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

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009.

1 Scope

This standard applies to medical device parts as raw materials (such as stitching or ligament fixation) for the use of ultra-high molecular weight polyethylene (UHMWPE) yarn.

The purpose of this standard is to describe the properties required for ultra high molecular weight polyethylene yarns as raw materials for medical devices and the test procedures to be followed sequence. This standard is not intended to address the tests required for the manufacture of medical devices or medical devices that are processed from the raw materials specified in this standard. this The basic principles of the standard are given in Appendix A.

This standard adopts the international unit system. This standard does not include other units of measurement.

The following warnings apply only to the test method section of Chapter 6 of this standard. This standard is not intended to address all safety concerns To elaborate, even those related to their use of security issues. Establish appropriate safety and operational specifications, and clearly manage before application The applicability of the restrictions is the responsibility of the user of this standard.

2 Normative reference documents

The following documents are indispensable for the application of this document. For dated references, only the dated edition applies to this document. For undated references, the latest edition (including all modifications) applies to this document.

GB/T 1033.1 Plastics - Determination of non-foam density - Part 1. Impregnation, liquid pycnometer and titration

GB/T 1632.3 Plastics - Determination of viscosity of polymer dilute solution using capillary viscometers - Part 3. Polyethylene and polypropylene

GB/T 3916 Textiles - Single yarn yarns - Determination of breaking strength and elongation at break (CRE method)

GB/T 4743 Textiles - Rolling yarns - Determination of linear density

GB/T 16886 (all parts) Biological evaluation of medical devices

GB/T 19701.1 Surgical implants - Ultrahigh molecular weight polyethylene - Part 1. Powders Surgical implants - Ultra - high molecular weight polyethylene - Part 2. Molded plastics GB/T Pharmacopoeia of the People's Republic of China (2)

3 Terms and definitions

The following terms and definitions apply to this document.