ISO/TR 19244:2014 - $45.00   BUY NOW

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

ISO/TR 19244:2014 Publication Description:

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.

International Classification for Standards (ICS)

ICS Classification Field ICS Field Sub-Group and Number
ICS-11-Health ICS Medical-Equipment General (11.040.01)

ICS Related Standards

Cart Document Number Document Title
$240.00 ISO 13485:2003 Medical devices - Quality management systems - Requirements for regulatory purposes
$240.00 ISO/TR 14969:2004 Medical devices - Quality mangement systems - Guidance on the application of ISO 13485: 2003
$232.00 ISO 14971:2007 Medical devices - Application of risk management to medical devices
$138.00 ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
$149.00 ISO 15223-1:2012 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
$103.00 ISO 15223-2:2010 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
$103.00 ISO 15225:2016 Medical devices - Quality management - Medical device nomenclature data structure
$149.00 ISO 15225:2010 Medical devices - Quality management - Medical device nomenclature data structure
$209.00 ISO 15378:2015 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
$123.00 ISO/TR 16142:2006 Medical devices - Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
$185.00 ISO 16142-1:2016 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
$103.00 ISO/TS 19218-1:2011 Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes
$19.00 ISO/TS 19218-1:2011/Amd1:2013 Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes- Amendment 1
$103.00 ISO/TS 19218-2:2012 Medical devices - Hierarchical coding structure for adverse events - Part 2: Evaluation codes
$68.00 ISO/TR 24971:2013 Medical devices - Guidance on the application of ISO 14971
$103.00 ISO/TR 80001-2-6:2014 Application of risk management for IT-networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements
$232.00 ISO/TR 80001-2-7:2015 Application of risk management for IT-networks incorporating medical devices - Application guidance - Part 2-7: Guidance for Healthcare Delivery Organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
$45.00 ISO/PAS 18761:2013 Use and handling of medical devices covered by the scope of ISO/TC 84 - Risk assessment on mucocutaneous blood exposure
$58.00 JIS Q 14971-1:2001 Medical devices -- Risk management -- Part 1: Application of risk analysis
$290.00 JIS T 0601-1-2:2012 Medical electrical equipment -- Part 1-2: General requirements for safety -- Electromagnetic compatibility -- Requirements and tests
$242.00 JIS T 14971:2012 Medical devices -- Application of risk management to medical devices
$185.00 ISO 16142-2:2017 Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
$232.00 ISO/TR 80002-2:2017 Medical device software - Part 2: Validation of software for medical device quality systems
$209.00 ISO 15378:2017 Primary packaging materials for medicinal products - Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)