Medical Device Aging Test

Medical Device Aging Test, Total:228 items.

The international standard classification for "Medical Device Aging Test" includes: Medical equipment in general , Laboratory medicine , Medical equipment .

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

Professional Standard - Medicine

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 91056-1999 Evaluating requirements for corrosion test of electroplated metallic coatings of medical instruments
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

国家药监局

YY/T 0802-2020 Processing of medical devices—Information to be provided by the medical device manufacturer
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

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
GB/Z 42217-2022 Medical device —Validation of software for medical device quality system
GB/T 42062-2022 Medical devices—Application of risk management to medical devices

国家食品药品监督管理局

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

Group Standards of the People's Republic of China

T/ZMDS 50002-2021 Medical device - Air purification system validation

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

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

GSO

BH GSO ASTM F1980:2022 Standard Guide for Accelerated Aging of Sterile Barrier Systems for 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 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
OS 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 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
BH GSO ISO 23128:2023 Medical devices — Transfusion set and blood bag compatibility test method
GSO ISO 23128:2022 Medical devices — Transfusion set and blood bag compatibility test method
BH GSO ISO 15225:2017 Medical devices -- Quality management -- Medical device nomenclature data structure
OS GSO IEC 62366:2014 Medical devices - Application of usability engineering to medical devices
GSO ISO 17664-2:2023 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non-critical medical devices
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
GSO ISO 15225:2016 Medical devices -- Quality management -- Medical device nomenclature data structure

SCC

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
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
BS BIP 0113:2012 Guide to European medical device trials and BS EN ISO 14155
CAN/CSA-ISO 14971:2007(C2012) Medical devices - Application of risk management to medical devices
AAMI/ISO 14971:2019 Medical devices - Application of risk management to medical devices
CEI UNI EN ISO 14971:2020 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
CSA Z314.23-16:2016 Chemical sterilization of reusable medical devices in healthcare settings
DANSK DS/EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
CAN/CSA-ISO 14971:2007(R2012) Medical Devices - Application of Risk Management to Medical Devices
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 EN 30993-1:1994 Biological evaluation of medical devices-Guidance on selection of tests
ISO 14971:2019 Plus Redline Medical devices - Application of risk management to medical devices
DANSK DS/ISO/TS 23128:2020 Medical devices – Transfusion set and blood bag compatibility test method
CAN/CSA-ISO 14971:2001(C2006) Medical devices - Application of risk management to medical devices
BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices
BS PD ISO/TS 23128:2019 Medical devices. Transfusion set and blood bag compatibility test method
DANSK DS/EN 62366:2008 Medical devices - Application of usability engineering to medical devices
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
AAMI/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
CEI UNI EN/ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
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
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
CAN/CSA Z314.8-2000(R2005) Decontamination of Reusable Medical Devices
DANSK DS/EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
MIL MIL-C-42068-1989 CHEST, MEDICAL INSTRUMENT AND SUPPLY SET
CAN/CSA-Z314.8-2000(C2007) Decontamination of reusable medical devices
CAN/CSA-Z314.8-2008(R2013) Decontamination of Reusable Medical Devices
CAN/CSA-Z314.8-2000(R2007) Decontamination of Reusable Medical Devices
CAN/CSA Z314.8-2008(R2013) Decontamination of Reusable 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
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
CEI EN 62366/A1:2008 Medical devices - Application of usability engineering to medical devices
AENOR UNE-EN 62366/A1:2009 Medical devices - Application of usability engineering to medical devices
CSA Z314.8-14:2014 Decontamination of reusable medical devices
CAN/CSA-Z314.8-2008(C2013) Decontamination of reusable 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
VDI/VDE 2426 BLATT 2-2000 Catalogs in the maintenance and management of medical technology — Standardized equipment catalog
BS 5736-11:1990 Evaluation of medical devices for biological hazards-Method of test for haemolysis
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
DIN 96056:2016 Medical instruments - Bone raspatory
DIN 58857:2019 Medical instruments - Directors
NS-EN 13824:2004 Sterilization of medical devices — Aseptic processing of liquid medical devices — Requirements
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
SN-CR 14060:2000 Medical device traceability
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
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

RU-GOST R

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 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 ISO 14971-2011 Medical devices. Application of risk management to medical devices
GOST ISO 10993-13-2011 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST ISO/TS 10993-19-2011 Medical devices. Biological evaluation of medical devices. Part 19. Tests physico-chemical, morphological and topographical characterization of materials
GOST R 52770-2016 Medical devices. Safety requirements. Methods of sanitation-chemical and toxicological tests
GOST ISO 10993-10-2011 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity
GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST ISO 10993-18-2011 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
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 10993-4-2011 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 15225-2014 Medical devices. Quality management. Medical device nomenclature data structure
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

