UNI EN ISO 8536-2 : 2010
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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INFUSION EQUIPMENT FOR MEDICAL USE - PART 2: CLOSURES FOR INFUSION BOTTLES
02-05-2023
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Superseded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 |
| Standards | Relationship |
| ONORM EN ISO 8536-2 : 2010 | Identical |
| ISO 8536-2:2010 | Identical |
| NEN EN ISO 8536-2 : 2010 | Identical |
| NF EN ISO 8536-2 : 2010 | Identical |
| SN EN ISO 8536-2:2010 | Identical |
| DIN EN ISO 8536-2:2010-08 | Identical |
| UNE-EN ISO 8536-2:2010 | Identical |
| NBN EN ISO 8536-2 : 2010 | Identical |
| EN ISO 8536-2:2010 | Identical |
| I.S. EN ISO 8536-2:2010 | Identical |
| BS EN ISO 8536-2:2010 | Identical |
| NS 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/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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