EN ISO / IEC 17020
| 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 laundries | type 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 procedures | type 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 institutes | type A | site inspection, documentation review, environmental investigation | inspection IVF institutes | |
| 21-070 (2019-12) | Site inspection, documentation review, environmental investigation | type 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, RKI | typ 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 professionals | type 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; RKI | type 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
| Document number (release) | 1) | Title of the standard or SOP | 2) | Executed testings/ Kinds of testings/Techniques/ Methods/ | Materials/Products | Components/ Parameters/ Features | Comment |
|---|---|---|---|---|---|---|---|
| ISO 16603 (2004-04) | N | Clothing for protection against contact with blood and body fluids - Determination of the resistance of protective clothing materials to penetration by blood and body fluids - Test method using synthetic blood | test method with synthetic blood | Protective Clothing | Resistance against penetration by blood and body fluids | ||
| ISO 16000-1 (2004-07) | N | Indoor air - Part 1: General aspects of sampling strategy | Sampling method | Indoor air | Sampling | ||
| ISO 10993-23 (2021-01) | N | Biological evaluation of medical devices - Part 23: Tests for irritation | Cell viability testing with reconstructed human epidermis (RhE model) using MTT reduction method | medical devices intended to meet the requirements of Biocompatibility 10993-1, Table 1, Skin Irritation. | ISO 10993-23, paragraph 6 - Determination of cell viability in vitro determination of cell viability in vitro | ||
| FprEN 17387 (2020-10) | N | Chemical disinfectants and antiseptics - Quantitative test for the evaluation of bactericidal and yeasticidal and/or fungicidal activity of chemical disinfectants in the medical area on non-porous surfaces without mechanical action - Test method and requirements (phase 2, step 2) | quantitative non-porous surface test | chemical disinfectants and antiseptics in the medical area | bactericidal and yeasticidal and/or fungicidal activity | ||
| EN ISO 11737-2 (2020-05) | N | Sterilization of health care products - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019) | Pour plate method, colony counting method | medical device | Sterility test | ||
| EN ISO 10993-5 (2009-06) | N | Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) | Testing of in vitro cytotoxicity using the neutral red method | medical device | Determination of cell viability | Including the following standard procedures: DIN EN ISO 10993-12: Biological evaluation of medical devices - Teil 12: Sample preparation and reference materials (ISO 10993-12:2012) | |
| EN ISO 10993-10 (2013-08) | N | Biological evaluation of medical devices - Part 10: Test for irritation and skin sensitization (ISO 10993-10:2010) | Examination of skin irritation with the LDHe method | medical device | Determination of the LDH distribution | Including the following standard procedures: DIN EN ISO 10993-12: Biological evaluation of medical devices - Teil 12: Sample preparation and reference materials (ISO 10993-12:2012) | |
| EN 455-1 (2020-05) | N | Medical gloves for single use - Part 1: Requirements and testing for freedom from holes | Leak test | Medical gloves for single use | Tightness | ||
| EN 17272 (2020-04) | N | Chemical disinfectants and antiseptics - Methods of airborne room disinfection by automated process - Determination of bactericidal, mycobactericidal, sporicidal, fungicidal, yeasticidal, virucidal and phagocidal activities | Quantitative germ carrier test | chemical disinfectants and antiseptics in the medical area, Veterinary Area and Food, Industrial, Domestic and Institutional Areas | Determination of Bactericidal, Fungicidal, Yeasticidal, Sporicidal, Tuberculocidal, Mycobactericidal, Virucidal and Phagocidal Activities |