ANSI AAMI ISO 10993-8-2000 pdf download
ANSI AAMI ISO 10993-8-2000 pdf download.Biological evaluation of medical devices
1 Scope
This part of ISO 10993 specifies requirements on the use of reference materials or certified reference materials used to determine the biological response of a material. It specifies the selection and qualification of reference materials for biological tests and the characteristics of reference materials for the use of reference materials as experimental controls.
2 Normative references
The following normative documents contain provisions which, through eference in this text, constitute provisions of this part of ISO 10993. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this part of ISO 10993 are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. ISO 10993-12, Biological evaluation of medical devices- -Part 12: Sample preparation and reference materials. ISO Guide 30:1 992, Terms and definitions used in connection with reference materials.
3Terms and definitions
For the purposes of this part of ISO 10993, the terms and definitions given in ISo 10993-12, ISO Guide 30, and the following apply.
3.1 certified reference material (CRM): Reference material, accompanied by a certificate, one or more of whose property values are certified 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 certified value is accompanied by an uncertainty at a stated level of confidence. [ISO Guide 30:1992, 2.2] NOTE- -Standard reference material (SRM) is a trademark protected certification supplied by the National Institutes for Standards and Technology, Gaithersburg, MD, USA.
3.2 reference material (RM): Material or substance one or more of whose property values are sufficiently homogeneous and well established to be used for the calibration of an apparatus， the assessment of a measurement method, or for assigning values to materials. [ISO Guide 30:1992, 2.1]
3.3 homogeneous: Condition of being of uniform structure or composition with respect to the biological endpoint under study. NOTE 1- -The RM is said to be homogeneous if the biological response to a specific test is found to lie within the specified uncertainty limits of the test, irrespective of the site in the batch or lot of material from where the test sample is taken. NOTE 2- Adapted from ISO Guide 30:1992, 2.6.
3.4 reference method: Thoroughly investigated test method that clearly and exactly describes the necessary conditions and procedures for the evaluation of a specific biological endpoint, has been shown to have accuracy and precision commensurate with its intended use and can, therefore, be used to characterize an RM. NOTE- Adapted from ISO Guide 30:1992, 3.10.
4 Use of certified reference materials or reference materials
Reference materials (RM) or certified reference materials (CRM) shall be used in biological tests as control materials to qualify in-house tests and control materials. They demonstrate the suitability of the procedure to yield a reproducible, predictable response, e.g., positive or negative. Use of a reference material in this way will ensure the comparability of the response between laboratories. The property values of any material used in this way shall be characterized with each biological test procedure for which the use of the material is desired. A material characterized and then certified for one reference test method or response, e.g., sensitization [6], shall not be used as a reference material for another, e.g., cytotoxicity [5], without additional characterization.
5 Characteristics of reference materials
5.1 One or more property values
RMs or CRMs used to determine the biological response of a material shall be evaluated with each biological test procedure for which the use of the material is desired. It is not sufficient to qualify a material for one type of reference test method or response, e.g., sensitization [6], and declare it a reference material for another, e.g., cytotoxicity [5], without additional qualification testing.
