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BS EN 556:1995 Sterilization of medical devices. Requirements for terminally-sterilized devices to be labelled 'Sterile'

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1.1 This European Standard specifies the requirements for a terminally-sterilized medical device to be labelled 'STERILE'. NOTE. For the purposes of the EC Directives for medical Ndevices and for active implantable medical devices (see annex A), labelling a medical device 'STERILE' is only permissible when a validated sterilization process has been used. Requirements for the validation and routine control of processes for the sterilization of medical devices are specified in EN 550, EN 552 and EN 554. 1.2 This European Standard is not applicable to in vitro diagnostic medical devices.
Contributor(s):
MAR - Data Entry Person
Primary Item Type:
British Standard
Identifiers:
ISBN 0580232042
ICS 11.080.01 Sterilization and disinfection in general
Language:
English
Subject Keywords:
Medical instruments; Quality assurance; Medical equipment; Marking; Sterile equipment; Quality control; Sterilization (hygiene); Microorganisms
First presented to the public:
2/24/2023
Original Publication Date:
3/15/1995
Previously Published By:
British Standards Institution
Place Of Publication:
London, United Kingdom
Citation:
Extents:
Number of Pages - 6
License Grantor / Date Granted:
  / ( View License )
Date Deposited
2023-02-24 10:59:02.87
Submitter:
Muhamad Azmil Ramli

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BS EN 556:1995 Sterilization of medical devices. Requirements for terminally-sterilized devices to be labelled 'Sterile'1 2023-02-24 10:59:02.87
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