Laboratory and Medical Devices

Laboratory and Medical Devices, Total:353 items.

The international standard classification for "Laboratory and Medical Devices" includes: Medical equipment in general , Medical Sciences and health care facilities in general , Medical equipment .

The Chinese standard classification for "Laboratory and Medical Devices" includes: Medical laboratory equipment , Medical apparatus and devices in general , General and microsurgical devices , Medical science , Public medical equipment .

Jiangsu Provincial Standard of the People's Republic of China

DB32/T 4271-2022 Medical device clean room (area) inspection specification
DB3211/T 1054-2022 Data collection and application specifications for household medical devices
DB3212/T 1141-2023 Implementation and Application Specifications for Unique Identification of Medical Devices

Shanxi Provincial Standard of the People's Republic of China

DB1409/T 44-2023 PCR laboratory medical waste disposal procedures

Guangdong Provincial Standard of the People's Republic of China

DB4403/T 218-2021 Implementation Specification for Unique Identification of Medical Devices

Anhui Provincial Standard of the People's Republic of China

DB34/T 4425-2023 Guidelines for the construction of therapeutic drug monitoring laboratories in medical institutions

Group Standards of the People's Republic of China

T/CAMDI 008-2016 General rules for the implementation of medical device manufacturing quality management regulations for sterile medical device manufacturing equipment
T/ZMDS 50004-2023 Medical device - validation for cleanroom and related controlled environments monitoring system
T/ZGXX 0003-2019 Medical device cleaning agent

Professional Standard - Medicine

YY/T 0049-1991 Drawings and design document formats for medical devices
YY/T 0316-2016 Medical devices-Application of risk management to medical devices
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 1943-2024 UDI implementation and application in medical device package levels
YY/T 0468-2015 Medical devices―Quality management―Medical device nomenclature data structure
YY/T 0690-2008 Clinical laboratory testing and in vitro medical devices—Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
YY/T 1911-2023 Test method of coagulation for 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
GB/T 43278-2023 Medical laboratories—Application of risk management to medical laboratories
GB/T 27780-2011 Laboratory efficacy test methods and criterions of public health equipment—Rodent sticky trap

未注明发布机构

DIN 96057 E:2022-08 Medical instruments - Raspatory type Sedillot
DIN 58852 E:2020-06 Medical instruments - Probes
DIN 58852 E:2014-02 Medical instruments - Probes
DIN 13173 E:2022-08 Medical instruments - Dressing forceps
DIN 58846 E:2017-06 Medical instruments - Raspatories
DIN 96057:2016-03 Medical instruments - Raspatory type Sedillot
ANSI/AAMI/ISO 15225:2016 Medical devices—Quality management—Medical device nomenclature data structure
ANSI/AAMI/ISO 14971:2019 Medical devices— Application of risk management to medical devices
DIN 96056:2023-03 Medical instruments - Bone raspatory
DIN EN ISO 14971 E:2018-08 Application of medical device risk management in medical devices (draft)
DIN 13145 E:2008-09 Medical instruments - Mallet of plastic material
DIN 96057 E:2015-09 Medical instruments - Raspatory type Sedillot
DIN 13119 E:2008-09 Medical instruments bowel scissors
ISO 13485-2016 Practical Guide Medical devices apracticalguide Advice from ISO/TC 210
DIN 13173 E:2016-07 Medical instruments - Dressing forceps
DIN 96056:2016-03 Medical instruments - Bone raspatory
DIN 96056 E:2015-09 Medical instruments - Bone raspatory
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
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
DIN EN ISO 14971:2022 Medical devices – applying risk management to medical devices
DIN 96056 E:2022-08 Medical instruments - Bone raspatory

Taiwan Provincial Standard of the People's Republic of China

CNS 14393.5-2004 Biological evaluation of medical devices – Part 5：Tests for in vitro cytotoxicity

国家食品药品监督管理局

YY/T 1474-2016 Medical devices－Application of risk management to medical devices

Military Standard of the People's Republic of China-General Armament Department

GJB 162-1986 Surface ship medical cabin layout and installation of medical equipment
GJB 4574-1990*GJBz 20032-1990 Service ship medical cabin layout and installation of medical equipment

