Source: http://hightechdesignsafety.com/2020/02/iec-ul-ansi-60601-standard-overview-safety-for-medical-equipment/
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IEC UL ANSI 60601 Standard Overview Safety for Medical Equipment
February 5, 2020 by htds2 ·
Are you envisioning, planning, designing, building, or selling medical equipment? As a startup on through a fortune 100 company you will need to get to market fast, and win, using our proven “Conformity Discovery Process” © 2019 you will uncover conformity requirements early in process, and understand based on the standards what is required to get to market. Typically, ROI on completing the “Conformity Discovery Process” can be from as little as 5x to100X and sometimes as much as the whole company.
Medical equipment, designed to the requirements of IEC ANSI UL 60601 will be globally accepted and can mean the big win for your team.
As a test, certification and evaluation laboratory providing services to equipment manufacturers, end users and clients, we are out to help make the process easier and faster thereby helping to create a safer environment. Today Steve speaks about IEC 60601, which is also a UL and ANSI standard 60601. This International Standard applies to the basic safety and essential performance of medical electrical equipment and medical electrical systems. It is for the electrical safety and reliability of electrical medical equipment.
Link to video also available here: https://youtu.be/Lk_-A8umIro
If you are producing medical equipment this standard will be very important to you to show due diligence and it is also required as part of the FDA process for approvals and even required for exempt products under FDA. 60601 deals with the electrical characteristics of this equipment…how it is protected from fire and causing shock…how it is grounded…how it is designed and developed. It is critical that you complete your design process and design reviews and product safety reviews to 60601 so that you know as you go through your process and you are prepared to get certified you will be complete, be comfortable and have high confidence that the product will be certified at the end of the process. Safety for medical equipment is extremely important. It is one of the most important standards I work with. The idea of providing a patient and clinician a safe environment to operate your equipment is crucial to the furtherance of your business. In the future we will go through IEC, UL, ANSI 60601 section-by-section so that you will understand the standard completely and be able to implement it in your product design and product review process.
Related Standards from IEC
IEC 60065:2001, Audio, video and similar electronic apparatus – Safety requirements
IEC 60068-2-2:1974, Environmental testing – Part 2: Tests. Tests B: Dry heat Amendment 1 (1993) Amendment 2 (1994)
IEC 60079-0, Electrical apparatus for explosive gas atmospheres – Part 0: General requirements
IEC 60079-2, Electrical apparatus for explosive gas atmospheres – Part 2: Pressurized enclosures “p”
IEC 60079-5, Electrical apparatus for explosive gas atmospheres – Part 5: Powder filling “q”
IEC 60079-6, Electrical apparatus for explosive gas atmospheres – Part 6: Oil-immersion “o”
60601-1  IEC:2005
IEC 60083, Plugs and socket-outlets for domestic and similar general use standardized in member countries of IECIEC 60085, Electrical insulation – Thermal classification
IEC 60086-4, Primary batteries – Part 4: Safety of lithium batteries IEC 60112, Method for the determination of the proof and the comparative tracking indices of solid insulating materials
IEC 60127-1, Miniature fuses – Part 1: Definitions for miniature fuses and general requirements for miniature fuse-links
IEC 60227-1:1993, Polyvinyl chloride insulated cables of rated voltages up to and including 450/750 V – Part 1: General requirements4)Amendment 1 (1995) Amendment 2 (1998)
IEC 60245-1:2003, Rubber insulated cables – Rated voltages up to and including 450/750 V – Part 1: General requirements
IEC 60252-1, AC motor capacitors – Part 1: General – Performance, testing and rating – Safety requirements – Guide for installation and operation
IEC 60320-1, Appliance couplers for household and similar general purposes – Part 1: General requirements
IEC 60335-1:2001, Household and similar electrical appliances – Safety – Part 1: General requirements
IEC 60364-4-41, Electrical installations of buildings – Part 4-41: Protection for safety – Protection against electric shock
IEC 60384-14:2005, Fixed capacitors for use in electronic equipment – Part 14: Sectional specification: Fixed capacitors for electromagnetic interference suppression and connection to the supply mains
IEC 60417-DB:2002, Graphical symbols for use on equipment 5)IEC 60445, Basic and safety principles for man-machine interface, marking and identification – Identification of equipment terminals and of terminations of certain designated conductors, including general rules for an alphanumeric system
IEC 60447, Basic and safety principles for man-machine interface, marking and identification – Actuating principles
IEC 60601-1-2, Medical electrical equipment – Part 1-2: General requirements for safety – Collateral standard: Electromagnetic compatibility – Requirements and tests
IEC 60601-1-3, Medical electrical equipment – Part 1: General requirements for safety – 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment
IEC 60601-1-6, Medical electrical equipment – Part 1-6: General requirements for safety – Collateral standard: Usability
IEC 60601-1-8, Medical electrical equipment – Part 1-8: General requirements for safety –- Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
IEC 60664-1:1992, Insulation coordination for equipment within low-voltage systems – Part 1: Principles, requirements and tests 7) Amendment 1 (2000) Amendment 2 (2002) IEC 60695-11-10, Fire hazard testing – Part 11-10: Test flames – 50 W horizontal and vertical flame test methods
IEC 60730-1:1999, Automatic electrical controls for household and similar use – Part 1: General requirements8)Amendment 1 (2003)
IEC 60825-1:1993, Safety of laser products – Part 1: Equipment classification, requirements and user’s guide Amendment 1 (1997) Amendment 2 (2001)
IEC 60851-3:1996, Winding wires – Test methods – Part 3: Mechanical properties10)Amendment 1 (1997) Amendment 2 (2003)
IEC 60851-5:1996, Winding wires – Test methods – Part 5: Electrical properties11)Amendment 1 (1997) Amendment 2 (2004)
IEC 60851-6:1996, Winding wires – Test methods – Part 6: Thermal properties Amendment 1 (1997)
IEC 60878:2003, Graphical symbols for electrical equipment in medical practice
Filed Under: Blog · Tagged: 60601, ANSI 60601, High Tech Design Safety, IEC 60601, medical, medical equipment, steve barcik amstel, UL 60601