YY 0120-2002 English PDF (YY0120-2002)

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YY 0120-2002: Implants for osteosynthesis--Metal correctional stick
YY 0120-2002
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.40
C 35
Replacing YY 0120-1993
Implants for osteosynthesis - Metal correctional stick
ISSUED ON: SEPTEMBER 24, 2002
IMPLEMENTED ON: APRIL 01, 2003
Issued by: National Medical Products Administration
Replaced
Table of Contents
Foreword ... 3 
1 Scope ... 4 
2 Normative references ... 4 
3 Classification ... 4 
4 Requirements ... 9 
5 Test methods ... 10 
6 Inspection rules ... 11 
7 Instructions for use ... 11 
8 Marks ... 11 
9 Packaging ... 11 
10 Transportation and storage ... 11 
11 Requirements for use ... 11 
Implants for osteosynthesis - Metal correctional stick
1 Scope
This Standard specifies classification, requirements, test methods, inspection
rules, instructions for use, marks, packaging, transportation and storage for
metal correctional stick [Translator note: Term “rod” is adopted in YY/T 0119.4-
2014].
This Standard is applicable to metal correctional stick (hereinafter referred to
as the correctional stick). This product is used for correction and internal fixation
when the spine bones are diseased or deformed.
2 Normative references
The provisions in following documents become the provisions of this Standard
through reference in this Standard. For dated references, the subsequent
amendments (excluding corrigendum) or revisions do not apply to this Standard,
however, parties who reach an agreement based on this Standard are
encouraged to study if the latest versions of these documents are applicable.
For undated references, the latest edition of the referenced document applies.
GB/T 228, Metallic materials - Tensile testing at ambient temperature
GB/T 4234, Stainless steel for surgical implants
GB/T 4340, Metallic materials - Vickers hardness test
GB/T 13810, Wrought titanium and titanium alloy for surgical implants (GB/T
13810-1997, eqv ISO 5832-2: 1993)
YY/T 0343, Liquid penetrant inspection of metallic surgical implants
YY0341, General technological requirements for non-active metallic surgery
implants of osteosynthesis
3 Classification
3.1 Example of product model of the correctional stick
Table 5
4.4.3 The surface of the correctional stick shall be smooth and free of defects
such as sharp edges (except the tip of the sacral thread), burrs, and
attachments.
4.4.4 Net knurling and thread profile shall be clear and complete.
4.5 Size
The D size of the correctional stick shall be checked during acceptance.
5 Test methods
5.1 Materials
The chemical composition and microstructure inspection of the correctional
stick products shall be carried out in accordance with the provisions in GB/T
4234 and GB/T 13810, which shall be in accordance with the provisions of 4.1.
5.2 Hardness inspection
Carry out the test according to the method specified in GB/T 4340. Measure
three points on the surface of the nail. Take the arithmetic average of the three
points, which shall be in accordance with the provisions of 4.2.
5.3 Tensile strength inspection
Carry out the test according to the method specified in GB/T 228, which shall
be in accordance with the provisions of 4.2.
5.4 Corrosion resistance inspection
Carry out the test according to the method specified in 5.3.1, 5.3.2 in YY 0341-
2002, which shall be in accordance with the provisions of 4.3.1.
5.5 Surface quality
5.5.1 Surface defect inspection: Carry out the test according to YY/T 0343,
which shall meet the provisions of 4.4.1.
5.5.2 Surface roughness inspection: Carry out according to the sample block
comparison method (or electrical measurement method), which shall meet the
provisions of 4.4.2.
5.5.3 Appearance requirements: Visually observe, which shall meet the
provisions of 4.4.3 and 4.4.4.
5.6 Size
Use general measuring tools to test, which shall meet the provisions of 4.5.
6 Inspection rules
The inspection rules for the correctional stick shall comply with the provisions
of Chapter 6 in YY 0341-2002.
7 Instructions for use
The instructions for use for the correctional stick shall comply with the
provisions of Chapter 7 in YY 0341-2002.
8 Marks
The marks for the correctional stick shall comply with the provisions of Chapter
8 in YY 0341-2002.
9 Packaging
The packaging for the correctional stick shall comply with the provisions of
Chapter 9 in YY 0341-2002.
10 Transportation and storage
The transportation and storage for the correctional stick shall comply with the
provisions of Chapter 10 in YY 0341-2002.
11 Requirements for use
The requirements for use for the correctional stick shall comply with the
provisions of Chapter 11 in YY 0341-2002.