国家药监局

YY/T 1808-2021 In vitro skin irritation test for medical devices
YY/T 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer

Professional Standard - Commodity Inspection

SN/T 1430.1-2004 Rules for the inspection of medical electrical equipment for improt - Ultrasonic medical diagnostic and therapy equipment

British Standards Institution (BSI)

BS EN ISO 10993-5:1999 Biological evaluation of medical devices - Tests for in vitro cytotoxicity
PD ISO/TR 10993-55:2023 Biological evaluation of medical devices. Interlaboratory study on cytotoxicity
BS EN 1614:2006 Health informatics - Representation of dedicated kinds of property in laboratory medicine
PD ISO/TS 11796:2023 Biological evaluation of medical devices. Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
BS ISO 17593:2022 Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
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 62366-1:2015 Medical devices. Application of usability engineering to medical devices
BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
BS EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
DD ENV 1613-1996 Medical informatics. Messages for exchange of laboratory information
BS PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering to medical devices
BS EN ISO 14971:2019+A11:2021 Medical devices - Application of risk management to medical devices
BS DD ENV 1613:1996 Medical informatics - Messages for exchange of laboratory information
21/30402425 DC BS ISO 17593. Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for selftesting of oral anticoagulant therapy
BS EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
BS EN 556-1:2024 Sterilization of medical devices. Requirements for medical devices to be designated "STERILE" - Requirements for terminally sterilized medical devices
BS EN 556-2:2015 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
BIP 0115-2014 Implementing an ISO 13485 Quality Management System for Medical Devices
BS EN 61010-2-045:2001 Safety requirements for electrical equipment for measurement, control and laboratory use - Particular requirements for washer disinfectors used in medical, pharmaceutical, veterinary and laboratory fields
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 EN ISO 7786:2001 Dental rotary instruments. Laboratory abrasive instruments

SCC

BS PD ISO/TR 10993-55:2023 Biological evaluation of medical devices-Interlaboratory study on cytotoxicity
MIL MIL-C-42068-1989 CHEST, MEDICAL INSTRUMENT AND SUPPLY SET
DANSK DS/ISO/TR 10993-55:2023 Biological evaluation of medical devices – Part 55: Interlaboratory study on cytotoxicity
BS PD ISO/TS 11796:2023 Biological evaluation of medical devices. Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
DANSK DS/ISO 15198:2004 Clinical laboratory medicine - In vitro diagnostic medical devices - Validation of user quality control procedures by the manufacturer
BS PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems
DANSK DS/ISO/TS 11796:2023 Biological evaluation of medical devices – Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
DANSK DS/ISO 17593:2007 Clinical laboratory testing and in vitro medical devices – Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
SA HB 13485:2020 AS ISO 13485:2017 - Medical devices - A practical guide
BS 5736-8:1984 Evaluation of medical devices for biological hazards-Method of test for skin irritation of solid medical devices
CAN/CSA-ISO 14971:2007(C2012) Medical devices - Application of risk management to medical devices
CEI UNI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
AAMI/ISO 14971:2019 Medical devices - Application of risk management to medical devices
CAN/CSA-ISO 14971:2007(R2012) Medical Devices - Application of Risk Management to Medical Devices
DANSK DS/EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
DANSK DS/ISO 14971:2020 Medical devices – Application of risk management to medical devices
CAN/CSA-ISO 14971:2001(R2006) Medical Devices - Application of Risk Management to Medical Devices
ISO 14971:2019 Plus Redline Medical devices - Application of risk management to medical devices
BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices
CAN/CSA-ISO 14971:2001(C2006) Medical devices - Application of risk management to medical devices
BS 5736-7:1983 Evaluation of medical devices for biological hazards-Method of test for skin irritation of extracts from medical devices
BS BIP 0115:2014 Implementing an ISO 13485 Quality Management System for Medical Devices
CEI UNI EN/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
DANSK DS/EN ISO 15225:2016 Medical devices – Quality management – Medical device nomenclature data structure
AAMI/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
CEI EN 62366:2008 Medical devices - Application of usability engineering to medical devices
AENOR UNE-EN 62366:2009 Medical devices - Application of usability engineering to medical devices
DANSK DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
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
AENOR UNE-EN 62366/A1:2009 Medical devices - Application of usability engineering to medical devices
CEI EN 62366/A1:2008 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/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
BS 5736-4:1981 Evaluation of medical devices for biological hazards-Method of test for intracutaneous reactivity of extracts from 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
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
DIN 58857:2019 Medical instruments - Directors
DIN 96056:2016 Medical instruments - Bone raspatory
SN-CR 14060:2000 Medical device traceability
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
UNE-EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements
DANSK DS/EN ISO 7786:2001 Dental rotary instruments - Laboratory abrasive instruments
BS 5736-10:1988 Evaluation of medical devices for biological hazards-Method of test for toxicity to cells in culture of extracts from 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
NS-ISO 7786:1990 Dental rotary instruments — Laboratory abrasive instruments
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
NS-EN ISO 14971:2019 Medical devices — Application of risk management to medical devices (ISO 14971:2019)
NS-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
NS-EN 556:1994 Sterilization of medical devices — Requirements for medical devices to be labelled "Sterile"
AENOR UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
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
UNE-EN ISO 14971:2001 Medical devices - Application of risk management to medical devices. (ISO 14971:2000)
UNE-EN ISO 14971:2007 Medical devices - Application of risk management to medical devices (ISO 14971:2007)
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)
DANSK DS/ISO 22367:2020 Medical laboratories – Application of risk management to medical laboratories
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 556-2:2003 Sterilization of medical devices — Requirements for medical devices to be designated "STERILE" — Part 2: Requirements for aseptically processed medical devices
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
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)
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
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
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
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
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
BS PD IEC/TR 80002-1:2009 Medical device software-Guidance on the application of ISO 14971 to medical device software
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
DANSK DS/ISO/TR 22869:2005 Medical laboratories – Guidance on laboratory implementation of ISO 15189:2003
DIN 58274:2016 Medical instruments - Iris forceps
DIN 96057:2016 Medical instruments - Raspatory type Sedillot
DIN 13184:2016 Medical instruments - Bone holding forceps Farabeuf's
DIN 58318:2019 Medical instruments - Elevators Langenbeck's
DIN 58319:2019 Medical instruments - Elevators Williger
NS-EN ISO 15225:2016 Medical devices — Quality management — Medical device nomenclature data structure (ISO 15225:2016)
NS-EN ISO 15225:2010 Medical devices — Quality management — Medical device nomenclature data structure (ISO 15225:2010)
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

