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Medical Device Testing Laboratory

Medical Device Testing Laboratory, Total:114 items.

In the international standard classification, Medical Device Testing Laboratory involves: Laboratory medicine, Vocabularies, Medical equipment, Applications of information technology, Medical sciences and health care facilities in general, Information sciences. Publishing, Wastes, Sterilization and disinfection, Construction materials.

British Standards Institution (BSI), Medical Device Testing Laboratory

• BS EN ISO 10993-5:1999 Biological evaluation of medical devices - Tests for in vitro cytotoxicity
• 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
• 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
• 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 EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
• BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to medical devices
• BS EN ISO 15195:2003 Laboratory medicine - Requirements for reference measurement laboratories
• 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 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 PD ISO/TR 19727:2017 Medical devices. Pump tube spallation test. General procedure

SCC, Medical Device Testing Laboratory

• 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
• BS PD ISO/TR 10993-55:2023 Biological evaluation of medical devices-Interlaboratory study on cytotoxicity
• 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 5736-8:1984 Evaluation of medical devices for biological hazards-Method of test for skin irritation of solid medical devices
• BS PD ISO/TR 80002-2:2017 Medical device software-Validation of software for medical device quality systems
• BS 5736-7:1983 Evaluation of medical devices for biological hazards-Method of test for skin irritation of extracts from medical devices
• BS 5736-4:1981 Evaluation of medical devices for biological hazards-Method of test for intracutaneous reactivity of extracts from medical devices
• 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
• 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
• 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
• SA HB 13485:2020 AS ISO 13485:2017 - Medical devices - A practical guide
• DIN 58921 E:2010 Draft Document - Test method to demonstrate the suitability of a medical device simulator during steam sterilisation - Medical device simulator testing
• SN-ISO/TS 10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
• DANSK DS/ISO/TS 10993-20:2006 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
• BS EN ISO 10993-1:1998 Biological evaluation of medical devices-Evaluation and testing

Korean Agency for Technology and Standards (KATS), Medical Device Testing Laboratory

• 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 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 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 10993-20-2009(2019) Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of 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 10993-20-2019 Biological evaluation of medical devices－Part 20：Principles and methods for immunotoxicology testing of medical devices
• KS P ISO TR 18112-2020 Clinical laboratory testing and in vitro diagnostic test systems－In vitro diagnostic medical devices for professional use－Summary of regulatory requirements for information supplied by the manufacturer

Professional Standard - Medicine, Medical Device Testing Laboratory

• 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 Medical device coagulation test methods

International Organization for Standardization (ISO), Medical Device Testing Laboratory

• 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/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 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/TR 19727:2017 Medical devices — Pump tube spallation test — General procedure

Jiangsu Provincial Standard of the People's Republic of China, Medical Device Testing Laboratory

• DB32/T 4271-2022 Medical device clean room (area) inspection specification

RO-ASRO, Medical Device Testing Laboratory

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

GSO, Medical Device Testing Laboratory

• 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
• GSO ISO/TR 19727:2021 Medical devices — Pump tube spallation test — General procedure
• 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/TS 10993-20:2017 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
• GSO ISO/TS 10993-20:2016 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
• BH GSO ISO/TR 19727:2022 Medical devices — Pump tube spallation test — General procedure
• BH GSO ISO/TR 80002-2:2022 Medical device software — Part 2: Validation of software for medical device quality systems

KR-KS, Medical Device Testing Laboratory

• 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

Anhui Provincial Standard of the People's Republic of China, Medical Device Testing Laboratory

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

Taiwan Provincial Standard of the People's Republic of China, Medical Device Testing Laboratory

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

RU-GOST R, Medical Device Testing Laboratory

• GOST ISO 10993-11-2011 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
• GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
• GOST R 51352-2013 In vitro diagnostic medical devices. Test methods
• 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 ISO 10993-5-2011 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
• GOST R ISO 10993-11-1999 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic to xicity
• GOST ISO 10993-6-2011 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
• GOST R ISO 10993-10-1999 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and sensitization
• 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 10993-10-2011 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity
• GOST R ISO 10993-6-1999 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation

