BS EN ISO 10993-10:2013
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
Biological evaluation of medical devices Tests for irritation and skin sensitization
Hardcopy , PDF
English
28-02-2014
08-02-2023
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General principles - Step-wise approach
5 Pretest considerations
6 Irritation tests
7 Skin sensitization tests
8 Key factors in interpretation of test results
Annex A (normative) - Preparation of materials for
irritation/sensitization testing
Annex B (normative) - Special irritation tests
Annex C (normative) - Human skin irritation test
Annex D (informative) - In vitro tests for skin
irritation
Annex E (informative) - Method for the preparation of
extracts from polymeric test materials
Annex F (informative) - Background information
Bibliography
Annex ZA (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 93/42/EEC
on Medical Devices
Annex ZB (informative) - Relationship between this
European Standard and the Essential
Requirements of EU Directive 90/385/EEC
on Active Implantable Medical Devices
Specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.
| Committee |
CH/194
|
| DevelopmentNote |
Supersedes BS 5736-6(1983), BS 5736-7(1983), BS 5736-8(1984) and BS 5736-9(1986) Supersedes 00/560455 DC & 92/53864 DC. (10/2002) Supersedes 08/30170164 DC. (10/2010)
|
| DocumentType |
Standard
|
| Pages |
80
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 10993-10 : 2014 | Identical |
| DIN EN ISO 10993-10:2003-02 | Identical |
| NBN EN ISO 10993-10 : 2013 | Identical |
| NEN EN ISO 10993-10 : 2013 | Identical |
| ISO 10993-10:2010 | Identical |
| DIN EN ISO 10993-10:2014-10 | Identical |
| I.S. EN ISO 10993-10:2013 | Identical |
| NS EN ISO 10993-10 : 2013 | Identical |
| EN ISO 10993-10:2013 | Identical |
| NF EN ISO 10993-10 : 2013 | Identical |
| UNE-EN ISO 10993-10:2013 | Identical |
| ISO 9394:2012 | Ophthalmic optics — Contact lenses and contact lens care products — Determination of biocompatibility by ocular study with rabbit eyes |
| ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation plans |
| ISO 10993-13:2010 | Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices |
| ISO 14155-1:2003 | Clinical investigation of medical devices for human subjects — Part 1: General requirements |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| ISO 10993-14:2001 | Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics |
| ISO 10993-18:2005 | Biological evaluation of medical devices — Part 18: Chemical characterization of materials |
| ISO 10993-12:2012 | Biological evaluation of medical devices — Part 12: Sample preparation and reference materials |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| ISO 10993-9:2009 | Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products |
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