAMI/ISO 17664:2017 Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices
ANSI/AAMI UL 2800-1-1-2022 Risk Concerns for Interoperable Medical Products

Canadian Standards Association (CSA)

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
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
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
CSA ISO 14971-07-CAN/CSA:2007 Medical Devices - Application of Risk Management to Medical Devices second edition
CAN/CSA-ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices (Second Edition)
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
CAN/CSA-ISO 14971-2007(R2017) Medical Devices - Application of Risk Management to Medical Devices (Adopted ISO 14971:2007, second edition, 2007-03-01)

GCC Standardization Organization

GSO 2628:2021 Medical devices and supplies classification criteria
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 13408-7:2015 Aseptic processing of health care products -- Part 7: Alternative processes for medical devices and combination products
BH GSO ISO 14971:2024 Medical devices — Application of risk management to medical devices
OS GSO ISO 14971:2024 Medical devices — Application of risk management to medical devices
GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices

Association for the Advancement of Medical Instrumentation

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 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of 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
AAMI/ISO TIR17665-3:2014(2016) Sterilization of health care products—Moist heat—Guidance on the designation of a medical product to a product family and processing category for steam sterilization
AAMI/ISO 13408-7:2012(R2018) Aseptic processing of health care products - Part 7: Alternative processes for atypical medical devices and combination products
AAMI ST98-2022 Healthcare Product Cleaning Validation - Development and Validation Requirements for Medical Device Cleaning Processes

Korean Agency for Technology and Standards (KATS)

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 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 10993-13-2018 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric 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 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 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

Danish Standards Foundation

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
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
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)
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/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 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)
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)
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)
DS/ISO/TS 22421:2021 Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
DANSK DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

Indonesia Standards

SNI ISO 17664-2:2021 Pemrosesan produk pelayanan kesehatan — Informasi yang disertakan oleh produsen alat kesehatan untuk pemrosesan alat kesehatan — Bagian 2: Alat kesehatan non-kritikal (ISO 17664-2:2021, IDT)
SNI ISO 17664-1:2021 Pemrosesan produk pelayanan kesehatan — Informasi yang disertakan oleh produsen alat kesehatan untuk pemrosesan alat kesehatan — Bagian 1: Alat kesehatan kritikal dan semi kritikal (ISO 17664-1:2021, IDT)

Bureau of Indian Standards

IS 18742-2-2024 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
IS/ISO 17664-2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
IS 18742-1-2024 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
IS 18287-2023 Sterilization Of Health Care Products Common Requirements For Sterilizers For Terminal Sterilization Of Medical Devices In Health Care Facilities
IS 18881-7-2024 Aseptic Processing of Health Care Products - Part 7 Alternative Processes for Medical Devices and Combination Products

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 17664-1:2021 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 17664-2:2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
ISO 14971:2019 Medical devices — Application of risk management to medical devices

Swedish Institute for Standards

SIS-ISO/TS 22421:2021 Sterilization of health care products - Common requirements for sterilizers forterminal sterilization of medical devices in health care facilities (ISO/TS 22421:2021)
SS-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)
SS-EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
SS-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)

