Shelf Life Medical Device Definition

Lab analysis the time interval that a drug product is expected to remain within the approved shelf life specification provided that it is stored under the conditions defined on the label and in the proposed container and closure.

Shelf life medical device definition.

Medical device shelf life aging studies medical device manufacturers wishing to gather data on the shelf life of their products may subject their devices to long term stability studies or accelerated aging studies. There are many different endpoints that can be used to assess the shelf life of a medical device including sterility or package integrity so. Medspeak a term borrowed from the food industry for the length of time that a blood product. Packaging validation and shelf life testing are essential components of any medical device sterility assurance program.

Why you should attend. Eto gamma steam. Inform readers of the food and drug administration fda regulations and policies relating to shelf life of medical devices. 1 changed shelf life to shelf validity period 2 adjusted some wording.

The shelf life of a product may vary between different countries regions depending on regulatory requirements. Intermediate requires basic knowledge about medical device. 3 modified the definition of implanted medical equipment consistent with the definition in medical device classification regulation cfda no. The period of time during which something lasts or remains popular.

Fitness for use can be impacted by both maintaining sterility of the package and the performance characteristics of the device. Maintaining the sterility and shelf life. The shelf life for a combination product is determined from drug stability device aging and sterile barrier aging with the shortest estimate determining the overall shelf life. Namsa s suite of validation tests ensure that sterility is maintained when a device is sealed until expiration.

Passive im plantable medical device shelf validity period registration guideline 2017 revised. Establishing shelf life of medical devices introduction the fda defines shelf life as the term or period during which a device remains suitable for its intended use. The purpose of this document is to.