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BSI - BS PD CEN ISO/TS 16775

Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2

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Organization: BSI
Publication Date: 31 May 2014
Status: active
Page Count: 126
ICS Code (Sterilized packaging): 11.080.30

Document History

PD CEN ISO/TS 16775
November 30, 2021
Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
A description is not available for this item.
BS PD CEN ISO/TS 16775
May 31, 2014
Packaging for terminally sterilized medical devices — Guidance on the application of ISO 11607-1 and ISO 11607-2
A description is not available for this item.

References

This document references:
ISO 14708-1 - Implants for Surgery - Active Implantable Medical Devices - Part 1: General Requirements for Safety, Marking and for Information to be Provided by the Manufacturer
Published by ISO on August 15, 2014
This part of ISO 14708 specifies requirements that are generally applicable to active implantable medical devices. NOTE 1 For particular types of active implantable medical devices, these general...
This document references:
EN 13428 - Packaging - Requirements specific to manufacturing and composition - Prevention by source reduction
Published by CEN on August 1, 2004
A description is not available for this item.
This document references:
ISO/ASTM 51649 - Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV
Published by ISO on March 15, 2015
This practice outlines dosimetric procedures to be followed in installation qualification (IQ), operational qualification (OQ) and performance qualifications (PQ), and routine processing at electron...
This document references:
EN 13432 - Packaging - Requirements for Packaging Recoverable Through Composting and Biodegradation - Test Scheme and Evaluation Criteria for the Final Acceptance of Packaging
Published by CEN on September 1, 2000
A description is not available for this item.
This document references:
EN 13428 - Packaging - Requirements specific to manufacturing and composition - Prevention by source reduction
Published by CEN on August 1, 2004
A description is not available for this item.
This document references:
EN 13432 - Packaging - Requirements for Packaging Recoverable Through Composting and Biodegradation - Test Scheme and Evaluation Criteria for the Final Acceptance of Packaging
Published by CEN on September 1, 2000
A description is not available for this item.
This document references:
ISO 14708-1 - Implants for Surgery - Active Implantable Medical Devices - Part 1: General Requirements for Safety, Marking and for Information to be Provided by the Manufacturer
Published by ISO on August 15, 2014
This part of ISO 14708 specifies requirements that are generally applicable to active implantable medical devices. NOTE 1 For particular types of active implantable medical devices, these general...
This document references:
ISO/ASTM 51649 - Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV
Published by ISO on March 15, 2015
This practice outlines dosimetric procedures to be followed in installation qualification (IQ), operational qualification (OQ) and performance qualifications (PQ), and routine processing at electron...
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