ISO 11608-2:2012
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Needle-based injection systems for medical use Requirements and test methods Part 2: Needles
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
07-04-2022
English, French
30-03-2012
ISO 11608-2:2012 specifies requirements and test methods for single-use, double-ended, sterile needles for needle-based injection systems (NISs) that fulfil the specifications of ISO 11608-1.
DevelopmentNote |
Supersedes ISO/DIS 11608-2. (04/2012)
|
DocumentType |
Standard
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Pages |
17
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PublisherName |
International Organization for Standardization
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Status |
Withdrawn
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SupersededBy | |
Supersedes |
Standards | Relationship |
DS EN ISO 11608-2 : 2012 | Identical |
ONORM EN ISO 11608-2 : 2012 | Identical |
DIN EN ISO 11608-2:2012-12 | Identical |
NF EN ISO 11608-2 : 2012 | Identical |
UNE-EN ISO 11608-2:2012 | Identical |
NBN EN ISO 11608-2 : 2012 | Identical |
NEN EN ISO 11608-2 : 2012 | Identical |
NS EN ISO 11608-2 : 2012 | Identical |
I.S. EN ISO 11608-2:2012 | Identical |
PN EN ISO 11608-2 : 2012 | Identical |
SN EN ISO 11608-2 : 2012 | Identical |
UNI EN ISO 11608-2 : 2012 | Identical |
SS-EN ISO 11608-2:2012 | Identical |
BS EN ISO 11608-2:2012 | Identical |
EN ISO 11608-2:2012 | 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 |
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 |
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 |
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) |
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 11608-3:2012 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 3: FINISHED CONTAINERS (ISO 11608-3:2012) |
13/30273499 DC : 0 | BS ISO 11040-4 - PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING |
BS EN ISO 11608-5:2012 | Needle-based injection systems for medical use. Requirements and test methods Automated functions |
10/30208977 DC : 0 | BS EN ISO 11608-1 - NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS |
UNI EN ISO 11608-5 : 2013 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 5: AUTOMATED FUNCTIONS |
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 |
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) |
ISO 11040-4:2015 | Prefilled syringes — Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling |
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 |
ISO 11608-4:2006 | Pen-injectors for medical use Part 4: Requirements and test methods for electronic and electromechanical pen-injectors |
ISO 11608-3:2012 | Needle-based injection systems for medical use Requirements and test methods Part 3: Finished containers |
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 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 |
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) |
PREN ISO 11608-1 : DRAFT 2010 | NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 1: NEEDLE-BASED INJECTION SYSTEMS |
ISO 11608-5:2012 | Needle-based injection systems for medical use Requirements and test methods Part 5: Automated functions |
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 ISO 11040-4:2017-07 | PREFILLED SYRINGES - PART 4: GLASS BARRELS FOR INJECTABLES AND STERILIZED SUBASSEMBLED SYRINGES READY FOR FILLING (ISO 11040-4:2015) |
ISO 15510:2014 | Stainless steels — Chemical composition |
ISO 9626:2016 | Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods |
ISO/IEC Guide 98-1:2009 | Uncertainty of measurement — Part 1: Introduction to the expression of uncertainty in measurement |
ISO 11608-1:2014 | Needle-based injection systems for medical use Requirements and test methods Part 1: Needle-based injection systems |
ISO 11608-3:2012 | Needle-based injection systems for medical use Requirements and test methods Part 3: Finished containers |
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 |
ISO 7000:2014 | Graphical symbols for use on equipment Registered symbols |
EN 10088-1:2014 | Stainless steels - Part 1: List of stainless steels |
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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