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YY/T 0127.4-2023 English PDF

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YY/T 0127.4-2023: Biological evaluation of medical devices used in dentistry - Part 4: Bone implant test
Status: Valid

YY/T 0127.4: Historical versions

Standard IDUSDBUY PDFLead-DaysStandard Title (Description)Status
YY/T 0127.4-2023279 Add to Cart 3 days Biological evaluation of medical devices used in dentistry - Part 4: Bone implant test Valid
YY/T 0127.4-2009140 Add to Cart Auto, < 3 mins Biological evaluation of medical devices used in dentistry - Part 2: Test method - Bone implant test Obsolete
YY/T 0127.4-1998199 Add to Cart 2 days Biological evaluation of dental materials. Unit2: Biological evaluation method of dental materials. Bone implant test Obsolete

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YY/T 0127.13   YY/T 0127.7   YY/T 0268   YY/T 0127.19   YY/T 0127.5   YY/T 0127.11   

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: 14,160
Date of Issue: 2023-11-22
Date of Implementation: 2024-12-01
Older Standard (superseded by this standard): YY/T 0127.4-2009
Issuing agency(ies): State 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.

YY/T 0127.4-2023: Biological evaluation of medical devices used in dentistry - Part 4: Bone implant test


---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
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

Foreword

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.
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