European Committee for Standardization (CEN), Medical Device Testing Laboratory

• 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)

German Institute for Standardization, Medical Device Testing Laboratory

• DIN 58298:2005 Medical instruments - Materials, finish and testing
• DIN 13277 E:2021-02 Refrigerators and freezers for laboratory and medical applications - Terminology, requirements, testing
• DIN 13277:2022-05 Refrigerators and freezers for laboratory and medical applications - Terminology, requirements, testing / Note: DIN 13221 (2016-08), DIN 58345 (2007-09), DIN 58371 (2010-09) and DIN 58375 (2004-11) remain valid alongside this standard until 2022-10-31.
• DIN 13277:2022 Refrigerators and freezers for laboratory and medical applications - Terminology, requirements, testing
• DIN 58298:2010 Medical instruments - Materials, finish and testing
• DIN 58921 E:2010-02 Test method to demonstrate the suitability of a medical device simulator during steam sterilisation - Medical device simulator testing
• DIN EN 540:1993 Clinical testing of medical devices on humans
• DIN EN ISO 15195:2004 Laboratory medicine - Requirements for reference measurement laboratories (ISO 15195:2003); German version EN ISO 15195:2003

國家藥監(jiān)局, Medical Device Testing Laboratory

• YY/T 1808-2021 In vitro skin irritation test for medical devices

PL-PKN, Medical Device Testing Laboratory

• PN Z54058-1990 Medical instruments Needle holders Re?uirements and tests
• PN Z54032-1989 Medical instruments Haemostatic forceps Re?uirements and tests

EU/EC - European Union/Commission Legislative Documents, Medical Device Testing Laboratory

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

GOST, Medical Device Testing Laboratory

• 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

Shanxi Provincial Standard of the People's Republic of China, Medical Device Testing Laboratory

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

Association Francaise de Normalisation, Medical Device Testing Laboratory

• 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

US-FCR, Medical Device Testing Laboratory

• FCR VA 22 63 00-2010 GAS SYSTEMS FOR LABORATORY AND HEALTHCARE FACILITIES

US-VA, Medical Device Testing Laboratory

• VA 22 63 00-2010 GAS SYSTEMS FOR LABORATORY AND HEALTHCARE FACILITIES

Indonesia Standards, Medical Device Testing Laboratory

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

Guangdong Provincial Standard of the People's Republic of China, Medical Device Testing Laboratory

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

Japanese Industrial Standards Committee (JISC), Medical Device Testing Laboratory

• 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, Medical Device Testing Laboratory

• EN ISO 14971:2007 Medical devices - Application of risk management to medical devices
• EN ISO 15195:2019 Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures
• EN ISO 14971:2000 Medical Devices - Application of Risk Management to Medical Devices (Incorporates Amendment A1: 2003)
• EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
• EN ISO 14971:2019 Medical devices - Application of risk management to medical devices

South African Bureau of Standard, Medical Device Testing Laboratory

• SANS 14971:2008 Medical devices - Application of risk management to medical devices

Group Standards of the People's Republic of China, Medical Device Testing Laboratory

• T/CAMDI 008-2016 General rules for the implementation of medical device manufacturing quality management regulations for sterile medical device manufacturing equipment

American National Standards Institute （ANSI), Medical Device Testing Laboratory

• ANSI/AAMI/ISO TIR10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
• AAMI/ISO TIR10993-20:2006(R2021) Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
• AAMI TIR12:2004 Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China, Medical Device Testing Laboratory

• GB/T 16886.20-2015 Biological evaluation of medical devices.Part 20:Principles and methods for immunotoxicology testing of medical devices

International Electrotechnical Commission (IEC), Medical Device Testing Laboratory

• 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

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