Medical Devices

Medical Devices, Total:200 items.

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

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

Taiwan Provincial Standard of the People's Republic of China

CNS 14393-13-2005 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
CNS 14990-2006 Medical devices - Symbols to be used with medical device labels,labelling and information to be supplied
CNS 14393.13-2005 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
CNS 14989-2006 Medical devices - Application of risk management to medical devices

Professional Standard - Medicine

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 0316-2003 Medical devices -- Application of risk management to medical devices
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 0316-2008 Medical devices - Application of risk management to 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/T 42062-2022 Medical devices—Application of risk management to medical devices

German Institute for Standardization

DIN 96160:2011 Medical instruments - Wire guide
DIN EN 1641:2010-02 Dentistry - Medical devices for dentistry - Materials; German version EN 1641:2009
DIN EN 1641:2004-09 Dentistry - Medical devices for dentistry - Materials
DIN EN 1641:2004 Dentistry - Medical devices for dentistry - Materials
DIN 58298-6:1983 Materials, Processing and Testing Medical Device Nest Diggers
DIN 13145:1979-06 Medical instruments; mallet of plastic material
DIN 13145 E:2008 Draft Document - Medical instruments - Mallet of plastic material
DIN 13145:2010-02 Medical instruments - Mallet of plastic material
DIN 58298:2005 Medical instruments - Materials, finish and testing
DIN 96160:2011-12 Medical instruments - Wire guide
DIN 58298:2010 Medical instruments - Materials, finish and testing
DIN 58846:1988-07 Medical instruments; raspatories
DIN EN ISO 14971:2022 Medical devices – applying risk management to medical devices
DIN EN 1641 E:2008 Draft Document - Dentistry - Medical devices for dentistry - Materials; German version prEN 1641:2008
DIN EN 1641 E:2008-09 Draft Document - Dentistry - Medical devices for dentistry - Materials; German version prEN 1641:2008
DIN EN ISO 9626:2002 Stainless steel needle tubing for manufacture of medical devices (ISO 9626:1991 + AMD 1:2001) (including amendment A1:2001); German version EN ISO 9626:1995 + A1:2001
DIN 58296:2008-01 Medical instruments - Raspatories Semb's
DIN 58846:2017-11 Medical instruments - Raspatories
DIN 58265:1974-09 Medical instruments; needle holder Finochietto's
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
DIN 58298:2005-12 Medical instruments - Materials, finish and testing
DIN 58319:2008-01 Medical instruments - Elevators Williger
DIN 58263:1973 Medical instruments; mouth gag Heister's
DIN 58298-3:1979 Materials, Processing and Testing Medical Device Tweezers
DIN 58298:2010-09 Medical instruments - Materials, finish and testing
DIN EN ISO 14971:2020-07 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
DIN 13176 E:2016-07 Medical instruments - Organ grasping forceps
DIN 58247 E:2016-07 Medical instruments retractor Roux's
DIN 96146 E:2017-06 Medical instruments - Retractors type Brunner
DIN 96075:2010-12 Medical instruments - Retractor type Finsen
DIN 96146:2017-11 Medical instruments - Retractors type Brunner
DIN 13176:2023 Medical instruments - Organ grasping forceps
DIN 13460 E:2016 Draft Document - Medical instruments - Needle holder type Heaney
DIN 58295:2017 Medical instruments - Retractor type Volkmann
DIN 58259:1976 Medical instruments; needle holder type Masson
DIN 96056 E:2015-09 Medical instruments - Bone raspatory
DIN 58794:1982 Medical instruments; ear forceps
DIN 58249:2010-02 Medical instruments - Retractors type Weitlaner
DIN 13464:2010-02 Medical instruments - Retractor type Schönborn
DIN 96079:2010-12 Medical instruments - Retractor type Middeldorpf
DIN 58288:1983-02 Medical instruments; retractor type Langenbeck
DIN 58312:1988-08 Medical instruments; rib contractor
DIN 58265:1974 Medical instruments; needle holder Finochietto's

Polski Komitet Normalizacyjny (PKN)

PN Z54550-1973 Medicall instruments Bon? joining elements Re?uirements and tests

Association Francaise de Normalisation

NF S99-301:1995 Medical devices. Electrically generated alarm signals.
NF S99-172:2003 Use of medical devices - Risk management relative to the use of medical devices in health care establishments.
NF S99-003:1998 Information supplied by the manufacturer with medical devices.
NF S99-003:2008 Information supplied by the manufacturer of medical devices.
NF S99-211:2013 Medical devices - Application of risk management to medical devices
NF S99-513:1999 Biological evaluation of medical devices. Part 13 : identification and quantification of degradation products from polymeric medical devices.
NF S93-004/A1:2001 Stainless steel needle tubing for the manufacture of medical devices.
NF S98-116-2*NF ISO 17664-2:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2 : non-critical medical devices
NF S99-211/A11*NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
NF EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
NF S90-701:1988 MEDICO-SURGICAL EQUIPMENT. BIOCOMPATIBILITY OF MATERIALS AND MEDICAL DEVICES. METHODS FOR EXTRACTION.
NF S90-304:1989 MEDICO-SURGICAL EQUIPMENT. HAEMODIALYSIS EQUIPMENT. OPERATING DATA.
NF S99-012:2010 Medical devices - Quality management - Medical device nomenclature data structure.
NF S90-300:1981 MEDICAL AND SURGICAL EQUIPMENT. OXYGENATORS.
NF S99-401:1994 Medical Devices - Medical Grade Silicone Elastomer

