ISO 14949 pdf download

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...