ISO 11608-1:2014
Superseded
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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 1: Needle-based injection systems
Available format(s)
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
Superseded date
07-04-2022
Superseded by
Language(s)
French, English
Published date
16-12-2014
Important note : Users cannot be edited or removed once added to your Multi user PDF.
ISO 11608-1:2014 specifies requirements and test methods for needle-based injection systems (NISs) intended to be used with needles and with replaceable or non-replaceable containers. Containers covered in ISO 11608-1:2014 include single- and multi-dose syringe-based and cartridge-based systems, filled either by the manufacturer or by the end-user.
| DevelopmentNote |
Supersedes ISO/DIS 11608-1. (12/2014)
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| DocumentType |
Standard
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| Pages |
42
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| PublisherName |
International Organization for Standardization
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| Status |
Superseded
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| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ONORM EN ISO 11608-1 : 2015 | Identical |
| NF EN ISO 11608-1 : 2015 | Identical |
| UNE-EN ISO 11608-1:2015 | Identical |
| NBN EN ISO 11608-1 : 2015 | Identical |
| NEN EN ISO 11608-1 : 2015 | Identical |
| NS EN ISO 11608-1 : 2015 | Identical |
| I.S. EN ISO 11608-1:2015 | Identical |
| SN EN ISO 11608-1 : 2015 | Identical |
| UNI EN ISO 11608-1 : 2012 | Identical |
| BS EN ISO 11608-1:2015 | Identical |
| EN ISO 11608-1:2015 | Identical |
| PN EN ISO 11608-1 : 2015 | Identical |
| DIN EN ISO 11608-1:2015-04 | Identical |
| 15/30296386 DC : 0 | BS EN ISO 9626 - STAINLESS STEEL NEEDLE TUBING FOR THE MANUFACTURE OF MEDICAL DEVICES - REQUIREMENTS AND TEST METHODS |
| 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 |
| ONORM EN ISO 11608-2 : 2012 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES (ISO 11608-2:2012) |
| ONORM EN ISO 11608-4 : 2007 | PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS |
| ONORM EN ISO 11608-5 : 2012 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS (ISO 11608-5:2012) |
| ONORM EN ISO 11608-3 : 2012 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 3: FINISHED CONTAINERS (ISO 11608-3:2012) |
| UNE-EN ISO 11608-5:2013 | Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012) |
| DIN EN ISO 11608-5:2013-01 | Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012) |
| 10/30208782 DC : DRAFT DEC 2010 | BS EN ISO 11608-3 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 3: FINISHED CONTAINERS |
| ISO 11040-8:2016 | Prefilled syringes — Part 8: Requirements and test methods for finished prefilled syringes |
| UNE-EN ISO 11608-3:2013 | Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012) |
| ISO 11608-7:2016 | Needle-based injection systems for medical use Requirements and test methods Part 7: Accessibility for persons with visual impairment |
| DIN EN ISO 11608-4:2016-03 (Draft) | PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS |
| I.S. EN ISO 8537:2016 | STERILE SINGLE-USE SYRINGES, WITH OR WITHOUT NEEDLE, FOR INSULIN (ISO 8537:2016) |
| I.S. EN ISO 11608-3:2012 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 3: FINISHED CONTAINERS (ISO 11608-3:2012) |
| I.S. EN ISO 11608-2:2012 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES (ISO 11608-2:2012) |
| 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) |
| PREN ISO 11608-2 : DRAFT 2010 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES |
| BS EN ISO 11608-5:2012 | Needle-based injection systems for medical use. Requirements and test methods Automated functions |
| UNI EN ISO 11608-5 : 2013 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS |
| 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) |
| UNI EN ISO 11608-2 : 2012 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES |
| I.S. EN ISO 11608-4:2007 | PEN-INJECTORS FOR MEDICAL USE - PART 4: REQUIREMENTS AND TEST METHODS FOR ELECTRONIC AND ELECTROMECHANICAL PEN-INJECTORS |
| UNI EN ISO 11608-3 : 2013 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 3: FINISHED CONTAINERS |
| 15/30304642 DC : 0 | BS ISO 11040-8 - PREFILLED SYRINGES - PART 8: REQUIREMENTS AND TEST METHODS FOR FINISHED PRIFILLED SYRINGES |
| 10/30209603 DC : 0 | BS EN ISO 11608-2 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 2: NEEDLES |
| I.S. EN ISO 11608-5:2012 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS (ISO 11608-5:2012) |
| BS EN ISO 11608-2:2012 | Needle-based injection systems for medical use. Requirements and test methods Needles |
| UNE-EN ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016) |
| BS EN ISO 11608-3:2012 | Needle-based injection systems for medical use. Requirements and test methods Finished containers |
| BS EN ISO 11608-4:2007 | Pen-injectors for medical use Requirements and test methods for electronic and electromechanical pen-injectors |
| BS EN ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin |
| ISO 11608-4:2006 | Pen-injectors for medical use Part 4: Requirements and test methods for electronic and electromechanical pen-injectors |
| DIN EN ISO 11608-2:2012-12 | Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012) |
| ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin |
| 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 |
| EN ISO 11608-2:2012 | Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles (ISO 11608-2:2012) |
| EN ISO 11608-5:2012 | Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions (ISO 11608-5:2012) |
| EN ISO 8537:2016 | Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016) |
| EN ISO 11608-3:2012 | Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012) |
| EN ISO 11608-4:2007 | Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors (ISO 11608-4:2006) |
| 10/30213842 DC : 0 | BS EN ISO 11608-5 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS |
| 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 13926-1:2004 | Pen systems Part 1: Glass cylinders for pen-injectors for medical use |
| ISO 11608-5:2012 | Needle-based injection systems for medical use Requirements and test methods Part 5: Automated functions |
| 15/30273313 DC : 0 | BS EN ISO 11608-7 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT |
| DIN EN ISO 11608-3:2013-01 | Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers (ISO 11608-3:2012) |
| 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) |
| ISO 11608-4:2006 | Pen-injectors for medical use Part 4: Requirements and test methods for electronic and electromechanical pen-injectors |
| 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 |
| IEC 62366:2007+AMD1:2014 CSV | Medical devices - Application of usability engineering to medical devices |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| ISO 16269-6:2014 | Statistical interpretation of data — Part 6: Determination of statistical tolerance intervals |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| IEC 61000-4-2:2008 | Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test |
| IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV | Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO 9000:2015 | Quality management systems — Fundamentals and vocabulary |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| IEC 60601-1-9:2007+AMD1:2013 CSV | Medical electrical equipment - Part 1-9: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design |
| ISO/IEC Guide 98-3:2008 | Uncertainty of measurement — Part 3: Guide to the expression of uncertainty in measurement (GUM:1995) |
| IEC 60068-2-30:2005 | Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle) |
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