YY/T 0660-2008Standard Specification for Polyetheretherketone(PEEK) polymers for Surgical Implant Applications (English PDF)

Foreword

This revised standard adopts ASTMF2026-07 "surgical implants PEEK Standard Specification (PEEK) polymer" technical content constant. The main differences between standard and ASTMF2026-07 follows.

--- According to Chinese customs for some formatting has been modified;

--- Some will apply to US standards formulation to apply our standard formulation;

--- The Chapter 2, "Normative references" has transformed the national standard for the country instead of the subject of international standard with the conversion;

--- The original Table 1 editorial errors modification;

--- Delete Chapter 8, "keywords." Appendix A of this standard is an informative annex.

1 Scope

This standard covers the PEEK polymer raw material provided by the suppliers of raw materials (pellets, powder, etc.). This standard provides when these thermoplastic Plastic manufacture implantable devices for the human body, such as requiring member during surgical implants, surgical or dental instruments and associated test method.

Any kind of materials, processing technology (such as molding, extrusion, machining, assembly, sterilization, etc.) production of parts or equipment when it can be changed performance. Suitable test methods for the performance of these polymers finished product from raw materials suppliers, medical device manufacturers and regulatory agencies recognized To be tested to ensure their safety and effectiveness.

Standards included only for the performance of polyetheretherketone polymer. Required performance standards applicable to injection molded products.

Finished, material or comprising a colorant, a filler, processing aids or other additives, and mixed with a polymer blend of PEEK material or reproducing This material is not within the standard scope.

The recommended standard of physical, chemical and biological test method is designed for PEEK polymer medical implantable devices used to establish Reasonable level of confidence in their performance. In the material selection process, should be in accordance with the requirements of the end-use performance considerations listed.

When in accordance with the requirements of this standard material for evaluation may involve hazardous materials, operations and equipment. This standard does not attempt For all the security issues involved elaborate, even those related to security issues associated with its use. Establish appropriate safety and operating Specifications, and suitability before applying clear administrative limit, this is the standard user's own responsibility.

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.

GB/T 16886.1-2001 Biological evaluation of medical devices - Part 1. Evaluation and testing (idt ISO 10993-1:1997)

GB/T 16886.2-2000 Biological evaluation of medical devices - Part 2. Animal welfare requirements (idt ISO 10993-2:1992)

GB/T 16886.3-1997 Biological evaluation of medical devices - Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity (Idt ISO 10993-3:1992)

GB/T 16886.4-2003 Biological evaluation of medical devices - Part 4. Selection of tests for interactions with blood (ISO 10993-4:2002, IDT)

GB/T 16886.5-2003 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity tests (ISO 10993-5:1999, IDT)

GB/T 16886.6-1997 Biological evaluation of medical devices - Part 6. Tests for local effects after implantation (idt ISO 10993-4.1994)

GB/T 16886.7-2001 Biological evaluation of medical devices - Part 7. Ethylene oxide sterilization residuals (idt ISO 10993-5.1995)

Qualitative and quantitative framework for potential degradation products. GB/T 16886.9-2001 Biological evaluation of medical devices - Part 9 (Idt ISO 10993-9:1999)

GB/T 16886.10-2005 Biological evaluation of medical devices - Part 10. irritation and delayed-type hypersensitivity test (ISO 10993-10:2002, IDT)