BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 13: IDENTIFICATION AND QUANTIFICATION OF DEGRADATION PRODUCTS FROM POLYMERIC MEDICAL DEVICES (ISO 10993-13:2010)

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2010

Publisher

National Standards Authority of Ireland

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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Degradation test methods
5 Test procedures
6 Test report
Annex A (informative) - Analytical methods
Annex B (informative) - Environmental stress cracking
        (ESC) of polymers
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 general requirements for the design of tests in a simulated environment for identifying and quantifying degradation products from finished polymeric medical devices ready for clinical use.

DocumentType	Standard
Pages	30
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN ISO 10993-13:2009

Standards	Relationship
DIN EN ISO 10993-13:2010-11	Identical
NBN EN ISO 10993-13 : 2010	Identical
NS EN ISO 10993-13 : 2010	Identical
UNE-EN ISO 10993-13:2010	Identical
BS EN ISO 10993-13:2010	Identical
SN EN ISO 10993-13:2010	Identical
NF EN ISO 10993-13 : 2010	Identical
UNI EN ISO 10993-13 : 2010	Identical
ISO 10993-13:2010	Identical
NEN EN ISO 10993-13 : 2010	Identical
EN ISO 10993-13:2010	Identical
DIN EN ISO 10993-13 E : 2010	Identical

ISO 13781:2017	Implants for surgery — Homopolymers, copolymers and blends on poly(lactide) — In vitro degradation testing
ISO 10993-12:2012	Biological evaluation of medical devices Part 12: Sample preparation and reference materials
ISO 10993-17:2002	Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances
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
ISO 3696:1987	Water for analytical laboratory use — Specification and test methods
ISO 14971:2007	Medical devices Application of risk management to medical devices

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I.S. EN ISO 10993-13:2010

Current

Table of Contents

Abstract

General Product Information

International Equivalents

Standards Referencing This Book

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