Germany

Valitech GmbH & Co. KG

Leipziger Straße 71, 14612, Falkensee, Germany

DAKKS|D-PL-18539-01-00ISO/IEC 17025Register refreshed 2026-09-25

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DAKKSRefreshed 2026-09-25: D-PL-18539-01-00Active

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 6222Water quality - Enumeration of culturable micro-organisms - Colony count by inoculation in a nutrient agar culture medium

As written on the certificate · Line 7 (DAKKS D-PL-18539-01-00)

DIN EN ISO 13485 2021-122; DIN EN ISO 6222 7-1403 SOP - Pseudomonas aeruginosa DIN EN ISO 16266 7-1403 SOP 7-0908 SOP - Escherichia coli und coliformen Bakterien ISO 9308-1 7-1403; ISO 13485 2021-122; ISO 14698-2 7-0911-SOP 7-0921-SOP Mitgeltend: ISO 14698-1 VDI 6022 Blatt 1 Leitfaden Umweltbundesamt Wasser und wässrige Lösungen Nachweis spezifizierter Mikroorganismen - Koloniezahl bei 22; ISO 6222 7-1403 SOP - Pseudomonas aeruginosa DIN EN ISO 16266 7-1403 SOP 7-0908 SOP - Escherichia coli und coliformen Bakterien ISO 9308-1 7-1403

ISO 7899-2Water quality - Detection and enumeration of intestinal enterococci - Part 2: Membrane filtration method

As written on the certificate · Line 8 (DAKKS D-PL-18539-01-00)

DIN EN ISO 13485: 2021-122; DIN EN ISO 14189 7-1403 SOP - Enterokokken DIN EN ISO 7899-2 7-1403 SOP - Legionellen DIN EN ISO 11731-2 7-1403 SOP 7-0909 SOP Mitgeltend: RKI-Empfehlung Infektionsprävention Zahnheilkunde Quellenverzeichnis Regelwerke/Prüfverfahren: DIN EN 285 : 2016-05; DIN EN ISO 9308-1 : 2017-09 Wasserbeschaffenheit - Zählung von Escherichia coli und coliformen Bakterien - Teil 1; DIN EN 868-5 : 2019-03; DIN EN 6222 : 1999-07

ISO 9308-1Water quality - Enumeration of Escherichia coli and coliform bacteria - Part 1: Membrane filtration method for waters with low bacterial background flora

As written on the certificate · Line 7 (DAKKS D-PL-18539-01-00)

As written on the certificate · Line 8 (DAKKS D-PL-18539-01-00)

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 2 (DAKKS D-PL-18539-01-00)

DIN EN ISO 10993-5 7-1501-SOP 7-1505-SOP 7-1506-SOP Mitgeltend: DIN EN ISO 10993-1 DIN EN ISO 10993-12; DIN EN ISO 11607-1 - Festigkeit von Siegelnähten DIN EN 868-5; DIN EN ISO 15883-1; DIN EN ISO 15883-2 3-0101-SOP 8-0601; ISO 10993-5 7-1501-SOP 7-1505-SOP 7-1506-SOP Mitgeltend: DIN EN ISO 10993-1 DIN EN ISO 10993-12

As written on the certificate · Line 9 (DAKKS D-PL-18539-01-00)

DIN EN ISO 10993-1 : 2021-05 Biologische Beurteilung von Medizinprodukten - Teil 1; DIN EN ISO 10993-5 : 2009-10 Biologische Beurteilung von Medizinprodukten - Teil 5; DIN EN ISO 10993-12 : 2021-08 Biologische Beurteilung von Medizinprodukten - Teil 12; DIN EN ISO 11607-1 : 2017-10 Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1; DIN EN ISO 11731 : 2019-03

ISO 11731Water quality - Enumeration of LegionellaCertificate says EN ISO 11731 2019-03 UBA Empfehlung 18. Probably the same standard; not checked against the EN document.

