ANSI AAMI ISO 10993-8 pdf free download

ANSI AAMI ISO 10993-8 pdf free download.Biological evaluation of medical devices- Part 8: Selection and qualification of reference materials for biological tests.
3.5 stability of property values: Ability of a material, when stored under specified conditions, to maintain the
stated biological response, within specified limits, for a specific period of time.
NOTE—Adapted from ISO Guide 30:1992, 2.7.
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.
5.2 Long-term availability of the reference material
To ensure the long-term availability of a reference material for determination of biological response, the user of the material should obtain a commitment as long as possible, preferably not less than five years, from the supplier of the RMs or CRMs.
A second, but less desirable, option is the publication by the reference material supplier of an “open formulation” for the material, i.e., publication of the source materials and details of the processing needed to ensure uniform batches of RM.
5.3 Certification of reference materials for biological safety testing
The biological response of the certified reference material under specific test conditions shall be established through interlaboratory studies.
6 Use of reference materials as experimental controls
6.1 Material screening versus biocompatibility of medical devices
The use of the reference materials described in ISO 10993-12 and elsewhere in this part of ISO 10993 are limited to
biological screening of the materials intended for use in the manufacture of medical devices. However, while not intended for the purpose, they are often used in the performance assessment of the finished medical device. The vertical standard for the device, when available, shall address the biological testing of the product in the performance environment of the device. Biological testing described in the vertical product standard takes precedence over testing performed to screen the materials for suitability.
6.2 Misuse of CRMs
The attention of the users of this part of ISO 10993 is directed to the discussion of “proper use” and “misuse” of
CRMs in the introduction to ISO Guide 33. This discussion points out areas of potential under- and over-utilization of
RMs and CRMs.
Users of this part of ISO 10993 shall note that the use of calibration materials to evaluate the biological response of materials under investigation within a single laboratory is acceptable.ANSI AAMI ISO 10993-8 pdf download.