Overview

This standard specifies safety and performance requirements for manually powered medical suction equipment intended for oro-pharyngeal suction. It includes equipment operated by foot or by hand. The commonest use of manually powered suction is in situations outside of health care settings often described as field use or transport use. Therefore, the standard considers specifications on environmental conditions as they may be exist outdoors or during transport. In respect to DIN EN ISO 10079-2:2009-07 general requirements for the risk management, usability, clinical investigation and biophysical or modelling research have been supplemented. Moreover, various technical requirements for the devices and their components have been revised or reworded. They include in particular revisions of requirements for the cleaning, disinfection or sterilization of parts intended for re-use, the supplement of requirements for suction 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 Technical Committee CEN/TC 215 "Anaesthetic and respiratory equipment" the secretariat of which is held by BSI (United Kingdom) in collaboration with Technical Committee ISO/TC 121 "Anaesthetic and respiratory equipment". The responsible body for the German collaboration is Working Committee NA 053-03-01 AA "Anästhesie und Beatmung" ("Anaesthesia and artificial respiration") at DIN Standards Committee Rescue Services and Hospital (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