BS EN ISO 8871-3:2004+A1:2019 Elastomeric parts for parenterals and for devices for pharmaceutical use. Determination of released-particle count

BS EN ISO 8871-3:2004+A1:2019

Elastomeric parts for parenterals and for devices for pharmaceutical use. Determination of released-particle count

Status : Current, Under review   Published : June 2004

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What is this standard about?

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 transferred to pharmaceutical preparations in contact with the elastomeric parts and affect the quality of such preparations.

This part of ISO 8871 specifies methods for the determination of the number of visible and subvisible particles, respectively, detached from elastomeric parts by rinsing.

It does not specify particle contamination limits. These will have to be agreed upon between manufacturer and user.




Standard NumberBS EN ISO 8871-3:2004+A1:2019
TitleElastomeric parts for parenterals and for devices for pharmaceutical use. Determination of released-particle count
StatusCurrent, Under review
Publication Date09 June 2004
Normative References(Required to achieve compliance to this standard)ISO 3696:1997
Informative References(Provided for Information)ISO 14644?1
ReplacesBS EN ISO 8871:1997
International RelationshipsISO 8871-3:2003/Amd 1:2018
Amended ByAmendment, April 2019
Draft Superseded By17/30359938 DC
DescriptorsAcidimetry, Marking, Turbidimetry, Sterilization (hygiene), Infrared radiation, Determination of content, Heavy, Storage, Elastomers, Drug administration, Natural rubber, Electro-analytical methods, Zinc, Medical equipment, Non-volatile matter determination, Electrical conductivity, Halides, Ammonia, Reagent solutions, Sulfides, Volatile matter determination, Metals, Injection instruments, Ultraviolet radiation, Reducing agents, Syringes, Alkalinity, Spectrophotometry, Synthetic rubber, Parenteral infusion equipment, Drugs, Aqueous extraction methods
ICS11.040.20
Title in FrenchÉléments en élastomère pour administration parentérale et dispositifs à usage pharmaceutique Détermination des particules libérées
Title in GermanElastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung Bestimmung von herausgelösten Partikeln
CommitteeCH/212
ISBN978 0 580 98392 4
PublisherBSI
FormatA4
DeliveryYes
Pages14
File Size398 KB
Price£112.00


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