ISO 15814:1999 PDF

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.

ISO 15814:1999 Referenced Document

ISO 13781:1997 Poly(L-lactide) resins and fabricated forms for surgical implants - In vitro degradation testing
ISO 14130:1997 Fibre-reinforced plastic composites - Determination of apparent interlaminar shear strength by short-beam method
ISO 1628-1:1998 Plastics - Determination of the viscosity of polymers in dilute solution using capillary viscosimeters - Part 1: General principles
ISO 178:1993 Plastics; determination of flexural properties
ISO 1805:1973 Fishing nets; Determination of breaking load and knot breaking load of netting yarns
ISO 180:1993 Plastics; determination of Izod impact strength
ISO 2062:1993 Textiles; yarns from packages; determination of single-end breaking force and elongation at break
ISO 3696:1987 Water for analytical laboratory use; Specification and test methods
ISO 5081:1977 Textiles; Woven fabrics; Determination of breaking strength and elongation (Strip method)
ISO 527-1:1993 Plastics; determination of tensile properties; part 1: general principles
ISO 527-2:1993 Plastics; determination of tensile properties; part 2: test conditions for moulding and extrusion plastics
ISO 537:1989 Plastics; testing with the torsion pendulum
ISO 604:1993 Plastics; Determination of compressive properties
ISO/TR 10993-9:1994 Biological evaluation of medical devices — Part 9: Degradation of materials related to biological testing

1999 ISO 15814:1999 Implants for surgery - Copolymers and blends based on polylactide - In vitro degradation testing