Class II Medical Device Inspection Standards

Class II Medical Device Inspection Standards, Total:200 items.

The international standard classification for "Class II Medical Device Inspection Standards" includes: Medical equipment in general , Medical equipment .

The Chinese standard classification for "Class II Medical Device Inspection Standards" includes: Medical apparatus and devices in general .

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Shanghai Provincial Standard of the People's Republic of China

• DB31/T 1378-2022 Service Specifications for Class II Medical Device Registration

Jiangsu Provincial Standard of the People's Republic of China

• DB32/T 4271-2022 Medical device clean room (area) inspection specification
• DB32/T 5325-2025 Technical Guidelines for Electronic Records in the Production and Inspection of Medical Devices

Group Standards of the People's Republic of China

• T/ZMDS 40003-2022 Medical Device Software Verification for Testing

Professional Standard - Commodity Inspection

• SN/T 1430.1-2004 Rules for the inspection of medical electrical equipment for improt - Ultrasonic medical diagnostic and therapy equipment
• SN/T 3061-2011 Rules of the Inspection of Packaging for Import Terminally Sterilized Medical Devices
• SN/T 4445.4-2023 Technical requirements for the inspection of medical equipment for importPart 4:Infusion pump
• SN/T 5473.1-2022 Technical requirements for the inspection of export medical devices - Part 1: Breathing machine
• SN/T 4445.1-2016 Technical requirements for the inspection of medical apparatus for import-Part 1: Medical electrical equipment

Professional Standard - Certification and Accreditation

• RB/T 217-2017 Competence assessment for inspection body and laboratory mandatory approval--Requirements for medical device inspection body

Professional Standard - Medicine

• 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 0316-2016 Medical devices-Application of risk management to medical devices
• YY/T 1911-2023 Test method of coagulation for medical devices
• YY/T 0316-2003 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

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(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 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

US Federal Contractor Registration (USFCR)

• FCR 21 CFR PART 860-2015 MEDICAL DEVICE CLASSIFICATION PROCEDURES
• FCR 21 CFR PART 860-2013 MEDICAL DEVICE CLASSIFICATION PROCEDURES

German Institute for Standardization

• DIN 58257:1983-02 Medical instruments; needle holder type Crile
• DIN 13105 E:2008 Draft Document - Medical instruments- Autopsy knife
• DIN 58259:2010-02 Medical instruments - Needle holder type Masson
• DIN 13452:2006-12 Medical instruments - Scissors type Kilner
• DIN 58257:2010-02 Medical instruments - Needle holder type Crile
• DIN 58262:2010-02 Medical instruments - Mouth gag type Jennings
• DIN 13452:2017-11 Medical instruments - Scissors type Kilner
• DIN 58858:2008-01 Medical Instruments - Director Type König
• DIN 58785:2010-02 Medical instruments - Ear specula type Hartmann
• DIN 58259:1976-03 Medical instruments; needle holder type Masson
• DIN 96111:2010-12 Medical instruments - Plaster knife type Körte
• DIN 96035:2009-12 Medical instruments - Haemostatic forceps type Semb
• DIN 58788:1982-09 Medical instruments; nasal specula type Hartmann-Halle
• DIN 58263 E:2008 Draft Document - Medical instruments - Mouth gag type Heister
• DIN 58286:2010-02 Medical instruments - Retractor type Kocher
• DIN 96086:2010-12 Medical instruments - Bone wire tightener type Loute
• DIN 96076:2010-12 Medical instruments - Self-retaining retractor type Wullstein
• DIN 58785:1982-09 Medical instruments; ear specula type Hartmann
• DIN 58867:2010-02 Medical instruments - Septum knife type Brünings
• DIN 58783:2010-02 Medical instruments - Ear curette type Buck
• DIN 58860:2010-02 Medical instruments - Osteotomes type Lexer
• DIN 96057:2009-12 Medical instruments - Raspatory type Sedillot
• DIN 96101:2010-12 Medical instruments - Bone raspatory type Jansen
• DIN 96115 E:2010-05 Draft Document - Medical instruments - Gauges type Lexer
• DIN 58285:2008-01 Medical instruments - Retractor type Volkmann
• DIN 96082:2010-12 Medical instruments - Self-retaining retractor type Beckmann-Adson
• DIN 58295:1983-02 Medical instruments; retractor type Volkmann
• DIN 13191:2005-12 Medical instruments - Rongeur type Stille
• 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 58858:2020-06 Draft Document - Medical instruments - Director type König
• DIN 13188:1983-02 Medical instruments; plaster cast spreader type Henning
• DIN 96025:2009-12 Medical instruments - Ethmoid rongeur forceps type Craig
• DIN 13199:2010 Medical instruments - Ethmoid rongeur forceps type Weil-Blakesley and Watson-Williams
• DIN 58240:2022-08 Draft Document - Medical instruments - Retractors type Israel
• DIN 58259 E:2008-09 Draft Document - Medical instruments - Needle holder type Masson
• DIN 58846:2017-11 Medical instruments - Raspatories
• DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
• DIN 58298-12:1994 Materials, finish and testing of medical instruments; hand saws
• DIN 58785 E:2008-09 Draft Document - Medical instruments - Ear specula type Hartmann
• DIN 58851:2010-02 Medical instruments - Cataract knives type Graefe
• DIN 58858 E:2020 Draft Document - Medical instruments - Director type König
• DIN 96091:2010-12 Medical instruments - Guiding probe type Brunner

