Standard

ISO 10993-17:2002

Nov 2002 Withdrawn

Note: Latest version: ISO 10993-17:2023

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Abstract

ISO 10993-17:2002 specifies 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. ISO 10993-17:2002 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. ISO 10993-17:2002 does not address the potential for exposure from such sources.

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Standard from ISO
Published: November 27 2002
Withdrawn: September 13 2023
Period for objection until: January 21 2000
Edition: 1
Document type: IS
Pages
ISBN:

Publisher: ISO
Distributor: ISO
ICS: 11.100.20
International TC: ISO/TC 194

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Revised by: ISO 10993-17:2023
Adopted by: SN EN ISO 10993-17:2009
Adopted by: NF EN ISO 10993-17:2009
Adopted by: NF EN ISO 10993-17:2003
Adopted by: SN EN ISO 10993-17:2003

ISO 10993-17:2002

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ISO 10993-17:2023

ISO 10993-17:2002

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ISO 10993-17:2023

ISO 10993-17:2002

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