Medical Device Coding

Medical Device Coding, Total:473 items.

The international standard classification for "Medical Device Coding" includes: Quality management and quality assurance , Medical equipment in general , Medical equipment .

The Chinese standard classification for "Medical Device Coding" includes: Medical apparatus and devices in general , Public medical equipment , General and microsurgical devices .

Professional Standard - Medicine

YY/T 0468-2015 Medical devices―Quality management―Medical device nomenclature data structure
YY/T 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer
YY 91050-1999 How to prepare medical device product design documents
YY/T 1752-2020 Basic data set of unique device identification database
YY/T 0316-2008 Medical devices - Application of risk management to medical devices
YY/T 0869-2013 Medical devices—Coding structure for adverse event type and cause
YY/T 0316-2016 Medical devices-Application of risk management to medical devices
YY/T 0050-1991 Numbering principle for medical device drawings and design documents
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 1474-2016 Medical devices－Application of risk management to medical devices
YY 0466-2003 Medical devices -- Symbols to be used with medical device labels labelling and information to be supplied
YY/T 0869.1-2016 Medical devices—Hierarchical coding structure for adverse events—Part 1:Event-type codes
YY/T 0869.2-2016 Medical devices-Hierarchical coding structure for adverse events一 Part 2:Evaluation codes
YY/T 91050-1999 Editorial method for design documents of medical device product
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/T 0316-2003 Medical devices -- Application of risk management to medical devices
YY/T 1753-2020 Reporting guide of unique device identification database

Guangdong Provincial Standard of the People's Republic of China

DB4403/T 541-2024 Technical Specifications for the Monitoring and Reporting of Adverse Events of Medical Devices in Healthcare Institutions
DB4403/T 218-2021 Implementation Specification for Unique Identification of Medical Devices
DB4403/T 219-2021 Medical device traceability system logo design and application specification

Shandong Provincial Standard of the People's Republic of China

DB3710/T 237-2024 Medical Device Unique Identification Application Technical Specification

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

Tianjin Provincial Standard of the People's Republic of China

DB12/T 1016-2020 General requirements for design and implementation of medical device traceability system

Jiangsu Provincial Standard of the People's Republic of China

DB32/T 3769-2020 Basic requirements for medical device network information security
DB3212/T 1141-2023 Implementation and Application Specifications for Unique Identification of 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

Group Standards of the People's Republic of China

T/ZGXX 0003-2019 Medical device cleaning agent
T/CAMDI 040-2020 Special requirements for the quality management system of metal additive manufacturing medical device production
T/CAMDI 026-2019 Group standard for special requirements for customized medical device quality system

Beijing Provincial Standard of the People's Republic of China

DB11/T 1645-2019 Coding specification for key control points of medical behavior

British Standards Institution (BSI)

BS DD ISO/TS 19218-1:2011+A1:2013 Medical devices. Hierarchical coding structure for adverse events. Event-type codes
PD CEN/TR 15133:2005 Nomenclature Collective terms and codes for groups 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 EN ISO 14971:2001 Medical devices - Application of risk management to 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 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 556-2:2015 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 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
BS PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems
BS EN 556-1:2001(2006) Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1 : Requirements for terminally sterilized medical devices
BS PD IEC/TR 80002-1:2009 Medical device software-Guidance on the application of ISO 14971 to medical device software
PD IEC/TR 62366-2:2016 Medical devices – Part 2: Guidance on the application of usability engineering to medical devices
PD ISO/TR 80002-2:2017 Medical device software — Part 2: Validation of software for medical device quality systems
BS PD ISO/TS 19218-2:2012 Medical devices. Hierarchical coding structure for adverse events-Evaluation codes
BS EN ISO 10993-17:2023 Biological evaluation of medical devices - Toxicological risk assessment of medical device constituents

Ente Nazionale Italiano di Unificazione

UNI ISO/TS 19218:2007 Medical devices - Coding structure for adverse event type and cause
UNI CEI EN ISO 14971:2002 Medical devices - Application of risk management to 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 14971:2022 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 14971:2009 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 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 ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
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
UNI EN ISO 17664:2018 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices
UNI EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
UNI EN 556:1996 Sterilization of medical devices. Requirements for medical devices to be labelled "Sterile".

