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