National foreword

This British Standard is the UK implementation of EN ISO 10993‑10:2010. It supersedes BS EN ISO 10993‑10:2009 which is withdrawn.

The UK participation in its preparation was entrusted to Technical Committee CH/194, Biological evaluation of medical devices.

A list of organizations represented on this committee can be obtained on request to its secretary.

This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application.

Compliance with a British Standard cannot confer immunity from legal obligations.

This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2010.

This European Standard was approved by CEN on 23 July 2010.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

Foreword

This document (EN ISO 10993‑10:2010) has been prepared by Technical Committee ISO/TC 194 "Biological evaluation of medical devices" in collaboration Technical Committee CEN/TC 206 “Biological evaluation of medical devices” the secretariat of which is held by NEN.

This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 2011, and conflicting national standards shall be withdrawn at the latest by February 2011.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.

This document supersedes EN ISO 10993‑10:2009.

This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directives.

For relationship with EU Directives, see informative Annex ZA and ZB, which are integral parts of this document.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.

Endorsement notice

The text of EN ISO 10993‑10:2010 has been approved by CEN as a EN ISO 10993‑10:2010 without any modification.

1 Scope

This part of ISO 10993 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.

This part of ISO 10993 includes:

pretest considerations for irritation, including in silico and in vitro methods for dermal exposure;
details of in vivo (irritation and sensitization) test procedures;
key factors for the interpretation of the results.

Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex B several special irritation tests are described for application of medical devices in areas other than skin.

2 Normative references

3 Terms and definitions

4 General principles — Step-wise approach

5 Pretest considerations

5.1 General

5.2 Types of material

5.3 Information on chemical composition

6 Irritation tests

6.1 In vitro irritation tests

6.2 In vivo irritation tests — Factors to be considered in design and selection of in vivo tests

6.3 Animal irritation test

6.4 Animal intracutaneous (intradermal) reactivity test

6.5 Human skin irritation test

7 Skin sensitization tests

7.1 Choice of test methods

7.2 Murine Local Lymph Node Assay (LLNA)

7.3 Guinea pig assays for the detection of skin sensitization

7.4 Important factors affecting the outcome of the test

7.5 Guinea pig maximization test (GPMT)

7.5.5 Observation of animals

7.5.6 Evaluation of results

7.5.7 Test report

7.6 Closed-patch test (Buehler test)

7.6.1 Principle

7.6.2 Test sample preparation

7.6.3 Animals and husbandry

7.6.4 Test procedure

7.6.5 Observation of animals

7.6.6 Evaluation of results

7.6.7 Test report

8 Key factors in interpretation of test results

Bibliography

BS EN ISO 10993-10:2010

Biological evaluation of medical devices - Tests for irritation and skin sensitization

Published:

31 Oct 2010

Withdrawn:

28 Feb 2014