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YY/T 0268-2008 English PDF

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YY/T 0268-2008: Dentistry - Biological evaluation of medical devices used in dentistry - Part 1: Evaluation and test
Status: Valid

YY/T 0268: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0268-2008English299 Add to Cart 3 days [Need to translate] Dentistry - Biological evaluation of medical devices used in dentistry - Part 1: Evaluation and test Valid YY/T 0268-2008
YY/T 0268-2001English520 Add to Cart 0--9 seconds. Auto-delivery Dentistry--Preclinical evaluation of biocompatibility of medical devices used in dentistry--Part 1: Evaluation and test methods selection Obsolete YY/T 0268-2001

PDF similar to YY/T 0268-2008


Standard similar to YY/T 0268-2008

YY 0270.1   YY 0304   YY 0271.2   YY 0272   YY/T 0273   

Basic data

Standard ID YY/T 0268-2008 (YY/T0268-2008)
Description (Translated English) Dentistry - Biological evaluation of medical devices used in dentistry - Part 1: Evaluation and test
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C33
Classification of International Standard 11.060.10
Word Count Estimation 13,113
Date of Issue 2008-04-25
Date of Implementation 2009-06-01
Older Standard (superseded by this standard) YY/T 0268-2001
Quoted Standard GB/T 6387; GB/T 9258.1; GB/T 16886.1; GB/T 16886.2; GB/T 16886.3; GB/T 16886.5; GB/T 16886.6; GB/T 16886.10; GB/T 16886.11; GB/T 16886.12; ISO/TS 22911; YY/T 0127.1; YY/T 0127.2; YY/T 0127.3; YY/T 0127.4; YY/T 0127.5; YY/T 0127.6; YY/T 0127.7; YY/T 0127.8; YY/T 0127.9; YY/T 0127.10; YY/T 0127.11; YY/T 0279; YY/T 0244; YY/T 0316
Adopted Standard ISO/FDIS 7405-2008, NEQ
Regulation (derived from) SFDA [2008] No. 192
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the oral biological evaluation of medical devices should be considered experimental and test methods. This standard includes medicines and equipment for the whole complex instruments. This standard does not include direct or indirect physical contact with the patient materials and equipment testing.

YY/T 0268-2008: Dentistry - Biological evaluation of medical devices used in dentistry - Part 1: Evaluation and 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.
Dentistry.Biological evaluation of medical devices used in dentistry.Part 1. Evaluation and test ICS 11.060.10 C33 People's Republic of China pharmaceutical industry standards Replacing YY/T 0268-2001 Oral Biological evaluation of medical devices dentistry Module 1. Evaluation and testing Posted 2008-04-25 2009-06-01 implementation State Food and Drug Administration issued

Foreword

This standard corresponds to ISO /FDIS7405.2008 "Dentistry Oral biocompatibility evaluation of medical devices." This standard ISO /FDIS7405.2008 non-equivalent degree of consistency. This standard is based on ISO /FDIS7405.2008 redrafted. This standard and ISO /FDIS7405. The main difference between the 2008 and the following reasons. --- Normative documents related to the increase in biological test methods series pharmaceutical industry standards, and in other trials involving these criteria Terms of the methods referenced; --- 3.3 Note. The increase "is also visible clinical status may be"; --- The ISO /FDIS7405.2008 6.1 to 6, the following article number postponed. Cancel ISO /FDIS7405.2008 specifically Test content (6.2 to 6.5). ISO /FDIS7405.2008 contains some of the specific test methods and procedures. This standard does not It includes specific test methods and test steps, only project selection. The specific test method has been since, respectively, there is a separate standard method Accurate, they Biological evaluation of medical devices for the oral standard series of the second unit content. These methods and standards This standard co With biological evaluation of medical devices constitute Oral series of standards; --- Cancel ISO /FDIS7405.2008 Appendices B and C, see reference content; --- Reference content was adjusted as needed. This standard is equivalent to using other content ISO /FDIS7405.2008. The repeal and replace the standard YY/T 0268-2001 "Dentistry for oral biocompatibility of medical devices pre-clinical evaluation Unit 1. Evaluation and testing project selection. " Compared with the standard YY/T 0268-2001 The main changes are as follows. --- Standard name to read. "Dentistry Oral Biological evaluation of medical devices Module 1. Evaluation and testing"; --- The standard text in the "Table 1 Oral biocompatibility preclinical evaluation of pilot projects," according to ISO /FDIS7405.2008 change For the "pilot project Table A.1 oral evaluation of biocompatibility of medical devices should be considered"; delete the original "A part of Dental Materials and Appendix Classification and Biological Evaluation and Test selection table "; --- Remove YY/T 0268-2001 preface "this standard and ISO 7405.1997 different"; --- Normative references corresponding increase in oral medical equipment Biological Test Method Series pharmaceutical industry standards; --- "5 Biological Evaluation and testing" to "5. Biological Evaluation Procedure"; --- According to ISO /FDIS7405.2008 Added "6 dental materials Biological test specimens prepared in principle." Appendix A of this standard is an informative annex. This standard was proposed by the State Food and Drug Administration. This standard by the National Standardization Technical Committee of Dental Materials and Devices and equipment. This standard by the State Drug Administration of Peking University Medical Device Quality Supervision and Testing Center is responsible for drafting. The main drafters of this standard. Lin Hong, a Liu Zheng Gang. This standard was first published in 1995 and revised in 2001 for the first time in 2008, the second amendment. This standard replaces the standards previously issued as follows. --- YY 0268-1995, YY/T 0268-2001.

