IEC 60601 is a vitally important technical series of standards for different electrical medical devices. It is not a single standard but there are several detailed standards in this series. So searching IEC 60601 will end you in a list of several different standards, which companies need to select based on the electrical device they are doing to develop. So it is possible that 3 to 4 standards can apply in this series for that specific medical device based on different systems it works on. In this blog, we will try to simplify the concept behind this technical series, the different standards as per the application and the aim of this series of technical standards. The purpose of this technical series is to confirm that medical electrical devices are designed and developed in a manner that their outcomes are safe with effective functionality.
Overview of IEC 60601
While presenting the overview it is important to note although it is a difficult series of standard, but we have tried to summarize the information in best possible way to educate our readers and offer them a way forward.
Why This Series in the First Place?
Suppose a patient in critical condition is there in a hospital emergency room. He/she is lying unconscious and immobile in bed and has been linked to several electrical devices that are assisting treat the patient so he/she can recover. A team of healthcare professionals is working in rush with these electrical appliances to protect the patient’s life and they rely on the technology at their usage will empower them to have the job successfully done.
Just to share the perspective what can actually go wrong with that patient in the given scenario or in the course of invasive treatment when the patient’s body skin no more offers a primary coating of insulation contrary to electrical streams, even a minor electrical shock off course can lead an individual’s heart to tremble or halt the respiratory system. Along with the fatal threats to patients, with the intense power of electrical devices, there is a prospect of fire, which in a specific case can aggravate to a huge explosion. So these are just two aspects of the risks associated with electrical devices, there can be many others including those projected to the healthcare professionals as well. For the patients, these risks are critical and there is no room for compromise, and therefore these devices are strictly regulated with these robust series of general and specific standards within IEC 60601 family.
Technical Series for Medical Device Software Developers
The IEC 60601 is a series of technical standards designed to ensure the safety and effectiveness of medical electrical equipment. This comprises any kind of medical electrical device, comprising from something as little as an endoscopic camera to somewhat as big as MRI or gamma high tech equipment imaging systems. IEC 60601 families are the keystone guide to electrical medical device design and development. It takes the precaution of all the risks that come across with the development and also encounters issues associated with software malfunction for these electrical devices. While conformance with this series can be to a certain extent a big ongoing project; the objective of these electrical equipment safety standards is quite clear: It is to ensure that no mechanical, functional, or electrical functional failure embarks an intolerable risk to patients and to the healthcare workers utilizing these devices.
Why this Technical Series?
The IEC 60601-1 (Edition 3.1) is the extensively acknowledged and compulsory standard for electrical medical devices put in the markets of the US, EU, Australia, Canada, Brazil, Japan, Russia, and others. These countries have been applying enforcement of this standard since January 2014, so if any company is planning to enter markets as a manufacturer & developer of electrical medical equipment, one needs to ensure that the device is compliant.
Documentation of IEC Standards & Family
Documents prepared under this series can be extensive, and sometimes, difficult to uphold. But having a grip on the standards and developing device software according to these standards can help companies save time, cost, and also result in the effective production and marketing of the product in terms of saving human lives while keeping the operational safety intact.
Also read our important blog on ISO 14971.TS Q & E
IEC 60601 – Medical electrical equipment Standards
It is a family of technical standards for the security and essential performance of medical electrical equipment, issued by the International Electrotechnical Commission. It was primarily published in 1977 and continually revised and reorganized. As of 2011; it consists of one general standard, and around 10 collateral standards, along with 80 particular standards.
