ISO 15814 pdf download

ISO 15814 pdf download.Implants for surgery — Copolymers and blends based on polylactide — In vitro degradation testing 1 Scope This International Standard is applicable to copolymers and/or blends based on polylactide, in bulk or processed forms, used for the manufacture of surgical implants. This International Standard describes methods for the determination of chemical and mechanical changes in the properties of these copolymers and/or blends under in vitro degradation testing conditions. The test methods specified in this International Standard are intended to determine the degradation rate and the changes in material properties of polylactide-based copolymers and/or blends with various comonomers (for example glycolid, trimethylene carbonate, ε-caprolactone) in vitro . These in vitro methods cannot be used to predict definitely the behaviour of these materials under in vivo conditions. The purpose of this International Standard is to compare and/or evaluate materials or processing conditions. 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 1 78:1 993, Plastics — Determination of flexural properties. ISO 1 80:1 993, Plastics — Determination of Izod impact strength. ISO 527-1 :1 993, Plastics — Determination of tensile properties — Part 1 : General principles. ISO 527-2:1 993, Plastics — Determination of tensile properties — Part 2: Test conditions for moulding and extrusion plastics. ISO 537:1 989, Plastics — Testing with the torsion pendulum. ISO 604:1 993, Plastics — Determination of compressive properties. 3 Terms and definitions For the purposes of this International Standard, the terms and definitions given in ISO 1 3781 , ISO/TR 1 0993-9 and the following apply. 3.1 copolymer polymeric material which consists of different monomer units 3.2 blend polymeric material which consists of different polymers mixed intensively together 3.3 resorption loss of morphology and loss of mass 4 Degradation methods 4.1 General The initial values for the following tests shall be determined directly before starting the degradation test (time zero). The tests shall be carried out on the degraded samples at...