About this document

Iso 7439-2023 by PT is a document available to read on EtoBox.

ISO 7439:2023 outlines the requirements and tests for copper-bearing contraceptive intrauterine devices (IUDs) and their insertion instruments, emphasizing quality verification, intended clinical performance, and design attributes. The document specifies that these devices are single-use, sterile, and must be manufactured under an integrated quality management system. Key updates in this fourth edition include revised clinical performance requirements and added packaging integrity requirements.

Author

PT

Language

EN