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Norm

ÖNORM EN 556-1

Issue date: 2006 12 01

Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices (consolidated version)

This European Standard specifies the requirements for a terminally-sterilized medical device to be designated STERILE. Part 2 of this European Standard specifies the req...

Valid

§ Legal References

Publisher:

Austrian Standards International

Format:

Digital | 10 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 a terminally-sterilized medical device to be designated STERILE. Part 2 of this European Standard specifies the requirements for an aseptically processed medical device to be designated STERILE. NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designation of a medical device as STERILE is only permissible when a validated sterilization process has been applied. Requirements for validation and routine control of processes for the sterilization of medical devices are specified in EN 550, EN 552, EN 554, EN ISO 14160 and EN ISO 14937.

ÖNORM EN 556-1

2006 12 01

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

Norm

↖

ÖNORM EN 556-1

2002 01 01

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

Norm

ÖNORM EN ISO 13485

Issue date : 2007 11 01

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