DS/EN ISO 10993-1
Biological evaluation of medical devices - Part 1: Evaluation and testing
inactive
| Organization: | DS |
| Publication Date: | 14 July 2009 |
| 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. 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 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...
DS/EN ISO 10993-1
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...
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...
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