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BS EN ISO 11608-3:2012

BS 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Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

View Superseded by
superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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

Available format(s)

Hardcopy , PDF

Superseded date

11-10-2022

Language(s)

English

Published date

10-31-2012

Publisher

British Standards Institution

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

Describes the functional and design considerations for containers to be used with needle-based injection systems (NIS) that fulfil the specifications of ISO 11608-1.

This part of ISO11608 specifies the functional and design considerations for containers to be used with needle-based injection systems (NIS) that fulfil the specifications of ISO11608-1. It is applicable to single and multi-dose containers (either filled by the manufacturer or by the end-user) which can be provided to the end-user integrated in the NIS or assembled with the NIS at the time of use.

This part of ISO11608 includes specifications and test methods to describe and evaluate cartridges for use in NIS with pen needles (as defined in ISO11608-2) and outlines design considerations for other potential containers, including syringes to be used with a NIS.

This part of ISO11608 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 this part of ISO11608.

NOTE See ISO7864 (needles), ISO8537 (insulin syringes) and ISO7886-1 (manual syringes).

Committee
CH/84
DevelopmentNote
Supersedes 97/563389 DC. (03/2005) Supersedes 10/30208782 DC. (10/2012)
DocumentType
Standard
Pages
20
PublisherName
British Standards Institution
Status
Superseded
SupersededBy
Supersedes

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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Hardcopy - English
PDF - English
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