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CEN
EN ISO 8536-2:2010

EN ISO 8536-2:2010

Withdrawn

Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Infusion equipment for medical use - Part 2: Closures for infusion bottles (ISO 8536-2:2010)

Withdrawn date

30-09-2010

Published date

15-03-2010

Publisher

Comite Europeen de Normalisation

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Foreword
Introduction
1 Scope
2 Normative references
3 Shape and dimensions
4 Designation
5 Material
6 Requirements
7 Labelling
Annex A (normative) - Determination of fragments
Annex B (normative) - Determination of spike penetration
        force
Annex C (normative) - Spike retention/sealability
Annex D (normative) - Closure piercing device
Bibliography

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.

Committee
CEN/BT
DevelopmentNote
Supersedes PREN ISO 8536-2. (11/2010)
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Withdrawn

ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates
ISO 7619-1:2010 Rubber, vulcanized or thermoplastic Determination of indentation hardness Part 1: Durometer method (Shore hardness)
ISO 8536-3:2009 Infusion equipment for medical use — Part 3: Aluminium caps for infusion bottles
ISO 3302-1:2014 Rubber — Tolerances for products — Part 1: Dimensional tolerances
ISO 3302-2:2008 Rubber Tolerances for products Part 2: Geometrical tolerances
ISO 48:2010 Rubber, vulcanized or thermoplastic Determination of hardness (hardness between 10 IRHD and 100 IRHD)
ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements and test methods
ISO 8536-1:2011 Infusion equipment for medical use Part 1: Infusion glass bottles

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