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PD ISO/TR 19244:2014

Current

Current

The latest, up-to-date edition.

Guidance on transition periods for standards developed by ISO/TC 84. Devices for administration of medicinal products and catheters

Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

31-08-2014

€130.88
Excluding VAT

Foreword
Introduction
1 Scope
2 Terms and definitions
3 Recommendations for implementing
  ISO/TC 84 standards
Bibliography

Describes the recommended transition plans for all the TC 84 standards: - Needle-based Injection systems [ISO 11608 (all parts)]; - Sharps Injury Protection (ISO 23908); - Sharps Containers (ISO 23907), - Aerosol Drug Delivery Devices (ISO 20072); - Needle-free injection systems (ISO 21649); - Syringes [ISO 7886 (all parts), ISO 8537, ISO 9626]; - Needles (ISO 6009, ISO 7864); and - Intravascular Catheters and Ports [ISO 10555 (all parts), ISO 11070].

Committee
CH/84
DocumentType
Standard
Pages
14
PublisherName
British Standards Institution
Status
Current

This Technical Report outlines the recommended transition plans for all the TC84 standards:

  • Needle-based Injection systems [ISO11608 (all parts)];

  • Sharps Injury Protection (ISO23908);

  • Sharps Containers (ISO23907),

  • Aerosol Drug Delivery Devices (ISO20072);

  • Needle-free injection systems (ISO21649);

  • Syringes [ISO7886 (all parts), ISO8537, ISO9626];

  • Needles (ISO6009, ISO7864);

  • Intravascular Catheters and Ports [ISO10555 (all parts), ISO11070].

Standards Relationship
ISO/TR 19244:2014 Identical

ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires
ISO 20072:2009 Aerosol drug delivery device design verification Requirements and test methods
ISO 21649:2006 Needle-free injectors for medical use — Requirements and test methods
ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin
ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
ISO 7864:2016 Sterile hypodermic needles for single use — Requirements and test methods
ISO 23908:2011 Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
ISO 14971:2007 Medical devices Application of risk management to medical devices
ISO 23907:2012 Sharps injury protection Requirements and test methods Sharps containers
ISO 6009:2016 Hypodermic needles for single use Colour coding for identification

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