NEN-EN-ISO 10993-1
Biological evaluation of medical devices - Part 1: Evaluation and testing
inactive
| Organization: | NEN |
| Publication Date: | 1 June 1995 |
| Status: | inactive |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
scope:
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 contact with the body; c) the selection of appropriate tests. ISO 10993 does not cover testing of materials and devices that do not come into contact with the patient's body directly or indirectly. Nor does it cover biological hazards arising from any mechanical failure. Other parts of ISO 10993 cover specific tests as indicated in the foreword.
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...
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...
NEN-EN-ISO 10993-1
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...