Medical Device Conformity

Medical Device Conformity, Total:200 items.

The international standard classification for "Medical Device Conformity" includes: Medical equipment , Medical equipment in general .

The Chinese standard classification for "Medical Device Conformity" includes: Medical apparatus and devices in general , Public medical equipment .

Professional Standard - Medicine

YY/T 0802.2-2024 Disposal of medical devices - Information to be provided by the medical device manufacturer - Part 2: Low-risk medical devices
YY/T 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer
YY/T 1474-2016 Medical devices－Application of risk management to medical devices
YY/T 1630-2018 Fundamental requirements for unique device identifier
YY/T 0316-2008 Medical devices - Application of risk management to medical devices
YY/T 0316-2003 Medical devices -- Application of risk management to medical devices
YY/T 0802.1-2024 Disposal of medical devices Information to be provided by the medical device manufacturer Part 1: Medium and high risk medical devices
YY/T 0316-2016 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/Z 44363-2024 Pyrogenicity—Principles and methods for pyrogen testing of medical devices
GB/T 42062-2022 Medical devices—Application of risk management to medical devices

Fujian Provincial Standard of the People's Republic of China

DB3502/T 183-2025 Guidelines for the implementation and application of unique identification of medical devices in medical institutions

Guangdong Provincial Standard of the People's Republic of China

DB4403/T 218-2021 Implementation Specification for Unique Identification of Medical Devices

Swedish Institute for Standards

SS-EN 475:1995 Medical devices - Electrically-generated alarm signals
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 62366-1:2016 Medical devices - Part 1: Application of usability engineering to medical devices
SS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)

Danish Standards Foundation

DANSK DS/EN 475:1995 Medical devices - Electrically-generated alarm signals
DANSK DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
DANSK DS/EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
DANSK DS/EN 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
DANSK DS/EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
DANSK DS/ISO 14971:2020 Medical devices – Application of risk management to medical devices
DS/EN ISO 14971:2013 Medical devices - Application of risk management to medical devices
DANSK DS/EN ISO 10993-10:2013 Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
DANSK DS/EN ISO 15225:2016 Medical devices – Quality management – Medical device nomenclature data structure
DS/EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure

British Standards Institution (BSI)

BS EN 475:1995 Medical devices. Electrically-generated alarm signals
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 5736-5:1982 Evaluation of medical devices for biological hazards-Method of test for systemic toxicity; assessment of pyrogenicity in rabbits of extracts from medical devices
BS PD ISO/TR 21582:2021 Pyrogenicity. Principles and methods for pyrogen testing of medical devices
BS EN ISO 10993-10:1996 Biological evaluation of medical devices-Tests for irritation and sensitization
BS PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering to medical devices
BS 5736-6:1983 Evaluation of medical devices for biological hazards-Methods of test for sensitization; assessment of the potential of medical devices to produce delayed contact dermatitis
PD IEC/TR 62366-2:2016 Medical devices – Part 2: Guidance on the application of usability engineering to medical devices
BS EN 30993-3:1994 Biological evaluation of medical devices-Tests for genotoxicity, carcinogenicity and reproductive toxicity
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 ISO 10993-3:2003 Biological evaluation of medical devices-Tests for genotoxicity, carcinogenicity and reproductive toxicity
BS EN ISO 10993-3:2009 Biological evaluation of medical devices-Tests for genotoxicity, carcinogenicity and reproductive toxicity
BS PD ISO/TS 11796:2023 Biological evaluation of medical devices. Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
BS EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices
BS EN ISO 14971:2019+A11:2021 Medical devices - Application of risk management to 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 ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
BS EN 556-2:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for aseptically processed 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 ISO 15225:2016 Medical devices. Quality management. Medical device nomenclature data structure
BS EN 62366:2008+A1:2015 Medical devices. Application of usability engineering to medical devices

Gosstandart of Russia

GOST ISO 10993-3-2011 Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
GOST ISO 10993-3-2018 Medical levices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicit
GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
GOST ISO 14971-2011 Medical devices. Application of risk management to 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 10993-11-2009 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 ISO 10993-11-2011 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST R ISO 10993-11-1999 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic to xicity
GOST R ISO 15225-2014 Medical devices. Quality management. Medical device nomenclature data structure
GOST R ISO 10993-3-2009 Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity

