Overview
EN ISO 26782:2009 - Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans - is a CEN-adopted ISO standard that specifies requirements for spirometers used to assess pulmonary function in humans weighing more than 10 kg. It applies to stand‑alone spirometers and spirometric modules integrated into larger lung function systems, regardless of measurement technology. The standard defines performance, safety, marking and documentation expectations and includes normative test methods and informative guidance.
Key Topics
- Scope and applicability: Devices for measuring timed forced expired volumes in humans (>10 kg), either integrated or stand‑alone.
- Performance requirements: Accuracy, linearity, repeatability and defined measurement ranges to ensure reliable timed volume measurements.
- Time criteria: Defined criteria for start and end of forced exhalation and for recording time and volume traces.
- Construction and safety: Electrical and mechanical safety requirements, impact/drop considerations for hand‑held components, and calibration provisions.
- User information and marking: Legibility, durability of markings, labelling of devices and packaging, and comprehensive instructions for use and technical descriptions.
- Hygiene and biocompatibility: Requirements for cleaning, disinfection, sterilization and biocompatibility of reusable and single‑use parts.
- Testing and verification: Normative test methods (Annex B) and defined test profiles (Annex C) for assessing accuracy, linearity and expiratory impedance.
- Regulatory alignment: Informative Annex ZA maps the standard to Essential Requirements of EU Directive 93/42/EEC (medical devices); references to electrical safety standards such as IEC 60601‑1 are noted.
- Supporting information: Annexes cover rationale, environmental aspects and conformity references.
Applications
EN ISO 26782:2009 is used to:
- Provide manufacturers with performance and safety criteria for design, verification and labeling of spirometers.
- Support test laboratories and quality teams in validating device accuracy, repeatability and calibration procedures.
- Help regulatory and compliance professionals demonstrate conformity with medical device directives and national standards.
- Guide hospital biomedical engineering, clinical respiratory departments and procurement teams in specifying and evaluating spirometers for clinical use, screening, pre‑operative assessment and research.
Who should use this standard
- Medical device manufacturers and designers of spirometers and lung function systems
- Test laboratories and conformity assessment bodies
- Regulatory affairs and quality assurance teams
- Clinical engineers, respiratory therapists and hospital procurement officers
- Standards committees and technical reviewers
Related standards
- IEC 60601‑1 (electrical safety of medical electrical equipment)
- ATS/ERS recommendations for spirometry (standardization guidance referenced in the ISO introduction)
Keywords: EN ISO 26782:2009, spirometer standard, spirometry, pulmonary function testing, timed forced expired volumes, medical device standard, CEN, IEC 60601-1.
