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What is the IECEE CCP?
The IECEE CCP programme for component and sub-assembly certification, expands beyond traditional CB Scheme certification. Previously, components were certified to specific component standards or as integral parts of an end-product certified to a relevant standard.
The IECEE CCP now allows components to be certified against IEC Standard 60601-1, provided they are intended for use in end-products to which this standard apply.
Why the IECEE CCP is important
All components and subassemblies intended for a medical product can now be certified against the IEC 60601-1 standard before they are integrated into the end medical product. As a component manufacturer can now provide an IECEE Component Certificate of Conformity (CCC) to the end-product manufacturer, this speeds up final product CB certification.
How TÜV SÜD can help you with the IECEE CCP
TÜV SÜD's technical professionals have in-depth expertise of testing all types of medical devices under the IECEE scheme. Our global network of over 1,500 dedicated medical health and services professionals, including noted scientists and physicians, provides a wide range of certification and auditing services to medical device manufacturers.
Our IECEE CCP service undertakes IEC 60601-1 testing and certifies safety relevant aspects of components and subassemblies before they are integrated into the end-product. Our experts understand the importance of selecting the right components and a well-defined test plan. This enables component manufacturers to supply end-product manufacturers with components that have IEC 60601-1 certification, to simplify and optimise the testing and certification process.
TÜV SÜD conducts electrical safety tests in our fully accredited global laboratories. Our electrical safety testing is internationally accredited through the IECEE CB Scheme, based on our compliance with ISO 17025. In addition to our laboratory testing capabilities, TÜV SÜD engineers can also conduct an electrical safety test at your facility. To ensure a smooth process, a dedicated project manager handles both the technical testing and the project organisation.
What our IECEE CCP service includes
To fulfil end-product manufacturers' requests for components and subassemblies that have IEC 60601-1 certification, our service includes:
- IEC 60601-1 testing and certification of components (subassemblies) based on the IECEE's CCP rules.
- We can also test and certify collateral and product specific standards of IEC 60601-family.
- National deviations (from IECEE) can also be applied.
- CCP can be combined with a TÜV SÜD Certification (TUV MARK U10) and the TÜV Mark displayed on the product.
Frequently asked questions (FAQ)
What is the IEC 60601-1 standard?
The IEC 60601 series of technical standards ensure the safety of medical electrical equipment, including e.g. ultrasonic medical devices, dialysis machines and breathing machines, etc. IEC 60601-1 deals with the basic safety and essential performance requirements of medical electrical equipment. It aims to ensure that no single electrical, mechanical, thermal or functional failure poses an unacceptable risk to patients and/or operators.
Is IEC 60601-1 certification mandatory?
Public health authorities in many countries recognise IEC 60601-1 as a pre-requisite for the commercialisation of electrical medical equipment. The standard has around 1,500 specific requirements, that are often recognised as state-of-the-art and are market entry requirements across the world. Before being placed on these markets, medical devices must complete compliance evaluation, testing and device approval.
What is the difference between IEC 60601-1 and IEC 60601-2-XX?
The main difference between IEC 60601-1 and IEC 60601-2-XX is their scope. A medical device manufacturer must demonstrate compliance with both the general standard (IEC 60601-1) and any standard that is applicable to their specific product type (IEC 60601-2-XX).
IEC 60601-1 is the base layer of the safety and performance levels that are required for all medical electrical equipment, while IEC 60601-2-XX standards are tailored the requirements for a particular device, such as a defibrillator or an ultrasonic device.
What components are covered by IEC 60601-1?
The IEC 60601-1 standard covers a wide range of components and subassemblies intended for use in medical products. Examples of components and subassemblies covered by IEC 60601-1 include PC components, medical switching power supplies, blood pressure modules, motors for medical beds, high frequency application parts, X-ray subassemblies and sensor modules for monitoring of physiological parameters.
What are the limitations of the IEC 60601-1 standard?
As IEC 60601-1 ensures basic safety and essential performance, it addresses risks like electrical shock, fire, mechanical hazards, and excessive temperature. However, it does not cover every potential risk associated with medical devices. It must therefore be supplemented with other relevant standards. For example, this could include, but is not limited to:
- IEC 62304: Medical device software — Software life cycle processes
- ISO 14971: Medical devices — Application of risk management to medical devices
- IEC 80001-1: Application of risk management for IT-networks incorporating medical devices
Disclaimer: TÜV SÜD's certification and testing services are independent of each other and do not impact one another. Our certification services are delivered by TÜV SÜD's recognised Certification Bodies, while our testing services are conducted through TÜV SÜD Testing Labs.