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BSI - BS EN ISO 13408-1

Aseptic processing of health care products Part 1: General requirements

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Organization: BSI
Publication Date: 31 August 2015
Status: active
Page Count: 62
ICS Code (Sterilization and disinfection in general): 11.080.01

Document History

21/30387349 DC
December 17, 2021
Draft BS EN ISO 13408-1 Aseptic processing of health care products. Part 1: General requirements
A description is not available for this item.
BS EN ISO 13408-1
August 31, 2015
Aseptic processing of health care products Part 1: General requirements
A description is not available for this item.
BS EN ISO 13408-1
October 30, 2011
Aseptic processing of health care products Part 1: General requirements
A description is not available for this item.
BS EN ISO 13408-1
October 30, 2011
Aseptic processing of health care products Part 1: General requirements
A description is not available for this item.

References

This document references:
EN 556-2 - Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 2: Requirements for aseptically processed medical devices
Published by CEN on September 1, 2015
This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'. NOTE For the purpose of the EU Directive(s) for medical devices (see...
This document references:
ISO 13408-2 - Aseptic processing of health care products - Part 2: Sterilizing filtration
Published by ISO on January 1, 2018
This document specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408-1. It also offers guidance to filter users...
This document references:
EN 1822-1 - High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking
Published by CEN on April 1, 2019
This document applies to high efficiency particulate and ultra-low penetration air filters (EPA, HEPA and ULPA) used in the field of ventilation and air conditioning and for technical processes, e.g....
This document references:
IEC 60812 - Failure modes and effects analysis (FMEA and FMECA)
Published by IEC on August 1, 2018
This document explains how failure modes and effects analysis (FMEA), including the failure modes, effects and criticality analysis (FMECA) variant, is planned, performed, documented and maintained....
This document references:
98/79/EC CORR - CORRIGENDUM to the European Parliament and of the Council on in Vitro Diagnostic Medical Devices
Published by EU on October 27, 1998
A description is not available for this item.
This document references:
EN 1822-1 - High efficiency air filters (EPA, HEPA and ULPA) - Part 1: Classification, performance testing, marking
Published by CEN on April 1, 2019
This document applies to high efficiency particulate and ultra-low penetration air filters (EPA, HEPA and ULPA) used in the field of ventilation and air conditioning and for technical processes, e.g....
This document references:
98/79/EC CORR - CORRIGENDUM to the European Parliament and of the Council on in Vitro Diagnostic Medical Devices
Published by EU on October 27, 1998
A description is not available for this item.
This document is referenced by:
BS EN ISO 22794 - Dentistry - Implantable materials for bone filling and augmentation in oral and maxillofacial surgery - Contents of a technical file
Published by BSI on September 30, 2009
A description is not available for this item.
This document is referenced by:
BS EN ISO 13408-7 - Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products
Published by BSI on February 28, 2013
A description is not available for this item.
This document is referenced by:
BS EN ISO 16671 - Ophthalmic implants - Irrigating solutions for ophthalmic surgery
Published by BSI on August 31, 2015
A description is not available for this item.
This document is referenced by:
BS EN ISO 14644-7 - Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
Published by BSI on October 14, 2004
A description is not available for this item.
This document is referenced by:
BS EN ISO 22803 - Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file
Published by BSI on January 13, 2006
A description is not available for this item.
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