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YY/T 0687-2008 English PDF

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YY/T 0687-2008: Surgical instruments. Non-cutting, articulated instruments. General specifications
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Standard similar to YY/T 0687-2008

YY/T 0664   YY/T 0618   YY/T 0708   YY/T 0916.7   YY/T 0870.8   YY/T 0688.1   

Basic data

Standard ID YY/T 0687-2008 (YY/T0687-2008)
Description (Translated English) Surgical instruments. Non-cutting, articulated instruments. General specifications
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C30;C33
Classification of International Standard 11.040.30
Word Count Estimation 10,145
Date of Issue 2008-10-17
Date of Implementation 2010-01-01
Older Standard (superseded by this standard) YY/T 0453-2003; YY/T 1030-2003; YY/T 91067-1999
Quoted Standard GB/T 230.1-2004; GB/T 1220-2007; GB/T 2828.1-2003; GB/T 2829-2002; GB/T 4340.1-1999; YY/T 0294.1-2005; YY/T 1052-2004
Adopted Standard ISO 7151-1988, MOD
Regulation (derived from) SFDA [2008] No. 605
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the requirements for non-cutting hinged instruments, test methods, inspection rules, marking, packaging, transportation and storage. This standard applies to non-cutting hinged equipment (hereinafter referred to as equipment).

YY/T 0687-2008: Surgical instruments. Non-cutting, articulated instruments. General specifications


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Surgical instruments.Non-cutting, articulated instruments.General specifications ICS 11.040.30 C30 People's Republic of China pharmaceutical industry standards Replacing YY/T 0453-2003, YY/T 1030-2003, YY/T 91067-1999 Surgical instruments Non-cutting hinge instrument general technical conditions (ISO 7151. 1988, Surgicalinstruments-Non-cutting, articulatedinstruments- Generalrequirementsandtestmethods, MOD) Posted 2008-10-17 2010-01-01 implementation State Food and Drug Administration issued

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. The main drafters. Zhang Hongxia. The standard standard replaces the previous editions. --- GB 8666.1-1988, YY/T 0453-2003; --- GB 11229-1976, GB 11229-1989, YY 91030-1999, YY/T 1030-2003; --- ZBC33008-1985, YY/T 91067-1999. Surgical instruments Non-cutting hinge instrument general technical conditions

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. Table 1 Material Grade instrument Material Grade YY/T 0294.1 GB/T 1220 Non-cutting hinge instrument (except open retractor device) B 20Cr13 Retractor Blades A, B, M 12Cr13,20Cr13,06Cr19Ni10 Noumenon Small A, B 12Cr13,20Cr13 Queen B 20Cr13

4 Requirements

4.1 Hardness Instrument (not including member 06Cr19Ni10 material manufactured) shall be subject to heat treatment, the hardness of 40HRC ~ 48HRC (about 390HV ~ 485HV), the difference between the two should be less than 4HRC; tungsten carbide inserts hardness of not less than 1000HV10, the difference between the two should not be Greater than 50HV10. NOTE. If you use other materials, heat treatment and hardness should be consistent with the corresponding heat treatment specifications. 4.2 manufacturing processes and performance Process equipment should be recognized standards.

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