British Standards Institution (BSI)

• BS EN ISO 10993-1:2003 Biological evaluation of medical devices - Evaluation and testing
• BS PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems
• 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
• PD ISO/TR 80002-2:2017 Medical device software — Part 2: Validation of software for medical device quality systems
• 09/30205582 DC BS EN 15986. Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates
• DD ISO/TS 10993-20:2006 Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices
• 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 5736-8:1984 Evaluation of medical devices for biological hazards-Method of test for skin irritation of solid medical devices
• BS EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
• BS 5736-7:1983 Evaluation of medical devices for biological hazards-Method of test for skin irritation of extracts from 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 PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering 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

National Standardisation Body (ASRO)

• STAS 10719/1-1984 MEDICAL INSTRUMENTS Clasification and terminology
• STAS E 10719/2-1986 Medical instruments RESISTANCE TESTING AT CORROSION AND REPEATED STERILIZATIONS STAINLESS STEEL MEDICAL INSTIUMENTS

Association Francaise de Normalisation

• 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 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 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 EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
• NF EN 13532:2002 General requirements for in vitro diagnostic medical devices for self-testing
• NF S99-012:2010 Medical devices - Quality management - Medical device nomenclature data structure.

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)

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 14971:2002 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
• 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

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

European Union/Commission

• MEDDEV 2.4/1 PART 2-2001 Guidelines for the Classification of Medical Devices Rev 8

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 ISO 10993-11-2011 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
• 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 2628:2021 Medical devices and supplies classification criteria
• GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
• GSO ISO/TR 80002-2:2021 Medical device software — Part 2: Validation of software for medical device quality systems
• 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

Kingdom of Bahrain Testing and Metrology Directorate

• BH GSO 2628:2022 Medical devices and supplies classification criteria
• BH GSO ISO/TR 80002-2:2022 Medical device software — Part 2: Validation of software for medical device quality systems
• 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

Bureau of Indian Standards

• IS/ISO/TR 80002-2-2017 Medical Device Software Part 2 Validation of Software for Medical Device Quality Systems

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)

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 TR 80002-2-2021 Medical device software — Part 2: Validation of software for medical device quality systems
• 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 TR 80002-2:2021 Medical device software — Part 2: Validation of software for medical device quality systems
• KS P ISO/TR 80002-2-2021 Medical device software — Part 2: Validation of software for medical device quality systems

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

Finnish Standards Institute

• SFS-EN 15986:2011 Symbol for use in the labelling of medical devices. Requirements for labelling of medical devices containing phthalates

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

European Committee for Standardization (CEN)

• 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 14971:2007 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)
• EN ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017)
• CENELEC EN 62366-2008 Medical devices - Application of usability engineering 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 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
• 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

Lithuanian Standards Office

• LST EN 15986-2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates

International Organization for Standardization (ISO)

• ISO 14971:2019 Medical devices — Application of risk management to medical devices
• ISO/TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
• ISO TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
• 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

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

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/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

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

Türk Standardları Enstitüsü

• TS EN ISO 14971:2020 Medical devices – Applying risk management to medical devices
• TS EN ISO 17664-1:2021 Processing of healthcare products - Information provided by medical device manufacturers for the processing of medical devices - Part 1: Critical and semi-critical medical devices

Others: Class II Medical Device Inspection Standards