IEC 60601 Medical Device Safety Testing services
Navigate global medical device compliance with confidence. Our IEC 60601 Medical Device Safety Testing services streamline your path to market through comprehensive single-location testing that's recognized worldwide. Whether you’re a start-up or an established manufacturer, we'll guide you through compliance requirements while reducing complexity and time-to-market.
What is IEC 60601 medical device safety testing at Element?
IEC 60601 is the international standard for safety and performance of electrical medical devices. At Element, we provide complete testing, certification, and guidance services to ensure your medical devices meet these critical standards. Our comprehensive approach covers everything from initial design consultation through final certification, helping you achieve compliance efficiently and effectively.
What can Element offer you for medical device safety testing?
Key tests offered
Key tests offered
Our IEC 60601 Medical Safety Testing services include:
- Training support for IEC 60601 - customized in-house or onsite training at customer premises
- Gap assessment to 60601 series, IEC62304, IEC62366, ISO14971, and other standards
- Advisory services for conformity to IEC 60601
- Test reports and certificates for IECEE CB Scheme
- Risk management and integrated quality system (ISO 13485 and/or ISO 14971) assessments
- IECEE CB accreditation for the international CB certification scheme
- Software and usability assessments to support various IEC 60601 clauses
- EMC testing and assessments according to IEC 60601-1-2
- Home healthcare assessments to support IEC 60601-1-11
- CE Marking of class I, IIa, IIb, and III devices
Components and materials we test
Components and materials we test
Get comprehensive testing for your electrical and electronic medical devices, from simple monitoring equipment to complex programmable systems. Element's testing capabilities cover all medical electrical equipment types specified under IEC 60601 standards.
Methods and solutions offered
Methods and solutions offered
Access end-to-end support throughout your product development journey. Our comprehensive approach includes design consultation, prototype evaluation, formal compliance testing, certification support, and ongoing regulatory guidance. We provide customized solutions for both established manufacturers and start-ups.
Support and guidance on ISO 14971 risk management, including:
- Bespoke and one-to-one training
- Documentation and procedure review
- Production of essential documentation
- Gap Analysis, remediation & mitigation
Design & Safety Testing for Electrical and Electronic Medical Devices:
Element ensures that your medical devices meet safety standards and perform effectively without causing harm or electromagnetic disturbances in their appropriate operating environment, allowing you to bring them to market with confidence.
Support in Early Product Development
Our Engaged Experts help determine the applicable standards, assess design specifications, and create an effective risk management program from the start. We also assist start-ups in navigating regulatory requirements and developing a go-to-market strategy.
Risk Assessment & File Management:
We provide impartial third-party support throughout product development, including safety testing, Declaration of Conformity (DoC), and Technical File compilation. Our experts offer consultative guidance to ensure your product meets market requirements.
Achieving ISO 14971 Compliance:
Compliance with ISO 14971 risk management is crucial for IEC 60601 standards. We provide training, review documentation, and assist with gap analysis, remediation, and CE Marking for electrical medical devices.
CE Marking & CB Scheme Certification:
Element guides you through the CE Marking process, ensuring a smooth launch. We also offer IECEE CB certification, which addresses most CE Marking requirements for medical equipment in Europe, streamlining the testing process.
Global Market Access:
Our Global Market Access (GMA) experts help navigate international testing, certification, and approvals, speeding up your product’s market entry with expert support on 3rd party testing, in-country representation, and translation.
