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YY/T 0616.5-2019

Chinese Standard: 'YY/T 0616.5-2019'
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YY/T 0616.5-2019English249 Add to Cart Days<=3 Medical gloves for single use -- Part 5: Test method for permeation of chemicals under conditions of continuous contact Valid YY/T 0616.5-2019
YY/T 0616.5-2019Chinese18 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

   

BASIC DATA
Standard ID YY/T 0616.5-2019 (YY/T0616.5-2019)
Description (Translated English) Medical gloves for single use -- Part 5: Test method for permeation of chemicals under conditions of continuous contact
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C48
Classification of International Standard 11.140.01
Word Count Estimation 13,140
Date of Issue 2019-10-23
Date of Implementation 2020-10-01
Quoted Standard GB/T 2941; GB/T 6682
Drafting Organization Shandong Medical Device Product Quality Inspection Center, Shijiazhuang Hongrui Group Co., Ltd., Lanfan Medical Co., Ltd.
Administrative Organization Shandong Medical Equipment Product Quality Inspection Center
Regulation (derived from) Announcement of the State Drug Administration No. 84 of 2019
Proposing organization State Drug Administration
Issuing agency(ies) State Drug Administration
Summary This standard specifies the test conditions, test procedures, and results reports for disposable medical gloves that are resistant to penetration by liquid chemicals under continuous contact conditions. This section applies to the evaluation of chemical penetration resistance of disposable medical gloves.

YY/T 0616.5-2019
Medical gloves for single use-Part 5. Test method for permeation of chemicals under conditions of continuous contact
ICS 11.140.01
C48
People's Republic of China Pharmaceutical Industry Standard
Single-use medical gloves. Part 5.
Test method for continuous penetration resistance against chemicals
Published on October 23,.2019
2020-10-01 implementation
Published by the State Drug Administration
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.
Please note that some elements of this document may involve patents. The issuer of this document is not responsible for identifying these patents.
This section is proposed by the State Drug Administration.
This section is under the jurisdiction of Shandong Medical Device Product Quality Inspection Center.
This section was drafted by. Shandong Medical Device Product Quality Inspection Center, Shijiazhuang Hongrui Group Co., Ltd., Lanfan Medical Co., Ltd.
Limited company.
The main drafters of this section. Zhang Limei, Guo Lijuan, Sun Xingxia, Liu Guixi, Liu Wei, Wu Changyan, and Sun Yupeng.
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 article
Pieces. 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 colectionmedium
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.).
Related standard: YY/T 0616.7-2020
Related PDF sample: YY/T 0487-2010    YY/T 0471.5-2017