ISO 10993-12:2021/Amd 1:2025 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

ISO 10993-12:2021/Amd 1:2025 Biological evaluation of medical devices — Part 12: Sample preparation and reference materials — AMENDMENT 1

Foreword

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This document was prepared by Technical Committee ISO/TC 194, Biological and clinical evaluation of medical devices, in collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 206, Biological and clinical evaluation of medical devices, in accordance with the Agreement on technical cooperation between ISO and CEN (Vienna Agreement).

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Biological evaluation of medical devices — Part 12: Sample preparation and reference materials — AMENDMENT 1

Clause 2

Replace the text of Clause 2 with:

The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

ISO 10993-18, Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process

ISO/TS 10993-19, Biological evaluation of medical devices — Part 19: Physico-chemical, morphological and topographical characterization of materials

ISO 14971, Medical devices — Application of risk management to medical devices

Clause 4

Change the wording in the first sentence of the first paragraph from “as described in ISO 14971” to “in accordance with ISO 14971”.

Clause 7

Change the wording in the first sentence of the first paragraph from “(see ISO 10993-1)” to “in accordance with ISO 10993-1”.

10.1

Change the wording in the second sentence of the first paragraph from “(see ISO 10993-18 and ISO/TS 10993-19)” to “in accordance with ISO 10993-18 and ISO/TS 10993-19”.

10.3.3, first paragraph

Add the following paragraph after the first paragraph:

For medical devices containing absorbent materials, the individual absorption capacity of these materials should be considered to determine the overall extraction volume (see Table 1).

10.3.3, Table 1

Replace Table 1 with:

Table 1

Standard surface areas and extract liquid volumes

Thickness^a mm	Extraction ratio (surface area or mass, per volume) ±10 %	Examples of forms of materials
<0,5	6 cm²/ml	film, sheet, tubing wall
0,5 to 1,0	3 cm²/ml	tubing wall, slab, small moulded items
>1,0	3 cm²/ml	larger moulded items
>1,0	1,25 cm²/ml	elastomeric materials
irregularly shaped solid devices	0,2 g/ml	powder, pellets, foam, non-absorbent moulded items, porous high-density materials
irregularly shaped porous devices (low-density materials)	0,1 g/ml	membranes, textiles

NOTE While there are no standardized methods available at present for testing solvent absorbing polymer materials
(e.g. absorbents and hydrocolloids), a suggested protocol is as follows:

— first, the volume of extraction vehicle that each 0,1 g or 1,0 cm² of material absorbs is determined;

— then, in performing the material extraction, the additional volume is added to each 0,1 g or 1,0 cm² in an extraction mixture.

a If the medical device includes multiple tissue contacting components with different thicknesses, the extraction ratio should be justified. One way to do this is to base the ratio on the thinnest material layer of that component.

10.3.4

Delete the last sentence: "For material such as elastomers and latex, it may be appropriate to use an extraction ratio of 1,25 cm²/ml, if justified".