EN ISO 11608-5:2012
Withdrawn
Withdrawn
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)
Published date
10-01-2012
Publisher
Withdrawn date
04-30-2013
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ISO 11608-5:2012 specifies requirements and test methods for the automated functions of needle-based injection systems with automated functions (NIS-AUTO), for the administration of medicinal products in humans.
| Committee |
CEN/TC 205
|
| DevelopmentNote |
Supersedes PREN ISO 11608-5. (10/2012)
|
| DocumentType |
Standard
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Standards | Relationship |
| DS EN ISO 11608-5 : 2012 | Identical |
| NEN EN ISO 11608-5 : 2012 | Identical |
| NS EN ISO 11608-5 : 2012 | Identical |
| ISO 11608-5:2012 | Identical |
| BS EN ISO 11608-5:2012 | Identical |
| I.S. EN ISO 11608-5:2012 | Identical |
| NBN EN ISO 11608-5 : 2012 | Identical |
| DIN EN ISO 11608-5:2013-01 | Identical |
| PN EN ISO 11608-5 : 2013 | Identical |
| NF EN ISO 11608-5 : 2012 | Identical |
| UNE-EN ISO 11608-5:2013 | Identical |
| ISO 11608-4:2006 | Pen-injectors for medical use — Part 4: Requirements and test methods for electronic and electromechanical pen-injectors |
| ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin |
| ISO 14253-1:2017 | Geometrical product specifications (GPS) — Inspection by measurement of workpieces and measuring equipment — Part 1: Decision rules for verifying conformity or nonconformity with specifications |
| 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 |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| ISO 11608-2:2012 | Needle-based injection systems for medical use — Requirements and test methods — Part 2: Needles |
| ISO 11608-3:2012 | Needle-based injection systems for medical use — Requirements and test methods — Part 3: Finished containers |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 23908:2011 | Sharps injury protection — Requirements and test methods — Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO/IEC Guide 98-3:2008 | Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) |
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