Medical device aging test industry

Medical device aging test industry, Total:139 items.

The international standard classification for "Medical device aging test industry" includes: Medical equipment in general , Laboratory medicine .

The Chinese standard classification for "Medical device aging test industry" includes: General and microsurgical devices , Medical apparatus and devices in general , Standardization and Quality Management .

Professional Standard - Medicine

YY/T 1000.2-2005 Development of medical devices industrial standards - Part2: Guidance for work
YY 91056-1999 Evaluating requirements for corrosion test of electroplated metallic coatings of medical instruments
YY/T 91051-1999 System table for standard of medical devices
YY/T 0681.1-2009 Test methods for sterile medical device package—Part 1:Test guide for accelerated aging
YY/T 1911-2023 Test method of coagulation for medical devices
YY/T 1292.1-2015 Test for reproductive and developmental toxicity of medical devices―Part 1:Screening test
YY/T 0681.1-2018 Test methods for sterile medical device package―Part 1:Test guide for accelerated aging
YY/T 1808-2021 In vitro skin irritation test for medical devices

Group Standards of the People's Republic of China

T/CAMDI 001-2024 China Medical Device Industry Association Medical Polymer Products Professional Branch Standard System Table
T/ZAMEI 0002-2024 Medical device industry credit compliance construction guide
T/TMAC 112.F-2024 Credit qualification evaluation of medical device companies
T/CAMDI 001-2016 Standard System Table of Medical Polymer Products Branch of China Medical Device Industry Association
T/ZMDS 50002-2021 Medical device - Air purification system validation
T/CAMDI 134.4-2024 Machinery and Equipment - High Polymer Materials and Packaging Materials for Medical Use - Guide to Accelerated Aging Tests - Part 4: Selection Method of Accelerated Aging Temperature
T/CARM 001-2022 Basic specification for rehabilitation medical services in senior care organization

General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China

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

Jiangsu Provincial Standard of the People's Republic of China

DB3210/T 1156-2023 Guide to the safe use of ethylene oxide in the medical device manufacturing industry

Hubei Provincial Standard of the People's Republic of China

DB42/T 2088.2-2023 Hubei Province Drugs, Medical Devices, and Cosmetics Supervision Data Collection Specifications Part 2: Medical Devices

RO-ASRO

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

GCC Standardization Organization

GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
GSO ISO 9626:2013 Stainless steel needle tubing for the manufacture of medical devices
GSO ASTM F1980:2021 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
GSO ASTM F1980:2024 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
GSO ISO/TR 19727:2021 Medical devices — Pump tube spallation test — General procedure
GSO ISO/TS 10993-20:2016 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
GSO ISO/TR 80002-2:2021 Medical device software — Part 2: Validation of software for medical device quality systems
GSO ISO 23128:2022 Medical devices — Transfusion set and blood bag compatibility test method
OS GSO ISO 22441:2024 Sterilization of health care products — Low temperature vaporized hydrogen peroxide — Requirements for the development, validation and routine control of a sterilization process for medical devices

American Society for Testing and Materials (ASTM)

ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM F1980-99e1 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
ASTM F1980-21 Standard Guide for Accelerated Aging of Sterile Medical Device Packages
ASTM F1980-07(2011) Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO ASTM F1980:2022 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
BH GSO ASTM F1980:2024 Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
BH GSO ISO/TS 10993-20:2017 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
BH GSO ISO 23128:2023 Medical devices — Transfusion set and blood bag compatibility test method

