Regulatory requirements applicable for Ventilators

According to the Article 8 – use of harmonized standard, medical devices must be in compliance with relevant harmonized standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union. From this list, the following standards are applicable for the ventilators:

• EN 794-3:1998+A2:2009 Lung ventilators — Part 3: Particular requirements for emergency and transport ventilators
• EN ISO 8835-5:2009 Inhalational anesthesia 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 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

The following harmonized standards are applicable for all manufacturers of the medical devices:

• EN 1041:2008 Information supplied by the manufacturer of medical devices
• EN ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2016)
• EN ISO 15223-1:2016 Medical devices — Symbols to be used with medical device labels, labeling and information to be supplied — Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)

For the decision are all of these standards applicable to your specific type of ventilators, I do not have enough data. Are there some other standards that are also applicable, the manufacturer must decide.

For more details, please see:

• EU MDR Article 8 – use of harmonized standard https://advisera.com/13485academy/mdr/use-of-harmonised-standards/
• Official Journal of the European Union https://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices_en

For more information on determining regulatory requirements according to ISO 13485:2016, see the following article:

• How to determine regulatory requirements according to ISO 13485:2016 https://advisera.com/13485academy/knowledgebase/how-to-determine-regulatory-requirements-according-to-iso-13485/