93/68/EEC : 1993 AMD 2 1998
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COUNCIL DIRECTIVE 93/68/EEC OF 22.7.93 AMENDING DIRECTIVES 87/404/EEC, 88/378/EEC, 89/106/EEC, 89/336/EEC, 89/392/EEC, 89/686/EEC, 90/384/EEC, 90/385/EEC, 90/396/EEC, 91/263/EEC, 92/42/EEC AND 73/23/EEC |
IEC 61025 : 2.0
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FAULT TREE ANALYSIS (FTA) |
ISO 14155-2 : 2003
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CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS |
IEC 60812 : 2.0
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ANALYSIS TECHNIQUES FOR SYSTEM RELIABILITY - PROCEDURE FOR FAILURE MODE AND EFFECTS ANALYSIS (FMEA) |
ISO 18113-1 : 2009(R2015)
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER (LABELLING) - PART 1: TERMS, DEFINITIONS AND GENERAL REQUIREMENTS |
IEC 60601-1:2005+AMD1:2012 CSV
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MEDICAL ELECTRICAL EQUIPMENT - PART 1: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE |
EN 1441 : 1997
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MEDICAL DEVICES - RISK ANALYSIS |
ISO 15189 : 2012
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MEDICAL LABORATORIES - REQUIREMENTS FOR QUALITY AND COMPETENCE |
IEC 60601-1-6 :2013 (CON ED) 3.1
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MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY |
ISO 13485 : 2016(R2020)
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MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES |
ISO 14155-1 : 2003
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CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS |
ISO TR 14969 : 2004
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MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - GUIDANCE ON THE APPLICATION OF ISO 13485:2003 |
ISO 10993-2 : 2006(R2015)
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 2: ANIMAL WELFARE REQUIREMENTS |
IEC 60601-1-8 : 2.1
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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 60513 : 2.0
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FUNDAMENTAL ASPECTS OF SAFETY STANDARDS FOR MEDICAL ELECTRICAL EQUIPMENT |
ISO 15198 : 2004
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CLINICAL LABORATORY MEDICINE - IN VITRO DIAGNOSTIC MEDICAL DEVICES - VALIDATION OF USER QUALITY CONTROL PROCEDURES BY THE MANUFACTURER |
ISO 18153 : 2003
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN BIOLOGICAL SAMPLES - METROLOGICAL TRACEABILITY OF VALUES FOR CATALYTIC CONCENTRATION OF ENZYMES ASSIGNED CALIBRATORS AND CONTROL MATERIALS |
IEC 62366 : 1.1
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MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES |
ISO 19001 : 2013(R2018)
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - INFORMATION SUPPLIED BY THE MANUFACTURER WITH IN VITRO DIAGNOSTIC REAGENTS FOR STAINING IN BIOLOGY |
ISO/IEC GUIDE 51 : 2014
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SAFETY ASPECTS - GUIDELINES FOR THEIR INCLUSION IN STANDARDS |
ISO 17511 : 2003
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IN VITRO DIAGNOSTIC MEDICAL DEVICES - MEASUREMENT OF QUANTITIES IN BIOLOGICAL SAMPLES - METROLOGICAL TRACEABILITY OF VALUES ASSIGNED TO CALIBRATORS AND CONTROL MATERIALS |
ISO 10993-17 : 2002(R2016)
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 17: ESTABLISHMENT OF ALLOWABLE LIMITS FOR LEACHABLE SUBSTANCES |
ISO 10993-1 : 2009
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BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS |
IEC 60300-3-9 : 1.0
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DEPENDABILITY MANAGEMENT - APPLICATION GUIDE - RISK ANALYSIS OF TECHNOLOGICAL SYSTEMS |
ISO 17593 : 2007
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CLINICAL LABORATORY TESTING AND IN VITRO MEDICAL DEVICES - REQUIREMENTS FOR IN VITRO MONITORING SYSTEMS FOR SELF-TESTING OF ORAL ANTICOAGULANT THERAPY |
ISO 9000 : 2015
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QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY |
ISO/IEC GUIDE 2 : 2004(R2016)
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STANDARDIZATION AND RELATED ACTIVITIES - GENERAL VOCABULARY |
EN 12442-1 : 2000
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ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
IEC 60050-191 : 1.0T
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INTERNATIONAL ELECTROTECHNICAL VOCABULARY - PART 191: DEPENDABILITY AND QUALITY OF SERVICE |
ISO 15197 : 2013(R2018)
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IN VITRO DIAGNOSTIC TEST SYSTEMS - REQUIREMENTS FOR BLOOD-GLUCOSE MONITORING SYSTEMS FOR SELF-TESTING IN MANAGING DIABETES MELLITUS |
IEC 60601-1-4 : 1.1
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MEDICAL ELECTRICAL EQUIPMENT - PART 1-4: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS |
ISO 9000-3 : 1997
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QUALITY MANAGEMENT AND QUALITY ASSURANCE STANDARDS - GUIDELINES FOR THE APPLICATION OF ISO 9001: 1994 TO THE DEVELOPMENT, SUPPLY, INSTALLATION AND MAINTENANCE OF COMPUTER SOFTWARE |