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

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

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

site inspection, documentation review, environmental

21-070 (2014-12)Site inspection, documentation review, environmental investigationtype A

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

21-074 (2018-04)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 parameter

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

inspections according to chapter 7

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

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

site inspection,documentation review

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

§4, inspection activity to create an inspection report

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

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

EN ISO / IEC 17025

Page 2 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 1276 (2019-08)NChemical disinfectants and antiseptics –Quantitative suspension test for the evaluation of bactericidal activity of chemical disinfectants and antiseptics used in food, industrial, domestic, and institutional areas – Test method and requirements (phase 2, step 1)quantitative suspension test

chemical disinfectants and antiseptics

bactericidal activity

EN 12791 (2016-12)NChemical disinfectants and antiseptics –Surgical hand disinfection – Test method and requirements (phase 2, step 2)quantitative suspension test

Surgical hand disinfection

Mode of action

EN 13098 (2019-09)NWorkplace exposure - Measurement of airborne microorganisms and microbial compoundspour plate method, colony counting method

Workplace exposure

airborne microorganisms and microbial compounds

EN 13274-7 (2019-06)NRespiratory protective devices – Methods of test - Part 7:Determination of particle filter penetrationaerosol penetration without

medical devices

barrier effect against particles

EN 13623 (2010-09)NChemical disinfectants and antiseptics –Quantitative non-porous surface test for the evaluation of bactericidal and/or fungicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas – Test method and requirements without mechanical action (phase 2, step 2)quantitative non-porous surface test

chemical disinfectants used in food, industrial, domestic and institutional areas

bactericidal and/or fungicidal activity

EN 13697 (2015-04)NChemical disinfectants and antiseptics –Quantitative non-porous surface test for the evaluation of bactericidal and/or fungicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas – Test method and requirements without mechanical action (phase 2, step 2)quantitative non-porous surface test

chemical disinfectants used in food, industrial, domestic and institutional areas

bactericidal and/or fungicidal activity

EN 13704 (2018-07)NChemical disinfectants – Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants used in food, industrial, domestic and institutional areas – Test method and requirements (phase 2, step 1)quantitative suspension test

chemical disinfectants used in food, industrial, domestic and institutional areas

sporicidal activity

EN 13727 (2012-05)NChemical disinfectants and antiseptics –Quantitative suspension test for the evaluation of bactericidal activity in the medical area – Test method and requirements (phase 2, step 1)quantitative suspension test

chemical disinfectants and antiseptics in the medical area

bactericidal activity

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