EN ISO 10993-10:2013
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (ISO 10993-10:2010)
28-02-2014
21-08-2013
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
ISO 10993-10:2010 describes the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.ISO 10993-10:2010 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 for the preparation of materials specifically in relation to the above tests and several special irritation tests are described for application of medical devices in areas other than skin.
| Committee |
CEN/TC 206
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Standards | Relationship |
| ONORM EN ISO 10993-10 : 2014 | Identical |
| DS EN ISO 10993-10 : 2013 | Identical |
| DIN EN ISO 10993-10:2003-02 | Identical |
| ISO 10993-10:2010 | Identical |
| DIN EN ISO 10993-10:2014-10 | Identical |
| I.S. EN ISO 10993-10:2013 | Identical |
| UNI EN ISO 10993-10 : 2013 | Identical |
| NS EN ISO 10993-10 : 2013 | Identical |
| NF EN ISO 10993-10 : 2013 | Identical |
| UNE-EN ISO 10993-10:2013 | Identical |
| SN EN ISO 10993-10:2013 | Identical |
| NBN EN ISO 10993-10 : 2013 | Identical |
| PN EN ISO 10993-10 : 2015 | Identical |
| NEN EN ISO 10993-10 : 2013 | Identical |
| BS EN ISO 10993-10:2013 | Identical |
| 15/30278540 DC : 0 | BS ISO 18562-4 - BIOCOMPATIBILITY EVALUATION OF BREATHING GAS PATHWAYS IN HEALTHCARE APPLICATIONS - PART 4: TESTS FOR LEACHABLES IN CONDENSATE |
| 17/30358658 DC : 0 | BS EN 13795-1 - SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS |
| 17/30358661 DC : 0 | BS EN 13795-2 - SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 2: CLEAN AIR SUITS |
| UNI EN 14683 : 2014 | MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS |
| BS EN 455-3:2015 | Medical gloves for single use Requirements and testing for biological evaluation |
| EN 12011 : 1998 | INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| VDI 5703:2015-09 | Systematical development for a model-based testing of medical devices |
| UNE-EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
| PREN 14683 : DRAFT 2017 | MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS |
| PREN 13795-1 : DRAFT 2017 | SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 1: SURGICAL DRAPES AND GOWNS |
| 13/30281504 DC : 0 | BS EN 455-3 - MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION |
| I.S. EN ISO 4074:2015 | NATURAL RUBBER LATEX MALE CONDOMS - REQUIREMENTS AND TEST METHODS (ISO 4074:2015) |
| VDI 3823 Blatt 4:2006-11 | Vacuum coating quality assurance - Testing of vacuum coated plastics |
| I.S. EN 12442-1:2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
| DIN EN 14683:2014-07 | MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS |
| CEN/TR 16953:2017 | Medical gloves for single use - Guidance for selection |
| DIN EN 455-3:2015-07 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
| BS EN 12442-1:2000 | Animal tissues and their derivatives utilized in the manufacture of medical devices Analysis and management of risk |
| EN ISO 3826-4:2015 | Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features (ISO 3826-4:2015) |
| S.R. CEN/TR 16953:2017 | MEDICAL GLOVES FOR SINGLE USE - GUIDANCE FOR SELECTION |
| BS EN ISO 25539-1:2017 | Cardiovascular implants. Endovascular devices Endovascular prostheses |
| I.S. EN 12011:1998 | INSTRUMENTATION TO BE USED IN ASSOCIATION WITH NON-ACTIVE SURGICAL IMPLANTS - GENERAL REQUIREMENTS |
| PREN 455-3 : DRAFT 2013 | MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION |
| BS EN 14683:2014 | Medical face masks. Requirements and test methods |
| I.S. EN ISO 25539-1:2017 | CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017) |
| PD CEN/TR 16953:2017 | Medical gloves for single use. Guidance for selection |
| 17/30359567 DC : 0 | BS EN 14683 - MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS |
| EN 14683:2014 | Medical face masks - Requirements and test methods |
| I.S. EN 14683:2014 | MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHODS |
| UNE-EN 455-3:2015 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
| I.S. EN 455-3:2015 | MEDICAL GLOVES FOR SINGLE USE - PART 3: REQUIREMENTS AND TESTING FOR BIOLOGICAL EVALUATION |
| EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches (ISO 7198:2016) |
| EN 455-3:2015 | Medical gloves for single use - Part 3: Requirements and testing for biological evaluation |
| EN ISO 4074:2015 | Natural rubber latex male condoms - Requirements and test methods (ISO 4074:2015) |
| BS EN ISO 7198:2017 | Cardiovascular implants and extracorporeal systems. Vascular prostheses. Tubular vascular grafts and vascular patches |
| 12/30260949 DC : 0 | BS EN 14683 - MEDICAL FACE MASKS - REQUIREMENTS AND TEST METHOD |
| BS EN ISO 3826-4:2015 | Plastics collapsible containers for human blood and blood components Aphaeresis blood bag systems with integrated features |
| I.S. EN ISO 3826-4:2015 | PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHAERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015) |
| PREN 13795-2 : DRAFT 2017 | SURGICAL CLOTHING AND DRAPES - REQUIREMENTS AND TEST METHODS - PART 2: CLEAN AIR SUITS |
| I.S. EN ISO 7198:2017 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - VASCULAR PROSTHESES - TUBULAR VASCULAR GRAFTS AND VASCULAR PATCHES (ISO 7198:2016) |
| BS EN 13503-5:2001 | Ophthalmic implants. Intraocular lenses Biocompatibility |
| ISO 3826-4:2015 | Plastics collapsible containers for human blood and blood components — Part 4: Aphaeresis blood bag systems with integrated features |
| BS EN ISO 4074:2015 | Natural rubber latex male condoms. Requirements and test methods |
| EN 12442-1 : 2000 | ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
| 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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