ISO 26782:2009

Name: ISO 26782:2009 — Anaesthetic and respiratory equipment — Spirometers intended for the measurement of time forced expired volumes in humans
SKU: ISO 26782:2009
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Anaesthetic and respiratory equipment — Spirometers intended for the measurement of time forced expired volumes in humans

Название (английский):

ISO 26782:2009

Anaesthetic and respiratory equipment — Spirometers intended for the measurement of time forced expired volumes in humans

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 27
Дата публикации:: 9 июля 2009 г.
Издание:: ISO IS 26782 edition 1 version 1
ICS:: 11.040.10

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Описание (английский):

ISO 26782:2009 specifies requirements for spirometers intended for the assessment of pulmonary function in humans weighing more than 10 kg. ISO 26782:2009 applies to spirometers that measure timed forced expired volumes, either as part of an integrated lung function device or as a stand-alone device, irrespective of the measuring method employed.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 26782:2009 - "Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans" defines requirements for spirometers used to assess pulmonary function in humans weighing more than 10 kg. The standard applies to stand‑alone spirometers and spirometry modules integrated into lung function systems, regardless of the measuring method. Continuous patient monitoring devices are excluded.

Key topics and technical requirements

ISO 26782 sets out requirements and test methods that give confidence in spirometer performance and safety. Major topics include:

Measurement scope: Timed forced expiratory volumes (e.g., FEVt) and forced vital capacity (FVC) over the vital‑capacity range for subjects >10 kg.

Performance requirements: Accuracy, linearity, repeatability, measurement range, and recording time - with defined test procedures (see Annexes for test profiles and methods).

Start and end criteria: Definitions and requirements for determining time zero, start and end of forced exhalation to ensure consistent FEV and FVC measurements.

Impedance and volume recording: Requirements for expiratory impedance and graphical/volume trace presentation (including aspect ratios and recording fidelity).

Safety and construction: Electrical and mechanical safety (referencing IEC 60601‑1), effects of dropping hand‑held components, calibration and re‑assembly considerations.

Identification and documentation: Marking, legibility, model references, accompanying documents and instructions for use.

Infection control and biocompatibility: Cleaning, sterilization and disinfection procedures, handling of reusable and sterile parts, and relevant biocompatibility obligations.

Testing and verification: Normative annexes describe accuracy, linearity and impedance tests plus defined test profiles for objective verification. Informative annexes include rationale and environmental aspects.

Practical applications and who uses it

ISO 26782 is essential for stakeholders involved in spirometry device development, procurement and clinical use:

Manufacturers - design, testing, labeling and instructions for spirometers and accessories to meet international requirements.

Test laboratories & conformity assessors - perform accuracy, linearity and impedance tests per the standard’s normative methods.

Clinical engineers & biomedical departments - implement calibration, maintenance and sterilization procedures compatible with the standard.

Regulatory and procurement teams - evaluate device compliance for hospital purchase or market clearance.

Clinicians and respiratory therapists - rely on compliant devices for reliable FEV/FVC measurements in pre‑op assessment, diagnostics, public health surveys and clinical trials.

Related standards

IEC 60601‑1 - medical electrical equipment safety

ISO 10993‑1 - biological evaluation of medical devices

ISO 14937 - sterilization process requirements

ISO 15223‑1 - medical device labeling symbols

ATS/ERS recommendations for standardized spirometry (complements clinical guidance)

Keywords: ISO 26782, spirometer standard, spirometry, pulmonary function, forced expiratory volume, FEV, FVC, medical device standard, spirometers standards.

ISO 26782:2009

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications and who uses it

Related standards

Технические детали

BS EN ISO 26782:2009

Anaesthetic and respiratory equipment. Spirometers intended for the measurement of time forced expired volume…

IEC 60601-1-12:2014

Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - C…

ISO 10993-12:2012

Biological evaluation of medical devices — Part 12: Sample preparation and reference materials

BS EN ISO 14937:2009

Sterilization of health care products. General requirements for characterization of a sterilizing agent and t…

ISO 15223-1:2016

Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — P…