KR-KS

KS P ISO 15198-2017 Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
KS P ISO 14971-2018 Medical devices — Application of risk management to medical devices
KS P ISO 14971-2021 Medical devices — Application of risk management to medical devices
KS P ISO TR 80002-2-2021 Medical device software — Part 2: Validation of software for medical device quality systems
KS P ISO 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 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

European Committee for Standardization (CEN)

EN 1614:2006 Health informatics - Representation of dedicated kinds of property in laboratory medicine
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
CENELEC EN 62366-2008 Medical devices - Application of usability engineering to medical devices
EN 556:1994 Sterilization of Medical Devices - Requirements for Medical Devices to Be Labelled `Sterile'
EN 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 27786:1991 Dental rotary instruments; laboratory abrasive instruments (ISO 7786:1990)
EN ISO 14971:2019/A11:2021 Medical devices - Application of risk management to medical devices (ISO 14971:2019)

International Organization for Standardization (ISO)

ISO/TS 11796:2023 Biological evaluation of medical devices — Requirements for interlaboratory studies to demonstrate the applicability of validated in vitro methods to assess the skin sensitization of medical devices
ISO/TR 10993-55:2023 Biological evaluation of medical devices — Part 55: Interlaboratory study on cytotoxicity
ISO 17593:2022 Clinical laboratory testing and in vitro medical devices — Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
ISO 14971:2019 Medical devices — Application of risk management to medical devices
ISO/TR 22869:2005 Medical laboratories - Guidance on laboratory implementation of ISO 15189:2003
ISO 14971:2000 Medical devices - Application of risk management to medical devices
IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
ISO 7786:1984 Dental rotary instruments — Laboratory abrasive instruments
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 7786:1990 Dental rotary instruments; Laboratory abrasive instruments

