Introduction
Medical devices that incorporate electrical components—whether a simple powered syringe pump or a complex imaging system—must undergo rigorous electrical safety testing to ensure they do not pose hazards to patients, users, or the environment.
In this article, we explore what electrical safety testing involves, why it matters, key standards and regulatory expectations, and best practices for manufacturers preparing for certification.
Why electrical safety matters in medical devices
Medical devices are often used in sensitive environments: hospitals, ambulances, clinics, and increasingly, patients’ homes. They are connected to mains power, batteries, data networks, and other devices. Electrical faults could result in:
- Electric shock to the patient or operator
- Fire hazards due to overheating, sparks, or insulation failure
- Interference with other critical devices, such as monitors or pacemakers
- Device malfunction, putting patient safety at risk
Because of these risks, electrical safety is one of the most fundamental elements considered by regulators, notified bodies, and testing labs during product approval processes.
Device classification and safety testing
Medical electrical devices are categorised according to their patient connections and safety requirements:
- Type B: Devices with no direct conductive connection to the patient (lowest protection)
- Type BF: Devices with conductive connections to the patient but not directly to the heart
- Type CF: Devices with conductive connections directly to the heart (highest protection)
Each classification has different limits for leakage current and stricter requirements as you move from B to CF.
What electrical safety testing involves
Electrical safety testing for medical devices encompasses a range of assessments designed to ensure that the device performs safely under normal and fault conditions. These assessments fall into a few major categories:
Leakage current testing
This test verifies that current leakage through the device’s enclosure or applied parts is within safe limits. Excessive leakage could result in dangerous shocks to patients or users. The limits depend on the device classification (Type B, BF, or CF) and intended use.
Dielectric strength testing
Also called hi-pot testing, this test checks the device’s insulation by applying a high voltage between various parts (e.g., live parts and accessible parts or earth) to ensure no breakdown occurs. It demonstrates that insulation can withstand transient overvoltages.
Ground (earth) bond testing
This test verifies the integrity of protective earthing connections, ensuring that accessible conductive parts are properly grounded and can safely carry fault current without posing a hazard.
Power input testing
Devices are tested to confirm they draw current within safe and expected limits during operation, startup, and under single-fault conditions.
Temperature rise testing
The device is monitored for surface temperatures and internal temperatures under normal and fault conditions to ensure that no part reaches a temperature that could burn the user or damage the device.
Mechanical and environmental testing (electrical safety-related)
While often treated as separate disciplines, electrical safety testing also interacts with:
- Protection against ingress (e.g., IP ratings for fluid and particle resistance)
- Drop and vibration testing (to ensure shocks don’t cause electrical hazards)
- Environmental conditions (e.g., safe function at temperature and humidity extremes)
Regulatory expectations for electrical safety testing
The cornerstone of medical device electrical safety testing is the IEC 60601-1 - Medical electrical equipment – Part 1: General requirements for basic safety and essential performance standard. This standard applies to almost all electrically powered medical equipment and lays down requirements for:
- Protection against electric shock
- Protection against mechanical hazards
- Protection against excessive temperatures
- Risk management for electrical and electronic components
- Essential performance and basic safety under normal and fault conditions
Manufacturers seeking CE marking in the EU, FDA clearance in the USA, TGA approval in Australia, or licensing in Canada typically need to demonstrate compliance with IEC 60601-1 (or national equivalents).
Risk management integration
IEC 60601-1 requires manufacturers to integrate electrical safety testing with their risk management process under ISO 14971: Medical devices — Application of risk management to medical devices. Testing should not be an isolated event but part of demonstrating that electrical hazards have been identified, controlled, and verified.
Under the Medical Device Regulation (EU 2017/745 - MDR) and in vitro Diagnostic Medical Device Regulation (EU 2017/746 - IVDR), manufacturers must demonstrate compliance with electrical safety requirements as part of the General Safety and Performance Requirements (GSPRs).
IEC 60601-1 is the harmonised standard most commonly used to meet these GSPRs.
The FDA recognises IEC 60601-1 (with US deviations through AAMI ES60601-1) for electrical safety. FDA submissions (510(k), PMA) typically include third-party test reports from accredited labs as evidence of compliance.
