Standard Swedish standard · SS-EN ISO 10993-17:2009

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

Status: Valid

Scope
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.

Subjects

Biological evaluation of medical devices (11.100.20)


Product information

Language: English

Written by: SIS - Hälso- och sjukvård

International title:

Article no: STD-69663

Edition: 2

Approved: 5/8/2009

No of pages: 40

Replaces: SS-EN ISO 10993-17