- Overview: Breast implants
- FDA Docket No. 2004D-0002 Fatigue test*
- ISO 14607:2018 Annex B Tests for shell integrity*
- ISO 14607:2018 Annex C.1 Fatigue Test*
- ISO 14607:2018 Annex C.2 Impaction Test*
- ISO 14607:2018 Annex D injection site competence
- ISO 14607:2018 Annex E Cohesion Test*
- ISO 14607:2018 Annex H Surface characteristics
- ISO 14607:2007 Static rupture strength
INNOPROOF GmbH
- Joachim-Jungius-Straße 9
- 18059 D-Rostock
- +49 381 8011 3000
- +49 381 8011 3009
- info@innoproof.de
- Download Businesscard
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- Breast implants
- ISO 14607:2018 Annex D injection site competence
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.
- Overview: Breast implants
- FDA Docket No. 2004D-0002 Fatigue test*
- ISO 14607:2018 Annex B Tests for shell integrity*
- ISO 14607:2018 Annex C.1 Fatigue Test*
- ISO 14607:2018 Annex C.2 Impaction Test*
- ISO 14607:2018 Annex D injection site competence
- ISO 14607:2018 Annex E Cohesion Test*
- ISO 14607:2018 Annex H Surface characteristics
- ISO 14607:2007 Static rupture strength
INNOPROOF GmbH
- Joachim-Jungius-Straße 9
- 18059 D-Rostock
- +49 381 8011 3000
- +49 381 8011 3009
- info@innoproof.de
- Download Businesscard