Standard

NS-EN ISO 21649:2009

Withdrawn

Note: This standard has a new edition: NS-EN ISO 21649:2023

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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.

Document information

  • Standard from SN
  • Published:
  • Withdrawn:
  • Edition: 2009-09
  • Version: 1
  • Document type: NAT
  • ICS 11.040.20
  • National Committee CEN/BT

Legal references

EU law: 2007/47/EC, 93/42/EEC

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