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UNI EN ISO 8536-2 : 2010

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

INFUSION EQUIPMENT FOR MEDICAL USE - PART 2: CLOSURES FOR INFUSION BOTTLES
Superseded date

02-05-2023

Published date

20-05-2010

PREMESSA
INTRODUZIONE
1 SCOPO E CAMPO DI APPLICAZIONE
2 RIFERIMENTI NORMATIVI
3 FORMA E DIMENSIONI
4 DESIGNAZIONE
5 MATERIALE
6 REQUISITI
7 ETICHETTATURA
APPENDICE A (normativa) - DETERMINAZIONE DEI FRAMMENTI
APPENDICE B (normativa) - DETERMINAZIONE DELLA FORZA DI
            PENETRAZIONE DEL PERFORATORE
APPENDICE C (normativa) - TENUTA/SIGILLABILITA DEL
            PERFORATORE
APPENDICE D (normativa) - DISPOSITIVO PER LA PERFORAZIONE
            DEL TAPPO
BIBLIOGRAFIA

This part of ISO 8536 specifies the shape, dimensions, material, performance requirements and labelling of closures for infusion bottles as specified in ISO 8536-1.

Committee
CT 44
DevelopmentNote
Bilingual (Italian + English) version issued in JULY 2011. (07/2011)
DocumentType
Standard
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Superseded
SupersededBy
Supersedes

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/TS 15510:2003 Stainless steels Chemical composition
ISO 8536-3:2009 Infusion equipment for medical use Part 3: Aluminium caps for infusion bottles
ISO 2230:2002 Rubber products — Guidelines for storage
ISO 3302-1:2014 Rubber — Tolerances for products — Part 1: Dimensional tolerances
ISO 15378:2017 Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
ISO 3302-2:2008 Rubber Tolerances for products Part 2: Geometrical tolerances
ISO 8871-5:2016 Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing
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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