YY/T 0661-2017Standard specification for semi-crystalline poly(lactide) polymer and copolymer resin for surgical implants (English PDF)

YY/T 0661-2017 is the English-translated version of 外科植入物 半结晶型聚丙交酯聚合物和共聚物树脂.

YY/T 0661-2017 is the Chinese standard "Standard specification for semi-crystalline poly(lactide) polymer and copolymer resin for surgical implants".

Its scope clause reads: This standard applies to surgical implants with a native semi-crystalline poly (L-lactide) or poly (D-lactide) homopolymer resin, also applies to L-lactide and other bio-absorbable monomer copolymerized semi-crystalline resin.

These monomers include but are not limited to glycolide, D-lactide and DL-lactide. Poly (L-lactide) or poly (D-lactide) homopolymers and copolymers in this standard contain lactide fragments long enough, So after annealing will cause its potential crystallization.

This polymer typically has a mole fraction of L-lactide equal to or greater than 50%. This standard It is especially suitable for the production of isotactic lactide-based block copolymers or composites of D-lactide and L-lactide with a total molar difference of more than 1.5% Synthesized polymer or copolymer.

This standard includes fully soluble in methylene chloride or chloroform at 30 ° C native semi-crystalline Type polylactic acid based resin. Note. Refer to Appendix A for the nomenclature of polymers.

This standard does not apply to glycolide molar fraction of greater than or equal to 70% (mass fraction of 65.3%) of lactide - glycolide copolymerization Does not apply to lactide glycolide copolymers that have a glycolide segment of sufficient size to provide a potential glycolide-based crystal, The material needs to be completely dissolved at room temperature using a fluorinated solvent (see ASTM F2313); it also does not apply to amorphous polymers or to total Copolymers of D-lactide and L-lactide complexes with a difference in molar fraction of more than 1.5% (see YY/T 0510).

This standard, the semi-crystalline resin is annealed by differential scanning calorimetry to determine the glass transition temperature above the heat of crystallization to define of.

While fragments of other copolymerization segments may also crystallize upon annealing (eg, glycolide), other than the crystalline structure formed from lactide The specific characterization of the crystal structure is outside the scope of this standard.

This standard specifies the material properties of primary semi-crystalline polylactide-based resins for surgical implants that are not suitable for use in the manufacture of these materials Packaged sterilized finished implant.

Any of the materials, processing techniques used to manufacture parts or equipment (such as molding, extrusion, machining, Assembly, sterilization, etc.) can change its performance.

Therefore, the resin processed products, the performance standards involved in this should be used to ensure its safety and Effective test method for evaluation.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 16 pages — is available in the English PDF.

YY/T 0647|YY/T 0752|YY/T 0695|YY/T 0651.4|YY/T 0663.2

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