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: 1 August 2018
Status: active
Page Count: 48
ICS Code (Biological evaluation of medical devices): 11.100.20
scope:

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 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 document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with:

- the patient's body during intended use;

- the user's body, if the medical device is intended for protection (e.g., surgical gloves, masks and others).

This document is applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.

This document also gives guidelines for the assessment of biological hazards arising from:

- risks, such as changes to the medical device over time, as a part of the overall biological safety assessment;

- breakage of a medical device or medical device component which exposes body tissue to new or novel materials.

Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Device specific or product standards address mechanical testing.

This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.

 

Document History

ISO 10993-1
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...
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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