Association for the Advancement of Medical Instrumentation

AAMI/ISO TIR19218:2005 Medical devices - Coding structure for adverse event type and cause
ANSI/AAMI/ISO TIR19218-2:2012 Medical devices - Hierarchal coding structure for adverse events - Part 2:Evaluation codes
AAMI/ISO TIR19218-1:2011 Medical devices - Hierarchal coding structure for adverse events - Part 1: Event type codes
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/IEC 62366:2007(R2013) Medical devices - Application of usability engineering to medical devices
AAMI/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
AAMI EQ93:2019(R2025) Medical equipment management - Vocabulary used in medical equipment programs
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/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/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
AAMI/ISO 17664:2017 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices.

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO ISO/TS 19218-2:2017 Medical devices -- Hierarchical coding structure for adverse events -- Part 2: Evaluation codes
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

GCC Standardization Organization

GSO ISO/TS 19218-2:2015 Medical devices -- Hierarchical coding structure for adverse events -- Part 2: Evaluation codes
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

Danish Standards Foundation

DANSK DS/ISO/TS 19218-2:2012 Medical devices - Hierarchical coding structure for adverse events - Part 2: Evaluation codes
DS/ISO/TS 19218-2:2012 Medical devices - Hierarchical coding structure for adverse events - Part 2: Evaluation codes
DANSK DS/ISO/TS 19218-1:2011 Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes
DS/ISO/TS 19218-1:2011 Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes
DANSK DS/ISO/TS 19218-1/AMD 1:2011 Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes
DS/CEN/TR 15133:2005 Nomenclature – Collective terms and codes for groups of medical devices
DS/ISO/TS 19218-1/Amd 1:2013 Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes - AMENDMENT 1
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 62366:2008 Medical devices - Application of usability engineering to medical devices
DANSK DS/EN ISO 15225:2016 Medical devices – Quality management – Medical device nomenclature data structure
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/CEN/TR 15133:2005 Nomenclature - Collective terms and codes for groups of 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
DS/CEN/CR 14060:2001 Medical device traceability
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
DANSK DS/EN 556-1/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
DANSK DS/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)
DS/EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices
DANSK DS/EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
DANSK DS/EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
DS/EN 556-1/AC:2006 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices
DS/EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices
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
DS/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 (ISO 17664-1:2021)
DANSK DS/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 (ISO 17664-1:2021)
DANSK DS/EN 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
DS/EN 556:1995 Sterilization of medical devices - Requirements for medical devices to be labelled "Sterile"

Gosstandart of Russia

GOST R 56032-2014 Medical devices. Hierarchical coding structure for adverse events. Part 2. Evaluation codes
GOST R 55746-2015 Medical devices. Hierarchical coding structure for adverse events. Part 1. Event-type codes
GOST R 55746-2013 Medical devices. Hierarchical coding structure for adverse events. Part 1. Event-type codes
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 EN 556-1-2011 Sterilization of medical devices. Requirements for medical devices to be designated «sterile». Part 1. Requirements for terminally sterilized medical devices
GOST ISO 10993-13-2016 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST ISO 10993-13-2011 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST ISO/TS 10993-20-2011 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
GOST R 55544-2013 Medical devices software. Part 1. Guidance on the application of ISO 14971 medical devices software

International Organization for Standardization (ISO)

