Medical device leachate

Medical device leachate, Total:121 items.

The international standard classification for "Medical device leachate" includes: Medical equipment in general .

The Chinese standard classification for "Medical device leachate" includes: Medical apparatus and devices in general .

Jiangsu Provincial Standard of the People's Republic of China

DB32/T 4768-2024 Identification of common fluorescent substances in polyvinyl chloride medical devices and determination of leaching amount

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

GB/T 16886.13-2017 Biological evaluation of medical devices-Part 13:Identification and quantification of degradation products from polymeric medical devices

Professional Standard - Medicine

YY/T 0316-2003 Medical devices -- Application of risk management to medical devices

SCC

AAMI/ISO 10993-16:1997(R2009) Biological evaluation of medical devices Part 16: Toxicokinetic study design for degradation products and leachables from medical devices

Standard Association of Australia （SAA）

AS ISO 10993.17:2004 Biological evaluation of medical devices - Establishment of allowable limits for leachable substances

British Standards Institution (BSI)

BS EN ISO 10993-17:2002 Biological evaluation of medical devices - Establishment of allowable limits for leachable substances
BS EN ISO 10993-17:2009 Biological evaluation of medical devices. Establishment of allowable limits for leachable substances
BS EN ISO 10993-16:2009 Biological evaluation of medical devices-Toxicokinetic study design for degradation products and leachables
BS EN ISO 10993-16:2017 Biological evaluation of medical devices - Toxicokinetic study design for degradation products and leachables
BS EN ISO 10993-16:2017(2020) Biological evaluation of medical devices Part 16 : Toxicokinetic study design for degradation products and leachables
BS EN ISO 10993-13:2009 Biological evaluation of medical devices-Identification and quantification of degradation products from polymeric medical devices
BS EN ISO 10993-13:2010 Biological evaluation of medical devices. Part 13: Identification and quantification of degradation products from polymeric 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 EN ISO 10993-17:2023 Biological evaluation of medical devices - Toxicological risk assessment of medical device constituents
08/30187781 DC BS EN ISO 10993-16. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
BS 5736-4:1981 Evaluation of medical devices for biological hazards-Method of test for intracutaneous reactivity of extracts from medical devices
BS EN 62366-1:2015+A1:2020 Medical devices. Application of usability engineering to 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
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 5736-8:1984 Evaluation of medical devices for biological hazards-Method of test for skin irritation of solid medical devices

Gosstandart of Russia

GOST R ISO 10993-17-2009 Medical devices. Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substance
GOST R ISO 10993.16-1999 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST ISO 10993-16-2021 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST R ISO 10993-16-2009 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST ISO 10993-16-2011 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST ISO 10993-16-2016 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
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 10993-13-2016 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST R ISO 18562-4-2022 Biocompatibility evaluation of breathing gas pathways in healthcare applications. Part 4. Tests for leachables in condensate
GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
GOST R ISO 10993-13-2009 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST R ISO 10993-12-1999 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
GOST ISO 10993-7-2011 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
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 IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
GOST R ISO 10993-11-1999 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic to xicity

Association Francaise de Normalisation

NF EN ISO 10993-17:2009 Biological evaluation of medical devices - Part 17: Establishment of permissible limits of leachable substances
NF EN ISO 10993-16:2017 Biological evaluation of medical devices - Part 16: design of toxicokinetic studies of degradation products and leachable substances
NF EN 60335-2-95:2017 Biological evaluation of medical devices - Part 16: design of toxicokinetic studies of degradation products and leachable substances
NF S99-501-16*NF EN ISO 10993-16:2017 Biological evaluation of medical devices - Part 16 : Toxicokinetic study design for degradation products and leachables
NF S99-211:2013 Medical devices - Application of risk management to medical devices
NF EN ISO 10993-13:2010 Biological assessment of medical devices - Part 13: identification and quantification of degradation products of polymer-based medical devices

Bureau of Indian Standards

IS/ISO 10993-17-2002 Biological Evaluation of Medical Devices Part 17 Establishment of Allowable Limits for Leachable Substances
IS/ISO 10993-16-2017 Biological Evaluation of Medical Devices Part 16 Toxicokinetic Study Design for Degradation Products and Leachables

CEN - European Committee for Standardization

EN ISO 10993-17:2009 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
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 14971:2019 Medical devices - Application of risk management to medical devices

GCC Standardization Organization

GSO ISO 10993-17:2016 Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances
BH GSO ISO 14971:2024 Medical devices — Application of risk management to medical devices
GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices

Korean Agency for Technology and Standards (KATS)