US-VA

VA FED H-08-6 SEC 516-1977 LIST OF LABORATORY WASHING AND MISCELLANEOUS HOSPITAL EQUIPMENT SYMBOLS
VA 22 63 00-2010 GAS SYSTEMS FOR LABORATORY AND HEALTHCARE FACILITIES
VA 22 62 00-2012 VACUUM SYSTEMS FOR LABORATORY AND HEALTHCARE FACILITIES

RO-ASRO

STAS E 10719/2-1986 Medical instruments RESISTANCE TESTING AT CORROSION AND REPEATED STERILIZATIONS STAINLESS STEEL MEDICAL INSTIUMENTS

Korean Agency for Technology and Standards (KATS)

KS P ISO 17593-2019 Clinical laboratory testing and in vitro medical devices－Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
KS P ISO 17593-2009(2019) Clinical laboratory testing and in vitro medical devices－Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
KS P ISO 14971:2021 Medical devices — Application of risk management to medical devices
KS P ISO 14971:2018 Medical devices — Application of risk management to medical devices
KS P ISO TR 80002-2:2021 Medical device software — Part 2: Validation of software for medical device quality systems
KS P ISO TR 22869:2009 Medical laboratories－Guidance on laboratory implementation of KS P ISO 15189：2006
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 22367-2023 Medical laboratories — Application of risk management to medical laboratories
KS P ISO 7786:2004 Dental rotary instruments-Laboratory abrasive instruments
KS P ISO 10993-20-2009(2019) Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices

GSO

OS GSO ISO 17593:2016 Clinical laboratory testing and in vitro medical devices -- Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
GSO ISO 17593:2016 Clinical laboratory testing and in vitro medical devices -- Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
BH GSO 2628:2022 Medical devices and supplies classification criteria
GSO 2628:2021 Medical devices and supplies classification criteria
GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
GSO ISO/TR 80002-2:2021 Medical device software — Part 2: Validation of software for medical device quality systems
BH GSO ISO/TR 80002-2:2022 Medical device software — Part 2: Validation of software for medical device quality systems
BH GSO ISO 14971:2017 Medical devices -- Application of risk management to medical devices
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
BH GSO ISO 15225:2017 Medical devices -- Quality management -- Medical device nomenclature data structure
GSO ISO 15225:2016 Medical devices -- Quality management -- Medical device nomenclature data structure
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
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
OS GSO ISO 7786:2016 Dental rotary instruments -- Laboratory abrasive instruments
BH GSO ISO 7786:2017 Dental rotary instruments -- Laboratory abrasive instruments
GSO ISO 7786:2016 Dental rotary instruments -- Laboratory abrasive instruments
GSO ISO/TR 22869:2016 Medical laboratories -- Guidance on laboratory implementation of ISO 15189: 2003
OS GSO ISO/TR 22869:2016 Medical laboratories -- Guidance on laboratory implementation of ISO 15189: 2003

EU/EC - European Union/Commission Legislative Documents

MEDDEV 2.15-2008 GUIDELINES ON MEDICAL DEVICES Committees/Working Groups contributing to the implementation of the Medical Device Directives (REV 3)

RU-GOST R

GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
GOST ISO 10993-11-2011 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST R ISO 15225-2014 Medical devices. Quality management. Medical device nomenclature data structure
GOST ISO 10993-5-2011 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
GOST ISO 10993-6-2011 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST R 51352-2013 In vitro diagnostic medical devices. Test methods
GOST R 50565-1993 Dental rotary instruments. Laboratory abrasive instruments. Head
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 10993-10-2011 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity

Association Francaise de Normalisation

NF S97-512*NF EN 1614:2006 Health Informatics - Representation of dedicated kinds of property laboratory medicine
NF S99-211:2013 Medical devices - Application of risk management to medical devices
NF EN ISO 14971:2019 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/A11:2021 Medical devices - Application of risk management to medical devices
NF S98-116-2*NF ISO 17664-2:2021 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2 : non-critical medical devices
NF S99-012:2010 Medical devices - Quality management - Medical device nomenclature data structure.
NF S99-401:1994 Dispositifs médicaux - Élastomère de silicone de qualité médicale
NF S98-136:2009 Sterilisation of medical devices - Risk management related to the preparation of sterile medical devices within health establishments.
NF EN 556-1:2002 Stérilisation des dispositifs médicaux - Exigences relatives aux dispositifs médicaux en vue d'obtenir l'étiquetage STERILE - Partie 1 : exigences relatives aux dispositifs médicaux stérilisés au stade terminal
NF EN ISO 7786:2001 Dental rotary instruments - Laboratory abrasive instruments
NF S91-118:1991 Dental rotary instruments. Laboratory abrasive instruments.
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

