w
44908
ISO 10993-1:2009
Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
This standard has been revised by ISO 10993-1:2018
ISO 10993-1:2009 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.
General information
-
Status : WithdrawnPublication date : 2009-10
-
Edition : 4
-
- ICS :
-
Biological evaluation of medical devices
Life cycle
A standard is reviewed every 5 years
Revisions / Corrigenda
-
Previously
ISO 10993-1:2003
-
Now withdrawn
ISO 10993-1:2009 -
Corrigenda/Amendments
ISO 10993-1:2009/Cor 1:2010
-
Revised by
ISO 10993-1:2018
Got a question?
Check out our FAQs
Customer care
+41 22 749 08 88
Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)
Keep up to date with ISO
Sign up to our newsletter for the latest news, views and product information