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EN ISO 21649:2009 Standard

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  Keywords:

#injection #chamber #intended #dose #often

  Directive

Medical devices Directive (93/42/EEC)

  Last Official Journal reference

Friday 17th of November 2017

  Description:

Needle-free injectors for medical use - Requirements and test methods (ISO 21649:2006)

  Purpose

This International Standard applies to safety and performance and testing requirements for single-use andmultiple-use needle-free injection systems intended for human use in clinics and other medical settings andfor personal use by patients.The dose chamber of the injection system is often disposable and intended to be replaced after either a singleuse 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 permanentinternal chamber designed to last through the claimed life of the device.

  Publication

Friday 17th of November 2017

  Reference

This standard superseed the "EN ISO 21649:2006".

Anyway is still possible use the "EN ISO 21649:2006" until March 21st, 2010

  Related Standards

EN 60601-2-25:1995/A1:1999 (IEC 60601-2-25:1993/A1:1999)

Medical devices Directive (93/42/EEC)

Medical electrical equipment - Part 2-25: Particular requirements for the safety of electrocardiographsIEC 60601-2-25:1993

EN ISO 5359:2008

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EN 794-3:1998 +A2:2009

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Lung ventilators - Part 3: Particular requirements for emergency and transport ventilators

EN 1041:2008

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Information supplied by the manufacturer of medical devices

EN 1422:1997 +A1:2009

Medical devices Directive (93/42/EEC)

Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods

EN 1639:2009

Medical devices Directive (93/42/EEC)

Dentistry - Medical devices for dentistry - Instruments

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