YY/T 0660-2008
Standard specification for polyetheretherketone (PEEK) polymers for surgical implant applications (English Version)

Standard No.

YY/T 0660-2008

Language

Chinese, Available in English version

Release Date

2008

Published By

Professional Standard - Medicine

Latest

YY/T 0660-2008

Scope

This standard covers PEEK polymer raw materials (pellets, powders, etc.) provided by raw material suppliers. This standard provides requirements and associated test methods when these thermoplastics are used in the manufacture of implantable devices for use in the human body, such as surgical implants, components of surgical or dental devices. For any material, the processing techniques used to produce parts or devices (e.g., molding, extrusion, machining, assembly, sterilization, etc.) can change its properties. The performance of these finished polymers is tested using appropriate test methods recognized by raw material suppliers, medical device manufacturers, and regulatory agencies to ensure their safety and effectiveness. The properties included in the standard apply only to polyetheretherketone polymers. The properties required in the standard apply to injection molded products. Finished products, materials or materials containing colorants, fillers, processing aids or other additives, as well as blends or recycled materials mixed with PEEK polymers are not within the scope of this standard. The purpose of this standard is to recommend physical, chemical, and biological test methods to establish a reasonable level of confidence in the performance of PPEK polymers used in medical implantable devices. In the selection process of materials, the listed properties should be considered in light of the end use requirements. When materials are evaluated against the requirements of this standard, hazardous materials, operations, and equipment may be involved. This standard does not attempt to address all safety issues covered, even those relevant to its use. It is the responsibility of the user of this standard to establish appropriate safe operating practices and to clarify applicable regulatory limitations prior to application.

YY/T 0660-2008 Referenced Document

• GB/T 16886.1-2001 Biological evaluation of medical devices--Part 1: Evaluation and testing
• GB/T 16886.10-2005 Biological evaluation of medical devices.Part 10:Tests for irritation and delayed-type hypersensitivity
• GB/T 16886.11-1997 Biological evaluation of medical devices--Part 11: Tests for systemic toxicity
• GB/T 16886.12-2005 Biological evaluation of medical devices-Part 12:Sample preparation and reference materials
• GB/T 16886.2-2000 Biological evaluation of medical devices--Part 2: Animal welfare requirements
• GB/T 16886.3-1997 Biological evaluation of medical devices--Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
• GB/T 16886.4-2003 Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
• GB/T 16886.5-2003 Biological evaluation of medical devices--Part 5: Test for in vitro cytotoxicity
• GB/T 16886.6-1997 Biological evaluation of medical devices--Part 6: Tests for local effects after implantation
• GB/T 16886.7-2001 Biological evaluation of medical devices--Part 7:Ethylene oxide sterilization residuals
• GB/T 16886.9-2001 Biological evaluation of medical devices-Part 9:Framework for identification and quantification of potential degradation product
• ISO 1133 Plastics - Determination of the melt mass-flow rate (MFR) and the melt volume-flow rate (MVR) of thermoplastics; Technical Corrigendum 1

YY/T 0660-2008 history

• 2008 YY/T 0660-2008 Standard specification for polyetheretherketone (PEEK) polymers for surgical implant applications