ASTM D6978-05 - 1.4.2005
 
Significance and Use

The objective of this practice is to provide a uniform procedure for assessing the resistance of medical glove materials to permeation by chemotherapy drugs, and to establish a consistent reporting of the test data.

 
1. Scope

1.1 This practice covers a protocol for the assessment of resistance of medical glove materials to permeation by potentially hazardous cancer chemotherapy drugs under conditions of continuous contact. An assessment is made based on the permeation (breakthrough) of nine chemotherapy drugs through the glove material over a certain period of time.

1.2 It is emphasized that the conditions used in this assessment are intended to approximate the worst-case condition for clinical uses. The data should be restricted to use on a relative basis when comparing glove materials.

This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

 
2. Referenced Documents

D471-16a(2021)

Standard Test Method for Rubber Property—Effect of Liquids (Includes all amendments and changes 6/25/2021).

D3577-19(2023)

Standard Specification for Rubber Surgical Gloves

D3578-19(2023)

Standard Specification for Rubber Examination Gloves

D3767-03(2020)

Standard Practice for Rubber´Measurement of Dimensions

D5250-19(2023)

Standard Specification for Poly(vinyl chloride) Gloves for Medical Application

D6319-19(2023)

Standard Specification for Nitrile Examination Gloves for Medical Application

D6977-19(2023)

Standard Specification for Polychloroprene Examination Gloves for Medical Application

F739-20

Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact