Used in countries around the world, IEC 60601 helps ensure the safety and effectiveness of electrical and electronic medical devices. We leverage our product qualification and EMC expertise to help ensure that your medical devices and products are in compliance with IEC 60601 standards, and ready for export to global markets.
Combining industry experience with state-of-the-art laboratory testing facilities, Element provides a full suite of medical device testing and certification services to ensure that you meet the necessary IEC 60601 product safety requirements recognized across the world. Our services span from product design and prototype evaluation to formal compliance testing, certification, and ongoing standards and regulatory advice.
Element can help you at any stage of your medical device project ensuring the best certification option for your product, your markets, and your business.
IEC 60601 Medical Safety Testing services
Some of our IEC 60601 Medical Safety Testing services include, not limited to:
- 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
Design and safety testing of electrical and electronic medical devices
Before we can categorize new devices as ‘safe’ for use in a medical working environment and brought to market, it is necessary to determine if a device can perform safely and effectively without causing harm and/or electromagnetic disturbances in its appropriate operating environment.
Support in the early stages of the product development lifecycle
Element’s Engaged Experts can help you with determining which standards apply to your device, assess your design specifications for conformity, and introduce an efficient risks management program right from the beginning of the project. We also offer additional support and guidance to start–up companies during their first stages of medical device development and design, ensuring barriers to entry are addressed as early as possible and a solid regulatory and go-to-market strategy is developed.
Risk assessment and file management
We offer impartial third-party support in all aspects of product development, from design consultation, full product safety testing, and completion of a Declaration of Conformity (DoC), to Technical File compilation and review. With world-class expertise in electrical and electronic medical device testing, our specialists provide you with consultative guidance and feedback throughout the whole product development process so you can be confident in placing your product on the market.
Achieving compliance with ISO 14971
The application of risk management to medical devices is a mandatory requirement when demonstrating compliance with the IEC 60601 series of standards. Without this documentation, compliance is not possible; we can assist you with this and provide 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
CE Marking of electrical medical devices
Element’s experts provide you with guidance through every step of the CE Marking process for medical devices, ensuring successful and efficient product launches.
CB Scheme certification & CE Marking for IEC 60601
IECEE CB certification addresses most CE Marking requirements for medical and electronic equipment safety in Europe, and means that you only have to test your product once at a single location.
With over 20 years of experience, Element is a leading provider of IECEE CB certificates covering a wide range of certification, including the IEC 60601 series for medical equipment. We are a National Certificate Body (NCB) and can provide internationally recognized certificates based on testing from our associated CB Scheme testing laboratories (CBTL) in the UK, the US, Germany, and China.
Global approvals for global market access
Our Global Market Access (GMA) experts understand the challenge of safety testing of medical products for international export and assist manufacturers with 3rd party testing, in-county representation, product translation, and more to achieve increased speed to market for successful product launches.
For more information about our IEC 60601 Medical Device Safety Testing services, or to request a quote, contact us today.
General Requirements for Basic Safety and Essential Performance
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)
Software Life Cycle Processes
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, 220.127.116.11 (environmental stress), 8.11.1e (supply mains switch), 18.104.22.168 (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
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
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 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
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 (1998)
Safety and Essential Performance of Automatic Cycling Non-Invasive Blood Pressure Monitoring Equipment
EN 60601 -2-30:2000
Medical Device Testing Services
We are globally recognized medical device testing partner. We provide testing and certification services for a wide variety of medical devices and products.
More from Element
Medical Device Regulatory Services
Element’s regulatory advisors have 30 years of domestic and international regulatory consulting experience, specializing in handling the most complex challenges and partnering with you on the path to submission.
Discover blog posts, articles, white papers, webinars, and advice from our world-leading testing, inspection, and certification experts.
Medical Device Wear Testing
Typical devices that Element performs wear testing on include Hip Prostheses, Total Knee Replacements, Spinal Device, and Small Bone or Join Replacements.
Medical Device Testing Experts
Our Engaged Experts are experienced in every stage of medical device testing - from test protocol development and prototype/feasibility trials to testing for 510(k), CE, and other regulatory submissions