Needle-free injectors for medical use – Requirements and test methods (ISO 21649:2006)
Abstract
ISO 21649:2006 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.
The dose chamber of the injection system is often disposable and intended to be replaced after either a single use or a limited number of uses. It is sometimes separable from the injection mechanism and often termed a “cartridge”, “ampoule”, “syringe”, “capsule” or “disc”. In contrast, the dose chamber also may be a permanent internal chamber designed to last through the claimed life of the device.
DIN EN ISO 21649:2010-01 (E)
Needle-free injectors for medical use – Requirements and test methods (ISO
21649:2006)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….3
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..5
3 Terms and definitions ……………………………………………………………………………………………………..6
4 Symbols and abbreviated terms ………………………………………………………………………………………8
5 Requirements …………………………………………………………………………………………………………………9
5.1 General requirements ……………………………………………………………………………………………………..9
5.2 Noise requirements ……………………………………………………………………………………………………….10
5.3 Dose specification requirements ……………………………………………………………………………………10
5.4 Uncertainty of measurements and conformance with specifications ………………………………11
5.5 Performance profile requirements …………………………………………………………………………………11
5.6 Test requirements …………………………………………………………………………………………………………11
6 Test methods ………………………………………………………………………………………………………………..14
6.1 General …………………………………………………………………………………………………………………………14
6.2 Test procedures ……………………………………………………………………………………………………………15
6.3 Test conditions ……………………………………………………………………………………………………………..22
6.4 Test evaluations ……………………………………………………………………………………………………………23
7 Test report …………………………………………………………………………………………………………………….24
8 Information supplied by the manufacturer ……………………………………………………………………..25
8.1 General …………………………………………………………………………………………………………………………25
8.2 Marking …………………………………………………………………………………………………………………………25
8.3 Instructions for use ……………………………………………………………………………………………………….26
Annex A (informative) Two-sided tolerance limit factors (k) …………………………………………………………..27
Annex B (informative) Examples of accuracy limit calculations and random settings …………………….32
Annex C (informative) Correspondence between ISO/IEC standards and EN standards …………………33
Bibliography …………………………………………………………………………………………………………………………………34
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices …………………………………………35