IEC 80001-1:2010
|
Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities |
IEC 60601-2-37:2007+AMD1:2015 CSV
|
Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment |
ISO 11137-1:2006
|
Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
IEC 60601-2-10:2012+AMD1:2016 CSV
|
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and musclestimulators |
IEC 60601-2-21:2009+AMD1:2016 CSV
|
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers |
IEC 60601-2-19:2009+AMD1:2016 CSV
|
Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators |
ISO 80601-2-13:2011
|
Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation |
ISO/TR 24971:2013
|
Medical devices Guidance on the application of ISO 14971 |
IEC 60601-2-5:2009
|
Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment |
ISO 10328:2016
|
Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods |
ISO 22523:2006
|
External limb prostheses and external orthoses — Requirements and test methods |
IEC 60601-1:2005+AMD1:2012 CSV
|
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
IEC 60601-2-47:2012
|
Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems |
IEC 60050-151:2001
|
International Electrotechnical Vocabulary (IEV) - Part 151: Electrical and magnetic devices |
IEC TR 62390:2005
|
Common automation device - Profile guideline |
IEC 60601-2-26:2012
|
Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs |
ISO 80601-2-56:2017
|
Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement |
2007/47/EC : 2007 COR 1 2015
|
DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE) |
ISO 13485:2016
|
Medical devices Quality management systems Requirements for regulatory purposes |
IEC 60601-1-10:2007+AMD1:2013 CSV
|
Medical electrical equipment - Part 1-10: General requirements forbasic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loopcontrollers |
IEC 60601-2-23:2011
|
Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment |
IEC 60601-2-33:2010+AMD1:2013+AMD2:2015 CSV
|
Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis |
IEC 60601-2-20:2009+AMD1:2016 CSV
|
Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transportincubators |
IEC 80601-2-59:2017
|
Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening |
IEC 60601-2-18:2009
|
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
ISO/IEC Guide 63:2012
|
Guide to the development and inclusion of safety aspects in International Standards for medical devices |
EN 1985 : 1998
|
WALKING AIDS - GENERAL REQUIREMENTS AND TEST METHODS |
IEC 60601-2-34:2011
|
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety and essential performance of invasive blood pressure monitoring equipment |
ISO 11135-1:2007
|
Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
IEC 60601-2-54:2009+AMD1:2015 CSV
|
Medical electrical equipment - Part 2-54: Particular requirementsfor the basic safety and essential performance of X-ray equipmentfor radiography and radioscopy |
IEC 60601-2-39:2007
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-39: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF PERITONEAL DIALYSIS EQUIPMENT |
IEC 60601-2-31:2008+AMD1:2011 CSV
|
Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source |
IEC 60601-2-4:2010
|
Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators |
ISO 80601-2-12:2011
|
Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators |
IEC 60601-2-16 : 4.0
|
MEDICAL ELECTRICAL EQUIPMENT - PART 2-16: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF HAEMODIALYSIS, HAEMODIAFILTRATION AND HAEMOFILTRATION EQUIPMENT |
IEC 60601-2-2:2017
|
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
IEC 62304:2006+AMD1:2015 CSV
|
Medical device software - Software life cycle processes |
ISO 13482:2014
|
Robots and robotic devices Safety requirements for personal care robots |
IEC 60601-2-40:2016
|
Medical electrical equipment - Part 2-40: Particular requirements for the basic safety and essential performance of electromyographs and evoked response equipment |
EN 12184:2014
|
Electrically powered wheelchairs, scooters and their chargers - Requirements and test methods |
ISO 11137-2:2013
|
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
IEC 60601-2-1:2009+AMD1:2014 CSV
|
Medical electrical equipment - Part 2-1: Particular requirements for the basic safety and essential performance of electron accelerators in the range 1 MeV to 50 MeV |
IEC 80601-2-30:2009+AMD1:2013 CSV
|
Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers |
IEC 60601-2-41:2009+AMD1:2013 CSV
|
Medical electrical equipment - Part 2-41: Particular requirementsfor the basic safety and essential performance of surgical luminaires and luminaires for diagnosis |
IEC 60601-2-43:2010+AMD1:2017 CSV
|
Medical electrical equipment - Part 2-43: Particular requirements for the basic safety and essential performance of X-ray equipment for interventional procedures |
IEC 60601-2-39:2007
|
Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment |
IEC 60601-2-27:2011
|
Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment |
IEC 60601-2-25:2011
|
Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs |
ISO 80601-2-61:2011
|
Medical electrical equipment Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment |
ISO 80601-2-55:2011
|
Medical electrical equipment Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors |
ISO/IEC Guide 71:2014
|
Guide for addressing accessibility in standards |
IEC 60601-2-24:2012
|
Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers |
ISO 14155:2011
|
Clinical investigation of medical devices for human subjects Good clinical practice |
ISO/IEC Guide 2:2004
|
Standardization and related activities General vocabulary |
ISO 16201:2006
|
Technical aids for persons with disability — Environmental control systems for daily living |
IEC TR 61850-90-7:2013
|
Communication networks and systems for power utility automation - Part 90-7: Object models for power converters in distributed energy resources (DER) systems |
ISO/TR 22411:2008
|
Ergonomics data and guidelines for the application of ISO/IEC Guide 71 to products and services to address the needs of older persons and persons with disabilities |
ISO 14971:2007
|
Medical devices Application of risk management to medical devices |
IEC 60947-2:2016
|
Low-voltage switchgear and controlgear - Part 2: Circuit-breakers |
IEC 60601-2-49:2011
|
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment |
ISO 22675:2016
|
Prosthetics Testing of ankle-foot devices and foot units Requirements and test methods |
ISO 17664:2017
|
Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
IEC 60601-2-45:2011+AMD1:2015 CSV
|
Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices |
ISO 8373:1994
|
Manipulating industrial robots — Vocabulary |
IEC 60730-1:2013+AMD1:2015 CSV
|
Automatic electrical controls - Part 1: General requirements |
IEC 60601-2-66:2015
|
Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing instruments and hearing instrument systems |