Leachable Medical Devices

Leachable Medical Devices, Total:156 items.

The international standard classification for "Leachable Medical Devices" includes: Medical equipment in general , Plants and equipment for the food industry , Medical equipment .

The Chinese standard classification for "Leachable Medical Devices" includes: Medical apparatus and devices in general , Grain and oil/fat processing machinery .

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

未注明发布机构

DIN EN ISO 14971:2022 Medical devices – applying risk management to medical devices
DIN EN ISO 10993-18:2009 Biological assessment of medical devices
DIN 13193 E:2016-07 Medical instruments - Rongeurs type Luer
ANSI/AAMI/ISO 10993-17:2002(2012) Biological evaluation of medical devices — Part 17: Methods for the establishment of allowable limits for leachable substances
DIN 13193 E:2022-08 Medical instruments - Rongeurs type Luer
ANSI/AAMI/ISO 14971:2019 Medical devices— Application of risk management to medical devices
ANSI/AAMI/ISO 10993-13:2010(2014) Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
DIN EN ISO 14971:2001 Medical devices - Application of risk management to medical devices

Professional Standard - Medicine

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

中华人民共和国国家质量监督检验检疫总局、中国国家标准化管理委员会

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

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

GB/T 26884-2011 Grain and oil machinery - Extractor
GB/T 16886.13-2001 Biogical evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
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

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
DANSK DS/EN ISO 10993-17:2009 Biological evaluation of medical devices – Part 17: 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
NS-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)
NS-EN ISO 10993-17:2002 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)
DANSK DS/EN ISO 10993-16:2017 Biological evaluation of medical devices – Part 16: Toxicokinetic study design for degradation products and leachables
CAN/CSA-ISO 10993-16-00:2000 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
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)
BS EN ISO 10993-13:2009 Biological evaluation of medical devices-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
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)
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)
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)
BS 5736-4:1981 Evaluation of medical devices for biological hazards-Method of test for intracutaneous reactivity of extracts from medical devices
08/30187781 DC BS EN ISO 10993-16. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
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).
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 5736-8:1984 Evaluation of medical devices for biological hazards-Method of test for skin irritation of solid medical devices
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).
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
CAN/CSA-ISO 14971:2007(C2012) Medical devices - Application of risk management to medical devices
CEI UNI EN ISO 14971:2020 Medical devices - Application of risk management to medical devices
AAMI/ISO 14971:2019 Medical devices - Application of risk management to medical devices
DANSK DS/EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
CAN/CSA-ISO 14971:2007(R2012) Medical Devices - Application of Risk Management to Medical Devices
DANSK DS/EN ISO 14971:2012 Medical devices – Application of risk management to medical devices
CAN/CSA-ISO 10993-13-00:2000 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric 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
ISO 14971:2019 Plus Redline Medical devices - Application of risk management to medical devices
BS EN ISO 14971:2019 Medical devices. Application of risk management to medical devices
CAN/CSA-ISO 14971:2001(C2006) Medical devices - Application of risk management to medical devices

Standard Association of Australia （SAA）

AS ISO 10993.17:2004 Biological evaluation of medical devices - Establishment of allowable limits for leachable substances
AS ISO 14971:2020 Medical devices — Application of risk management to medical devices

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 10993-16:2017 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 10993-13:2010 Biological evaluation of medical devices. Part 13: Identification and quantification of degradation products from polymeric medical devices
BS EN ISO 10993-17:2023 Biological evaluation of medical devices - Toxicological risk assessment of medical device constituents
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 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 EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
BS PD IEC/TR 62366-2:2016 Medical devices. Guidance on the application of usability engineering to medical devices
BS EN ISO 14971:2019+A11:2021 Medical devices - Application of risk management to medical devices

GOST

GOST R ISO 10993-17-2009 Medical devices. Biological evaluation of medical devices. Part 17. Establishment of allowable limits for leachable substance
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 R ISO 18562-4-2022 Biocompatibility evaluation of breathing gas pathways in healthcare applications. Part 4. Tests for leachables in condensate
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

Association Francaise de Normalisation

NF EN ISO 10993-17:2009 Évaluation biologique des dispositifs médicaux - Partie 17 : établissement des limites admissibles des substances relargables
NF EN 60335-2-95:2017 Biological evaluation of medical devices - Part 16: design of toxicokinetic studies of degradation products and 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 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
NF EN ISO 14971:2019 Medical devices - Application of risk management to medical devices
NF S99-501-13*NF EN ISO 10993-13:2010 Biological evaluation of medical devices - Part 13 : identification and quantification of degradation products from polymeric medical devices
NF S99-211/A11*NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices
NF EN ISO 14971/A11:2021 Medical devices - Application of risk management to medical devices

GSO

BH GSO ISO 10993-17:2017 Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances
OS GSO ISO 10993-17:2016 Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances
GSO ISO 10993-17:2016 Biological evaluation of medical devices -- Part 17: Establishment of allowable limits for leachable substances
GSO ISO 14971:2015 Medical devices -- Application of risk management to medical devices
BH GSO ISO 14971:2017 Medical devices -- Application of risk management to medical devices
OS GSO ISO 10993-13:2016 Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices
BH GSO ISO 10993-13:2017 Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices
GSO ISO 10993-13:2016 Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices
OS 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 Biological evaluation of medical devices — Part 17：Establishment of allowable limits for leachable substances
KS P ISO 10993-17:2006 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 10993-16:2021 Biological evaluation of medical devices —Part 16: Toxicokinetic study design for degradation products and leachables
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 10993-13:2007 Biological evaluation of medical devices－Part 13：Identification and quantification of degradation products from polymeric medical devices
KS P ISO 10993-13-2023 Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric 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

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
ISO 10993-13:1998 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
ISO 10993-13:2010 Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices

KR-KS

KS P ISO 10993-17-2017(2022) Biological evaluation of medical devices — Part 17：Establishment of allowable limits for leachable substances
KS P ISO 10993-17-2017 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 10993-16-2021 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 10993-13-2018(2023) Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices

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 14971:2007 Medical devices - Application of risk management to medical devices
EN ISO 14971:2009 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

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 10993-16:2018 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2017)
DIN 58846:2017-11 Medical instruments - Raspatories
DIN 13193:2023-03 Medical instruments - Rongeurs type Luer

RU-GOST R

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 10993-16-2011 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 ISO 14971-2011 Medical devices. Application of risk management to medical devices
GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST R IEC 62366-2013 Medical devices. Application of usability engineering to medical devices
GOST ISO 10993-7-2011 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST R ISO 10993-12-1999 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference 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 10993-11-2011 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 10993-18-2011 Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of materials
GOST R ISO 10993-10-1999 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and sensitization

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 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

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 10993-16:2010 Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables (ISO 10993-16:2010)

US-AAMI

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

American National Standards Institute （ANSI)

ANSI/AAMI/ISO 10993-16:2020(R2022) Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables

ES-UNE

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 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)

DIN

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

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

ZA-SANS

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

International Electrotechnical Commission (IEC)

IEC 62366:2014 Medical devices - Application of usability engineering to medical devices

Danish Standards Foundation

DS/EN ISO 14971:2013 Medical devices - Application of risk management to medical devices