YY/T 0127.5-2014 English PDF

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YY/T 0127.5-2014: Biological evaluation of medical devices used in dentistry. Part 5: Inhalation toxicity test
Status: Valid

YY/T 0127.5: Historical versions

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
YY/T 0127.5-2014	259	Add to Cart	3 days	Biological evaluation of medical devices used in dentistry. Part 5: Inhalation toxicity test	Valid
YY/T 0127.5-1999	279	Add to Cart	3 days	Biological evaluation of dental materials. Unit 2: Biological test methods of dental materials. Inhalation toxicity test	Obsolete

Similar standards

YY/T 0127.13   YY/T 0127.7   YY/T 0268   YY/T 0127.19   YY/T 0127.4   YY/T 0127.3   

Basic data

Standard ID: YY/T 0127.5-2014 (YY/T0127.5-2014)
Description (Translated English): Biological evaluation of medical devices used in dentistry. Part 5: Inhalation toxicity test
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C33
Classification of International Standard: 11.060.10
Word Count Estimation: 11,172
Date of Issue: 6/17/2014
Date of Implementation: 7/1/2015
Older Standard (superseded by this standard): YY/T 0127.5-1999
Quoted Standard: GB/T 16886.2
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 the evaluation at room temperature or have significant volatility oral medical equipment or components under conditions of inhalation toxicity. This Standard specifies the method of oral inhalation toxicity testing of medical devi

YY/T 0127.5-2014: Biological evaluation of medical devices used in dentistry. Part 5: Inhalation toxicity 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 5. Inhalation toxicity test ICS 11.060.10 C33 People's Republic of China pharmaceutical industry standards Replacing YY/T 0127.5-1999 Biological Evaluation of Medical Devices Oral Part 5. Inhalation Toxicity Test Part 5. Inhalationtoxicitytest Issued on. 2014-06-17 2015-07-01 implementation China Food and Drug Administration released

Foreword

This section is "Oral Biological evaluation of medical devices" series standard part of the standard. 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 and YY/T 0244 "Test methods for dental materials biological short-term systemic toxicity test. the oral route" oral health Device 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 Dental Materials and biological test methods - Part 3. Application Test of the root canal; --- YY/T 0127.4 Test methods for dental materials Biology Unit 2. Biological test methods of dental materials Bone implants trials; --- YY/T 0127.5 Oral Biological evaluation of medical devices - Part 5. Biological test methods of dental materials 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 Dental Materials Unit 2. Biological test methods of dental materials cytotoxicity test. Joan Fat cover 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 section YY/T Section 50127 of. This section drafted in accordance with GB/T 1.1-2009 given rules. This section instead of YY/T 0127.5-1999 "Biological Evaluation of Dental Materials Unit 2. Test methods for inhalation toxicity testing." With YY/T 0127.5-1999 following major technical changes, these changes are based on OECD436.2009 and OECD 403.2008 in which the content. --- Modify the acute inhalation toxicity of definition, "in the short term (24h or less than 24h)" read "in the short term (4h ~ 6h); --- Remove the "median lethal dose LD50", "lethal concentration LC50", the definition of "dynamic exposure device"; --- Increased "concentration", "a finite concentration", the definition of "limit test"; --- Chapter 5, "experimental animals," added "animal welfare" of the content; --- Added "static body inhalation device" in exposure mode selection; --- In the "dynamic systemic inhalation device," added gas mixing device, shown in Figure 2, 5; --- The exposure time is usually defined as rats 6h, mice typically 4h; --- To increase the content of "limit test and the main test", delete the words "maximum tolerated dose trial"; --- The number of test animals from "n = 10" to "n = 6"; --- After the test period was observed from the "7d" to "14d"; --- Results of the evaluation, the LC50 no longer as criteria, but at a dose level of "≥5000mg/m3 test, whether an animal Obvious symptoms of poisoning or death "as the criteria; 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. This section is drafted. Sichuan biomaterials and medical devices products inspection center (Sichuan University), the State Food and Drug Administration North Big Medical Device Quality Supervision and Inspection Center. The main drafters of this section. Jie Liang, Han Jianmin, Lin Hong, Yuan Tun, Du Heng Peng Qiang, Zhu Tong, Zhu Wei fine. Biological Evaluation of Medical Devices Oral Part 5. Inhalation Toxicity Test

1 Scope

YY/T 0127 This section provides oral inhalation toxicity testing of medical devices. This section applies to the evaluation at room temperature or inhalation toxicity has significant volatility oral medical devices or components thereof under application conditions.

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

The following terms and definitions apply to this document. 3.1 Acute inhalation toxicity acuteinhalationtoxicity In the short period of time (4h ~ 6h), a continuous suction side effects after the test substance is caused. 3.2 Concentration concentration Mass per unit volume of air being test substance (mg/L, mg/m3). 3.3 Limit concentration limitconcentration The maximum concentration of inhalation toxicity test requirements, the test substance is determined by the physical state. When using GSH classification system, steam limit Given concentration of.20000mg/m3, or the test substance reach the maximum possible concentration. 3.4 Limit test limittest Single animals inhaled a clear concentration of test substance is completed inhalation toxicity tests. 3.5 Median lethal time medianlethaltime; LT50 Overall a substance in the test animals, causing 50% of the time the animals died.

4 appliances and equipment

4.1 Flowmeter. LF meter 100L/h, 200L/h, 4% accuracy. 4.2 Analytical balance. Indexing is 0.0001g. 4.3 GC. 4.4 static exposure apparatus. ......

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