Health Canada
Health Canada accepts CAN/CSA-C22.2 NO. 60601-1, which aligns with IEC 60601-1. Compliance is typically shown through testing by a recognised certification body.
Australia Therapeutic Goods Administration (TGA)
The TGA requires evidence that medical devices meet the Essential Principles, including protection against electrical hazards. IEC 60601-1 is the accepted standard for demonstrating conformity.
U.K. Medicines and Healthcare products Regulatory Agency (MHRA)
Following Brexit, the UK continues to recognise IEC 60601-1as the standard for demonstrating compliance with the UK Medical Devices Regulations 2002 (as amended)
Best practices for manufacturers
- Engage early with testing experts: Incorporate electrical safety considerations from the design stage, not after prototypes are complete. Devices designed without early consideration of creepage distances, clearance, and insulation coordination may fail dielectric or leakage current tests, requiring costly redesigns.
- Select components with proven compliance: Using pre-certified power supplies or connectors can simplify testing. Changes in power supplies, connectors, or materials can affect test outcomes. Manufacturers must carefully control their supply chain and component approvals.
- Run pre-compliance testing: Identify and resolve issues before formal third-party testing to save time and cost.
- Integrate risk management: Document risk control measures clearly - demonstrate how design choices address and mitigate identified electrical hazards. Test labs often focus on pass/fail results, but regulators expect manufacturers to tie these results to their risk management files. Gaps here can delay approvals.
- Consider all intended use environments: Portable, home-use, or transportable devices may need additional testing for unique hazards.
- Plan for international deviations: Local deviations (e.g., US, Canada) mean a device might pass testing in one jurisdiction but need adjustments for another. Manufacturers aiming for global markets should plan testing accordingly.
- Plan for maintenance and servicing: Ensure continued electrical safety over the device’s lifetime through design and instructions.
Conclusion
Electrical safety testing is a non-negotiable part of bringing a medical device to market. Compliance with IEC 60601-1 and its derivatives demonstrates that a device meets the fundamental requirement of not harming patients or users through electrical means. By understanding the scope of testing, regulatory expectations, and common challenges, manufacturers can streamline the path to approval and ensure their devices are safe and reliable.
If developing a medical device and preparing for electrical safety testing, consider partnering with experienced testing laboratories and integrating electrical safety considerations into the design from the outset. This proactive approach simplifies compliance and ultimately contributes to safer devices for users.
Resources
European Union: MDR/IVDR
Under the Medical Device Regulation (EU 2017/745 - MDR) and in vitro Diagnostic Medical Device Regulation (EU 2017/746 - IVDR), manufacturers must demonstrate compliance with electrical safety requirements as part of the General Safety and Performance Requirements (GSPRs).
- Regulation (EU) 2017/745, Annex I — General Safety and Performance Requirements (GSPRs), particularly GSPR 5, 9, 14.2, 22
- Regulation (EU) 2017/746, Annex I — GSPRs
IEC 60601-1 is the harmonised standard most commonly used to meet these GSPRs.
U.S.A Food and Drug Administration
The FDA recognises IEC 60601-1 (with US deviations through
- AAMI ES60601-1 for electrical safety. FDA submissions (510(k), PMA) typically include third-party test reports from accredited labs as evidence of compliance.
- FDA Recognised Consensus Standards
Health Canada
- Medical Devices Regulations (SOR/98-282)
- CAN/CSA-C22.2 NO. 60601-1, which aligns with IEC 60601-1. Compliance is typically shown through testing by a recognised certification body.
- Health Canada recognised standards
Australia Therapeutic Goods Administration (TGA)
The TGA requires evidence that medical devices meet the Essential Principles, including protection against electrical hazards. IEC 60601-1 is the accepted standard for demonstrating conformity.
U.K. Medicines and Healthcare products Regulatory Agency (MHRA)
Following Brexit, the UK continues to recognise IEC 60601-1as the standard for demonstrating compliance with the UK Medical Devices Regulations 2002 (as amended)
International Standards
- IEC 60601-1 - Medical electrical equipment – Part 1: General requirements for basic safety and essential performance Manufacturers seeking CE marking in the EU, FDA clearance in the USA, TGA approval in Australia, or licensing in Canada typically need to demonstrate compliance with IEC 60601-1 (or national equivalents).
