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YY 0304-2009 English PDF (YY0304-2009)

YY 0304-2009 English PDF (YY0304-2009)

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YY 0304-2009: Plasma sprayed hydroxyapatite coated-titanium dental implant

This Standard specifies the technical requirements, test methods, product classification, marks, labels, packaging, transport and storage for plasma sprayed hydroxyapatite coated - titanium dental implant. This Standard is applicable to the plasma sprayed hydroxyapatite coated - titanium dental implant that is implanted in jawbone after the loss of a teeth.
YY 0304-2009
YY
NATIONAL PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE REPUBLIC OF CHINA
ICS 11.060.10
C 33
Replacing YY 0304-1998
Plasma sprayed hydroxyapatite coated ?€?
titanium dental implant
????????????????????? - ??????????????????
ISSUED ON. DECEMBER 30, 2009
IMPLEMENTED ON. JUNE 1, 2011
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 ... 9
6 Marks, labels, packaging, transport, storage ... 11
Foreword
This Standard mainly supplemented and modified the original standard content according to the latest version of the relevant standard. The technical content that this Standard shall contain is verified and supplemented in full compliance with the provisions of International Standard ISO 10451-2002 "Dental implant systems - Contents of technical file". All contents relating to plasma sprayed hydroxyapatite coated - titanium dental implant are written in this new edition according to the requirements of the international standard. The performance requirements and test method of plasma sprayed hydroxyapatite coated
respectively and equivalently adopt ISO 13779.2-2000 "Implants for surgery- Hydroxyapatite - Part 2. Coatings of hydroxyapatite", ISO 13779.3-2008
"Implants for surgery-Hydroxyapatite - Part 3. Chemical analysis and
characterization of crystallinity and phase purity" and ISO 13779.4-2002 "Implants for surgery-Hydroxyapatite - Part 4. Determination of coating adhesive strength".
This Standard replaces the previous edition YY 0304-1998 "Plasma sprayed hydroxyapatite coated titanium dental implant". Compared with the previous edition, the main changes and reasons in this edition are as follows.
- in definitions, "dental implant" was specified as "plasma sprayed
hydroxyapatite coated - titanium dental implant" directly related in this Standard, and added the definition of "endosseous implant"; their
definition are based on ISO/TR 11175.1993;
- the biological evaluation stated that the selection and evaluation of test items were conducted in accordance with the relevant national standards GB/T 16886 and the pharmaceutical industry standard YY/T 0268, and the
main requirements items and test methods were not listed item by item;
correspondingly, Annex A on biological testing method were also deleted; - in the geometrical accuracy, added two items. neck surface roughness
and main important connection dimensions and tolerances; the testing
method of the geometric dimension accuracy part shall be no longer
specified, so as to adapt to the differences in the detection equipment configuration of various production plants and the advanced methods and instruments that are continuously emerging.
Chemical composition has the following changes.
- the HA content in the coating and the index of crystallinity were changed to 95% and 45% according to the requirements of ISO 13779.2; added
"4.3.2.1.3 Atomic ratio of calcium and phosphorus";
- "4.3.2.2 Titanium chemical composition " was changed to "Chemical
Plasma sprayed hydroxyapatite coated ?€?
titanium dental implant
1 Scope
This Standard specifies the technical requirements, test methods, product classification, marks, labels, packaging, transport and storage for plasma sprayed hydroxyapatite coated - titanium dental implant.
This Standard is applicable to the plasma sprayed hydroxyapatite coated - titanium dental implant that is implanted in jawbone after the loss of a teeth. 2 Normative references
The following standards contain the provisions which, through reference in this Standard, constitute the provisions of this Standard. For dated references, subsequent amendments (excluding corrections) or revisions do not apply to this Standard. However, the parties who enter into agreement based on this Standard are encouraged to investigate whether the latest versions of these documents are applicable. For undated reference documents, the latest
