RO
SR EN ISO 20857:2013
Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 20857:2010)
ISO 20857:2010 specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices. Although ISO 20857:2010 primarily addresses dry heat sterilization, it also specifies requirements and provides guidance in relation to depyrogenation processes using dry heat.
Status :
Valid
Approval date : 9/30/2013
Number of pages : 72
ICS : 11.080.01 Sterilization and desinfectation
Technical Committee : 377 - Medical devices
- Normative reference SR EN 61010-2-040:2006
- Normative reference SR EN ISO 11607-2:2006
- Normative reference SR EN 61010-1:2011
- Normative reference SR EN ISO 11138-4:2007
- Normative reference SR EN ISO 10993-17:2009
- Normative reference SR EN ISO 11737-1:2006
- Normative reference SR EN ISO 10993-1:2010
- Normative reference SR EN ISO 13485:2012
- Normative reference SR EN ISO 11140-1:2009
- Normative reference SR EN ISO 11138-1:2007
- Normative reference SR EN ISO 11737-2:2010
- Normative reference SR EN ISO 11607-1:2009
- Normative reference SR EN ISO 10012:2004