ISO 10993-12:2021 pdf download

ISO 10993-12:2021 pdf download

ISO 10993-12:2021 pdf download.Biological evaluation of medical devices — Part 12: Sample preparation and reference materials
1 Scope
This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series. Specifically, this document addresses the following: — 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. This document is not applicable to live cells but can be relevant to the material or medical device components of combination products containing live cells. Extractions for chemical characterization are covered in ISO 10993-18. Clause 7, 8 , 9, 10 [with the exception of 10.3.5 and 10.3.11 b)], and 11 can apply to extractions for chemical characterization. Information given in C.1 to C.4 can also be relevant.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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3.1 blank
extraction vehicle not containing the test material, which is exposed to identical vessels and conditions as the test sample during extraction
Note 1 to entry: The purpose of the blank is to evaluate possible confounding effects due to the extraction vessel,extraction vehicle and extraction process.
3.2 CRM
certified reference material
reference material (RM) characterized by a metrologically valid procedure for one or more specified properties, accompanied by an RM certificate that provides the value of the specified property, its associated uncertainty, and a statement of metrological traceability
Note 1 to entry: The concept of value includes a nominal property or a qualitative attribute such as identity or sequence. Uncertainties for such attributes may be expressed as probabilities or levels of confidence.
Note 2 to entry: Metrologically valid procedures for the production and certification of RMs are given in, among others, ISO 17034 and ISO Guide 35.
Note 3 to entry: ISO Guide 31 gives guidance on the contents of RM certificates.
Note 4 to entry: ISO/IEC Guide 99:2007 has an analogous definition (5.14).
[SOURCE: ISO Guide 30:2015, 2.1.2]
3.3 exaggerated extraction
extraction that is intended to result in a greater amount of a chemical constituent being released as compared to the amount generated under the simulated conditions of use
Note 1 to entry: It is important to ensure that the exaggerated extraction does not result in a chemical change of the material.