YY/T 0616.5-2019Medical gloves for single use - Part 5: Test method for permeation of chemicals under conditions of continuous contact (English PDF)
一次性使用医用手套 第5部分:抗化学品渗透 持续接触试验方法
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
October 23, 2019
Implementation date
October 1, 2020
Scope
YY/T 0616.5-2019 is the English-translated version of 一次性使用医用手套 第5部分:抗化学品渗透 持续接触试验方法.
YY/T 0616.5-2019 is the Chinese pharmaceutical industry standard that gives the test method for the resistance of single-use medical gloves to permeation by liquid chemicals under continuous contact.
It is the fifth part of the YY/T 0616 series and sets the test conditions, the procedure and the reporting: the chemicals and their concentrations, the cell holding the glove material, the temperature and duration of exposure, the sampling of the collecting medium and the breakthrough time or permeation rate to be stated. Issued on 23 October 2019, it has applied since 1 October 2020.
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Document preview — YY/T 0616.5-2019
National Standard of the People's Republic of China
- ICS
- 11.140.01
- Classification
- C 48
Issued by: National Medical Products Administration of the People's Republic of China
Contents
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
Foreword
YY/T 0616 `` Disposable Medical Gloves '' is intended to be divided into the following parts.
--- Part 1. Biological evaluation requirements and tests;
--- Part 2. Requirements and tests for determining shelf life;
--- Part 3. Method for determining the actual time expiry date with the finished gloves in storage;
--- Part 4. Puncture resistance test method;
--- Part 5. Test method for continuous exposure to chemical penetration; This part is Part 5 of YY/T 0616.
This section is drafted in accordance with the rules given in GB/T 1.1-2009.
Introduction
Medical workers may be exposed to chemicals that are harmful to healthy people at work (such as various disinfectants, chemical sterilants, Chemicals, etc.), causing various levels of harm to the human body, such as acute trauma such as skin irritation and burns, and chronic diseases such as cancer Variant disease. To avoid such hazards, medical personnel need to wear products with appropriate protective properties (such as medical gloves) to achieve effective The purpose of protection.
The penetration of chemicals into protective product materials usually includes two forms. penetration and permeation, both of which The mechanism is completely different. The permeation tests in this section are based on the permeation mechanism (see 4.1). Penetration is when a substance passes through the medicine at a non-molecular level Use the movement of the voids in the glove material (including joint gaps, incomplete seals, and/or holes, holes, etc. in the material itself). Needless to penetrate The state changes, that is, the solid chemical passes through the voids of the material in a solid state, the liquid passes in a liquid state, and the gas passes in a gas state.
At present, European and American countries require such protective gloves to indicate the type of protection (such as chemotherapy) or protection level (Such as level 1). A set of chemical resistance test equipment for medical gloves and a standard test method established in this section can be used to evaluate medical The resistance of gloves to liquid chemicals can better guide medical staff to choose suitable products for effective protection.
This section establishes a general test method for chemical resistance of medical glove materials.It will give a specific application, that is, determine the resistance of medical glove materials to chemotherapy. Test method for drug permeability. Single-use medical gloves. Part 5. Test method for continuous penetration resistance against chemicals
1 Scope
This part of YY/T 0616 specifies the test of resistance to the penetration of liquid chemicals by disposable medical gloves under continuous exposure Test conditions, test procedures and results report.
This section applies to the evaluation of chemical penetration resistance of disposable medical gloves.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this document. For undated references, the latest version (including all amendments) applies to this document.
GB/T 2941 Rubber physical test method General procedure for sample preparation and adjustment
GB/T 6682 Analytical laboratory water specifications and test methods
3 Terms and definitions
The following terms and definitions apply to this document.
3.1 Breakthrough detection time
The time elapsed from the start of exposure to the test chemical to the first detection of the test chemical.
Note. The breakthrough detection time depends on the sensitivity of the method.
3.2 Standardizedbreakthroughtime
Time when the permeation rate reaches 0.1 µg/(cm2 · min).
3.3 Steady-state permeation
When chemicals are in continuous contact and all influencing infiltration factors have reached equilibrium, a constant velocity infiltration is formed after the breakthrough.
3.4 Collection medium
A liquid that can absorb, adsorb, dissolve, suspend, or capture test chemicals without affecting the detection of penetrating chemicals.
3.5 Cumulative permeation
The total amount of chemicals that penetrated a specific area of glove material from the time the material began to contact the test chemicals to a specific time.
3.6 Degradation
Harmful changes in one or more properties of the glove material.
Note. Usually the most concerned is the change of physical properties (such as swelling, etc.).
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 18 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
GB/T 6682-2008 — Water for analytical laboratory use - Specification and test methods
YY/T 0616.6-2021 — Medical gloves for single use - Part 6: Test method for assessment of resistance to permeation by chemotherapy drugs
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YY/T 0616.5-2019
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