What are the types of medical devices

What are the types of medical devices, Total:210 items.

The international standard classification for "What are the types of medical devices" includes: Implants for surgery, prosthetics and orthotics , Medical equipment , Surgical instruments and materials , Medical equipment in general , Sterilization and disinfection in general .

The Chinese standard classification for "What are the types of medical devices" includes: Medical apparatus and devices in general , Orthopedic devices , Public medical equipment .

未注明发布机构

DIN 58853 E:2014-02 Medical instruments - Probes with eye
DIN 58855 E:2014-02 Medical instruments - Director type Kirschner
ANSI/AAMI/ISO 16142-1:2016 Medical devices—Recognized essential principles of safety and performance of medical devices—Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
DIN EN 980:2008 Quality management and corresponding general aspects for medical devices
DIN 58853 E:2020-06 Medical instruments - Probes with eye
DIN 58858 E:2014-02 Medical instruments - Director type König
YY 91049-1999 Expanded classification method for three-level categories of medical device standard documents
DIN EN 556-2 E:2014-02 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
DIN 58857 E:2019-05 Medical instruments - Directors
DIN 58858 E:2020-06 Medical instruments - Director type König

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 277-2022 Medical device unique identification data interface specification
DB4403/T 218-2021 Implementation Specification for Unique Identification of Medical Devices

Group Standards of the People's Republic of China

T/SAMD 0005-2023 Technical Guidelines for Domestic Class I Medical Device Filing

国家药监局

YY/T 1630-2018 Fundamental requirements for unique device identifier
YY/T 1753-2020 Reporting guide of unique device identification database
YY/T 1752-2020 Basic data set of unique device identification database
YY/T 1681-2019 Basic terms of unique device identification system
YY/T 0989.5-2022 Implants for surgery-Active implantable medical devices-Part 5:Circulatory support devices

Shanghai Provincial Standard of the People's Republic of China

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

Professional Standard - Medicine

YY/T 1879-2022 Creation and placement of unique device identifier
YY/T 1943-2024 UDI implementation and application in medical device package levels
YY/T 1942-2024 Form and content of the unique device identifier
YY/T 0995-2015 Medical devices for human assisted reproductive technology―Terminology and definitions
YY/T 0869-2013 Medical devices—Coding structure for adverse event type and cause
YY 91055-1999 Paint coating for medical devices. Classification and speciation
YY/T 1914-2023 Medical devices for human assisted reproductive technology―General requirements of apparatus products
YY/T 91049-1999 Third class category expansion variety method for medical devices standard literature

国家食品药品监督管理局

YY 0989.6-2016 Implants for surgery―Active implantable medical devices―Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia(including implantable defibrillators)

Jiangsu Provincial Standard of the People's Republic of China

DB3212/T 1141-2023 Implementation and Application Specifications for Unique Identification of Medical Devices

国家药品监督管理局

YY/T 1600-2018 Product family and processing category for steam sterilization of medical devices

Association Francaise de Normalisation

NF S99-401:1994 Dispositifs médicaux - Élastomère de silicone de qualité médicale
NF S98-107-2:2004 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2 : requirements for aseptically processed medical devices".
NF EN 15986:2011 Symbole à utiliser pour l'étiquetage des dispositifs médicaux - Exigences relatives à l'étiquetage des dispositifs médicaux contenant des phtalates
NF EN 45502-2-1:2004 Active implantable medical devices - Part 2-1: special rules for active implantable medical devices intended to treat bradyarrhythmia (pacemakers)
NF EN 45502-2-2:2008 Dispositifs médicaux implantables actifs - Partie 2-2 : exigences particulières pour les dispositifs médicaux implantables actifs destinés au traitement des tachyarythmies (y compris les défibrillateurs implantables)
NF EN ISO 14708-2:2022 Implants chirurgicaux - Dispositifs médicaux implantables actifs - Partie 2 : Stimulateurs cardiaques

European Committee for Standardization (CEN)

EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
prEN 556-1991 Sterilization of medical devices; sterility assurance level for medical devices labelled "Sterile"; requirements
EN ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood (ISO 6717:2021)

