EN ISO 8536-2:2010

Name: EN ISO 8536-2:2010
Brand: CEN

Withdrawn

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

Withdrawn date

09-30-2010

Published date

03-15-2010

Publisher

Comite Europeen de Normalisation

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.

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Status	Withdrawn

Standards	Relationship
ONORM EN ISO 8536-2 : 2010	Identical
DS EN ISO 8536-2 : 2010	Identical
ISO 8536-2:2010	Identical
UNE-EN ISO 8536-2:2010	Identical
NEN EN ISO 8536-2 : 2010	Identical
NBN EN ISO 8536-2 : 2010	Identical
PN EN ISO 8536-2 : 2010	Identical
NF EN ISO 8536-2 : 2010	Identical
I.S. EN ISO 8536-2:2010	Identical
SN EN ISO 8536-2:2010	Identical
BS EN ISO 8536-2:2010	Identical
NS EN ISO 8536-2 : 2010	Identical
DIN EN ISO 8536-2:2010-08	Identical
UNI EN ISO 8536-2 : 2010	Identical

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