ISO 13926-3:2019 PDF

Scope: This document specifies the shape, dimensions, material, performance requirements and labelling of seals for pen-injectors for medical use. NOTE The potency, purity, stability and safety of a medicinal product during its manufacture and storage can be significantly affected by the nature and performance of the primary packaging.

ISO 13926-3:2019 Referenced Document

ISO 11608-3 Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths*， 2022-04-07 Update
ISO 13926-1 Pen systems - Part 1: Glass cylinders for pen-injectors for medical use
ISO 13926-2 Pen systems - Part 2: Plunger stoppers for pen-injectors for medical use
ISO 48-4 Rubber, vulcanized or thermoplastic - Determination of hardness - Part 4: Indentation hardness by durometer method (Shore hardness)
ISO 7864 Sterile hypodermic needles for single use - Requirements and test methods
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 8871-5:2016 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing
ISO 8872 Aluminium caps and aluminium/plastic caps for infusion bottles and injection vials — General requirements and test methods*， 2022-11-15 Update

2019 ISO 13926-3:2019 Pen systems — Part 3: Seals for pen-injectors for medical use
2012 ISO 13926-3:2012 Pen systems - Part 3: Seals for pen-injectors for medical use