ISO 10993-12-2021 pdf free.Biological evaluation of medical devices 一 Part 12: Sample preparation and reference material ls.
5 Designation
5.1 General
An infusion glass bottle for medical use compiying witfl me requirements laid aown in tnis part of ISO 8536 is designated using the descriptor infusion bottle followed by, in the order given, a reference to this part of Iso 8536, the model of the infusion bottle, the nominal capacity, the colour and the hydrolytic resistance container dass (see 8.1).
EXAMPLE 1 An infusion bottle (model A) with a nominal capacity of 500 ml. made of colourless glass (Cl) of hydrolytic resistance container class HC 2 complying with the requirements laid down in this part of ISO 8536 is designated as follows:
Infusion bottle ISO 8536-1 — A — 500 — cI — HC 2
EXAMPLE 2 An infusion bottle (model C) with a nominal capadty of 500 ml, made of colourless glass (ci) of hydrolytic resistance container class HC 2 complying with the requirements laid down in this part of ISO 8536 is designated as follows:
Infusion bottle ISO 8536-1 — C — 500 — cI — HC 2
5.2 Location of designation marks
The designation marks on the bottom, as specified in Figure 1 a). may also be fixed at the body of the bottle but not at the cylindrical part. The manufacturer’s code can also be placed at the shoulder of the bottle. If marked at the lower bottom radius, r2, or at the shoulder. r3, the diameter at these places should not exceed the diameter. d1. of the bottle. The designation of hydrolytic resistance container class is abbreviated as given in 9.1.
6 Material
Infusion bottles shall be constructed from
a) colourless (cl)or amber (br) borosilicate glass (see ISO 4802-1:2010, 3.6, and ISO 4802-2:2010, 3.6). or
b) soda-lime-silica glass (see ISO 4802-1:2010, 3.7, and ISO 4802-2:2010, 3.7) of the following hydrolytic resistance grain class:
ISO 720 — HGA 1;
– IS0719—HGB3orISO72O—HGA2.
A change in the composition of the glass material or of the colouring oxides shall be notified to the user at least nine months in advance.
RMs used as experimental controls shall meet the established quality assurance procedures of the manufacturer and test laboratory. They shall be identified in relation to source, manufacturer, grade and type. RMs are processed as described in Clause 8.
When RMs are used as experimental controls, they shall be in the same material class as the test sample, i.e. polymer, ceramic, metal, colloid. However, pure chemicals may be used as experimental controls for mechanistically-based test procedures, for example, genotoxicity and immune delayed- type hypersensitivity assays.
7 Test sample selection
Testing shall be performed on the final product, representative samples from the final product, materials processed in the same manner as the final product (see ISO 10993-1), or on appropriate extracts of any of these. The choice of test sample shall be justified.
NOTE In the case of materials that cure in situ, different test samples representative of the cured material versus the uncured state of the material might be needed.
For absorbable materials that could potentially have toxic degradants and residuals, testing of intermediate products should be considered.
The same test sample selection procedure applies when an extract is required.
8 Test sample and RM preparation
Test samples and RMs shall be handled with care to prevent contamination. Any residue from the manufacturing processes, intentional or unintentional additives or contaminants, shall be considered integral to the medical device, medical device portion or component, or representative sample.
NOTE For additional guidance on preparation, see Annex B.
— Test samples from sterilized medical devices and RMs shall be handled aseptically, if appropriate to the test procedure.
— Test samples which are clean, sterile and disinfected, shall be processed by the method recommended by the manufacturer and handled aseptically, if appropriate to the test procedure.
— The influence of the cleaning process and cleaning agent shall be considered in the selection and handling of the test sample.
Test samples from medical devices not required to be sterile in use shall be used as supplied and handled aseptically throughout the test sample preparation. If sterile test samples are required for a test procedure, e.g. for cytotoxicity testing, the effect of the sterilization or resterilization process on the test sample and RM shall be considered.ISO 10993-12 pdf download.