ISO 14607:2018 Annex D injection site competence

Annex D of ISO 14607:2018 describes the testing of the injection site of inflatable tissue expanders (breast implants). The injection site is punctured five times with a needle, while a water column applies hydrostatic pressure to the injection site. As a result of the punctures and after a waiting time of 30 seconds, the injection site must not show any leakage.
We offer testing for injection site competence with preparation of the samples as part of our breast implant testing services.