Toxicological evaluation of Class I medical devices

Toxicological evaluation of Class I medical devices, Total:117 items.

The international standard classification for "Toxicological evaluation of Class I medical devices" includes: Laboratory medicine , Medical equipment in general , Surgical instruments and materials , Dental materials .

The Chinese standard classification for "Toxicological evaluation of Class I medical devices" includes: Medical apparatus and devices in general , Stomatologic device, equipment and material .

未注明发布机构

DIN EN ISO 10993-18:2009 Biological assessment 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
ANSI/AAMI/ISO 10993-5:2009(2014) Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
ANSI/AAMI/ISO 10993-11:2017 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity

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

GB/T 16886.11-1997 Biological evaluation of medical devices--Part 11: Tests for systemic toxicity
GB/T 16886.5-2017 Biological evaluation of medical devices―Part 5:Tests for in vitro cytotoxicity
GB/T 16886.11-2011 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity
GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity
GB/T 16886.20-2015 Biological evaluation of medical devices―Part 20:Principles and methods for immunotoxicology testing of medical devices

Professional Standard - Medicine

YY/T 1815-2022 Biological evaluation of medical devices-Application for the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
YY/T 1295-2015 Biological evaluation of medical devices―Nanomaterial:Endotoxin test
YY/T 0127.5-2014 Biological evaluation of medical devices used in dentistry―Part 5:Inhalation toxicity test

国家药监局

YY/T 1670.1-2019 Evaluation of neurotoxicity of medical devices―Part 1:Standard guide for selecting tests to evaluate potential neurotoxicity

国家市场监督管理总局、中国国家标准化管理委员会

GB/T 16886.11-2021 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity

Jiangsu Provincial Standard of the People's Republic of China

DB3212/T 1065-2021 Standards for Quality Evaluation of Medical Devices Used in Medical Institutions

British Standards Institution (BSI)

BS EN ISO 10993-17:2023 Biological evaluation of medical devices - Toxicological risk assessment of medical device constituents
DD ISO/TS 10993-20:2006 Biological evaluation of medical devices. Principles and methods for immunotoxicology testing of medical devices
21/30379304 DC BS EN ISO 10993-17. Biological evaluation of medical devices - Part 17. Toxicological risk assessment of medical device constituents
PD ISO/TS 21726:2019 Biological evaluation of medical devices. Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
24/30482502 DC BS EN ISO 10993-17:2023/Amd 1 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents — Amendment
BS EN ISO 10993-11:2018(2022) Biological evaluation of medical devices Part 11 : Tests for systemic toxicity
BS EN ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices
BS EN ISO 10993-11:2018 Biological evaluation of medical devices. Tests for systemic toxicity
PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices. General requirements
BS PD ISO/TS 37137-1:2021 Biological evaluation of absorbable medical devices. General requirements
PD ISO/TR 10993-55:2023 Biological evaluation of medical devices. Interlaboratory study on cytotoxicity

German Institute for Standardization

DIN EN ISO 10993-17:2021-12 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO/DIS 10993-17:2021); German and English version prEN ISO 10993-17:2021 / Note: Date of issue 2021-11-12*Intended as replacement for DIN...
DIN EN ISO 10993-17:2024-02 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023); German version EN ISO 10993-17:2023
DIN EN ISO 10993-11:2018-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017); German version EN ISO 10993-11:2018
DIN EN 556-2:2004 Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices; German version EN 556-2:2003

Standard Association of Australia （SAA）

ISO 10993-17:2023 Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
AS ISO 10993.11:2002/Amdt 1:2005 Biological evaluation of medical devices Systemic toxicity testing

SCC

DANSK DS/ISO 10993-17:2023 Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents
DANSK DS/ISO/TS 10993-20:2006 Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
SN-ISO/TS 10993-20:2006 Biological evaluation of medical devices — Part 20: Principles and methods for immunotoxicology testing of medical devices
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 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 21726:2019 Biological evaluation of medical devices. Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
DANSK DS/ISO/TS 21726:2019 Biological evaluation of medical devices – Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
DIN EN ISO 10993-17 E:2021 Draft Document – Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents (ISO/DIS 10993-17:2021); German and English version prEN ISO 10993-17:2021
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
BS EN ISO 10993-1:1998 Biological evaluation of medical devices-Evaluation and testing
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
CAN/CSA-ISO 10993.11-1998(R2002) Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
BS PD ISO/TR 10993-33:2015 Biological evaluation of medical devices-Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3
CAN/CSA-ISO 10993.11-1998(C2002) Biological evaluation of medical devices - Part 11: Systemic toxicity testing
AAMI/ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
BS EN 30993-5:1994 Biological evaluation of medical devices-Tests for cytotoxicity, in vitro methods
BS EN ISO 10993-3:2009 Biological evaluation of medical devices-Tests for genotoxicity, carcinogenicity and reproductive toxicity
BS PD ISO/TR 10993-55:2023 Biological evaluation of medical devices-Interlaboratory study on cytotoxicity
DANSK DS/EN ISO 10993-11:2009 Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
BS EN ISO 10993-3:2003 Biological evaluation of medical devices-Tests for genotoxicity, carcinogenicity and reproductive toxicity
BS EN 30993-3:1994 Biological evaluation of medical devices-Tests for genotoxicity, carcinogenicity and reproductive toxicity
AAMI/ISO 10993-5:1999 Biological evaluation of medical devices - Part 5: Tests for In Vitro Cytotoxicity
DANSK DS/EN 13612/AC:2003 Performance evaluation of in vitro diagnostic medical devices
AAMI/ISO 10993-16:1997(R2009) Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables from medical devices

