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YY/T 0127.4-2023 English PDF

YY/T 0127.4-2023 (YY/T0127.4-2023, YYT 0127.4-2023, YYT0127.4-2023)
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YY/T 0127.4-2023English279 Add to Cart 3 days [Need to translate] Biological evaluation of medical devices used in dentistry -- Part 4: Bone implant test Valid YY/T 0127.4-2023


BASIC DATA
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Older Standard (superseded by this standard) YY/T 0127.4-2009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.

Standards related to: YY/T 0127.4-2023

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.
...