As written on the certificate · Line 9 (DAKKS D-PL-18539-01-00)

ISO 11731-2Water quality - Detection and enumeration of Legionella - Part 2: Direct membrane filtration method for waters with low bacterial counts

As written on the certificate · Line 8 (DAKKS D-PL-18539-01-00)

As written on the certificate · Line 12 (DAKKS D-PL-18539-01-00)

DIN EN ISO 16266 7-0909; DIN EN ISO 11731-2 7-0911; DIN 10113; ISO 16266 7-0909; ISO 11731-2 7-0911

ISO 14189Water quality - Enumeration of Clostridium perfringens - Method using membrane filtration

As written on the certificate · Line 8 (DAKKS D-PL-18539-01-00)

ISO 14698-1Cleanrooms and associated controlled environments - Biocontamination control - Part 1: General principles and methods

As written on the certificate · Line 6 (DAKKS D-PL-18539-01-00)

DIN EN ISO 17665-1 2-0101-SOP Mitgeltend: DIN EN 13060 DIN EN 285 DGKH-Empfehlung Validierung Sattdampf Umgebungsüberwachung in der Herstellung und Prüfung der Sauberkeit der Produkte gemäß DIN EN ISO 13485: 2021-122; ISO 17665-1 2-0101-SOP Mitgeltend: DIN EN 13060 DIN EN 285 DGKH-Empfehlung Validierung Sattdampf Umgebungsüberwachung in der Herstellung und Prüfung der Sauberkeit der Produkte gemäß DIN EN ISO 13485: 2021-122; ISO 14698-2 7-0911-SOP - Semiquantitatives Abklatschverfahren 7-0709-SOP - Differenzierung nach pathogenen Mikroorganismen 7-0912-SOP Mitgeltend: ISO 14698-1 VDI 6022 Blatt 1; VDI 6022 Blatt 1; EN ISO 17665-1 2-0101-SOP Mitgeltend: DIN EN 13060 DIN EN 285 DGKH-Empfehlung Validierung Sattdampf Umgebungsüberwachung in der Herstellung und Prüfung der Sauberkeit der Produkte gemäß DIN EN ISO 13485: 2021-122

As written on the certificate · Line 7 (DAKKS D-PL-18539-01-00)

ISO 14698-2Cleanrooms and associated controlled environments - Biocontamination control - Part 2: Evaluation and interpretation of biocontamination data

As written on the certificate · Line 6 (DAKKS D-PL-18539-01-00)

As written on the certificate · Line 7 (DAKKS D-PL-18539-01-00)

ISO 16266Water quality - Detection and enumeration of Pseudomonas aeruginosa - Method by membrane filtration

As written on the certificate · Line 7 (DAKKS D-PL-18539-01-00)

As written on the certificate · Line 10 (DAKKS D-PL-18539-01-00)

DIN EN ISO 15883-4 : 2019-09 Reinigungs-Desinfektionsgeräte - Teil 4; DIN EN ISO 15883-6 : 2016-04 Reinigungs-Desinfektionsgeräte - Teil 6; DIN EN ISO 15883-7 : 2016-10 Reinigungs-Desinfektionsgeräte - Teil 7; DIN EN ISO 16266 : 2008-05; DIN EN ISO 17664 : 2018-04

As written on the certificate · Line 12 (DAKKS D-PL-18539-01-00)

DIN EN ISO 16266 7-0909; DIN EN ISO 11731-2 7-0911; DIN 10113; ISO 16266 7-0909; ISO 11731-2 7-0911

ISO 17664Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices

As written on the certificate · Line 4 (DAKKS D-PL-18539-01-00)

DIN EN ISO 15883-1; DIN EN ISO 15883-7 8-0601-SOP Mitgeltend: DIN ISO/TS 15883-5 DIN 58341; DIN EN ISO 17664 Reinigung/Desinfektion Sterilisation - mit feuchter Hitze 8-0601-SOP 7-0606-SOP 7-0608-SOP 7-0503-SOP 7-0607; DIN 58341; ISO 15883-1

