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ASTM D7161 - 16(2023)
ASTM International (ASTM)
Title

"Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions"

Description

This practice provides a study design for determining shelf life of medical gloves using product in its final packaging configuration that has been stored under typical warehouse conditions.

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
Physical
  • Physical
Thermal
  • Temperature
Standard References
Referenced Standard

ASTM D3577 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD357719(2023)) - Standard Specification for Rubber Surgical Gloves

ASTM D3578 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD357819(2023)) - Standard Specification for Rubber Examination Gloves

ASTM D5151 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD515119(2023)) - Standard Test method for detection of holes in medical gloves

ASTM D5250 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD525019(2023)) - Standard Specification for poly(vinyl chloride) gloves for medical application

ASTM D6319 - 19(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD631919(2023)) - Standard Specification for Nitrile Examination Gloves for Medical Application

ASTM D7160 - 16(2023)(https://wwwn.cdc.gov/PPEInfo/Standards/Info/ASTMD716016(2023)) - Standard Practice for Determination of Expiration Dating for Medical Gloves

Conformity Assessment Notes

This practice provides an accepted proecdure for performing an operation or function.  Please see the full standard for complete details. 

Comments

Additional References:

ASTM Standards

  • D412 Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
  • D3078 Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
  • D3577 Specification for Rubber Surgical Gloves
  • D3578 Specification for Rubber Examination Gloves
  • D5151 Test Method for Detection of Holes in Medical Gloves
  • D5250 Specification for Poly(vinyl chloride) Gloves for Medical Application
  • D6319 Specification for Nitrile Examination Gloves for Medical Application
  • D7160 Practice for Determination of Expiration Dating for Medical Gloves
  • F88 Test Method for Seal Strength of Flexible Barrier Materials
  • F1929 Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration

ISO Standard

  • ISO 2859 Sampling Procedures for Inspection by Attributes
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