Gosstandart of Russia

GOST ISO 10993-11-2011 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST R 51352-2013 In vitro diagnostic medical devices. Test methods
GOST R ISO 14155-2-2008 Clinical investigation of medical devices for human subjects. Part 2. Clinical investigation plans
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 ISO/TS 10993-20-2009 Medical devices. Biological evaluation of medical devices. Part 20. Principles and methods for immunotoxicology testing of medical devices
GOST R 57502-2017 Medical equipment. Industrial production regulation
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 10993-10-2011 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity
GOST R 52770-2016 Medical devices. Safety requirements. Methods of sanitation-chemical and toxicological tests
GOST ISO/TS 10993-19-2011 Medical devices. Biological evaluation of medical devices. Part 19. Tests physico-chemical, morphological and topographical characterization of materials
GOST R ISO 14155-1-2008 Clinical investigation of medical devices for human subjects. Part 1. General requirements
GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
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 10993-18-2011 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
GOST ISO 10993-4-2020 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST ISO 10993-4-2011 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST R ISO 10993-11-1999 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic to xicity
GOST R ISO 10993-10-1999 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and sensitization
GOST ISO 10993-3-2011 Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
GOST ISO 10993-3-2018 Medical levices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicit

British Standards Institution (BSI)

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
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
PD ISO/TR 80002-2:2017 Medical device software — Part 2: Validation of software for medical device quality systems
BS PD ISO/TR 19727:2017 Medical devices. Pump tube spallation test. General procedure
BS EN ISO 10993-1:1998 Biological evaluation of medical devices-Evaluation and testing
BS EN ISO 17664:2017 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices
BS BIP 0113:2012 Guide to European medical device trials and BS EN ISO 14155
BS EN 30993-1:1994 Biological evaluation of medical devices-Guidance on selection of tests
BS EN ISO 10993-11:1996 Biological evaluation of medical devices-Tests for systemic toxicity
BS EN ISO 10993-11:2006 Biological evaluation of medical devices-Tests for systemic toxicity
BS PD ISO/TS 23128:2019 Medical devices. Transfusion set and blood bag compatibility test method
BS 5736-3:1981 Evaluation of medical devices for biological hazards-Method of test for systemic toxicity; assessment of acute toxicity of extracts from medical devices
BS 5736-5:1982 Evaluation of medical devices for biological hazards-Method of test for systemic toxicity; assessment of pyrogenicity in rabbits of extracts from medical devices
BS EN ISO 10993-5:1999 Biological evaluation of medical devices - Tests for in vitro cytotoxicity
BS 5736-11:1990 Evaluation of medical devices for biological hazards-Method of test for haemolysis
BS EN ISO 10993-14:2001 Biological evaluation of medical devices - Identification and quantification of degradation products from ceramics
BS EN ISO 10993-18:2020+A1:2023 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process

German Institute for Standardization

DIN 58298:2005 Medical instruments - Materials, finish and testing
DIN 58298:2010 Medical instruments - Materials, finish and testing
DIN 5343:2020 Cleanliness of medical devices - Process design and test methods; Text in German and English
DIN EN ISO 11135:2014-10 Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)

Society of Automotive Engineers (SAE)

SAE J3020_201405 Medical Device Shot Peening

Association of German Mechanical Engineers

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
VDI/VDE 2426 Blatt 2-1995 Standardized catalogue of medical devices
VDI 5201 BLATT 1-2015 Adaptability - Description and measurement of the adaptability of manufacturing companies - Medical device industry
VDI 5201 BLATT 1-2017 Adaptability - Description and measurement of the adaptability of manufacturing companies - Medical device industry
VDI/VDE 2426 BLATT 2-2000 Catalogs in the maintenance and management of medical technology — Standardized equipment catalog

Canadian Standards Association (CSA)

CAN/CSA Z314.4-1987 Industrial Sterilization of Medical Devices by the Steam Process
CSA Z314.5-1979 Industrial Sterilization of Medical Devices by the Ethylene Oxide Process
CAN/CSA Z314.5-1988 Industrial Sterilization of Medical Devices by the Ethylene Oxide Process
CSA Z314.4-M1979-1979 Industrial Sterilization of Medical Devices by the Steam Process
CAN/CSA-Z314.5-1988 Industrial Sterilization of Medical Devices by the Ethylene Oxide Process
CAN/CSA-Z314.4-1987 Industrial Sterilization of Medical Devices by the Steam Process
CSA Z314.23-16:2016 Chemical sterilization of reusable medical devices in healthcare settings
CAN/CSA Z314.8-2000(R2005) Decontamination of Reusable Medical Devices
CAN/CSA Z314.8-2008(R2013) Decontamination of Reusable Medical Devices
CAN/CSA-Z314.8-2000(R2007) Decontamination of Reusable Medical Devices
CAN/CSA-Z314.8-2000(C2007) Decontamination of reusable medical devices
CAN/CSA-Z314.8-2008(R2013) Decontamination of Reusable Medical Devices
CAN/CSA-Z314.8-2008(C2013) Decontamination of reusable medical devices
CSA Z314.8-14:2014 Decontamination of reusable medical devices