German Institute for Standardization

DIN EN 13726-4:2003 Non-active medical devices - Test methods for primary wound dressings - Part 4: Conformability; German version EN 13726-4:2003
DIN EN ISO 14971:2022 Medical devices – applying risk management to medical devices
DIN 58846:2017-11 Medical instruments - Raspatories
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
DIN EN 62366 E:2006-09 Draft Document - Medical devices - Application of usability engineering to medical devices (IEC 62A/535/CDV:2006); German version prEN 62366:2006
DIN EN ISO 14971:2020-07 Medical devices - Application of risk management to medical devices (ISO 14971:2019)

International Electrotechnical Commission (IEC)

IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
IEC 62366:2007/AMD1:2014 Medical devices - Application of usability engineering to medical devices
IEC/TR 62366-2:2016 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
IEC TR 62366-2:2016 Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
IEC TR 62366-2-2016 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
IEC 62366-1:2020 Medical devices - Part 1: Application of usability engineering to medical devices
IEC 62366:2007/AMD 1:2014 Medical devices — Application of usability engineering to medical devices — Amendment 1
IEC 62366-1:2015/COR1:2016 Medical devices - Part 1: Application of usability engineering to medical devices
IEC 62366-1:2015+AMD1:2020 CSV Medical devices - Part 1: Application of usability engineering to medical devices

Bureau of Indian Standards

IS/ISO 14971-2019 Medical devices - Application of risk management to medical devices First Revision
IS 12572-6-1988 Guide for Evaluation of Medical Devices for Biological Hazards Part 6 Method of Test for Systemic Toxicity; Assessment of Pyrogenicity In Rabits of Extracts from Medical Devices
IS 12572-7-1988 Guide for Evaluation of Medical Devices for Biological Hazards Part 7 Method of Test for Sensitization: Assessment of the Potential of Medical Devices to Produce Delayed Contact Dermatitis
IS/IEC 62366-1-2015 Medical Devices Part 1 Application of Usability Engineering to Medical Devices
IS 12572 Pt.7-1988 Guidelines for Biohazard Assessment of Medical Devices Part 7 Sensitization Test Methods: Assessing the Potential of Medical Devices to Produce Delayed Contact Dermatitis
IS/ISO 10993-3-2014 Biological Evaluation of Medical Devices Part 3 Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity ( First Revision )
IS/IEC/TR 62366-2-2016 Medical devices Part 2 Guidance on the Application of Usability Engineering to Medical Devices

Association for the Advancement of Medical Instrumentation

AAMI/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
AAMI/IEC 62366:2007(R2013) Medical devices - Application of usability engineering to medical devices
AAMI/ISO 14971:2019 Medical devices - Application of risk management to medical devices
AAMI/ISO 14971:2007(R2016) Medical Devices - Application of Risk Management to Medical Devices
AAMI/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/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 EQ93:2019(R2025) Medical equipment management - Vocabulary used in medical equipment programs

European Committee for Standardization (CEN)

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

The Directorate General of Specifications and Metrology (DGSM)

OS GSO IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
OS GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
OS GSO ISO 10993-10:2016 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization

European Committee for Electrotechnical Standardization（CENELEC）

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

Comitato Elettrotecnico Italiano

CEI EN 62366:2008 Medical devices - Application of usability engineering to medical devices
CEI EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
CEI EN 62366-1:2016 Medical devices Part 1: Application of usability engineering to medical devices
CEI UNI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
CEI UNI EN/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure

Association Francaise de Normalisation

NF S99-401:1994 Medical Devices - Medical Grade Silicone Elastomer
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 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 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 S99-012:2010 Medical devices - Quality management - Medical device nomenclature data structure.

