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SNV - SN EN ISO 22413

Transfer sets for pharmaceutical preparations - Requirements and test methods

inactive
Organization: SNV
Publication Date: 1 June 2013
Status: inactive
Page Count: 26
ICS Code (Transfusion, infusion and injection equipment): 11.040.20
scope:

This International Standard applies to sterilized single use transfer sets that are used for pharmaceutical preparations.

Document History

SN EN ISO 22413
August 1, 2021
Transfer sets for pharmaceutical preparations - Requirements and test methods
This document specifies requirements and test methods for sterilized single-use transfer sets that are used for pharmaceutical preparations.
SN EN ISO 22413
June 1, 2013
Transfer sets for pharmaceutical preparations - Requirements and test methods
This International Standard applies to sterilized single use transfer sets that are used for pharmaceutical preparations.
SN EN ISO 22413
September 1, 2011
Transfer sets for pharmaceutical preparations - Requirements and test methods
This International Standard applies to sterilized single use transfer sets that are used for pharmaceutical preparations.

References

This document references:
ISO 8871-2 - Elastomeric parts for parenterals and for devices for pharmaceutical use — Part 2: Identification and characterization
Published by ISO on May 1, 2020
This document specifies identification and characterization procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices. The physical and...
This document references:
ISO 8871-5 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 5: Functional requirements and testing
Published by ISO on October 15, 2016
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...
This document references:
ISO 8871-4 - Elastomeric parts for parenterals and for devices for pharmaceutical use Part 4: Biological requirements and test methods
Published by ISO on June 15, 2006
A description is not available for this item.
This document references:
ISO 8871-3 - Elastomeric parts for parenterals and for devices for pharmaceutical use Part 3: Determination of released-particle count
Published by ISO on August 1, 2003
Elastomeric closures may be superficially contaminated with visible and subvisible particles, and fragments can also be produced when the closure is pierced by a needle. Such particles may be...
This document references:
ISO 8871-1 - Elastomeric parts for parenterals and for devices for pharmaceutical use Part 1: Extractables in aqueous autoclavates
Published by ISO on October 1, 2003
This part of ISO 8871 defines procedures for classifying elastomeric parts for primary packs and medical devices used in direct contact with preparations for parenteral use, including both aqueous...
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