93/68/EEC : 1993 AMD 2 1998
|
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 61025:2006
|
Fault tree analysis (FTA) |
ISO 14155-2:2003
|
Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
IEC 60812:2006
|
Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) |
ISO 18113-1:2009
|
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
|
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
EN 1441 : 1997
|
MEDICAL DEVICES - RISK ANALYSIS |
ISO 15189:2012
|
Medical laboratories — Requirements for quality and competence |
IEC 60601-1-6:2010+AMD1:2013 CSV
|
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
ISO 13485:2016
|
Medical devices Quality management systems Requirements for regulatory purposes |
ISO 14155-1:2003
|
Clinical investigation of medical devices for human subjects Part 1: General requirements |
ISO/TR 14969:2004
|
Medical devices Quality management systems Guidance on the application of ISO 13485: 2003 |
ISO 10993-2:2006
|
Biological evaluation of medical devices — Part 2: Animal welfare requirements |
IEC 60601-1-8:2006+AMD1:2012 CSV
|
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 |
ISO 15198:2004
|
Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer |
ISO 18153:2003
|
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 62366:2007+AMD1:2014 CSV
|
Medical devices - Application of usability engineering to medical devices |
ISO 19001:2013
|
In vitro diagnostic medical devices — Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology |
ISO/IEC Guide 51:2014
|
Safety aspects Guidelines for their inclusion in standards |
ISO 17511:2003
|
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
|
Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
ISO 10993-1:2009
|
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
IEC 60300-3-9:1995
|
Dependability management - Part 3: Application guide - Section 9: Risk analysis of technological systems |
ISO 17593:2007
|
Clinical laboratory testing and in vitro medical devices Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy |
ISO 9000:2015
|
Quality management systems — Fundamentals and vocabulary |
ISO/IEC Guide 2:2004
|
Standardization and related activities General vocabulary |
EN 12442-1 : 2000
|
ANIMAL TISSUES AND THEIR DERIVATIVES UTILIZED IN THE MANUFACTURE OF MEDICAL DEVICES - PART 1: ANALYSIS AND MANAGEMENT OF RISK |
ISO 15197:2013
|
In vitro diagnostic test systems — Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus |
IEC 60601-1-4:1996+AMD1:1999 CSV
|
Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
ISO 9000-3:1997
|
Quality management and quality assurance standards Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software |