EN ISO / IEC 17020
| 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 sterilizers | type A | documentation review, thermoelectric examination, biological indicators | inspection small steam sterilizers | |
| EN 14180 (2014-05) | Sterilizers for medical purposes – Low temperature steam and formaldehyde sterilizers – Requirements and testing | type A | documentation review, thermoelectric examination, biological indicators, chemical indicators, desorption review | inspection low temperature steam and formaldehyde sterilizers | |
| EN 16442 (2015-03) | Controlled environment storage cabinet for processed thermolabile endoscopes | type A | documentation review, thermoelectric examination, examination of process- and program parameters, testing of cleaning and disinfection, water analysis | inspection storage cabinet for endoscopes | |
| EN 285 (2015-12) | Sterilization – Steam sterilizers – Large sterilizers | type A | documentation review, thermoelectric examination, measurement of inert gas, water analysis, biological indicators | inspection large steam sterilizers | |
| 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 | inspection low temperature ethylene oxide sterilizers | |
| 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 | documentation review, thermoelectric examination, biological indicators, chemical indicators, microbiological analysis | inspection low temperature hydrogen-peroxide / plasma sterilizers | |
| 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 | General requirements inspection washer-disinfector | |
| 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 | inspection washer-disinfector | |
| 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 | inspection washer-disinfector (Plug-in basin) |
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 |