A Short History of IEC 60601-1
The first edition of IEC 60601-1 for medical devices was published in 1977. The second edition was published in 1988 and focused on safety in the vicinity of a patient. The third edition was released in 2005, and was expanded to look at “means of protection” (MOP) both for patients and equipment operators. Edition 3.1 was released in 2012 and was a substantial update to the third edition. It addressed a number of ambiguities arising from the evolution of medical equipment technology.
What is IEC 60601-1?
IEC 60601-1 Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance is an international standard that applies to the basic safety and essential performance of medical electrical equipment. IEC 60601-1 is the parent of a series of standards relating to the safety of medical electrical equipment. The series also contains:
- Collateral Standards (indicated by IEC 60601-1-NN) which specify additional requirements covering specific aspects, e.g. 60601-1-2 covers electromagnetic compatibility.
- Particular Standards (indicated by IEC 60601-2-NN) which specifies safety requirements for specific types of medical electrical equipment.
- Performance Standards (indicated by IEC 60601-3-NN) which specifies performance requirements for specific types of medical electrical equipment. There are currently no performance standards that are in effect.
IEC 60601-1 and its related standards always apply to medical electrical equipment and covers any type of medical electrical equipment, ranging from battery-operated thermometers to medical lasers to accelerators for proton therapy. However, it can also apply to medical equipment that contains no electrical components because it also describes how to handle a large number of potential hazards, e.g. moving parts and radiation. Essentially, this standard aims to ensure that no electrical, mechanical, or functional failure poses an unacceptable risk to patients or operators.
This standard assumes that the medical device is developed and maintained within a risk management system (RMS).
Note on the QMS and RMS
IEC 60601-1 doesn’t explicitly refer to an existing quality management system (QMS), but compliance with ISO 13485 is recommended when developing medical devices.
IEC 60601-1 refers to the risk management process defined by ISO 14971 and specifies a few exceptions.
As with most international standards, some countries adapt the requirements of the standard to their specific legislations, e.g. USA, while others use the IEC version unchanged, e.g. EU (EN 60601-1) and Canada (CSA 60601-1).
This standard together with all its collateral standards is complex and there are many requirements that need to be taken into account and it is best if this is done from the beginning of the device development process because early compliance minimises the chances of non-conformances during the certification process.
What are the IEC 60601-1 general requirements for basic safety and essential performance?
The standard refers to medical electrical (ME) equipment and ME systems. ME equipment is defined as electrical equipment having an applied part or transferring energy to or from the patient or detecting such energy transfer to or from the patient and which is:
- provided with not more than one connection to a particular supply mains; and
- intended by its manufacturer to be used:
- in the diagnosis, treatment, or monitoring of a patient; or
- for compensation or alleviation of disease, injury or disability.
An applied part is a part of the device that in normal use necessarily comes into physical contact with the patient for the device to perform its function, e.g. a cable, or, electrode.
An ME system is a combination of individual devices which are connected to each other and of which at least one is classed as ME equipment.
In many cases, the detailed requirements of IEC 60601-1 is specified in other standards, e.g. its Collateral Standards (indicated by IEC 60601-1-NN), its Particular Standards (indicated by IEC 60601-2-NN) and other related standards, like ISO 14971.
The main sections of the standard are:
- General Requirements which state that the requirements for risk management, specifically that manufacturers must comply with ISO 14971 to demonstrate the safety of the device.
- General Requirements for Testing ME Equipment which state the general requirements for testing the device.
- Classification of ME Equipment deals with how to determine which classifications apply to the device in terms of protection against electrical shock, protection against harmful ingress of water or particulate matter, whether or not it requires sterilization, whether the device is suitable for use in an oxygen-rich environment and its mode of operation. The results of this process determines the types and limits of the tests that need to be performed on the device. This classification should be done very early in the design process.
- Equipment Identification, Marking and Documents describes requirements for measurement units, symbols used, durability and legibility, information provided on the device label and contents of the instructions for use.
- Protection Against Electrical Hazards introduces the concepts of Means Of Patient Protection (MOPP) and Means Of Operator Protection (MOOP) and describes in detail the means of protection that should be employed to prevent leakage current and other limits from being exceeded.
