ISO 14949 pdf download – lmplants for surgery —Two-part addition-cure silicone elastomers

ISO 14949 pdf download – lmplants for surgery —Two-part addition-cure silicone elastomers.
e) Purity of the inhibitor
The purity of the inhibitor used shall be determined based on an appropnate analysis and shall be greater than 95 % mass fraction (see 121 for further information).
I) Structure of the inhibitor
The structure of the inhibitor used shall be determined by a suitable method such as infrared spectroscopy (see (2J for further information),
5 Blocompatibility
The biological and physical properties of the cured silicone elastomer depend largely on the formulation as contained In the two-part starting material Processing conditions to produce silicone parts (extrusion or molding) can also Impact biological and physical properties. The validation and consistency of production should be part of the quality system of the supplier. In order to ensure consistent final product properties, the manufacturer should ensure thai the supplier has rstalled measures to control for processing and formulation parameters in accordance with ISO 9001, ISO 14969 and good manufacturing practice. In addition, process validation should indude a biological assessment, since production could introduce contaminants, arid the functiorialities incorporated into silicone elastomers can impart biological activity.
Demonstration of biocompatibility shall be established in accordance with ISO 10993-1. Testing should be carried out at the time of material qualification and then repeated at least every 5 years to 10 years.
6 Characterization and testing
6.1 Test slab preparation
A test slab with a thickness of (2± 0.2) mm shall be prepared in accordance with ISO 34-1 and with the recommended cure schedule as well as the post-cure schedule It needed,
6.2 Identification
To analyse the cured elastorrier as a silicone, the following test shall be performed on at least an audit basis:
examine a slab of elastomer by infrared absorption spectroplloiometry. recording the spectrum by the multiple reflection method for solids. There should be absorption maxima at approximately (2 962 ± 5) an ‘. (2 906 ± 5) cm”1 (1 260 ± 5)cm ‘1and (1 094 ± 5)cni-1 10(1 022± 5)an-1.
6.3 PurIty testing
6.3.1 Metal contamination
Each production lot of two-part addition-cure silicone elastomer shall be tested for metal contamination, The cured elastorner shall be tested and comply with the following specification on metal impurities. if one of these metals comprises part of a formulation component (for example BaSO4), it shall not be tested as an impurity.
tear strength, die B (kNIm):
— hardness (IRHD):
— relative dens4y, or specific gravity (kglm3).
7 Documentation
7.1 Data sheet
The supplier shall povide. upon request and for each type of two-part addition-cure silicone etastomer, a data sheet induding at least the following information:
a) the raw material supplier’s name, address and telephone number.
b) the product reference:
C) the recommended procedure and conditions to store the non-crosslinked material in its original unopened container and the shelf-life expected under these conditions;
d) the recommended cure procedure. induding the recommended mixing procedure with ratio of part A to part B. the recommended cure schedule (time and temperature) and recommended post-cure schedule if needed:
e) the range of properties, with defined specification limits and test methods, including cure/post-cure conditions:
1) the recommended sterilization methods. including the method(s) that Is (are) not recommended;
g) any known restriction of use andlor statement about applications that are not recommended:
h) the biological and physical properties of the cured silicone elastomer, including conditions of sample preparation Biological properties should be addressed by supplying compatibility test data summaries:
i) the time needed to reach 90% of the final torque shall be part of the product specification (see ISO 3417).
7.2 Certificate of analysis
For each production lot of addition-cure silicone efastomer. the supplier shaM provide a certificate of analysis that lists the results of the testing performed lii accordance with the specifations and requirements listed in clause 6 of this International Standard, and a statement that This two-part addition-cure silicone elastomer meets the requirements for qualification testing as described in ISO 14949. Implants for surgery — Two—part addition-cure sitcone elastomers.