NF EN 455-3
NF EN 455-3

NF EN 455-3

May 2015
Standard Current
  • Free consultation authorized exceptionally by ISO and IEC in the context of the Covid-19 crisis

Medical gloves for single use - Part 3 : requirements and testing for biological evaluation

Le présent document spécifie les exigences permettant d'évaluer la sécurité biologique des gants médicaux à usage unique. Il mentionne les exigences d'étiquetage des gants et de diffusion des informations concernant les méthodes d'essai utilisées.

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Main informations

Collections

National standards and national normative documents

Publication date

June 2015

Number of pages

35 p.

Reference

NF EN 455-3

ICS Codes

11.100.20   Biological evaluation of medical devices
11.140   Hospital equipment
83.140.99   Other rubber and plastics products

Classification index

S97-001-3

Print number

1

European kinship

EN 455-3:2015
Sumary
Medical gloves for single use - Part 3 : requirements and testing for biological evaluation

Le présent document spécifie les exigences permettant d'évaluer la sécurité biologique des gants médicaux à usage unique. Il mentionne les exigences d'étiquetage des gants et de diffusion des informations concernant les méthodes d'essai utilisées.
Replaced standards (1)
NF EN 455-3
NF EN 455-3
February 2007
Standard Cancelled
Medical gloves for single use - Part 3 : requirements and testing for biological evaluation

Le présent document vient à l'appui des exigences essentielles de la Directive UE 93/42/CEE sur les dispositifs médicaux. La présente partie de l'EN 455 spécifie les exigences et essais permettant d'évaluer la sécurité biologique des gants médicaux à usage unique, ainsi que les exigences d'étiquetage des gants.

Table of contents
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  • Avant-propos
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences
  • 5 Méthodes d'essai
  • 6 Rapport d'essai
  • Annexe A (normative)Méthode de dosage des protéines extractibles en milieu aqueux contenues dans les gants à base de caoutchouc naturel par l'essai Lowry modifié
  • Annexe B (informative)Méthodes immunologiques de dosage des allergènes du latex de caoutchouc naturel
  • Annexe C (informative)Analyse des aminoacides (AAA) par chromatographie liquide haute pression (CLHP)
  • Annexe ZARelation entre la présente Norme européenne et les exigences essentielles de la Directive UE 93/42/CEErelative aux dispositifs médicaux
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