YY/T 0127.4-2009Biological evaluation of medical devices used in dentistry - Part 2: Test method - Bone implant test (English PDF)
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Issued by
The State Food and Drug Administration
Level / Type
National · Recommended
Issue date
December 30, 2009
Implementation date
June 1, 2011
Scope
YY/T 0127.4-2009 (Biological evaluation of medical devices used in dentistry - Part 2: Test method - Bone implant test) is available as an English-translated PDF.
YY/T 0127.4-2009 — This Standard specifies the test method of bone implantation of dental medical devices. This Standard shall be used to evaluate the biological reactions of bone tissue of which the dental bone issue is planned to contact with dental medical devices in long-term.
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Document preview — YY/T 0127.4-2009
National Standard of the People's Republic of China
- ICS
- 11.040.99
- Classification
- C 40
Issued by: The State Food and Drug Administration
Contents
- Foreword...3
- 1 Scope...6
- 2 Normative References...6
- 3 Sample Preparation...6
- 4 Test Cycles...7
- 5 Experimental Animals...7
- 6 Test Position...7
- 7 Surgical Procedure...8
- 8 Post-operative Evaluation...8
- 9 Killing of Animal...8
- 10 Biological Reaction Evaluation...8
- Appendix A...13
- References...16
- Translation References and Original Chinese Documents...17
Foreword
This Standard is one of the series standards of "Dental Medical device Biology
Assessment".
The 1st unit, YY/T 0268.2008 "Dentistry. Biological evaluation of medical devices used in
dentistry. Part 1.Evaluation and test" of Dental Medical device Biology Assessment series
standards, is an option for dental medical device biology assessment and test items; it is
a guideline standard.
The 2nd unit of the series standards is "Dental medical devices specific biological test
methods". It is divided into the following sections.
1 YY/T 0127.1-93 Dental materials biological test methods Hemolysis test
2 YY/T 0127.2-2009 Biological evaluation of medical devices used in dentistry. Part 2.
Test method. Acute systemic toxicity. intravenous path
3 YY/T 0127.3-1998 Biological evaluation of dental materials - Unit 2.Biological
evaluation method of dental materials - Endodontic usage test
4 YY/T 0127.4-2009 Biological evaluation of medical devices used in dentistry. Part 2.
Test method Bone implant test
5 YY/T 0127.5-1999 Biological evaluation of dental materials - Unit 2.Biological test
methods of dental materials - Inhalation toxicity test
6 YY/T 0127.6-1998 Biological evaluation of dental materials - Unit 2.Biological test
methods of dental materials - Dominant lethal test
7 YY/T 0127.7-2001 Biological evaluation of dental materials. Part 2.Biological evaluation
test method of dental materials. Pulp and dentine usage test
8 YY/T 0127.8-2001 Biological evaluation of dental materials. Part 2.Biological evaluation
test method of dental materials. Subcutaneous implant test
9 YY/T 0127.9-2009 Biological evaluation of medical devices used in dentistry. Part 2.
Test method - Cytotxicity tests. Agar diffusion test and filter diffusion test
10 YY/T 0127.10-2009 Biological evaluation of medical devices used in dentistry. Part 2.
Test method. Salmonella typhimurium reverse mutation assay (Ames mutagenicity test)
11 YY/T 0127.11-2001 Dentistry - Preclinical evaluation of biocompatibility of medical
devices used in dentistry. Part 2.Biological evaluation test method of dental materials -
Pulp capping test
12 YY/T 0127.12-2008 Dentistry. Biological evaluation of medical devices used in
dentistry Part 2.Test method - Micronucleus test
13 YY/T 0127.13-2009 Dentistry. Biological evaluation of medical devices used in
dentistry Part 2.Test method - Micronucleus test
14 YY/T 0244-1996 Biological test methods of dental materials - Short term systemic
toxicity test. dental route
15 YY/T 0127.14-2009 Biological evaluation of medical devices used in dentistry. Part 2.
Test method. Acute oral toxicity test
16 YY/T 0127.15-2009 Biological evaluation of medical devices used in dentistry. Part 2.
Test method Subacute and subchronic toxicity test - Oral route
This Standard is Part 4 of YY/T 0127 series standards.
