NF EN ISO 8536-2

NF EN ISO 8536-2

August 2010
Standard Cancelled

Infusion equipment for medical use - Part 2 : closures for infusion bottles

ISO 8536‑2:2010 specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1.The dimensional requirements are not applicable to barrier-coated closures.Closures specified in ISO 8536‑2:2010 are intended for single use only.

See more
View the extract
Main informations

Collections

National standards and national normative documents

Publication date

August 2010

Number of pages

20 p.

Reference

NF EN ISO 8536-2

ICS Codes

11.040.20   Transfusion, infusion and injection equipment

Classification index

S93-123-2

Print number

1 - 12/08/2010

International kinship

ISO 8536-2:2010

European kinship

EN ISO 8536-2:2010
Sumary
Infusion equipment for medical use - Part 2 : closures for infusion bottles

ISO 8536‑2:2010 specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1.

The dimensional requirements are not applicable to barrier-coated closures.

Closures specified in ISO 8536‑2:2010 are intended for single use only.

Replaced standards (1)
NF EN ISO 8536-2
January 2003
Standard Cancelled
Infusion equipment for medical use - Part 2 : closures for infusion bottles

Le présent document prescrit la conception, les dimensions et les exigences de performance des bouchons pour flacons de perfusion à usage unique ainsi que les matériaux à partir desquels ils peuvent être fabriqués et les essais auxquels ils doivent être soumis.

Standard replaced by (1)
NF EN ISO 8536-2
February 2023
Standard Current
Infusion equipment for medical use - Part 2 : closures for infusion bottles

This document specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this document are intended for single use only. NOTE       The potency, purity, stability and safety of a medicinal product during its manufacture and storage can strongly be affected by the nature and performance of the primary packaging.

Table of contents
  • Avant-propos
    iv
  • Introduction
    v
  • 1 Domaine d'application
    1
  • 2 Références normatives
    1
  • 3 Formes et dimensions
    2
  • 4 Désignation
    3
  • 5 Matériau
    3
  • 6 Exigences
    3
  • 6.1 Généralités
    3
  • 6.2 Exigences physiques
    3
  • 6.3 Exigences chimiques
    4
  • 6.4 Exigences biologiques
    4
  • 7 Étiquetage
    4
  • Annexe A (normative) Essai de fragmentation
    5
  • Annexe B (normative) Détermination de la force de perforation du trocart
    7
  • Annexe C (normative) Tenue du trocart et étanchéité autour du trocart
    9
  • Annexe D (normative) Dispositif de perçage du bouchon
    11
  • Bibliographie
    12
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!
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