AAMI ISO 10651-4:2002 pdf download – Lung ventilators
1 Scope
This European Standard specifies requirements for operator-powered resuscitators intended for use with all age groups and which are portable and intended to provide lung ventilation to individuals whose breathing is inadequate. Operator-powered resuscitators for infants and children are designated according to body mass range and approximate age equivalent. Electrically-and gas-powered resuscitators are not covered by this European Standard. NOTE Annex B contains rationale statements for this Part of this European Standard. The clauses and subclauses which have corresponding rationale statements are marked with R) after their number.
2 Normative references
This European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies (including amendments).
EN 148-1, Respiratory protective devices – Threads for facepieces –Part 1: Standard thread connection.
EN 556: 1994+A1:1998, Sterilization of medical devices – Requirements for terminally-sterilized medical devices to be labelled “STERILE”.
EN 737-1, Medical gas pipeline systems – Part 1: Terminal units for compressed medical gases and vacuum.
EN 868-1, Packaging materials and systems for medical devices which are to be sterilized – Part 1: General requirements and test methods .
EN 1041, Information supplied by the manufacturer with medical devices.
EN 1281-1, Anaesthetic and respiratory equipment – Conical connectors – Part 1: Cones and sockets.
prEN 13544-2:2000, Respiratory therapy equipment – Part 2 : Specifications for tubing and connectors.
EN ISO 4135:1996, Anaesthesiology – Vocabulary (ISO 4135 :1995).
3 Terms and definitions
For the purposes of this part of EN ISO 10651, the terms and definitions given in EN ISO 4135:1996 and the following terms and definitions apply.
NOTE Some of the definitions have been taken from EN ISO 4135, but they are included in this European Standard for convenience; other definitions, which are given in EN ISO 4135, for apparatus in general, have been modified slightly for the purposes of this European Standard as they apply specifically to resuscitators.
3.1 reverse leakage
volume of expired gas which does not pass through the expiratory port but returns to the resuscitator
3.2 bag inlet valve
valve activated by the subatmospheric pressure in the compressible unit of the resuscitator to refill the compressible unit with gas at ambient pressure
3.3 bag refill valve
valve, with no manual trigger, activated by the sub-atmospheric pressure in the compressible unit of the resuscitator to refill the compressible unit from a pressurized gas source
3.4 compressible unit
that part of an operator-powered resuscitator e.g. a bag or bellows that, when compressed by the operator,delivers a volume of gas
3.5 delivered oxygen concentration
average concentration of oxygen in the gas delivered from the resuscitator
3.6 delivered volume
volume of gas, expressed in millilitres, leaving the resuscitator through the patient connection port during the inspiratory phase
3.7 forward leakage
volume of gas produced by the resuscitator during the inspiratory phase which does not pass through the patient port to the patient but passes to the atmosphere