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  • Abstract:
    This document provides requirements for label information about chemicals used in product manufacture, particularly potentially allergenic substances employed and remaining in medical gloves. It also provides information on extraction media, methods of extraction and quantitative assay of residual chemicals. This document does not provide information on the allergenic potential or safety to the user of any product. This should be assessed in the light of all available toxicity and biocompatibility data on the products concerned as part of a risk management process.
  • Document number:
    DIN EN 455-5
  • Issuing date:
  • Document type:
  • Title:
    Medical gloves for single use - Part 5: Extractable chemical residues; German and English version prEN 455-5:2023
  • Author:
    DIN Standards Committee Health Technologies
  • Search term:
    Chemical residues; Chemicals; Definitions; Disposable; Disposable gloves; Extractable; Latices; Marking; Marking of roads; Medical; Medical equipment; Occupational safety; Protective clothing; Specification (approval); Surgical gloves; Testing
  • Application areas:
    09.10 Medizinische Produkte; 30.35 Hand- und Armschutz
  • Hazards:
    AB Terminologische Festlegungen in Normen mit Arbeitsschutzbezug; AC Mess- und Prüfverfahren für die Ermittlung von Belastungen und Gefährdungen; BD Allergene
  • ICS:
    11.140 Hospital equipment
  • Price:
    115,20 EUR
  • Identical with:
    prEN 455-5(2023-04)<IDT>
  • Update flag:
  • Deadline for comments: