AAMI/ISO 11137-2:2012 PDF

AAMI/ISO 11137-2:2012 PDF

Name:
AAMI/ISO 11137-2:2012 PDF

Published Date:
05/03/2012

Status:
Active

Description:

Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

Publisher:
Association for the Advancement of Medical Instrumentation/International Org. for Standardization

Document status:
Active

Format:
Electronic (PDF)

Delivery time:
10 minutes

Delivery time (for Russian version):
200 business days

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$42.9
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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 106. 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.
ANSI : ANSI Approved
File Size : 1 file , 850 KB
ISBN(s) : 1570204446
Note : This product is unavailable in Ukraine, Russia, Belarus
Number of Pages : 94
Published : 05/03/2012
Same As : AAMI/ISO 11137-2:2012

History

AAMI/ISO 11137-2:2013 (R2019)
Published Date: 07/10/2013
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
$82.5
AAMI/ISO 11137-2:2012
Published Date: 05/03/2012
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
$42.9
AAMI/ISO 11137-2:2006
Published Date: 04/21/2009
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (Corrected 21 April 2009)
$39.6
AAMI/ISO 11137-2:2006
Published Date: 08/01/2006
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
$39.6

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AAMI/ISO 11137-3:2017 (R)2023
Published Date: 10/06/2017
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine
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AAMI/ISO 11137-2:2013 (R2019)
Published Date: 07/10/2013
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
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