EN ISO 11197:2016
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Medical supply units (ISO 11197:2016) |
EN 60601-2-39:2008/A11:2011
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-39: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PERITONEAL DIALYSIS EQUIPMENT (IEC 60601-2-39:2007) |
ISO 3744:2010
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Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane |
IEC 60601-1-6:2010+AMD1:2013 CSV
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Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
ISO 8638:2010
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Cardiovascular implants and extracorporeal systems Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters |
IEC 60601-1-10:2007+AMD1:2013 CSV
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Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers |
EN 60601-1-6:2010/A1:2015
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MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013) |
EN 60601-1-10:2008/A1:2015
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MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS (IEC 60601-1-10:2007) |
ISO 13958:2014
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Concentrates for haemodialysis and related therapies |
IEC 60601-1-8:2006+AMD1:2012 CSV
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Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems |
IEC 62366:2007+AMD1:2014 CSV
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Medical devices - Application of usability engineering to medical devices |
IEC 60601-2-39:2007
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-39: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PERITONEAL DIALYSIS EQUIPMENT |
IEC 60601-1-2:2014
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Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
EN 60601-1-2:2015
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Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
IEC 60601-2-16 : 4.0
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MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT |
ISO 11197:2016
|
Medical supply units |
EN ISO 3744:2010
|
Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Engineering methods for an essentially free field over a reflecting plane (ISO 3744:2010) |
EN ISO 8638:2014
|
Cardiovascular implants and extracorporeal systems - Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (ISO 8638:2010) |
IEC 60601-2-39:2007
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Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment |
EN 62366 : 2008 AMD 1 2015
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MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007/A1:2014) |
EN 1275:2005
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Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic fungicidal or basic yeasticidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1) |
EN 1040:2005
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Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics - Test method and requirements (phase 1) |
ISO 594-2:1998
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Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings |
EN 60601-1-11:2015
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Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment |
EN 60601-2-16:2015
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Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
EN 60601-1-8:2007/A11:2017
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MEDICAL ELECTRICAL EQUIPMENT - PART 1-8: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: GENERAL REQUIREMENTS, TESTS AND GUIDANCE FOR ALARM SYSTEMS IN MEDICAL ELECTRICAL EQUIPMENT AND MEDICAL ELECTRICAL SYSTEMS (IEC 60601-1-8:2006/A1:2012) |