BS EN ISO 21649:2009
Needle-free injectors for medical use - Requirements and test methods

Standard No.

BS EN ISO 21649:2009

Release Date

2009

Published By

British Standards Institution (BSI)

Status

Be replaced 2023-02

Replace By

BS EN ISO 21649:2023

Latest

BS EN ISO 21649:2023

Replace

BS EN ISO 21649:2006

Scope

This International Standard 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. Excluded from this International Standard 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.

BS EN ISO 21649:2009 Referenced Document

• IEC 60068-2-27:1987 Environmental testing. Part 2: Tests. Test Ea and guidance: Shock
• IEC 60068-2-30:2005 Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle)
• IEC 60068-2-32:1975 Basic environmental testing procedures. Part 2 : Tests. Test Ed: Free fall
• IEC 60068-2-64:1993 Environmental testing; part 2: test methods; test Fh: vibration, broad-band random (digital control) and guidance
• IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety; Collateral standard: Safety requirements for medical electrical systems
• IEC 61000-4-3:2002 Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques; Radiated, radio-frequency, electromagnetic field immunity test
• ISO 10993 Biological evaluation of medical devices — Part 9: Framework for identification and quantification of potential degradation products*， 2019-11-26 Update
• ISO 11201:1995 Acoustics - Noise emitted by machinery and equipment - Measurement of emission sound pressure levels at a work station and at other specified positions - Engineering method in an essentially free field over a reflecting plane
• ISO 11202:1995 Acoustics - Noise emitted by machinery and equipment - Measurement of emission sound pressure levels at a work station and at other specified positions - Survey method in situ
• ISO 11204:1995 Acoustics - Noise emitted by machinery and equipment - Measurement of emission sound pressure levels at a work station and at other specified positions - Method requiring environmental corrections
• ISO 14155-1:2003 Clinical investigation of medical devices for human subjects - Part 1: General requirements
• ISO 14155-2:2003 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plants
• ISO 14253-1:1998 Geometrical Product Specifications (GPS) - Inspection by measurement of workpieces and measuring equipments - Part 1: Decision rules for proving conformance or non-conformance with specifications
• ISO 3207:1975 Statistical interpretation of data; Determination of a statistical tolerance interval
• ISO 3746:1995 Acoustics - Determination of sound power levels of noise sources using sound pressure - Survey method using an enveloping measurement surface over a reflecting plane

BS EN ISO 21649:2009 history

• 2023 BS EN ISO 21649:2023 Needle-free injection systems for medical use. Requirements and test methods
• 2009 BS EN ISO 21649:2009 Needle-free injectors for medical use - Requirements and test methods
• 0000 BS EN ISO 21649:2006