US-FCR

FCR VA 22 63 00-2010 GAS SYSTEMS FOR LABORATORY AND HEALTHCARE FACILITIES
FCR VA 22 62 00-2012 VACUUM SYSTEMS FOR LABORATORY AND HEALTHCARE FACILITIES
FCR 21 CFR PART 810-2014 MEDICAL DEVICE RECALL AUTHORITY
FCR 21 CFR PART 810-2013 MEDICAL DEVICE RECALL AUTHORITY
FCR 21 CFR PART 810-2015 MEDICAL DEVICE RECALL AUTHORITY

Indonesia Standards

SNI ISO 15198:2009 Clinical laboratory medicine - In vitro diagnostic medical devices - validation of user quality control procedures by the manufacturer

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

CEN - European Committee for Standardization

EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
EN ISO 14971:2000 Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
EN ISO 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 13824:2004 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

ZA-SANS

SANS 14971:2008 Medical devices - Application of risk management to medical devices
SANS 15189:2004 Medical laboratories - Particular requirements for quality and competence

GOST

GOST R ISO 14155-2022 Clinical investigation of medical devices for human subjects. Good clinical practice
GOST R ISO/TS 10993-20-2009 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices

International Electrotechnical Commission (IEC)

ISO/TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
ISO TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
ISO/TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
IEC 62366:2014 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 61010-2-045:2000 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-045: Particular requirements for washer disinfectors used in medical, pharmaceutical, veterinary and laboratory fields
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

American Society for Testing and Materials (ASTM)

ASTM E3418-23 Standard Practice for Calculating Scientifically Justifiable Limits of Residues for Cleaning of Pharmaceutical and Medical Device Manufacturing Equipment and for Medical Devices
ASTM E3418-23e1 Standard Practice for Calculating Scientifically Justifiable Limits of Residues for Cleaning of Pharmaceutical and Medical Device Manufacturing Equipment and for Medical Devices
ASTM F2503-20 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
ASTM F619-79(1997)e1 Standard Practice for Extraction of Medical Plastics
ASTM F619-20 Standard Practice for Extraction of Materials Used in Medical Devices

TH-TISI

TIS 14971-2013 Medical devices.application of risk management to medical devices

Military Standards (MIL-STD)

DOD MIL-C-37106-1974 CASE, MEDICAL LABORATORY EQUIPMENT SET
DOD MIL-C-37106 VALID NOTICE 1-1989 CASE, MEDICAL LABORATORY EQUIPMENT SET

