EN 285:1996

EN 285:1996 is a standard published by the European Committee for Standardization (CEN). Its full title is "Sterilization - Steam sterilizers - Large sterilizers". This standard covers: 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).

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).

EN 285:1996 is classified under the following ICS (International Classification for Standards) categories: 11.080 - Sterilization and disinfection. The ICS classification helps identify the subject area and facilitates finding related standards.

EN 285:1996 has the following relationships with other standards: It is inter standard links to EN 285:2006, EN 867-5:2001, EN 13060:2004+A2:2010, EN 14222:2003, EN 285:1996/AC:1998. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN 285:1996 is associated with the following European legislation: EU Directives/Regulations: 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.

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