Meaning and use

5.1 Compatibility of packaging materials with medical devices is a requirement of many regulatory bodies. Since most medical devices are used or implanted in, around, or above the human body, the benefits of these devices need to outweigh the risks. Therefore, it is also necessary to assess and determine that packaging materials that come into contact with medical devices are safe for human use, as they do not have a negative effect on the physical, chemical or biological properties of the devices. This assessment may include research and practical testing of relevant experience with packaging materials. If the material has a specific role with a demonstrable history of safe use (the same as the packaging in the design), this assessment may conclude that testing is not necessary.

5.2 The medical device manufacturer shall consider the interaction between the device/package, if any, to determine whether appropriate testing is required. When information about packaging biocompatibility needs to be screened, a supplier’s cytotoxicity test is usually performed.

ASTM F2475-2020 Standard Guide for BioCompatibility Assessment of Packaging Materials for Medical Devices

Step 1: Scope

1.1 This guidance provides information to determine biocompatibility testing for medical device packaging materials that may be associated directly or indirectly with patients.

1.2 This guide does not apply to secondary or tertiary packaging materials.

1.3 This standard is not intended to address all safety concerns associated with its use. It is the responsibility of users of this standard to establish appropriate safety, health and environmental specifications and to determine the applicability of regulatory restrictions prior to use.

1.4 This international standard is based on internationally recognized standardization principles established in the Decision on Principles for the Development of International Standards, Guidelines and Recommendations issued by the WTO Technical Barriers to Trade (TBT) Committee.

ASTM F2475-2020 Standard Guide for BioCompatibility Assessment of Packaging Materials for Medical Devices

2. Refer to the file

ASTM standard

F17 Terms relating to main barrier packaging