Introduction

Oral Biological evaluation of medical devices series standard consists of two parts. This standard as the first unit, oral medical equipment biological Learn to select and evaluate the pilot project, to guide standards. The second unit is a dental instrument specific biological test methods. Some trials The method is specific test methods for dental instruments, these methods in the field of oral application have extensive experience and are known in the oral and maxillofacial A domain is particularly desirable. This standard does not contain specific content of the test method, the relevant test methods to choose the appropriate pharmaceutical industry standards, national standards and national International standards. This standard should be applied with GB/T 16886-ISO 10993 "Biological Evaluation of Medical Devices" standards and/or related biological test Standard test method in combination with the pharmaceutical industry. This standard includes a selection test methods and classification and biological evaluation of medical devices oral test should be considered. Recommended Test Method , The priority should be given to minimize the use of animals. Only after careful analysis that the overall evidence suggests that the same results can not be When using other types of alternative tests, before considering the use of tests involving animals. In order to ensure a minimum number of animals needed for the test, the guarantee The case meets the test object can be simultaneously carried out multiple tests on the same animal, such as pulp and dentine usage test and pulp capping test. According to GB/T 16886.2 requirements of these tests should be effective and humane manner. In any case, when the animal trials It should be compassionate, according to each test specified standard test procedures. This standard follows the GB/T 16886.1-ISO 10993.1 basic principles, emphasizing the biological evaluation of biological experiments are two different the concept of. The Standard Appendix A, Table A. 1 pilot project listed in the framework of the biological evaluation. In the application, according to the materials used Way, the items listed in the framework of time to organize and contact with the material may be exposed by the biological evaluation of biological evaluation is carried out, but not listed All items are to be tested. Therefore, when biological evaluation, to focus on the reasonable evaluation procedures and make full use of existing information Evaluation. Before biological evaluation, as the first instrument for qualitative and quantitative analysis of materials to minimize conducted biological tests; if you choose When biological tests, in vitro screening test should be carried out to minimize the in vivo test in order to protect animals. In the biological evaluation of materials/equipment When security, in accordance with YY/T 0316, and considering the risk analysis. This standard does not explicitly test methods and risks related to occupational description. Appendix A is an informative annex, is for the user to understand the use of standards or standards provide some recommendations and suggestions, which are listed Biological evaluation of projects is the project should be considered, rather than meet the standard requirements to be followed by the "Terms." Oral Biological evaluation of medical devices dentistry Module 1. Evaluation and testing

1 Scope

This standard specifies the test methods for biological evaluation of medical devices and oral tests should be considered. This standard includes pharmaceutical ingredients and equipment for the whole complex instruments. This standard does not include direct or indirect contact with the patient's body to test materials and equipment.

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard. However, according to research encourages the parties to the agreement Study whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard. GB/T 6387 material Dental Terminology (idt ISO 1942) GB/T 9258.1 coated abrasives Analysis Part 1 abrasive particle size. Grain size (GB/T 9258.1-2000, idt ISO 6344-1.1998) GB/T 16886.1 Biological evaluation of medical devices - Part 1. Evaluation and testing (GB/T 16886.1-2001, idt ISO 10993-1.1997) GB/T 16886.2 Biological evaluation of medical devices - Part 2. Animal welfare requirements (GB/T 16886.2-2000, idt ISO 10993-2.1992) GB/T 16886.3 Biological evaluation of medical devices - Part 3. Tests for genotoxicity, carcinogenicity and reproductive toxicity (GB/T 16886.3-1997, ISO 10993-3.2003, IDT) GB/T 16886.5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test (GB/T 16886.5-2003, ISO 10993-5.1999, IDT) GB/T 16886.6 Biological evaluation of medical devices - Part 6. Tests for local effects after implantation (GB/T 16886.6-1997, idt ISO 10993-6.1994) GB/T 16886.10 Biological evaluation of medical devices - Part 10. irritation and delayed-type hypersensitivity test (GB/T 16886.10- 2005, ISO 10993-10.2002, IDT) GB/T 16886.11 Biological evaluation of medical devices - Part 11. Tests for systemic toxicity (GB/T 16886.11-1997, idt ISO 10993-11.1993) GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference materials (GB/T 16886.12-2005, ISO 10993-12.2002, IDT) ISO /T immediately before the celebration animal test method for evaluating S22911 Dentistry Dental Implant System YY/T 0127.1 Test methods for dental materials biological hemolysis test YY/T 0127.2 Test methods for dental materials biological intravenous acute systemic toxicity test YY/T 0127.3 Biological Evaluation of Dental Materials Unit 2. Biological test methods of dental materials in root canal Application Test Biological evaluation of YY/T 0127.4 Dental Materials Unit 2. Biological test methods of dental materials Bone implants trials Biological evaluation of YY/T 0127.5 Dental Materials Unit 2. Biological test methods of dental materials inhalation toxicity test Biological evaluation of YY/T 0127.6 Dental Materials Unit 2. Biological test methods of dental materials dominant lethal test Biological evaluation of YY/T 0127.7 Dental Materials Unit 2. Biological test methods of dental materials dental pulp dentin test

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