Table of Contents

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

Abstract

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 ISO 10993.

General Product Information

Published
Document Type	Standard
Status	Current
Publisher	International Organization for Standardization
Pages
ISBN
Committee	TC 194
Supersedes	ISO/DIS 10993-12 : 60.00 (2012)