ANSI/AAMI/ISO 10993-12-2012 pdf download.Biological evaluation of medical devices - Part 12: Sample preparation and reference materials.
This part of ISO 10993 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, 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 part of ISO 10993 is not applicable to live cells, but can be relevant to the material or device components of combination products containing live cells.
2 Normative references
The following referenced documents are indispensable for the application 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 (all parts), Biological evaluation of medical devices
ISO 14971, Medical devices一Application of risk management to medical devices
3 Terms and definitions
For the purposes of this document, the fllowing terms and definitions apply.
3.1 accelerated extraction
extraction that provides a measure of the leachable or extractable materials of the device or material,using condtions that shorten the time for leaching of the substances into the extraction vehicle but do not result in a chemical change of the substances being extracted EXAMPLE Elevated temperature, agitation, changing of the extraction vehicle.
3.2 blank
extraction vehicle not containing the test material, which is retained in a vessel identical to that holdin the test sample and subjected to conditions identical to the ones the test sample is subjected to during its extraction
NOTE The purpose of the blank is to evaluate possible confounding ffcts due to the extraction vessel, extraction vehicle and extracton process.
3.3 CRM certified reference material
reference material, accompanied by a certificate, one or more of whose property values are certifhed by a procedure which establishes its traceability to an accurate realization of the unit in which the property values are expressed, and for which each ceritfied value is accompanied by an uncertainty at a stated level of confidence
[SO Guide 30:1992. definition 2.2]
exaggerated extraction
extraction that is intended to result in a greater amount of a chemical constiluent being released as compared to the amount generated under the simulated conditions of use
NOTE I is important如o ensure that the exaggratod extraction does not result in a chemical change of the material.
3.5 exhaustive extraction
extraction conducted until the amount of extractable material in a subsequent extraction is less than 10 % by gravimetric analysis of that detected in the inital extraction
NOTE As it is not possible to demonstrate the exhaustive nature of residual recowery, the definilin of exhaustive extraclion adopted is as above. See also Annex C.
3.6 experimental control
substance. with wel-characterized responses, which is used in a specic test system to assist in evaluating if the test system has responded in a reproducible and appropriate manner
3.7 extract
liquid that results from extraction of the test sample or control.ANSI/AAMI/ISO 10993-12 pdf download.