Overview
ISO 23747:2015 - Anaesthetic and respiratory equipment: Peak expiratory flow meters (pefm) - specifies safety and performance requirements for devices that measure peak expiratory flow (PEF) in spontaneously breathing humans. It applies to standalone peak flow meters and pefms integrated into larger lung-function systems. The standard defines measurement range, marking, test methods, and lifecycle/environmental considerations (Annex E), ensuring pefms are safe, accurate, and fit for clinical and home use.
Key Topics and Requirements
- Scope and definitions: Clear definitions of PEF, pefm, rise time, dwell time, and related terms to standardize vocabulary across manufacturers and testers.
- Performance requirements: Includes requirements for error of measurement, linearity, resistance to flow, and frequency response (see Clauses 6–7 and normative Annexes B–C for test methods).
- Identification and marking: Scales or displays must be in litres per minute or litres per second; graduated scales have defined increment limits (≤ 10 L/min increments ≤ 700 L/min, ≤ 20 L/min > 700 L/min). Digital displays must step by no more than 5 L/min.
- Safety and mechanical design: Mechanical basic safety (avoid sharp edges, burrs); electrical pefms must comply with IEC 60601-1 (Clause 4.1).
- Durability tests: Requirements and test methods for dismantling/reassembly, mechanical ageing, and dropping (Clause 8–10, Annex D).
- Cleaning, sterilization and biocompatibility: Provisions for reusable and sterile-delivered pefms and compatibility with substances (Clause 11–13; references to ISO 10993‑1 and ISO 14937).
- Documentation and usability: Labelling, instructions for use, and technical descriptions (Clause 5).
- Environmental considerations: Life-cycle environmental aspects addressed in Annex E; links to risk management in ISO 14971.
Applications and Users
- Manufacturers and product designers use ISO 23747:2015 to design and validate peak flow meters that meet international safety and accuracy benchmarks.
- Clinical engineers, respiratory therapists, and pulmonologists rely on standardized pefm performance for diagnosis and monitoring of asthma and other airway conditions.
- Regulatory bodies and testing laboratories use the standard for conformity assessment and for establishing test protocols.
- Procurement teams and hospitals evaluate devices for interoperability, labelling clarity, and home-use suitability.
Related Standards
ISO 23747:2015 helps ensure reliable, comparable peak expiratory flow measurements across devices, improving clinical decision-making and patient self-monitoring while addressing safety, usability, and environmental impact.