YY/T 1137-2017 (YY/T1137-2017, YYT 1137-2017, YYT1137-2017) & related versions
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General technique requirements for orthopaedics saw
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YY/T 1137-2017
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YYT 1137-2017
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| YY 1137-2005 | English | 319 |
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General technical requirements for orthopaedics saw
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YY/T 1137-2017: PDF in English (YYT 1137-2017)
YY/T 1137-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 35
Replacing YY 1137-2005
General technique requirements for orthopaedics saw
ISSUED ON. MAY 2, 2017
IMPLEMENTED ON. APRIL 1, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative references ... 4
3 Classification ... 4
4 Requirements ... 5
5 Test methods ... 6
6 Marking ... 7
7 Packaging, transport, storage ... 8
Appendix A (Normative) Bending resistance test ... 9
References ... 11
Foreword
This Standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This Standard replaces YY 1137-2005 “General technique requirements for
orthopaedics saw”. As compared with YY 1137-2005, the main technical
changes are as follows.
- ADD YY/T 0294.1 and ASTM F899 standards for “chemical composition”
(SEE 4.2), and EXPAND the range of materials used;
- MAKE corresponding adjustments to appearance (SEE 4.3) and
performance (SEE 4.4) requirements of the former standard;
- CHANGE the former standard’s Rockwell hardness to Vickers hardness
(SEE 4.5);
- ADD bending resistance (SEE 4.8 and Appendix A);
- DELETE the content of inspection rules (SEE Chapter 6 of YY 1137-2005).
Attention is drawn to the possibility that some of the elements of this document
may be the subject of patent rights. The issuing authority of this document shall
not be held responsible for identifying any or all such patent rights.
This Standard was proposed by China Food and Drug Administration.
This Standard shall be under the jurisdiction of National Technical Committee
110 on Implants for Surgery and Orthopedic Devices of Standardization
Administration of China (SAC/TC 110).
Drafting organizations of this Standard. Tianjin Medical Device Quality
Supervision and Inspection Center, Naton Intl. Orthopaedic Research Center,
Beijing Fule Science & Technology Development Co., Ltd.
Main drafters of this Standard. Li Nan, Duan Qingjiao, Jiang Yao, Li Renyao,
Qiu Wanyu, Guo Zixue.
The previous releases of versions of YY 1137-2005 and YY 1137 replaced by
this Standard are.
- WS 2-199-1975;
- YY 91137-1999.
General technique requirements for orthopaedics saw
1 Scope
This Standard specifies the classification, requirements, test methods, marking,
packaging, transport, storage, etc. of orthopaedics saw.
This Standard applies to orthopaedics saws for cutting bones and plaster saws
for cutting plaster.
2 Normative references
The following documents are indispensable for the application of this Standard.
For the dated references, only the versions with the dates indicated are
applicable to this document. For the undated references, the latest version
(including all the amendments) are applicable to this Standard.
GB/T 1184 Geometrical tolerancing - Geometrical tolerance for features
without individual tolerance indications
GB/T 1220 Stainless steel bars
GB/T 4340.1 Metallic materials - Vickers hardness test - Part 1. Test method
GB/T 8013.1 Anodic oxide coating and organic polymer coatings on
aluminum and its alloys - Part 1. Anodic oxide coatings
YY/T 0149-2006 Medical instruments of stainless steel - Test methods of
corrosion resistance
YY/T 1052 Marking requirements for surgical instruments
YY/T 0294.1 Surgical instruments - Metallic materials - Part 1. Stainless steel
3 Classification
The classification of orthopaedics saw products is shown in Table 1.
Table 1 -- Classification of orthopaedics saw products
For cutting bones For cutting plaster
Blade saw Wire saw Plaster saw
certificate.
a) Manufacturer’s name;
b) Inspector’s code;
c) Date of inspection.
7 Packaging, transport, storage
7.1 Packaging
7.1.1 The orthopaedics saw shall, after rust-proof treatment, be placed in a
neutral plastic bag. There shall be an inspection certificate in the bag. The bag
needs to be sealed.
7.1.2 PUT the sealed orthopaedics saw into a packaging box. The box shall be
labeled with a seal.
7.1.3 If there are special requirements, it shall be packaged according to the
order contract.
7.2 Transport
The requirements for transport of orthopaedics saw shall be in accordance with
the order contract.
7.3 Storage
The packaged orthopaedics saw shall be stored in a room with a relative
humidity of no more than 80%, no corrosive gas, and good ventilation.
......
| Standard ID | YY/T 1137-2017 (YY/T1137-2017) | | Description (Translated English) | General technique requirements for orthopaedics saw | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 10,141 | | Date of Issue | 2017-05-02 | | Date of Implementation | 2018-04-01 | | Older Standard (superseded by this standard) | YY 1137-2005 | | Drafting Organization | Tianjin Medical Device Quality Supervision and Inspection Center, Beijing Natong Medical Technology Research Institute Co., Ltd., Beijing Fuller Technology Development Co., Ltd. | | Administrative Organization | National Surgical Implants and Orthopedic Instruments Standardization Technical Committee (SAC/TC 110) | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration |
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