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

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Biological evaluation of medical devices —Part 12: Sample preparation and reference materials由国际标准化组织(International Organization for Standardization，简称ISO)于2021-01发布，适用于世界范围。

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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 a nd definiti ons

For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https://w ww. iso. org/o bp

— IEC Electropedia: available at http://w ww. electropedia .org/ 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

c er t i f ie d r efer enc e m at er i a l

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.

3.4

exhaustive extraction

extraction conducted until the amount of extractable material in a subsequent extraction is less than 10 % by gravimetric analysis (or that achieved by other means) of that detected in the initial extraction

Note 1 to entry: As it is not possible to demonstrate the exhaustive nature of residual recovery, the definition of exhaustive extraction adopted is as above. See also Annex C.

3.5

experimental control

substance with well-characterized responses, which is used in a specific test system to assist in evaluating if the test system has responded in a reproducible and appropriate manner

3.6

extract

liquid that results from extraction of the test sample or control

3.7

extractable substance

substance that can be released from a medical device or material using either extraction solvents or extraction conditions, or both, that are expected to be at least as aggressive as the conditions of clinical use

3.8

homogeneity

consistency of a material's chemical and physical compositions, and uniformity in response to a biological endpoint

Note 1 to entry: A reference material is said to be homogeneous if the biological response in a specific test is found to lie within the specified uncertainty limits of the test, irrespective of the batch or lot of material from which the test sample is extracted.

3.9

leachable substance

substance that can be released from a medical device or material during clinical use

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