Class I medical equipment and maintenance

Class I medical equipment and maintenance, Total:159 items.

The international standard classification for "Class I medical equipment and maintenance" includes: Medical equipment in general , Medical equipment .

The Chinese standard classification for "Class I medical equipment and maintenance" includes: Medical apparatus and devices in general .

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Group Standards of the People's Republic of China

• T/SAMD 0005-2023 Technical Guidelines for Domestic Class I Medical Device Filing
• T/GDMDMA 0012.9-2022 Specifications for the Management of Medical Equipment in Hospitals - Part 9: Maintenance and Repair Management

Guangdong Provincial Standard of the People's Republic of China

• DB4420/T 45-2024 Specifications for registration management of Class I medical device products
• DB4403/T 218-2021 Implementation Specification for Unique Identification of Medical Devices

Fujian Provincial Standard of the People's Republic of China

• DB3502/T 183-2025 Guidelines for the implementation and application of unique identification of medical devices in medical institutions

Professional Standard - Medicine

• YY/T 0316-2003 Medical devices -- Application of risk management to medical devices
• YY/T 0316-2008 Medical devices - Application of risk management to medical devices
• YY/T 1630-2018 Fundamental requirements for unique device identifier
• 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

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

Association of German Mechanical Engineers

• VDI/VDE 2426 Blatt 4-2000 Catalogues in maintenance and management of medical devices - Maintenance measures
• VDI/VDE 2426 Blatt 1-2000 Catalogues in maintenance and management of medical devices - General
• VDI/VDE 2426 Blatt 2-2000 Catalogues in maintenance and management of medical devices - Standardized device catalogue
• VDI VDE 2426 Blatt 2-2000 Catalogues in maintenance and management of medical devices - Standardized Device Catalogue
• VDI VDE 2426 Blatt 3-2000 Fault catalogues in maintenance and management of medical devices
• VDI/VDE 2426 BLATT 1-2019 Catalogues in maintenance and management of medical devices - Fundamentals
• VDI/VDE 2426 Blatt 3-2000 Catalogues in maintenance and management of medical devices - Fault catalogues
• VDI/VDE 2426 Blatt 4-1996 Catalogues in maintenance and management of medical devices - Precautions for maintenance

Association Francaise de Normalisation

• NF S99-170:2013 Maintenance of medical devices - Quality management system for the maintenance and management of risks associated with the operation of medical devices
• NF S99-172:2017 Use and maintenance of medical devices - Risk management system for risks associated with the use of medical devices
• NF S99-171:2006 Maintenance of medical devices - Model and definition for establishment and management of the medical device security, quality and maintenance register (RSQM).
• 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
• 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

Gosstandart of Russia

• GOST R 57501-2017 Maintenance of medical devices. Requirements for governmental purchases
• GOST R EN 13718-1-2015 Medical vehicles and their equipment. Air Ambulances. Part 1. Requirements for medical devices used in air ambulances
• GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
• GOST 18250-1980 Medical apparatus and devices. Fiber lightguides. Connecting dimensions
• GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices

Kingdom of Bahrain Testing and Metrology Directorate

• BH GSO 2628:2022 Medical devices and supplies classification criteria
• BH GSO 2680:2022 Halal medical device – General requirements
• BH GSO ISO 14971:2017 Medical devices -- Application of risk management to medical devices

GCC Standardization Organization

• GSO 2628:2021 Medical devices and supplies classification criteria
• BH GSO ISO 14971:2024 Medical devices — Application of risk management to medical devices
• GSO 2680:2021 Halal medical device – General requirements
• 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

Military Standards (MIL-STD)

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

US Federal Contractor Registration (USFCR)

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

Spanish Association for Standardization (UNE)

• AENOR UNE 209001 IN:2002 Guide for the management and maintenance of non-implantable active medical devices.
• UNE 209001:2002 IN Guide for the management and the maintenance of active non implantable medical devices.
• 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)

