Elastomeric parts for parenterals and for devices for pharmaceutical use - Biological requirements and test methods Ingestion-build-146508 • bushings applied with gaseous

• bushings applied with gaseous insulation (other than air at atmospheric pressure) external to the bushing

the ignition risk assessment

It also provides a means of preparation of calibration gas mixtures at pressures above barometric pressure

This European Standard does not specify requirements for the validation and routine control of sterilization by moist heat

Deposition onto horizontal surfaces is relevant to the assessment of the risk of contamination of

Elastomeric parts for parenterals and for devices for pharmaceutical use - Biological requirements and test methods Ingestion-build-146508 • bushings applied with gaseous1 Scope This part of ISO 8871 specifies biological requirements for elastomeric parts for parenterals and for devices for pharmaceutical use. It also specifies the test methods, i. e. it offers the extraction procedures for elastomeric parts, and it makes reference to relevant biological test instructions in Pharmacopoeias and standards.