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prEN ISO 19211 Public enquiry
Comment end date 2025-06-17
Anaesthetic and respiratory equipment - Fire-activated oxygen shut-off devices for use during oxygen therapy (ISO 19211:2024)

This document specifies requirements for fire activated oxygen shut-off devices that stop the flow of oxygen in respiratory therapy tubing when activated by fire. NOTE 1        Typical arrangements for fire activated oxygen shut-off devices are shown in Annex C. NOTE 2        Respiratory therapy tubing is covered by ISO 17256. NOTE 3        Use of fire activated oxygen shut-off devices in medical devices or accessories is not mandated in this document. The fire activated oxygen shut-off devices specified in this document are not suitable for use with oxygen therapy systems with flows in excess of 20 l/min). NOTE 4        There is rationale for this clause in A.2. The requirements in this device-specific standard take precedence over any conflicting requirements in the general standard for airway devices (ISO 18190). All the common requirements that appear in the general standard for airway devices have been removed from this document.

prEN ISO 10524-3 Archived
Comment end date 2025-05-20
Pressure regulators for use with medical gases - Part 3: Pressure regulators integrated with cylinder valves (VIPRs) (ISO/DIS 10524‑3:2025)

This document specifies design, type testing, and marking requirements for cylinder valves with integrated pressure regulators [as defined in 3.26 and referred to hereafter as valves with integrated pressure regulators (VIPRs)] intended for the administration of medical gases in the treatment, management, diagnostic evaluation and care of patients or for gases used for driving surgical tools. Examples of gases include oxygen, medical air and oxygen/nitrous oxide mixtures. This document applies to VIPRs mounted on refillable cylinders with a working pressure up to 30 000 kPa (300 bar) intended to be filled in cylinder filling facilities or on self-filling systems as used in homecare applications. VIPRs covered by this document are pressure pre-set and provided with a pressure outlet and/or pre-set flow outlet(s).

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