Bifurcating Name Genealogy of Important Standards in Series
In order to bring a clear understanding of the family of standards within the series, the experts of TSQ & E have gone one step forward to present the different important standards within the family by bifurcating the name genealogy of the standard with its standard reference name, Part number, Type of the standard such as general or particular and finally the central application of that standard. We do hope that this resource will really help all those who are looking to learn about the IEC 60601 family of standards. One needs to understand which set of the standards from the family apply for a specific electrical medical device.
|Standard Reference Number||Standard Part Number||Standard Type||Standard Specifics Regarding the Type of Electrical Medical Device|
|IEC 60601-1-2||Medical electrical equipment – Part 1-2||General requirements for basic safety and essential performance – Collateral Standard||Electromagnetic Disturbances – Requirements and Tests|
|IEC 60601-1-3||Medical electrical equipment – Part 1-3||General requirements for basic safety and essential performance – Collateral Standard||Radiation Protection in Diagnostic X-Ray Equipment|
|IEC 60601-1-6||Medical electrical equipment – Part 1-6||General requirements for basic safety and essential performance – Collateral standard||Usability|
|IEC 60601-1-8||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 60601-1-9||Medical electrical equipment – Part 1-9||General requirements for basic safety and essential performance – Collateral Standard||Requirements for Environmentally Conscious Design|
|IEC 60601-1-10||Medical electrical equipment – Part 1-10||General requirements for basic safety and essential performance – Collateral Standard||Requirements for the Development of Physiologic Closed-Loop Controllers|
|IEC 60601-1-11||Medical electrical equipment – Part 1-11||General requirements for basic safety and essential performance – Collateral Standard||Requirements for Medical Electrical Equipment and Medical Electrical Systems Used In the Home Healthcare Environment|
|IEC 60601-1-12||Medical electrical equipment – Part 1-12||General requirements for basic safety and essential performance – Collateral Standard||Requirements for Medical Electrical Equipment and Medical Electrical Systems Intended For Use in the Emergency Medical Services Environment|
|IEC 60601-2-1||Medical electrical equipment – Part 2-1||Particular requirements for the basic safety and essential performance||Electron Accelerators in the Range 1 Mev|
|IEC 60601-2-2||Medical electrical equipment – Part 2-2||Particular requirements for the basic safety and essential performance||High Frequency Surgical Equipment and High Frequency Surgical Accessories|
|IEC 60601-2-3||Medical electrical equipment – Part 2-3||Particular requirements for the basic safety and essential performance||Short-Wave Therapy Equipment|
|IEC 60601-2-4||Medical electrical equipment – Part 2-4||Particular requirements for the basic safety and essential performance||Cardiac Defibrillators|
|IEC 60601-2-5||Medical electrical equipment – Part 2-5||Particular requirements for the basic safety and essential performance||Ultrasonic Physiotherapy Equipment|
|IEC 60601-2-6||Medical electrical equipment – Part 2-6||Particular requirements for the basic safety and essential performance||Microwave Therapy Equipment|
|IEC 60601-2-8||Medical electrical equipment – Part 2-8||Particular requirements for basic safety and essential performance||Therapeutic X-Ray Equipment Operating In the Range 10 Kv To 1|
|IEC 60601-2-10||Medical electrical equipment – Part 2-10||Particular requirements for the basic safety and essential performance||Nerve and Muscle Stimulators|
|IEC 60601-2-11||Medical electrical equipment – Part 2-11||Particular requirements for the basic safety and essential performance||Gamma Beam Therapy Equipment|
|IEC 60601-2-12||Medical electrical equipment – Part 2-12||Particular requirements for the basic safety and essential performance||Critical Care Ventilators|
|IEC 60601-2-16||Medical electrical equipment – Part 2-16||Particular requirements for basic safety and essential performance||Haemodialysis, Haemodiafiltration and Haemofiltration Equipment|
|IEC 60601-2-17||Medical electrical equipment – Part 2-17||Particular requirements for the basic safety and essential performance||Automatically Controlled Brachytherapy Afterloading Equipment|
