ISO 21881:2019 PDF

Scope: This document specifies the characteristics of sterile and ready for filling empty glass cartridges for injectable preparations, including the minimum requirements of materials, packaging systems and analytical test methods.

ISO 21881:2019 Referenced Document

ISO 10993-7 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals; Technical Corrigendum 1
ISO 11607-1 Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems — Amendment 1
ISO 11608-3:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers
ISO 13926-1:2018 Pen systems - Part 1: Glass cylinders for pen-injectors for medical use
ISO 720 Glass — Hydrolytic resistance of glass grains at 121 °C — Method of test and classification*， 2020-09-11 Update
ISO 8871-1 Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates