Overview
EN ISO 4135:2022 (ISO 4135:2022) establishes a standardized vocabulary for anaesthetic and respiratory equipment and related supply systems. This fourth-edition international standard defines terms and definitions used across devices, components, gases, metrology, physiological concepts and clinical workflows to ensure consistent communication between manufacturers, clinicians, regulators and standards bodies.
Key features:
- Centralized, domain‑specific terminology to avoid multiple definitions.
- Use of a general category plus domain specifiers and pre‑coordinated domain‑specific term names.
- Official ISO terms and definitions provided in English and French; German equivalents are included under the responsibility of the German member body.
Key topics and technical scope
ISO 4135 is a vocabulary standard rather than a performance specification. Its structured glossary covers terms across these technical areas:
- General concepts: properties of gases and materials, equipment properties, metrology, components, physiological terms, use environment and workflow.
- Medical gas supply systems: pipeline systems, terminal units, low‑pressure hoses, pressure regulators, cylinders and accessories.
- Anaesthetic machines and workstations: general terms and component definitions.
- Ventilators and resuscitators: ports, pressures, flowrates and related nomenclature.
- Oxygen delivery and liquid oxygen systems.
- Breathing systems: classification, adaptors, valves, masks and cannulae.
- Humidifiers, nebulizers and heat & moisture exchangers.
- Airways and intubation equipment: tracheal and tracheostomy tubes, bronchial blockers, laryngoscopes.
- Scavenging/plume evacuation and suction devices.
- Monitoring terminology: gas monitors, pulse oximetry, thermometry, ECG, blood pressure and transcutaneous gas monitors.
Practical applications - who uses this standard
ISO 4135 is essential for stakeholders who need precise and consistent terminology:
- Medical device manufacturers - product specifications, labeling, user manuals and technical documentation.
- Clinical professionals (anesthesiologists, respiratory therapists, intensive care teams) - clear device descriptions, protocols and training materials.
- Biomedical engineers and maintenance teams - spare parts lists, system integration and procurement.
- Regulators and standards committees - harmonized definitions for conformity assessment and regulatory submissions.
- Technical writers and translators - consistent multilingual terminology for documentation and localization.
Related standards
ISO 4135 complements other ISO/CEN/IEC standards covering medical device safety, performance, gas pipeline installations and electrical/EMC requirements. It was prepared by ISO/TC 121 (Anaesthetic and respiratory equipment) in collaboration with CEN/TC 215.
For precise term definitions and authoritative usage, consult the full ISO 4135:2022 text or your national standards body.