- ISO 14971:2019 Medical devices — Application of risk management to medical devices
Acceptance Criteria: The predefined standards and specifications that a device must meet during testing and evaluation to be deemed suitable for its intended use and to comply with regulatory requirements.
CE Marking: A certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA).
Change Control: The systematic process of managing and documenting modifications to a device or its manufacturing process to ensure that all changes are assessed, approved, implemented, and tracked in compliance with regulatory standards and quality management systems.
Classification: The process of categorising devices into different classes based on their intended use, level of risk to patients and users, and regulatory controls necessary to ensure safety and effectiveness.
Compliance: Adherence to regulations, standards, and guidelines set forth by regulatory authorities.
Conformity Assessment: A process used to determine whether a product, service, system, or entity meets specified standards, regulations, or requirements.
Harm: Physical injury or damage to the health of people or damage to property or the environment.
Harmonisation: The process of aligning standards, requirements, and procedures across different jurisdictions to ensure consistent safety and efficacy evaluations and market access for medical devices.
Hazard: A potential source of harm.
Hazardous Situation: Circumstances in which people, property, or the environment are exposed to one or more hazards.
Instructions for Use (IFU): The document provided by the manufacturer that includes essential information on a medical device’s intended purpose, proper handling, operation, maintenance, and safety precautions for users.
Intended purpose: The use for which a medical device is intended according to the information provided by the manufacturer on the labelling, in the instructions for use (IFU), or in promotional materials. This may also be referred to as the Intended Use in some jurisdictions. Also see Indication of Use.
International Medical Device Regulators Forum (IMDRF): A global regulatory collaboration focused on harmonising medical device regulations to facilitate patient access to safe and effective devices. This organisation was formerly the Global Harmonization Task Force (GHTF).
in vitro Diagnostics (IVD): Medical tests conducted on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections outside the body.
ISO 13485: An international standard that specifies requirements for a quality management system (QMS) specific to the medical devices industry.
Labelling: The label on a medical device and all descriptive and informational literature associated with the device. Also see Instructions for Use (IFU)
Maintenance: Regular, planned actions taken to ensure that the devices remain in optimal working condition, including inspection, calibration, cleaning, and repair. Also see Preventative Maintenance and Corrective Maintenance.
Manufacturer: A legal entity that designs, produces, assembles, or labels a medical device with the intention of placing it on the market.
Quality Management System (QMS): A formalised system that documents the structure, responsibilities, and procedures required to achieve effective quality management.
Regulation: The rules, laws, standards, and requirements set by regulatory authorities to ensure the safety, efficacy, and quality of devices intended for medical use.
Regulatory Authority: An official body overseeing and enforcing laws, regulations, and standards within a specific industry or sector to ensure compliance and protect public interests. Also known as a Regulatory Authority. Also see Competent Authority and Notified Body.
Regulatory Submission: The formal process of submitting documentation and data to regulatory authorities for review and approval to market or sell the device within a specific jurisdiction.
Residual Risk: The risk remaining after risk control measures have been taken.
Risk: The combination of the probability of occurrence of harm and the severity of that harm.
Risk Analysis: The systematic use of available information to identify hazards and to estimate the risk.
Risk Assessment: The overall process comprising risk analysis and risk evaluation.
Risk Communication: The exchange of information about risks between decision-makers and other stakeholders.
Risk Control: The process by which decisions are made, and measures are implemented to reduce or maintain risks within specified levels. It is also known as Risk Mitigation.
Risk Evaluation: The process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk.
Risk Management (RM): The systematic application of management policies, procedures, and practices to the tasks of analysing, evaluating, controlling, and monitoring risk.
Risk Management File (RMF): A compilation of all documents and records generated during the risk management process.
Safety: The condition of being protected from or unlikely to cause danger, risk, or injury.
Standard: A document that provides guidance, requirements, or specifications established by regulatory bodies, industry organisations, or international consensus groups.
Supply Chain: Activities, processes, and entities involved in the sourcing, manufacturing, distribution, and logistics management of these devices from suppliers to end-users.
Technical Documentation: All documents that demonstrate the design, manufacture, and performance of the device, essential for ensuring compliance with regulatory requirements. This is also known as the Technical File.
User: Any individual who operates or interacts with a medical device, including healthcare professionals, patients, and caregivers.