EN ISO 11608-5:2012
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012)
30-04-2013
01-10-2012
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Withdrawn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 |
| ONORM EN ISO 11608-5 : 2012 | Identical |
| DS EN ISO 11608-5 : 2012 | Identical |
| NEN EN ISO 11608-5 : 2012 | Identical |
| UNI EN ISO 11608-5 : 2013 | 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 |
| SN 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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