Which labs offer this service
Which labs offer this service
Access our CB Scheme testing laboratories (CBTL) in:
- United Kingdom
- United States
- Germany
- China
Standards we test to and products we test
General Requirements for Basic Safety and Essential Performance
- IEC 60601-1:1988
- IEC 60601-1:1988/AMD1:1991
- IEC 60601-1:1988/AMD2:1995
- IEC 60601-1-2, Ed 2.1 (2004-11)
- EN 60601-1-2 (2002)
- IEC 60601-1-2, Ed. 3.0 (2007)
- IEC 60601-1-2, Ed. 4, (2014-02)
- EN 60601-1-2 (2007)
- EN 60601-1-2:2015
- IEC 60601-1:2005
- IEC 60601-1:2005/AMD1:2012
Software Life Cycle Processes
- IEC 62304:2006
- IEC 62304:2006/AMD1:2015
Medical Electrical Intended for Oxygen-Rich Environment, Use with Flammable Anaesthetics Programmable Electrical Medical Systems (PEMS)
- EN 60601-1:1990 + A13:1995
- EN.60601-1:2006 +, A1:2013 + A12:2014, 8.5.5 (defibrillation-proof applied, 8.8.4.2 (environmental stress), 8.11.1e (supply mains switch), 9.6.2.1 (noise measurement), 9.6.3 (hand transmitted vibration), 9.7.5 (pressure tests), 10.4
Safety of Multifunction Patient Monitoring Equipment
- EN 60601-2-49:2001, Excluding: - 17 Defibrilation devices, 49.2 Software Validation, 51 Alarms
Safety of Nerve and Muscle Stimulators
- EN 60601-2-10:2000+A1:2001
Safety of Home Healthcare Equipment
- EN 60601-1-11: 2010
- EN 60601-1-11: 2015
Safety of Infusion Pumps
- IEC 60601-2-24: 2012 (Excluding:- 208 (alarm noise level measurement)
Safety of Non-Laser Light Source Equipment for Therapeutic, Diagnostic, Monitoring and Cosmetic/Aesthetic Use
- EN 60601-2-57: 2011
Medical Electrical Equipment
- IEC 60601-1-6:2010/AMD1:2013
Alarm Systems in Medical Electrical Equipment
- IEC 60601-1-8:2006 + A1
- EN 60601-1-8:2007 + A1
Safety and Essential Performance of Electrocardiograph
- IEC 60601-2-25 ed. 2.0, (2011-10), Clause 202
Particular Requirements for the Safety, Including Essential Performance, of Electrocardiographic Monitoring Equipment
- IEC 60601-2-27:2005
- EN 60601-2-27:2006
- IEC 60601-2-27 ed. 3.0 (2011), Clause 202
Safety and Essential Performance of External Cardiac Pacemakers with Internal Power Source
- IEC 60601-2-3 1 (2008) + Al (2011)
Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
- EN 60601-2-37 (2008)
Particular Requirements for the Basic Safety and Essential Performance of Cardiac Defibrillators
- IEC 60601-2-4 Ed. 3.0 (2010), Clause 202
- EN 60601-2-4 (2003), Clause 202
Safety and Essential Performance of Ambulatory Electrocardiographic Systems
- IEC 60601-2-47:2006
- EN 60601-2-47:2001
Safety of Electroencephalographs
- lEC 60601-2-26 (2003)
- EN 60601-2-26 (2003)
- IEC 60601-2-26, Ed. 2.0 (2002-11)
- lEC 60601-2-26, Ed. 3.0 (2012-05)
Safety of Infusion Pumps and Controllers
- IEC 60601-2-24:2012
- IEC 60601-2-24 (1998)
Safety and Essential Performance of Automatic Cycling Non-Invasive Blood Pressure Monitoring Equipment
- IEC 60601-2-30:1999
- EN 60601 -2-30:2000
- Multifunction Patient Monitoring Equipment
- Nerve and Muscle Stimulators
- Home Healthcare Equipment
- Infusion Pumps
- Light Source Equipment for Therapeutic/Diagnostic Use
- Electrocardiograph Equipment
- External Cardiac Pacemakers
- Ultrasonic Medical Equipment
- Cardiac Defibrillators
- Electroencephalographs
- Blood Pressure Monitoring Equipment
Your Challenges, Our Solutions
Complex Global Market Requirements
Required Risk Management Documentation Burden
Early Design Uncertainties
Certification Process Complexity
Why Choose Element
Global Recognition & Reach
Comprehensive Single-Provider Solution
Specialized Start-up Support
Unparalleled Technical Experience
20+Years’ experience
4Strategic locations worldwide
8,500+Engaged experts globally
190Years’ providing certainty
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Frequently asked questions
What is the CB Scheme and how does it benefit me?
The CB Scheme allows testing at a single location for recognition across multiple global markets, reducing time and costs for international market access.
Does Element offer training for IEC 60601 compliance?
Yes, we provide customized in-house training and on-site training at your premises, helping your team understand IEC 60601 requirements and compliance processes.
What support do you provide for Technical Files?
We offer impartial third-party support for Technical File compilation and review, plus assistance with completing your Declaration of Conformity (DoC) documentation.