Germany

Synergy Health Radeberg

Juri-Gagarin-Straße 15, 01454, Radeberg, Germany

DAKKS D-PL-20594-01-01ISO/IEC 17025Register refreshed 2026-10-23

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Accredited standards: 11
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 11 standard numbers and the 8 official names we hold. When no standard matches, it searches the method text of every scope line.

ISO4

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

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

ISO 13004Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD

ISO 14937Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices

ISO 11737 series3

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

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

ISO 11737-3Sterilization of health care products - Microbiological methods - Part 3: Bacterial endotoxin testing

USP3

USP 38

USP 85

USP 161

Other standards1

EN 17141Cleanrooms and associated controlled environments - Biocontamination control

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

Scope as published by DAKKS

4 lines

DAKKS

ISO/IEC 17025

Active

D-PL-20594-01-01

View scope

Accredited scope, certificate D-PL-20594-01-01

Line	Method	Matrix	Range
1	DIN EN ISO/IEC 17025:2018	Medizinprodukten; Sterilisationsverfahren; Umgebungsüberwachung	-
2	DIN EN ISO 11737-2; DIN EN ISO 11737-1; DIN EN ISO 13004; DIN EN ISO 11137-1; DIN EN ISO 11137-2; DIN EN ISO 13485 : 2021; ISO 11737-3; Ph. Eur. 2.6.14; USP <85>; USP <161>; ANSI/AAMI ST72; Ph.Eur. 5.1.10; DIN EN 17141	Medizinprodukte; Luft	-
3	DIN EN 17141; DIN EN ISO 11137-1; DIN EN ISO 11137-2; DIN EN ISO 11737-1; DIN EN ISO 11737-2; ISO 11737-3; DIN EN ISO 13004; DIN EN ISO 14937	Oberflächen	-
4	DIN EN 17141 : 2021-02; Ph. Eur. 8, 2.6.14; Ph. Eur. 8, 5.1.10; USP 38 <85>; USP 38 <161>; ANSI/AAMI ST72:2019; AA 1000_001_00v16; AA 1000_002_00v18; AA 1000_010_00v16; AA 1000_027_00v05	Reinräume und zugehörige Reinraumbereiche; Umgebungsproben; Luftkeimzahl; Oberflächenproben	-

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

Juri-Gagarin-Straße 15, Radeberg, 01454, DE

51.10071, 13.90893

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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.