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  • Search: 09.01 - Medical devices in general
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 No.Document numberIssuing DateTitle
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1 DIN 58341 2020-07-01 Requirements for the validation of cleaning and disinfection processes
2 DIN 58936-2 2001-06-01 Quality management in laboratory medicine - Part 2: Terminology for quality and application of test procedure
3 DIN 58943-3 2011-03-01 Medical microbiology - Diagnosis of tuberculosis - Part 3: Detection of mycobacteria by culture methods; Text in German and English
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4 DIN 58943-4 2009-02-01 Medical microbiology - Diagnosis of tuberculosis - Part 4: Primary samples for the diagnosis of tuberculosis and mycobacteria - Qualitative and quantitative requirements, extraction, transport and storage; Text in German and English
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5 DIN 58943-4 Beiblatt 1 2011-03-01 Medical microbiology - Diagnosis of tuberculosis - Part 4: Primary samples for the diagnosis of tuberculosis and mycobacteria - Qualitative and quantitative requirements, extraction, transport and storage - Supplement 1: Prevention of contaminations of clinical specimens with mycobacteria during processing in the laboratory; Text in German and English
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6 DIN 58943-9 2007-11-01 Medical microbiology - Diagnostics of tuberculosis - Part 9: Phenotypic differentiation of tubercle bacilli; text in German and English
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7 DIN 58943-32 2015-05-01 Medical microbiology - Diagnosis of tuberculosis - Part 32: Detection of mycobacteria by microscopic methods; Text in German and English
8 DIN 58950-2 2021-06-01 Sterilization - Steam sterilizers for pharmaceutical products - Part 2: Technical requirements; Text in German and English
9 DIN 58950-3 2021-06-01 Sterilization - Steam sterilizers for pharmaceutical products - Part 3: Tests; Text in German and English
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10 DIN EN 1041 2013-12-01 Information supplied by the manufacturer of medical devices; German version EN 1041:2008+A1:2013
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11 DIN EN 17126 2019-02-01 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of sporicidal activity of chemical disinfectants in the medical area - Test method and requirements (phase 2, step 1); German version EN 17126:2018
12 DIN EN 60601-2-5; VDE 0750-2-5 2016-08-01 Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment (IEC 60601-2-5:2009); German version EN 60601-2-5:2015
13 DIN EN 60601-2-52; VDE 0750-2-52 2016-04-01 Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds (IEC 60601-2-52:2009 + Cor.:2010 + A1:2015); German version EN 60601-2-52:2010 + AC:2011 + A1:2015
14 DIN EN IEC 61340-6-1; VDE 0300-6-1 2019-08-01 Electrostatics - Part 6-1: Electrostatic control for healthcare - General requirements for facilities (IEC 61340-6-1:2018); German version EN IEC 61340-6-1:2018
15 DIN EN 62366-1; VDE 0750-241-1 2021-08-01 Medical devices - Part 1: Application of usability engineering to medical devices (IEC 62366-1:2015 + COR1:2016 + A1:2020); German version EN 62366-1:2015 + AC:2015 + A1:2020
16 DIN EN IEC 80601-2-52; VDE 0750-2-52 2021-08-01 Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds (IEC 62D/1759A/CD:2020); Text in German and English
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17 DIN EN ISO 4073 2009-10-01 Dentistry - Information system on the location of dental equipment in the working area of the oral health care provider (ISO 4073:2009); German version EN ISO 4073:2009
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18 DIN EN ISO 11137-1 2020-04-01 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd.1:2013 + Amd.2:2018); German version EN ISO 11137-1:2015 + A2:2019
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19 DIN EN ISO 11137-2 2015-11-01 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (ISO 11137-2:2013); German version EN ISO 11137-2:2015
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20 DIN EN ISO 11137-2/A1 2021-02-01 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose - AMENDMENT 1 (ISO 11137-2:2013/DAM 1:2021); German and English version EN ISO 11137-2:2015/prA1:2021