German Institute for Standardization

DIN 58853:2014 Medical instruments - Probes with eye
DIN 58853:2021 Medical instruments - Probes with eye
DIN 58857:2008 Medical instruments - Directors
DIN 58853:1976 Medical instruments; probes with eye
DIN 58853:2008 Medical instruments - Probes with eye
DIN 58855:2008 Medical instruments - Director type Kirschner
DIN 58858:2021 Medical instruments - Director type König
DIN 58855:2014 Medical instruments - Director type Kirschner
DIN 58858:2014 Medical instruments - Director type König
DIN 58858:2008 Medical instruments - Director type K?nig
DIN EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2003
DIN 58267:1974 Medical instruments; needle holder Mathieu's with inside catch
DIN 58316:2008 Medical instruments - Abdominal spatulas, malleable
DIN 58267:2010 Medical instruments - Needle holder type Mathieu with inside catch
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 556-2:2015 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
DIN 96121:2011 Medical instruments - Needle holder type Crile-Wood with carbide inserts
DIN EN ISO 15223-1/A1:2019 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016); German and English version EN ISO 15223-1:2016/prA1:2019
DIN EN ISO 15223-1:2020 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO/DIS 15223-1:2020); German and English version prEN ISO 15223-1:2020
DIN 58236-2:2016 Medical instruments - Needle holder type Mathieu - Part 2: With carbide inserts
DIN 58236-2:2010 Medical instruments - Needle holder type Mathieu - Part 2: With carbide inserts

SCC

NS-EN 556:1994 Sterilization of medical devices — Requirements for medical devices to be labelled "Sterile"
CSA Z314.0-13:2014 Reprocessing of medical devices — General requirements Proprietary copy
CSA Z314-2023 Reprocessing of medical devices in Canada in all healthcare settings
DIN 58263 E:2008 Draft Document - Medical instruments - Mouth gag type Heister
BS EN 20594-1:1994 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment-General requirements
DANSK DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
CEI UNI EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
NS-EN 556:1994+A1:1998 Sterilization of medical devices — Requirements for terminally-sterilized medical devices to be labelled "Sterile" (including amendment A1:1998)
NS-EN 15986:2011 Symbol for use in the labelling of medical devices — Requirements for labelling of medical devices containing phthalates
AENOR UNE-EN 15986:2011 Symbol for use in the labeling of medical devices - Requirements for labeling of medical devices containing phthalates
DANSK DS/EN 45502-2-1:2004 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (Cardiac pacemakers)
AAMI/ISO 16142-2:2017 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
NS-EN 45502-2-1:2003 Active implantable medical devices — Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
DANSK DS/ISO 16142-2:2017 Medical devices – Recognized essential principles of safety and performance of medical devices – Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
DIN 58858 E:2020 Draft Document - Medical instruments - Director type KÃ¶nig
VDI 5707 BLATT 1-2023 Repeat tests on active medical devices in medical use — test principles
VDI 5707 BLATT 1-2023 Repeat tests on active medical devices in medical use — test principles
DANSK DS/ISO 16142-1:2016 Medical devices – Recognized essential principles of safety and performance of medical devices – Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standard...
AAMI/ISO 16142-1:2016 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
CEI EN 45502-2-1:2005 Active implantable medical devices - Part 2: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
AENOR UNE-EN 45502-2-1:2005 Active implantable medical devices — Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
DIN EN 15986 E:2009 Draft Document - Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates; German version prEN 15986:2009
BS EN 556:1995 Sterilization of medical devices. Requirements for terminally-sterilized devices to be labelled 'Sterile'
CEI UNI EN 45502-2-2/AB:2019 Active implantable medical devices Part 2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
AENOR UNE-EN 45502-2-2 CORR:2008 Active implantable medical devices — Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
AAMI/ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
AENOR UNE-EN 45502-2-2:2008 Active implantable medical devices — Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
DANSK DS/EN 45502-2-2:2008 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
CAN/CSA Z314-2023 Canadian medical device reprocessing in all health care settings, Includes Update No. 1 (2024)
NS-EN 45502-2-2:2008 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
CEI UNI EN 45502-2-2:2019 Active implantable medical devices Part 2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
CAN/CSA-ISO 14971-2001 Medical Devices - Application of Risk Management to Medical Devices (Adopted ISO 14971:2000, first edition, 2000-12-15)
AAMI/ISO 15223-1:2022 Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
DANSK DS/ISO 14708-6:2022 Implants for surgery – Active implantable medical devices – Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
CEI UNI EN ISO 14708-6:2023 Implants for surgery - Active implantable medical devices Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
BS EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects-General requirements
AS 1600.1:1988 Medical equipment - Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - General requirements
AENOR UNE 209001 IN:2002 Guide for the management and maintenance of non-implantable active medical devices.
BS EN ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied-General requirements
08/30191609 DC BS ISO 14708-6. Implants for surgery. Active implantable medical devices. Part 6. Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
DANSK DS/ISO 15223-1:2007 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
AAMI/ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
DIN EN ISO 14708-6:2022 Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO 14708-6:2019); German version EN ISO 14708-...
NS-EN ISO 14708-6:2022 Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO 14708-6:2019)
DIN EN ISO 14708-6 E:2018 Draft Document - Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators); German and English version prE...
DANSK DS/EN ISO 14708-6:2022 Implants for surgery – Active implantable medical devices – Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO 14708-6:2019)
09/30176675 DC BS EN ISO 15223-1. Medical devices. Symbols to be used with medical device labels , labelling and information to be supplied. Part 1. General requirements
AAMI/ISO TIR19218:2005 Medical devices - Coding structure for adverse event type and cause

