ISO 26782 Anaesthesia and Respiratory Equipment - Spirometers Designed for the Measurement of Time-Forced Exhaled Volumes in Man

The standard "ISO 26782 Anaesthesia and respiratory equipment - Spirometers designed for the measurement of timed forced expiratory volumes in humans", also published by the International Organization for Standardization (ISO), describes the requirements for spirometers designed for the assessment of lung function in humans weighing more than 10 kg. This standard applies to a device (spirometer) that measures timed forced expiratory volumes, whether as part of an integrated lung function device or as a stand-alone device, regardless of the measurement method used. Devices designed for continuous patient monitoring are outside the scope of this standard.

For the purposes of this standard, the following terms and definitions apply:

• Accessories are additional parts used with the spirometer. They are used to achieve its intended use, to adapt it to some specific use, to facilitate its use and to allow its functions to be integrated with those of other equipment.
• The accompanying document is the document that accompanies the spirometer or accessory and contains information, particularly safety-related, for those responsible for its installation, use and maintenance.
• Expected service life is the maximum useful life defined by the manufacturer.
• Forced expiratory volume after time is the expiratory volume of a patient under forced conditions within a specified time.
• Forced vital capacity is the maximum volume of air that can be exhaled with continuous maximum forced expiratory effort from the point of maximum inspiration.
• Intended use refers to the use of a product, process or service in accordance with the specifications, instructions and information provided by the manufacturer. Intended use is not the same as normal use. While intended use focuses on medical purposes, normal use includes not only medical purposes but also processes such as maintenance, service and transportation.
• The manufacturer is the natural or legal person responsible for the design, production, packaging or labelling of the spirometer or for adapting the spirometer, whether these operations are carried out by the person himself or by a third party on his behalf.
• The measuring range is the set of values ​​of measured quantities for which the error of a measuring instrument is intended to lie within specified limits.
• A model or type reference is a shape, letter, or combination of both used to identify a particular model of spirometer or accessory.
• Normal use is the period of waiting according to the operating and usage instructions, including routine inspection and adjustments by any user. Normal use includes not only medical purpose, but also maintenance, service, transportation and similar processes.
• A spirometer is a device that records forced expiratory volume over a period of time.

Spirometers using electrical power must meet the requirements defined in “IEC 60601-1 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance” in addition to the requirements in this standard.

For mechanical safety, spirometers must comply with the IEC 60601-1 standard.

The scale or indicator of a spirometer should be marked as follows.

• The scale or indicator should be in litres.
• The numbering on a scale or digital display should not exceed the measuring range.
• For spirometers with volume traces as the primary output, the increment between any two adjacent graduation lines should represent a volume difference of no greater than 0,1 L, and numbering on a scale should appear at intervals of no greater than 1,0 L.
• For digital display spirometers, the increment step should not be greater than 0,01 L.

The markings required in this standard shall be removable only by a tool or significant force and shall be sufficiently durable to remain clearly legible throughout the expected service life of the spirometer. The effects of normal use shall be taken into account when assessing the durability of the markings.

Our organization, which has been trying to support businesses from every sector with its testing, measurement, analysis and evaluation studies carried out in a wide range for years, has a strong staff that closely follows the developments in the world in the field of science and technology and constantly improves itself. In this context, testing services are also provided to businesses in accordance with the "ISO 26782 Anesthesia and respiratory equipment - Spirometers designed for the measurement of time-forced exhalation volumes in humans" standard.