YY/T 0687-2008Surgical instruments-Non-cutting, articulated instruments General specifications (English PDF)

Foreword

This revised standard adopts ISO 7151. 1988 "Non-surgical cutting instrument articulating instruments - General requirements and test methods." This standard is based on ISO 7151. 1988 re-drafted. The standard lists the reg number and ISO 7151 in Appendix A. 1988 reg Control list numbered.

According to the work of standardization, combined with the actual situation, the use of ISO 7151. 1988, this standard made some changes. related Technical differences have been incorporated into the text, and they are involved in terms of the margin of a single vertical line identification. These are given in Appendix B List of technical differences and their causes.

Instead of the standard YY/T 0453-2003 "extraction forceps general technical conditions", YY/T 1030-2003 "Common technical Needle Holders Member ", YY/T 91067-1999" wearing gills clamp type mechanic technical conditions. " The Standard Appendix A, Appendix B is an informative annex.

The standard surgical instrument by the National Standardization Technical Committee and centralized.

Drafting of this standard. Shanghai Medical Devices (Group) Co., surgical instruments factory.

1 Scope

This standard specifies the requirements for non-hinged cutting instrument, test methods, inspection rules, marking, packaging, transportation and storage.

This standard applies to the non-cutting hinge device (hereinafter referred to as the instrument).

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 230.1-2004 metal Rockwell hardness test - Part 1. Test methods (A, B, C, D, E, F, G, H, K, N, T standard Feet) (ISO 6508-1:1999, MOD)

GB/T 1220-2007 stainless steel rod

GB/T 2828.1-2003 Sampling procedures for inspection - Part 1. by acceptance quality limit (AQL) retrieval batch test sample Programme (ISO 2859-1:1999, IDT)

GB/T 2829-2002 periodic inspection Sampling procedures and tables (suitable for process stability test)

GB/T 4340.1-1999 Vickers hardness test - Part 1. Test method (eqv ISO 6507-1:1997)

YY/T 0294.1-2005 surgical instrument metallic materials - Part 1. Stainless steel (ISO 7153-1:1991, MOD)

YY/T 1052-2004 mark surgical instruments

3 Materials

In addition to the mosaic pieces, equipment specified in Table 1 of the material should be used or in compliance with Chapter 4 manufacturing materials required.

4 Requirements