devices- Biologicalevaluationofmedical
Part 6: Testsforlocaleffectsafter implantation
Evaluation biologique des dispositifs medicaux Partie 6: Essais concernant les effets locaux apres implantation
International Standard
Fourth edition 2026-04
Contents
5 General aspects and requirements for implantation test. 4
5.1 Tissue and implantation site. 45.2 5.3 Test periods. Animal model. .6 55.4 Surgery and testing conditions. Evaluation. .85.5 5.5.1 General. .9 .95.5.2 5.5.3 Macroscopic assessment Implant retrieval and tissue sample collection. .9 .95.5.4 Microscopic assessment. Evaluation of responses.. 105.5.5 11
Test report. 11
6.1 General. 116.2 6.3 Test laboratory Implant samples. 12 126.4 S9 Animals and implantation. Retrieval and histological procedure. 12 126.6 Macroscopic and microscopic evaluation. 136.7 Final evaluation.. 13
ISO 10993-6:2026(en)
Foreword
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This document was prepared byTechnical Committee ISO/TC 194 Biological and clinicalevaluation ofmedicaldevices in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 206 Biological and clinical evaluation of medical devices in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This fourth edition cancels and replaces the third edition (ISO 10993-6:2016) which has been technicallyrevised.
The main changes are as follows:
"steady-state and “reference control" have been added to Clause 3:-a new paragraph on the use of smaller positionally representative samples or coupons has been added to 4.2.2;- a new subclause 4.3 *Selection of control materials" has been added; the discussion of assessment of lymph nodes for certain materials has been expanded;--a new Annex E “Test methods for devices contacting peripheral nerve tissue” and Annex G “Microscopicevaluation of tissue responses to implanted materials" have been added;- tissue and pathological terminology has been updated throughout this document;-bibliographical entries have been updated.
A list of all parts in the ISO 10993 series can be found on the ISO website.
poq speps eu sasn a o paap a pnous quaop s to susanb o qpaa uplete listing of these bodies can be found at
ISO 10993-6:2026(en)
Introduction
The objective of the implantation test methods is to characterize the local tissue response after implantationof a medical device or material (test sample) including integration degradation or absorption in an appropriate animal model.
The test sample is implanted into an anatomical site appropriate for the evaluation of the local effects of the medical device (or portion of) in an animal.
The medical device or material local effects are evaluated by a parison of the tissue response causedby a test sample to that caused by parative or reference control samples used in medical devices whoseclinical acceptability and biopatibility characteristics have been established.
Careful study design can include other relevant biological effects to reduce the number of animals used toevaluate safety and efficacy while acplishing all study objectives. Additionally a long-term systemicoutes of implantation testing can satisfy the requirements of this document and ISO 10993-11.
