Standard Specification for Virgin Poly(L-Lactic Acid) Resin for Surgical Implants

1.1 This specification covers virgin poly(L-lactic acid) resin (or abbreviated as PLLA resin) intended for use in surgical implants. This specification does not cover stereoisomeric composition based on various D, L, DL copolymer ratios.

1.2 This specification addresses material characteristics of virgin poly(L-lactic acid) resin and does not apply to packaged and sterilized finished implants fabricated from this material.

1.3 As with any material, some characteristics may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, etc.) required for the production of a specific part or device. Therefore, properties of fabricated forms of this resin should be evaluated using those test methods which are appropriate to assure safety and efficacy.

1.4 The values stated in SI units are to be regarded as the standard.

1.5 The following precautionary statement pertains only to the test method portion, Section 6, of this specification: This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.