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EN ISO 10993-17:2009 Standard

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  Keywords:

#part #standards #sources #diagnostic #exposure

  Directive

Active implantable medical devices Directive (90/385/EEC)

  Last Official Journal reference

Wednesday 14th of April 2021

  Description:

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

  Purpose

This part of ISO 10993 specifies a method for the determination of allowable limits for substances leachable from medical devices. It is intended for use in deriving standards and estimating appropriate limits where standards do not exist. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified.   This part of ISO 10993 is not applicable to devices that have no patient contact (e.g. in vitro diagnostic devices). Exposure to a particular chemical substance may arise from sources other than the device, such as food, water or air. This part of ISO 10993 does not address the potential for exposure from such sources.

  Publication

Friday 17th of November 2017

  Reference

This standard supersedes the "EN ISO 10993-17:2002"

Anyway is still possible use the "EN ISO 10993-17:2002" until March 21st, 2010

  Related Standards

EN ISO 10993-18:2009

Active implantable medical devices Directive (90/385/EEC)

Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)

EN ISO 11135-1:2007

Active implantable medical devices Directive (90/385/EEC)

Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a...

EN ISO 10993-3:2014

Active implantable medical devices Directive (90/385/EEC)

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:...

EN ISO 10993-4:2009

Active implantable medical devices Directive (90/385/EEC)

Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (ISO 10993-4:2002, including Amd...

EN ISO 10993-5:2009

Active implantable medical devices Directive (90/385/EEC)

Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

EN ISO 10993-6:2009

Active implantable medical devices Directive (90/385/EEC)

Biological evaluation of medical devices - Part 6: Tests for local effects after implantation (ISO 10993-6:2007)

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