BS EN ISO 21649:2009

Cross References:
ISO 3207:1975
ISO 3746:1995
ISO 10993
ISO 11201:1995
ISO 11202:1995
ISO 11204:1995
ISO 14155-1:2003
ISO 14155-2:2003
ISO 14253-1:1998
IEC 60068-2-27:1987
IEC 60068-2-30:2005
IEC 60068-2-32:1975
IEC 60068-2-64:1993
IEC 60601-1-1:2000
IEC 60721-3-7:2002
IEC 61000-4-2:2001
IEC 61000-4-3:2002
IEC 61672-1:2002
GUM:1995
ISO 10993-1:2003
EN ISO 10993-1:2003
EN ISO 11201:1995
EN ISO 11202:1995
EN ISO 11204:1995
EN ISO 14155-1:2003
EN ISO 14155-2:2003
EN ISO 14253-1:1998
EN 60068-2-27:1993
EN 60068-2-30:1999
EN 60068-2-32:19
EN 60068-2-64:1994
EN 60721-3-7:1995
EN 61000-4-2:2001
EN 61000-4-3:2002
EN 61672-1:2003
ISO 7886-1:1993
ISO 9000:2005
ISO 11134:1994
ISO 11135:1994
ISO 11137:1995
ISO 13485:2003
ISO 15223:2000
IEC 60601-1-2:2001
IEC 61000-4-1:2000
IEC 61000-4-2:1999
IEC 61000-4-3:1998
93/42/EEC


All current amendments available at time of purchase are included with the purchase of this document.



Keywords: Injection instruments; Medical instruments; Medical equipment; Drug administration; Disposable; Safety; Performance; Performance testing; Instructions for use; Inspection; Visual inspection (testing)

Product Code(s): 30203372,30203372

This product references:ISO 11201:1995 - Acoustics - Noise emitted by machinery and equipment - Measurement of emission sound pressure levels at a work station and at other specified positions - Engineering method in an essentially free field over a reflecting plane
ISO 11204:1995 - Acoustics - Noise emitted by machinery and equipment - Measurement of emission sound pressure levels at a work station and at other specified positions - Method requiring environmental corrections
ISO 11202:1995 - Acoustics - Noise emitted by machinery and equipment - Measurement of emission sound pressure levels at a work station and at other specified positions - Survey method in situ
ISO 14155-1:2003 - Clinical investigation of medical devices for human subjects - Part 1: General requirements
ISO 15223:2000 - Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied
ISO 13485:2003 - Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 11135:1994 - Medical devices -- Validation and routine control of ethylene oxide sterilization
ISO 7886-1:1993 - Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use
BS EN 61672-1:2003 - Electroacoustics. Sound level meters. Specifications
BS EN 60068-2-27:1993 - Environmental testing. Test methods. Environmental testing procedures. Tests. Test Ea and guidance. Shock
BS EN ISO 14155-2:2003 - Clinical investigation of medical devices for human subjects. Clinical investigation plans
BS EN ISO 10993-1:2003 - Biological evaluation of medical devices. Evaluation and testing
ISO 10993-1:2003 - Biological evaluation of medical devices - Part 1: Evaluation and testing
ISO 3746:1995 - Acoustics - Determination of sound power levels of noise sources using sound pressure - Survey method using an enveloping measurement surface over a reflecting plane
BS EN ISO 14155-1:2003 - Clinical investigation of medical devices for human subjects. General requirements
ISO 14155-2:2003 - Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans
ISO 11134:1994 - Sterilization of health care products -- Requirements for validation and routine control -- Industrial moist heat sterilization
BS EN 60068-2-30:1999 - Environmental testing. Test methods. Test Db and guidance: damp heat, cyclic (12 12 hour cycle)
ISO 9000:2005 - Quality management systems - Fundamentals and vocabulary
BS EN 61000-4-3:2002 - Electromagnetic compatibility (EMC). Testing and measurement techniques. Radiated, radio-frequency, electromagnetic field immunity test
ISO 11137:1995 - Sterilization of health care products -- Requirements for validation and routine control -- Radiation sterilization
ISO 14253-1:1998 - Geometrical Product Specifications (GPS) - Inspection by measurement of workpieces and measuring equipment - Part 1: Decision rules for proving conformance or non-conformance with specifications
This product replaces:BS EN ISO 21649:2006 - Needle-free injectors for medical use. Requirements and test methods
This product same asISO 21649:2006 - Needle-free injectors for medical use. Requirements and test methods