ISO/TS 19218-1:2011/Amd 1:2013 Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes; Amendment 1
ISO/TS 19218-2:2012 Medical devices - Hierarchical coding structure for adverse events - Part 2: Evaluation codes
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/TS 19218-1:2011 Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes
ISO 14971:2019 Plus Redline Medical devices - Application of risk management to medical devices
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
ISO 14971:2000/AMD1:2003 Amendment 1 - Medical devices - Application of risk management to medical devices

European Committee for Standardization (CEN)

EN ISO 14971:2000 Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
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
CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
CEN/TR 15133:2005 Nomenclature - Collective terms and codes for groups of 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
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 (ISO 17664-1:2021)
EN ISO 14971:2019/A11:2021 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
EN 556-2:2015 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed 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
JIS T 62366-1:2022 Medical devices -- Part 1: Application of usability engineering to medical devices

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
KS P 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
KS P 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
KS P IEC 62366-1-2018 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 62366-1-2021 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

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
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 S99-012:2010 Medical devices - Quality management - Medical device nomenclature data structure.
NF EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to obtain STERILE labeling - Part 1: Requirements for terminally sterilized medical devices
NF S98-136:2009 Sterilisation of medical devices - Risk management related to the preparation of sterile medical devices within health establishments.
NF S99-401:1994 Medical Devices - Medical Grade Silicone Elastomer
NF S98-107-2*NF EN 556-2:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2 : requirements for aseptically processed medical devices
NF EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
NF EN 556-2:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2 : requirements for aseptically processed medical devices
NF S98-107-2*NF EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2 : requirements for aseptically processed medical devices
NF S98-107-1*NF EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
NF EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to obtain the "STERILE" label - Part 2: Requirements for medical devices subject to aseptic processing
NF S90-300:1981 MEDICAL AND SURGICAL EQUIPMENT. OXYGENATORS.

