ISO 14949 pdf download.Implants for surgery — Two-part addition-cure silicone elastomers
1 Scope
This International Standard specifies the characteristics of, and corresponding test methods for, the two-part addition-cure high consistency or liquid silicone elastomer for use in the manufacture (partially or totally) of surgical implants.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For dated references, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard 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 34-1:1994, Rubber, vulcanized or thermoplastic — Determination of tear strength — Part 1: Trouser, angle and crescent test pieces ISO 48:1994, Rubber, vulcanized or thermoplastic — Determination of hardness (hardness between 10 IRHD and 100 IRHD) ISO 527-2:1993, Plastics — Determination of tensile properties — Part 2: Test conditions for moulding and extrusion plastics ISO 3417:1991, Rubber — Measurement of vulcanization characteristics with the oscillating disc curemeter ISO 6502:1999, Rubber — Guide to the use of curemeters ISO 10993-1:1997, Biological evaluation of medical devices — Part 1: Evaluation and testing ISO 10993-5:1999, Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity
3 Terms and definitions
For the purposes of this International Standard, the following terms and definitions apply. 3.1 catalyst organometallic complex, typically containing platinum substituted by ligands made of any suitable combination of the elements carbon, hydrogen, oxygen, chlorine or silicon (with the exclusion of aromatic rings).3.3 filler reinforcing agent 〈for the purposes of this International Standard〉 silicate or high purity amorphous silica NOTE 1 Such agents are commercially known as fumed or precipitated silica. NOTE 2 Silica can be treated with silylating agents, for example, those of the formula Me 3 SiX or Me 2 SiX 2 where X is a hydrolysable group, or polysiloxane oligomer of the formula HOMe 2 SiO(SiMe 2 O) p (SiMeRO) q SiMe 2 OH where R is a methyl or a vinyl group. NOTE 3 Agents that impart radiopacity to the elastomer (e.g. BaSO 4 ) may have reinforcing properties. 3.4 inhibitor compound or material that has the effect of slowing down or stopping a chemical reaction such as crosslinking 3.5 lot batch defined quantity of material manufactured in a single or multi-step process such that the material obtained can be considered as homogeneous NOTE in the case of a continuous process, the term corresponds to a defined fraction of the production, characterized by its intended homogeneity. 3.6 manufacturer company who manufactures the final medical device in question 3.7 raw materials materials from which two-part addition-cure silicone elastomer is manufactured 3.8 silicone elastomer synthetic rubber obtained by the crosslinking of silicone polymer chains essentially made of repeat siloxane units
5 Biocompatibility
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 that the supplier has installed measures to control for processing and formulation parameters in accordance with ISO 9001, ISO 14969 and good manufacturing practice. In addition, process validation should include a biological assessment, since production could introduce contaminants, and the functionalities 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.