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  3. AAMI/ISO TIR13004:2013/(R)2016 [HISTORICAL] PDF

AAMI/ISO TIR13004:2013/(R)2016 [HISTORICAL] PDF

AAMI/ISO TIR13004:2013/(R)2016 [HISTORICAL] PDF

Name:
AAMI/ISO TIR13004:2013/(R)2016 [HISTORICAL] PDF

Published Date:
10/04/2013

Status:
Active

Description:

Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose: Method VDmaxSD [HISTORICAL]

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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Choose Document Language:
$82.5
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This Technical Specification describes a method for substantiating a selected sterilization dose of 17.5, 20, 22.5, 27.5, 30, 32.5 or 35 kGy that achieves a sterility assurance level (SAL) of 10-6 or less for radiation sterilization of health care products. This Technical Specification also specifies a method of sterilization dose audit used to demonstrate the continued effectiveness of the substantiated sterilization dose.
ANSI : ANSI Approved
File Size : 1 file , 4.8 MB
Note : This product is unavailable in Ukraine, Russia, Belarus
Number of Pages : 85
Published : 10/04/2013

History

AAMI/ISO 13004:2022
AAMI/ISO 13004:2022
Published Date: 02/09/2024
Sterilization of health care products—Radiation—Substantiation of selected sterilization dose: Method VDmaxSD
$90.9
AAMI/ISO TIR13004:2013/(R)2016 [HISTORICAL]
AAMI/ISO TIR13004:2013/(R)2016 [HISTORICAL]
Published Date: 10/04/2013
Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose: Method VDmaxSD [HISTORICAL]
$82.5

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