EN 285:1996

Sterilization - Steam sterilizers - Large sterilizers

Publication date:   Jan 22, 2004

General information

99.60 Withdrawal effective   May 31, 2006

CEN

CEN/TC 102 Sterilizers and associated equipment for processing of medical devices

European Norm

11.080   Sterilization and disinfection

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Scope

1.1 This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of one or more sterilization modules for wrapped goods (instruments etc. and porous loads). Large steam sterilizers can also be used during the commercial production of medical devices. Note: Sterilizers conforming to this standard can offer a single automatic sterilization cycle or a number of selectable automatic sterilization cycles, e.g. with different operating temperatures (see 28.3b). 1.2 This European Standard is not applicable to small steam sterilizers nor to steam sterilizers used for the sterilization of pharmaceutical products in containers. Note: The use of sterilizers for unwrapped instruments and utensils for immediate use in aseptic areas and for fluid-sterilizers will be the subject of a separate standards. 1.3 This European Standard does not describe a quality assurance system for the control of all stages of the manufacture of the sterilizer. Note: Attention is drawn to the standards for quality systems (see EN ISO 9001, EN ISO 9002, EN ISO 9004-1 and EN 46001 and EN 46002).

Related legislation

Legislation related to this standard

93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

NOW

WITHDRAWN
EN 285:1996
99.60 Withdrawal effective
May 31, 2006

CORRIGENDA / AMENDMENTS

WITHDRAWN
EN 285:1996/AC:1998

REVISED BY

WITHDRAWN
EN 285:2006

Relations

Adopted from DIN 58 946 NOT_EQUIVALENT