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BS EN ISO 21649:2023

BS EN ISO 21649:2023

$189.07

Needle-free injection systems for medical use. Requirements and test methods

Published By Publication Date Number of Pages
BSI 2023 48
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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 “cartridge”, “ ampoule”, “syringe”, “capsule” or “disc”. 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: —    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); —    generate aerosols, droplets, powders or other formulations for inhalation, insufflation, intranasal or oral deposition (such as sprays, inhalers, misters); —    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); —    apply sonic or electromagnetic energy (such as ultrasonic or iontophoretic devices); —    infusion systems for adding or metering medication into or through systems of artificial tubes, catheters, and/or needles which themselves enter the body.

PDF Catalog

PDF Pages PDF Title
2 undefined
4 European foreword
Endorsement notice
7 Foreword
9 Introduction
11 1 Scope
2 Normative references
12 3 Terms and definitions
14 4 Symbols
15 5 Requirements
5.1 General requirements
16 5.2 Noise requirements
17 5.3 Dose accuracy specification requirements
5.4 Usability engineering
5.5 Risk approach
5.6 Uncertainty of measurements and conformance with specifications
18 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)
19 5.8.2 Dry heat storage – Preconditioning
5.8.3 Damp heat storage – Preconditioning
5.8.4 Cold storage – Preconditioning
20 5.8.5 Cyclical testing – Preconditioning
5.8.6 Free fall – Preconditioning
5.8.7 Vibration and shock – Preconditioning
5.8.8 Transport – Preconditioning
21 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
22 6 Test methods
6.1 General
23 6.2 Test procedures
6.2.1 General
24 6.2.2 NFISs subjected to standard, cool and hot atmospheres and claimed lifetime test
26 6.2.3 NFISs subjected to dry heat storage atmosphere
6.2.4 NFISs subjected to damp-heat storage atmosphere
27 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
28 6.2.8 NFISs subjected to vibration and shock
29 6.2.9 NFISs with electrical components subjected to electromagnetic compatibility (EMC) testing
30 6.2.10 Noise testing
31 6.2.11 Water and dust resistance
32 6.2.12 Auto-disable feature
6.3 Test evaluations
6.3.1 Dose accuracy
33 6.3.2 Inspection
34 7 Test report
8 Information supplied with the NFIS
8.1 General
35 8.2 Marking
8.3 Instructions for use
36 Annex A (informative) Two-sided tolerance limit factors (k)
42 Annex B (informative) Examples of accuracy limit calculations and random settings
43 Annex C (normative) Instructions for use, marking and age warning
45 Annex D (informative) Example for k factor
46 Bibliography

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BS EN ISO 21649:2023
$189.07