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List of Medical Device and Implant Standards

427 standards

American National Standards Institute Inc.

  • ASTM E1280 – Standard Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell Mutagenicity (Withdrawn 2015)

  • ASTM E1299 – Standard Specification for Reusable Phase-Change-Type Fever Thermometer for Intermittent Determination of Human Temperature

  • ASTM E1262 – Standard Guide for Performance of Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay

  • ASTM E1263 – Standard Guide for Conduct of Micronucleus Assays in Mammalian Bone Marrow Erythrocytes (Withdrawn 2015)

  • ASTM E1202 – Standard Guide for Development of Micronucleus Assay Standards (Withdrawn 2013)

  • ASTM E1104 – Standard Specification for Clinical Thermometer Probe Covers and Sheaths

  • ASTM E1112 – Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature

  • ASTM E1061 – Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers

  • ASTM D8419 – Standard Specification for Anesthesia Reservoir Bags

  • ASTM D8389 – Standard Performance Specification for Urinary Intermittent Catheters

  • ASTM D8238 – Standard Test Method for Immunological Assay to Quantify Extractable Guayule Natural Rubber (GNR) Proteins

  • ASTM D7907 – Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves

  • ASTM D7866 – Standard Specification for Radiation Attenuating Protective Gloves

  • ASTM D7850 – Standard Specification for Biological Properties of Industry Reference Materials (IRM)

  • ASTM D7661 – Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms

  • ASTM D7558 – Standard Test Method for Colorimetric/Spectrophotometric Procedure to Quantify Extractable Chemical Dialkyldithiocarbamate, Thiuram, and Mercaptobenzothiazole Accelerators in Natural Rubber Latex and Nitrile Gloves

  • ASTM D7427 – Standard Test Method for Immunological Measurement of Four Principal Allergenic Proteins (Hev b 1, 3, 5 and 6.02) in Hevea Natural Rubber and Its Products Derived from Latex

  • ASTM D7329 – Standard Specification for Food Preparation and Food Handling (Food Service) Gloves

  • ASTM D7246 – Standard Test Method for Detection of Holes in Polyethylene Food Service Gloves

  • ASTM D7198 – Standard Specification for Disposable Embalming Gloves for Single-Use Applications

  • ASTM D7160 – Standard Practice for Determination of Expiration Dating for Medical Gloves

  • ASTM D7161 – Standard Practice for Determination of Real Time Expiration Dating of Mature Medical Gloves Stored Under Typical Warehouse Conditions

  • ASTM D7102 – Standard Guide for Determination of Endotoxin on Sterile Medical Gloves

  • ASTM D7103 – Standard Guide for Assessment of Medical Gloves

  • ASTM D6977 – Standard Specification for Polychloroprene Examination Gloves for Medical Application

  • ASTM D6978 – Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs

  • ASTM D6976 – Standard Specification for Rubber Contraceptives—Vaginal Diaphragms

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