Standards Norway

NS-EN 1641:1996 Dentistry — Medical devices for dentistry — Materials
NS-EN 1641:2009 Dentistry — Medical devices for dentistry — Materials
NS-EN 1641:2004 Dentistry — Medical devices for dentistry — Materials

Danish Standards Foundation

DANSK DS/EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
DS/EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
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 15225:2016 Medical devices – Quality management – Medical device nomenclature data structure
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/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/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
DS/EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure

Ente Nazionale Italiano di Unificazione

UNI EN 1641:2010 Dentistry - Medical devices for dentistry - Materials
UNI EN 1641:2004 Dentistry - Medical devices for dentistry - Materials
UNI EN ISO 14971:2008 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 14971:2004 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 14971:2020 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2022 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 14971:2009 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 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 CEI EN ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure

Asociación Española de Normalización (AENOR)

AENOR UNE-EN 1641:2010 Dentistry - Medical devices for dentistry - Materials

Swedish Institute for Standards

SS-EN 1641:2005 Dentistry - Medical devices for dentistry - Materials
SS-EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
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 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)

Lithuanian Standards Office

LST EN 1641-2010 Dentistry - Medical devices for dentistry - Materials

Spanish Association for Standardization (UNE)

UNE-EN 1641:2004 Dentistry - Medical devices for dentistry - Materials
UNE-EN 1641:2010 Dentistry - Medical devices for dentistry - Materials
UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN ISO 14971:2020/A11:2022 Medical devices - Application of risk management to medical devices (ISO 14971:2019)

Gosstandart of Russia

GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
GOST ISO 10993-18-2011 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
GOST ISO 10993-12-2011 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and control materials
GOST R ISO 15225-2014 Medical devices. Quality management. Medical device nomenclature data structure

GCC Standardization Organization

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 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

Korean Agency for Technology and Standards (KATS)

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
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

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
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 60601-1/A13:2025-03*VDE 0750-1/A13:2025-03 Medical electrical equipment
DIN EN IEC 60601-2-68:2025-12*VDE 0750-2-68:2025-12 Medical electrical equipment
DIN EN IEC 60601-2-54:2025-05*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
DIN EN 60601-2-3:2025-07*VDE 0750-2-3:2025-07 Medical electrical equipment
DIN IEC/TS 60601-4-2:2025-06*VDE V 0750-4-2:2025-06 Medical electrical equipment

British Standards Institution (BSI)

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
BS EN 1642:2011 Dentistry. Medical devices for dentistry. Dental implants
BS EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
BS EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
BS EN ISO 10993-18:2020+A1:2023 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
BS PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering 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 556-2:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for aseptically processed medical devices
BS EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
BS EN 556-2:2015 Sterilization of medical devices. Requirements for medical devices to be designated 'STERILE'. Requirements for aseptically processed medical devices
08/30184612 DC BS EN 1641. Dentistry. Medical devices for dentistry. Materials
BS EN ISO 15225:2016 Medical devices. Quality management. Medical device nomenclature data structure
BS PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems

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 14971:2019 Plus Redline Medical devices - Application of risk management to medical devices
ISO 10993-18:2020/Amd.1:2022 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process

European Committee for Standardization (CEN)

EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
EN ISO 14971:2000 Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
EN ISO 14971:2007 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 1641:1996 Dentistry - Medical Devices for Dentistry - Materials
EN 1641:2004 Dentistry - Medical devices for dentistry - Materials
EN 1641:2009 Dentistry - Medical devices for dentistry - Materials
CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'

South African Bureau of Standard

SANS 14971:2008 Medical devices - Application of risk management to medical devices

Thai Industrial Standards Institute (TISI)

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

International Electrotechnical Commission (IEC)

IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
IEC 62366:2007 Medical devices - Application of usability engineering to medical devices

Association for the Advancement of Medical Instrumentation

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 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/IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
AAMI/ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
AAMI/IEC 62366:2007(R2013) Medical devices - Application of usability engineering to medical devices
AAMI EQ93:2019(R2025) Medical equipment management - Vocabulary used in medical equipment programs

Comitato Elettrotecnico Italiano

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
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

Canadian Standards Association (CSA)

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 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

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO ISO 14971:2017 Medical devices -- Application of risk management to medical devices
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
BH GSO ISO 15225:2017 Medical devices -- Quality management -- Medical device nomenclature data structure

Standard Association of Australia （SAA）

AS ISO 14971:2020 Medical devices — Application of risk management to medical devices

The Directorate General of Specifications and Metrology (DGSM)

OS GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
OS GSO IEC 62366:2014 Medical devices - Application of usability engineering to medical devices

American National Standards Institute （ANSI)

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 15225:2016 Medical devices—Quality management—Medical device nomenclature data structure

Military Standards (MIL-STD)

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

European Committee for Electrotechnical Standardization（CENELEC）

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

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

Others: Medical Devices