Institut für Implantattechnologie und Biomaterialien e.V. (IIB e.V.)
Friedrich-Barnewitz-Straße 4, 18119, Rostock-Warnemünde, Germany
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Register record
- DAKKSRefreshed
- D-PL-13185-01-01Active
Certificates and scope
1ISO/IEC 17025
ActiveD-PL-13185-01-01
Accredited scope, certificate D-PL-13185-01-01
| Discipline | Method | Matrix | Range |
|---|---|---|---|
| materials | DIN EN ISO 25539-1; DIN EN ISO 25539-2; DIN EN ISO 10555-1; USP <788>; Acta Rad 1966; RW-01; RW-04; RW-05; ISO 14708-1; ASTM F 3211; DIN EN ISO 14708-2; RW-08; Int. J. Card. 2013 | Stents; Katheter, Stents, sonstige Medizinprodukte | - |
| materials | DIN EN ISO/IEC 17025:2018 | Medizinprodukten, Gefäßimplantaten (Stents) und Einführsystemen | - |
| mechanical | DIN EN ISO 25539-1; DIN EN ISO 25539-2; DIN EN ISO 10555-1; DIN EN ISO 10555-4; ASTM F 2081; ASTM F 2394 | Einführsysteme und Stents; Einführsysteme | - |
| mechanical | DIN EN ISO 10555-4 : 2024-03; ISO 14708-1 : 2014-08; ASTM E 3060 – 23; ASTM F 2079 – 09 (2022); ASTM F 2081 – 06 (2022); ASTM F2082/F2082M - 23; ASTM F 2394 – 07 (2022); ASTM F 2477 – 24; ASTM F 2942 – 19; ASTM F 3067 – 14 (2021); ASTM F 3211 – 17; ASTM F 3505 - 21; USP 48<788> 2025-02; Acta Rad 1966 (1966); RW-01:2021-05; RW-02 : 2025-05; RW-03 : 2021-05; RW-04 : 2024-01; RW-05 : 2024-01 | Intravaskuläre Katheter; Sterile Katheter zur einmaligen Verwendung; Ballondilatationskatheter; Implants for surgery; Active implantable medical devices; Biopharmaceutical Manufacturing; Balloon-Expandable Stents; Vascular Stents; Nickel-Titanium Shape Memory Alloys; Endovascular Prostheses; Cardiovascular Medical Devices; Stent and Endovascular Prosthesis; PTCA-Ballons; Stentsystemen; Stents; Arterielle Stents | - |
| mechanical | RW-06; RW-07; RW-08 | Fixierungselementen implantierbarer Leadless-Pacemaker (iLP); Stents | - |
| mechanical | DIN EN ISO 25539-1; DIN EN ISO 25539-2; ASTM F 3505; ASTM F 3067; ASTM F 2477; ASTM F 2942 | Stents | - |
| mechanical | ASTM E 3060; DIN EN ISO 25539-1; DIN EN ISO 7198; DIN EN ISO 10555-1; ASTM F2082/F2082M | Katheter; Stents; sonstige Medizinprodukte; vaskulärer Prothesen; Nitinolstrukturen | - |
Ranges are reproduced from the accredited scope document as published. An absent range means the register did not state one.
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