US-FCR

FCR 21 CFR PART 860-2015 MEDICAL DEVICE CLASSIFICATION PROCEDURES
FCR 21 CFR PART 860-2013 MEDICAL DEVICE CLASSIFICATION PROCEDURES
FCR 21 CFR PART 26-2014 MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY
FCR 21 CFR PART 26-2013 MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY
FCR 21 CFR PART 26-2015 MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY

RO-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
STAS 12916-1991 Human use medical instruments. Retractors. General technical requirements for quality
SR ISO 594-1:1993 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements

US-CFR-file

CFR 21-803.42-2013 Food and Drugs. Part803:Medical device reporting; (Eff. Until 8-14-15). Section803.42:If I am an importer, what information must I submit in my individual adverse event reports?
CFR 21-803.33-2013 Food and Drugs. Part803:Medical device reporting; (Eff. Until 8-14-15). Section803.33:If I am a user facility, what must I include when I submit an annual report?
CFR 21-803.21-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.21:Where can I find the reporting codes for adverse events that I use with medical device reports?
CFR 21-803.52-2013 Food and Drugs. Part803:Medical device reporting; (Eff. Until 8-14-15). Section803.52:If I am a manufacturer, what information must I submit in my individual adverse event reports?
CFR 21-803.32-2013 Food and Drugs. Part803:Medical device reporting; (Eff. Until 8-14-15). Section803.32:If I am a user facility, what information must I submit in my individual adverse event reports?
CFR 21-803.11-2014 Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.11:What form should I use to submit reports of individual adverse events and where do I obtain these forms?

Standard Association of Australia （SAA）

AS ISO 14155.1:2004 Clinical investigations of medical devices for human subjects - General requirements
AS 1600.1:2004 Medical equipment - Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - General requirements
AS EN 45502.1:2002(R2014) General requirements for safety, labeling and information provided by manufacturers of active implantable medical devices

IX-EU/EC

MEDDEV 2.4/1 PART 2-2001 Guidelines for the Classification of Medical Devices Rev 8
MEDDEV 2.1/1-1994 GUIDELINES RELATING TO THE APPLICATION OF: THE COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES
COM(92) 356-1992 Amended Proposal for a Council Directive Relating to the Medical Devices
90/385/EEC-1990 COUNCIL DIRECTIVE on the approximation of the laws of the Member States relating to active implantable medical devices
MEDDEV 2.2/3-1998 GUIDELINES RELATING TO THE APPLICATION OF: THE COUNCIL DIRECTIVE 90/385 EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES "USE-BY DATE" (Rev. 3)
MEDDEV 2.1/3-2009 GUIDELINES RELATING TO THE APPLICATION OF: THE COUNCIL DIRECTIVE 90/385/EEC ON ACTIVE IMPLANTABLE MEDICAL DEVICES THE COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES (Rev 3)

DIN

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

GSO

BH GSO 2680:2022 Halal medical device – General requirements
GSO 2680:2021 Halal medical device – General requirements
BH GSO 2628:2022 Medical devices and supplies classification criteria
GSO 2628:2021 Medical devices and supplies classification criteria
BH GSO ISO 16142-2:2022 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
GSO ISO 16142-2:2021 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
GSO ISO 16142-1:2021 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
BH GSO ISO 16142-1:2022 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standard...
GSO IEC/TR 62354:2014 General testing procedures for medical electrical equipment
GSO ISO 15223-1:2020 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
OS GSO ISO 15223-1:2020 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
GSO ISO/TR 19727:2021 Medical devices — Pump tube spallation test — General procedure
BH GSO ISO/TR 19727:2022 Medical devices — Pump tube spallation test — General procedure
GSO ISO 14708-6:2015 Implants for surgery -- Active implantable medical devices -- Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
GSO ISO 14708-6:2024 Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
BH GSO ISO 14708-6:2017 Implants for surgery -- Active implantable medical devices -- Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
OS GSO ISO 14708-6:2015 Implants for surgery -- Active implantable medical devices -- Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
GSO ISO 14708-2:2015 Implants for surgery -- Active implantable medical devices -- Part 2: Cardiac pacemakers

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 15223-2019 Medical devices－Symbols to be used with medical device labels, labelling and information to be supplied
KS P ISO 16142-2:2020 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical d
KS P ISO 16142-1:2019 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medic
KS P ISO 15223-1:2019 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements

AENOR

UNE-EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
UNE-EN 45502-2-1:2005 Active implantable medical devices -- Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
UNE-EN 45502-2-2:2008 Active implantable medical devices -- Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
UNE-EN 14254:2004 In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans
UNE 209001:2002 IN Guide for the management and the maintenance of active non implantable medical devices.