Korean Agency for Technology and Standards (KATS)

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 14971:2021 Medical devices — Application of risk management to medical devices
KS P IEC 62366-1:2021 Medical devices — Part 1: Application of usability engineering 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
KS P IEC 62366-1-2021 Medical devices — Part 1: Application of usability engineering to medical devices
KS P IEC 62366-1-2018 Medical devices — Part 1:Application of usability engineering to medical devices
KS P IEC 62366-1:2018 Medical devices — Part 1:Application of usability engineering to medical devices
KS P ISO 15223-2019 Medical devices－Symbols to be used with medical device labels, labelling and information to be supplied
KS P IEC TR 62366-2-2020 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
KS P IEC TR 62366-2:2020 Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
KS P ISO/TS 11796-2025 Biological evaluation of medical devices — Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of 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 15225-2023 Medical devices — Quality management — Medical device nomenclature data structure

GCC Standardization Organization

GSO 2680:2021 Halal medical device – General requirements
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
GSO ISO 10993-10:2016 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
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

American National Standards Institute （ANSI)

ANSI/AAMI/IEC 62366/A1:2014 Medical devices - Application of usability engineering to medical devices - Amendment 1
ANSI/AAMI/IEC TIR80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
ANSI/AAMI/ISO 14971:2019 Medical devices— Application of risk management to medical devices
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 10993-10:2010(2014) Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
ANSI/AAMI/ISO 15225:2016 Medical devices—Quality management—Medical device nomenclature data structure

Spanish Association for Standardization (UNE)

UNE-CR 14060:2001 Medical device traceability.
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)

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO 2680:2022 Halal medical device – General requirements
BH GSO ISO 14971:2017 Medical devices -- Application of risk management to medical devices
BH GSO ISO 10993-10:2017 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
BH GSO ISO 15225:2017 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

Asociación Española de Normalización (AENOR)

AENOR UNE-CR 14060:2001 Medical device traceability.
AENOR 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)

Finnish Standards Institute

SFS-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 14971:2003 Medical devices -- Application of risk management to medical devices
JIS T 62366-1:2022 Medical devices -- Part 1: Application of usability engineering to medical devices
JIS T 14971:2012 Medical devices -- Application of risk management to medical devices
JIS T 14971:2020 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
DIN IEC/TS 60601-4-2:2025-06*VDE V 0750-4-2:2025-06 Medical electrical equipment
DIN EN 60601-2-3:2025-07*VDE 0750-2-3:2025-07 Medical electrical equipment
DIN EN IEC 60601-2-54:2025-05*VDE 0750-2-54:2025-05 Medical electrical equipment
DIN EN IEC 60601-2-16:2026-02*VDE 0750-2-16:2026-02 Medical electrical equipment

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
ISO 14971:2019 Plus Redline Medical devices - Application of risk management to medical devices

Ente Nazionale Italiano di Unificazione

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 14971:2012 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 EN 30993-3:1995 Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity.
UNI CEI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
EC 1-2004 UNI CEI EN ISO 14971:2004 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2022 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
UNI EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated ?STERILE? - Requirements for terminally sterilized medical devices
UNI CEI EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
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

Canadian Standards Association (CSA)

CAN/CSA-ISO 10993.10-1998(R2003) Biological evaluation of medical devices - Part 10: Tests for irritation and sensitization
CAN/CSA-ISO 14971:2007(C2012) Medical devices - Application of risk management to medical devices
CAN/CSA-ISO 14971:2007(R2012) Medical Devices - Application of Risk Management to Medical Devices
CAN/CSA-ISO 14971:2001(R2006) Medical Devices - Application of Risk Management to Medical Devices
CAN/CSA-ISO 14971:2001(C2006) Medical devices - Application of risk management to medical devices
CSA ISO-10993.3-97-CAN/CSA:1997 Biological Evaluation of Medical Devices - Part 3: Tests Concerning Genotoxicity, Cancerogenicity and Reproductive Toxicity First Edition
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

Polski Komitet Normalizacyjny (PKN)

PN-EN 62366-1-2015-07/A1-2021-03 E Medical devices -- Part 1: Application of usability engineering to medical devices

South African Bureau of Standard

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

Underwriters Laboratories (UL)

UL 2800-1-2019 UL Standard for Safety Medical Device Interoperability (First Edition)

Standard Association of Australia （SAA）

AS ISO 10993.10:2002 Biological evaluation of medical devices - Tests for irritation and sensitization
AS ISO 14971:2020 Medical devices — Application of risk management to medical devices
AS 1094:1993 Medical equipment - Single-use syringes (sterile) for general medical use

Thai Industrial Standards Institute (TISI)

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

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)

Military Standards (MIL-STD)

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