Acceptance criteria for newly established medical oxygen production enterprises

Establishment Criteria of Medical Oxygen Production Enterprise Medical oxygen is a very important life-sustaining medical gas in clinical medical treatment, and its application is becoming more and more extensive. In order to ensure the safety and effectiveness of medical oxygen, the establishmen......

Establishment Criteria of Medical Oxygen Production Enterprise

Medical oxygen is a very important life-sustaining medical gas in clinical medical treatment, and its application is becoming more and more extensive. In order to ensure the safety and effectiveness of medical oxygen, the establishment of a medical oxygen production enterprise must meet the relevant standards.

1. Production Environment Requirements

The production environment of medical oxygen production enterprises must meet the hygienic requirements, and it must have a good indoor ventilation system. The daily average temperature of the workshop should not exceed 30 ℃, and the relative humidity should not exceed 75%. Pollution sources such as noise, dust, and ammonia should not be present in the workshop.

2. Equipment Description Requirements

Medical oxygen production enterprises must have the right number of air compressors when producing medical oxygen, and the noise made by the air compressors must not exceed the specified value. The oxygen production plant must be equipped with air filters, drying equipment and other necessary equipment.

3. Service Terms

Medical oxygen production enterprises must not only provide medical-grade oxygen to ensure product quality, but also ensure prompt delivery of Oxygen and sufficient inventories in order to meet the demand at any time.

4. Safety Requirements

It is necessary to maintain good safety management measures in the production of medical-grade oxygen, and to ensure that production personnel understand, operate safely, and use them properly. All hazardous areas such as storage and distribution, cylinders, and breathing machines must have fire prevention and safety insurance measures.

5. Quality Requirements

The quality of medical gas is of great significance to the health of patients. Medical oxygen production enterprises must implement a quality management system to ensure the quality of medical oxygen. Oxygen content and oxygen impurity content must meet national standards.

In summary, the production environment, equipment model, service terms, safety requirements and quality requirements are the general requirements for the opening of medical oxygen production enterprises, concentrating on these requirements in the production of medical oxygen can better ensure product safety and effectiveness.

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