ISO 21649:2006 

Needle-free injectors for medical use -- Requirements and test methods

Media and price

Language Format Add to basket
English PDF (364 kB) CHF 124,00
English Paper CHF 124,00
French PDF (391 kB) CHF 124,00
French Paper CHF 124,00
Russian PDF (449 kB) CHF 124,00
Russian Paper CHF 124,00

General information

Number of Pages: 32


Edition: 1 (Monolingual) ICS: 11.040.20
Status: Published Stage: 90.60 (2009-09-17)
TC/SC: TC 84  

Abstract

ISO 21649:2006 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.

These standards could also interest you

  • ISO 20072:2009
    Aerosol drug delivery device design verification -- Requirements and test methods
  • ISO 8537:2007
    Sterile single-use syringes, with or without needle, for insulin
  • ISO 11608-4:2006
    Pen-injectors for medical use -- Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
 
The following article has been added to your basket
Continue shopping  Proceed to checkout