IEC 60601 – Elucidating Standards Series for Electrical Medical Devices’ Manufacturers

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.

Illustrative Summary of IEC 60601 Standards Family
Illustrative Summary of IEC 60601 Standards Family

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 NumberStandard Part NumberStandard TypeStandard Specifics Regarding the Type of Electrical Medical Device
IEC 60601-1-2 Medical electrical equipment – Part 1-2General requirements for basic safety and essential performance – Collateral StandardElectromagnetic 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
IEC 60601 Series of Technical Standards

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.

About the Author

Waqas Imam

S. M. Waqas Imam is associated with TS Quality as a Regional Partner. He is also an ambassador of Medical Device Community. He is an Industrial Engineer by qualification and served the manufacturing industry since 2011. He is also IRCA CQI Lead Auditor of ISO 9001 and other management system standards. He had served as Quality Assurance and Regulatory Affairs Manager in QSA Surgical Pvt. Ltd. and Ultimate Medical Products. He managed requirements of ISO 13485:2003, EU directives, CE marking and FDA. He also served as Expert Blog Writer for 13485Academy and wrote expert articles on various topics of ISO 13485:2016.