Ventilators are used in hospitals and these machines provide ventilation by moving breathable air into and out of the lungs, to deliver breaths to a patient who is physically unable to breathe, or breathing insufficiently. They are also called respirator. According to FDA, there are five types of ventilators (respirators):
1) Continuous ventilator
A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
2) Noncontinuous ventilator (IPPB)
(intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient’s lungs or to assist a patient’s breathing.
3) Manual emergency ventilator
is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient’s airway.
4) Powered emergency ventilator
is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient’s airway.
5) External negative pressure ventilator
(e.g., iron lung, cuirass) is a device chamber that is intended to support a patient’s ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient.
For USA, FDA, with Electronic Code of Federal Regulations (eCFR), regulates ventilators. Title 21: Food and Drugs, Chapter I → Subchapter H → Part 868 sets forth the classification of anesthesiology devices intended for human use that are in commercial distribution.
Europe regulates ventilators (respirators) with Medical Device Directive (93/42/EC). Harmonised standards related to ventilators are listed below. For recent standard list, you have to check current version of harmonised standards list.
You can click on the links to reach a preview of the standard.
EN 794-3:1998+A2:2009 Lung ventilators – Part 3: Particular requirements for emergency and transport ventilators
EN 60601-2-12:2006 Medical electrical equipment – Part 2-12: Particular requirements for the safety of lung ventilators – Critical care ventilators
IEC 60601-2-12:2001
EN ISO 8835-5:2009 Inhalational anaesthesia systems – Part 5: Anaesthetic ventilators (ISO 8835-5:2004)
EN ISO 10651-2:2009 Lung ventilators for medical use – Particular requirements for basic safety and essential performance – Part 2: Home care ventilators for ventilator-dependent patients (ISO 10651-2:2004)
EN ISO 10651-4:2009 Lung ventilators – Part 4: Particular requirements for operator-powered resuscitators (ISO 10651-4:2002)
EN ISO 10651-6:2009 Lung ventilators for medical use – Particular requirements for basic safety and essential performance – Part 6: Home-care ventilatory support devices (ISO 10651-6:2004)
EN 12342:1998+A1:2009 Breathing tubes intended for use with anaesthetic apparatus and ventilators
Do you need any testing or certification service for a ventilator (respirator)?
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