Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO 10993-12:2012)
Abstract
ISO 10993-12:2012 specifies 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. Specifically, ISO 10993-12:2012 addresses the following:
- test sample selection;
- selection of representative portions from a device;
- test sample preparation;
- experimental controls;
- selection of, and requirements for, reference materials;
- preparation of extracts.
ISO 10993-12:2012 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.
Overview:
This standard specifies 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 series ISO 10993. Specifically, this part of ISO 10993 addresses the following: – test sample selection, – selection of representative portions from a device, – test sample preparation, – experimental controls, – selection of, and requirements, for reference materials, – preparation of extracts. This standard is not applicable to materials or products containing live cells. This standard is directed at manufacturers of medical devices and test laboratories. The committee responsible for this standard is NA 027-02-12 AA “Biologische Beurteilung von Medizinprodukten” (“Biological evaluation of medical devices”) at DIN.
DIN EN ISO 10993-12:2012-10 (E)
Biological evaluation of medical devices – Part 12: Sample preparation and reference
materials (ISO 10993-12:2012)
Contents Page
Foreword ………………………………………………………………………………………………………………………………………. 3
Introduction …………………………………………………………………………………………………………………………………… 4
1 Scope …………………………………………………………………………………………………………………………….. 5
2 Normative references …………………………………………………………………………………………………….. 5
3 Terms and definitions …………………………………………………………………………………………………….. 5
4 General requirements …………………………………………………………………………………………………….. 7
5 Reference materials (RMs) ……………………………………………………………………………………………… 8
5.1 General ………………………………………………………………………………………………………………………….. 8
5.2 Certification of RMs for biological safety testing …………………………………………………………….. 8
6 Use of RMs as experimental controls ……………………………………………………………………………… 8
7 Test sample selection …………………………………………………………………………………………………….. 9
8 Test sample and RM preparation …………………………………………………………………………………….. 9
9 Selection of representative portions from a device …………………………………………………………. 9
10 Preparation of extracts of samples ……………………………………………………………………………….. 10
10.1 General ………………………………………………………………………………………………………………………… 10
10.2 Containers for extraction ……………………………………………………………………………………………… 10
10.3 Extraction conditions and methods ………………………………………………………………………………. 10
10.4 Extraction conditions for hazard identification and risk estimation in the exaggerateduse
condition (points to consider in relation to Annex D) ………………………………………………. 13
11 Records ……………………………………………………………………………………………………………………….. 13
Annex A (informative) Experimental controls ……………………………………………………………………………….. 14
Annex B (informative) General principles on, and practices of, test sample preparation and sample
selection ………………………………………………………………………………………………………………………. 16
Annex C (informative) Principles of test sample extraction …………………………………………………………… 18
Annex D (informative) Exhaustive extraction of polymeric materials for biological evaluation ……….. 21
Bibliography ………………………………………………………………………………………………………………………………… 23
Annex ZA …………………………………………………………………………………………………………………………………….. 25
Annex ZB …………………………………………………………………………………………………………………………………….. 26