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DANSK DSF/EN ISO 11137-2/PRA1 PDF

DANSK DSF/EN ISO 11137-2/PRA1 PDF

Name:
DANSK DSF/EN ISO 11137-2/PRA1 PDF

Published Date:

Status:
[ Draft-Obsolete ]

Description:

Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose – Amendment 1 (ISO 11137-2:2013/DAmd 1:2021)

Publisher:
Dansk Standard

Document status:
Active
Format:
Electronic (PDF)
Delivery time:
10 minutes
Delivery time (for Russian version):
200 business days
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$8.7
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DRAFT * W/D S/S BY DS/EN ISO 11137-2

This part of ISO 11137 specifies methods of 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 dose auditing in order to demonstrate the continued effectiveness of the sterilization dose. This part of ISO 11137 defines product families for dose establishment and dose auditing.


Edition : 21
File Size : 1 file , 910 KB
Number of Pages : 17
Product Code(s) : DSF-009, DSF-009

History

DANSK DSF/EN ISO 11137-2/PRA1
DANSK DSF/EN ISO 11137-2/PRA1
Published Date:
Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose – Amendment 1 (ISO 11137-2:2013/DAmd 1:2021)
$8.7
DANSK DS/EN ISO 11137-2
DANSK DS/EN ISO 11137-2
Published Date: 07/06/2015
Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose
$35.7
DANSK DS/EN ISO 11137-2
DANSK DS/EN ISO 11137-2
Published Date: 06/21/2013
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
$35.7
DANSK DS/EN ISO 11137-2
DANSK DS/EN ISO 11137-2
Published Date: 04/27/2012
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
$35.7
DANSK DS/EN ISO 11137-2
DANSK DS/EN ISO 11137-2
Published Date: 06/14/2007
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
$33

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