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BS EN ISO 10993-12:2012

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Biological evaluation of medical devices Sample preparation and reference materials
Available format(s)

Hardcopy , PDF

Superseded date

06-21-2021

Language(s)

English

Published date

10-31-2012

Publisher

British Standards Institution

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
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

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 series.

Committee
CH/194
DevelopmentNote
Supersedes 94/504568 DC and 01/562154 DC. (12/2004) Supersedes 06/30145887 DC. (01/2008)
DocumentType
Standard
Pages
34
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

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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Hardcopy - English
PDF - English
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