BS EN 12297:1998 PDF

Scope: This European Standard gives guidance on general testing procedures to assess the sterilizability for micro-organisms of equipment (components and units of equipment) used in biotechnological processes. This European Standard gives guidance on the assessment of the sterilizability of biotechnological equipment with respect to a release of process micro-organisms that can affect the safety of the worker (occupational health) and/or that can have adverse effects to the environment. This European Standard is applicable to plants or components, such as valves and fittings, tanks, pumps, piping, separating and filling devices as well as instrumentation in contact with process fluids. This European Standard applies if the intended use of the equipment includes hazardous or potentially hazardous micro-organisms. This European Standard is not applicable to testing for sterility of media and equipment prior to processing or operation, respectively. NOTE 1 For disinfection of external surfaces such as walls, working benches and floors, attention is drawn to national and European Standards. NOTE 2 For sterilization of equipment and media in autoclaves attention is drawn to national and European Standards such as EN 285 and EN 554 (see annex C [21], [22]).

BS EN 12297:1998 history

1998 BS EN 12297:1998 Biotechnology - Equipment - Guidance on testing procedures for sterilizability