In the ISO 5362 standard developed by the International Standards Organization (ISO), the safety and performance characteristics and test methods of anesthesia balloons are described. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 5362 Anesthesia balloons. This standard has replaced the abolished TS EN 1820 + A1 standard.
This standard describes requirements for antistatic and non-antistatic reservoir bags for use with anesthetic apparatus or lung ventilators (breathing systems). These requirements include requirements for the design of the neck, size definition, strain and, where relevant, electrical resistance.
The ISO 5362 standard covers both disposable and reusable bags. Reusable bags must comply with the requirements of this standard for the recommended product life. This standard does not apply to special purpose bags such as bellows and self-expanding bags. Bags used with anesthetic gas cleaning systems are not considered as anesthetic reservoir bags and are therefore not covered by this standard.
It is widely accepted that anesthesia balloons must be electrically conductive when used with a flammable anesthetic. These balloons are therefore particularly important when rhythmically compressed by the anesthetic provider to provide intermittent positive pressure ventilation.
Since the test method given in the standard annex involves filling the bag with water, its routine use in production control does not seem practical. Therefore, another test method using air instead of water is presented for the information in the standard annex. Since this test method gives equivalent results, it is considered an appropriate test method.
The standards referred to as normative in the implementation of this standard are: ISO 4287, ISO 5356-1, ISO 7000, ISO 11607-1, IEC 60601-1, EN 556 and EN 980.
Our organization also provides ISO 5362 safety and performance testing services for anesthesia balloons to businesses as part of our laboratory services .
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
