General Medical Devices

General Medical Devices, Total:162 items.

The international standard classification for "General Medical Devices" includes: Sterilization and disinfection , Medical equipment in general , Steel wire, wire ropes and link chains , Laboratory medicine , Graphical symbols for use on specific equipment , Medical equipment , Medical Sciences and health care facilities in general .

The Chinese standard classification for "General Medical Devices" includes: Sanitation in general , Medical apparatus and devices in general , Steel wire and wire rope , General requirements on medical devices , Standardization and quality management , Medical science .

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 27949-2011 General Requirements for Disinfectants for Medical Devices
GB 27949-2020 General requirements of disinfectant of medical instruments
GB/Z 42217-2022 Medical device —Validation of software for medical device quality system
GB/T 43312-2023 Steel wire ropes for medical devices

Professional Standard - Medicine

YY/T 0466.1-2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
YY/T 1681-2019 Basic terms of unique device identification system
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 0316-2003 Medical devices -- Application of risk management to medical devices
YY/T 1437-2016 Medical devices—Guidance on the applicantion of ISO 14971
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 91049-1999 Expanded classification method for three-level categories of medical device standard documents
YY/T 0316-2016 Medical devices-Application of risk management to medical devices
YY/T 1474-2016 Medical devices－Application of risk management to medical devices
YY/T 1437-2023 Medical devices-Guidance on the application of GB/T 42062
YY/T 0466.2-2015 Medical devices―Symbols to be used with medical device labels, labelling,and information to be supplied―Part 2:Symbol development,selection and validation
YY/T 1441-2016 General requirements of performance evaluation of in vitro diagnostic medical devices
YY/T 0467-2016 Medical devices-Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
YY 0288-1996 Quality system. Medical devices. GB/T 19002—Special requirements for ISO 9002 applications
YY/T 0467-2003 Medical devices - Guide to the selection of standards in support of recognized essential principles of safety and performance of medical devices
YY/T 0466.1-2009 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
YY/T 0316-2008 Medical devices - Application of risk management to medical devices

Jiangsu Provincial Standard of the People's Republic of China

DB32/T 5123-2025 General Technical Specification for Usability Testing of Medical Devices
DB32/T 4553-2023 Guidelines of adverse events monitoring for hospital medical device

Guangdong Provincial Standard of the People's Republic of China

DB4420/T 45-2024 Specifications for registration management of Class I medical device products

Professional Standard - Hygiene

WS/T 654-2019 Safety management for medical devices

British Standards Institution (BSI)

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 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 PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering to 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 ISO 15223-1:2012 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
BS EN ISO 15223-1:2017 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied. General requirements
PD IEC/TR 62366-2:2016 Medical devices – Part 2: Guidance on the application of usability engineering to medical devices
BS PD IEC/TR 80002-1:2009 Medical device software-Guidance on the application of ISO 14971 to medical device software

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/TS 22421:2023 Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities

Gosstandart of Russia

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 R 50444-1992 Medical instruments, apparatus and equipment. General specifications
GOST R ISO 15223-1-2014 Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Part 1. General requirements
GOST R ISO 15223-1-2020 Medical devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Part 1. General requirements

European Committee for Standardization (CEN)

EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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 14971:2019 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 ISO 14971:2019/A11:2021 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
EN ISO 15223-1:2021 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021)
EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (Remains Current)

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 IEC 62366-1-2021 Medical devices — Part 1: Application of usability engineering 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

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

Ente Nazionale Italiano di Unificazione

UNI EN ISO 14971:2008 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 14971:2004 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2002 Medical devices - Application of risk management to medical devices
EC 1-2004 UNI CEI EN ISO 14971:2004 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
UNI CEI EN ISO 14971:2009 Medical devices - Application of risk management to 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
ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
ISO 14971:2000/AMD1:2003 Amendment 1 - Medical devices - Application of risk management to medical devices
ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements

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
JIS T 62366-1:2022 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

Association Francaise de Normalisation

NF S99-211:2013 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 S99-211/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
XP S98-224*XP ISO/TS 22421:2021 Sterilization of health care products - Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
XP ISO/TS 22421:2021 Sterilization of healthcare products - Common requirements for sterilizers used for terminal sterilization of medical devices in healthcare settings
NF S99-014-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1 : general requirements.

