Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide not-eligible NOTE 1 The device that
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Description
NOTE 1 The device that is commonly referred to as an active implantable medical device can in fact be a single device
the objects of which are as follows:
ISO 20558-1 applies to materials ready for normal use in the form of powder
This PAS acts as an umbrella PAS
This document specifies the methods of preparation of test specimens and the standard test methods to be used in determining the properties of thermoplastic polyketone moulding and extrusion materials
Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide not-eligible NOTE 1 The device that1 Scope 1. 1 This specification covers both virgin poly(glycolide) homopolymer and poly(glycolide co lactide) copolymer resins intended for use in surgical implants. The poly(glycolide colactide) copolymers covered by this specification possess nominal mole fractions greater than or equal to 70 % glycolide (65. 3 % in mass fraction). This specification is also applicable to lactide co glycolide copolymers that possess glycolide segments sufficient in
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