Danish Standards Foundation

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
DANSK DS/ISO/TS 10993-20:2006 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
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/ISO/TS 23128:2020 Medical devices – Transfusion set and blood bag compatibility test method

Bureau of Indian Standards

IS/ISO/TR 80002-2-2017 Medical Device Software Part 2 Validation of Software for Medical Device Quality Systems
IS/ISO/TS 10993-20-2006 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
IS 12572-9-1988 Guide for Evaluation of Medical Devices for Biological Hazards Part 9 Method of Test for Skin Irritation by Solid Medical Devices
IS 12572-5-1988 Guide for Evaluation of Medical Devices for Biological Hazards Part 5 Method of Test for Intracutaneous Reactivity of Extracts from Medical Devices
IS 12572-8-1988 Guide for Evaluation of Medical Devices for Biological Hazards Part 8 Method of Test for Skin Irritation of Extracts from Medical Devices: and

Swedish Institute for Standards

SS-EN ISO 18472:2006 Sterilization of health care products - Biological and chemical indicators - Test equipment (ISO 18472:2006)

Ente Nazionale Italiano di Unificazione

UNI EN ISO 10993-1:1999 Biological evaluation of medical devices - Evaluation and testing

Korean Agency for Technology and Standards (KATS)

KS P ISO 10993-20-2009(2024) Biological evaluation of medical devices － Part 20: Principles and methods for immunotoxicology testing of medical devices
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 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 TR 80002-2:2021 Medical device software — Part 2: Validation of software for medical device quality systems
KS T 5011-2020 Packaging—Complete, filled transport packages —Test methods for transport packaging of medical devices

American National Standards Institute （ANSI)

AAMI/ISO TIR10993-20:2006(R2021) Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
ANSI/AAMI/ISO TIR10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices

Standards Norway

SN-ISO/TS 10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices

International Organization for Standardization (ISO)

ISO/TR 19727:2017 Medical devices — Pump tube spallation test — General procedure
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
ISO/TS 23128:2019 Medical devices — Transfusion set and blood bag compatibility test method
ISO/TR 21582:2021 Pyrogenicity — Principles and methods for pyrogen testing of medical devices
ISO 10993-18:2020/Amd.1:2022 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process

The Directorate General of Specifications and Metrology (DGSM)

OS GSO ISO/TS 10993-20:2016 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices

Association Francaise de Normalisation

NF S90-463 Medical surgical equipment. Surgical medical instruments. Scissors. Dimensions and tests.
NF S90-463:1982 Medical and surgical equipment. Surgical instruments. Scissors. Dimensions and tests.

IN-BIS

IS 12572 Pt.8-1988 Guidelines for Biohazard Assessment of Medical Devices Part 8 Skin Irritation Test Methods for Medical Device Extracts
IS 12572 Pt.9-1988 Guidelines for Biohazard Evaluation of Medical Devices Part 9 Test Methods for Skin Irritation from Solid Medical Devices
IS 12572 Pt.5-1988 Guidelines for Biohazard Evaluation of Medical Devices Part 5 Test Method for Intradermal Reactivity of Medical Device Extracts

Standard Association of Australia （SAA）

AS ISO 10993.10:2002 Biological evaluation of medical devices - Tests for irritation and sensitization
AS ISO 10993.11:2002/Amdt 1:2005 Biological evaluation of medical devices Systemic toxicity testing

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