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Dastex Group GmbHDastex Group GmbH

Important certifications and tests for cleanroom gloves

Disposable gloves

Regulations / Norms Personal and product safety Personal safety Sterile
production 		Non-sterile
production 		Lot specific
Regulation (EU) 2016/425
of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC (Text with EEA relevance).
Conformity assessment procedures are classified into three risk categories: I, II and III 		■        
EN ISO 374-5:2016
Protective gloves against dangerous chemicals and micro-organisms – Part 5: Terminology and performance requirements for micro-organisms risks 		  ■      
EN 16523-1:2015+A1:2018 (replaces EN ISO 374-3)
Determination of material resistance to permeation by chemicals – Part 1: Permeation by potentially hazardous liquid chemicals under conditions of continuous contact
   ■      
EN 455-3:2015
Medical gloves for single use – Part 3: Requirements and testing for biological evaluation
5.3: The standard test for extractable proteins stipulates that a value below 50 µg/g cannot be indicated. The German Employers' Liability Insurance Association for Occupational Safety and Health (BGAG) requires a content of ≤ 30 µg/g for PPE latex gloves 		■        
EN 455-3:2015
Medical gloves for single use – Part 3: Requirements and testing for biological evaluation
5.1: LAL test for the detection of endotoxin levels / "low in endotoxins" 		  ■ ■   ■
EN 455-3:2015
Medical gloves for single use – Part 3: Requirements and testing for biological evaluation
5.2: Powder 		  ■ ■   ■
EN ISO 21171:2006
Medical gloves – Determination of removable surface powder 		  ■ ■   ■
EN ISO 11137-1:2020-04
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices 		    ■   ■
EN 455-2:2015
Medical gloves for single use – Part 2: Requirements and testing for physical properties 		■ ■ ■    
EN ISO 10993-10:2013
Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization 		  ■      
EN 16350:2014
Protective gloves – Electrostatic properties 		■ ■      
IEST-RP-CC005.4
Gloves and finger cots used in cleanrooms and other controlled environments
Tests of this Recommended Practice are provided for determining cleanliness, physical and chemical integrity, and other relevant properties. The RP covers barrier gloves, knitted or woven gloves (with or without barrier palms), and heat-resistant gloves. It includes tests for tensile properties, cut and abrasion resistance, barrier integrity, outgassing, static charge, particle release, extractable matter, micro-organisms, and others.		   ■ ■    
ASTM D6978-05(2019)
Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs*
*The standard was developed especially for the protection of persons handling cytostatic substances		 ■ ■ ■    

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