Standard Guide for Biocompatibility Evaluation of Medical Device Packaging Materials
|Publication Date:||1 April 2005|
|ICS Code (Other standards related to pharmaceutics):||11.120.99|
|ICS Code (Packaging and distribution of goods in general):||55.020|
This guide provides information to determine the appropriate testing for biocompatibility of packaging materials used to contain a medical device.
This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and to determine the applicability of regulatory limitations prior to use.