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Elastomeric parts for parenterals and for devices for pharmaceutical use - Functional requirements and testing

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Description

Elastomeric parts for parenterals and for devices for pharmaceutical use - Functional requirements and testing1 Scope This part of ISO 8871 specifies requirements and test methods for functional parameters of elastomeric closures used in combination with vials and when pierced by an injection needle. NOTE Functional testing with spikes is specified in ISO 8536 2 and in ISO 8536 6.

PD CEN/TR 16798-8 accompanies the suite of EPB standards on thermal transmission properties of building elements

BS ISO/IEC TR 13335-4:2000 provides guidance on the selection of safeguards

Telecommunications cabling (e

Requirements for pressure testing

provides mechanical support

ISO/IEC 27001:2013 rather than the previous edition (ISO/IEC 27001:2005)

reactive silicon dioxide and the limits for phosphate

13 Test report

which may be different to the methods referred to here

with the agreement of the relevant parties it can be used to guide the maintenance or any modification of existing vessels

Indeed the different means available to reduce these risks are a matter for the technical information to which the manufacturer may resort

BS EN 12574-3 provides manufacturers with the necessary information and health and safety checks to be performed on the containers

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