This document applies to safety and performance and testing requirements for single-use and multiple-use Needle-Free Injection Systems (NFISs) intended for human use in clinics and other medical settings and for personal use by patients. The dose chamber of the NFIS 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 \u201ccartridge\u201d, \u201c ampoule\u201d, \u201csyringe\u201d, \u201ccapsule\u201d or \u201cdisc\u201d. In contrast, the dose chamber can also incorporate a permanent internal chamber designed to last through the claimed life of the device, and an additional member or members which eliminate the risk of cross-contamination. Excluded from this document are drug delivery methods which: \u2014 involve penetration of a part of the device itself into or through skin or mucous membranes (such as needles, tines, micro-needles, implantable slow-release drug devices); \u2014 generate aerosols, droplets, powders or other formulations for inhalation, insufflation, intranasal or oral deposition (such as sprays, inhalers, misters); \u2014 deposit liquids, powders, or other substances on the surface of skin or mucosal surfaces for passive diffusion or ingestion into the body (such as transdermal patches, liquid drops); \u2014 apply sonic or electromagnetic energy (such as ultrasonic or iontophoretic devices); \u2014 infusion systems for adding or metering medication into or through systems of artificial tubes, catheters, and\/or needles which themselves enter the body.<\/p>\n
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| 2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
| 4<\/td>\n | European foreword Endorsement notice <\/td>\n<\/tr>\n | ||||||
| 7<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
| 9<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
| 11<\/td>\n | 1 Scope 2 Normative references <\/td>\n<\/tr>\n | ||||||
| 12<\/td>\n | 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
| 14<\/td>\n | 4 Symbols <\/td>\n<\/tr>\n | ||||||
| 15<\/td>\n | 5 Requirements 5.1 General requirements <\/td>\n<\/tr>\n | ||||||
| 16<\/td>\n | 5.2 Noise requirements <\/td>\n<\/tr>\n | ||||||
| 17<\/td>\n | 5.3 Dose accuracy specification requirements 5.4 Usability engineering 5.5 Risk approach 5.6 Uncertainty of measurements and conformance with specifications <\/td>\n<\/tr>\n | ||||||
| 18<\/td>\n | 5.7 Performance profile requirements 5.8 Test requirements 5.8.1 NFISs subjected to standard, cool and hot atmospheres and after claimed lifetime testing (in-use conditions) <\/td>\n<\/tr>\n | ||||||
| 19<\/td>\n | 5.8.2 Dry heat storage – Preconditioning 5.8.3 Damp heat storage \u2013 Preconditioning 5.8.4 Cold storage – Preconditioning <\/td>\n<\/tr>\n | ||||||
| 20<\/td>\n | 5.8.5 Cyclical testing – Preconditioning 5.8.6 Free fall – Preconditioning 5.8.7 Vibration and shock \u2013 Preconditioning 5.8.8 Transport \u2013 Preconditioning <\/td>\n<\/tr>\n | ||||||
| 21<\/td>\n | 5.8.9 NFISs with electrical components subjected to electromagnetic compatibility (EMC) 5.8.10 Water and dust resistance 5.8.11 Auto-disable feature <\/td>\n<\/tr>\n | ||||||
| 22<\/td>\n | 6 Test methods 6.1 General <\/td>\n<\/tr>\n | ||||||
| 23<\/td>\n | 6.2 Test procedures 6.2.1 General <\/td>\n<\/tr>\n | ||||||
| 24<\/td>\n | 6.2.2 NFISs subjected to standard, cool and hot atmospheres and claimed lifetime test <\/td>\n<\/tr>\n | ||||||
| 26<\/td>\n | 6.2.3 NFISs subjected to dry heat storage atmosphere 6.2.4 NFISs subjected to damp-heat storage atmosphere <\/td>\n<\/tr>\n | ||||||
| 27<\/td>\n | 6.2.5 NFISs subjected to cold storage atmosphere 6.2.6 NFISs subjected to a cyclical atmosphere 6.2.7 NFISs subjected to free fall <\/td>\n<\/tr>\n | ||||||
| 28<\/td>\n | 6.2.8 NFISs subjected to vibration and shock <\/td>\n<\/tr>\n | ||||||
| 29<\/td>\n | 6.2.9 NFISs with electrical components subjected to electromagnetic compatibility (EMC) testing <\/td>\n<\/tr>\n | ||||||
| 30<\/td>\n | 6.2.10 Noise testing <\/td>\n<\/tr>\n | ||||||
| 31<\/td>\n | 6.2.11 Water and dust resistance <\/td>\n<\/tr>\n | ||||||
| 32<\/td>\n | 6.2.12 Auto-disable feature 6.3 Test evaluations 6.3.1 Dose accuracy <\/td>\n<\/tr>\n | ||||||
| 33<\/td>\n | 6.3.2 Inspection <\/td>\n<\/tr>\n | ||||||
| 34<\/td>\n | 7 Test report 8 Information supplied with the NFIS 8.1 General <\/td>\n<\/tr>\n | ||||||
| 35<\/td>\n | 8.2 Marking 8.3 Instructions for use <\/td>\n<\/tr>\n | ||||||
| 36<\/td>\n | Annex A (informative) Two-sided tolerance limit factors (k) <\/td>\n<\/tr>\n | ||||||
| 42<\/td>\n | Annex B (informative) Examples of accuracy limit calculations and random settings <\/td>\n<\/tr>\n | ||||||
| 43<\/td>\n | Annex C (normative) Instructions for use, marking and age warning <\/td>\n<\/tr>\n | ||||||
| 45<\/td>\n | Annex D (informative) Example for k factor <\/td>\n<\/tr>\n | ||||||
| 46<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Needle-free injection systems for medical use. Requirements and test methods<\/b><\/p>\n |