ISO 14949:2001 PDF

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.

ISO 14949:2001 Referenced Document

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
ISO 34-1:1994 Rubber, vulcanized or thermoplastic; determination of tear strength; part 1: trouser, angle and crescent test pieces
ISO 3417:1991 Rubber; measurement of vulcanization characteristics with the oscillating disc curementer
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 6502:1999 Rubber - Guide to the use of curemeters

2001 ISO 14949:2001 Implants for surgery - Two-part addition-cure silicone elastomers