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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...
Withdrawn: 2024 08 15
Publisher:
Austrian Standards International
Format:
Digital | 10 Pages
Language:
German
| English
| Download GER/ENG
Currently valid:
Optionally co-design standards:
ICS
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
2024 08 15
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Par...
Norm
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
Norm
Issue date :
2007 11 01
Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2003) (consolidated version)
Norm
Issue date :
2024 08 15
Sterilization of medical devices - Requirements for medical devices to be designated "STERILE" - Part 1: Requirements for terminally sterilized medical devices