KS P ISO 10993-17-2022 Biological evaluation of medical devices — Part 17：Establishment of allowable limits for leachable substances
KS P ISO 10993-17-2017(2022) Biological evaluation of medical devices — Part 17：Establishment of allowable limits for leachable substances
KS P ISO 10993-17-2024 Biological evaluation of medical devices — Part 17: Toxicological risk assessment of medical device constituents
KS P ISO 10993-17:2006 Biological evaluation of medical devices-Part 17:Establishment of allowable limits for leachable substances
KS P ISO 10993-17:2017 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
KS P ISO 10993-17-2017 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
KS P ISO 10993-16-2017 Biological evaluation of medical devices — Part16:Toxicokinetic study design for degradation products and leachables
KS P ISO 10993-16:2017 Biological evaluation of medical devices — Part16:Toxicokinetic study design for degradation products and leachables
KS P ISO 10993-16:2021 Biological evaluation of medical devices —Part 16: Toxicokinetic study design for degradation products and leachables
KS P ISO 10993-16-2021 Biological evaluation of medical devices —Part 16: Toxicokinetic study design for degradation products and leachables
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 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 10993-13-2018(2023) Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices

Kingdom of Bahrain Testing and Metrology Directorate

BH GSO ISO 10993-17:2017 Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances

International Organization for Standardization (ISO)

ISO 10993-17:2002 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
ISO/CD 10993-1.2:2023 Biological evaluation of medical devices
ISO 14971:2019 Medical devices — Application of risk management to medical devices
ISO 14971:2000 Medical devices - Application of risk management to medical devices

TH-TISI

TIS 2395.17-2008 Biological evaluation of medical devices.part 17: establishment of allowable limits for leachable substances
TIS 14971-2013 Medical devices.application of risk management to medical devices

The Directorate General of Specifications and Metrology (DGSM)

OS GSO ISO 10993-17:2016 Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances

Danish Standards Foundation

DANSK DS/EN ISO 10993-17:2009 Biological evaluation of medical devices – Part 17: Establishment of allowable limits for leachable substances
DANSK DS/EN ISO 10993-16:2017 Biological evaluation of medical devices – Part 16: Toxicokinetic study design for degradation products and leachables

German Institute for Standardization

DIN EN ISO 10993-17:2009-08 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002); German version EN ISO 10993-17:2009 / Note: DIN EN ISO 10993-17 (2003-06) remains valid alongside this standard until 20...
DIN EN ISO 10993-16:2018-02 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017); German version EN ISO 10993-16:2017
DIN EN ISO 10993-16:2010-06 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)
DIN EN ISO 10993-16:1997 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)
DIN EN ISO 10993-16:2009 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)
DIN EN ISO 10993-18:2009 Biological assessment of medical devices
DIN EN ISO 10993-16:2018 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
DIN EN ISO 10993-16 E:2016 Draft Document - Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO/DIS 10993-16:2016); German and English version prEN ISO 10993-16:2016

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 10993-17:2002(2012) Biological evaluation of medical devices — Part 17: Methods for the establishment of allowable limits for leachable substances
ANSI/AAMI/ISO 10993-16:2020(R2022) Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

Swedish Institute for Standards

SS-EN ISO 10993-17:2009 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
SS-EN ISO 10993-16:2009 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)

European Committee for Standardization (CEN)

EN ISO 10993-17:2002 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances ISO 10993-17: 2002
EN ISO 18562-4:2024 Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (ISO 18562-4:2024)
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

US-AAMI

ANSI/AAMI/ISO 10993-16:2017 Biological evaluation of medical devices-Part 16: Toxicokinetic study design for degradation products and leachables

Spanish Association for Standardization (UNE)

UNE-EN ISO 10993-17:2009 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
AENOR UNE-EN ISO 10993-17:2009 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
UNE-EN ISO 10993-17:2003 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
UNE-EN ISO 10993-16:2018 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
UNE-EN ISO 10993-16:2009 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)
UNE-EN ISO 10993-16:1998 BIOLOGICAL EVALUATION OF MEDICAL DEVICES. PART 16: TOXICOKINETIC STUDY DESIGN FOR DEGRADATION PRODUCTS AND LEACHABLES. (ISO 10993-16:1997).
UNE-EN ISO 10993-16:2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)
AENOR UNE-EN ISO 10993-16:2018 Biological evaluation of medical devices. Part 16: Design of the toxicokinetic study of degradation products and leachable substances. (ISO 10993-16:2017).

Standards Norway

NS-EN ISO 10993-17:2009 Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
NS-EN ISO 10993-17:2002 Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
NS-EN ISO 10993-16:2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)
NS-EN ISO 10993-16:2009 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)
NS-EN ISO 10993-16:2017 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
NS-EN ISO 10993-16:1997 Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:1997)

Ente Nazionale Italiano di Unificazione

UNI EN ISO 10993-16:2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
UNI EN ISO 14971:2008 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2002 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2012 Medical devices - Application of risk management to medical devices
UNI CEI EN ISO 14971:2004 Medical devices - Application of risk management to medical devices
UNI EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices

Canadian Standards Association (CSA)

CAN/CSA-ISO 10993-16-00:2000 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

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

South African Bureau of Standard

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