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-Fachbericht CEN TR 15133:2005-09 Terminology Medical device classification terms and codes
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
DIN 58846:2017-11 Medical instruments - Raspatories
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 EN ISO 14971 E:2018-08 Application of medical device risk management in medical devices (draft)
DIN 96160:2011-12 Medical instruments - Wire guide
DIN 13117:2013 Medical instruments.Bone shears
DIN 58852:2014-09 Medical instruments - Probes
DIN 96056 E:2015-09 Medical instruments - Bone raspatory
DIN 58794:1982 Medical instruments; ear forceps
DIN 58794:2010 Medical instruments - Ear forceps
DIN 58852 E:2020-06 Medical instruments - Probes
DIN 13119:2010-02 Medical instruments - Bowel scissors
DIN EN 1639:2004-09 Dentistry - Medical devices for dentistry - Instruments
DIN 13119 E:2008-09 Medical instruments bowel scissors
DIN 96056:2009 Medical instruments - Bone raspatory
DIN 58857:2019 Medical instruments - Directors
DIN 96056:2023-03 Medical instruments - Bone raspatory
DIN EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
DIN 58852:2008 Medical instruments - Probes
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 58852:1976 Medical instruments; probes
DIN 96056 E:2022-08 Medical instruments - Bone raspatory
DIN EN 556-2:2015-11 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 / Note: To be replaced by DIN EN 556-2 (2023-02).
DIN 13119:1980 Medical instruments; bowel scissors
DIN 13117:2013-01 Medical instruments - Bone shears
DIN 13117:1980-06 Medical instruments; bone shears
DIN 13193:2016-12 Medical instruments - Rongeurs type Luer
DIN 58857:2019-12 Medical instruments - Directors
DIN 96056:2016-03 Medical instruments - Bone raspatory
DIN 13185:2005-12 Medical instruments - Onychia forceps
DIN 58846:2010-02 Medical instruments - Raspatories
DIN 13117:1980 Medical instruments; bone shears
DIN 13119:2010 Medical instruments - Bowel scissors
DIN 58852:2014 Medical instruments - Probes
DIN 58852 E:2014-02 Medical instruments - Probes
DIN 58852:2021 Medical instruments - Probes
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
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 EN 556-1:2002-03 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 / Note: To be replaced by DIN EN 556-1 (2023-02).
DIN EN 556-1:2023-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German and English version prEN 556-1:2023 / Note: Date of issue 2023-01-06*Intended as r...
DIN EN ISO 14971:2007-07 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
DIN 96060:2009-12 Medical instruments - Elevator type Langenbeck
DIN EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
DIN EN 13824:2005-02 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
DIN 58296:2008-01 Medical instruments - Raspatories Semb's
DIN EN 556-2 E:2014 Draft Document - Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE'' - Part 2: Requirements for aseptically processed medical devices; German version prEN 556-2:2014
DIN EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
DIN EN 556-1 E:2023 Draft Document - Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices; German and English version prEN 556-1:2023
DIN 58265:1974-09 Medical instruments; needle holder Finochietto's
DIN EN ISO 15225:2010-10 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010)
DIN 58263:1973 Medical instruments; mouth gag Heister's
DIN 58319:2008-01 Medical instruments - Elevators Williger
DIN 58318:2019-12 Medical instruments - Elevators Langenbeck's
DIN 13105:1983-02 Medical instruments; autopsy knife
DIN 13111:2018 Medical instruments - Bandage scissors
DIN 58846:2017 Medical instruments - Raspatories
DIN 13184:2016 Medical instruments - Bone holding forceps Farabeuf's
DIN 96056:2009-12 Medical instruments - Bone raspatory
DIN 96057 E:2022-08 Medical instruments - Raspatory type Sedillot
DIN 58794:2010-02 Medical instruments - Ear forceps
DIN 58250:1976-03 Medical instruments; scalpels
DIN 58862:1988 Medical instruments; bone curettes
DIN 58292:1972 Medical instruments; tracheal hook
DIN 58230:1974 Medical instruments; amputation knives
DIN 58292:2010 Medical instruments - Tracheal hook
DIN 13173:2005 Medical instruments - Dressing forceps
DIN 13145 E:2008-09 Medical instruments - Mallet of plastic material
DIN 13173 E:2022-08 Medical instruments - Dressing forceps
DIN 13119:1980-06 Medical instruments; bowel scissors
DIN 13458:2009-01 Medical instruments - Ligature needle
DIN 58292:2010-02 Medical instruments - Tracheal hook
DIN 58278:1983-02 Medical instruments; cilia forceps
DIN EN ISO 15225:2016-11 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2016)
DIN 96056:2023 Medical instruments - Bone raspatory
DIN 96057:2016-03 Medical instruments - Raspatory type Sedillot
DIN 58274:2016 Medical instruments - Iris forceps
DIN 58273:2009-01 Medical instruments - Fixation forceps
DIN 58862:1988-07 Medical instruments; bone curettes
DIN EN 556-1:2024-09 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
DIN 13103:1973 Medical instruments; dissecting scalpels
DIN 13111:2006 Medical instruments - Bandage scissors
DIN 13173:2023-03 Medical instruments - Dressing forceps
DIN 58274:2009-01 Medical instruments - Iris forceps
DIN 58230:2010-02 Medical instruments - Amputation knives
DIN 58846 E:2017-06 Medical instruments - Raspatories
DIN 13458:1988 Medical instruments; ligature needle
DIN 13173:2023 Medical instruments - Dressing forceps
DIN 13173:2016-12 Medical instruments - Dressing forceps
DIN EN 556-2:2004-03 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed medical devices
DIN 96057 E:2015-09 Medical instruments - Raspatory type Sedillot
