BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 12: SAMPLE PREPARATION AND REFERENCE MATERIALS (ISO 10993-12:2012)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2012

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 requirements
5 Reference materials (RMs)
6 Use of RMs as experimental controls
7 Test sample selection
8 Test sample and RM preparation
9 Selection of representative portions from a device
10 Preparation of extracts of samples
11 Records
Annex A (informative) - Experimental controls
Annex B (informative) - General principles on, and practices
        of, test sample preparation and sample selection
Annex C (informative) - Principles of test sample extraction
Annex D (informative) - Exhaustive extraction of polymeric
        materials for biological evaluation
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

Describes requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of the ISO 10993.

DocumentType	Standard
Pages	30
PublisherName	German Institute for Standardisation (Deutsches Institut für Normung)
Status	Current

Standards	Relationship
ONORM EN ISO 10993-12 : 2012	Identical
ISO 10993-12:2012	Identical
NBN EN ISO 10993-12 : 2012	Identical
NEN EN ISO 10993-12 : 2012	Identical
NS EN ISO 10993-12 : 2012	Identical
I.S. EN ISO 10993-12:2012	Identical
SN EN ISO 10993-12 : 2012	Identical
UNI EN ISO 10993-12 : 2012	Identical
BS EN ISO 10993-12:2012	Identical
UNE-EN ISO 10993-12:2013	Identical
EN ISO 10993-12:2012	Identical
NF EN ISO 10993-12 : 2012	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 10993-13 E : 2010	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES
DIN EN ISO 10993-10 E : 2003	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)
DIN EN ISO 10993-11 E : 2009	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
DIN EN ISO 10993-15 E : 2009	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 15: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM METALS AND ALLOYS
DIN EN ISO 11979-6 E : 2015	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 6: SHELF-LIFE AND TRANSPORT STABILITY TESTING (ISO 11979-6:2014)
DIN EN ISO 11979-5 E : 2010	OPHTHALMIC IMPLANTS - INTRAOCULAR LENSES - PART 5: BIOCOMPATIBILITY
DIN EN ISO 10993-11:2009-08	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 11: TESTS FOR SYSTEMIC TOXICITY
DIN EN ISO 10993-6:2017-09	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 6: TESTS FOR LOCAL EFFECTS AFTER IMPLANTATION (ISO 10993-6:2016)
DIN EN ISO 10993-10:2003-02	BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 10: TESTS FOR IRRITATION AND SKIN SENSITIZATION (ISO 10993-10:2010)

ISO 10993-3:2014	Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
ISO Guide 33:2015	Reference materials Good practice in using reference materials
ISO Guide 35:2017	Reference materials Guidance for characterization and assessment of homogeneity and stability
ISO 10993-18:2005	Biological evaluation of medical devices Part 18: Chemical characterization of materials
ISO 10993-10:2010	Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
ISO Guide 30:2015	Reference materials Selected terms and definitions
CFR 40(PTS700-789) : JUL 2016	PROTECTION OF ENVIRONMENT - ENVIRONMENTAL PROTECTION AGENCY
ISO 10993-1:2009	Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 14971:2007	Medical devices Application of risk management to medical devices
ISO Guide 31:2015	Reference materials — Contents of certificates, labels and accompanying documentation
NFS 90 701 : 1988	MEDICO-SURGICAL EQUIPMENT - BIOCOMPATIBILITY OF MATERIALS AND MEDICAL DEVICES
ISO Guide 34:2009	General requirements for the competence of reference material producers

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DIN EN ISO 10993-12 E : 2012

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referenced By This Book

Standards Referencing This Book

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