Germany

BBF Sterilisationsservice

Willy-Rüsch-Straße 10/1, 71394, Kernen im Remstal, Germany

DAKKS|D-PL-18204-01-00DAKKS|D-PL-18204-01-02DAKKS|D-PL-18204-01-01ISO/IEC 17025Register refreshed 2026-10-09

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DAKKSRefreshed 2026-10-09: D-PL-18204-01-00Active; D-PL-18204-01-02Active; D-PL-18204-01-01Active

Accredited standards

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.

ISO

ISO 7405Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

As written on the certificate · Line 2 (DAKKS D-PL-18204-01-02)

DIN EN ISO 10993-1 DIN EN ISO 10993-12 DIN EN ISO 7405 DIN EN ISO 11979-5 Mikrobiologisch- hygienische Prüfungen Medizinprodukte Prüfung auf Sterilität - Membranfiltration - Direktbeschickung DIN EN ISO 11737-2; DIN EN ISO 11137-1 DIN EN ISO 11137-2 SOP AA M 0050 - Leistungsqualifikation Mitgeltend: DIN EN ISO 11137-3 DIN CEN ISO/TS 13004 Festlegung und Überprüfung der Strahlendosis bei der Strahlen-Sterilisation DIN EN ISO 11137-2 SOP AA M 0050; DIN EN IS O 10993-5 - Zellproliferationstest bei Kontakt mit Extrakten SOP AA M 0022 Mitgeltend: DIN EN ISO 10993-1 DIN EN ISO 10993-12 DIN EN ISO 7405 DIN EN ISO 11979-5 Mikrobiologisch- hygienische Prüfungen Medizinprodukte Prüfung auf Sterilität - Membranfiltration - Direktbeschickung DIN EN ISO 11737-2; ISO 10993-1 DIN EN ISO 10993-12 DIN EN ISO 7405 DIN EN ISO 11979-5 Mikrobiologisch- hygienische Prüfungen Medizinprodukte Prüfung auf Sterilität - Membranfiltration - Direktbeschickung DIN EN ISO 11737-2; ISO 11137-1 DIN EN ISO 11137-2 SOP AA M 0050 - Leistungsqualifikation Mitgeltend: DIN EN ISO 11137-3 DIN CEN ISO/TS 13004 Festlegung und Überprüfung der Strahlendosis bei der Strahlen-Sterilisation DIN EN ISO 11137-2 SOP AA M 0050

As written on the certificate · Line 5 (DAKKS D-PL-18204-01-02)

DIN EN ISO 7405 : 2019-03; DIN EN ISO 10993-1 : 2021-05; DIN EN ISO 10993-5 : 2009-10; DIN EN ISO 10993-12 : 2021-08 Biologische Beurteilung von Medizinprodukte n - Teil 12; DIN EN ISO 11137-1 : 2020-04

ISO 11607-1Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems

As written on the certificate · Line 3 (DAKKS D-PL-18204-01-02)

DIN EN ISO 11607-1 - Beschleunigte Alterung ASTM F 1980 SOP AA M 0035 - Siegelnahtfestigkeit DIN EN 868-5; DIN EN ISO 13485 : 2021 1; DIN EN 868-5 DIN CEN ISO/TS 16775 Umgebungsüberwachung in der Herstellung und Prüfung der Sauberkeit der Produkte gemäß DIN EN ISO 13485 : 2021 1; ISO 11607-1 - Beschleunigte Alterung ASTM F 1980 SOP AA M 0035 - Siegelnahtfestigkeit DIN EN 868-5; ISO/TS 16775 Umgebungsüberwachung in der Herstellung und Prüfung der Sauberkeit der Produkte gemäß DIN EN ISO 13485 : 2021 1

As written on the certificate · Line 6 (DAKKS D-PL-18204-01-02)

DIN EN ISO 14644-2 : 2016-05 Reinraumräume und zuge hörige Reinraumbereiche - Teil 2; DIN EN 17141 : 2021-02 Reinräume und zugehörige Rei nraumbereiche - Biokontaminationskontrolle ANSI/AAMI ST 72 : 2019; ISO 14644-2 : 2016-05 Reinraumräume und zuge hörige Reinraumbereiche - Teil 2; ISO 14644-1:2015; ISO/TS 16775:2014-10 Verpackungen für in de r Endverpackung sterilisierte Medizinprodukte - Leitfaden für die Anwendung von ISO 11607-1 und ISO 11607-2

ISO 11607-2Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes

As written on the certificate · Line 6 (DAKKS D-PL-18204-01-02)

ISO 11737-1Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products

As written on the certificate · Line 4 (DAKKS D-PL-18204-01-02)

