Accreditation

Internationally recoginzed

As an accredited testing laboratory (EN ISO/IEC 17025) and inspection body (EN ISO/IEC 17020), we give our customers the certainty of an internationally recognized test of products and processes.

Due to its accreditation as a testing laboratory in accordance with EN ISO/IEC 17025 and as an inspection body in accordance with EN ISO/IEC 17020 by the Federal Ministry for Digital and Economic Affairs in Vienna, Austria, HygCen meets all conformity requirements of those bodies. 

Accreditation means "according credibility" and is the formal national and international recognition as a testing laboratory and inspection body for the carrying out of certain activities, tests, and inspections. 

If laws, regulations, directives, etc. do not require any study/testing/inspection by an accredited body, for instance, then the current legal interpretation is "that the obligation to exercise due diligence is only met through the selection of an accredited institution." In other words, "Those who chose an unaccredited institution must be able to give good justification for doing so."
Due to its scope of accreditation, HygCen Austria GmbH is able to not only offer isolated tests for products or processes to be tested but also a broad but interconnected inspection, analysis, evaluation, and test matrix. 
In addition to decades of know-how, our primary strengths also include flexibility and speed.

EN ISO / IEC 17020

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Document number of the standard or SOP Title of the standard or SOP Type Inspection procedures/inspection methods Scope Comment
EN 13060 (2014-12)Small steam sterilizerstype A

documentation review,thermoelectric examination,biological indicators

EN 14180 (2014-05)Sterilizers for medical purposes – Low temperature steam and formaldehyde sterilizers – Requirements and testingtype A

documentation review,thermoelectric examination,biological indicators, chemical indicators,desorption review

EN 16442 (2015-03)Controlled environment storage cabinet for processed thermolabile endoscopestype A

documentation review,thermoelectric examination,examination of process- and program parameters, testing of cleaning and disinfection,water analysis

EN 285 (2015-12)Sterilization – Steam sterilizers – Large sterilizerstype A

documentation review,thermoelectric examination,measurement of inert gas, water analysis,biological indicator

EN ISO 11135 (2014-07)Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014)type A

documentation review,thermoelectric examination,biological indicators, chemical indicators,regulation for residual gas

EN ISO 14937 (2009-10)Sterilization 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 14937:2009)type A

among others for hydrogen-peroxide / plasma-method in use;documentation review,thermoelectric examination,biological indicators, chemical indicators,microbiological analysis

EN ISO 15883-1/A1 (2014-07)Washer-disinfectors - Part 1: General requirements, definitions and tests (ISO 15883-1:2006 + Amd 1:2014)type A

documentation review,thermoelectric examination,examination of process- and program parameters, testing of cleaning and disinfection,water analysis

EN ISO 15883-2 (2009-06)Washer-disinfectors - Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. (ISO 15883-2:2006)type A

documentation review,thermoelectric examination,examination of process- and program parameters, testing of cleaning and disinfection,water analysis

EN ISO 15883-3 (2009-06)Washer-disinfectors - Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers (ISO15883-3:2006)type A

documentation review,thermoelectric examination,examination of process- and program parameters, testing of cleaning and disinfection,water analysis

EN ISO / IEC 17025

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Document number (release) 1) Title of the standard or SOP 2) Executed testings/ Kinds of testings/Techniques/ Methods/ Materials/Products Components/ Parameters/ Features Comment
16-009 (2014-05)STesting of the cleaning efficacy of washer disinfectors for thermostable & thermolabile medical devices in accordance with the guideline of ÖGSV respectively DGKH, DGSV and AKIPhotometry

hermolabile medical devices

Protein residues after cleaning

The cleaning performance is checked with the aid of test specimens which are soiled; the evaluation according to the modified OPA-method

16-010 (2014-11)STesting of the cleaning efficacy of washer disinfectors for thermolabile endoscopes in accordance with the guideline of ÖGSVPhotometry

thermolabile endoscopes

Residual proteins after cleaning

The cleaning performance is checked with the help of endoscopicDummies; the evaluation is done optically

17-008 (2012-09)SQuantitative determination of free NH2 groups of blood-proteins by the modified OPA methodPhotometry

aqueous liquids

NH2-Gruppen (Proteins)

The determination of the residual proteins of soiling by the modified OPA-method is carried out photometrically and serves to demonstrate the cleaning performance.

ASTM F 1670/F 1670Ma (2017-01)NStandard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic BloodPenetration procedure with synthetic blood

Fabrics of Protective Clothing

Resistance to penetration

ASTM F 1671/F 1671M (2013-01)NStandard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test SystemPhi-X174-Bacteriophage- Intrusion procedure

Fabrics for Protective Clothing

Pathogenic germs

DIN 38409-9 (1980-07)NGerman standard methods for the examination of water, waste water and sludge; general measures of effects and substances (group H), determination of the settleable matter by volume in water and waste water (H9)Volumetric process

Drinking water, ground and surface water, process water, waste water

removable substances

DVG test guidelines, V.animal husbandry (2017-11)NMethods of testing chemical disinfectants for animal husbandryQuantitative carrier test on poplar wood

chemical disinfectants for keeping animals

virucidal activity

EN 1040 (2005-12)NChemical disinfectants and antiseptics –Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics –Test method and requirements (phase 1)quantitative suspension test

chemical disinfectants and antiseptics

bactericidal activity

EN 1275 (2005-12)NChemical disinfectants and antiseptics –Quantitative suspension test for the evaluation of basic fungicidal or basic yeasticidal activity of chemical disinfectants and antiseptics – Test method and requirements (phase 1)quantitative suspension test

chemical disinfectants and antiseptics

fungicidal or yeasticidal activity