Standard Swedish standard · SS-EN ISO 10993-1:2009

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

Status: Withdrawn

· Replaced by: SS-EN ISO 10993-1:2020 Corrected by: SS-EN ISO 10993-1:2009/AC:2010
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Standard Swedish standard · SS-EN ISO 10993-1:2009

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

Subjects

Biological evaluation of medical devices (11.100.20)


Buy this standard

Standard Swedish standard · SS-EN ISO 10993-1:2009

Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
Subscribe on standards - Read more Dölj
Price: 1 152 SEK
standard ikon pdf

PDF

Price: 1 152 SEK
standard ikon

Paper

Price: 1 843,20 SEK
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Product information

Language: English

Written by: Svenska institutet för standarder

International title:

Article no: STD-71574

Edition: 4

Approved: 10/26/2009

No of pages: 36

Replaces: SS-EN ISO 10993-1:2009

Replaced by: SS-EN ISO 10993-1:2020