YY/T 1678-2019 Active Industry standards-Medicine

YY/T 1678-2019 Test method for molecular weight averages and molecular weight distribution of polylactic acid and its copolymers for surgical implants

Publish Date: 2019-10-23 Implement Date: 2020-10-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1678-2019

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Surgical instruments and materials

Publish Date: 2019-10-23

Implement Date: 2020-10-01

Pages: 10 pages

Scope

This standard specifies a method for determining the average molecular weight (MW) and molecular weight distribution of soluble polylactic acid using high-performance size-exclusion chromatography (HPSEC).
This standard applies to materials used in surgical implants that can be completely dissolved in methyl chloride (or other solvents), including poly(L-lactic acid) resins (PLLA), poly(D-lactic acid) resins (PDLA), DL copolymers of any ratio, as well as polylactide (PLA) and polylactide-co-glycolide (PLGA) copolymers.