Overview
EN ISO 23747:2015 (ISO 23747:2015) specifies requirements for peak expiratory flow meters (PEFMs) intended to assess pulmonary function in spontaneously breathing humans. Adopted by CEN, this international standard applies to PEFMs used as standalone devices or as part of integrated lung‑function systems. It updates and supersedes the 2009 edition and provides technical, safety and testing guidance for manufacturers, test laboratories and regulatory bodies.
Key topics and technical requirements
The standard addresses the following core technical subjects and requirements:
- Scope and definitions: Applicability to medical devices that measure peak expiratory flowrate in spontaneously breathing humans.
- General safety: Mechanical and electrical basic safety principles for respiratory and anaesthetic equipment.
- Performance requirements:
- Measurement range and error of measurement
- Linearity, resistance to flow, and frequency response
- Repeatability and measurement uncertainty
- Testing methods: Normative test procedures are given in Annexes B–D for error, frequency response, dismantling, ageing and drop tests.
- Durability & maintenance: Procedures for dismantling/reassembly, effects of mechanical ageing and dropping (hand‑held devices).
- Cleaning, sterilization and disinfection: Requirements for reusable devices and sterile‑delivered parts.
- Identification, marking and documentation: Labelling of scales/displays, device/packaging marking, and instructions for use.
- Biocompatibility and material compatibility: Expectations for materials in contact with patients.
- Environmental aspects: Lifecycle environmental impact considerations are addressed in Annex E; ISO 14971 is referenced for additional risk/environmental considerations.
- Regulatory alignment: Informative Annex ZA maps clauses to EU Medical Device Directive 93/42/EEC essential requirements.
Applications and who uses this standard
EN ISO 23747:2015 is intended for:
- Manufacturers and designers of PEFMs (stand‑alone or integrated) to ensure device safety, performance and regulatory conformity.
- Test laboratories and conformity assessment bodies performing performance and durability testing per the standard’s normative methods.
- Regulatory and procurement specialists assessing compliance with EU and international medical device requirements.
- Healthcare providers and clinical engineers who specify or validate peak flow measurement devices for pulmonary function assessment.
Practical applications include device design validation, type testing, regulatory submissions and quality assurance for peak expiratory flow measurement instruments.
Related standards
- ISO 14971 (medical device risk management) - referenced for broader environmental and risk considerations.
- EU Directives and national standards - Annex ZA relates EN ISO 23747 to Directive 93/42/EEC essential requirements.
Keywords: EN ISO 23747:2015, ISO 23747:2015, peak expiratory flow meter, PEFM, pulmonary function, peak expiratory flowrate, respiratory equipment, medical device standard.
