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YY/T 0616.4-2018

Search Result of Chinese Standard: 'YY/T 0616.4-2018'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 0616.4-2018English129 Add to Cart Days<=3 Medical glove for single use - Part 4: Test method for the puncturation resistance Valid YY/T 0616.4-2018
YY/T 0616.4-2018Chinese16 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

   
Detail Information of YY/T 0616.4-2018; YY/T0616.4-2018
Description (Translated English): Medical glove for single use - Part 4: Test method for the puncturation resistance
Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard: C48
Classification of International Standard: 11.140
Word Count Estimation: 7,772
Date of Issue: 2018-12-20
Date of Implementation: 2020-01-01
Quoted Standard: GB/T 2941
Drafting Organization: Shandong Medical Device Product Quality Inspection Center
Administrative Organization: Shandong Medical Device Product Quality Inspection Center
Regulation (derived from): State Drug Administration Announcement No. 97 of 2018
Proposing organization: State Drug Administration
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the test conditions, test procedures and results reports for the puncture resistance of disposable medical gloves. This standard applies to the evaluation of the puncture resistance of disposable medical gloves.


YY/T 0616.4-2018
(Disposable medical gloves - Part 4. Puncture test methods)
ICS 11.140
C48
People's Republic of China Pharmaceutical Industry Standard
Disposable medical gloves
Part 4. Anti-puncture test methods
Medicalgloveforsingleuse-
Part 4. Testmethodforthepuncturationresistance
Published on.2018-12-20
2020-01-01 implementation
State Drug Administration issued
Foreword
YY/T 0616 "Disposable Medical Gloves" consists of the following.
--- Part 1. Biological evaluation requirements and tests;
--- Part 2. Determination of shelf life requirements and tests;
--- Part 3. Method for determining the actual time lapse date by using finished gloves in storage;
--- Part 4. Anti-puncture test method.
This part is the fourth part of YY/T 0616.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This part is proposed by the State Drug Administration.
This part is under the jurisdiction of Shandong Medical Device Product Quality Inspection Center.
This section drafted by. Shandong Province Medical Device Product Quality Inspection Center, Shijiazhuang Hongrui Group Co., Ltd., Lanfan Medical Co., Ltd.
Limited company.
The main drafters of this section. Zhang Bo, Liu Guixi, Liu Wenjing, Liang Jinkui, Liu Wei.
Disposable medical gloves
Part 4. Anti-puncture test methods
1 Scope
This part of YY/T 0616 specifies the test conditions, test procedures and results report for the puncture resistance of disposable medical gloves.
This section applies to the evaluation of the puncture resistance of disposable medical gloves.
Note. The method given in this section is not designed to evaluate the ability of an anti-sharp device (such as an injection needle) to puncture.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 2941 Rubber Physical Testing Methods General Procedures for Sample Preparation and Regulation
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Puncture resistance punctureresistance
The ability of a medical glove to resist puncture is characterized by the force required to puncture the sample.
3.2
Puncture displacement puncturedeflection
The displacement produced by the puncture device starting to contact the sample to puncture the sample.
4 instruments
4.1 Thickness Gauge
The thickness gauge conforming to GB/T 2941 has an accuracy of 0.01 mm and is used to determine the thickness of the medical glove sample.
4.2 Testing machine
The following conditions should be met.
a) The specimen should be firmly fixed and the two clamps can move at a uniform rate;
b) capable of collecting data on the load as a function of displacement until the sample is punctured;
c) the error of the machine within its load range should not exceed ± 2%;
d) The compression unit should be configured. The compression unit of the test machine shall be capable of being connected to the upper and lower arms of the test machine. The compression unit should have enough
To penetrate the moving range of the sample.
4.3 Puncture device
4.3.1 The piercer should be manufactured to the dimensions shown in Figure 1. The puncturing device should be made of stainless steel with a Rockwell hardness of not less than 35.
Related standard:   YY/T 0616.3-2018  YY/T 0616.1-2016
   
 
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