EN ISO 10993-12 Biological Evaluation of Medical Devices - Test Standard for Sample Preparation and Reference Materials

This standard specifies and guides primarily the requirements for procedures for the selection of reference materials and preparation of samples for medical device testing in biological test systems in accordance with one or more parts of the ISO 10993 series.

It is important that the sample preparation methods are suitable for both the biological evaluation methods and the materials being evaluated. Each biological test method requires selection of materials, extraction solvents and conditions.

This standard specifically addresses the following:

• Test sample selection;
• Selection of representative sections from a medical device;
• Test sample preparation;
• Experimental controls;
• Selection and requirements of reference materials;
• Preparation of extracts.

This standard does not apply to living cells, but may relate to material or medical device components of combination products containing living cells.

ISO 10993-12 is based on existing national and international specifications, regulations and standards wherever possible.

 

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