|IEC 60601-2-18||Medical electrical equipment – Part 2-18||Particular requirements for the basic safety and essential performance||Endoscopic Equipment|
|IEC 60601-2-19||Medical electrical equipment – Part 2-19||Particular requirements for the basic safety and essential performance||Infant Incubators|
|IEC 60601-2-20||Medical electrical equipment – Part 2-20||Particular requirements for the basic safety and essential performance||Infant Transport Incubators|
|IEC 60601-2-21||Medical electrical equipment – Part 2-21||Particular requirements for the basic safety and essential performance||Infant Radiant Warmers|
|IEC 60601-2-22||Medical electrical equipment – Part 2-22||Particular requirements for basic safety and essential performance||Surgical, Cosmetic, Therapeutic and Diagnostic Laser Equipment|
|IEC 60601-2-23||Medical electrical equipment – Part 2-23||Particular requirements for the basic safety and essential performance||Transcutaneous Partial Pressure Monitoring Equipment|
|IEC 60601-2-24||Medical electrical equipment – Part 2-24||Particular requirements for the basic safety and essential performance||Infusion Pumps and Controllers|
|IEC 60601-2-25||Medical electrical equipment – Part 2-25||Particular requirements for the basic safety and essential performance||Electrocardiographs|
|IEC 60601-2-26||Medical electrical equipment – Part 2-26||Particular requirements for the basic safety and essential performance||Electroencephalographs|
|IEC 60601-2-27||Medical electrical equipment – Part 2-27||Particular requirements for the basic safety and essential performance||Electrocardiographic Monitoring Equipment|
|IEC 60601-2-28||Medical electrical equipment – Part 2-28||Particular requirements for the basic safety and essential performance||X-Ray Tube Assemblies for Medical Diagnosis|
|IEC 60601-2-29||Medical electrical equipment – Part 2-29||Particular requirements for the basic safety and essential performance||Radiotherapy Simulators|
|IEC 60601-2-31||Medical electrical equipment – Part 2-31||Particular requirements for the basic safety and essential performance||External Cardiac Pacemakers with Internal Power Source|
|IEC 60601-2-33||Medical electrical equipment – Part 2-33||Particular requirements for the basic safety and essential performance||Magnetic Resonance Equipment for Medical Diagnosis|
|IEC 60601-2-34||Medical electrical equipment – Part 2-34||Particular requirements for the basic safety and essential performance||Invasive Blood Pressure Monitoring Equipment|
|IEC 60601-2-36||Medical electrical equipment – Part 2-36||Particular requirements for the basic safety and essential performance||Equipment for Extracorporeally Induced Lithotripsy|
|IEC 60601-2-37||Medical electrical equipment – Part 2-37||Particular requirements for the basic safety and essential performance||Ultrasonic Medical Diagnostic and Monitoring Equipment|
|IEC 60601-2-39||Medical electrical equipment – Part 2-39||Particular requirements for basic safety and essential performance||Peritoneal Dialysis Equipment|
|IEC 60601-2-40||Medical electrical equipment – Part 2-40||Particular requirements for the basic safety and essential performance||Electromyographs and Evoked Response Equipment|
|IEC 60601-2-41||Medical electrical equipment – Part 2-41||Particular requirements for the basic safety and essential performance||Surgical Luminaires and Luminaires for Diagnosis|
|IEC 60601-2-43||Medical electrical equipment – Part 2-43||Particular requirements for the basic safety and essential performance||X-Ray Equipment for Interventional Procedures|
|IEC 60601-2-44||Medical electrical equipment – Part 2-44||Particular requirements for the basic safety and essential performance||X-Ray Equipment for Computed Tomography|
|IEC 60601-2-45||Medical electrical equipment – Part 2-45||Particular requirements for basic safety and essential performance||Mammographic X-Ray Equipment and Mammomagraphic Stereotactic Devices|
|IEC 60601-2-46||Medical electrical equipment – Part 2-46||Particular requirements for the basic safety and essential performance||Operating Tables|
|IEC 60601-2-47||Medical electrical equipment – Part 2-47||Particular requirements for the basic safety and essential performance||Ambulatory Electrocardiographic Systems|
