ISO 11608-5:2012
Withdrawn
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions
Available format(s)
Hardcopy , PDF
Language(s)
French, English
Published date
20-09-2012
Withdrawn date
09-04-2025
Superseded by
€63.00
Excluding VAT
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 |
ISO/TC 84
|
| DevelopmentNote |
Supersedes ISO/DIS 11608-5. (09/2012)
|
| DocumentType |
Standard
|
| Pages |
17
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| DS EN ISO 11608-5 : 2012 | Identical |
| ONORM EN ISO 11608-5 : 2012 | Identical |
| NF EN ISO 11608-5 : 2012 | Identical |
| NBN EN ISO 11608-5 : 2012 | Identical |
| NEN EN ISO 11608-5 : 2012 | Identical |
| NS EN ISO 11608-5 : 2012 | Identical |
| I.S. EN ISO 11608-5:2012 | Identical |
| PN EN ISO 11608-5 : 2013 | Identical |
| BS EN ISO 11608-5:2012 | Identical |
| EN ISO 11608-5:2012 | Identical |
| DIN EN ISO 11608-5:2013-01 | Identical |
| UNE-EN ISO 11608-5:2013 | Identical |
| 16/30282706 DC : 0 | BS ISO 11608-6 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 6: ON-BODY DELIVERY SYSTEMS |
| BS ISO 11040-4:2015 | Prefilled syringes Glass barrels for injectables and sterilized subassembled syringes ready for filling |
| ISO 11040-8:2016 | Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes |
| ISO 11608-7:2016 | Needle-based injection systems for medical use — Requirements and test methods — Part 7: Accessibility for persons with visual impairment |
| I.S. EN ISO 8537:2016 | STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN (ISO 8537:2016) |
| I.S. EN ISO 11608-7:2017 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016) |
| 13/30273499 DC : 0 | BS ISO 11040-4 - PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING |
| DIN EN ISO 11608-7:2015-08 (Draft) | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016) |
| EN ISO 11608-7:2017 | Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016) |
| 15/30304642 DC : 0 | BS ISO 11040-8 - PREFILLED SYRINGES - PART 8: REQUIREMENTS AND TEST METHODS FOR FINISHED PRIFILLED SYRINGES |
| ISO 11040-4:2015 | Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling |
| BS EN ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin |
| ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin |
| EN ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016) |
| DIN ISO 11040-4:2007-10 | PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015) |
| DIN EN ISO 11608-7:2017-10 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016) |
| DIN ISO 11040-4:2017-07 | Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling (ISO 11040-4:2015) |
| UNE-EN ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016) |
| UNE-EN ISO 11608-7:2018 | Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016) |
| 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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