Korean Agency for Technology and Standards (KATS)

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 TS 21726-2023 Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
KS P ISO 10993-11-2007(2017) Biological evaluation of medical devices－Part 11：Tests for systemic toxicity
KS P ISO 10993-11:2021 Biological evaluation of medical devices —Part 11: Tests for systemic toxicity
KS P ISO 10993-5-2023 Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
KS P ISO TS 20993-2009(2014) Biological evaluation of medical devices－Guidance on a risk－management process

RU-GOST R

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 10993-11-2011 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST R ISO 10993-11-1999 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic to xicity
GOST ISO 10993-5-2011 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
GOST ISO 10993-7-2016 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST ISO 10993-3-2011 Medical devices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity
GOST ISO 10993-16-2016 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST R ISO 10993.5-1999 Medical devices. Biological evaluation of medical devices. Part 5. Tests for cytotoxicity: in vitro methods

GSO

GSO ISO/TS 10993-20:2016 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
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/TS 10993-20:2017 Biological evaluation of medical devices -- Part 20: Principles and methods for immunotoxicology testing of medical devices
GSO ISO 10993-11:2015 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
GSO ISO/TS 21726:2021 Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
BH GSO ISO/TS 21726:2022 Biological evaluation of medical devices — Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
OS GSO ISO 10993-11:2015 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
BH GSO ISO 10993-11:2017 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
BH GSO ISO 10993-5:2017 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
GSO ISO 10993-5:2015 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity

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 10993-11:2017(R2023) Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ANSI/AAMI/ISO 10993-5:2009(R2022) Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ANSI/AAMI/ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

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
GOST ISO 10993-11-2021 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST R ISO 10993-11-2009 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity

DIN

DIN EN ISO 10993-17:2024 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)

European Committee for Standardization (CEN)

FprEN ISO 10993-17 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO/FDIS 10993-17:2023)
EN ISO 10993-17:2023 Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
EN 556-2:2003 Sterilization of medical devices Requirements for medical devices to be designated STERILE Part 2: Requirements for aseptically processed medical devices
EN ISO 10993-11:1995 Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity (ISO 10993-11 : 1993)
EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

GOSTR

GOST ISO 10993-3-2018 Medical levices. Biological evaluation of medical devices. Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicit
GOST ISO/TR 10993-33-2018 Medical levices. Biological evaluation of medical devices. Part 33. Guidance on tests to evaluate genotoxicity. Supplement to ISO 10993-3

International Organization for Standardization (ISO)

ISO/CD 10993-1.2:2023 Biological evaluation of medical devices
ISO 10993-11:1993 Biological evaluation of medical devices; part 11: tests for systemic toxicity
ISO 17664:2004 Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices

Association Francaise de Normalisation

NF S98-136:2009 Sterilisation of medical devices - Risk management related to the preparation of sterile medical devices within health establishments.
NF EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: systemic toxicity testing
NF S99-501-11:2009 Biological evaluation of medical devices - Part 11 : tests for systemic toxicity.
NF S99-501-11*NF EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11 : tests for systemic toxicity
NF EN ISO 10993-5:2010 Biological evaluation of medical devices - Part 5: testing for in vitro cytotoxicity

CEN - European Committee for Standardization

EN 556-2:2015 "Sterilization of medical devices - Requirements for medical devices to be designated ""STERILE"" - Part 2: Requirements for aseptically processed medical devices"
EN ISO 10993-11:2009 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
EN ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

VN-TCVN

TCVN 7391-11-2007 Biological evaluation of medical devices.Part 11: Tests for systemic toxicity
TCVN 7391-5-2005 Biological evaluation of medical devices.Part 5: Tests for in vitro cytotoxicity

TH-TISI

TIS 2395.11-2008 Biological evaluation of medical devices.part 11: tests for systemic toxicity
TIS 2395.5-2008 Biological evaluation of medical devices.part 5: tests for in vitro cytotoxicity

ES-UNE

UNE-EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (ISO 10993-11:2017)

PH-BPS

PNS ISO 10993-11:2021 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

KR-KS

KS P ISO 10993-11-2021 Biological evaluation of medical devices —Part 11: Tests for systemic toxicity
KS P ISO 10993-5-2018(2023) Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

Others: