Kahulugan at paggamit

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. Kaya nga, 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, kung meron man, 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

Hakbang 1: Saklaw

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. Responsibilidad ng mga gumagamit ng pamantayang ito na magtatag ng angkop na kaligtasan, kalusugan at kapaligiran pagtutukoy at upang matukoy ang pagiging angkop ng mga paghihigpit sa regulasyon bago gamitin.

1.4 Ang internasyonal na pamantayang ito ay batay sa mga prinsipyo ng standardisasyon na kinikilala ng internasyonal na itinatag sa Desisyon sa mga Prinsipyo para sa Pag unlad ng mga Internasyonal na Pamantayan, Mga Patnubay at Rekomendasyon na inisyu ng WTO Technical Barriers sa Trade (TBT) Komite.

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

2. Sumangguni sa file

Pamantayan ng ASTM

F17 Terms relating to main barrier packaging