In other cases, medical devices under Rule 4 in particular products, which by their design shipping

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When ISO 13485 is needed? Implementation of the Quality Management System based on ISO 13485: 2012 Quality Management System implementation based on the PN-EN ISO 13485: 2012 Quality Management System implementation based on the PN-EN ISO 13485:2012 - Legal Requirements
If, in accordance with Rule 1 medical device does not have contact with the patient or contact with intact skin only be assigned to Class I. In accordance with the abovementioned rule in the classroom and will include products such as dental chairs, immobilizing shipping container for sale device body, hospital beds, stethoscopes, ECG electrodes, wheelchairs, compression stockings, projectors X-rays, containers for fluids without shipping container for sale the possibility of reverse flow, and more.
If the product is used for its intended purpose as a mechanical barrier or to absorb secretions, it will be subject to the Rule 4a and will be classified as Class I. There will be products such as bandages and gauze dressings.
If the intended purpose medical device will be applied to wounds causing major break in the skin will be in Rule 4b and Class IIb. Examples of medical devices that can bring this case are wound dressings or owrzodziałych odleżynowych.
In other cases, medical devices under Rule 4 in particular products, which by their design shipping container for sale are intended to keep the wound microenvironment shipping container for sale is effective class IIa, such as hydrogel dressings.
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