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YY/T 0127.2-2009 English PDF

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YY/T 0127.2-2009: Biological evaluation of medical devices used in dentistry. Part 2: Test method. Acute systemic toxicity: intravenous path
Status: Obsolete

YY/T 0127.2: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusPDF
YY/T 0127.2-2009English279 Add to Cart 3 days [Need to translate] Biological evaluation of medical devices used in dentistry. Part 2: Test method. Acute systemic toxicity: intravenous path Obsolete YY/T 0127.2-2009
YY/T 0127.2-1993English199 Add to Cart 2 days [Need to translate] Biotic experiment method for dental materials Acute general toxicity test for mainline Obsolete YY/T 0127.2-1993

PDF similar to YY/T 0127.2-2009


Standard similar to YY/T 0127.2-2009

YY/T 0127.13   YY/T 0127.7   YY 0270.1   YY/T 0127.4   YY/T 0127.3   YY/T 0127.5   

Basic data

Standard ID YY/T 0127.2-2009 (YY/T0127.2-2009)
Description (Translated English) Biological evaluation of medical devices used in dentistry. Part 2: Test method. Acute systemic toxicity: intravenous path
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C33
Classification of International Standard 11.060.10
Word Count Estimation 7,763
Date of Issue 2009-06-16
Date of Implementation 2010-12-01
Older Standard (superseded by this standard) YY/T 0127.2-1993
Quoted Standard GB/T 16886.12
Regulation (derived from) Industry standard filing Notice 2009 No. 9
Issuing agency(ies) State Food and Drug Administration
Summary This standard specifies the Oral medical acute systemic toxicity test: intravenous route test methods. This standard applies to proposed oral contact with the blood of medical devices acute systemic toxicity evaluation.

YY/T 0127.2-2009: Biological evaluation of medical devices used in dentistry. Part 2: Test method. Acute systemic toxicity: intravenous path


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Biological evaluation of medical devices used in dentistry.Part 2. Test method.Acute systemic toxicity. intravenous path ICS 11.060.10 C33 People's Republic of China pharmaceutical industry standards Replacing YY/T 0127.2-1993 Biological Evaluation of Medical Devices Oral Unit 2. Test methods Acute systemic toxicity test. intravenous route Posted 2009-06-16 2010-12-01 implementation State Food and Drug Administration issued

Foreword

"Oral Biological evaluation of medical devices" the first series of standards unit 1, YY/T 0268-2008 "Dentistry Oral Health Medical Devices Evaluation was Module 1. Evaluation and testing "is the choice of oral biological evaluation of medical devices with the pilot project, as a guide standard. YY/T 0127 "Biological Evaluation of Dental Materials Unit 2", is divided into the following sections. --- YY/T 0127.1-1993 Test methods for dental materials biological hemolysis test; --- YY/T 0127.2-2009 Biological evaluation of medical devices oral Unit 2. Test methods for acute systemic toxicity test. Intravenous route; Biological Evaluation --- YY/T 0127.3-1998 Dental Materials Unit 2. Biological test methods of dental materials within the root canal should Test; --- YY/T 0127.4-1998 Biological Evaluation of Dental Materials Unit 2. Biological test methods of dental materials Bone implants test; Biological Evaluation --- YY/T 0127.5-1999 Dental Materials Unit 2. Biological test methods of dental materials inhalation toxicity test; --- YY/T 0127.6-1998 Biological Evaluation of Dental Materials Unit 2. Biological test methods of dental materials dominant lethal test; Biological Evaluation --- YY/T 0127.7-2001 Dental Materials Unit 2. Biological test methods of dental materials of the dental pulp Quality application test; Biological Evaluation --- YY/T 0127.8-2001 Dental Materials Unit 2. Biological test methods of dental materials implanted subcutaneously test; --- YY/T 0127.9-2001 Biological Evaluation of Dental Materials Unit 2. Biological test methods of dental materials cytotoxic Test (agar overlay method and molecular filtration method); --- YY/T 0127.10-2009 Oral Biological evaluation of medical devices Unit 2. Test methods for Salmonella typhimurium Reverse mutation assay (Ames test); Preclinical evaluation of biocompatibility of medical devices Module 2 --- YY/T 0127.11-2001 dentistry for the oral cavity. the mouth Biological test method cavity material pulp capping test; --- YY/T 0127.12-2008 Dentistry Oral Biological evaluation of medical devices Module 2. Test methods micronucleus test; --- YY/T 0127.13-2009 Oral Biological evaluation of medical devices Module 2. Test methods to stimulate the oral mucosa test; --- YY/T 0127.14-2009 Oral Biological evaluation of medical devices Unit 2. Test methods for acute oral systemic toxicity test; --- YY/T 0244-1996 Test method for short-term biological material of oral systemic toxicity test. oral route. This section YY/T Section 20127 of. This section instead of YY/T 0217.2-1993 "Test methods for dental materials biological intravenous acute systemic toxicity test." Section compared with YY/T 0217.2-1993, major changes in the following. --- Standard name to read. "Oral Biological evaluation of medical devices Unit 2. Test methods for acute systemic toxicity test. Intravenous way"; --- Make changes in the number of experimental animals, from "20" to "10"; --- Modify Normative references to. GB/T 16886.12 "Biological evaluation of medical devices - Part 12. Sample preparation and reference Samples "(ISO 10993.12, IDT); --- 4.3.2 adds support for curing type material requirements; --- 4.3.2.4 The pore size 4.5μm ~ 9μm of a sintered funnel to a pore size of 1μm sterile filtration membranes; --- Remove Appendix A. This part of ISO 10993-11.2006 "Biological evaluation of medical devices - Part 11. Tests for systemic toxicity" increased compared to solid Class material requirements and increase the result of the determination of specific targets. This part is proposed by the State Food and Drug Administration. This part of the jurisdiction of the National Standardization Technical Committee of Dental Materials and Devices and equipment. This part by the State Food and Drug Administration Peking University Medical Device Quality Supervision and Testing Center is responsible for drafting. The main drafters of this section. Lin Hong, Hao Peng, Li Yuan. This section was first released in 1993. In 2009, the first revision. This part of the standard replaces the previous editions are. --- YY/T 0127.2-1993. Biological Evaluation of Medical Devices Oral Unit 2. Test methods Acute systemic toxicity test. intravenous route

1 Scope

YY/T 0127 provisions of this part of the dental instrument acute systemic toxicity test. Test methods intravenous route. This section applies to the proposed oral contact with the blood of medical devices acute systemic toxicity evaluation.

2 Normative references

The following documents contain provisions which, through reference YY/T 0127 and become part of the provisions of this section. For dated reference documents Member, all subsequent amendments (not including errata content) or revisions do not apply to this section, however, encouraged to reach under this section Research into whether the parties to the agreement to use the latest versions of these documents. For undated references, the latest version applies to This section. 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)

3 Terms and Definitions

The following terms and definitions apply YY/T 0127 to the present section. 3.1 Liquid material for extraction. 3.2 Extracting material from the resulting liquid extraction medium. 3.3 Free material extraction medium. And extracts do comparison. 3.4 Extracts away from the injection site adverse reactions occurred. 3.5 14d after injection of extracts or fewer adverse reactions observation period of several days. Test Method 4 4.1 test animals At least 10 albino mice. Weight 17g ~ 23g. Standard diet, without restrictions on drinking water. The mice were randomly divided into two experimental and control Groups of at least five. Each cage put the same extract injection when the mice were bred 5, and labeled mouse.

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