NEN-EN-ISO 10993-1
Biological evaluation of medical devices - Part 1: Evaluation and testing
inactive
| Organization: | NEN |
| Publication Date: | 1 September 2003 |
| Status: | inactive |
| Page Count: | 30 |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
scope:
This part of ISO 10993 describes: a) the general principles governing the biological evaluation of medical devices; b) the categorization of devices based on the nature and duration of their contact with the body; c) the selection of appropriate tests.
Document History
December 1, 2020
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
This document specifies:
— the general principles governing the biological evaluation of medical devices within a risk management process;
— the general categorization of medical devices based on...
June 1, 2010
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
A description is not available for this item.
October 1, 2009
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
This part of ISO 10993 describes: - the general principles governing the biological evaluation of medical devices within a risk management process; - the general categorization of devices based on...
July 1, 2009
Biological evaluation of medical devices - Part 1: Evaluation and testing
This part of ISO 10993 describes a) the general principles governing the biological evaluation of medical devices; b) the categorization of devices based on the nature and duration of their contact...
November 1, 2006
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system
This part of ISO 10993 describes: - the general principles governing the biological evaluation of medical devices within a risk management process; - the general categorization of devices based on...
NEN-EN-ISO 10993-1
September 1, 2003
Biological evaluation of medical devices - Part 1: Evaluation and testing
This part of ISO 10993 describes: a) the general principles governing the biological evaluation of medical devices; b) the categorization of devices based on the nature and duration of their contact...
January 1, 1998
Biological evaluation of medical devices - Part 1: Evaluation and testing
This part of ISO 10993 describes a) the fundamental principles governing the biological evaluation of medical devices; b) the definition of categories of devices based on the nature and duration of...
June 1, 1995
Biological evaluation of medical devices - Part 1: Evaluation and testing
This part of ISO 10993 describes a) the fundamental principles governing the biological evaluation of medical devices; b) the definition of categories of devices based on the nature and duration of...