BS EN ISO 8871-2:2020 - Elastomeric parts for parenterals and for devices for pharmaceutical use. Identification and characterization

BS EN ISO 8871-2:2020

Elastomeric parts for parenterals and for devices for pharmaceutical use. Identification and characterization

Status : Current   Published : June 2020

Format
PDF

Format
HARDCOPY



This document specifies identification and characterization procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices.

The physical and chemical test procedures specified in this document permit the determination of the typical characteristics of elastomeric parts including coatings and surface treatments and can serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. Depending upon the type of elastomer and its application, an appropriate set of tests is selected.




Standard NumberBS EN ISO 8871-2:2020
TitleElastomeric parts for parenterals and for devices for pharmaceutical use. Identification and characterization
StatusCurrent
Publication Date08 June 2020
Normative References(Required to achieve compliance to this standard)ISO 2781:2018, ISO 247-1:2018, ISO 48-4, ISO 8871-1
Informative References(Provided for Information)ISO 3696, ISO 815-1, ISO 8362-5:2016, ISO 11999-1:2015, ISO 9924-1:2016, ISO 8536-6:2016
ReplacesBS EN ISO 8871-2:2004+A1:2014
International RelationshipsEN ISO 8871-2:2020,ISO 8871-2:2020
Draft Superseded By19/30384004 DC
DescriptorsDetermination of content, Syringes, Drug administration, Drug containers, Parenteral infusion equipment, Injection instruments, Medical equipment, Drugs, Synthetic rubber, Identification methods, Physical property measurement, Chemical analysis and testing, Natural rubber, Elastomers
ICS11.040.20
Title in FrenchÉléments en élastomère pour administration parentérale et dispositifs à usage pharmaceutique dentification et caractérisation
Title in GermanElastomere Teile für Parenteralia und für Geräte zur pharmazeutischen Verwendung Identifizierung und Charakterisierung
CommitteeCH/212
ISBN978 0 539 02555 2
PublisherBSI
FormatA4
DeliveryYes
Pages32
File Size1.111 MB
Price£186.00


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