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EN ISO 11137-2:2015 Standard

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  Keywords:

#part #methods #kgy #sterility #achieve

  Directive

In vitro diagnostic medical devices Directive (98/79/EC)

  Last Official Journal reference

Wednesday 25th of March 2020

  Description:

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013)

  Purpose

This part of ISO 11137 specifies methods for determining the minimum dose needed to achieve a specified requirement for sterility and methods to substantiate the use of 25 kGy or 15 kGy as the sterilization dose to achieve a sterility assurance level, SAL, of 10−6. This part of ISO 11137 also specifies methods of sterilization dose audit used to demonstrate the continued effectiveness of the sterilization dose. This part of ISO 11137 defines product families for sterilization dose establishment and sterilization dose audit.

  Publication

Friday 17th of November 2017

  Reference

This standard superseed the "EN ISO 11137-2:2013"

Anyway is still possible use the "EN ISO 11137-2:2013" until June 30th, 2016

  Related Standards

EN 556-1:2001

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Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminal...

EN ISO 13408-5:2011

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Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

EN ISO 15194:2009

In vitro diagnostic medical devices Directive (98/79/EC)

In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified refer...

EN ISO 14971:2012

In vitro diagnostic medical devices Directive (98/79/EC)

Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)

EN 14820:2004

In vitro diagnostic medical devices Directive (98/79/EC)

Single-use containers for human venous blood specimen collection

EN 14254:2004

In vitro diagnostic medical devices Directive (98/79/EC)

In vitro diagnostic medical devices - Single-use receptacles for the collection of specimens, other than blood, from humans

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