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YY/T 0127.3-2014: Biological evaluation of medical devices used in dentistry-Part 3: Endodontic usage test
Status: Valid YY/T 0127.3: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| YY/T 0127.3-2014 | English | 209 |
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Biological evaluation of medical devices used in dentistry-Part 3: Endodontic usage test
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YY/T 0127.3-2014
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| YY/T 0127.3-1998 | English | 199 |
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Biological evaluation of dental materials. Unit 2: Biological evaluation method of dental materials. Endodontic usage test
| Obsolete |
YY/T 0127.3-1998
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PDF similar to YY/T 0127.3-2014
Basic data | Standard ID | YY/T 0127.3-2014 (YY/T0127.3-2014) | | Description (Translated English) | Biological evaluation of medical devices used in dentistry-Part 3: Endodontic usage test | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C33 | | Classification of International Standard | 11.060.10 | | Word Count Estimation | 9,983 | | Date of Issue | 6/17/2014 | | Date of Implementation | 7/1/2015 | | Older Standard (superseded by this standard) | YY/T 0127.3-1998 | | Quoted Standard | GB/T 16886.2 | | Adopted Standard | ISO 7405-2008, MOD | | Regulation (derived from) | China Food and Drug Administration in 2014 Bulletin No. 30 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard applies to evaluate the apical pulp stump and periapical tissues of the root canal tissue biocompatibility. During operation material in clinical use required also included in this evaluation. This Standard specifies the root canal dental ma | YY/T 0127.3-2014: Biological evaluation of medical devices used in dentistry-Part 3: Endodontic usage 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.
Biological evaluation of medical devices used in dentistry-Part 3. Endodontic usage test
ICS 11.060.10
C33
People's Republic of China pharmaceutical industry standards
Replacing YY/T 0127.3-1998
Biological Evaluation of Medical Devices Oral
Part 3. root canal Application Test
Part 3. Endodonticusagetest
(ISO 7405.2008, MOD)
Issued on. 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
Foreword
This part of oral biological evaluation of medical devices in a standard series of standards.
YY/T 0268 "Dentistry Oral Biological evaluation of medical devices Module 1. Evaluation and testing" oral biology Medical Devices
Evaluation of the pilot project selection criteria as a guide.
YY/T 0127 oral medical equipment specific biological test method standards, where YY/T 0127 is divided into the following sections.
--- YY/T 0127.1 Test methods for dental materials biological hemolysis test;
--- YY/T 0127.2 Biological evaluation of medical devices oral Unit 2. Test methods for acute systemic toxicity test. Intravenous
way;
--- YY/T 0127.3 Oral Biological evaluation of medical devices - Part 3. Application Test of the root canal;
--- YY/T 0127.4 Oral Biological evaluation of medical devices Unit 2. Biological test methods of dental materials Bone implants trials;
--- YY/T 0127.5 Oral Biological evaluation of medical devices - Part 5. inhalation toxicity test;
--- YY/T 0127.6 Biological Evaluation of Dental Materials Unit 2. Biological test methods of dental materials dominant lethal test;
--- YY/T 0127.7 Biological Evaluation of Dental Materials Unit 2. Biological test methods of dental materials Pulp and dentine usage
test;
Biological Evaluation --- YY/T 0127.8 Dental Materials Unit 2. Biological test methods of dental materials subcutaneous implantation test;
--- YY/T 0127.9 Biological evaluation of medical devices oral Unit 2. Biological test methods of dental materials cytotoxicity test
Test. agar overlay method and molecular filtration method;
--- YY/T 0127.10 Biological evaluation of medical devices oral Unit 2. Test methods for Salmonella typhimurium reply projections
Variable test (Ames test);
--- YY/T 0127.11 dentistry for preclinical evaluation of biocompatibility of medical devices oral Unit 2. Dental Materials
Biological test methods of pulp capping test;
--- YY/T 0127.12 Dentistry Oral Biological evaluation of medical devices Module 2. Test methods micronucleus test;
--- YY/T 0127.13 Biological evaluation of medical devices oral Unit 2. Test methods oral mucosa irritation test;
--- YY/T 0127.14 Oral Biological evaluation of medical devices Unit 2. Test methods for acute oral systemic toxicity tests;
--- YY/T 0127.15 Biological evaluation of medical devices oral Unit 2. Test methods subacute and subchronic systemic toxicity
Test. the oral route;
--- YY/T 0127.16 Oral Biological evaluation of medical devices Unit 2. Test methods for mammalian cells in vitro chromosomal
Aberration test;
--- YY/T 0127.17 Oral Biological evaluation of medical devices - Part 17. mouse lymphoma cells (TK) gene mutation
test.
