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DIN EN ISO 10993-17

Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)

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Organization: DIN
Publication Date: 1 August 2009
Status: active
Page Count: 36
ICS Code (Biological evaluation of medical devices): 11.100.20

Document History

DIN EN ISO 10993-17
February 1, 2024
Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents (ISO 10993-17:2023)
A description is not available for this item.
DIN EN ISO 10993-17
December 1, 2021
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
A description is not available for this item.
DIN EN ISO 10993-17
August 1, 2009
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
A description is not available for this item.
DIN EN ISO 10993-17/A1
February 1, 2009
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002); English version prEN ISO 10993-17:2008, Amendment 1
A description is not available for this item.
DIN EN ISO 10993-17
June 1, 2003
Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances (ISO 10993-17:2002)
A description is not available for this item.

References

This document is referenced by:
DIN EN ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
Published by DIN on May 1, 2021
A description is not available for this item.
This document is referenced by:
DIN EN ISO 14971 - Medical devices - Application of risk management to medical devices (ISO 14971:2019)
Published by DIN on July 1, 2020
A description is not available for this item.
This document is referenced by:
DIN EN ISO 20857 - Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
Published by DIN on August 1, 2013
Inclusions This International Standard specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices. NOTE Although the scope of...
This document is referenced by:
DIN EN ISO 7198 - Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016)
Published by DIN on July 1, 2017
This International Standard specifies requirements for the evaluation of vascular prostheses and requirements with respect to nomenclature, design attributes and information supplied by the...
This document is referenced by:
DIN EN ISO 15621 - Absorbent incontinence aids for urine and/or faeces - General guidelines on evaluation (ISO 15621:2017)
Published by DIN on September 1, 2017
This document gives guidelines for evaluating absorbent incontinence aids for urine and/or faeces. It provides a context for the procedures described in other International Standards and published...
This document is referenced by:
DIN EN ISO 10993-4 - Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2017)
Published by DIN on December 1, 2017
This document specifies general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical devices that are intended for use in contact...
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