BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2003

Publisher

German Institute for Standardisation (Deutsches Institut für Normung)

National foreword
National Annex NA (informative) - Bibliography
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
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
Bibliography

Specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation and skin sensitization.

DocumentType	Standard
Pages	56
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Current

Standards	Relationship
ISO 10993-10:2010	Identical
NBN EN ISO 10993-10 : 2013	Identical
NEN EN ISO 10993-10 : 2013	Identical
NS EN ISO 10993-10 : 2013	Identical
I.S. EN ISO 10993-10:2013	Identical
SN EN ISO 10993-10:2013	Identical
UNI EN ISO 10993-10 : 2013	Identical
BS EN ISO 10993-10:2013	Identical
UNE-EN ISO 10993-10:2013	Identical
EN ISO 10993-10:2013	Identical
NF EN ISO 10993-10 : 2013	Identical
ONORM EN ISO 10993-10 : 2014	Identical

DIN EN ISO 3826-4 E : 2015	PLASTICS COLLAPSIBLE CONTAINERS FOR HUMAN BLOOD AND BLOOD COMPONENTS - PART 4: APHERESIS BLOOD BAG SYSTEMS WITH INTEGRATED FEATURES (ISO 3826-4:2015)
DIN EN ISO 11979-5 E : 2010	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY
DIN EN ISO 9394 E : 2013	OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - DETERMINATION OF BIOCOMPATIBILITY BY OCULAR STUDY WITH RABBIT EYES (ISO 9394:2012)

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
DIN EN ISO 14155-1 E : 2003	CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS
DIN EN ISO 10993-18 E : 2009	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
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
DIN EN ISO 10993-14 E : 2009	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 14: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM CERAMICS
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
DIN EN ISO 10993-13 E : 2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
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
DIN EN ISO 10993-12 E : 2012	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:2012)
DIN EN ISO 14155-2 E : 2003	CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS
ISO 10993-9:2009	Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products
DIN EN ISO 10993-15 E : 2009	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS

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DIN EN ISO 10993-10 E : 2003

Current

Table of Contents

Abstract

General Product Information

International Equivalents

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