NEN-EN-ISO 10993-1:2009 (Cor. 2009-10) en

Withdrawn standard
21 Pages
Publication date 2009-10-01
Log in
Create an account
This document is withdrawn and replaced by:
This document has been modified by:
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 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.
This document replaces:
Extra information
Registration date
CEN/TC 206
ICS code
11.100.20 Biological Evaluation Of Medical Devices
Related to
ISO 10993-1:2009 en, IDT * EN ISO 10993-1:2009-10, IDT
Evaluation standards - Testing - Biological analysis and testing - Surgical instruments - Medical sciences - Health services - Laboratory testing - Medical equipment - Medical devices - Dental instruments - Dental materials

Number of users reached

Number of simultaneous users for this license reached. Try again later or contact your company administrator to ask for access to this license.