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Norm
ISO 10993-1:2003
Ausgabedatum: 2003 07 28
Biological evaluation of medical devices — Part 1: Evaluation and testing
ISO 10993-1:2003 describes
the general principles governing the biological evaluation of medical devices;the categorization of devices based on the nature and duration of...
Weiterlesen
ZURÜCKGEZOGEN
: 2009 10 13
Herausgeber:
International Organization for Standardization
Format:
Digital | 14 Seiten
Sprache:
Englisch
Aktuell Gültig:
ICS
ISO 10993-1:2003 describes
- the general principles governing the biological evaluation of medical devices;
- the categorization of devices based on the nature and duration of their contact with the body;
- the selection of appropriate tests.
It 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.
Other parts of ISO 10993 cover specific tests.
ISO 10993-1:2018
2018 08 17
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management p...
Norm
ISO 10993-1:2009
2009 10 13
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management p...
Norm
ISO 10993-1:2003
2003 07 28
Biological evaluation of medical devices — Part 1: Evaluation and testing
Norm
↖
ISO 10993-1:1997
1997 12 11
Biological evaluation of medical devices — Part 1: Evaluation and testing
Norm
ISO 10993-1:1992/Cor 1:1992
1992 09 09
Biological evaluation of medical devices — Part 1: Guidance on selection of tests — Technical Corrig...
Norm
ISO 10993-1:1992
1992 04 23
Biological evaluation of medical devices — Part 1: Guidance on selection of tests
Norm
Norm
ISO 10993-1:2009
Ausgabedatum :
2009 10 13
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process