1 Scope
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 ...
BS EN ISO 21649:2023 Referenced Document
IEC 60529 Degrees of Protection Provided by Enclosures (IP Code) (Edition 2.1 ***Applies to French text only***)*, 2024-04-22 Update
IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measuring techniques - Electrostatic discharge immunity test
IEC 61000-4-3:2020 Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices*, 2024-04-22 Update
ISO 11201 Acoustics - Noise emitted by machinery and equipment - Determination of emission sound pressure levels at a work station and at other specified positions in an essentially free field over a reflecting plane with negligible environmental corrections
ISO 11202 Acoustics — Noise emitted by machinery and equipment — Determination of emission sound pressure levels at a work station and at other specified positions applying approximate environmental corrections
ISO 11204 Acoustics - Noise emitted by machinery and equipment - Determination of emission sound pressure levels at a work station and at other specified positions applying accurate environmental corrections
ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 14971:2019 Medical devices — Application of risk management to medical devices
ISO 7886-3:2020 Sterile hypodermic syringes for single use — Part 3: Auto-disabled syringes for fixed-dose immunization
BS EN ISO 21649:2023 history
2023BS EN ISO 21649:2023 Needle-free injection systems for medical use. Requirements and test methods
2009BS EN ISO 21649:2009 Needle-free injectors for medical use - Requirements and test methods