M00016345
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016)
British Standards Institution
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Availability date: 11/05/2021
European foreword<br>Foreword<br>1 Scope<br>2 Normative references<br>3 Terms and definitions<br>4 Common provisions for implantation test methods<br>5 Test methods, general aspects<br>6 Test report<br>Annex A (normative) - Test methods for <br> implantation in subcutaneous tissue<br>Annex B (normative) - Test method for implantation <br> in muscle<br>Annex C (normative) - Test method for implantation <br> in bone<br>Annex D (normative) - Test method for implantation <br> in brain tissue<br>Annex E (informative) - Examples of evaluation of local <br> biological effects after implantation<br>Bibliography<br>Annex ZA (informative) - Relationship between this <br> European Standard and the essential <br> requirements of Directive 93/42/EEC <br> [OJ L 169] aimed to be covered <br>Annex ZB (informative) - Relationship between this <br> European Standard and the essential<br> requirements of Directive 90/385/EEC <br> [OJ L 189] aimed to be covered
Describes test methods for the assessment of the local effects after implantation of biomaterials intended for use in medical devices.
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Document Type | Standard |
Status | Current |
Publisher | British Standards Institution |
Pages | |
ISBN | |
Committee | CH/194 |
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