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YY/T 1015-2016 | English | 139 |
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Ophthalmic needle holder
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YY/T 1015-2016
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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| Word Count Estimation | 7,727 | Date of Issue | 2016-01-26 | Date of Implementation | 2017-01-01 | Older Standard (superseded by this standard) | YY 91015-1999 | Quoted Standard | GB/T 1220-2007; GB/T 3620.1-2007; GB/T 4340.1-2009; YY/T 0149-2006; YY 0167-2005; YY/T 0173-2010; YY/T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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