CEN - EN ISO 10993-1
Biological evaluation of medical devices - Part 1: Evaluation and testing
inactive
| Organization: | CEN |
| Publication Date: | 1 June 2009 |
| Status: | inactive |
| Page Count: | 26 |
| 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.
This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure.
NOTE Other parts of ISO 10993 cover specific tests (see also the rationale in A.2).
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...
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...
EN ISO 10993-1
June 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...
August 1, 2003
Biological evaluation of medical devices Part 1: Evaluation and testing
A description is not available for this item.
December 1, 1997
Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
A description is not available for this item.