YY/T 0127.4-2023_English: PDF (YY/T0127.4-2023)
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Biological evaluation of medical devices used in dentistry -- Part 4: Bone implant test
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Biological evaluation of medical devices used in dentistry - Part 2: Test method - Bone implant test
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Biological evaluation of dental materials. Unit2: Biological evaluation method of dental materials. Bone implant test
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| Standard ID | YY/T 0127.4-2023 (YY/T0127.4-2023) | | Description (Translated English) | Biological evaluation of medical devices used in dentistry -- Part 4: Bone implant test | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.10 | | Word Count Estimation | 14,154 | | Date of Issue | 2023-11-22 | | Date of Implementation | 2024-12-01 | | Older Standard (superseded by this standard) | YY/T 0127.4-2009 | | Drafting Organization | Oral Medical Device Inspection Center of Peking University School of Stomatology, Sichuan University (Sichuan Medical Device Biomaterials and Products Inspection Center), Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | | Administrative Organization | National Standardization Technical Committee for Dental Materials and Equipment (SAC/TC 99) | | Proposing organization | State Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This standard specifies the bone implant test method for oral medical devices. This standard is applicable to the evaluation of biological responses of tissues to oral medical devices intended to be in long-term or persistent contact with oral bone tissue. | | Standard ID | YY/T 0127.4-2009 (YY/T0127.4-2009) | | Description (Translated English) | Biological evaluation of medical devices used in dentistry - Part 2: Test method - Bone implant test | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.10 | | Word Count Estimation | 11,142 | | Date of Issue | 2009-12-30 | | Date of Implementation | 2011-06-01 | | Older Standard (superseded by this standard) | YY/T 0127.4-1998 | | Quoted Standard | GB/T 13810; GB/T 16886.6; GB/T 16886.12 | | Drafting Organization | Peking University School of Stomatology, Medical Device Inspection Center | | Administrative Organization | National Standardization Technical Committee of Dental Materials and Devices Equipment | | Summary | This standard specifies test methods for oral bone implanted medical devices. This standard is used to evaluate the biological response of bone tissue for the proposed long-term oral bone tissue in contact with the oral medical devices. | | Standard ID | YY/T 0127.4-1998 (YY/T0127.4-1998) | | Description (Translated English) | Biological evaluation of dental materials. Unit2: Biological evaluation method of dental materials. Bone implant test | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.10 | | Word Count Estimation | 5,587 | | Date of Issue | 1998/4/8 | | Date of Implementation | 1998/10/1 | | Adopted Standard | ISO/TR 7405-84, NEQ | | Drafting Organization | State Administration of Pharmaceutical Materials Quality Inspection Center | | Administrative Organization | National Standard Committee on Oral Materials and Equipment | | Proposing organization | State Administration of Medicine | | Issuing agency(ies) | State Administration of Medicine |
YY/T 0127.4-2023.Biological evaluation of oral medical devices Part 4.Bone implantation test
ICS 11.060.10
CCSC33
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY/T 0127.4-2009
Biological evaluation of oral medical devices
Part 4.Bone implantation test
Part 4.Bone implant test
Released on 2023-11-22
2024-12-01 implementation
The State Drug Administration issued
Preface
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
This document is part 4 of YY/T 0127 “Biological Evaluation of Oral Medical Devices”. YY/T 0127 has been published in the following parts.
---YY/T 0127.1 "Biological test methods for oral materials - Hemolysis test";
---YY/T 0127.3 "Biological evaluation of oral medical devices Part 3.Root canal application test";
---YY/T 0127.4 "Biological evaluation of oral medical devices Unit 2.Test method Bone implantation test";
---YY/T 0127.5 "Biological evaluation of oral medical devices Part 5.Inhalation toxicity test";
---YY/T 0127.6 "Biological evaluation of oral materials Unit 2.Biological test methods for oral materials Dominant lethal test";
---YY/T 0127.7 "Biological evaluation of oral medical devices Part 7.Application test on dental pulp and dentin";
---YY/T 0127.8 "Biological evaluation of oral materials Unit 2.Biological test methods for oral materials Subcutaneous implantation test";
---YY/T 0127.9 Biological evaluation of oral medical devices Unit 2.Test methods Cytotoxicity test. Agar diffusion method
and membrane diffusion method”;
---YY/T 0127.10 Biological evaluation of oral medical devices Unit 2.Test methods for Salmonella typhimurium response mutation
Variation test (Ames test)";
---YY/T 0127.11 "Biological evaluation of oral medical devices Part 11.Pulp capping test";
---YY/T 0127.12 "Dentistry - Biological evaluation of oral medical devices - Unit 2.Test method - Micronucleus test";
---YY/T 0127.13 "Biological evaluation of oral medical devices Part 13.Oral mucosal irritation test";
---YY/T 0127.14 "Biological evaluation of oral medical devices Unit 2.Test method Acute oral systemic toxicity test";
---YY/T 0127.15 Biological evaluation of oral medical devices Part 15.Subacute and subchronic systemic toxicity tests. Oral
way";
---YY/T 0127.16 Biological evaluation of oral medical devices Unit 2.Test methods for chromosomes in vitro in mammalian cells
Distortion test";
---YY/T 0127.17 Biological evaluation of oral medical devices Part 17.Mouse lymphoma cell (TK) gene mutation test
Test";
---YY/T 0127.18 "Biological evaluation of oral medical devices Part 18.Dentin barrier cell toxicity test";
---YY/T 0127.19 Biological evaluation of oral medical devices Part 19.Subacute and subchronic systemic toxicity tests. Implantation
way".
