ISO 10993-12 specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing.
It is important that sample preparation methods be appropriate for both the biological evaluation methods and the materials being evaluated. Each biological test method requires the selection of materials, extraction solvents and conditions. ISO 10993-12 is based on existing national and international standards and regulations, wherever possible.
ISO 10993-12 addresses:
— 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.
The text of ISO 10993-12:2021 has been approved in Europe as EN ISO 10993-12:2021 without any changes.