German Institute for Standardization

DIN 58846:2017-11 Medical instruments - Raspatories
DIN 58794:1982 Medical instruments; ear forceps
DIN 58794:2010 Medical instruments - Ear forceps
DIN 96056:2009 Medical instruments - Bone raspatory
DIN 58852:2008 Medical instruments - Probes
DIN 13119:1980 Medical instruments; bowel scissors
DIN 58852:2014 Medical instruments - Probes
DIN 13119:2010 Medical instruments - Bowel scissors
DIN 13117:1980 Medical instruments; bone shears
DIN 58852:2021 Medical instruments - Probes
DIN 13117:2013 Medical instruments.Bone shears
DIN 58857:2019-12 Medical instruments - Directors
DIN 58852:1976 Medical instruments; probes
DIN EN 1614:2006 Health informatics - Representation of dedicated kinds of property in laboratory medicine; English version EN 1614:2006
DIN 58298:2005 Medical instruments - Materials, finish and testing
DIN EN ISO 7786:2001-09 Dental rotary instruments - Laboratory abrasive instruments (ISO 7786:2001); German version EN ISO 7786:2001
DIN 58864:2010 Medical instruments - Bone curettes type Simon, type Schröder and type Halle
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 58298:2010 Medical instruments - Materials, finish and testing
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 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 58795:2010 Medical instruments - Mouth gags - Dimensions for slide bars and tongue depressors
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 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 ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
DIN 58263:1973 Medical instruments; mouth gag Heister's
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 ISO 22367:2020-09 Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020); German version EN ISO 22367:2020
DIN 13173:2005 Medical instruments - Dressing forceps
DIN 58292:2010 Medical instruments - Tracheal hook
DIN 58292:1972 Medical instruments; tracheal hook
DIN 58230:1974 Medical instruments; amputation knives
DIN 58862:1988 Medical instruments; bone curettes
DIN 96057:2023-03 Medical instruments - Raspatory type Sedillot
DIN 58319:2019-12 Medical instruments - Elevators Williger
DIN 13104:2010 Medical instruments - Cartilage knife
DIN 58857:1976 Medical instruments; directors
DIN 13173:2023-03 Medical instruments - Dressing forceps
DIN 13111:2006 Medical instruments - Bandage scissors
DIN 13103:1973 Medical instruments; dissecting scalpels
DIN 58318:2019-12 Medical instruments - Elevators Langenbeck's
DIN 13111:2018 Medical instruments - Bandage scissors
DIN 58846:2017 Medical instruments - Raspatories
DIN 58858:2021-02 Medical instruments - Director type König
DIN 58230:2010 Medical instruments - Amputation knives
DIN 13458:2009 Medical instruments - Ligature needle
DIN 13145:1979 Medical instruments; mallet of plastic material
DIN 58862:2010 Medical instruments - Bone curettes
DIN 13145:2010 Medical instruments - Mallet of plastic material
DIN 58846:1988 Medical instruments; raspatories
DIN 58846:2010 Medical instruments - Raspatories
DIN 13173:2016 Medical instruments - Dressing forceps
DIN 13458:1988 Medical instruments; ligature needle

ES-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)
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 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 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 ISO 22367:2020 Medical laboratories - Application of risk management to medical laboratories (ISO 22367:2020)

Standard Association of Australia （SAA）

AS ISO 14971:2020 Medical devices — Application of risk management to medical devices
AS ISO 22367:2021 Medical laboratories — Application of risk management to medical laboratories

Danish Standards Foundation

DS/EN ISO 14971:2013 Medical devices - Application of risk management to medical devices
DS/EN ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
DS/CEN/CR 14060:2001 Medical device traceability
DS/EN ISO 7786:2001 Dental rotary instruments - Laboratory abrasive instruments
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/EN 556-1:2002 Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 1: Requirements for terminally sterilized medical devices

CZ-CSN

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

American National Standards Institute （ANSI)

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

CENELEC - European Committee for Electrotechnical Standardization

EN 62366:2008 Medical devices - Application of usability engineering to medical devices

DIN

DIN EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements
DIN 96056:2023 Medical instruments - Bone raspatory
DIN 13173:2023 Medical instruments - Dressing forceps

AENOR

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

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 556-2-2004 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)
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

Canadian Standards Association (CSA)

CSA ISO 14971-07-CAN/CSA:2007 Medical Devices - Application of Risk Management to Medical Devices second edition
CAN/CSA-ISO 14971:2007 Medical Devices - Application of Risk Management to Medical Devices (Second Edition)

GOSTR

GOST R ISO/TR 22869-2009 Medical laboratories. Quidance on laboratory implementation of ISO 15189:2003

PL-PKN

PN Z54061-1986 Medical instruments Ears Dimensions

TR-TSE

TS 3521-1980 CONICALFITTINGS FOR SYRINGES NEEDLES AND OTHER MEDICAL EQUIPMENT

Others: Laboratory and Medical Devices,Medical Device Testing Laboratory,Medical Device Laboratory,Labware and its name,Medical Device Laboratory,Medical Device Central Laboratory,Medical Device Biological Laboratory,Inter-laboratory and intra-laboratory comparisons,The following laboratory operations and,Laboratory design and installation,Laboratory Management and Application,Laboratory and Testing Capabilities,laboratory specifications and,Development and development of a class of medical devices,Class I medical equipment and maintenance,Inter-laboratory and intra-laboratory comparisons,Maintenance and maintenance of Class II medical devices,Laboratory and testing conditions,biochemical technology and medical devices,Medical Device Testing Laboratory