PD ISO/TR 19244:2014
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
Hardcopy , PDF
English
31-08-2014
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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