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National standards and national normative documents

Publication date

June 2003

Number of pages

37 p.

Reference

NF EN ISO 10993-17

ICS Codes

11.040.01 Medical equipment in general

11.100.20 Biological evaluation of medical devices

Classification index

S99-517

Print number

1 - 18/06/2003

International kinship

ISO 10993-17:2002

European kinship

EN ISO 10993-17:2002

Sumary

Biological evaluation of medical devices - Part 17 : establishment of allowable limits for leachable substances

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.

Standard replaced by (1)

NF EN ISO 10993-17

August 2009

Standard Cancelled

Biological evaluation of medical devices - Part 17 : Establishment of allowable limits for leachable substances

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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