YY 0315-2008 English PDF (YY0315-2008)

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YY 0315-2008: Wrought titanium and titanium dental implant
YY 0315-2008
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.060.10
C 33
Replacing YY 0315-1999
Wrought titanium and titanium dental implant
ISSUED ON. APRIL 25, 2008
IMPLEMENTED ON. DECEMBER 01, 2009
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 ... 5 
4 Material ... 6 
5 Requirements ... 6 
6 Test method ... 7 
7 Marking, labeling, instruction manual ... 8 
8 Packaging, transportation, storage ... 9 
Foreword
All the technical contents of this standard are mandatory.
This standard replaces AND repeals YY 0315-1999 “Pure titanium artificial
dental implants”.
As compared with YY 0315-1999, the main changes of this standard are as
follows.
- CHANGE the standard name into “Wrought titanium and titanium dental
implant”;
- EXPAND the scope of application of the standard, from “pure titanium” to
“titanium and titanium alloy”;
- The standard is no longer involved in the contents of “inspection rules”,
which will be left to the enterprise to determine based on its production
scale;
- In this standard, ADD the chapters on specifying the materials;
- In this standard, ADD the sterility requirements of the product;
- There is no longer a lot of biological tests in the standard. It only specifies
following the relevant provisions of YY 0268. In accordance with the
descriptions of the introduction of ISO 5832.2, long-term clinical
experience shows that under the appropriate application conditions,
titanium metal in the human body has not yet found adverse reactions,
AND the biological response level is completely acceptable;
- MODIFY the requirements for the product “dimensions”, changing it into
“the tolerance of the geometric dimensions of artificial dental implant shall
comply with the following requirements. length ± 0.08 mm, the other ± 0.06
mm.” which is more scientific, applicable and operable as compared with
the requirements in 1999 version that “± 0.02 mm”.
This standard was proposed by China Food and Drug Administration.
This standard shall be under the jurisdiction of the National Dental Material
Equipment Standardization Technical Committee.
The drafting organization of this standard. Huaxi Medical University Health
Department Oral Implanting Technology Center.
The main drafters of this standard. Zhou Zhenhua, Yang Xiaodong.
Introduction
This standard, with reference to the relevant requirements of YY 0268
“Biological evaluation of dental materials - Unit 1. Guideline of biological
evaluation of dental materials” AND GB 12417-1990 “The general
technological conditions of surgical metal implant”, is modified from YY
0315-1999 to normalize and unify all the technical requirements of the titanium
and titanium alloy artificial dental implants products, AND to make the standard
implementation more scientific, applicable and operable.
Wrought titanium and titanium dental implant
1 Scope
This standard specifies the definition, requirements, test methods, marking and
packaging of artificial dental implants made of titanium and titanium alloys.
This standard applies to artificial dental implants made of titanium and titanium
alloys.
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 4698-1996 Methods for chemical analysis of sponge titanium, titanium
and titanium alloys
GB 12417-1990 The general technological conditions of surgical metal
implant
GB/T 13810-1997 Wrought titanium and titanium alloys for surgical implants
Pharmacopoeia of the People 's Republic of China, 2005 version, volume II
Sterile test method - Sterilization method
3 Terms and definitions
The following terms and definitions apply to this standard.
Dental implant
A specially designed medical device that is surgically implanted into the jaw
tissue of a human body with missing teeth to provide support and retention for
the denture.
The biological properties of the dental implants shall make reference to the
relevant provisions of YY 0268.
6 Test method
6.1 Chemical composition
The method of chemical composition analysis of dental implants shall be in
accordance with the relevant provisions in GB 4698-1996 AND shall comply
with the provisions of 5.1.
6.2 Dimensions
The method of testing the geometry of the implant is carried out in accordance
with the following provisions.
USE the vernier caliper and micrometer to make measurement, AND the
results shall comply with the provisions of 5.2.
6.3 Surface properties
6.3.1 The macroscopic quality of the dental implants shall be visually inspected
AND shall comply with the provisions of 5.3.1.
6.3.2 Surface microscopic inspection shall be carried out in accordance with
the provisions of 5.1 of GB 12417-1990 AND shall comply with the provisions
of 5.3.2 of this standard.
6.3.3 The roughness of the contact portion between the implant and the oral
mucosa and soft tissue. tested by comparison or needle profiling method, AND
it shall comply with the provisions of 5.3.3.
Comparison method uses the roughness comparison sample block, AND the 5
to 10-folds magnifying glass for comparison test.
Needle profiling method uses the electric profiler to directly measure the Ra
value of the measured surface directly.
The roughness of the contact portion between the implant and the oral mucosa
and soft tissue uses the needle profiling method as the arbitration method.
6.4 Internal quality inspection
MAKE inspection in accordance with the provisions of GB 12417-1990, AND
the results shall comply with the provisions of 5.4.