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Norm

ÖNORM EN 556-2

Issue date: 2015 10 15

Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Part 2: Requirements for aseptically processed medical devices

This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'.

Valid

§ Legal References

Publisher:

Austrian Standards International

Format:

Digital | 18 Pages

Language:

German | English | Download GER/ENG

Optionally co-design standards:

Committee 215: Sterilization and disinfection of medical devices

ICS

11.080.01

Topics

Healthcare, Sterilization and disinfection of medical devices, Sterilization and disinfection in general

This European Standard specifies the requirements for an aseptically processed medical device to be designated 'STERILE'.

ÖNORM EN 556-2

2015 10 15

Sterilization of medical devices - Requirements for medical devices to be designated ''STERILE" - Pa...

Norm

↖

ÖNORM EN 556-2

2004 03 01

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Par...

Norm

ÖNORM EN ISO 14160

Issue date : 2011 10 01

Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011)

Norm

ÖNORM EN ISO 17665-1

Issue date : 2006 11 01

Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006)

Norm

ÖNORM EN ISO 14937

Issue date : 2010 03 15

Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009)

Norm

ÖNORM EN ISO 13408-5

Issue date : 2011 09 15

Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006)

Norm

ÖNORM EN ISO 25424

Issue date : 2011 08 01

Sterilization of medical devices - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2009)

Norm

ÖNORM EN ISO 13408-2

Issue date : 2011 09 15

Aseptic processing of health care products - Part 2: Filtration (ISO 13408-2:2003)

Norm

ÖNORM EN ISO 13485

Issue date : 2012 11 01

Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003 + Cor 1:2009) (consolidated version)

Norm

ÖNORM EN ISO 20857

Issue date : 2013 08 01

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)

Norm

ÖNORM EN ISO 11135

Issue date : 2015 03 15

Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)