YY/T 0520-2009 English PDF (YYT0520-2009)

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YY/T 0520-2009: Titanium and titanium alloy dental implant attachments
YY/T 0520-2009
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.060.10
C 33
Titanium and titanium alloy dental implant attachments
ISSUED ON. DECEMBER 30, 2009
IMPLEMENTED ON. JUNE 01, 2011
Issued by. China Food and Drug Administration
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Table of Contents
Foreword ... 3 
Introduction ... 4 
1 Scope ... 5 
2 Normative references ... 5 
3 Terms and definitions ... 6 
4 Material ... 7 
5 Requirements ... 7 
6 Test method ... 9 
7 Packaging, marking and instruction manual ... 10 
References ... 13 
Foreword
All the technical contents of this standard are recommended.
Please note that some of the contents of this standard may involve patents.
The issuer of this standard shall not be responsible for the identification of
these patents.
This standard was proposed by China Food and Drug Administration.
The standard shall be under the jurisdiction of the National Dental Materials
and Equipment Standardization Technical Committee (SAC/TC 99).
The responsible drafting organization of this standard. Peking University
School of Stomatology Oral Medical Equipment Testing Center.
The participating drafting organizations of this standard. Peking University
School of Stomatology.
The main drafters of this standard. Lin Hong, Zhang Yan, Li Yuan, Zheng Gang,
Qiu Lixin.
Titanium and titanium alloy dental implant attachments
1 Scope
This standard specifies the performance requirements and corresponding test
methods for the dental implant attachments of titanium and titanium alloys, as
well as the packaging.
The dental implants in this standard refer to various ancillary components used
in conjunction with dental implants to support the upper structure (prosthesis)
of the implanted denture, including abutments and central screws. The dental
implant attachments in this standard also include the cover screw, healing cap,
and healing abutment which are used on the implant before assembling the
upper structure. This standard does not cover the devices used for the upper
structure which is made in the dental laboratory (e.g. transfer body, retention
screw, connection ring, and upper structure, etc.).
2 Normative references
The provisions in following documents become the provisions of this Standard
through reference in this Standard. For the dated references, the subsequent
amendments (excluding corrections) 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 4698-1996 Methods for chemical analysis of sponge titanium, titanium
and titanium alloys
GB/T 9937.1-2008 Dental vocabulary - Part 1. General and clinical terms
(ISO 1942-1.1989, IDT)
GB/T 9937.2-2008 Dental vocabulary - Part 2. Dental material (ISO
1942-2.1989, IDT)
GB/T 13810-2007 Wrought titanium and titanium alloy for surgical implants
YY/T 0343-2002 Liquid penetrant inspection of metallic surgical implants
(ISO 9583.1993, NEQ)
YY/T 0521-2009 Dentistry implants - Dynamic fatigue test for endosseous
dental implants (ISO 14801. 2007, IDT)
Note. The abutment can be connected to the implant via a central screw,
OR otherwise connected to the implant through embedding or other
methods.
3.5
Central screw
A screw that penetrates the center of the abutment AND fastens the
abutment onto the implant.
3.6
Cover screw, healing screw, closure screw
After the implant is implanted in the jaw, the cap structure above the implant
is screwed in to avoid tissue growth. During secondary operation, the cover
screw is taken out, AND the abutment is installed in place.
3.7
Healing cap/hygiene screw, hygiene cover screw, hygiene cap
Attachments which are temporarily installed onto the abutment end.
3.8
Healing abutment
A transitional abutment. In the soft tissue healing period after surgery, the
healing abutment is attached to the implant, which helps the soft tissue to
be shaped in accordance with the shape of the healing abutment AND then
replaced by the abutment.
4 Material
It shall comply with GB/T 13810-2007 Wrought titanium and titanium alloy for
surgical implants.
5 Requirements
5.1 Appearance
the tweezers to take all the implant attachments out from the beaker; USE the
qualitative filter paper to filter the liquid in the beaker; AND there shall be no
visible attachment on the filter paper.
6.7 Fatigue limits
MAKE test in accordance with YY/T 0521-2009, AND the test results shall
comply with the provisions of clause 5.7.
6.8 Chemical composition
MAKE test in accordance with GB/T 4698-1996, AND the chemical
composition shall comply with the provisions of clause 5.8.
6.9 Sterile
MAKE test in accordance with the Appendix XI H “Sterile test method” of the
Pharmacopoeia of the People’s Republic of China (Volume II), AND the test
results shall comply with the provisions of clause 5.9.
6.10 Pyrogen
MAKE test in accordance with the Appendix XI H “Pyrogen test method” of the
Pharmacopoeia of the People’s Republic of China (Volume II), AND the test
results shall comply with the provisions of clause 5.10.
7 Packaging, marking and instruction manual
7.1 Product marking
If the size and surface conditions of the dental implant attachment permit,
under the preconditions of not affecting the use performance of the dental
implant attachment, it shall make clear manufacturer marking, product batch
(serial) number, and specification marking on an appropriate region at each
dental implant attachment surface. However, if the size and surface conditions
do not permit, it shall use the label or other methods to provide the information
required, in order to ensure the traceability.
7.2 Labeling and packaging mark
The labeling and packaging mark of dental implant attachment shall include at
least the following.
a) Product name, model, specification;
b) Manufacturer's name, address, and contact information;