YY/T 1806.1-2021 Active Industry standards-Medicine

YY/T 1806.1-2021 Evaluation method for in vitro degradation performance of biomedical materials—Part 1:Degradable polyester

Publish Date: 2021-09-06 Implement Date: 2022-09-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: YY/T 1806.1-2021

Standard Type: Industry standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: Integrated medical equipment

Publish Date: 2021-09-06

Implement Date: 2022-09-01

Pages: 7 pages

Scope

This document specifies the evaluation method for the degradation performance of biomedical materials/devices made from homopolymers, copolymers, or blends of lactide, glycolide, and ε-caprolactone, whose degradation mechanism is primarily the hydrolysis of ester bonds.
This document is applicable to the in vitro degradation performance evaluation of degradable polyester-based biomedical materials/devices.

Development Information

Word Count: 14 Thousand words Pages: 7 pages

Same series standard

YY/T 1806.2-2021 Evaluation method for in vitro degradation performance of biomedical materials—Part 2:Mussel adhesive protein

Referenced Standards

中华人民共和国药典(2020年版四部) GB/T 1632.1-2008 Plastics—Determination of the viscosity of polymers in dilute solution using capillary viscometers—Part 1:General principles 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 1632.1-2024 Plastics—Determination of the viscosity of polymers in dilute solution using capillary viscometers—Part 1:General principles

Related Standards

GB/T 16886.11-1997 Replaced

GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity

Publish Date: 1997-06-26

GB/T 16886.3-1997 Replaced

GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity

Publish Date: 1997-06-26

GB/T 16886.6-1997 Replaced

GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation

Publish Date: 1997-06-26

GB/T 16886.1-2001 Replaced

GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing

Publish Date: 2001-09-24

GB/T 16886.13-2001 Replaced

GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices

Publish Date: 2001-09-24

GB/T 16886.7-2001 Replaced

GB/T 16886.7-2001 Biological evaluation of medical devices—Part 7:Ethylene oxide sterilization residuals

Publish Date: 2001-09-24