YY/T 1431-2016
Implants for surgery.Medical-grade ultra-high molecular weight polyethylene yarns (English Version)

Standard No.

YY/T 1431-2016

Language

Chinese, Available in English version

Release Date

2016

Published By

Professional Standard - Medicine

Latest

YY/T 1431-2016

Scope

This standard applies to ultra-high molecular weight polyethylene (UHMWPE) yarns used as raw materials for medical device components (such as sutures or ligament fixation). The purpose of this standard is to describe the required properties and the test procedures to be followed for ultra-high molecular weight polyethylene yarns used as raw materials for medical devices. This standard is not intended to address the testing required for medical devices or components of medical devices processed from the raw materials specified in this standard. See Appendix A for the basic principles of this standard. This standard uses the International System of Units. This standard does not cover other units of measurement. The following warning text applies only to the test methods section of Chapter 6 of this standard: This standard does not attempt to address all safety issues involved, even those related to its use. It is the responsibility of the user of this standard to establish appropriate safety and operating practices and to clarify the applicability of regulatory limitations prior to application.

YY/T 1431-2016 Referenced Document

• GB/T 1033.1 Plastics.Methods for determining density of non-celluar plastics.Part1:Immersion method,liquid pyknometer method and titration method
• GB/T 1632.3 Plastics.Determination of the viscosity of polymers in dilute solution using capillary viscometer.Part 3:Polyethylenes and polypropylenes
• GB/T 16886.1 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process*， 2022-04-15 Update
• GB/T 16886.10 Biological evaluation of medical devices—Part 10: Tests for irritation and skin sensitization*， 2017-12-29 Update
• GB/T 16886.11 Biological evaluation of medical devices—Part 11: Tests for systemic toxicity*， 2021-11-26 Update
• GB/T 16886.12 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials*， 2023-11-27 Update
• GB/T 16886.13 Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices*， 2017-12-29 Update
• GB/T 16886.14 Biological evaluation of medical devices--Part 14: Identification and quantification of degradation products from ceramics
• GB/T 16886.15 Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys*， 2022-12-30 Update
• GB/T 16886.16 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables*， 2021-11-26 Update
• GB/T 16886.17 Biological evaluation of medical devices.Part 17:Establishment of allowable limits for leachable substances
• GB/T 16886.18 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process*， 2022-12-30 Update
• GB/T 16886.19 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials*， 2022-12-30 Update
• GB/T 16886.2 Biological evaluation of medical devices.Part 2: Animal welfare requirements
• GB/T 16886.20 Biological evaluation of medical devices.Part 20:Principles and methods for immunotoxicology testing of medical devices
• GB/T 16886.3 Biological evaluation of medical devices—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity*， 2019-06-04 Update
• GB/T 16886.4 Biological evaluation of medical devices—Part 4: Selection of tests for interactions with blood*， 2022-04-15 Update
• GB/T 16886.5 Biological Evaluation of Medical Devices Part 5: In Vitro Cytotoxicity Tests*， 2018-07-01 Update
• GB/T 16886.6 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation*， 2022-04-15 Update
• GB/T 16886.7 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals
• GB/T 16886.9 Biological Evaluation of Medical Devices Part 9: Qualitative and Quantitative Framework for Potential Degradation Products*， 2022-12-30 Update
• GB/T 19701.1 Implants for surgery.Ultra-high-molecular-weight polyethylene.Part 1:Powder form*， 2016-12-13 Update
• GB/T 19701.2 Implants for surgery.Ultra-high-molecular-weight polyethylene.Part 2: Moulded forms*， 2016-12-13 Update
• GB/T 3916 Textiles.Yarns from packages.Determination of single-end breaking force and elongation at break using constant rate of extension (CRE) tester
• GB/T 4743 Textiles-Yarn from packages-Determination of linear density (mass per unit length) by the skein method

YY/T 1431-2016 history

• 2016 YY/T 1431-2016 Implants for surgery.Medical-grade ultra-high molecular weight polyethylene yarns