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ISO 21649

Needle-free injectors for medical use Requirements and test methods

active, Most Current
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Organization: ISO
Publication Date: 1 June 2006
Status: active
Page Count: 40
ICS Code (Transfusion, infusion and injection equipment): 11.040.20

Document History

21649
January 1, 2023
Needle-free injection systems for medical use — Requirements and test methods
This document applies to safety and performance and testing requirements for single-use and multiple-use Needle-Free Injection Systems (NFISs) intended for human use in clinics and other medical...
ISO 21649
June 1, 2006
Needle-free injectors for medical use Requirements and test methods
A description is not available for this item.

References

This document is referenced by:
ISO TR 19244 - Guidance on transition periods for standards developed by ISO/TC 84 - Devices for administration of medicinal products and catheters
Published by ISO on August 15, 2014
This Technical Report outlines the recommended transition plans for all the TC 84 standards: - Needle-based Injection systems [ISO 11608 (all parts)]; - Sharps Injury Protection (ISO 23908); - Sharps...
This document is referenced by:
ISO 16142-1 - Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non‐IVD medical devices and guidance on the selection of standards
Published by ISO on March 1, 2016
This part of ISO 16142, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical...
This document is referenced by:
AAMI 16142-1 - Medical devices-Recognized essential principles of safety and performance of medical devices-Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
Published by AAMI on January 1, 2016
This part of ISO 16142, which includes the essential principles of safety and performance, identifies significant standards and guides that can be used in the assessment of conformity of a medical...
This document is referenced by:
AAMI TIR105 - Risk management guidance for combination products
Published by AAMI on January 1, 2020
Inclusions This TIR provides recommendations on the application of risk management principles and processes during development and marketing of combination products that include a device constituent...
This document is referenced by:
ISO 20069 - Guidance for assessment and evaluation of changes to drug delivery systems
Published by ISO on August 1, 2019
This document provides guidance for assessment and evaluation of planned changes to drug delivery systems that are integral with, packaged with, or cross-labelled for use with a specified medicinal...
This document is referenced by:
BS ISO 16142-1 - TC - Tracked Changes (Redline) - Medical devices — Recognized essential principles of safety and performance of medical devices Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
Published by BSI on February 24, 2020
A description is not available for this item.
This document is referenced by:
BS PD ISO/TR 19244 - Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters
Published by BSI on August 31, 2014
A description is not available for this item.
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