This is Part 3 YY/T 0127 standards.
This section drafted in accordance with GB/T 1.1-2009 given rules.
This part is YY/T 0127.3-1998 "Biological Evaluation of Dental Materials Unit 2. Biological test methods of dental materials in root canal
App test "amendments. This section instead of YY/T 0127.3-1998.
This section of YY/T 0127.3-1998 following major technology changes, these changes are based on ISO 7405.2008 and carried out
modify.
--- Delete references to normative documents "YY 0272-1995 Dental zinc oxide eugenol cement," adds "GB/T 16886.2
Animal protection requirements ";
--- The "negative control material" to "reference material";
--- In Chapter 6, "animal" added "animal welfare" content. Selection of experimental animals increased ferrets;
--- Test cycle from 28d ± 6d and 6 months, instead 28d ± 3d and 90d ± 5d;
--- For teeth and disinfection operation region, the concentration of hydrogen peroxide from 30% down to 3%, deleted disinfection iodine content, by
Plus polyethylene containing slightly more than iodine or chlorhexidine disinfectants;
--- Will "expand the root canal up to 035 ~ 040 endodontic file thickness" with "in accordance with the length of the experimental work, using progressively increasing, sterile root
Canal file root canal preparation, root canal until expanded to fill the appropriate size. ";
--- Modify the filling materials and types of base materials after root canal filling is completed;
--- Tissue slice thickness from 5μm ~ 10μm to 5μm ~ 7μm;
--- The evaluation is divided into 0-3 to level 0 to 4;
--- Deleted YY/T 0127.3-1998 result in 11.1 ~ 11.4 evaluation of the content;
--- Increase in the content of the test report.
This section uses redrafted law revision using ISO 7405.2008 "biocompatibility of medical devices used in dentistry oral evaluation"
6.6 "Application Test of the canal." This section lists the reg and 7405 ISO in Appendix A.2008 reg control list numbered.
This section 7405 and ISO .2008 main difference is as follows.
--- In the preparation of the format, for ease of use users, according to a general description of the test method was reclassified as an increase. Chapter 1
Range; Chapter 2 Normative references; Chapter 3 is defined in the definition of "work test length"; Chapter 4 samples;
--- Chapter 5 reference material;
--- Chapter 6 animals and animal welfare, will be distributed in the standard in relation to other animals and teeth everywhere, all concentrated in the
This chapter specifically described;
--- 8.3 from the "shoot apical tissue fixative after X-ray", the words "after the filling (28 ± 3) d and (90 ± 5) d, the combined use
After fixative or tissue. suitable anesthetic anesthetized animals, and each test dental X-ray taken note "and increase."
Shoot apical X-ray ";
--- 8.2.1 clearly states placing a rubber dam;
--- 8.2.3 adds "If reconcile reconcile board test material and the reference material, should avoid microbiological contamination" content.
Please note that some of the content of this section may involve patents. This part of the release mechanism should not bear the responsibility to identify these patents.
This part is proposed by the China Food and Drug Administration.
The oral part of the National Standardization Technical Committee materials and appliances and equipment (SAC/TC99) centralized.
Drafting this Part. North State Food and Drug Administration Medical Device Quality Supervision and Inspection Center, Peking University, Oral Medicine
College.
The main drafters of this section. Lin Hong, Han Jianmin, Yue Lin.
Biological Evaluation of Medical Devices Oral
Part 3. root canal Application Test
1 Scope
YY/T 0127 provisions of this section within the root canal dental materials application test methods. This test method is used to evaluate the apical pulp off
End tissue and periapical tissue biocompatibility of the root canal material. Also it includes some materials during the operation in the clinical application of necessary
Evaluation.
NOTE. biologically active material is appropriate root canal root canal trials evaluating applications, for example, whether it is filled or when the positive use of down filling, can promote the apical hard tissue
Material.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 16886.2 Biological evaluation of medical devices - Part 2. Animal welfare requirements
3 Terms and Definitions
This section uses the following terms and definitions.
3.1
Test working length experimentalworkinglength
Measuring X-ray teeth incisal incisal or cusp to the apical length, this value decrease (1.0 ± 0.5) mm is the test work
length.
4 Sample
According to the manufacturer's instructions to reconcile, preparation and application materials.
5 reference material
Select the appropriate reference material.
Note. zinc oxide eugenol cements used alone or in combination with other additives such as blocking agent Grossman additives, can be used as a suitable
The reference material.
6 animals and animal welfare
6.1 Animal Welfare
Animal welfare should follow.
a) GB/T 16886.2, or
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