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

Standard No.
ISO 8536-2:2010
Release Date
2010
Published By
International Organization for Standardization (ISO)
Status
 2023-01
Replace By
ISO 8536-2:2023
Latest
ISO 8536-2:2023
Scope
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. The dimensional requirements are not applicable to barrier-coated closures. Closures specified in this part of ISO 8536 are intended for single use only.

ISO 8536-2:2010 Referenced Document

  • ISO 3302-1 Rubber - Tolerances for products - Part 1: Dimensional tolerances*2014-07-01 Update
  • ISO 3302-2 Rubber — Tolerances for products — Part 2: Geometrical tolerances*2022-05-23 Update
  • ISO 48 Rubber, vulcanized or thermoplastic - Determination of hardness (hardness between 10 IRHD and 100 IRHD)*2010-09-01 Update
  • ISO 7619-1 Rubber, vulcanized or thermoplastic - Determination of indentation hardness - Part 1: Durometer method (Shore hardness)*2010-10-01 Update
  • ISO 8536-1 Infusion equipment for medical use - Part 1: Infusion glass bottles*2011-09-01 Update
  • ISO 8536-3 Infusion equipment for medical use — Part 3: Aluminium caps for infusion bottles — Amendment 1*2022-06-16 Update
  • ISO 8871-1 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates
  • ISO 8871-4 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods

ISO 8536-2:2010 history

  • 2023 ISO 8536-2:2023 Infusion equipment for medical use — Part 2: Closures for infusion bottles
  • 2010 ISO 8536-2:2010 Infusion equipment for medical use - Part 2: Closures for infusion bottles
  • 2003 ISO 8536-2:2001/Cor 1:2003 Infusion equipment for medical use - Part 2: Closures for infusion bottles; Technical Corrigendum 1
  • 2001 ISO 8536-2:2001 Infusion equipment for medical use - Part 2: Closures for infusion bottles
  • 1992 ISO 8536-2:1992 Infusion equipment for medical use; part 2: closures for infusion bottles
Infusion equipment for medical use - Part 2: Closures for infusion bottles



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