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DIN EN ISO 10993-1

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009)

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Organization: DIN
Publication Date: 1 April 2010
Status: active
Page Count: 31
ICS Code (Management systems): 03.100.70
scope:

This part of ISO 10993 describes:

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.
 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

April 1, 2017
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO/DIS 10993-1:2017); German and English version prEN ISO 10993-1:2017
A description is not available for this item.
DIN EN ISO 10993-1
April 1, 2010
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system (ISO 10993-1:2009)
This part of ISO 10993 describes: This part of ISO 10993 describes:    — the general principles governing the biological evaluation of medical devices within a risk management process;    — the...
October 1, 2009
Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)
A description is not available for this item.
March 1, 2009
Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003); English version FprEN ISO 10993-1:2009, Amendment 1
A description is not available for this item.
December 1, 2003
Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:2003)
A description is not available for this item.
June 1, 1998
Biological evaluation of medical devices - Part 1: Evaluation and testing (ISO 10993-1:1997); German version EN ISO 10993-1:1997
A description is not available for this item.

References

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