AS ISO 10993.17:2004
Biological evaluation of medical devices - Establishment of allowable limits for leachable substances

Standard No.

AS ISO 10993.17:2004

Release Date

2004

Published By

Standard Association of Australia （SAA）

Latest

AS ISO 10993.17:2004

Scope

Specifies a method for the determination of allowable limits for substances leachable from medical devices. It describes a systematic process through which identified risks arising from toxicologically hazardous substances present in medical devices can be quantified. Not applicable to devices that have no patient contact, e.g. in？vitro diagnostic devices. The Standard is identical to, and has been reproduced from, ISO？10993-17:2002.

AS ISO 10993.17:2004 history

• 2004 AS ISO 10993.17:2004 Biological evaluation of medical devices - Establishment of allowable limits for leachable substances