DIN EN ISO 13485 : 2021 1; DIN EN ISO 11737-1; DIN EN ISO 11137-1; DIN EN ISO 14644-1 DIN EN ISO 14644-2 DIN EN 17141 SOP AA M 0002 SOP AA M 0030; DIN EN ISO 14644-1 DIN EN ISO 14644-2 SOP AA M 0067 Quellenverzeichnis Regelwerke/Prüfverfahren: DIN EN 868-5 : 2019-03

ISO 11737-2Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process

As written on the certificate · Line 2 (DAKKS D-PL-18204-01-02)

ISO 11979-5Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility

As written on the certificate · Line 2 (DAKKS D-PL-18204-01-02)

ISO 10993 series

ISO 10993-1Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of biological safety within a risk management process

As written on the certificate · Line 2 (DAKKS D-PL-18204-01-02)

As written on the certificate · Line 5 (DAKKS D-PL-18204-01-02)

ISO 10993-5Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity

As written on the certificate · Line 5 (DAKKS D-PL-18204-01-02)

ISO 10993-12Biological evaluation of medical devices - Part 12: Sample preparation and reference materials

As written on the certificate · Line 2 (DAKKS D-PL-18204-01-02)

As written on the certificate · Line 5 (DAKKS D-PL-18204-01-02)

ISO 11137 series

ISO 11137-1Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

As written on the certificate · Line 2 (DAKKS D-PL-18204-01-02)

As written on the certificate · Line 4 (DAKKS D-PL-18204-01-02)

As written on the certificate · Line 5 (DAKKS D-PL-18204-01-02)

As written on the certificate · Line 2 (DAKKS D-PL-18204-01-01)

DIN EN ISO 11137 -1:2020; DIN EN ISO 11137 -2:2015; ISO 11137 -1:2020; ISO 11137 -2:2015; EN ISO 11137 -1:2020

ISO 11137-2Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose

As written on the certificate · Line 2 (DAKKS D-PL-18204-01-02)

As written on the certificate · Line 2 (DAKKS D-PL-18204-01-01)

DIN EN ISO 11137 -1:2020; DIN EN ISO 11137 -2:2015; ISO 11137 -1:2020; ISO 11137 -2:2015; EN ISO 11137 -1:2020

ISO 11137-3Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control

As written on the certificate · Line 2 (DAKKS D-PL-18204-01-02)

ISO 14644 series

ISO 14644-1Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness by particle concentration

As written on the certificate · Line 4 (DAKKS D-PL-18204-01-02)

As written on the certificate · Line 6 (DAKKS D-PL-18204-01-02)

ISO 14644-2Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration

As written on the certificate · Line 4 (DAKKS D-PL-18204-01-02)

As written on the certificate · Line 6 (DAKKS D-PL-18204-01-02)

As written on the certificate · Line 3 (DAKKS D-PL-18204-01-01)

DIN EN ISO 14644 -2:2016; DIN EN ISO 14644 -3:2020; DIN EN 17141 :2021; ISO 14644 -2:2016; ISO 14644 -3:2020

ISO 14644-3Cleanrooms and associated controlled environments - Part 3: Test methods

As written on the certificate · Line 3 (DAKKS D-PL-18204-01-01)

DIN EN ISO 14644 -2:2016; DIN EN ISO 14644 -3:2020; DIN EN 17141 :2021; ISO 14644 -2:2016; ISO 14644 -3:2020

Other standards

ASTM F1980Name not checked yet

As written on the certificate · Line 3 (DAKKS D-PL-18204-01-02)

EN 868-5Name not checked yet

As written on the certificate · Line 3 (DAKKS D-PL-18204-01-02)

As written on the certificate · Line 4 (DAKKS D-PL-18204-01-02)

EN 17141Cleanrooms and associated controlled environments - Biocontamination control

As written on the certificate · Line 4 (DAKKS D-PL-18204-01-02)

As written on the certificate · Line 6 (DAKKS D-PL-18204-01-02)

As written on the certificate · Line 3 (DAKKS D-PL-18204-01-01)

DIN EN ISO 14644 -2:2016; DIN EN ISO 14644 -3:2020; DIN EN 17141 :2021; ISO 14644 -2:2016; ISO 14644 -3:2020

Scope as published by DAKKS

12 lines

DAKKS

ISO/IEC 17025

Active

D-PL-18204-01-00

View scope

DAKKS

ISO/IEC 17025

Active

D-PL-18204-01-02

View scope

DAKKS

ISO/IEC 17025

Active

D-PL-18204-01-01

View scope

Location

Willy-Rüsch-Straße 10/1, Kernen im Remstal, 71394, DE

48.81475, 9.31449

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