Germany

Institut für Implantattechnologie und Biomaterialien e.V. (IIB e.V.)

Friedrich-Barnewitz-Straße 4, 18119, Rostock-Warnemünde, Germany

DAKKS D-PL-13185-01-01ISO/IEC 17025Register refreshed 2026-10-23

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Accredited standards: 19
DAKKS certificate: 1
Site in our directory: 1

DAKKS accredited scope

What this lab is accredited for

Our reading of the DAKKS scope: each standard once, with its official name where we have checked it.

Search this lab’s scope for a standard or test

Only this lab. Searches the 19 standard numbers and the 7 official names we hold. When no standard matches, it searches the method text of every scope line.

ASTM10

ASTM E3060

ASTM F2079

ASTM F2081

ASTM F2082

ASTM F2394

ASTM F2477

ASTM F2942

ASTM F3067

ASTM F3211

ASTM F3505

ISO7

ISO 7198Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches

ISO 10555-1Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements

ISO 10555-4Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters

ISO 14708-1Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

ISO 14708-2Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers

ISO 25539-1Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses

ISO 25539-2Cardiovascular implants - Endovascular devices - Part 2: Vascular stents

Other standards2

USP 48

USP 788

Read from the scope as published by DAKKS. Register refreshed 2026-10-23.

Scope as published by DAKKS

7 lines

DAKKS

ISO/IEC 17025

Active

D-PL-13185-01-01

View scope

Accredited scope, certificate D-PL-13185-01-01

Line	Method	Matrix	Range
1	DIN EN ISO/IEC 17025:2018	Medizinprodukten, Gefäßimplantaten (Stents) und Einführsystemen	-
2	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	-
3	DIN EN ISO 25539-1; DIN EN ISO 25539-2; ASTM F 3505; ASTM F 3067; ASTM F 2477; ASTM F 2942	Stents	-
4	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	-
5	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	-
6	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	-
7	RW-06; RW-07; RW-08	Fixierungselementen implantierbarer Leadless-Pacemaker (iLP); Stents	-

Ranges are reproduced from the accredited scope document as published, and only where we found that range printed in the document for the line. Otherwise the cell reads “See scope document”. An absent range means the register did not state one. Line numbers are ours, for cross-reference; they follow the order of the scope document.

Location

Friedrich-Barnewitz-Straße 4, Rostock-Warnemünde, 18119, DE

54.17247, 12.07834

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Accreditation data refreshed from the DAKKS register on 2026-10-23.

This page mirrors a public register. For a purchasing, audit or regulatory decision, confirm against the DAKKS entry linked above.