ISO 8536-6:2016
Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles

Standard No.
ISO 8536-6:2016
Release Date
2016
Published By
International Organization for Standardization (ISO)
Latest
ISO 8536-6:2016

ISO 8536-6:2016 Referenced Document

  • ISO 15378:2015 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
  • ISO 15510:2014 Stainless steels - Chemical composition
  • ISO 2230:2002 Rubber products - Guidelines for storage
  • 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 7619-1:2010 Rubber, vulcanized or thermoplastic - Determination of indentation hardness - Part 1: Durometer method (Shore hardness)
  • ISO 8536-1:2011 Infusion equipment for medical use - Part 1: Infusion glass bottles
  • ISO 8536-3:2009 Infusion equipment for medical use - Part 3: Aluminium caps for infusion bottles
  • ISO 8871-1:2003 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates
  • ISO 8871-4:2006 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods
  • ISO 8871-5:2016 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing

ISO 8536-6:2016 history

  • 2016 ISO 8536-6:2016 Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles
  • 2009 ISO 8536-6:2009 Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles
  • 1995 ISO 8536-6:1995 Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles
Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles



Copyright ©2023 All Rights Reserved