Overview

Safety and performance requirements for medical suction equipment powered from a vacuum or positive pressure gas source generating venturi suction are specified. The standard applies to equipment connected to medical gas pipeline systems or cylinders and venturi attachments. The equipment can be stand-alone or part of an integrated system. With respect to DIN EN ISO 10079-3:2009-07, general requirements for the risk management, usability, clinical investigation and biophysical or modelling research have been supplemented. Furthermore, various technical modifications for the equipment and their parts have been revised or reorganized. They include in particular revisions of requirements for the cleaning, disinfection or sterilization of parts intended for re-use, the inclusion of requirements for equipment with interrupted suction, the revision of test methods and the revision of requirements for marking and information to be supplied by the manufacturer. The standard has been prepared by CEN/TC 215 "Respiratory and anaesthetic equipment", the secretariat of which is held by BSI (United Kingdom). The responsible German committee is Working Committee NA 053-03-01 AA "Anästhesie und Beatmung" ("Anaesthesia and respiration") at the Rescue Services and Hospital Standards Committee (NARK).

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-05-03 AA - Anaesthesia and artificial respiration  

Responsible european committee

CEN/TC 215 - Respiratory and anaesthetic equipment  

Responsible international committee

ISO/TC 121/SC 8 - Suction devices