BS EN ISO 11608-3:2012
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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Needle-based injection systems for medical use. Requirements and test methods Finished containers
Hardcopy , PDF
11-10-2022
English
10-31-2012
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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
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.
| 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Superseded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 |
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).
| Standards | Relationship |
| ONORM EN ISO 11608-3 : 2012 | Identical |
| EN ISO 11608-3:2012 | Identical |
| NF EN ISO 11608-3 : 2012 | Identical |
| SN EN ISO 11608-3:2012 | Identical |
| UNI EN ISO 11608-3 : 2013 | Identical |
| NEN EN ISO 11608-3 : 2012 | Identical |
| I.S. EN ISO 11608-3:2012 | Identical |
| ISO 11608-3:2012 | Identical |
| DIN EN ISO 11608-3:2013-01 | Identical |
| UNE-EN ISO 11608-3:2013 | Identical |
| NS EN ISO 11608-3 : 2012 | Identical |
| NBN EN ISO 11608-3 : 2012 | Identical |
| 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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