YY/T 0474-2004 Active Industry standards-Medicine

YY/T 0474-2004 Poly(L-lactide) resins and fabricated forms for surgical implants—In vitro degradation testing

YY/T 0474-2004 Poly(L-lactide) resins and fabricated forms for surgical implants—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 0474-2004

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 describes the method for determining the changes in the chemical or mechanical properties of polylactic acid under in vitro degradation test conditions. The purpose of this standard is to compare and/or evaluate materials or processing conditions. This standard applies to various forms of polylactic acid used in the production of surgical implants, including: a) blocks; b) processed materials; c) final products (implants that have been packaged and sterilized). The test methods specified in this standard are used to determine the in vitro degradation rate of polylactic acid and the changes in material properties. However, these in vitro test methods cannot be used to accurately predict the behavior of the material under in vivo conditions.

Development Information

Word Count: 15 Thousand words Pages: 10 pages

Referenced Standards

GB/T 1450-1 GB/T 1843-1996 Plastics—Determination of izod impact strength GB/T 9341-2000 Plastics—Determination of flexural properties ISO 6721-2:1994 ISO 527-1:1993 ISO 527-2:1993 ISO 527-3:1995 ISO 1805:1973 ISO 5081:1977 DIN 53137:1977 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 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 2918-1998 Plastics—Standard atmospheres for conditioning and testing GB/T 2918-2018 Plastics—Standard atmospheres for conditioning and testing 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 13022-1991 Plastics—Determination of tensile properties of films GB/T 13096.4-1991 Test method for apparent horizontal shear strength of pultruded glass fiber reinforced plastic rods by the short-beam method 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 0167-2005 Non-absorbable surglcal suture YY 0167-2020 Non-absorbable surgical suture 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 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 13781:1997

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