Please select and order
€56.10
excl. VAT
Add to cart
Norm
ISO 10993-1:2009
Issue date: 2009 10 13
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
ISO 10993-1:2009 describes:
the general principles governing the biological evaluation of medical devices within a risk management process;
the general categorization of...
Withdrawn: 2018 08 17
Publisher:
International Organization for Standardization
Format:
Digital | 21 Pages
Language:
English
Currently valid:
ICS
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.
ISO 10993-1:2018
2018 08 17
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management p...
Norm
ISO 10993-1:2009
2009 10 13
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management p...
Norm
↖
ISO 10993-1:2003
2003 07 28
Biological evaluation of medical devices — Part 1: Evaluation and testing
Norm
ISO 10993-1:1997
1997 12 11
Biological evaluation of medical devices — Part 1: Evaluation and testing
Norm
ISO 10993-1:1992/Cor 1:1992
1992 09 09
Biological evaluation of medical devices — Part 1: Guidance on selection of tests — Technical Corrig...
Norm
ISO 10993-1:1992
1992 04 23
Biological evaluation of medical devices — Part 1: Guidance on selection of tests
Norm
Norm
Issue date :
2018 08 17
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process (Corrected version 2018-10)
Norm
Issue date :
2010 06 04
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process — Technical Corrigendum 1
