National Class II Medical Devices
National Class II Medical Devices, Total:200 items.
The international standard classification for "National Class II Medical Devices" includes: Medical equipment in general , Medical equipment .
The Chinese standard classification for "National Class II Medical Devices" includes: Medical apparatus and devices in general , Public medical equipment .
Group Standards of the People's Republic of China
- T/GDMDMA 0037-2024 Specification for Home Medical Device Leasing Services
- T/CHAS 10-4-7-2021 Quality and safety management of Chinese hospital—— Part 4-7: Medical management —— medical devices management
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 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 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 0802.2-2024 Disposal of medical devices - Information to be provided by the medical device manufacturer - Part 2: Low-risk medical devices
- YY/T 0802.1-2024 Disposal of medical devices Information to be provided by the medical device manufacturer Part 1: Medium and high 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
Qinghai Provincial Standard of the People's Republic of China
- DB63/T 2466-2025 Provincial-level On-site Sampling Technical Specifications for Medical Devices
Jiangsu Provincial Standard of the People's Republic of China
- DB3211/T 1054-2022 Data collection and application specifications for household medical devices
- DB32/T 4856-2024 Data collection and application specifications for home medical devices
Association Francaise de Normalisation
- NF S99-401:1994 Medical Devices - Medical Grade Silicone Elastomer
- 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 15986:2011 Symbol for use in the labeling of medical devices - Requirements for the labeling of medical devices containing phthalates
- 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 EN ISO 14971:2019 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/A11:2021 Medical devices - Application of risk management to medical devices
- NF S99-012:2010 Medical devices - Quality management - Medical device nomenclature data structure.
Canadian Standards Association (CSA)
- 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 14971-2007(R2017) Medical Devices - Application of Risk Management to Medical Devices (Adopted ISO 14971:2007, second edition, 2007-03-01)
- 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
European Committee for Standardization (CEN)
- prEN 556-1991 Sterilization of medical devices; sterility assurance level for medical devices labelled "Sterile"; requirements
- 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 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
- 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 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
- EN 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
Swedish Institute for Standards
- SS-EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
- SS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
- 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
Ente Nazionale Italiano di Unificazione
- 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 14971:2012 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 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 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
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
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
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
- 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
- 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 ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
- 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 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
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
- BH GSO ISO/TR 24971:2024 Medical devices — Guidance on the application of ISO 14971
- OS GSO ISO/TR 24971:2024 Medical devices — Guidance on the application of ISO 14971
- 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
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 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
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
- KS P ISO 15225-2014(2019) 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 IEC 60601-2-68:2025-12*VDE 0750-2-68:2025-12 Medical electrical equipment
- DIN EN 60601-1/A13:2025-03*VDE 0750-1/A13:2025-03 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
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 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 62366:2008 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
- 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
- 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
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 556-1-2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized 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
Standards Norway
- NS-EN 15986:2011 Symbol for use in the labelling of medical devices — Requirements for labelling of medical devices containing phthalates
- NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements
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
Thai Industrial Standards Institute (TISI)
- TIS 14971-2013 Medical devices.application of risk management to medical devices
German Institute for Standardization
- DIN EN 15986 E:2009-08 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
- 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 EN ISO 14971:2022 Medical devices – applying risk management to medical devices
- DIN 13199:2010 Medical instruments - Ethmoid rongeur forceps type Weil-Blakesley and Watson-Williams
- DIN 58846:2017-11 Medical instruments - Raspatories
- DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
- DIN EN 15986 E:2009 Draft Document - Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version prEN 15986:2009
- DIN EN ISO 14971:2020-07 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
- DIN 58846:1988-07 Medical instruments; raspatories
- DIN 96160:2011-12 Medical instruments - Wire guide
- DIN 96056 E:2015-09 Medical instruments - Bone raspatory
- DIN 58794:1982 Medical instruments; ear forceps
- 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 13119:2010-02 Medical instruments - Bowel scissors
- DIN 58852 E:2020-06 Medical instruments - Probes
- DIN 58794:2010 Medical instruments - Ear forceps
- 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
- DIN 13119 E:2008-09 Medical instruments bowel scissors
- DIN 58857:2019 Medical instruments - Directors
- DIN 96056:2023-03 Medical instruments - Bone raspatory
- DIN 96056:2009 Medical instruments - Bone raspatory
- DIN EN ISO 14971 E:2018-08 Application of medical device risk management in medical devices (draft)
- DIN 13117:2013-01 Medical instruments - Bone shears
- DIN 13119:1980 Medical instruments; bowel scissors
- DIN 58852:1976 Medical instruments; probes
- DIN 96056 E:2022-08 Medical instruments - Bone raspatory
- DIN EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
- DIN 58852:2014-09 Medical instruments - Probes
- DIN 13117:2013 Medical instruments.Bone shears
- DIN EN 556-1 Berichtigung 1:2006-12 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German version EN 556-1:2001, Corrigenda to DIN EN 556-1:2002-03; German version EN 556-1...
- DIN EN 556-2:2023-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: requirements for aseptically processed medical devices; German and English version prEN 556-2:2023 / Note: Date of issue 2023-01-06*Intended as r...
- DIN 96060:2009-12 Medical instruments - Elevator type Langenbeck
- DIN 13193:2016-12 Medical instruments - Rongeurs type Luer
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/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
- 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
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
Standard Association of Australia （SAA）
- AS ISO 14971:2020 Medical devices — Application of risk management to medical devices
European Union/Commission
- MEDDEV 2.10-2 ATT 3-2001 UK MEDICAL DEVICES NOTIFIED BODY GROUP (Rev 1)
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
- ANSI/NEMA SC 1-2020 American National Standard for Supplier Credentialing in Healthcare
- 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
European Committee for Electrotechnical Standardization（CENELEC）
- EN 62366:2008 Medical devices - Application of usability engineering to medical devices
Military Standards (MIL-STD)
- MIL MIL-C-42068-1989 CHEST, MEDICAL INSTRUMENT AND SUPPLY SET
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
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