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YY/T 0127.4-2009

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YY/T 0127.4-2009 英文版 580 购买 现货,9秒内自动发货PDF,有增值税发票。 口腔医疗器械生物学评价 第2单元: 试验方法 骨埋植试验 有效

   
标准详细信息 YY/T 0127.4-2009; YY/T0127.4-2009; YYT 0127.4-2009; YYT0127.4-2009
中文名称: 口腔医疗器械生物学评价 第2单元: 试验方法 骨埋植试验
英文名称: Biological evaluation of medical devices used in dentistry - Part 2: Test method - Bone implant test
行业: 医药行业标准 (推荐)
中标分类: C33
国际标准分类: 11.060.10
字数估计: 11,000
发布日期: 2009-12-30
实施日期: 2011-06-01
旧标准 (被替代): YY/T 0127.4-1998
引用标准: GB/T 13810; GB/T 16886.6; GB/T 16886.12
起草单位: Peking University School of Stomatology, Medical Device Inspection Center
归口单位: National Standardization Technical Committee of Dental Materials and Devices Equipment
范围: 本标准规定了口腔医疗器械的骨埋植试验方法。本标准用于评价骨组织对拟长期与口腔骨组织接触的口腔医疗器械的生物学反应。


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
口腔医疗器械生物学评价
第 2单元. 试验方法
骨埋植试验
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.
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”.
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
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
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
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
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
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
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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