NBN EN ISO 10993-6 : 2009
Current
The latest, up-to-date edition.
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION
01-12-2013
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Common provisions for implantation test methods
4.1 General
4.2 Preparation of specimens for implantation
5 Test methods, general aspects
5.1 Tissue and implantation site
5.2 Animals
5.3 Test periods
5.4 Surgery and testing conditions
5.5 Evaluation
6 Test report
Annex A (informative) - General considerations regarding
implantation periods and tissue responses to
degradable/resorbable materials
Annex B (normative) - Test methods for implantation in
subcutaneous tissue
Annex C (normative) - Test method for implantation in muscle
Annex D (normative) - Test method for implantation in bone
Annex E (informative) - Examples of evaluation of local
biological effects after implantation
Annex ZA (informative) - Clauses of this International Standard
addressing essential requirements or other provisions
of EU Directives 90/385/EEC for Active Implantable
Medical Devices and 93/42/EEC for Medical Devices
Bibliography
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