This Standard is the revised version of YY/T 0127.4-1998 "Biological evaluation of medical
devices used in dentistry. Part 2.Test method Bone implant test". During the drafting
process, it references to the ISO 10993.6-2007 "Biological evaluation of medical devices -
Part 6.Tests for local effects after implantation". Test principles of ISO 10993.6-2007 are
applicable to this Standard.
Compared with the standard YY/T 0127.4-1998, the main changes are as follows.
- Standard name is renamed as. "Biological evaluation of medical devices used in dentistry.
Part 2.Test method Bone implant test".
- 3.1 Sample preparation adds samples with different types of materials. The sample
quantity number of each test cycle is changed to at least 10.
- 3.2, 4, 5, 6 add a variety of options.
- 7 During surgical procedure, "25g/L iodine and 75% ethanol" are changed to
"5g/L iodine".
- 10 Biological evaluation is modified.
- ADD Appendix A.
Appendix A is an informative appendix.
From the date of implementation, this Standard will replace the obsolete Y/T 0217.4-1998
"Biological evaluation of medical devices used in dentistry. Part 2.Test method - Bone
implant test".
This Standard was proposed by the State Food and Drug Administration.
This Standard is administered by the National Dental Materials and Appliances Equipment
Standardization Technical Committee (SAC/TC 99).
This Standard was responsibly drafted by Dental Medical Device Inspection Center,
School of Stomatology of Peking University.
1 Scope
This Standard specifies the test method of bone implantation of dental medical devices.
This Standard shall be used to evaluate the biological reactions of bone tissue of which the
dental bone issue is planned to contact with dental medical devices in long-term.
2 Normative References
The articles contained in the following documents have become part of this Standard when
they are quoted herein. For the dated documents so quoted, all the modifications (excluding
corrections) or revisions made thereafter shall not be applicable to this Standard. For the
undated documents so quoted, the latest edition shall be applicable to this Standard.
GB/T 13810 Wrought titanium and titanium alloy for surgical implants
GB/T 16886.6 Biological evaluation of medical devices - Part 6.Tests for local effects after
implantation (GB/T 16886.6-1997, ISO 10993-6.1994, IDDT)
GB/T 16886.12 Biological evaluation of medical devices - Part 12.Sample preparation and
reference materials (GB/T 16886.12 2005, ISO 10993-12.2005, IDT)
3 Sample Preparation
3.1 CONDUCT preparation, processing, cleaning, and disinfection for the implanted
materials according to the same method used for final product. At least 10 samples shall be
used for each test cycle.
3.1.1 Solid sample. sample shall be made in cylinder with diameter of 2 mm, height of 6 mm,
with smooth surface.
same position; so as to ensure the minimum influence of relative movement between tissue
and the implants.
For cylindrical sample, the observation position shall be at the central part of the column; for
slotted cylindrical implants, the central part of the slot and the top flat surface are suitable
for evaluation.
10.1 Visual evaluation
USE low-magnification loupe to observe the cut tissue from the implanting position; it shall
include the evaluation of local draining lymph nodes. RECORD the characteristics and
degree of the observed tissue reaction, including hematoma, edema, fiber wrapping and (or)
any general findings. RECORD the implant's state, shape and location, including the
possible residues of biodegradable materials. Observation results shall be archived with
photographs.
In addition, when observing the implanting position, if the animal exhibits pathological or
reaction to the implant, gross necropsy shall be carried out if necessary.
10.2 Sampling and preparation of tissue sample
In order to evaluate the local biological reaction, cut tissue samples shall include those
sufficient unaffected tissue from the implanting position and surrounding areas.
If the implant is not obvious in the observation position (biodegradable material/ absorbable
material), it shall expand the sampling area, including those normal tissue located within few
millimeters. For non-degradable materials, it shall include the abnormal draining lymph
nodes shown by the result of gross pathology. For biod...
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 13810Wrought titanium and titanium alloys for surgical implants
- GB/T 16886.6Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
- GB/T 16886.6-1997Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
- GB/T 16886.12Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ISO 10993
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Related Standards
GB/T 13810-2017 — Wrought titanium and titanium alloys for surgical implants
GB/T 16886.12-2023 — Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
GB/T 16886.6-2022 — Biological evaluation of medical devices - Part 6: Tests for local effects after implantation
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