The standard "EN ISO 5362 Anaesthetic reservoir bags", which has its basis in a European standard and is published by the International Standards Organization (ISO), describes the requirements for antistatic and non-antistatic reservoir bags for use with anaesthetic apparatus or lung ventilator breathing systems. These requirements include requirements for neck design, size definition, tension and, where relevant, electrical resistance.
The EN ISO 5362 standard includes requirements for both single-use and reusable bags. Reusable bags are designed to 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 in conjunction with anesthetic gas scavenging systems are not considered anesthetic reservoir bags and are therefore outside the scope of this standard.
For the purposes of this standard, the following terms and definitions apply:
The anaesthetic reservoir bag is a collapsible container from which the patient can draw their tidal volume (respiratory volume). This bag must be leak-proof. Bag size is specified by the nominal capacity expressed in litres. The preferred size range is recommended to be 0,5 - 1 - 1,5 - 2 - 3 and 5 litres.
The capacity of the bag is subject to a tolerance of 15 percent of the nominal capacity when tested in accordance with the appropriate procedure. When testing, the bag is placed in a water tank and the bottom opening of the bag, if any, is closed. The bag is held vertically with the top of the opening 25 mm above the surface of the water in the tank. The bag is filled with water. The volume of water in the bag is then measured.
Under the conditions described in the standard, the pressure head of the water shall not be less than 30 cm of water and shall not exceed 50 cm of water at any time during the test. After this test, the bag shall return to its original capacity within 10 minutes with a tolerance of 30 percent according to the actual capacity.
When performing the pressure-volume test, the bag is placed in a water tank and the bottom opening of the bag, if any, is closed. The bag is held vertically so that the upper edge of the opening is 25 mm above the surface of the water in the tank. The bag is filled with water for a period of 5 minutes. A suitable sized stopper is fitted to the neck of the bag, through which a pipe of at least 10 mm diameter is passed and of sufficient length to provide a water pressure head of 50 cm. Water is added through a funnel through the pipe connected to the bag, so that the water volume is four times the nominal capacity of the bag. The pressure head is determined. This test should be performed with water at a temperature of 20 degrees plus/minus 3 degrees.
The electrical conductivity of a bag subjected to this test may decrease and result in failure to meet the requirements of appropriate electrical resistance tests.
In terms of electrical conductivity, the electrical properties of bags made of electrically conductive material for use with flammable anaesthetic agents should be determined and tested in accordance with the IS0 2878 and IS0 2882 standards and the requirements of the relevant national authorities.
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