PPE-Info - Standard Details

ASTM D6978 - 05(2023)

ASTM International (ASTM)

Title

"Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs"

Description

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.

Standard Type(s)

Practice

A definitive set of instructions for performing one or more specific operations that does not produce a test result: Examples of practices include, but are not limited to, application, assessments, cleaning, collection, decontamination, inspections, installation, preparation, sampling, screening, and training.

Personal Protective Equipment

Hand and Arm Protection

All equipment and/or accessories (whether or not detachable) designed and manufactured specifically to protect the arm and/or the hand this includes all garments protecting the hand or part of the hand, including gloves, fingerless gloves, mittens, garments protecting the fingers only or the palm only, etc. Potential hazards include skin absorption of harmful substances, chemical or thermal burns, electrical dangers, bruises, abrasions, cuts, punctures, fractures and amputations.

Medical gloves

Hazards

Chemical

Chemical

SOC Codes

29-0000 Healthcare Practitioners and Technical Occupations

29-2000 Health Technologists and Technicians
- 29-2012 Medical and Clinical Laboratory Technicians

Standard References

Referenced Standard

ASTM D3577 - 19(2023) - Standard Specification for Rubber Surgical Gloves

ASTM D3578 - 19(2023) - Standard Specification for Rubber Examination Gloves

ASTM D5250 - 19(2023) - Standard Specification for poly(vinyl chloride) gloves for medical application

ASTM D6319 - 19(2023) - Standard Specification for Nitrile Examination Gloves for Medical Application

ASTM D6977 - 19(2023) - Standard Specification for Polychloroprene Examination Gloves for Medical Application

Conformity Assessment Notes

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. Please see the full standard for complete details.

Comments

Additional References:

ASTM Standards

D471 Test Method for Rubber Property—Effect of Liquids
D3577 Specification for Rubber Surgical Gloves
D3578 Specification for Rubber Examination Gloves
D3767 Practice for Rubber—Measurement of Dimensions
D5250 Specification for Poly(vinyl chloride) Gloves for Medical Application
D6319 Specification for Nitrile Examination Gloves for Medical Application
D6977 Specification for Polychloroprene Examination Gloves for Medical Application
F739 Test Method for Permeation of Liquids and Gases through Protective Clothing Materials under Conditions of Continuous Contact

Testing Laboratories

ICS Laboratories, Inc - Brunswic, OH, 44212

Notes

A2LA ISO/IEC 17025

Contact

Phone Number: (330) 220-0515
Email: spfriem@icslabs.com

Accreditations

ISO 17025

Scope of Accreditation

ANSI/ISEA Z87.1-2020 , ASTM D120 - 22 , ASTM D5250 - 19(2023) , ASTM D6978 - 05(2023) , ASTM D7246 - 06(2021) , ASTM F1446 - 20 , ASTM F1383 - 20 , ASTM F1407 - 12(2017) , ASTM F1670 / F1670M - 17a , ASTM F1671 / F1671M - 22 , ASTM F739 - 20 , ASTM F903 - 18

Intertek - Cortland, NY, 13045

Contact

Phone Number: (607) 753-6711
Email: jason.allen@intertek.com

Accreditations

ISO 17025

Scope of Accreditation

ANSI/ISEA Z87.1-2020 , ASTM F2412 - 18a , ASTM D120 - 22 , ASTM D3577 - 19(2023) , ASTM D3578 - 19(2023) , ASTM D5250 - 19(2023) , ASTM D5712 - 15(2020) , ASTM D6319 - 19(2023) , ASTM D6978 - 05(2023) , ASTM D7246 - 06(2021) , ASTM F1446 - 20 , ANSI/AAMI PB70:2022 , ASTM F1342 / F1342M - 05(2022) , ASTM F1359 / F1359M - 22 , ASTM F1670 / F1670M - 17a , ASTM F1671 / F1671M - 22 , ASTM F1790 / F1790M - 15 (Reapproved 2021) , ASTM F2588 - 12(2020) , ASTM F739 - 20 , ASTM F903 - 18 , ASTM F1862 / F1862M - 17 , ASTM F2100 - 23 , ASTM F2101 - 23 , ASTM F2299 / F2299M - 24 , ANSI/AAMI PB70 - Class 4 , ANSI/AAMI PB70 - Class 3

Akron Rubber Development Laboratory, Inc. - Akron, OH, 44322-1016

Notes

Accredited Gloves Testing Methods ASTM Testing Methods

ASTM D6319 - Standard Specification for Nitrile Examination Gloves for Medical Application
ASTM D6978 - Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
ASTM D7558 - Colorimetric/Spectrophotometric Procedure to Quantify Extractable Chemical Dialkyldithiocarbamate, Thiuram and Mercaptobenzothiazole Accelerators in Natural Rubber Latex and Nitrile Gloves
ASTM D120 — Standard Specification for Rubber Insulating Gloves
ASTM D3577 — Standard Specification for Rubber Surgical Gloves
ASTM D3578 — Standard Specification for Rubber Examination Gloves
ASTM D5151 — Standard Test Method for Detection of Holes in Medical Gloves
ASTM D6124 — Standard Test Method for Residual Powder on Medical Gloves
ASTM D5250 - Standard Specification for Poly (Vinyl Chloride) Gloves for Medical Application
ARDL 2140 - Lubricant Compatibility Testing on Gloves
ASTM D5712 - Analysis of Aqueous Extractable Protein in Latex, Natural Robber and Elastomeric Products Using the Modified Lowry Method
ASTM D6499 - Immunological Measurement of Antigenic Protein in Natural Rubber and Its Products
ASTM F739 — Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact
ASTM F1383 - Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Intermittent Contact
ASTM F1670 - Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
ASTM F1671/F1671M — Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
ASTM F903 — Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Liquids
ASTM E96/E96M Water Vapor Transmission of Materials
ASTM D6977 — Standard Specification for Polychloroprene Examination Gloves for medical Application
ASTM D7246 — Standard Test Method for Detection of Holes in Polyethylene Food Service Gloves
ASTM D7329 — Standard Specification for Food Preparation and Food Handling Glove