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DS/EN ISO 8871

Elastomeric parts for aqueous parenteral preparations

inactive
Organization: DS
Publication Date: 30 September 1997
Status: inactive
ICS Code (Transfusion, infusion and injection equipment): 11.040.20
scope:

This Standard specifies a series of comparative test methods for chemical and biological evaluation (see clause 6) and describes the various fields of application for elastomeric parts. Dimensions and functional characteristics are specified in the relevant international Standards.

Document History

DS/EN ISO 8871/A1
September 13, 1999
Elastomeric parts for aqueous parenteral preparations
This standard defines procedures for identifying and classifying elastomeric parts for primary packs and medical devices used in direct contact with aqueous preparations for parenteral use including...
DS/EN ISO 8871
September 30, 1997
Elastomeric parts for aqueous parenteral preparations
This Standard specifies a series of comparative test methods for chemical and biological evaluation (see clause 6) and describes the various fields of application for elastomeric parts. Dimensions...

References

This document is replaced by:
DS/EN ISO 8871-3 - Elastomeric parts for parenterals and for devices for pharmaceuticals use - Part 3: Determination of released-particle count
Published by DS on November 22, 2004
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 is replaced by:
DS/EN ISO 8871-4 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 4: Biological requirements and test methods
Published by DS on August 21, 2006
This part of ISO 8871-4 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...
This document is replaced by:
DS/EN ISO 8871-1 - Elastomeric parts for parenterals and for devices for pharmaceutical use - Part 1: Extractables in aqueous autoclavates
Published by DS on February 17, 2005
This standard defines procedures for classifying elastomeric parts for primary packaging and medical devices used in direct contact with preparations for parenteral use, including both aqueous...
This document is replaced by:
DS/EN ISO 8871-2 - Elastomeric parts for parenterals and for devices for pharmaceutical use – Part 2: Identification and characterization (ISO 8871-2:2020)
Published by DS on June 8, 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...
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