NEN-EN-ISO 11137-2
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
active
| Organization: | NEN |
| Publication Date: | 1 June 2015 |
| Status: | active |
| Page Count: | 87 |
| ICS Code (Sterilization and disinfection in general): | 11.080.01 |
scope:
NEN-EN-ISO 11137-2 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.
Document History
May 1, 2023
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
A description is not available for this item.
NEN-EN-ISO 11137-2
June 1, 2015
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
NEN-EN-ISO 11137-2 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...
June 1, 2013
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
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...
April 1, 2012
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
A description is not available for this item.
July 1, 2009
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
A description is not available for this item.
April 1, 2009
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
A description is not available for this item.
May 1, 2006
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
May 1, 2006
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (corrected and reprinted)
This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.
May 1, 2004
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
This part of ISO 11137 specifies requirements for the development, validation and routine control of a radiation sterilization process for medical devices.