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YY/T 1015-2016 English PDF

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YY/T 1015-2016: Ophthalmic needle holder
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YY/T 1015-2016English139 Add to Cart 3 days [Need to translate] Ophthalmic needle holder Valid YY/T 1015-2016

PDF similar to YY/T 1015-2016


Standard similar to YY/T 1015-2016

YY 1001   GB/T 2766   GB/T 1962.1   YY/T 0290.4   YY/T 0942   

Basic data

Standard ID YY/T 1015-2016 (YY/T1015-2016)
Description (Translated English) Ophthalmic needle holder
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C32
Classification of International Standard 11.040.30
Word Count Estimation 7,727
Date of Issue 2016-01-26
Date of Implementation 2017-01-01
Older Standard (superseded by this standard) YY 91015-1999
Quoted Standard GB/T 1220-2007; GB/T 3620.1-2007; GB/T 4340.1-2009; YY/T 0149-2006; YY 0167-2005; YY/T 0173-2010; YY/T 1052-2004
Regulation (derived from) China Food and Drug Administration Bulletin 2016 No.25
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the classification, requirements, test methods, inspection rules, marking and instructions, packaging, shipping and storage requirements for ophthalmic needle clamps. This standard applies to the eye with a needle clamp (hereinafter referred to as the needle clamp), for eye surgery when the suture needle suture the eye microvascular and soft tissue.

YY/T 1015-2016: Ophthalmic needle holder

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Ophthalmic needle holder ICS 11.040.30 C32 People's Republic of China Pharmaceutical Industry Standard Replacing YY 91015-1999 Eye with needle clamp 2016-01-26 release 2017-01-01 Implementation State Food and Drug Administration issued

Foreword

This standard is drafted in accordance with the rules given in GB/T 1.1-2009. This standard replaces YY 91015-1999 "tweezers eye with needle clamp", compared with YY 91015-1999, in addition to editorial changes outside the main The technical changes are as follows. --- standard name changed its name to "eye with needle clamp"; Replacement form; --- increase manufacturing materials; --- modify and improve the stability, clamping performance requirements and test methods; --- increase the opening and closing performance, limit lock performance, color requirements and test methods. Please note that some of the contents of this document may involve patents. The issuer of this document does not assume responsibility for the identification of these patents. This standard is proposed and centralized by the National Standardization Technical Committee for Surgical Instruments (SAC/TC94). The drafting of this standard. Suzhou six six visual technology Co., Ltd., Shanghai Medical Devices Testing Institute. The main drafters of this standard. Zhang Jianping, Zheng Qiang. This standard replaced the previous version of the standard release. --- WS2-74-74; --- YY 91015-1999. Eye with needle clamp

1 Scope

This standard specifies the classification, requirements, test methods, inspection rules, marking and instructions, packaging, transport and storage of eye clamps Claim. This standard applies to the eye with a needle clamp (hereinafter referred to as needle clamp), for eye surgery when the needle suture the eye microvascular and soft group Weaving.

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 article Pieces. For undated references, the latest edition (including all modifications) applies to this document. GB/T 1220-2007 stainless steel rods Titanium and titanium alloys - Grade and chemical composition GB/T 3620.1-2007 Metallic materials - Vickers hardness test - Part 1. Test methods GB/T 4340.1-2009 Test method for corrosion resistance of stainless steel medical equipment Non - Absorbent Surgical Suture Surgical instruments Gill shafts, screws and rivets Surgical Instruments Signs YY/T 1052-2004

3 classification

3.1 The structure of the needle clamp and the selection of the size should be consistent with the provisions of Table 1 and Figure 1, the head can be made straight, curved and lateral bending, Can be made with a limit lock or limit nail. 3.2 Gill shaft screw with needle clamp is selected according to YY/T 0173-2010. Table 1 holding the needle clamp size units in millimeters Form Length L Head Length h Head Width b Head Thickness δ Head Curve R (For bending) Straight, curved Side bend 110 to 140 9 ~ 14 14 ~ 16 14 ~ 16 ± 0.3 0.3 to 0.5 ± 0.05 0.25 to 0.4 ± 0.05 8 to 10 0.5 to 1.2 ± 0.07 0.4 to 0.8 0.3 to 0.5 ± 0.05 0.4 to 0.8 ± 0.1 15 ~ 17 Note. (recommended value) L is 5mm pitch a file, h is 1mm pitch a file, b is 0.1mm pitch a file, δ is 0.05mm pitch a file, R is 1mm pitch a file.

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