YY 0304-2009Plasma sprayed hydroxyapatite coated-titanium dental implant (English PDF)

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";

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 Requirements

5 Test methods