ISO 8536-6:2016
Current
Current
The latest, up-to-date edition.
Infusion equipment for medical use — Part 6: Freeze drying closures for infusion bottles
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Language(s)
English
Published date
21-11-2016
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ISO 8536-6:2016 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, that is used in connection with the freeze-drying (or lyophilization) of drugs and biological materials.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this document are intended for single use only.
| DevelopmentNote |
Supersedes ISO/DIS 8536-6. (11/2016)
|
| DocumentType |
Standard
|
| Pages |
16
|
| PublisherName |
International Organization for Standardization
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| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DIN ISO 8536-6:2017-09 | Identical |
| NEN ISO 8536-6 : 2016 | Identical |
| DIN ISO 8536-6:2012-09 | Identical |
| BS ISO 8536-6:2016 | Identical |
| 00/560909 DC : DRAFT MAR 2000 | BS ISO 8871-2 - ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION |
| DIN EN ISO 8871-5:2015-08 (Draft) | ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING (ISO 8871-5:2016) |
| I.S. EN ISO 8871-5:2016 | ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING (ISO 8871-5:2016) |
| ISO 8871-5:2016 | Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 5: Functional requirements and testing |
| UNI EN ISO 8871-2 : 2014 | ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION |
| 15/30324254 DC : 0 | BS EN ISO 8871-5 - ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING |
| BS EN ISO 8871-1:2004 | Elastomeric parts for parenterals and for devices for pharmaceutical use Extractables in aqueous autoclavates |
| DIN EN ISO 8871-2:2014-08 | ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION (ISO 8871-2:2003 + AMD.1:2005) |
| I.S. EN ISO 8871-2:2004 | ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION (ISO 8871-2:2003) |
| BS EN ISO 8871-5:2016 | Elastomeric parts for parenterals and for devices for pharmaceutical use Functional requirements and testing |
| ISO 8871-2:2003 | Elastomeric parts for parenterals and for devices for pharmaceutical use Part 2: Identification and characterization |
| ISO 8871-1:2003 | Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 1: Extractables in aqueous autoclavates |
| EN ISO 8871-5:2016 | Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016) |
| EN ISO 8871-1:2004 | Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates (ISO 8871-1:2003) |
| UNE-EN ISO 8871-5:2017 | Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing (ISO 8871-5:2016) |
| BS EN ISO 8871-2 : 2004 | ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 2: IDENTIFICATION AND CHARACTERIZATION |
| DIN EN ISO 8871-5:2017-03 | ELASTOMERIC PARTS FOR PARENTERALS AND FOR DEVICES FOR PHARMACEUTICAL USE - PART 5: FUNCTIONAL REQUIREMENTS AND TESTING (ISO 8871-5:2016) |
| 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 15510:2014 | 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 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 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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