Overview
ISO 4135:2022 - Anaesthetic and respiratory equipment - Vocabulary provides a consistent, domain‑specific vocabulary for anaesthetic and respiratory equipment, related devices and medical gas supply systems. Its purpose is to reduce ambiguity across standards, test protocols, regulation and product documentation by defining terms and their domain specifiers. The fourth edition updates the 2001 version, aligns terminology with other ISO work (for example ISO 19223), and includes German equivalents for reference (only the English and French terms are ISO‑official).
Key topics
This vocabulary standard covers a broad set of topics used across anaesthesia and respiratory care standards:
- General concepts: properties of gases and materials, equipment properties, metrology concepts, equipment components, physiological terms, environment and workflow.
- Medical gas supply systems: pipeline systems, terminal units, low‑pressure hose assemblies, pressure regulators, gas cylinders and accessories.
- Anaesthetic machines and workstations: general terms and component names to support consistent product descriptions and testing.
- Ventilators and resuscitators: terms for devices, ports, pressures and flowrates (with ventilator‑specific items cross‑referenced to ISO 19223).
- Oxygen therapy and liquid oxygen systems.
- Breathing systems and interfaces: adaptors, valves, circuits, masks, tracheal tubes, tracheostomy tubes, bronchial devices.
- Humidifiers, nebulizers and heat‑moisture exchangers.
- Anaesthetic gas scavenging and plume evacuation systems.
- Suction devices and catheters.
- Monitoring terminology: gas monitors, pulse oximetry, thermometry, ECG, blood pressure (sphygmomanometers), transcutaneous gas monitors.
- Annexes and index: alphabetized index of defined terms and bibliography for further reference.
Practical applications
ISO 4135:2022 is a reference tool that improves clarity and consistency when producing or using technical documents for:
- Manufacturers - product specifications, user manuals, design documentation, and regulatory submissions.
- Test and calibration laboratories - harmonized test reports and interpretation of test methods.
- Regulators and notified bodies - consistent interpretation of device descriptions and conformity assessment.
- Standards developers and committees - avoiding duplicated or conflicting definitions across standards.
- Procurement and clinical engineering - clear device inventories, procurement specifications and clinical protocols.
Using ISO 4135 reduces misunderstandings between stakeholders, speeds regulatory review and supports safer device design and interoperability.
Related standards
- ISO 19223 (ventilator terminology) - referenced for ventilator‑specific terms.
- ISO 14971 (risk management) - applicable general standard used across medical device standards.
- IEC/TC 62 standards - electromechanical medical device standards that may be used alongside ISO 4135.
Keywords: ISO 4135:2022, anaesthetic and respiratory equipment, vocabulary, terminology, medical gas, ventilators, anaesthetic machines, breathing systems, monitoring.