This International Standard applies to safety and performance and testing requirements for single-use and multiple-use needle-free injection systems intended for human use in clinics and other medical settings and for personal use by patients.
EN ISO 21649:2009 Referenced Document
IEC 60068-2-27:1987 Environmental testing. Part 2: Tests. Test Ea and guidance: Shock
IEC 60068-2-30:2005 Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle)
IEC 60068-2-32:1975 Basic environmental testing procedures. Part 2 : Tests. Test Ed: Free fall
IEC 60068-2-64:1993 Environmental testing; part 2: test methods; test Fh: vibration, broad-band random (digital control) and guidance
IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety; Collateral standard: Safety requirements for medical electrical systems
ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products*， 2019-11-26 Update
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 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 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 14155-1:2003 Clinical investigation of medical devices for human subjects - Part 1: General requirements
ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants
ISO 14253-1:1998 Geometrical Product Specifications (GPS) - Inspection by measurement of workpieces and measuring equipments - Part 1: Decision rules for proving conformance or non-conformance with specifications
ISO 3207:1975 Statistical interpretation of data; Determination of a statistical tolerance interval
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
EN ISO 21649:2009 history
2023EN ISO 21649:2023 Needle-free injection systems for medical use - Requirements and test methods (ISO 21649:2023)
2009EN ISO 21649:2009 Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)
2006EN ISO 21649:2006 Needle-free injectors for medical use Requirements and test methods