YY/T 0616.6-2021Medical gloves for single use - Part 6: Test method for assessment of resistance to permeation by chemotherapy drugs (English PDF)

Foreword

YY/T 0616 "Disposable Medical Gloves", consists of 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 expiration date with finished gloves in storage;

--- Part 4: Test method for puncture resistance;

--- Part 5: Test method for resistance to chemical penetration and continuous exposure;

--- Part 6: Test method for evaluating the permeability of anti-chemotherapy drugs;

--- Part 7: Immunological determination of antigenic protein content. This part is part 6 of YY/T 0616.

This section is drafted in accordance with the rules given in GB/T 1.1-2009.

Introduction

At work, medical staff may come into contact with some chemicals (such as various disinfectants, chemical sterilants, chemicals, etc.), causing various degrees of damage to the human body, such as acute trauma such as skin irritation or burns, as well as some chronic variable diseases sick. In order to avoid such hazards, products with corresponding protective properties (such as disposable medical gloves) are required, and the protection category (such as chemical Medical use) or protection level (such as level 1), so as to better guide medical staff to choose suitable products to wear for effective protection.

YY/T 0616.5 establishes a general test method for chemical penetration resistance of disposable medical glove materials. This section will give specific Application, that is, a test method for evaluating the anti-chemotherapy drug penetration performance of disposable medical glove materials.

1 Scope

This part of YY/T 0616 specifies the evaluation of anti-chemotherapy drug penetration performance of disposable medical gloves under continuous contact conditions. Test conditions, test procedures and report of results.

This section applies to single-use medical gloves intended for protection against chemotherapeutic drugs.

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 edition (including all amendments) applies to this document.

GB/T 2941 Rubber Physical Test Methods General Procedures for Specimen Preparation and Conditioning

YY/T 0616.5-2019 Disposable medical gloves-Part 5: Resistance to chemical penetration and continuous exposure test method

3 Terms and Definitions

The terms and definitions defined in YY/T 0616.5-2019 and the following terms and definitions apply to this document.

4 Method overview

4.1 The anti-chemotherapy drug penetration performance of disposable medical gloves is evaluated by measuring the breakthrough detection time of the drug passing through the gloves.

Add the tested chemotherapeutic drug solution to the challenge chamber of the penetration test pool, and add a suitable collection medium to the collection chamber (that is, the collection medium does not affect the test drug). permeability to substances such as water or other liquids). If the test drug can penetrate the test glove, after the drug has passed through the test material, it will continue to pass through, and its concentration The degree increases with time. The collection medium is sampled and quantitatively analyzed at specified time intervals to determine the chemotherapeutic agent in the collection medium content of the substance. According to the test method specified in YY/T 0616.5-2019, the breakthrough detection time and permeability are calculated from the drug content in the collection medium. penetration rate.

4.2 When evaluating the anti-chemotherapy drug penetration performance of disposable medical gloves, refer to Table A.1 in Appendix A to select 7 kinds of test drugs. and refer to Table A.2 to select at least 2 more representative clinical drugs.

5 Test device

Closed test test device and test method given in YY/T 0616.5-2019, for single-use medical gloves for anti-chemotherapy drugs Substance penetration test.