AAMI/ISO 11137-1:2006/(R)2010 PDF

AAMI/ISO 11137-1:2006/(R)2010 PDF

Name:
AAMI/ISO 11137-1:2006/(R)2010 PDF

Published Date:
12/23/2005

Status:
Active

Description:

Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

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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$46.2
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Specifies requirements for validation, process control, and routine monitoring in the radiation sterilization for health care products. It applies to continuous and batch type gamma irradiators using the radionuclides 60 Co and 137 Cs, and to irradiators using a beam from an electron or X-ray generator.
ANSI : ANSI Approved
File Size : 1 file , 270 KB
Note : This product is unavailable in Ukraine, Russia, Belarus
Number of Pages : 54
Part of : AAMI STBK10-3
Published : 12/23/2005

History

AAMI/ISO 11137-1:2006/(R)2015 & A1:2003 & A2:2019 (Consolidated Text)
Published Date: 12/30/2013
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices, Includes A1:2013 & A2:2019
$82.5
AAMI/ISO 11137-1:2006/(R)2010
Published Date: 12/23/2005
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices
$46.2
AAMI/ISO 11137:1994 + Amendment 1
Published Date: 01/01/2002
Sterilization of Health Care Products: Requirements for Validation and Routine Control, Radiation Sterilization, 3ed.
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AAMI/ISO 10993-1:2018
Published Date: 04/27/2020
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
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