This standard has been revised by ISO 10993-1:2018
Abstract
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.
-
Status: WithdrawnPublication date: 2009-10
-
Edition: 4Number of pages: 21
-
- ICS :
- 11.100.20 Biological evaluation of medical devices
Life cycle
-
Previously
WithdrawnISO 10993-1:2003
-
Now
-
00
Preliminary
-
10
Proposal
-
20
Preparatory
-
30
Committee
-
40
Enquiry
-
50
Approval
-
60
Publication
-
90
Review
-
95
Withdrawal
Corrigenda / Amendments
WithdrawnISO 10993-1:2009/Cor 1:2010
-
00
-
Revised by
PublishedISO 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)