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

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

07-08-2014

Publisher

International Organization for Standardization

ISO/TR 19244:2014 outlines the recommended transition plans for all the TC 84 standards:

Needle-based Injection systems;
Sharps Injury Protection;
Sharps Containers,
Aerosol Drug Delivery Devices;
Needle-free injection systems;
Syringes;
Needles;
Intravascular Catheters and Ports.

Committee	ISO/TC 84
DocumentType	Technical Report
Pages	3
PublisherName	International Organization for Standardization
Status	Current

Standards	Relationship
PD ISO/TR 19244:2014	Identical
NEN NPR ISO/TR 19244 : 2014	Identical

ISO 20697:2018	Sterile drainage catheters and accessory devices for single use
BS EN ISO 7864:2016	Sterile hypodermic needles for single use. Requirements and test methods
BS EN ISO 6009 : 1995	HYPODERMIC NEEDLES FOR SINGLE USE - COLOUR CODING FOR IDENTIFICATION
ISO 11608-7:2016	Needle-based injection systems for medical use Requirements and test methods Part 7: Accessibility for persons with visual impairment
I.S. EN ISO 6009:2016	HYPODERMIC NEEDLES FOR SINGLE USE - COLOUR CODING FOR IDENTIFICATION (ISO/DIS 6009:2014)
I.S. EN ISO 9626:2016	STAINLESS STEEL NEEDLE TUBING FOR THE MANUFACTURE OF MEDICAL DEVICES - REQUIREMENTS AND TEST METHODS
I.S. EN ISO 7864:2016	STERILE HYPODERMIC NEEDLES FOR SINGLE USE - REQUIREMENTS AND TEST METHODS (ISO/DIS 7864:2014)
ISO 20696:2018	Sterile urethral catheters for single use
UNE-EN ISO 9626:2017	Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)
BS EN ISO 9626:2016	Stainless steel needle tubing for the manufacture of medical devices. Requirements and test methods
ISO 9626:2016	Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods
EN ISO 11608-7:2017	Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016)
UNE-EN ISO 6009:2017	Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016)
ISO 7864:2016	Sterile hypodermic needles for single use — Requirements and test methods
ISO 6009:2016	Hypodermic needles for single use Colour coding for identification
UNE-EN ISO 7864:2017	Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
EN ISO 7864:2016	Sterile hypodermic needles for single use - Requirements and test methods (ISO 7864:2016)
EN ISO 6009:2016	Hypodermic needles for single use - Colour coding for identification (ISO 6009:2016)
EN ISO 9626:2016	Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods (ISO 9626:2016)
DIN EN ISO 11608-7 E : 2017	NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016)
I.S. EN ISO 11608-7:2017	NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016)
DIN EN ISO 11608-7:2015-08 (Draft)	NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016)
UNE-EN ISO 11608-7:2018	Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment (ISO 11608-7:2016)
DIN EN ISO 11608-7:2017-10	NEEDLE-BASED INJECTION SYSTEMS FOR MEDICAL USE - REQUIREMENTS AND TEST METHODS - PART 7: ACCESSIBILITY FOR PERSONS WITH VISUAL IMPAIRMENT (ISO 11608-7:2016)

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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ISO/TR 19244:2014

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

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