ISO 21649:2023
Needle-free injection systems for medical use — Requirements and test methods

Standard No.

ISO 21649:2023

Release Date

2023

Published By

International Organization for Standardization (ISO)

Latest

ISO 21649:2023

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 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.

ISO 21649:2023 Referenced Document

• IEC 60529 Degrees of Protection Provided by Enclosures (IP Code) (Edition 2.1 ***Applies to French text only***)*， 2024-04-21 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 61672-1 Electroacoustics - Sound level meters - Part 1: Specifications
• IEC 62366-1 Medical devices - Part 1: Application of usability engineering to medical devices*， 2024-04-21 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

ISO 21649:2023 history

• 2023 ISO 21649:2023 Needle-free injection systems for medical use — Requirements and test methods
• 2006 ISO 21649:2006 Needle-free injectors for medical use - Requirements and test methods