German Institute for Standardization

DIN EN ISO 17664:2018-04 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017)
DIN EN ISO 17664 E:2016-06 Disposal of Healthcare Products Information provided by medical device manufacturers for medical devices (draft)
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 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 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...
DIN 58257:1983-02 Medical instruments; needle holder type Crile
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 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 58259:2010-02 Medical instruments - Needle holder type Masson
DIN 13452:2006-12 Medical instruments - Scissors type Kilner
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)
DIN 58257:2010-02 Medical instruments - Needle holder type Crile
DIN 58262:2010-02 Medical instruments - Mouth gag type Jennings
DIN 58785:2010-02 Medical instruments - Ear specula type Hartmann
DIN 13452:2017-11 Medical instruments - Scissors type Kilner
DIN 58858:2008-01 Medical Instruments - Director Type KÃ¶nig
DIN 58259:1976-03 Medical instruments; needle holder type Masson
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 96111:2010-12 Medical instruments - Plaster knife type Körte
DIN 96035:2009-12 Medical instruments - Haemostatic forceps type Semb
DIN 58788:1982-09 Medical instruments; nasal specula type Hartmann-Halle
DIN 58263 E:2008 Draft Document - Medical instruments - Mouth gag type Heister
DIN 58286:2010-02 Medical instruments - Retractor type Kocher
DIN 96086:2010-12 Medical instruments - Bone wire tightener type Loute
DIN 96076:2010-12 Medical instruments - Self-retaining retractor type Wullstein
DIN 58785:1982-09 Medical instruments; ear specula type Hartmann
DIN 58867:2010-02 Medical instruments - Septum knife type Brünings
DIN 58783:2010-02 Medical instruments - Ear curette type Buck
DIN 58860:2010-02 Medical instruments - Osteotomes type Lexer
DIN 96057:2009-12 Medical instruments - Raspatory type Sedillot
DIN 96101:2010-12 Medical instruments - Bone raspatory type Jansen
DIN 96115 E:2010-05 Draft Document - Medical instruments - Gauges type Lexer
DIN 58285:2008-01 Medical instruments - Retractor type Volkmann
DIN EN ISO 17664-1 E:2021 Draft Document - 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 17664-1:2020); German and English v...
DIN 96082:2010-12 Medical instruments - Self-retaining retractor type Beckmann-Adson
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:...

Standards Norway

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 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 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017)

Finnish Standards Institute

SFS-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)

Spanish Association for Standardization (UNE)

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 17664:2018 Information that medical device manufacturers should provide when dealing with medical products (ISO 17664:2017)
UNE-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 17664-1:2021 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)
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 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
EN ISO 14971:2007 Medical devices - Application of risk management to medical devices
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
EN ISO 14971:2019 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)

British Standards Institution (BSI)

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 ISO 17664:2017 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of 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
09/30205582 DC BS EN 15986. Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates
BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to medical devices
BS EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
BS EN 62366-1:2015 Medical devices. Application of usability engineering to medical devices

Military Standards (MIL-STD)

MIL MIL-C-42068-1989 CHEST, MEDICAL INSTRUMENT AND SUPPLY SET

Austrian Standards

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)

US Federal Contractor Registration (USFCR)

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

Swiss Association for Standardization (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)

National Certification and Accreditation Administration

CNCA 08C-032-2001 Implementation Rules for Compulsory Certification of Medical Device Products ECG Machine
CNCA 08C-035-2001 Implementation Rules for Compulsory Certification of Medical Device Products Hollow Fiber Dialyzer
CNCA 08C-033-2001 Implementation Rules for Compulsory Certification of Medical Device Products Hemodialysis Devices
CNCA 08C-036-2001 Implementation Rules for Compulsory Certification of Medical Device Products Implantable Cardiac Pacemakers

National Standardisation Body (ASRO)

STAS 10719/1-1984 MEDICAL INSTRUMENTS Clasification and terminology

Thai Industrial Standards Institute (TISI)

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

South African Bureau of Standard

SANS 1593:1994 Disinfectants based on glutaraldehyde for use on medical instruments
SANS 14971:2008 Medical devices - Application of risk management to medical devices

European Union/Commission

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

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

Association for Electrical, Electronic & Information Technologies (VDE)

DIN EN IEC 60601-2-21:2025-07*VDE 0750-2-21 Berichtigung 1:2025-07 Medical electrical equipment
DIN EN IEC 60601-2-68:2025-12*VDE 0750-2-68:2025-12 Medical electrical equipment
DIN EN IEC 60601-2-83:2026-03*VDE 0750-2-83:2026-03 Medical electrical equipment
DIN EN 60601-1/A13:2025-03*VDE 0750-1/A13:2025-03 Medical electrical equipment

Lithuanian Standards Office

LST EN 15986-2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates