Semnificație și utilizare

5.1 Compatibilitatea materialelor de ambalare cu dispozitivele medicale este o cerință a multor organisme de reglementare. 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. Prin urmare, 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, dacă există, to determine whether appropriate testing is required. When information about packaging biocompatibility needs to be screened, a supplier’s cytotoxicity test is usually performed.

Ghid standard ASTM F2475-2020 pentru evaluarea biocompatibilității materialelor de ambalare pentru dispozitive medicale

Etapa 1: Domeniul de aplicare

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. Este responsabilitatea utilizatorilor acestui standard să stabilească siguranța corespunzătoare, health and environmental specifications and to determine the applicability of regulatory restrictions prior to use.

1.4 Acest standard internațional se bazează pe principiile de standardizare recunoscute la nivel internațional stabilite în Decizia privind principiile pentru elaborarea standardelor internaționale., 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