ISO 23747:2015 PDF

Anaesthetic and respiratory equipment — Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans

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Title (English):

ISO 23747:2015

Anaesthetic and respiratory equipment — Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 26
Publication date:: July 28, 2015
Edition:: ISO IS 23747 edition 2 version 1
ICS:: 11.040.10

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Description (English):

ISO 23747:2015 specifies requirements for a peak expiratory flow meter (pefm) intended for the assessment of pulmonary function in spontaneously breathing humans. ISO 23747:2015 covers all medical devices that measure peak expiratory flowrate in spontaneously breathing humans either as part of an integrated lung function medical device or as a stand-alone medical device. Planning and design of products applying to this International Standard are to consider the environmental impact from the product during its life cycle. Environmental aspects are addressed in Annex E. NOTE Additional aspects of environmental impact are addressed in ISO 14971.

Technical details

Technical committee: ISO/TC 121/SC 3 - Respiratory devices and related equipment used for patient care
SKU: ISO 23747:2015

Abstract

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 14971 - Risk management for medical devices
IEC 60601-1 - Medical electrical equipment safety
ISO 10993-1 - Biological evaluation (biocompatibility)
ISO 15223-1 - Medical device symbols and labelling
ISO 14937 - Sterilization process requirements

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.

Related standards

Standards mentioned in the description

Abstract

Overview

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 14971 - Risk management for medical devices
IEC 60601-1 - Medical electrical equipment safety
ISO 10993-1 - Biological evaluation (biocompatibility)
ISO 15223-1 - Medical device symbols and labelling
ISO 14937 - Sterilization process requirements

ISO 23747:2015 PDF

Technical details

Abstract

Overview

Key Topics and Requirements

Applications and Users

Related Standards

Related standards

Abstract

Overview

Key Topics and Requirements

Applications and Users

Related Standards

Related standards

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