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

Page 1 out of 3
Document number of the standard or SOP Title of the standard or SOP Type Inspection procedures/inspection methods Scope Comment
21-010 (2015-11)Hygiene Management System in laundriestype A

site inspection, documentation review, environmental investigation, air technology systems, thermoelectric examination, examination of process- and program parameters, testing of cleaning and disinfection

inspection Laundry

21-011 (2014-04)Hygiene Management System - reprocessing of textile operating room materials - examination of processes and procedurestype A

site inspection, documentation review, environmental investigation, air technology systems, determination of a population of microorganisms on products, thermoelectric examination, examination of process- and program parameters, sterility testing of operation materials used as medical devices for patients, clinic staff and devices,

inspection operating theatre centre, reprocessing of surgical textiles

21-055 (2014-05)Hygienic assessment of IVF institutestype A

site inspection, documentation review, environmental investigation

inspection IVF institutes

21-070 (2019-12)Site inspection, documentation review, environmental investigationtype A

documentation review, testing of cleaning and disinfection, thermoelectric examination, impression investigation, examination of process- and program parameters

inspection dishwashing system

21-074 (2020-02)Validation of manual cleaning and manual chemical disinfection of medical devices (guideline 2013)type A

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

inspection medical devices

AK KAB - Arbeitskreis Käfigaufbereitung (2016-01)Cage processing in animal facilities (5th Edition)type A

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

cage, animal facilities

BGBl. 04/2002 (2002-04)Hygiene requirements to the structural and functional design and equipment of endoscopy units, RKItyp A

site inspection, documentation review

inspection endoscopy units

BGBl. II Nr. 262/2008 (2008-07)Regulation of the Minister of Economy and Labor on exercise rules for foot care, cosmetics and massage by professionalstype A

site inspection, documentation review, environmental investigation, determination of a population of microorganisms on products, sterility of products, thermoelectric examination, biological indicators

§ 4, inspection activity for the preparation of a certificate of harmlessness for piercing, tattoo, permanent make-up and foot care.

BGesBl. 07/1995 (1995-07)Hygiene requirements to laundry and washing procedures and conditions for granting of laundry reprocessing to commercial laundries; RKItype A

site inspection, documentation review, environmental investigation, thermoelectric examination, examination of process- and program parameters, testing of cleaning and disinfection

inspection Laundry

EN ISO / IEC 17025

Page 4 out of 11
Document number (release) 1) Title of the standard or SOP 2) Executed testings/ Kinds of testings/Techniques/ Methods/ Materials/Products Components/ Parameters/ Features Comment
EN 14126 (2003-09)NProtective clothing - Performance requirements and test methods for protective clothing against infective agentsdifferential pressure method, penetration method

Protective Clothing against infective agents

Penetration resistance, pathogenic germs, microbial penetration dry and wet

EN 14204 (2012-11)NChemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants and antiseptics used in the veterinary area – Test method and requirements (phase 2, step 1)quantitative suspension test

chemical disinfectants and antiseptics used in the veterinary area

mycobactericidal activity

EN 14347 (2005-03)NChemical disinfectants and antiseptics – Basic sporicidal activity – Test method and requirements (phase 1)basic test

chemical disinfectants and antiseptics

sporicidal activity

EN 14348 (2005-01)NChemical disinfectants and antiseptics – Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants – Test method and requirements (phase 2, step 1)quantitative suspension test

chemical disinfectants and antiseptics in the medical area, instrument disinfectants

mycobactericidal activity

EN 14349 (2012-11)NChemical disinfectants and antiseptics – Quantitative surface test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in the veterinary area on non-porous surfaces without mechanical action – Test method and requirements (phase 2, step 2)quantitative surface test

chemical disinfectants and antiseptics used in the veterinary area

bactericidal activity on non-porous surfaces without mechanical action

EN 14476 (2013-08)NChemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of virucidal activity in the medical area - Test method and requirements (phase 2, step 1)quantitative suspension test

chemical disinfectants and antiseptics in the medical area

virucidal activity

EN 14561 (2006-05)NChemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area – Test method and requirements (phase 2, step 2)quantitative carrier test

chemical disinfectants and antiseptics for instruments in the medical area

bactericidal activity

EN 14562 (2006-05)NChemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area – Test method and requirements (phase 2, step 2)quantitative carrier test

chemical disinfectants and antiseptics for instruments in the medical area

fungicidal or yeasticidal activity

EN 14563 (2008-11)NChemical disinfectants and antiseptics – Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area – Test method and requirements (phase 2, step 2)quantitative carrier test

chemical disinfectants and antiseptics for instruments in the medical area

mycobactericidal activity