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.

See more
View the extract
Main informations

Collections

National standards and national normative documents

Publication date

May 2015

Release date

novembre 2025 par NF EN 455-3 de 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
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
  • 1 Domaine d'application
  • 2 Références normatives
  • 3 Termes et définitions
  • 4 Exigences
  • 5 Méthodes d'essai
  • 6 Rapport d'essai
  • Annexe A 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 Méthodes immunologiques de dosage des allergènes du latex de caoutchouc naturel
  • Annexe C Analyse des aminoacides (AAA) par chromatographie liquide haute pression (CLHP)
  • Annexe ZA Relation entre la présente Norme européenne et les exigences essentielles de la Directive UE 93/42/CEE relative aux dispositifs médicaux
ZOOM ON ... the Requirements department
To comply with a standard, you need to quickly understand its issues in order to determine its impact on your activity.

The Requirements department helps you quickly locate within the normative text:
- mandatory clauses to satisfy,
- non-essential but useful clauses to know, such as permissions and recommendations.

The identification of these types of clauses is based on the document “ISO / IEC Directives, Part 2 - Principles and rules of structure and drafting of ISO documents ”as well as on a constantly enriched list of verbal forms.

With Requirements, quickly access the main part of the normative text!

With Requirements, quickly access the main part of the normative text!
What is the Redline format?
The Redline + service - standards comparator allows you to easily and simply identify major changes between the current standard and its last canceled version.

At a glance, you will be able to identify the additions, deletions or modifications to a text, table, figure and formula.
At a glance, you will be able to identify the additions, deletions or modifications to a text, table, figure and formula

The Redlines + service is offered to you on the collection of French standards in force, in French language and in HTML and PDF format.

For an overview of the service, click on View a standard in redline format
Need to identify, monitor and decipher standards?

COBAZ is the simple and effective solution to meet the normative needs related to your activity, in France and abroad.

Available by subscription, CObaz is THE modular solution to compose according to your needs today and tomorrow. Quickly discover CObaz!

Request your free, no-obligation live demo

I discover COBAZ