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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 2026-09-25
Certificates
1
Scope items
7
Standards
19
Locations
1

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DAKKSRefreshed
D-PL-13185-01-01Active

Accredited standards

19

Our reading of the DAKKS scope: each standard once, with its official name where we have checked it. Click a standard to see the scope line it comes from, word for word.

ASTM

ASTM E3060Name not checked yet
As written on the certificate · Line 5 (DAKKS D-PL-13185-01-01)

ASTM E 3060; DIN EN ISO 25539-1; DIN EN ISO 7198; DIN EN ISO 10555-1; ASTM F2082/F2082M

As written on the certificate · Line 6 (DAKKS D-PL-13185-01-01)

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

ASTM F2079Name not checked yet
As written on the certificate · Line 6 (DAKKS D-PL-13185-01-01)

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

ASTM F2081Name not checked yet
As written on the certificate · Line 2 (DAKKS D-PL-13185-01-01)

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

As written on the certificate · Line 6 (DAKKS D-PL-13185-01-01)

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

ASTM F2082Name not checked yet
As written on the certificate · Line 5 (DAKKS D-PL-13185-01-01)

ASTM E 3060; DIN EN ISO 25539-1; DIN EN ISO 7198; DIN EN ISO 10555-1; ASTM F2082/F2082M

As written on the certificate · Line 6 (DAKKS D-PL-13185-01-01)

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

ASTM F2394Name not checked yet
As written on the certificate · Line 2 (DAKKS D-PL-13185-01-01)

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

As written on the certificate · Line 6 (DAKKS D-PL-13185-01-01)

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

ASTM F2477Name not checked yet
As written on the certificate · Line 3 (DAKKS D-PL-13185-01-01)

DIN EN ISO 25539-1; DIN EN ISO 25539-2; ASTM F 3505; ASTM F 3067; ASTM F 2477; ASTM F 2942

As written on the certificate · Line 6 (DAKKS D-PL-13185-01-01)

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

ASTM F2942Name not checked yet
As written on the certificate · Line 3 (DAKKS D-PL-13185-01-01)

DIN EN ISO 25539-1; DIN EN ISO 25539-2; ASTM F 3505; ASTM F 3067; ASTM F 2477; ASTM F 2942

As written on the certificate · Line 6 (DAKKS D-PL-13185-01-01)

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

ASTM F3067Name not checked yet
As written on the certificate · Line 3 (DAKKS D-PL-13185-01-01)

DIN EN ISO 25539-1; DIN EN ISO 25539-2; ASTM F 3505; ASTM F 3067; ASTM F 2477; ASTM F 2942

As written on the certificate · Line 6 (DAKKS D-PL-13185-01-01)

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

ASTM F3211Name not checked yet
As written on the certificate · Line 4 (DAKKS D-PL-13185-01-01)

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

As written on the certificate · Line 6 (DAKKS D-PL-13185-01-01)

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

ASTM F3505Name not checked yet
As written on the certificate · Line 3 (DAKKS D-PL-13185-01-01)

DIN EN ISO 25539-1; DIN EN ISO 25539-2; ASTM F 3505; ASTM F 3067; ASTM F 2477; ASTM F 2942

As written on the certificate · Line 6 (DAKKS D-PL-13185-01-01)

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

ISO

ISO 7198Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches
As written on the certificate · Line 5 (DAKKS D-PL-13185-01-01)

ASTM E 3060; DIN EN ISO 25539-1; DIN EN ISO 7198; DIN EN ISO 10555-1; ASTM F2082/F2082M

ISO 10555-1Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements
As written on the certificate · Line 2 (DAKKS D-PL-13185-01-01)

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

As written on the certificate · Line 4 (DAKKS D-PL-13185-01-01)

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

As written on the certificate · Line 5 (DAKKS D-PL-13185-01-01)

ASTM E 3060; DIN EN ISO 25539-1; DIN EN ISO 7198; DIN EN ISO 10555-1; ASTM F2082/F2082M

ISO 10555-4Intravascular catheters - Sterile and single-use catheters - Part 4: Balloon dilatation catheters
As written on the certificate · Line 2 (DAKKS D-PL-13185-01-01)

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

As written on the certificate · Line 6 (DAKKS D-PL-13185-01-01)

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

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
As written on the certificate · Line 4 (DAKKS D-PL-13185-01-01)

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

As written on the certificate · Line 6 (DAKKS D-PL-13185-01-01)

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

ISO 14708-2Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
As written on the certificate · Line 4 (DAKKS D-PL-13185-01-01)

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

ISO 25539-1Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
As written on the certificate · Line 2 (DAKKS D-PL-13185-01-01)

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

As written on the certificate · Line 3 (DAKKS D-PL-13185-01-01)

DIN EN ISO 25539-1; DIN EN ISO 25539-2; ASTM F 3505; ASTM F 3067; ASTM F 2477; ASTM F 2942

As written on the certificate · Line 4 (DAKKS D-PL-13185-01-01)

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

As written on the certificate · Line 5 (DAKKS D-PL-13185-01-01)

ASTM E 3060; DIN EN ISO 25539-1; DIN EN ISO 7198; DIN EN ISO 10555-1; ASTM F2082/F2082M

ISO 25539-2Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
As written on the certificate · Line 2 (DAKKS D-PL-13185-01-01)

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

As written on the certificate · Line 3 (DAKKS D-PL-13185-01-01)

DIN EN ISO 25539-1; DIN EN ISO 25539-2; ASTM F 3505; ASTM F 3067; ASTM F 2477; ASTM F 2942

As written on the certificate · Line 4 (DAKKS D-PL-13185-01-01)

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

Other standards

USP 48Name not checked yet
As written on the certificate · Line 6 (DAKKS D-PL-13185-01-01)

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

USP 788Name not checked yet
As written on the certificate · Line 4 (DAKKS D-PL-13185-01-01)

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

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

LineDisciplineMethodMatrixRange
1materialsDIN EN ISO/IEC 17025:2018Medizinprodukten, Gefäßimplantaten (Stents) und Einführsystemen-
2mechanicalDIN EN ISO 25539-1; DIN EN ISO 25539-2; DIN EN ISO 10555-1; DIN EN ISO 10555-4; ASTM F 2081; ASTM F 2394Einführsysteme und Stents; Einführsysteme-
3mechanicalDIN EN ISO 25539-1; DIN EN ISO 25539-2; ASTM F 3505; ASTM F 3067; ASTM F 2477; ASTM F 2942Stents-
4materialsDIN 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. 2013Stents; Katheter, Stents, sonstige Medizinprodukte-
5mechanicalASTM E 3060; DIN EN ISO 25539-1; DIN EN ISO 7198; DIN EN ISO 10555-1; ASTM F2082/F2082MKatheter; Stents; sonstige Medizinprodukte; vaskulärer Prothesen; Nitinolstrukturen-
6mechanicalDIN 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 : 2024-01Intravaskuläre 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-
7mechanicalRW-06; RW-07; RW-08Fixierungselementen implantierbarer Leadless-Pacemaker (iLP); Stents-

Ranges are reproduced from the accredited scope document as published. 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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