German Institute for Standardization

• DIN 58257:1983-02 Medical instruments; needle holder type Crile
• DIN 58257:2010-02 Medical instruments - Needle holder type Crile
• DIN 13452:2006-12 Medical instruments - Scissors type Kilner
• DIN 58259:2010-02 Medical instruments - Needle holder type Masson
• DIN 13452:2017-11 Medical instruments - Scissors type Kilner
• DIN 58858:2008-01 Medical Instruments - Director Type König
• DIN 58262:2010-02 Medical instruments - Mouth gag type Jennings
• 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 58867:2010-02 Medical instruments - Septum knife type Brünings
• DIN 58785:1982-09 Medical instruments; ear specula type Hartmann
• 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 58783:2010-02 Medical instruments - Ear curette type Buck
• DIN 58295:1983-02 Medical instruments; retractor type Volkmann
• DIN 58285:2008-01 Medical instruments - Retractor type Volkmann
• DIN 96082:2010-12 Medical instruments - Self-retaining retractor type Beckmann-Adson
• DIN 13191:2005-12 Medical instruments - Rongeur type Stille
• 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 58259 E:2008-09 Draft Document - Medical instruments - Needle holder type Masson
• DIN 58240:2022-08 Draft Document - Medical instruments - Retractors type Israel
• DIN 58846:2017-11 Medical instruments - Raspatories
• DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
• DIN 58298:2005-12 Medical instruments - Materials, finish and testing

Bureau of Indian Standards

• IS/ISO 14971-2019 Medical devices - Application of risk management to medical devices First Revision
• IS 23485-2019 Medical Devices —— Quality Management System Requirements and Essential Principles of Safety and Performance for Medical Devices

National Standardisation Body (ASRO)

• STAS 10719/1-1984 MEDICAL INSTRUMENTS Clasification and terminology
• STAS 12902-1990 Human being medical instruments. Dental extracting forceps. General technical requirements for quality

Standard Association of Australia （SAA）

• AS ISO 14155.1:2004 Clinical investigations of medical devices for human subjects - General requirements
• AS 4187:1998 Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment, and maintenance of associated environments in health care facilities
• AS ISO 14971:2020 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

Ente Nazionale Italiano di Unificazione

• UNI EN 13718-1:2021 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
• UNI EN 13718-1:2008 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
• UNI EN 13718-1:2014 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances
• 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
• UNI EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated ?STERILE? - Requirements for terminally sterilized medical devices

Swedish Institute for Standards

• SS-EN 13718-1:2014+A1:2020 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances

Standards Norway

• NS-EN 13718-1:2014+A1:2020 Medical vehicles and their equipment - Air ambulances - Part 1: Requirements for medical devices used in air ambulances

Danish Standards Foundation

• DANSK DS/EN 13718-1+A1:2020 Medical vehicles and their equipment – Air ambulances – Part 1: Requirements for medical devices used in air ambulances
• 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

Korean Agency for Technology and Standards (KATS)

• KS P ISO 15223-2007(2012) Medical devices－Symbols to be used with medical device labels, labelling and information to be supplied
• 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 15223-2019 Medical devices－Symbols to be used with medical device labels, labelling and information to be supplied

Canadian Standards Association (CSA)

• CSA Z8002-2014 Operation and maintenance of health care facilities (First Edition)
• 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

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

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)

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
• 06/30106983 DC EN 13718-1. Medical vehicles and their equipment. Air ambulances. Part 1 . Requirements of medical devices used in air ambulances
• BS PD ISO/TS 11633-1:2019 Health informatics. Information security management for remote maintenance of medical devices and medical information systems-Requirements and risk analysis
• BS PD ISO/TR 11633-1:2009 Health informatics. Information security management for remote maintenance of medical devices and medical information systems-Requirements and risk analysis
• 18/30371211 DC BS EN 13718-1. Medical vehicles and their equipment. Air ambulances. Part 1. Requirements for medical devices used in air ambulances
• BS EN ISO 14971:2001 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 14971:2019 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

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 15223-1:2021 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
• ISO 14971:2019 Plus Redline 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
• SANS 15223:2006 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied

National Certification and Accreditation Administration

• CNCA 08C-035-2001 Implementation Rules for Compulsory Certification of Medical Device Products Hollow Fiber Dialyzer

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

Comitato Elettrotecnico Italiano

• CEI UNI EN ISO 14971:2020 Medical devices - Application of risk management 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

American National Standards Institute （ANSI)

• ANSI/AAMI/IEC TIR80002-1:2009 Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
• ANSI/AAMI/ISO 14971:2019 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

Czech Standards Institute (UNMZ)

• CSN 84 7106-1983 Medlcal eguipment. Methods, means and processes of sterllization and desinfection of items for medical use. Terms and definitions.

Others: Development and development of a class of medical devices,Class I medical equipment and maintenance,Maintenance and maintenance of Class II medical devices