|IEC 60601-2-49||Medical electrical equipment – Part 2-49||Particular requirements for the basic safety and essential performance||Multifunction Patient Monitoring Equipment|
|IEC 60601-2-50||Medical electrical equipment – Part 2-50||Particular requirements for the basic safety and essential performance||Infant Phototherapy Equipment|
|IEC 60601-2-52||Medical electrical equipment – Part 2-52||Particular requirements for the basic safety and essential performance||Medical Beds|
|IEC 60601-2-54||Medical electrical equipment – Part 2-54||Particular requirements for the basic safety and essential performance||X-Ray Equipment for Radiography and Radioscopy|
|IEC 60601-2-57||Medical electrical equipment – Part 2-57||Particular requirements for the basic safety and essential performance||Non-Laser Light Source Equipment Intended For Therapeutic, Diagnostic, Monitoring and Cosmetic aesthetic use|
|IEC 60601-2-62||Medical electrical equipment – Part 2-62||Particular requirements for the basic safety and essential performance||High Intensity Therapeutic Ultrasound (HITU) Equipment|
|IEC 60601-2-63||Medical electrical equipment – Part 2-63||Particular requirements for the basic safety and essential performance||Dental Extra-Oral X-Ray Equipment|
|IEC 60601-2-64||Medical electrical equipment – Part 2-64||Particular requirements for the basic safety and essential performance||Light Ion Beam Medical Electrical Equipment|
|IEC 60601-2-65||Medical electrical equipment – Part 2-65||Particular requirements for the basic safety and essential performance||Dental Intra-Oral X-Ray Equipment|
|IEC 60601-2-66||Medical electrical equipment – Part 2-66||Particular requirements for the basic safety and essential performance||Hearing Instruments and Hearing Instrument Systems|
|IEC 60601-2-68||Electrical medical equipment – Part 2-68||Particular requirements for the basic safety and essential performance||X-Ray-Based Image-Guided Radiotherapy Equipment for Use with Electron Accelerators, Light Ion Beam Therapy Equipment and Radionuclide Beam Therapy Equipment|
|IEC 60601-2-75||Medical electrical equipment – Part 2-75||Particular requirements for the basic safety and essential performance||Photodynamic Therapy and Photodynamic Diagnosis Equipment|
|IEC 60601-2-76:2018||Medical electrical equipment – Part 2-76||Particular requirements for the basic safety and essential performance||Low Energy Ionized Gas Haemostasis Equipment|
|IEC 60601-2-83:2019||Medical electrical equipment – Part 2-83||Particular requirements for the basic safety and essential performance||Home Light Therapy Equipment|
|IEC 60601-2-84:2018||Medical electrical equipment – Part 2-83||Particular requirements for the basic safety and essential performance||Emergency and Transport Ventilators|
Compliance with the Series is the Way Forward for Electrical Medical Equipment
Most medical device manufacturers and developers go through a similar misleading step when they encounter the IEC 60601 standards series. Companies just starting off with new electrical devices give it a second thought, as they will do it later, but then again they have to re-plan and redesign from scratch when they reach the point where they consider it for compliance. The difficulty of the standard series means that just testing can easily consume several months to comply with the basic standards, and not being ready and equipped for this process means going back to the designing process, again and again, not to state the lost time, money and other resources.
This is a difficult standards series and is complex. Sometimes it can be exasperating with its implementation process however it is important to ensure that your designed electrical device is safe for patients and users. And then of course one can move forward and can lead their products to market without a glitch and that makes all the process worth doing. We can conclude this technical series compliance for electrical medical devices as ‘proactive designing and development for compliance’. We duly understand that the process can be hell difficult, and companies need a lot of knowledge and expertise to go on, that is where TS Q & E consultants can help to get on with the process and move forward with the design and development of electrical medical equipment. Contact the team of experts at TS Q & E today and inquire us about your challenges with medical device equipment.