Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
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.
DIN EN ISO 10993-1:2010-04 (E)
Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk
management system (ISO 10993-1:2009 )
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..6
4 General principles applying to biological evaluation of medical devices …………………………..7
5 Categorization of medical devices …………………………………………………………………………………10
5.1 General …………………………………………………………………………………………………………………………10
5.2 Categorization by nature of body contact ………………………………………………………………………10
5.3 Categorization by duration of contact ……………………………………………………………………………11
6 Biological evaluation process ……………………………………………………………………………………….12
6.1 Material characterization ……………………………………………………………………………………………….12
6.2 Biological evaluation tests …………………………………………………………………………………………….12
7 Interpretation of biological evaluation data and overall biological safety assessment …….18
Annex A (informative) Biological evaluation tests …………………………………………………………………………19
Annex B (informative) Guidance on the risk management process ………………………………………………..20
Annex C (informative) Suggested procedure for literature review ………………………………………………….23
Bibliography …………………………………………………………………………………………………………………………………25
Requirements of EU Directive 93/42/EEC on Medical devices ………………………………………………………..26
Requirements of EU Directive 90/385/EEC on Active Implantable Medical Devices …………………………27