NF EN ISO 22413

NF EN ISO 22413

August 2013
Standard Cancelled

Transfer sets for pharmaceutical preparations - Requirements and test methods

ISO 22413:2010 applies to sterilized single use transfer sets that are used for pharmaceutical preparations.

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Main informations

Collections

National standards and national normative documents

Publication date

August 2013

Number of pages

26 p.

Reference

NF EN ISO 22413

ICS Codes

11.040.20   Transfusion, infusion and injection equipment

Classification index

S93-201

Print number

1 - 05/08/2013

International kinship

ISO 22413:2010

European kinship

EN ISO 22413:2013
Sumary
Transfer sets for pharmaceutical preparations - Requirements and test methods

ISO 22413:2010 applies to sterilized single use transfer sets that are used for pharmaceutical preparations.

Replaced standards (1)
NF EN ISO 22413
August 2011
Standard Cancelled
Transfer sets for pharmaceutical preparations - Requirements and test methods

<p>ISO 22413:2010 applies to sterilized single use transfer sets that are used for pharmaceutical preparations.</p>

Standard replaced by (1)
NF EN ISO 22413
June 2021
Standard Current
Transfer sets for pharmaceutical preparations - Requirements and test methods

<p>This document specifies requirements and test methods for sterilized single-use transfer sets that are used for pharmaceutical preparations.</p>

Table of contents
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  • Avant-propos
    v
  • Introduction
    VI
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Conception et désignation
    1
  • 3.1 Conception
    1
  • 3.2 Conception d'un ensemble de transfert avec boîtier
    4
  • 3.3 Désignation
    4
  • 4 Matériaux
    4
  • 5 Exigences physiques
    5
  • 5.1 Contamination particulaire
    5
  • 5.2 Résistance à la traction
    5
  • 5.3 Étanchéité
    5
  • 5.4 Écoulement libre
    5
  • 5.5 Dispositif perforateur
    5
  • 5.6 Force de pénétration
    5
  • 5.7 Fragmentation
    6
  • 5.8 Prise d'air et sortie d'air
    6
  • 5.9 Capuchons protecteurs
    6
  • 5.10 Ensembles de transfert avec boîtier
    6
  • 5.11 Connecteur de type Luer
    6
  • 5.12 Filtre à particules
    6
  • 6 Exigences chimiques
    6
  • 7 Exigences biologiques
    6
  • 8 Essais des exigences physiques
    7
  • 8.1 Contamination particulaire
    7
  • 8.2 Résistance à la traction
    7
  • 8.3 Étanchéité de l'ensemble de transfert
    7
  • 8.4 Écoulement libre
    7
  • 8.5 Dispositif perforateur
    7
  • 8.6 Force de pénétration
    7
  • 8.7 Essais de fragmentation
    7
  • 8.8 Efficacité de la prise d'air et de la sortie d'air avec filtre à air
    7
  • 8.9 Efficacité des capuchons protecteurs
    8
  • 8.10 Connecteur de type Luer
    8
  • 8.11 Filtre à particules
    8
  • 9 Essais relatifs aux exigences chimiques
    8
  • 10 Essais relatifs aux exigences biologiques
    8
  • 11 Emballage
    8
  • 12 Stockage
    8
  • 13 Étiquetage
    8
  • 13.1 Présentation individuelle
    8
  • 13.2 Présentation en boite ou en emballage groupé
    9
  • Annexe A (normative) Essais de fragmentation d'ensembles de transfert munis de dispositifs perforateurs en plastique
    10
  • Annexe B (normative) Essais de fragmentation d'ensembles de transfert munis de dispositifs perforateurs en métal
    12
  • Bibliographie
    14
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