German Institute for Standardization

DIN 58298:2005 Medical instruments - Materials, finish and testing
DIN 58298:2010 Medical instruments - Materials, finish and testing
DIN EN ISO 14971:2022 Medical devices – applying risk management to medical devices
DIN 58846:2017-11 Medical instruments - Raspatories
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
DIN 5343:2020 Cleanliness of medical devices - Process design and test methods; Text in German and English
DIN 58794:1982 Medical instruments; ear forceps
DIN 96056 E:2015-09 Medical instruments - Bone raspatory
DIN 58794:2010 Medical instruments - Ear forceps
DIN 58852 E:2020-06 Medical instruments - Probes
DIN 58852:2008 Medical instruments - Probes
DIN 13117:1980 Medical instruments; bone shears
DIN 13119:2010 Medical instruments - Bowel scissors
DIN 58852:2014 Medical instruments - Probes
DIN 58852:2021 Medical instruments - Probes
DIN 58852 E:2014-02 Medical instruments - Probes
DIN 96056:2016-03 Medical instruments - Bone raspatory
DIN 58857:2019-12 Medical instruments - Directors
DIN 13117:2013 Medical instruments.Bone shears
DIN 96056:2009 Medical instruments - Bone raspatory
DIN 13119 E:2008-09 Medical instruments bowel scissors
DIN 96056:2023-03 Medical instruments - Bone raspatory
DIN 13119:1980 Medical instruments; bowel scissors
DIN EN ISO 14971 E:2018-08 Application of medical device risk management in medical devices (draft)
DIN 58852:1976 Medical instruments; probes
DIN 96056 E:2022-08 Medical instruments - Bone raspatory

VDI - Verein Deutscher Ingenieure

VDI/VDE 2426 Blatt 2-1995 Standardized catalogue of medical devices

GOST

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

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

Korean Agency for Technology and Standards (KATS)

KS P ISO 14971:2021 Medical devices — Application of risk management to medical devices
KS P ISO 14971:2018 Medical devices — Application of risk management to medical devices
KS P ISO 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 T 5011-2020 Packaging—Complete, filled transport packages —Test methods for transport packaging of medical devices
KS P ISO 15225-2023 Medical devices — Quality management — Medical device nomenclature data structure
KS P ISO 15225-2014(2019) Medical devices — Quality management — Medical device nomenclature data structure

European Committee for Standardization (CEN)

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'

KR-KS

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

Association Francaise de Normalisation

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

British Standards Institution (BSI)

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 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
BS PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering to medical devices
BS EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
BS EN ISO 14971:2019+A11:2021 Medical devices - Application of risk management to medical devices
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 EN ISO 10993-5:1999 Biological evaluation of medical devices - Tests for in vitro cytotoxicity
BS ISO 17664-2:2021 Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Non-critical medical devices
BS EN ISO 10993-18:2020+A1:2023 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
ISO 10993-18:2020/Amd.1:2022 Biological evaluation of medical devices - Chemical characterization of medical device materials within a risk management process
BS EN ISO 10993-14:2001 Biological evaluation of medical devices - Identification and quantification of degradation products from ceramics

CEN - European Committee for Standardization

EN ISO 14971:2007 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 14971:2009 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

International Organization for Standardization (ISO)

ISO 14971:2019 Medical devices — Application of risk management to medical devices
ISO/TR 19727:2017 Medical devices — Pump tube spallation test — General procedure
ISO 14971:2000 Medical devices - Application of risk management to medical devices
ISO/TS 23128:2019 Medical devices — Transfusion set and blood bag compatibility test method
IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
ISO/TR 21582:2021 Pyrogenicity — Principles and methods for pyrogen testing of medical devices

South African Bureau of Standard

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

American National Standards Institute （ANSI)

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
ANSI/AAMI/ISO 14971:2019 Medical devices— Application of risk management to medical devices
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 15225:2016 Medical devices—Quality management—Medical device nomenclature data structure
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

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

TH-TISI

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

Spanish Association for Standardization (UNE)

UNE-EN ISO 14971:2020/A11:2022 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN ISO 14971:2020 Medical devices - Application of risk management to medical devices (ISO 14971:2019)
UNE-EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements

Standard Association of Australia （SAA）

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

GOSTR

GOST ISO 10993-4-2020 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST ISO 10993-3-2018 Medical levices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicit

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

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

CENELEC - European Committee for Electrotechnical Standardization

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

PL-PKN

PN Z54058-1990 Medical instruments Needle holders Re?uirements and tests

DIN

DIN EN 13824:2005 Sterilization of medical devices - Aseptic processing of liquid medical devices - Requirements