In the short course below, I will show you what safety is, the general requirements for safety, and how to navigate and apply the standards.
Safety standards for electrical medical devices
All manufacturers of medical devices aim to ensure that their products are safe and effective. It is also a regulatory requirement for any market where you would sell your product.
Considering the diversity of medical devices, how they are used and the technologies they employ – this can be challenging. Therefore, standards have been developed to help manufacturers, test houses and regulators.
By knowing how the safety standards for electrical medical devices are structured, you can navigate the standards and identify the relevant requirements with greater ease.
All these standards in combination define what is called basic safety and essential performance for different types of medical devices.
Structure of the 60601 series
The general standard, relevant for safety for electrical medical devices is IEC 60601-1. This standard specifies general requirements for basic safety and essential performance. The general standard is an umbrella standard based on collateral standards and particular standards.
What is a collateral standard?
The collateral standards specify general requirements applicable to subgroups of devices as well as specific characteristics of devices not covered by the general standard.
The topics of these standards include EMC, usability, alarms, environmental design, closed-loop controllers, home healthcare and EMS. In principle, each of these collateral standards apply in parallel with the general standard.
What is a particular standard?
In addition to the general standard and the collateral standards, there are also particular standards. Each of these apply to a very specific type of product. The particular standards may modify, replace or delete requirements contained in the general and the collateral standards.
As the scope is any medical device, this series of standards define requirements for a lot of hazards and risks. These include among others:
- Electrical requirements such as insulation, leakage current and protective earth
- Mechanical requirements including structural integrity, moving parts, patient support systems, noise and vibration
- Radiation requirements which include X-ray, alpha, beta, gamma, neutron, microwave and light radiation
- Temperature and other hazards such as heat, cold, fire, spillage, cleaning, ingress of water and particulate matter
Additional hazards can include:
- Use-related requirements such as usability, home healthcare, alarms and hazardous outputs
- Software requirements for the development process and risk management
- Constructional requirements related to controls, indicators, serviceability, connectors, replacement of components and wiring
- Functional requirements which are often defined in particular standards and in some of the collateral standards
You will have to identify and manage all these hazards, and other hazards relevant to your device through the risk management process. If you want to know more about risk management, take a look at our online course Introduction to Risk Management for Medical Devices and ISO 14971:2019.
Basic safety and essential performance
The goal with all of these requirements is to ensure basic safety and essential performance, which basically means that the patient and other users should have freedom from unacceptable risk.
Freedom from unacceptable risk is achieved through proactive risk management, requirement management and verification during all product development phases.
To establish that the device is safe, you need to manage all risks relevant for electrical medical devices.
Proactive management of requirements
Most manufacturers fail to address safety by design in a proactive manner in one specific aspect. In my experience, the most common problem manufacturers face is lack of proactive management of these requirements.
The safety standards define type tests – but if you wait to address them in detail, until you submit to the lab at the end of your product development project, you are sure to fail the test.
Typically, safety related activities are performed late in the design verification phase or even as late as the design validation phase. This results in failed tests, redesign and retesting – which adds to cost and delays.
To avoid costly delays, I recommend that you identify the few relevant requirements early, during the design phase and decide how the design will meet these requirements.
Proactive safety by design
The key to proactive safety by design is to start early and, based on the intended purpose and technologies, identify which standards, hazards and requirements are applicable to your device. Then document how the product is designed to be safe in the design notes.
It is critical to do this as a cross-functional team exercise, because it is the combination of electronic, mechanic and software solutions that must meet the requirements.
Identify the key features which are critical to the product, and then focus on these. Next, ask stakeholders for their input, this includes team members, management, and suppliers. Consult standards and guidelines to ensure that you understand all the aspects of the requirements.
When you have clarified what the key requirements are and analyzed the ways they can be managed; then and only then it is time to identify and document solutions. To make safety engineering easier, focus on clarification and analysis before execution.
Would you like to know more about safety for electrical devices?
Our online courses are frequently taken by competent authorities, notified bodies and medical device manufacturers and distributors.
Claus Rømer Andersen
He is recognized as having a pragmatic and solution oriented approach to helping development teams focus on relevant issues throughout the entire product life-cycle.