BS EN ISO 10993-17:2009


Biological evaluation of medical devices. Establishment of allowable limits for leachable substancesBritish Standard / European Standard / International Organization for Standardization / 30-Jun-2009 / 36 pages ISBN: 9780580658235

BS EN ISO 10993-17:2009 specifies a method for the determination of allowable limits for substances leachable frommedical devices. It is intended for use in deriving standards and estimating appropriate limits where standards donot exist. It describes a systematic process through which identified risks arising from toxicologically hazardoussubstances present in medical devices can be quantified.
BS EN ISO 10993-17:2009 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 orair. BS EN ISO 10993-17:2009 does not address the potential for exposure from such sources.
Cross References:
ISO 10993-1
ISO 10993-7
ISO 14971

All current amendments available at time of purchase are included with the purchase of this document.

Keywords: Medical equipment; Biological analysis and testing; Leaching; Risk assessment; Toxic materials; Toxicity; Toxicology; Safety measures; Hazards; Statistical methods of analysis
Product Code(s): 30195362,30195362

Add to Cart:

  • Model: D9QHF4VV
  • 8888 Units in Stock

This product was added to our catalog on Thursday 01 January, 1970.

Your IP Address is:
Copyright © 2018 Buy Standards.