YY/T 0616.4-2018Medical glove for single use - Part 4: Test method for the puncturation resistance (English PDF)
一次性使用医用手套 第4部分：抗穿刺试验方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
December 20, 2018
Implementation date
January 1, 2020
Scope
YY/T 0616.4-2018 is the English-translated version of 一次性使用医用手套 第4部分：抗穿刺试验方法.
YY/T 0616.4-2018 is the Chinese pharmaceutical industry standard that gives the test for the puncture resistance of single-use medical gloves. It is the fourth part of the YY/T 0616 series and sets the test conditions, the procedure and the reporting: the probe and its geometry, the rate of penetration and the force recorded at puncture.
The method judges resistance to blunt puncture and is not designed to assess resistance to a sharp device such as a hypodermic needle. Issued on 20 December 2018, it has applied since 1 January 2020.
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Document preview — YY/T 0616.4-2018
National Standard of the People's Republic of China
- ICS
- 11.140
- Classification
- C 48
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Instruments
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.
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 document. 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
The ability of a medical glove to resist puncture is characterized by the force required to puncture the sample.
3.2 Puncture displacement
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.
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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 20 pages — is available in the English PDF.
Referenced standards
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Related Standards
GB/T 2941-2025 — Rubber - General procedures for preparing and conditioning test pieces for physical test methods
YY/T 0616.5-2019 — Medical gloves for single use - Part 5: Test method for permeation of chemicals under conditions of continuous contact
YY/T 0616.3-2018 — Medical gloves for single use - Part 3: Determination of real time expiration dating of mature medical gloves stored under typical warehouse conditions
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