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YY/T 0510-2009 PDF English

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YY/T 0510-2009: Amorphous Poly (lactide) and Poly (lactide-co-glycolide) Resins for Surgical Implants
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YY/T 0510-2009English349 Add to Cart 3 days [Need to translate] Amorphous Poly (lactide) and Poly (lactide-co-glycolide) Resins for Surgical Implants

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Basic data

Standard ID YY/T 0510-2009 (YY/T0510-2009)
Description (Translated English) Amorphous Poly (lactide) and Poly (lactide-co-glycolide) Resins for Surgical Implants
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C35
Classification of International Standard 11.040.40
Word Count Estimation 15,157
Date of Issue 2009-12-30
Date of Implementation 2011-06-01
Quoted Standard GB/T 16886.9; ASTM D1505; ASTM D1898; ASTM D2857; ASTM D3536; ASTM D3593; ASTM D4603; ASTM E386; ASTM E1252; ASTM F748; United States Pharmacopeia (USP) 26 version; ICH Q3C (R3)
Issuing agency(ies) State Food and Drug Administration
Summary This standard applies to 30��C can be completely dissolved in methylene chloride or chloroform native polylactide and lactide glycolide copolymer resin. The polymer described in the standard D, L-lactide homopolymer is amorphous (i. e. non-crystalline), the meso-lactide, or an equimolar amount of D-lactide and L-lactide (racemic) polymerization. Described in this standard D, L-lactide glycolide copolymer also refers to amorphous, the glycolide-lactide and meso or racemic equimolar D-lactide and L- copolymerizing lactide, which typically share lactide copolymer molar fraction equal to or more than 50%. This standard does not apply to contain sufficient scale lactide isotactic polymer segment which will cause potential crystalline homopolymer or copolymer. This standard does not apply to contain sufficient scale glycolide chains and can cause potential lactide crystals glycolide copolymer at room temperature so as to completely dissolve fluorinated solvent required. This standard does not apply to particular glycolide molar fraction greater than or equal to 70% (mass fraction 65. 3%) lactide glycolide copolymer. This standard does not apply to the total block copolymer or a difference more than 1. 5 mole percent (1. 5% of the total number of moles) of D-lactide and L-lactide synthetic homopolymer or copolymer.

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