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CEN
EN ISO 11608-3:2012

EN ISO 11608-3:2012

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012)

Superseded date

30-05-2022

Published date

01-10-2012

Publisher

Comite Europeen de Normalisation

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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Test methods
6 Information supplied by the manufacturer
Bibliography

This part of ISO 11608 specifies the functional and design considerations for containers to be used withneedle-based injection systems (NIS) that fulfil the specifications of ISO 11608-1. It is applicable to single andmulti-dose containers (either filled by the manufacturer or by the end-user) which can be provided to the enduserintegrated in the NIS or assembled with the NIS at the time of use.This part of ISO 11608 includes specifications and test methods to describe and evaluate cartridges for usein NIS with pen needles (as defined in ISO 11608-2) and outlines design considerations for other potentialcontainers, including syringes to be used with a NIS.This part of ISO 11608 is not applicable to cartridges intended for dental use.Syringes and needles that are sold separately and not intended for use in a NIS are outside the scope of thispart of ISO 11608.NOTE See ISO 7864 (needles), ISO 8537 (insulin syringes) and ISO 7886-1 (manual syringes).

Committee
CEN/TC 205
DocumentType
Standard
PublisherName
Comite Europeen de Normalisation
Status
Superseded

03/113382 DC : DRAFT SEP 2003 BS EN ISO 21649 - NEEDLE-FREE INJECTORS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS

ISO 13926-1:2004 Pen systems Part 1: Glass cylinders for pen-injectors for medical use
ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
ISO 11608-1:2014 Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems
ISO 11040-3:2012 Prefilled syringes — Part 3: Seals for dental local anaesthetic cartridges
ISO 11608-2:2012 Needle-based injection systems for medical use Requirements and test methods Part 2: Needles
ISO 7886-1:2017 Sterile hypodermic syringes for single use — Part 1: Syringes for manual use
ISO 13926-2:2011 Pen systems Part 2: Plunger stoppers for pen-injectors for medical use
ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
ISO 9000:2015 Quality management systems — Fundamentals and vocabulary

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