DIN 13145:1979 Medical instruments; mallet of plastic material
DIN 58858:2021-02 Medical instruments - Director type König
DIN 58230:2010 Medical instruments - Amputation knives
DIN 13458:2009 Medical instruments - Ligature needle
DIN 58794:1982-09 Medical instruments; ear forceps
DIN 58278:2010-02 Medical instruments - Cilia forceps
DIN 13104:1973-11 Medical instruments; cartilage knife
DIN 58230:1974-09 Medical instruments; amputation knives
DIN 58292:1972-11 Medical instruments; tracheal hook
DIN 13173:2016 Medical instruments - Dressing forceps
DIN 58846:2010 Medical instruments - Raspatories
DIN 58319:2019 Medical instruments - Elevators Williger
DIN 58862:2010 Medical instruments - Bone curettes
DIN 13145:2010 Medical instruments - Mallet of plastic material
DIN 13173 E:2016-07 Medical instruments - Dressing forceps
DIN 58846:1988 Medical instruments; raspatories
DIN 58318:2019 Medical instruments - Elevators Langenbeck's
DIN 58250:2010-02 Medical instruments - Scalpels
DIN 58862:2010-02 Medical instruments - Bone curettes
DIN 13104:2010-02 Medical instruments - Cartilage knife
DIN 13111:2006-12 Medical instruments - Bandage scissors
DIN 58857:1976 Medical instruments; directors
DIN 13104:2010 Medical instruments - Cartilage knife
DIN 58319:2019-12 Medical instruments - Elevators Williger
DIN 96057:2016 Medical instruments - Raspatory type Sedillot
DIN 13173:2005-12 Medical instruments - Dressing forceps
DIN 13176:2005-12 Medical instruments - Organ grasping forceps
DIN 96057:2023-03 Medical instruments - Raspatory type Sedillot
DIN 58317:1973-12 Medical instruments; elevator Henke's
DIN 58857:2008-01 Medical instruments - Directors
DIN EN 556-2:2025 Sterilization of Medical Devices - Requirements for Medical Devices to be Designated "STERILE" - Part 2: Requirements for Aseptically Processed Medical Devices
DIN EN ISO 17664-2 E:2023 Draft Document - 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 and English version prEN ISO 176...
DIN EN ISO 17664-1:2021-11 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 (ISO 17664-1:2021); German version EN ISO 17664-1:2021
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 58855:1983 Medical instruments; director type Kirschner
DIN 58256:1976 Medical instruments; needle holder, type T?nnis
DIN 58259:2017-08 Medical instruments; needle holder type Masson
DIN 58259 E:2017-03 Medical instruments needle holder type Masson
DIN 13460:1982-09 Medical instruments; needle holder type Heaney
DIN 58249:1983-02 Medical instruments; retractors type Weitlaner
DIN 58263:1973-12 Medical instruments; mouth gag Heister's
DIN 58312:2010-02 Medical instruments - Rib contractor
DIN 96164:2011-12 Medical instruments - Reamer type Perthes
DIN 96053:2021 Medical instruments - Retractor type Ollier
DIN 13176 E:2016-07 Medical instruments - Organ grasping forceps
DIN 13460 E:2016 Draft Document - Medical instruments - Needle holder type Heaney
DIN 58295:2017 Medical instruments - Retractor type Volkmann
DIN 13176:2023 Medical instruments - Organ grasping forceps
DIN 58259:1976 Medical instruments; needle holder type Masson
DIN 58247 E:2016-07 Medical instruments retractor Roux's
DIN 96075:2010-12 Medical instruments - Retractor type Finsen
DIN 96146:2017-11 Medical instruments - Retractors type Brunner
DIN 58795:1988 Medical instruments; mouth gags
DIN 96053:2009 Medical instruments - Retractor type Ollier
DIN 58247:2010 Medical instruments - Retractors type Roux
DIN 58285:2008 Medical instruments - Retractor type Volkmann
DIN 58288:2017 Medical instruments - Retractor type Langenbeck
DIN 58285 E:2014-02 Medical instruments retractor type Volkmann
DIN 96057:2023 Medical instruments - Raspatory type Sedillot
DIN 96081:2010-12 Medical instruments - Retractor type Alm
DIN 58248:1983-02 Medical instruments; retractor type Jansen
DIN EN 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 (ISO 17664-2:2021); German and English version prEN ISO 17664-2:2023
DIN 58265:1974 Medical instruments; needle holder Finochietto's
DIN 58285:1983 Medical instruments; retractor type Volkmann
DIN 58287:2017 Medical instruments - Retractor type KÃ¶rte
DIN 58247:2023-03 Medical instruments - Retractors type Roux
DIN 58247:2016 Medical instruments - Retractors type Roux
DIN 58249:2010-02 Medical instruments - Retractors type Weitlaner
DIN 13464:2010-02 Medical instruments - Retractor type Schönborn
DIN 96079:2010-12 Medical instruments - Retractor type Middeldorpf
DIN 58288:1983-02 Medical instruments; retractor type Langenbeck
DIN 58312:1988-08 Medical instruments; rib contractor
DIN 58285:2021 Medical instruments - Retractor type Volkmann
DIN 96053:2021-02 Medical instruments - Retractor type Ollier
DIN 58288:2017-08 Medical instruments - Retractor type Langenbeck
DIN 13176:2016 Medical instruments - Organ grasping forceps
DIN 58286:2017-08 Medical instruments - Retractor type Kocher
DIN 58315:1979 Medical instruments; retractors Cushing's
DIN 58249:1983 Medical instruments; retractors type Weitlaner
DIN 58296:1973 Medical instruments; raspatories Semb's
DIN 58247:2023 Medical instruments - Retractors type Roux
DIN 96149:2011 Medical instruments - Bone curettes type Daubenspeck
DIN 58285:2014 Medical instruments - Retractor type Volkmann
DIN 58285 E:2020-06 Medical instruments retractor type Volkmann
DIN 58257:1983 Medical instruments; needle holder type Crile
DIN 58286:1983 Medical instruments; retractor type Kocher
DIN 58863:1979 Medical instruments; bone curettes type Volkmann
DIN 58259:2017 Medical instruments - Needle holder type Masson
DIN 13176:2023-03 Medical instruments - Organ grasping forceps
DIN EN ISO 17664:2018-04 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017)

