Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials

Importancia y uso:

5.1 The compatibility of packaging materials with a medical device is a requirement of many regulatory bodies. Since most medical devices are used or implanted in, around, or on the human body, the benefits of these devices must outweigh the risks. Therefore, the packaging materials that come in contact with the medical device must also be evaluated and determined to be safe for use with the human body in that they have no negative impact on the physical, chemical, or biological properties of the device. This evaluation may include both a study of relevant experience with, and actual testing of, packaging materials. Such an evaluation may result in the conclusion that no testing is needed if the material has a demonstrable history of safe use in the specific role that is the same as that of the package under design.

5.2 The medical device manufacturer determines the need for appropriate testing, with consideration of the device/package interactions, if any. When screening information is needed regarding the biocompatibility of the packaging, cytotoxicity testing from the supplier is typically performed.

Subcomité:

F02.15

Referida por:

F2097-23, F3510-21, F0099-21, F2559_F2559M-21, F2097-23, F3659-24

Volúmen:

15.10

Número ICS:

11.120.99 (Other standards related to pharmaceutics), 55.020 (Packaging and distibution of goods in general)

Palabras clave:

biocompatibility; cytotoxicity; medical device; medical device packaging; toxicity;