DS/EN ISO 10993-1
Biological evaluation of medical devices - Part 1: Evaluation and testing
inactive
| Organization: | DS |
| Publication Date: | 11 February 1998 |
| Status: | inactive |
| Page Count: | 23 |
| ICS Code (Biological evaluation of medical devices): | 11.100.20 |
scope:
This part of the Standard 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 21, 2020
Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
A description is not available for this item.
July 8, 2010
Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
This part of ISO 10993 describes: a) the general principles governing the biological evaluation of medical devices within a risk managementframework; b) the general categorization of devices based on...
November 5, 2009
Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
This part of ISO 10993 describes: a) the general principles governing the biological evaluation of medical devices within a risk managementframework; b) the general categorization of devices based on...
July 14, 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...
September 26, 2003
Biological evaluation of medical devices - Part 1: Evaluation and testing
This part of the standard 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...
DS/EN ISO 10993-1
February 11, 1998
Biological evaluation of medical devices - Part 1: Evaluation and testing
This part of the Standard 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...
Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (ISO/FDIS 10993-1:2018)
This part document describes: – the general principles governing the biological evaluation of medical devices within a risk management process; – the general categorization of devices based on the...
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO/DIS 10993-1:2006)
This part of ISO 10993 describes:
. the general principles governing the biological evaluation of medical devices within a risk management framework;
. the general categorization of devices based on...
Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)
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...
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO/FDIS 10993-1:2009)
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...