I.S. 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 3: FINISHED CONTAINERS (ISO 11608-3:2012)
Hardcopy , PDF
English
01-01-2012
18-06-2022
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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.
| DocumentType |
Standard
|
| Pages |
23
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 11608-3 : 2012 | Identical |
| EN ISO 11608-3:2012 | Identical |
| NF EN ISO 11608-3 : 2012 | Identical |
| BS EN ISO 11608-3:2012 | Identical |
| NEN EN ISO 11608-3 : 2012 | Identical |
| ISO 11608-3:2012 | Identical |
| DIN EN ISO 11608-3:2013-01 | Identical |
| NS EN ISO 11608-3 : 2012 | Identical |
| NBN EN ISO 11608-3 : 2012 | Identical |
| UNE-EN ISO 11608-3:2013 | 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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