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 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 62366:2007/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 62366-1:2015+AMD1:2020 CSV Medical devices - Part 1: 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

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 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
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 17664:2018 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices
CAN/CSA-ISO 17664-1-2023 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
CAN/CSA-ISO 14971-2021 Medical devices – Application of risk management to medical devices (ISO 14971:2019, IDT)

Comitato Elettrotecnico Italiano

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/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 EN 62366-1:2016 Medical devices Part 1: Application of usability engineering to medical devices

Spanish Association for Standardization (UNE)

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)
AENOR UNE-EN 62366/A1:2009 Medical devices - Application of usability engineering to medical devices
AENOR UNE-EN 62366:2009 Medical devices - Application of usability engineering to medical devices
UNE-EN 556-1:2002/AC:2007 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
UNE-EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
UNE-EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
UNE-EN 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
UNE-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
AENOR UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN ISO 14971:2001 Medical devices - Application of risk management to medical devices. (ISO 14971:2000)
AENOR UNE-EN 556-2:2016 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
UNE-EN 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 (ISO 17664-1:2021)
UNE-EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated STERILE - Part 2: Requirements for aseptically processed medical devices
UNE-EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure (ISO/FDIS 15225:2009)

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 15225:2016 Medical devices—Quality management—Medical device nomenclature data structure
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 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
ANSI/AAMI/IEC 62366/A1:2014 Medical devices - Application of usability engineering to medical devices - Amendment 1

Swedish Institute for Standards

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
SS 872805:2012 In vitro diagnostic medical devices - Colour coding for safety cap on vacuum tubes for human venous blood specimen collection
SS-EN 556-2:2024 Sterilization of medical devices — Requirements for medical devices to be designated ''STERILE" — Part 2: requirements for aseptically processed medical devices
SS-EN 556-2:2015 Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices
SS-EN 556-1:2001 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
SS-EN 556-1:2024 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1: Requirements for terminally sterilized medical devices
SS-EN 62366-1:2016 Medical devices - Part 1: Application of usability engineering to medical devices

