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BS EN ISO 10993-12:2021 – TC

BS EN ISO 10993-12:2021 – TC

$217.84

Tracked Changes. Biological evaluation of medical devices – Sample preparation and reference materials

Published By Publication Date Number of Pages
BSI 2021 84
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This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series.

Specifically, this document addresses the following:

  • test sample selection;

  • selection of representative portions from a medical device;

  • test sample preparation;

  • experimental controls;

  • selection of, and requirements for, reference materials;

  • preparation of extracts.

This document is not applicable to live cells but can be relevant to the material or medical device components of combination products containing live cells.

Extractions for chemical characterization are covered in ISO 10993-18. Clause 7, 8, 9, 10 [with the exception of 10.3.5 and 10.3.11 b)], and 11 can apply to extractions for chemical characterization. Information given in C.1 to C.4 can also be relevant.

PDF Catalog

PDF Pages PDF Title
52 National foreword
56 European foreword
57 Annex ZA (informative) Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered
60 Foreword
61 Introduction
63 1 Scope
2 Normative references
3 Terms and definitions
65 4 General requirements
66 5 Reference materials (RMs)
5.1 General
5.2 Certification of RMs for biological safety testing
6 Use of RMs as experimental controls
67 7 Test sample selection
8 Test sample and RM preparation
68 9 Selection of representative portions from a medical device
10 Preparation of extracts of samples
10.1 General
10.2 Containers for extraction
69 10.3 Extraction conditions and methods
72 10.4 Extraction conditions for materials that polymerize in situ
11 Records
73 Annex A (informative) Experimental controls
75 Annex B (informative) General principles on, and practices of, test sample preparation and sample selection
77 Annex C (informative) Principles of test sample extraction
80 Annex D (informative) Exhaustive extraction of polymeric materials for biological evaluation
82 Bibliography

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BS EN ISO 10993-12:2021 - TC
$217.84