ISO 26782-2009 PDF

Full title and description

St ISO 26782-2009 — Anaesthetic and respiratory equipment — Spirometers intended for the measurement of time forced expired volumes in humans. This International Standard specifies performance, construction, marking and testing requirements for spirometers used to measure timed forced expired volumes (e.g., FEVt and FVC) for humans weighing more than 10 kg, whether as stand‑alone devices or as modules within larger lung-function systems.

Abstract

ISO 26782:2009 defines requirements and test methods to ensure accurate, repeatable measurement of timed forced expired volumes. It covers measurement range, accuracy limits, recording time, start/end criteria (including retro‑extrapolation methods), graphical display conventions, calibration, cleaning/sterilization and basic safety/construction requirements for spirometers intended for clinical pulmonary function testing. A technical corrigendum (ISO 26782:2009/Cor 1:2009) was published to correct the original text.

General information

• Status: Published (International Standard; under periodic review and subject to revision processes).
• Publication date: July 2009 (2009-07).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.10 — Anaesthetic and respiratory equipment.
• Edition / version: Edition 1 (2009). Corrigendum: ISO 26782:2009/Cor 1:2009 (Nov 2009).
• Number of pages: 27 (ISO published text).

Scope

This standard applies to spirometers that measure timed forced expired volumes for use in the assessment of pulmonary function in humans weighing more than 10 kg. It covers devices used as independent spirometers or as integrated modules within lung-function systems and excludes continuous patient-monitoring equipment. The scope includes required measurement range, environmental conditions for testing, and the definition of start/end of forced expiratory maneuvers.

Key topics and requirements

• Measurement range: device shall measure from 0 to at least 8 L (referenced to BTPS conditions).
• Accuracy: maximum permissible error ±3.0 % of reading or 0.05 L (whichever is greater) within specified ambient conditions (temperature, humidity, pressure).
• Recording time: when measuring FVC, the spirometer must record volume for at least 15 s.
• Standardized determination of time zero, start and end of forced exhalation (including retro‑extrapolation methods for FEV measurements).
• Graphical display conventions: default aspect ratios (volume vs time 1 L:1 s for at least 6 s; flow vs volume 2 L/s: 1 L across the curve) and volume/flow trace fidelity requirements.
• Linearity, repeatability and expiratory impedance requirements and specified test methods (see normative test annexes).
• Construction, safety and durability: electrical/mechanical safety, effects of dropping hand‑held components, calibration and dismantling/re‑assembly instructions.
• Cleaning, disinfection/sterilization and biocompatibility requirements for reusable parts; marking, labelling and accompanying technical documentation requirements (including indication whether volumes are BTPS or require conversion).

These topics and specific test procedures (including Annex B test methods and informative Annex A content) are detailed in the published standard.

Typical use and users

Primary users include medical device manufacturers (spirometer and lung-function system vendors), clinical engineers, hospital respiratory departments, pulmonary function laboratories, conformity assessment and test laboratories, procurement and regulatory teams evaluating device compliance, and standards committees developing or referencing spirometry requirements.

Related standards

Standards commonly referenced alongside ISO 26782 include other ISO standards for respiratory measurement and related medical device safety standards (for example, ISO documents addressing peak expiratory flow meters and particular medical device safety standards). National and regional adoptions (EN, DIN, STN etc.) exist that incorporate ISO 26782 and its corrigendum.

Keywords

spirometer, spirometry, forced expiratory volume, FEV, FVC, BTPS, pulmonary function, spirometry accuracy, respiratory equipment, ISO 26782, anaesthetic equipment.

FAQ

Q: What is this standard?

A: ISO 26782:2009 is an international standard specifying requirements and test methods for spirometers intended to measure timed forced expired volumes in humans (>10 kg), ensuring consistent, accurate spirometry measurements across devices.

Q: What does it cover?

A: It covers measurement range, accuracy limits, recording time, start/end criteria for forced expiratory maneuvers (including retro‑extrapolation), display conventions, linearity/repeatability/impedance requirements, calibration, construction, cleaning/sterilization and marking/documentation. Normative and informative annexes provide test methods and explanatory material.

Q: Who typically uses it?

A: Manufacturers of spirometers and lung-function equipment, clinical and pulmonary function labs, biomedical engineers, test and certification bodies, and regulatory/procurement professionals. Clinicians rely on compliant devices for diagnostic and monitoring use.

Q: Is it current or superseded?

A: The 2009 edition is published and a technical corrigendum was issued in 2009. The standard is subject to periodic review and, at times, work to revise or replace it has been registered (committee drafts and subsequent revision activity have been recorded). Users should check the latest ISO status for any replacement or updated edition.

Q: Is it part of a series?

A: It sits within ISO technical work on anaesthetic and respiratory equipment (ISO/TC 121/SC 3) and is used alongside related respiratory standards (for example, standards for peak expiratory flow meters and other respiratory measurement devices and applicable medical electrical equipment safety standards).

Q: What are the key keywords?

A: Spirometer, spirometry, forced vital capacity, forced expiratory volume (FEV), BTPS, accuracy, recording time, retro‑extrapolation, calibration, pulmonary function.