Standards Norway

SN-CEN/TR 15133:2005 Nomenclature - Collective terms and codes for groups of medical devices
NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements
SN-CR 14060:2000 Medical device traceability
NS-EN 556:1994 Sterilization of medical devices — Requirements for medical devices to be labelled "Sterile"
NS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
NS-EN 556-2:2003 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 2: Requirements for aseptically processed medical devices
NS-EN ISO 14971:2019 Medical devices — Application of risk management to medical devices (ISO 14971:2019)
NS-EN 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 (ISO 17664-2:2021)
NS-EN 556-1:2024 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
NS-EN ISO 15225:2010 Medical devices — Quality management — Medical device nomenclature data structure (ISO 15225:2010)
NS-EN 556-2:2015 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 2: Requirements for aseptically processed medical devices
NS-EN 556-1:2001 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 1: Requirements for terminally sterilized medical devices
NS-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 (ISO 17664-1:2021)
NS-EN ISO 15225:2016 Medical devices — Quality management — Medical device nomenclature data structure (ISO 15225:2016)

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
IS/ISO 14971-2019 Medical devices - Application of risk management to medical devices First Revision
IS 18742-1-2024 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
IS/IEC 62366-1-2015 Medical Devices Part 1 Application of Usability Engineering to Medical Devices
IS/ISO/TR 80002-2-2017 Medical Device Software Part 2 Validation of Software for Medical Device Quality Systems
IS/ISO 17664-2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices

Lithuanian Standards Office

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
LST EN 556-1-2002/AC-2006 Sterilization of medical devices - Requirements for medical devices to be designated 'STERILE' - Part 1: Requirements for terminally sterilized medical devices
LST EN 556-2-2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
LST EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure (ISO 15225:2010)

Indonesia Standards

SNI ISO 14971:2019 Healthcare Devices – Application of Risk Management to Healthcare Devices (ISO 14971:2019, IDT)
SNI ISO 17664-1:2021 Pemrosesan produk pelayanan kesehatan — Informasi yang disertakan oleh produsen alat kesehatan untuk pemrosesan alat kesehatan — Bagian 1: Alat kesehatan kritikal dan semi kritikal (ISO 17664-1:2021, IDT)
SNI ISO 14971:2015 Alat kesehatan - Penerapan manajemen risiko pada alat kesehatan (ISO 14971:2007, IDT)
SNI ISO 17664-2:2021 Pemrosesan produk pelayanan kesehatan — Informasi yang disertakan oleh produsen alat kesehatan untuk pemrosesan alat kesehatan — Bagian 2: Alat kesehatan non-kritikal (ISO 17664-2:2021, IDT)

US Federal Contractor Registration (USFCR)

FCR 21 CFR PART 810-2015 MEDICAL DEVICE RECALL AUTHORITY
FCR 21 CFR PART 810-2014 MEDICAL DEVICE RECALL AUTHORITY
FCR 21 CFR PART 810-2013 MEDICAL DEVICE RECALL AUTHORITY

Austrian Standards

OENORM 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 (ISO/FDIS 17664-1:2021)

Polski Komitet Normalizacyjny (PKN)

PN Z54061-1986 Medical instruments Ears Dimensions
PN-EN 62366-1-2015-07/A1-2021-03 E Medical devices -- Part 1: Application of usability engineering to medical devices

Swiss Association for Standardization (SNV)

SN 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 (ISO 17664-1:2021)

Association of German Mechanical Engineers

VDI-EE 5702 BLATT 3-2024 Medizinprodukte-Software - Medical SPICE - Empfehlungen fuer die Softwareentwicklung

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