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NBN EN ISO 10993-6 : 2009

Current

Current

The latest, up-to-date edition.

BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION

Published date

12-01-2013

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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

Describes test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices.

DevelopmentNote
Supersedes NBN EN 30993-6. (11/2007)
DocumentType
Standard
PublisherName
Belgian Standards
Status
Current

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