What are the medical devices

What are the medical devices, Total:200 items.

The international standard classification for "What are the medical devices" includes: Medical equipment in general , Medical equipment .

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

Professional Standard - Medicine

YY/T 1474-2016 Medical devices－Application of risk management to medical devices
YY/T 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer
YY/T 0316-2003 Medical devices -- Application of risk management to medical devices
YY/T 0316-2016 Medical devices-Application of risk management to medical devices
YY/T 0316-2008 Medical devices - Application of risk management to medical devices
YY/T 0802.2-2024 Disposal of medical devices - Information to be provided by the medical device manufacturer - Part 2: Low-risk 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
GB/Z 42217-2022 Medical device —Validation of software for medical device quality system

Association Francaise de Normalisation

NF S99-401:1994 Medical Devices - Medical Grade Silicone Elastomer
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 S99-211:2013 Medical devices - Application of risk management to medical devices
NF EN 15986:2011 Symbol for use in the labeling of medical devices - Requirements for the labeling of medical devices containing phthalates
NF S99-211/A11*NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
NF EN 45502-2-1:2004 Active implantable medical devices - Part 2-1: special rules for active implantable medical devices intended to treat bradyarrhythmia (pacemakers)
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.

German Institute for Standardization

DIN 58853 E:2014-02 Medical instruments - Probes with eye
DIN 58857 E:2019-05 Medical instruments - Directors
DIN 58853:2008 Medical instruments - Probes with eye
DIN 58853:2021 Medical instruments - Probes with eye
DIN 58853:2014 Medical instruments - Probes with eye
DIN 58853:1976 Medical instruments; probes with eye
DIN 58853 E:2020-06 Medical instruments - Probes with eye
DIN 58857:2008 Medical instruments - Directors
DIN 58858:2014 Medical instruments - Director type König
DIN 58858:2021 Medical instruments - Director type König
DIN 58855:2008 Medical instruments - Director type Kirschner
DIN 58855 E:2014-02 Medical instruments - Director type Kirschner
DIN 58858 E:2014-02 Medical instruments - Director type König
DIN 58858 E:2020-06 Medical instruments - Director type König
DIN 58855:2014 Medical instruments - Director type Kirschner
DIN 58853:2008-01 Medical instruments - Probes with eye
DIN 58853:2014-09 Medical instruments - Probes with eye
DIN 58858:2008 Medical instruments - Director type K?nig
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 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 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
DIN 58267:1974 Medical instruments; needle holder Mathieu's with inside catch
DIN EN ISO 14971:2022 Medical devices – applying risk management to medical devices
DIN EN 15986:2011-05 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version EN 15986:2011, with CD-ROM
DIN 58846:2017-11 Medical instruments - Raspatories
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
DIN 58267:2010 Medical instruments - Needle holder type Mathieu with inside catch
DIN 58316:2008 Medical instruments - Abdominal spatulas, malleable
DIN 96123:2011-12 Medical instruments - Needle holder type Finochietto with carbide inserts
DIN EN ISO 14971:2020-07 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
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 96160:2011-12 Medical instruments - Wire guide
DIN 58846:1988-07 Medical instruments; raspatories
DIN 13461:1982-09 Medical instruments; neddle holder type De Bakey with carbide inserts
DIN 96056:2016-03 Medical instruments - Bone raspatory
DIN 58857:2019-12 Medical instruments - Directors
DIN 13185:2005-12 Medical instruments - Onychia forceps
DIN 58846:2010-02 Medical instruments - Raspatories
DIN 96056:2016 Medical instruments - Bone raspatory
DIN EN 62304:2016-10*VDE 0750-101:2016-10 Medical device software
DIN 58852:2008-01 Medical instruments - Probes
DIN 58852:2008 Medical instruments - Probes

European Committee for Standardization (CEN)

EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
prEN 556-1991 Sterilization of medical devices; sterility assurance level for medical devices labelled "Sterile"; requirements
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)
CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

Standards Norway

NS-EN 556:1994 Sterilization of medical devices — Requirements for medical devices to be labelled "Sterile"
NS-EN 556:1994+A1:1998 Sterilization of medical devices — Requirements for terminally-sterilized medical devices to be labelled "Sterile" (including amendment A1:1998)
NS-EN 15986:2011 Symbol for use in the labelling of medical devices — Requirements for labelling of medical devices containing phthalates
NS-EN 45502-2-1:2003 Active implantable medical devices — Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements

Ente Nazionale Italiano di Unificazione

UNI EN 556:1996 Sterilization of medical devices. Requirements for medical devices to be labelled "Sterile".
UNI EN 556:2000 Sterilization of medical devices - Requirements for terminally-sterilized medical devices to be labelled "Sterile"
UNI EN 556-2:2025 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
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 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
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
UNI CEI EN 45502-2-2:2022 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
UNI EN 556-2:2005 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices

Code of Federal Regulations (CFR)

CFR 21-803.21-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.21:Where can I find the reporting codes for adverse events that I use with medical device reports?
CFR 21-803.42-2013 Food and Drugs. Part803:Medical device reporting; (Eff. Until 8-14-15). Section803.42:If I am an importer, what information must I submit in my individual adverse event reports?
CFR 21-803.33-2013 Food and Drugs. Part803:Medical device reporting; (Eff. Until 8-14-15). Section803.33:If I am a user facility, what must I include when I submit an annual report?
CFR 21-803.52-2013 Food and Drugs. Part803:Medical device reporting; (Eff. Until 8-14-15). Section803.52:If I am a manufacturer, what information must I submit in my individual adverse event reports?

Canadian Standards Association (CSA)

CSA Z314-2023 Reprocessing of medical devices in Canada in all healthcare settings
CAN/CSA-ISO 14971:2007(R2012) Medical Devices - Application of Risk Management to Medical Devices
CAN/CSA-ISO 14971:2007(C2012) 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

Bureau of Indian Standards

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

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

Gosstandart of Russia

GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
GOST R ISO 15225-2014 Medical devices. Quality management. Medical device nomenclature data structure
GOST R 58450-2019 Medical devices with measuring functions. Condition monitoring

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 ISO 14971:2001 Medical devices - Application of risk management to medical devices
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
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
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

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

Korean Agency for Technology and Standards (KATS)

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 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

South African Bureau of Standard

SANS 14971:2008 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

Spanish Association for Standardization (UNE)

UNE-EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
UNE-EN ISO 14971:2020/A11:2022 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN 45502-2-1:2005 Active implantable medical devices -- Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)

Thai Industrial Standards Institute (TISI)

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

Danish Standards Foundation

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
DANSK DS/EN 45502-2-1:2004 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (Cardiac pacemakers)
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
DS/EN 45502-2-1:2004 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (Cardiac pacemakers)
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/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
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

Lithuanian Standards Office

LST EN 15986-2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
LST EN 45502-2-1-2004 Active implantable medical devices -- Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)

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

Comitato Elettrotecnico Italiano

CEI UNI EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
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
CEI EN 45502-2-1:2005 Active implantable medical devices - Part 2: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)

Standard Association of Australia （SAA）

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

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/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/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

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

Association of German Mechanical Engineers

VDI 5707 Blatt 1-2023 Retesting of active medical devices in medical use - Testing principles

Swedish Institute for Standards

SS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
SS-EN 45502-2-2:2008 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (Includes implantable defibrillators)
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 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

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

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