ISO-10993-1 › Historical Revision Information
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process

ISO-10993-1 - 1ST EDITION CORRIGENDUM 1 - SUPERSEDED
Show Complete Document History

Document Center Inc. is an authorized dealer of ISO standards.
The following bibliographic material is provided to assist you with your purchasing decision:


ISO 10993-1:2009 describes:

  • the general principles governing the biological evaluation of medical devices within a risk management process;
  • the general categorization of devices based on the nature and duration of their contact with the body;
  • the evaluation of existing relevant data from all sources;
  • the identification of gaps in the available data set on the basis of a risk analysis;
  • the identification of additional data sets necessary to analyse the biological safety of the medical device;
  • the assessment of the biological safety of the medical device.
ORDER

To find similar documents by classification:

11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)

This document comes with our free Notification Service, good for the life of the document.

This document is available in either Paper or PDF format.

Document Number

ISO-10993-1

Revision Level

1ST EDITION CORRIGENDUM 1

Status

Superseded

Publication Date

Jan. 1, 1992

Committee Number

ISO/TC 194