BS ISO 11040-6:2019 Prefilled syringes. Plastic barrels for injectables and sterilized subassembled syringes ready for filling

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BS ISO 11040-6:2019

Prefilled syringes. Plastic barrels for injectables and sterilized subassembled syringes ready for filling

Status : Current   Published : January 2019

Format
PDF

Format
HARDCOPY



What is this standard about?

This document specifies materials, dimensions, quality, and performance requirements, as well as test methods for polymer barrels and sterilized subassembled syringes ready for filling, intended for single use only.

This document also specifies those components that are part of the sterilized subassembled syringe ready for filling.

Polymer barrels and sterilized subassembled syringes ready for filling in accordance with this document are intended for single use only.

Components to complete the subassembled syringe, such as plunger and rod, are not specified in this document.

Prefilled syringes can be produced on dedicated and specifically designed processing equipment such as inline moulding and filling. This document does not apply but can be used also for such dedicated prefilled syringes.




Standard NumberBS ISO 11040-6:2019
TitlePrefilled syringes. Plastic barrels for injectables and sterilized subassembled syringes ready for filling
StatusCurrent
Publication Date11 January 2019
Cross ReferencesISO 7864:2016, ISO 9626, ISO 14971, ISO 8871-1, ISO 80369-1, ISO 10993-1, ISO 7886-1, ISO 80369-7, ISO 11040-4, ISO 13926-2, ISO 80369-20, ISO 7619-1, ISO 13485, ASTM D7210-06, ISO 17665-1, ISO 11040-7, ISO 3951 (all parts), ISO/IEC Guide 98-3, ISO 11137 (all parts), ISO 10993-7, ISO 11040-5, ISO 14644-1, ISO 15378, ISO 15747, ISO 2859-1, ISO 11135, ISO 14937, ISO 3826-1, AAMI ST72:2011
ReplacesBS ISO 11040-6:2012
International RelationshipsISO 11040-6:2019
Draft Superseded By17/30357741 DC
DescriptorsDisposable, Dimensions, Medical instruments, Syringes, Anaesthetic equipment, Injection instruments, Specification (approval)
ICS11.040.25
Title in FrenchSeringues préremplies Cylindres en plastique pour produits injectables et seringues pré-assemblées stérilisées préremplissables
CommitteeCH/212
ISBN978 0 580 97883 8
PublisherBSI
FormatA4
DeliveryYes
Pages62
File Size1.525 MB
Price£246.00


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