YY/T 0473-2004 Active Industry standards-Medicine

YY/T 0473-2004 Implants for surgery—Copolymers and blends based on polylactide—In vitro degradation testing

YY/T 0473-2004 Implants for surgery—Copolymers and blends based on polylactide—In vitro degradation testing

Publish Date: 2004-03-23 Implement Date: 2005-01-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 0473-2004

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Surgical implants, prostheses, and orthoses

Publish Date: 2004-03-23

Implement Date: 2005-01-01

Pages: 10 pages

Scope

This standard applies to blocks or processed materials of poly(lactide-co-glycolide) copolymers and/or blends used in the production of surgical implants. This standard describes the determination of changes in the chemical and/or mechanical properties of these copolymers and/or blends under in vitro degradation conditions. The test methods specified in this standard are used to determine the degradation rate and changes in material properties of poly(lactide-co-glycolide) copolymers and/or blends containing different comonomers (such as glycolide, trimethylene carbonate, and ε-caprolactone) in vitro. These in vitro test methods cannot be used to accurately predict the behavior of materials under in vivo conditions. The purpose of this standard is to compare and/or evaluate materials or processing conditions.

Development Information

Word Count: 15 Thousand words Pages: 10 pages

Referenced Standards

ISO 527-1:1993 ISO 527-2:1993 ISO 537:1989 ISO 1805:1973 ISO 5081:1977 ISO 14130:1997 GB/T 1039-1992 Plastics—General rules for the test method of mechanical properties GB/T 1041-2008 Plastics—Detemination of compressive properties GB/T 1450.1-2005 Fibre-reinforced plastic composites—Determination of interlaminar shear strength GB/T 1632-1993 Determination of viscosity number and limiting viscosity number of polymers in dilute solution GB/T 1632.1-2008 Plastics—Determination of the viscosity of polymers in dilute solution using capillary viscometers—Part 1:General principles GB/T 1632.3-2010 Plastics—Determination of the viscosity of polymers in dilute solution using capillary viscometer—Part 3:Polyethylenes and polypropylenes GB/T 1632.4-2020 Plastics—Determination of the viscosity of polymers in dilute solution using capillary viscometers—Part 4:Polycarbonate(PC) moulding and extrusion materials GB/T 1632.5-2008 Plastics—Determination of the viscosity of polymers in dilute solution using capillary viscometers—Part 5:Thermoplastic polyester(TP) homopolymers and copolymers GB/T 1843-1996 Plastics—Determination of izod impact strength GB/T 1843-2008 Plastics—Determination of izod impact strength GB/T 3916-1997 Textiles—Yarns from packages—Determination of single-end breaking force and elongation at break GB/T 3916-2013 Textiles—Yarns from packages—Determination of single-end breaking force and elongation at break using constant rate of extension(CRE) tester GB/T 6682-1992 Water for analytical laboratory use—Specification and test methods GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods GB/T 9341-2000 Plastics—Determination of flexural properties GB/T 9341-2008 Plastics—Determination of flexural properties GB/T 13022-1991 Plastics—Determination of tensile properties of films GB/T 14337-1993 Testing method for breaking strength and breaking elongation of synthetic staple fibres GB/T 14337-2008 Testing method for tensile properties of man-made staple fibres GB/T 14337-2022 Man-made fibre—Test method for tensile properties of staple fibre YY/T 0474-2004 Poly(L-lactide) resins and fabricated forms for surgical implants—In vitro degradation testing YY 0167-1998 Non-absorbable Surgical Suture GB/T 1632.1-2024 Plastics—Determination of the viscosity of polymers in dilute solution using capillary viscometers—Part 1:General principles YY/T 0474-2025 Implants for surgery—Homopolymers,copolymers and blends on poly(lactide)—In vitro degradation testing GB/T 1632.2-2025 Plastics—Determination of the viscosity of polymers in dilute solution using capillary viscometers—Part 2:Poly(vinyl chloride) resins

Adopt standards

ISO 15814:1999

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