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ISO 10993-1

Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

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Organization: ISO
Publication Date: 15 October 2009
Status: inactive
Page Count: 28
ICS Code (Biological evaluation of medical devices): 11.100.20
scope:

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 the nature and duration of their contact with the body;

- the evaluation of existing relevant data from all sources;

- the identification of gaps in the available data set on the basis of a risk analysis;

- the identification of additional data sets necessary to analyse the biological safety of the medical device;

- the assessment of the biological safety of the medical device.

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. Other parts of ISO 10993 cover specific tests, as indicated in the Foreword.

Document History

August 1, 2018
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...
August 1, 2018
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 15, 2010
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process TECHNICAL CORRIGENDUM 1
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...
ISO 10993-1
October 15, 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...
August 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...
December 15, 1997
Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing
A description is not available for this item.
January 1, 1992
Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests; (Corrigendum 1-1992) (CEN EN 30993-1: 1994)
A description is not available for this item.

References

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