YY/T 1122-2017 (YY/T1122-2017, YYT 1122-2017, YYT1122-2017)
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General technique requirememts for orthopaedics clamp(scissor)
| Valid |
YY/T 1122-2017
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Standards related to: YY/T 1122-2017
| Standard ID | YY/T 1122-2017 (YY/T1122-2017) | | Description (Translated English) | General technique requirememts for orthopaedics clamp(scissor) | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C35 | | Classification of International Standard | 11.040.40 | | Word Count Estimation | 6,653 | | Date of Issue | 2017-03-28 | | Date of Implementation | 2018-04-01 | | Older Standard (superseded by this standard) | YY/T 1127-2006; YY 1122-2005 | | Drafting Organization | Tianjin Medical Device Quality Supervision and Inspection Center, Beijing Fuller Technology Development Co., Ltd., Beijing Natong Medical Technology Research Institute Co., Ltd., Beijing Medical Device Technical Evaluation Center | | Administrative Organization | National Surgical Implants and Orthopedic Instruments Standardization Technical Committee (SAC/TC 110) | | Regulation (derived from) | China Food & Drug Administration Announcement 2017 No. 38 | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | YY/T 1122-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 35
Replacing YY 1122-2005 and YY/T 1127-2006
General technique requirements
for orthopaedics clamp (scissor)
ISSUED ON. MARCH 28, 2017
IMPLEMENTED ON. APRIL 1, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 6
4 Requirements... 6
5 Test methods ... 7
6 Marking ... 8
Bibliography ... 9
Foreword
This Standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This Standard replaces YY 1122-2005, General technique requirements for
orthopaedics clamp (scissor), and YY/T 1127-2006, Rongeur. Compared with YY 1122-
2005 and YY/T 1127-2006, the major technical changes are as follows.
-- it adds the new standards YY/T 0294.1 and ASTM F899 in the material
requirements (see 4.1);
-- it standardizes the hardness requirements and adds the new Vickers hardness
test method (see 4.2);
-- it specifies that the roughness measurement locations are the working surfaces
(see 4.4.1);
-- it deletes the inspection rules (see Clause 6 of YY 1122-2005 and YY/T 1127-
2006), instructions for use (see 7.2 of YY 1122-2005) and packaging,
transportation and storage (see Clause 8 of YY 1122-2005 and YY/T 1127).
Attention is drawn to the possibility that some of the elements of this document may
be the subject of patent rights. The issuer 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
Surgical Implants and Orthopaedic Instruments of Standardization Administration of
China (SAC/TC 110).
The drafting organizations of this Standard. Tianjin Centre for Quality Supervision and
Testing of Medical Devices, Beijing Fule Technology Development Co., Ltd., Beijing
Naton Medical Technology Institute Co., Ltd., Beijing Centre for Medical Device
Evaluation.
The main drafters of this Standard. Zhang Lu, Fu Ruizhi, Qiu Wanyu, Guo Zixue, Jiang
Yao, Li Renyao, Yu Yong, Wang Chen.
This Standard replaces YY 1122-2005 and YY/T 1127-2006.
The previous editions of YY 1122-2005 are as follows.
-- WS 2-54-1974 and YY 91122-1999;
-- WS 2-182-1974 and YY 91134-1999.
General technique requirements
for orthopaedics clamp (scissor)
1 Scope
This Standard specifies the material, hardness, corrosion resistance, surface quality,
basic dimensions, usability, test methods and marking for orthopaedics clamps
(scissors).
This Standard applies to orthopaedics clamps (scissors) which are used to cut or
correct bones.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition dated applies to this document. For
undated references, the latest edition of the referenced documents (including all
amendments) applies to this document.
GB/T 191, Packaging – Pictorial marking for handling of goods
GB 4793.1, Safety requirements for electrical equipment for measurement, control,
and laboratory use – Part 1. General requirements
GB 4793.9, Safety requirements for electrical equipment for measurement, control
and laboratory use – Part 9. Particular requirements for automatic and semi-
automatic laboratory equipment for analysis and other purposes
GB/T 230.1, Metallic materials – Rockwell hardness test – Part 1. Test method
(scales A, B, C, D, E, F, G, H, K, N, T)
GB/T 1220, Stainless steel bars
GB/T 1910, Newsprint
GB/T 4340.1, Metallic materials – Vickers hardness test – Part 1. Test method
GB/T 10610, Geometrical product specifications (GPS) – Surface texture. Profile
method – Rules and procedures for the assessment of surface texture
4.4.2 Appearance
The appearance of orthopaedics clamps (scissors) shall be smooth and symmetrical
without sharp edges, burrs or cracks. The handle part can be provided with patterns
or none and the patterns on the handle shall be clear and complete.
4.5 Dimensions
The basic dimensions and tolerances of orthopaedics clamps (scissors) shall be as
specified in the technical requirements of products.
4.6 Usability
4.6.1 The cutting edge of orthopaedics clamps (scissors) shall be sharp without tipping
or flaking. After orthopaedics clamps (scissors) are closed, their clamp head shall be
matched to each other without staggering.
4.6.2 The grill shaft bolt shall be fixed on one piece of clamps (scissors) securely; when
orthopaedics clamps (scissors) are open, the bolt shall not move with them.
4.6.3 When orthopaedics clamps (scissors) are open, the grill part and the joint shall
be relaxed, without swinging or locking.
5 Test methods
5.1 Material
Use the approved method for chemical analysis to carry out test and the results shall
be as specified in 4.1.
5.2 Hardness
As specified in GB/T 230.1 or GB/T 4340.1, measure three points respectively on the
surface of the head of the pieces on the left and right; take the arithmetic mean value
of the three points of each location; and the results shall be as specified in 4.2.
5.3 Corrosion resistance
Carry out test using the boiling water method specified in YY/T 0149-2006 and the
results shall be as specified in 4.3.
5.4 Surface quality
5.4.1 The surface roughness inspection shall be carried out using the electrical
measuring method or sample piece comparison method as specified in GB/T 10610.
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