20/30382352 DC - BS EN ISO 11608-3. Needle-based injection systems for medical use. Requirements and test methods. Part 3. NIS containers and integrated fluid paths

20/30382352 DC

BS EN ISO 11608-3. Needle-based injection systems for medical use. Requirements and test methods. Part 3. NIS containers and integrated fluid paths

Status : Current, Draft for public comment   Published : February 2020

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This document specifies requirements and test methods for design verification of containers and integrated fluid paths to be used with Needle-Based Injection Systems (NIS) that fulfil the requirements of ISO 11608-1 (and other subparts as appropriate). It is applicable to single and multi-dose containers (either filled by the manufacturer [primary container closure] or by the end-user [reservoir]) and fluid paths that are integrated with the NIS at the point of manufacture.

NOTE

Prefilled syringes (ISO 11040-8) are included in the scope when used with a NIS; see also scope of ISO 11608-1:20xx.

Products excluded from scope are:

  • sterile hypodermic needles for single use;

  • sterile hypodermic syringes for single use;

  • sterile single-use syringes, with or without needle, for insulin;

  • containers that can be refilled multiple times;

  • containers intended for dental use;

  • catheters or infusion sets that are attached or assembled separately by the user.




Standard Number20/30382352 DC
TitleBS EN ISO 11608-3. Needle-based injection systems for medical use. Requirements and test methods. Part 3. NIS containers and integrated fluid paths
StatusCurrent, Draft for public comment
Publication Date28 February 2020
Normative References(Required to achieve compliance to this standard)ISO 7864:2016, ISO 9626:2016, ISO 10555-5:2013, ISO 21881:2019, ISO 10555-1:2013, ISO 11608-1, ISO 13926-3, ISO 13926-1, ISO 11040-8, ISO 11040-6, ISO 8872, ISO 11040-5, ISO 10993-17, ISO 80369-7, ISO 11040-4, ISO 11607-1, ISO 10993-11, ISO 13926-2
Informative References(Provided for Information)ISO 8537, ISO 8536-4, ISO 11608-6, ISO 7886-1, ISO 13485, ISO/TR 19244, ISO 10993-1, ISO 9000, ISO 10993-18
International RelationshipsISO/DIS 11608-3
Draft Expiry Date12 April 2020
DescriptorsSyringes, Performance testing, Medical equipment, Performance, Injection instruments, Design, Leak tests, Measuring cylinders, Medical instruments, Injection guns, Parenteral infusion equipment, Dimensions, Containers, Drug administration
ICS11.040.25
Title in FrenchSystèmes d'injection à aiguille pour usage médical -- Exigences et méthodes d'essai Partie 3: Conteneurs NIS et chemins de fluide intégrés
CommitteeCH/84
PublisherBSI
FormatA4
DeliveryYes
Pages34
File Size1.396 MB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


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