DIN EN ISO 80601-2-84:2024-04

This document specifies the basic safety and essential performance of an EMS ventilator in combination with its accessories. The scope includes accessory parts intended by their manufacturer to be connected to the ventilator breathing system or to an EMS ventilator, if the characteristics of these accessory parts may affect the basic safety or essential performance of the EMS ventilator. Compared to the first edition, this second edition has undergone a major technical revision. The changes include, in particular, updates based on the revision of IEC 60601-1 on the general safety and essential performance requirements for medical electrical equipment, additional requirements for a responsible organizational protocol, and clarification of the requirements for the maximum limit pressure. This document (EN ISO 80601-2-84:2023) has been prepared by Technical Committee ISO/TC 121 "Anaesthetic and respiratory equipment" in collaboration with Technical Committee CEN/TC 215 "Respiratory and anaesthetic equipment", the secretariat of which is held by BSI (United Kingdom). The responsible German standardization committee is Working Committee NA 176-05-03 AA "Anästhesie und Beatmung" ("Anaesthesia and artificial respiration") at DIN Standards Committee Health Technologies (NAGesuTech).