PD IEC/TR 60601-4-1:2017
Current
The latest, up-to-date edition.
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English
06-23-2017
IEC TR 60601-4-1:2017(E) is intended to help a manufacturer through the key decisions and steps to be taken to perform a detailed risk management and usability engineering processes for medical electrical equipment or a medical electrical system, hereafter referred to as MEE or MES, employing a degree of autonomy (DOA).
This document provides a definition of DOA of MEE or MES and a medical robot, and also provides guidance on:
- methodologies to perform the risk management process and usability engineering for an MEE or MES with a DOA;
- considerations of basic safety and essential performance for an MEE and MES with a DOA; and
- identifying the use of DOA, and similar concepts in existing ISO/IEC standards dealing with MEE or MES with the goal to facilitate alignment of standards by consistent use of the concept of DOA; and
- distinguishing between medical robots, and other MEE and MES.
Unless specified otherwise, this document considers MEE and MES together.
The manufacturer of an MEE or MES with a DOA is expected to design and manufacture an MEE or MES that fulfils its intended use and does not have unacceptable risk throughout its life-cycle.
This document provides guidance to help the manufacturer in complying with the requirements of IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012 for MEE and MES with DOA. The document is also intended as guidance for future standard writers.
There are no prerequisites to this document.
Committee |
CH/62/1
|
DocumentType |
Standard
|
Pages |
84
|
PublisherName |
British Standards Institution
|
Status |
Current
|
Standards | Relationship |
IEC TR 60601-4-1:2017 | Identical |
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 |
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