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BSI - BS EN ISO 11607-1

Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems

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Organization: BSI
Publication Date: 31 January 2020
Status: active
Page Count: 58
ICS Code (Sterilized packaging): 11.080.30

Document History

BS EN ISO 11607-1
January 31, 2020
Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
A description is not available for this item.
BS EN ISO 11607-1 + A1
January 31, 2020
Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
A description is not available for this item.
BS EN ISO 11607-1
January 31, 2020
Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
A description is not available for this item.
BS EN ISO 11607-1 + A11
January 31, 2020
Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
A description is not available for this item.
BS EN ISO 11607-1
May 31, 2018
Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
A description is not available for this item.
BS EN ISO 11607-1
February 28, 2010
Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
A description is not available for this item.
BS EN ISO 11607-1
February 28, 2010
Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
A description is not available for this item.
BS EN ISO 11607-1
May 31, 2006
Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
A description is not available for this item.
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References

This document references:
BS EN ISO 11137-1 - Sterilization of health care products — Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Published by BSI on July 31, 2015
A description is not available for this item.
This document references:
AAMI ST65 - Processing of reusable Surgical textiles for use in health care facilities
Published by AAMI on January 1, 2008
General This recommended practice provides guidelines for properly handling, processing, and preparing reusable surgical textiles for use in health care facilities. These guidelines describe a...
This document references:
AAMI ST77 - Containment devices for reusable medical device sterilization
Published by AAMI on January 1, 2013
General This standard applies to containment devices intended for use in sterilizing reusable medical devices in health care facilities. NOTE—For purposes of this standard, “health care facilities”...
This document references:
AAMI ST79 - Comprehensive guide to steam sterilization and sterility assurance in health care facilities
Published by AAMI on January 1, 2017
General This document includes guidance for sterile processing facility design, personnel, receiving, transporting, handling, cleaning, decontamination, preparation, packaging, steam sterilization of...
This document references:
AAMI ST90 - Processing of health care products-Quality management systems for processing in health care facilities
Published by AAMI on January 1, 2017
This document is intended for sterile processing personnel and specifies minimum requirements for a quality management system (QMS) in a health care organization to effectively, efficiently, and...
This document references:
F2391 - Standard Test Method for Measuring Package and Seal Integrity Using Helium as the Tracer Gas
November 15, 2022
This test method includes several procedures that can be used for the measurement of overall package and seal barrier performance of a variety of package types and package forms, as well as...
This document references:
BS EN ISO 11137-1 - Sterilization of health care products — Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
Published by BSI on July 31, 2015
A description is not available for this item.
This document is referenced by:
BS EN ISO 25539-2 - Cardiovascular implants - Endovascular devices Part 2: Vascular stents
Published by BSI on October 31, 2020
A description is not available for this item.
This document is referenced by:
BS EN ISO 7199 - Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators)
Published by BSI on January 31, 2017
A description is not available for this item.
This document is referenced by:
BS EN ISO 11979-4 - Ophthalmic implants - Intraocular lenses Part 4: Labelling and information
Published by BSI on February 28, 2009
A description is not available for this item.
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