Overview
EN ISO 10524-1:2019/A1:2023 (ISO 10524-1:2018/Amd 1:2023) is an amendment to the international and European standard for pressure regulators for use with medical gases - Part 1, covering pressure regulators and pressure regulators with flow‑metering devices. Approved by CEN in June 2023 and published as an amendment in November 2023, it updates specific connector and outlet pressure requirements and bibliographic references. The amendment was prepared by ISO/TC 121 (Anaesthetic and respiratory equipment) in collaboration with CEN/TC 215.
Key topics and requirements
This amendment focuses on clarifying and tightening requirements related to outlets and outlet pressure. Principal changes include:
- Scope exclusion for integral devices: Several provisions apply except for pressure regulators that are an integral part of medical equipment, i.e., standalone regulators are targeted.
- Outlet connector requirements (clause changes to 6.4.2.1 and 6.4.2.3):
- Outlet connector(s) must comply with ISO 9170-1 for specified gases or use a recognized gas‑specific system for other medical gases.
- Examples of recognized connector systems noted include Diameter-Indexed Safety System (DISS) and non-interchangeable screw-threaded (NIST) connectors.
- Outlet pressure setting (6.5.1.1):
- When a pressure regulator is fitted with a pressure outlet (and is not integral to another device), the outlet pressure shall be pre-set.
- Bibliography update:
- Reference updated from EIGA Doc 180/13 to EIGA Doc 180/19.
These targeted amendments refine connector compatibility and safety measures to reduce risk of misconnections and ensure predictable outlet pressures for medical gas applications.
Applications and users
This amendment is directly relevant to:
- Manufacturers of medical gas pressure regulators and flow‑metering devices (design, testing, marking)
- Medical device designers and integrators who incorporate regulators into gas delivery systems
- Biomedical engineering and maintenance teams in hospitals and clinics (specification and procurement)
- Regulatory and compliance professionals ensuring conformity with European and international standards
Practical applications include regulators used in anaesthesia machines, oxygen delivery, respiratory therapy equipment and portable medical gas systems.
Related standards
- ISO 9170-1 - Connectors for medical gas supply systems (referenced for gas‑specific outlet connectors)
- EIGA Doc 180/19 - Updated industry guidance cited in the bibliographic section
- ISO/TC 121 and CEN/TC 215 are the technical committees behind the standard.
This amendment helps ensure safer, interoperable medical gas regulator designs by clarifying connector and outlet‑pressure requirements - essential for minimizing misconnections and ensuring consistent gas delivery in clinical settings.