Thai Industrial Standards Institute (TISI)

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

German Institute for Standardization

DIN EN ISO 14971:2022 Medical devices – applying risk management to medical devices
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
DIN EN ISO 14971:2020-07 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
DIN EN ISO 14971 E:2018-08 Application of medical device risk management in medical devices (draft)
DIN EN ISO 14971:2007-07 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
DIN EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
DIN EN ISO 14971:2022-04 Medical devices - Application of risk management to medical devices (ISO 14971:2019); German version EN ISO 14971:2019 + A11:2021

Danish Standards Foundation

DANSK DS/EN 62366:2008 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/A1:2008 Medical devices - Application of usability engineering to medical devices
DANSK DS/EN ISO 14971:2012 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/ISO 14971:2020 Medical devices – Application of risk management to medical devices
DS/ISO/TS 22421:2021 Sterilization of health care products – Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities
DANSK DS/EN 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices

Association for the Advancement of Medical Instrumentation

AAMI/IEC 62366:2007(R2013) Medical devices - Application of usability engineering to medical devices
AAMI/IEC 62366:2007 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 EQ93:2019(R2025) Medical equipment management - Vocabulary used in medical equipment programs
AAMI ST108:2023 Water for the processing of 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 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
SS-EN 62366-1:2016 Medical devices - Part 1: Application of usability engineering to medical devices

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

European Committee for Electrotechnical Standardization（CENELEC）

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

Comitato Elettrotecnico Italiano

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

Spanish Association for Standardization (UNE)

AENOR UNE-EN 62366/A1:2009 Medical devices - Application of usability engineering to medical devices
UNE-EN ISO 14971:2020/A11:2022 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
AENOR UNE-EN 62366:2009 Medical devices - Application of usability engineering to medical devices
UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
AENOR UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
UNE-EN ISO 14971:2001 Medical devices - Application of risk management to medical devices. (ISO 14971:2000)

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(C2006) Medical devices - Application of risk management to medical devices
CAN/CSA-ISO 14971:2001(R2006) Medical Devices - Application of Risk Management to 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 14971-2021 Medical devices – Application of risk management to medical devices (ISO 14971:2019, IDT)

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO ISO 14971:2017 Medical devices -- Application of risk management to medical devices
BH GSO ISO/TS 22421:2023 Sterilization of health care products — Common requirements for sterilizers for terminal sterilization of medical devices in health care facilities

Standard Association of Australia （SAA）

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

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 14971:2019 Medical devices— Application of risk management to medical devices
ANSI/AAMI/IEC 62366/A1:2014 Medical devices - Application of usability engineering to medical devices - Amendment 1
ANSI/AAMI ST108:2023 Water for the processing of medical devices

Bureau of Indian Standards

IS 18287-2023 Sterilization Of Health Care Products Common Requirements For Sterilizers For Terminal Sterilization Of Medical Devices In Health Care Facilities
IS/ISO 14971-2019 Medical devices - Application of risk management to medical devices First Revision
IS/IEC 62366-1-2015 Medical Devices Part 1 Application of Usability Engineering to Medical Devices

Military Standards (MIL-STD)

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

Standards Norway

NS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
NS-EN ISO 14971:2019 Medical devices — Application of risk management to medical devices (ISO 14971:2019)

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

Indonesia Standards

SNI ISO 14971:2015 Alat kesehatan - Penerapan manajemen risiko pada alat kesehatan (ISO 14971:2007, IDT)
SNI ISO 14971:2019 Healthcare Devices – Application of Risk Management to Healthcare Devices (ISO 14971:2019, IDT)