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BS EN ISO 21649-2006 needle-free injectors for medical use requirements and test methods

Standard Number:  BS EN ISO 21649-2006
Title:  needle-free injectors for medical use requirements and test methods
Language:  English
Replaced by Standard:  BS EN ISO 21649-2009

Replacing Standard:  03/113382 DC

Publication Date:  2006/6/30
Execute Date:  2006/6/30
Adopted International Standard:  ISO 3207:1975, ISO 3746:1995, ISO 10993, ISO 11201:1995, ISO 11202:1995, ISO 11204:1995, ISO 14155-1:2003, ISO 14155-2:2003, ISO 14253-1:1998, IEC 60068-2-27:1987, IEC 60068-2-30:2005, IEC 60068-2-32:1975, IEC 60068-2-64:1993, IEC 60601-1-1:2000, IEC 60721-3-7:2002, IEC 61000-4-2:2001, IEC 61000-4-3:2002, IEC 61672-1:2002, GUM:1995, 93/42/EEC, ISO 7886-1:1993, ISO 9000:2005, ISO 11134:1994, ISO 11135:1994, ISO 11137:1995, ISO 13485:2003, ISO 15223:2000, IEC 60601-1-2:2001, IEC 61000-4-1:2000, IEC 61000-4-2:1999, IEC 61000-4-3:1998
Status:  withdrawn
Publisher:  British Standards
Number of Pages:46  

Preface:Injection instruments, Medical instruments, Medical equipment, Drug administration, Disposable, Safety, Performance, Performance testing, Instructions for use, Inspection, Visual inspection (testing)  
Description: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.  
Cross References:ISO 3207-1975; ISO 3746-1995; ISO 10993; ISO 11201-1995; ISO 11202-1995; ISO 11204-1995; ISO 14155-1-2003; ISO 14155-2-2003; ISO 14253-1-1998; IEC 60068-2-27-1987; IEC 60068-2-30-2005; IEC 60068-2-32-1975; IEC 60068-2-64-1993; IEC 60601-1-1-2000; IEC 60721-3-7-2002; IEC 61000-4-2-2001; IEC 61000-4-3-2002; IEC 61672-1-2002; GUM-1995; 93/42/EEC; ISO 7886-1-1993; ISO 9000-2005; ISO 11134-1994; ISO 11135-1994; ISO 11137-1995; ISO 13485-2003; ISO 15223-2000; IEC 60601-1-2-2001; IEC 61000-4-1-2000; IEC 61000-4-2-1999; IEC 61000-4-3-1998  
File Format:  PDF(Acrobat Reader) or Word version doc Document
File Size:  396KB
Tile in English:  needle-free injectors for medical use requirements and test methods

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