versions apply to this Standard.
GB/T 13810-2007, Wrought titanium and titanium alloy for surgical implants GB/T 16886.1, Biological evaluation of medical devices - Part 1. Evaluation and testing within a risk management process (GB/T 16886.1-2001,ISO
10993-1.1997, IDT)
YY/T 0268, Dentistry - Biological evaluation of medical devices used in dentistry Part 1. Evaluation and test (YY/T 0268-2008, ISO/FDIS 7405.2008, NEQ)
YY/T 0313-1998, Package, label, transport and storage for medical polymer products
Pharmacopoeia of the People's Republic of China, 2005 Edition, Part II, Annex XI "H sterility test method", Annex VIII "H heavy metal test method" ISO 13779. 3-2008, Implants for surgery - Hydroxyapatite - Part 3. Chemical analysis and characterization of crystallinity and phase purity
ISO 13779. 4-2002, Implants for surgery - Hydroxyapatite - Part 4.
D is the nominal size of the neck diameter, its limit deviation is ??0.1mm. L is the nominal size of the root length, its limit deviation is ??0.2mm. The diameter and length of each ladder segment shall also meet the limit deviation specified in the design requirements.
4.2.4 Connection thread
For pile-removable dental implant, the connection thread shall give thread code and thread tolerance zone code. The processing accuracy and the tolerance zone shall ensure that the root and crown pile connection threads of crown-pile- removable implant shall cooperate well.
4.2.5 Neck surface roughness
For a dental implant with a malleolus neck design, neck surface roughness. Ra???1.6??m.
4.2.6 Size and tolerance of important connection site
For pile-removable dental implant, the connection and structure of the
connection site shall be specified and comply with the specified concentricity, size and tolerance requirements.
4.3 Physical and chemical properties
4.3.1 Appearance
The uncoated titanium surface of the dental implant shall be free from defects such as cracks, hairless flaws, and scratches due to mechanical processing. The root and crown pile of two-stage implant shall be well balanced. No visible gaps and offsets between mating faces.
Hydroxyapatite coating is gray and white porous layer. The surface of the coating is evenly covered and tightly covered with hydroxyl groups, without any spots or cracks.
4.3.2 Chemical composition
4.3.2.1 Chemical composition of HA coating
4.3.2.1.1 HA content and crystallinity in coating
HA content ???95%, HA crystallinity ???45%.
4.3.2.1.2 Impurity element limit
Arsenic ??? 3mg/kg, cadmium ??? 5mg/kg, mercury ??? 5mg/kg, lead ??? 30mg/kg.
The total amount of heavy metals (in terms of lead) ??? 50mg/kg.
also be different. This Standard does not make specific provisions so as to adapt to different designs and advanced detection methods and detection instruments that are constantly emerging.
5.2 Physical and chemical properties
5.2.1 Appearance
Visually inspected.
5.2.2 Chemical composition
5.2.2.1 Chemical composition of hydroxyapatite coating
5.2.2.1.1 HA content and crystallinity
The testing of HA content and crystallinity are performed in accordance with the methods specified in ISO 13779.3.
5.2.2.1.2 Impurity element limit
The test method of trace impurities is in accordance with ISO 13779.3. The total content of heavy metal elements is performed according to Pharmacopoeia of the People's Republic of China, 2005 Edition, Part II, Annex VIII "H heavy metal test method".
5.2.2.1.3 Atomic ratio of calcium and phosphorus
The test method is in accordance with ISO 13779.3.
5.2.2.2 Chemical compositions of titanium and titanium alloy materials
In accordance with GB/T 13810.
5.2.3 Tensile adhesive strength of coating and titanium substrate
The testing of tensile adhesive strength is in accordance with ISO 13779.4. 5.2.4 Dynamic fatigue test
The dynamic fatigue test is performed according to ISO 14801, 3 samples in total.
NOTE. For pile-removable dental implant, after the pile and the implant are firmly connected with connection screws, fix the dental implant on the sample table in a fixed manner according to ISO 14801. After 1000 preload cycles, tighten the connection screws again to ensure the reliability of the connection between the pile and the implant, and then conduct a formal test. The torque of tightening connection screws shall be proper. If the torque is too small, it shall be unable to fix the connection screws firmly enough. If the

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