Lithuanian Standards Office

LST EN 15986-2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
LST EN 45502-2-1-2004 Active implantable medical devices -- Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
LST EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2012)

Danish Standards Foundation

DS/EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
DS/EN 45502-2-1:2004 Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (Cardiac pacemakers)
DS/EN ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
DS/EN 20594-1:1994 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment. Part 1: General requirements

ZA-SANS

SANS 15223:2006 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied

International Organization for Standardization (ISO)

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 16142-2:2017 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical d
ISO/TR 19727:2017 Medical devices — Pump tube spallation test — General procedure
ISO 15223-1:2007 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
ISO 6717:2021 In vitro diagnostic medical devices - Single-use containers for the collection of specimens from humans other than blood
ISO 15223-1:2007/Amd 1:2008 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements; Amendment 1
ISO 14708-6:2019 Implants for surgery — Active implantable medical devices — Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillato
ISO 16142-1:2016 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 16142-2:2017 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards

BE-NBN

NBN-EN 20594-1-1994 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment. Part 1: General requirements (ISO 594-1:1986)

KR-KS

KS P ISO 16142-1-2019 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 1: General essential principles and additional specific essential principles for all non-IVD medic
KS P ISO 16142-2-2020 Medical devices — Recognized essential principles of safety and performance of medical devices — Part 2: General essential principles and additional specific essential principles for all IVD medical d
KS P ISO 15223-1-2019 Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements

British Standards Institution (BSI)

BS ISO 16142-2:2017 Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
BS ISO 16142-1:2016 Medical devices. Recognized essential principles of safety and performance of medical devices. General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of s...
BS PD ISO/TR 19727:2017 Medical devices. Pump tube spallation test. General procedure
BS EN 45502-2-2:2008(2009) Active implantable medical devices — Part 2 - 2 : Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
BS EN ISO 14708-6:2022 Implants for surgery. Active implantable medical devices - Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices. General requirements
BS PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices. General requirements

GOSTR

GOST R 58450-2019 Medical devices with measuring functions. Condition monitoring
GOST R EN 14254-2010 In vitro diagnostic medical devices. Single-use receptacles for the collection of specimens, other than blood, from humans

US-AAMI

ANSI/AAMI/ISO 15223-1:2012 Medical devices.Symbols to be used with medical device labels, labeling, and information to be supplied.Part 1: General requirements

Canadian Standards Association (CSA)

CSA Z314.23-2012 Sterilization by chemical agent of reusable medical devices in healthcare establishments (first edition)
CAN/CSA-CEI/IEC 62304:2014 Medical device software - Software life cycle processes (First Edition)
CAN/CSA-Z17510-2015 Medical devices - Sleep apnoea breathing therapy - Masks and application accessories (First Edition)

ES-UNE

UNE-EN 45502-2-2:2008 CORR:2009 Active implantable medical devices -- Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
UNE-EN ISO 14708-6:2023 Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators) (ISO 14708-6:2019)

RU-GOST R

GOST R 57506-2017 Medical devices. Implantable defibrillators and other active implantable medical devices intended to treat tachyarrhythmia. Technical requirements for governmental purchases
GOST R 57497-2017 Medical devices. Implantable active devices intended to circulatory support. Technical requirements for governmental purchases
GOST R 59745-2021 Active implantable medical devices. Axial pumps for auxiliary blood circulation. General technical requirements

VN-TCVN

TCVN 6916-1-2008 Medical devices.Symbols to be used with medical device labels, labelling and information to be supplied.Part 1: General requirements

EU/EC - European Union/Commission Legislative Documents

MEDDEV 2.14/1-2012 GUIDELINES ON MEDICAL DEVICES IVD Medical Device Borderline and Classification issues A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES (REV 2)

GOST

GOST R 50444-2020 Medical instruments, apparatus and equipment. General technical requirements
GOST ISO 10993-11-2021 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST R ISO 10993-11-2009 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity

NZ-SNZ

AS/NZS 2696:1996 Medical Devices - Polymer Urethral Catheters for General Medical Use (Amendment 1 March 1999)

Underwriters Laboratories (UL)

UL 2800-1-2019 UL Standard for Safety Medical Device Interoperability (First Edition)

US-HHS

HHS 21 CFR PART 26-2011 MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY

VDE - VDE Verlag GmbH@ Berlin@ Germany

VDE-AR-E 2750-200-2013 Approach to the classification of medical devices and the selection of conformity assessment procedures

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