- Protection Against Mechanical Hazards lists requirements for moving parts, trapping zones, emergency stops and stability.
- Protection Against Radiation Hazards describes requirements for infrared, ultraviolet, microwave, X-ray, and particle radiation.
- Protection Against Excessive Temperatures & Other Hazards covers the requirements for hazards arising from too high temperatures, fire prevention and flammability, liquid overflow, and biocompatibility.
- Accuracy of Controls stresses the importance of usability engineering in the design of a safe medical device.
- Hazardous Situations and Fault Conditions lists a number of specific hazards that are not permitted to occur under single fault conditions. It is important to note that a specific hazard not being listed in this section does not imply that the hazard is permitted. These hazards should be identified and mitigated as part of the standard Risk Analysis.
- Programmable Electrical Medical Systems (PEMS) covers safety in devices containing firmware or software. If the software included in your device provides basic safety support, or failure of the software leads to a form of unacceptable risk, then the software performance and efficiency must be designed, tested and evaluated according to the requirements of this section. There is a significant overlap between this section and IEC 62304 and it is most likely that manufacturers have to comply with both.
- Construction of ME Equipment details the requirements for serviceability, impact and drop tests, cords and connectors, batteries, and transformer construction.
- ME Systems covers the requirements when ME equipment is connected to each other with data or power cables. These requirements include additional documentation, separation devices, and handling supplies simply because of the connection.
- Electromagnetic Compatibility (EMC) describes how performance and safety can be affected by electrostatic discharge (ESD), radiated and conducted immunity, and power line perturbations.
- The thirteen Annexes are categorized as Informative or Normative and they give guidance or specify requirements, respectively.
Does IEC 60601-1 define a medical device classification?
The standard defines a medical device classification. Classifying the device helps to identify the applicable requirements and consequently what testing is needed for the device.
There are 5 parts to the classification that need to be considered:
- Protection against electrical shock applies to all devices.
- Class I: device with a grounded power source
- Class II: ungrounded device
- Internally powered: devices with an internal power source or battery
- Applied parts are classified as:
- Type B: No electrical contact the with patient and maybe earthed
- Type BF: Electrically connected to the patient but not directly to the heart
- Type CF: Electrically connected to the heart of the patient
- Applied parts may be also be classified as defibrillation-proof applied parts.
- Protection against harmful ingress of water or particulate matter applies to how effective the seal on the electrical enclosure is against intrusion from water or particulate matter. This is stated in terms of an Ingress Protection (IP) rating. Testing is determined by the IP rating.
- Method(s) of sterilization apply if the device or its parts is intended to be sterilized.
- Suitability for use in an OXYGEN RICH ENVIRONMENT applies if the device is intended for use in an oxygen-rich environment.
- Mode of operation applies to all devices and can be either:
What are the collateral standards?
The IEC 60601-1 collateral standards define the requirements for specific aspects of electrical safety and performance in medical devices. There are eight collateral standards that cover:
- IEC 60601-1-2 (Electromagnetic disturbances – Requirements and tests)
- IEC 60601-1-3 (Radiation protection in diagnostic X-ray equipment)
- IEC 60601-1-6 (Usability)
- IEC 60601-1-8 (General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems)
- IEC 60601-1-9 (Requirements for environmentally conscious design)
- IEC 60601-1-10 (Requirements for the development of physiologic closed-loop controllers)
- IEC 60601-1-11 (Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment)
- IEC 60601-1-12 (Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment).
What is the latest version?
The latest version of IEC 60601-1 is version 3.1 that was released in 2012. This is the version that is used in most parts of the world, e.g. Europe, USA, Canada and Japan.
There is a 4th edition for the collateral standard IEC 60601-1-2: Electromagnetic disturbances – Requirements and tests that was released in 2014. This version is in use in many parts of the world.
However, always confirm what version of this standard applies to your target market before you start development.
For more information
IEC 60601-1 is a long document (~450 pages, not counting all the collateral standards!) and we understand how applying this standard to your medical device might seem daunting. However, we at ArrowFast are here to ease your worries. Contact us at email@example.com and we can help you from the beginning of your design phase to correctly apply this standard.