If a device can be connected to an active medical device storage container in Class IIa or higher,

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Rule 2 covers the medical devices which, according to the intended use are designed for downloading or storing storage container blood, body fluids, tissues, liquids or gases in potential applications for infusion, administration or introduction into the body.
If a device can be connected to an active medical device storage container in Class IIa or higher, then classify the medical device Class IIa under Rule 2a. You will find here include products such as tubing and syringe infusion pumps. storage container
If the product will be used for downloading or storing blood, body liquids and tissues it is subject to the Rule 2b. If such a medical device storage container for blood bag will then apply a special rule 18, and the product will be classified in Class IIb. If, however, they are products other than blood bags such as containers for transplants will be covered by product class IIa.
Under Rule 2 Rule 2c was isolated also covering other medical devices that do not fit in the rules 2a and 2b. Here you will find, for example, injections or medication spoons. Products such as Class I classify.
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ISO 13485: 18-19 Krakow
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