NF EN 13795-1
NF EN 13795-1

NF EN 13795-1

January 2025
Standard Current

Surgical clothing and drapes - Requirements and test methods - Part 1 : surgical drapes and gowns

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Main informations

Collections

National standards and national normative documents

Publication date

January 2025

Number of pages

40 p.

Reference

NF EN 13795-1

ICS Codes

11.140   Hospital equipment

Classification index

S97-165-1

Print number

1

European kinship

EN 13795-1:2025
Replaced standards (1)
NF EN 13795-1
NF EN 13795-1
April 2019
Standard Cancelled
Surgical clothing and drapes - Requirements and test methods - Part 1 : surgical drapes and gowns

Le présent document spécifie les informations à fournir aux utilisateurs et aux vérificateurs tiers en plus de l'étiquetage usuel des dispositifs médicaux (voir la NF EN 1041 et la NF EN ISO 15223-1) concernant les exigences de fabrication et de traitement. Le présent document fournit des informations sur les caractéristiques des champs chirurgicaux et des casaques chirurgicales, qu'ils soient {usage unique ou réutilisables, utilisés en tant que dispositifs médicaux pour les patients, le personnel médical et les équipements et destinés {empêcher la transmission d'agents infectieux entre le personnel chirurgical et les patients au cours des interventions chirurgicales et autres interventions invasives. Le présent document spécifie les méthodes d'essai permettant d'évaluer les caractéristiques identifiées des champs et casaques chirurgicaux et établit des exigences de performance pour ces produits.

Table of contents
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences de performance
  • 5 Exigences et documentation de fabrication et de traitement
  • 6 Informations à fournir avec le produit
  • A Essais
  • B Justifications
  • C Informations relatives aux autres caractéristiques
  • D Effet sur l'environnement
  • E Recommandations aux utilisateurs pour la sélection des produits
  • ZA Relation entre la présente Norme européenne et les exigences générales en matière de sécurité et de performances concernées du Règlement (UE) 2017/745
  • Bibliographie
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