This document replaces YY/T 0127.4-2009 "Biological Evaluation of Oral Medical Devices Unit 2.Test Method Bone Implantation Test".
Compared with YY/T 0127.4-2009, in addition to structural adjustments and editorial changes, the main technical changes are as follows.
a) The description of specimen preparation has been changed, a reference table for specimen size selection has been added, and the description of reference materials has been deleted (see 4.1, 4.2,
3.1 and 3.2 of the.2009 edition);
b) The experimental control has been changed (see Chapter 5, 3.2 of the.2009 edition);
c) Added experimental animals and animal welfare (see Chapter 6);
d) The test cycle has been changed and the test cycle setting for degradable/absorbable materials has been added (see 7.1, 7.2,.2009 edition).
Chapter 4);
e) The test site was changed and the description of the implantation site was added (see 8.1, Chapter 6 of the.2009 edition);
f) The surgical procedure has been changed (see Chapter 9, Chapter 7 of the.2009 edition);
g) The evaluation by naked eye observation has been modified (see 12.1, 10.1 of the.2009 edition);
h) The implant extraction and tissue specimen preparation were changed, and the non-decalcified specimen preparation method was added (see 12.2, 10.3 of the.2009 edition);
i) The microscopic evaluation was changed and the treatment method for adverse histopathological results was added (see 12.3,.2009
Version 10.2);
j) The reaction classification has been changed (see 12.4, 10.4 of the.2009 edition);
k) The result judgment has been changed (see 12.5, 10.5 of the.2009 edition).
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed by the State Food and Drug Administration.
This document is under the jurisdiction of the National Technical Committee for Standardization of Dental Materials and Instruments (SAC/TC99).
This document was drafted by. Oral Medical Device Testing Center, Peking University School of Stomatology, Sichuan University (Sichuan Medical Device Biomaterials
and Product Inspection Center), the Ninth People's Hospital affiliated to Shanghai Jiao Tong University School of Medicine.
The main drafters of this document are. Han Jianmin, Yuan Tun, Liu Xin, Wu Yang, Lin Hong, Dai Zhengning, Jia Lifang, Liang Jie, Sun Jiao, Ren Xinxin, Chai Yuan,
Sui Baiyan.
The previous versions of this document and the documents it replaces are as follows.
---First published in.1998 as YY/T 0127.4-1998, first revised in.2009;
---This is the second revision.
Biological evaluation of oral medical devices
Part 4.Bone implantation test
1 Scope
This document describes the bone implantation test methods for dental medical devices.
This document is applicable to the evaluation of the biological response of tissues to oral medical devices intended to come into long-term or permanent contact with oral bone tissue.
2 Normative references
The contents of the following documents constitute the essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies to
This document.
GB/T 13810 Titanium and titanium alloy processed materials for surgical implants
GB/T 16886.2 Biological evaluation of medical devices Part 2.Animal welfare requirements
GB/T 16886.6 Biological evaluation of medical devices Part 6.Local reaction test after implantation
GB/T 16886.12 Biological evaluation of medical devices Part 12.Sample preparation and reference materials
3 Terms and definitions
There are no terms or definitions that require definition in this document.
4.Sample preparation
4.1 Sample processing
The test samples should be prepared, processed, cleaned and sterilized in the same way as the final product, and the finished product should be used for bone implantation testing.
Select and prepare specimens of appropriate size according to the experimental animals and implantation sites.
For materials that need to be cured or polymerized at the application site, it is recommended to implant them into the bone before curing. If this is not possible, special instructions should be given.
It is recommended to implant immediately after curing, and record the curing conditions, storage status before implantation, etc. If the material is provided in a non-sterile state, its sterilization method should be
At least 10 specimens are required for each test cycle.
4.2 Specimen size
Small experimental animals, such as rats and rabbits, are preferred; larger experimental animals can also be selected according to the particularity of the test samples.
The specimen size is determined according to the experimental animal selected and the size of the bone at the implantation site, see Table 1.
......
YY/T 0127.4-2009
ICS 11.040.99
C 40
INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
Biological evaluation of medical
devices used in dentistry
Part 2. Test method
Bone implant test
ISSUED ON. DECEMBER 30, 2009
IMPLEMENTED ON. JUNE 01, 2011
Issued by. The State Food and Drug Administration
Table of 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.
The main drafters of this Standard. Lin Hong, Li Shenglin, and Hao Peng.
This Standard was first-published in 1998, it is first-revised in 2009. The previous edition
which is substituted by this Standard is.
- YY/T 0127.4-1998
Biological evaluation of medical devices
used in dentistry
Part 2. Test method
Bone implant test
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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