As written on the certificate · Line 10 (DAKKS D-PL-18539-01-00)

ISO 17665-1Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices

As written on the certificate · Line 6 (DAKKS D-PL-18539-01-00)

EN

EN 285Name not checked yet

As written on the certificate · Line 6 (DAKKS D-PL-18539-01-00)

As written on the certificate · Line 8 (DAKKS D-PL-18539-01-00)

EN 868-5Name not checked yet

As written on the certificate · Line 2 (DAKKS D-PL-18539-01-00)

As written on the certificate · Line 8 (DAKKS D-PL-18539-01-00)

EN 6222Name not checked yet

As written on the certificate · Line 8 (DAKKS D-PL-18539-01-00)

EN 13060Name not checked yet

As written on the certificate · Line 6 (DAKKS D-PL-18539-01-00)

EN 16442Name not checked yet

As written on the certificate · Line 3 (DAKKS D-PL-18539-01-00)

DIN EN ISO 15883-1 - mit thermischer oder chemo- thermischer Desinfektion für Behälter für menschliche Ausscheidungen Installationsqualifikation Betriebsqualifikation Leistungsqualifikation DIN EN ISO 15883-3 3-0101-SOP 8-0601; DIN EN ISO 15883-4 DIN EN 16442 3-0101-SOP 3-0103-SOP Mitgeltend: DIN ISO/TS 15883-5 DIN 58341; DIN EN ISO 15883-6 8-0601; DIN 58341; ISO 15883-1 - mit thermischer oder chemo- thermischer Desinfektion für Behälter für menschliche Ausscheidungen Installationsqualifikation Betriebsqualifikation Leistungsqualifikation DIN EN ISO 15883-3 3-0101-SOP 8-0601

EN 16616Name not checked yet

As written on the certificate · Line 11 (DAKKS D-PL-18539-01-00)

DIN EN 16616 7-0503; VDI 6022 Blatt 1; EN 16616

ISO 15883 series

ISO 15883-1Washer-disinfectors - Part 1: General requirements, terms and definitions and tests

As written on the certificate · Line 2 (DAKKS D-PL-18539-01-00)

As written on the certificate · Line 3 (DAKKS D-PL-18539-01-00)

As written on the certificate · Line 4 (DAKKS D-PL-18539-01-00)

ISO 15883-2Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for critical and semi-critical medical devices

As written on the certificate · Line 2 (DAKKS D-PL-18539-01-00)

ISO 15883-3Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers

As written on the certificate · Line 3 (DAKKS D-PL-18539-01-00)

ISO 15883-4Washer-disinfectors - Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes

As written on the certificate · Line 3 (DAKKS D-PL-18539-01-00)

As written on the certificate · Line 10 (DAKKS D-PL-18539-01-00)

ISO 15883-6Washer-disinfectors - Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-critical medical devices and health care equipment

As written on the certificate · Line 3 (DAKKS D-PL-18539-01-00)

As written on the certificate · Line 10 (DAKKS D-PL-18539-01-00)

ISO 15883-7Washer-disinfectors - Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment

As written on the certificate · Line 4 (DAKKS D-PL-18539-01-00)

As written on the certificate · Line 10 (DAKKS D-PL-18539-01-00)

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-18539-01-00)

As written on the certificate · Line 9 (DAKKS D-PL-18539-01-00)

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

As written on the certificate · Line 2 (DAKKS D-PL-18539-01-00)

As written on the certificate · Line 9 (DAKKS D-PL-18539-01-00)

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

As written on the certificate · Line 2 (DAKKS D-PL-18539-01-00)

As written on the certificate · Line 9 (DAKKS D-PL-18539-01-00)

Scope as published by DAKKS

12 lines

DAKKS

ISO/IEC 17025

Active

D-PL-18539-01-00

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Location

Leipziger Straße 71, Falkensee, 14612, DE

52.54706, 13.10430

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Accreditation data refreshed from the DAKKS register on 2026-09-25.

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