Biocompatibility Testing for Medical Devices
We provide a Biocompatibility Testing Service for Medical Devices applying for new MDR CE Marking and US FDA 510k Clearance. Our Labs in India, Hong Kong & Israel, are accredited. We offer quick and economical pricing. Bio-compatibility refers to the interaction of medical devices with human tissues and physiological systems during the treatment process.
The aim of biocompatibility testing for non-active and active medical devices is to show that they are safe to use with human tissues and physiological systems. The demonstration is critical for US FDA 510k and MDR CE Marking regulatory submissions for all risk classes and types of medical devices. Analytical chemistry, in vitro experiments, and animal models are used to study system biocompatibility.
Biocompatibility Testing depends on the following factors:
- Chemical and Physical nature of the materials used in the construction of the device
- Type of patient tissue and area of exposure
- Duration of human contact
European Harmonized Standards and US FDA recommend the current version of ISO 10993-1 (Guidelines for Biological Evaluation of Medical Devices) for regulatory compliance.
The following are the important biocompatibility testing to be followed by medical device manufacturers according to ISO 10993-1 (Biological evaluation of medical devices, Part 1: Evaluation and testing within a risk management process )
CE candidates are becoming more mindful that they will be asked to provide this information by the reviewer.
However, since this is a newer concept than biocompatibility testing, the existing requirements in this field are also a little hazy.
Our labs in Israel, Germany, Hong Kong, and India are accredited by AAALAC, NABL, ISO 9001, DSIR, US FDA, and IBSC
. Before the start of the actual research, we have protocols. Our toxicologist will respond to technical questions from FDA 510k reviewers as well as concerns from Notified Bodies. There isn’t a single laboratory that does it!!! We offer Tax-Free best prices Globally!!!
Medical Device Testing
Medical Device Testing Services & Certification. Medical devices are very critical as they have a direct impact on the lives of humans. To deliver superior and safe experiences to humans, medical device manufacturers continuously innovate the devices with State of Art technology, software, and materials.
However, the benefits of improvements come with hazards and should be mitigated by taking appropriate measures. The importance of medical device testing comes in this gesture.
Medical Devices have to demonstrate safety and clinical effectiveness based on the intended purpose. Certified laboratories should perform these tests to prove that the device is safe and clinically effective both for the user and the patient.
India is one of the most economical destinations for testing globally with GLP / FDA / DEA / ISO/IEC 17025:2005 accredited Laboratories. We accept business from all over the world.
EU MDR and FDA 510k Test requirements for below Medical Devices
A. Testing of Medical Equipment’s functions on electrical Energy (Active Medical Device)
B. Software Medical Device testing (considered under active Medical Device)
C. Non-Active and Implantable Medical Device testing.
A. Active Medical Device Testing
Electrical Safety & Electromagnetic Safety (IEC 60601-1 Series – Third Edition)
The third edition of IEC 60601-1 represents a major standard in the family of IEC 60601 medical electrical equipment safety standards. First published in 1977, IEC 60601-1 has become the ‘bible’ of electromedical equipment safety and the parent standard of over 60 particular device standards ranging from diagnostic electrocardiographs to electron accelerators used in radiotherapy. These tests should be carried out on all active electrical products. Compliance with all these standards should be taken into account during the design process.
B. Software Medical Device Testing
The number of medical devices which are software-operated is rising sharply in recent years. Malfunction of the software may be life-risking. Therefore, software validation tests have become most demanding. Conformity Assessment procedures require consideration of the development lifecycle procedures for document control and configuration management and control of combinations between software versions and intended hardware. Published software medical device standards (not an exhaustive list) include IEC 62304 (2006), Medical Device Software-Software Life Cycle Processes, ISO/IEC 90003 (2004), and IEC 60601 series.
C. Non-Active and Implantable Medical Device Testing
The Non-Active Medical Devices generally considered are the following
- A device that, in whole or part, penetrates inside the body, either through a body orifice or through the surface of the body.
- Any natural opening in the body, the external surface of the eyeball, or any permanent artificial opening, such as a stoma.
- A device that penetrates inside the body through the body’s surface, with the aid or in the context of a surgical operation.
- Any device which is intended to be totally introduced into the human body or to replace an epithelial surface or the surface of the eye by a surgical intervention which is intended to remain in place after the procedure
Biocompatibility Testing of Medical Devices is done to verify that the product is not toxic and does not cause allergic reactions. These tests are based on the ISO 10993-1 harmonized standard. Selection of test and understanding of each test is very important.
Medical EMC and Electrical Testing
Medical electrical devices and equipment must meet the IEC 60601-1 and IEC 60601-1-2 standards for general safety and EMC. Aside from that, product-specific collateral requirements must be followed. The latest version of the specification, IEC 60601 3rd Edition, Am. 1, is accepted by medical device regulators in most markets worldwide.
Medical device regulators require electromagnetic compatibility (EMC) testing in markets such as the United States, Europe, and Australia to ensure the products are stable and perform well for consumers and patients. Regulators require EMC testing to decide whether a system can operate safely and efficiently in its intended operating environment without creating electromagnetic disruptions.
In General Safety Testing as per IEC 60601-1 following are the key test parameters:
- Earth-bond Testing
- Leakage Measurement including
- Earth Leakage,
- Enclosure Leakage and
- Applied Part or Patient Leakage: Normal Condition
- Patient Leakage: Single Fault Condition, Supply Open
- Patient Leakage: Single Fault Condition, Earth Open
- Patient Leakage F-Type
- Patient Auxiliary Current: Single Fault, Supply Open
- Patient Auxiliary Current: Single Fault, Earth Open
We offer Testing Services as per IEC 60601-1 requirement.
We offer testing services for EMC as per IEC 60601-1-2, namely:
- Electrostatic discharge (ESD) immunity test
- Electrical fast transient (EFT) immunity test
- High Energy Surge immunity test
- Damped Oscillatory waves immunity test
- Voltage Dips and Interruptions
We can also provide Product Specific Standard testing services for Medical Electrical Devices such as Baby Warmers, Electrosurgical Cautery, Foetal Doppler, Suction Units, Hospital Furniture, Autoclaves, Beds, OT Lights, OT Tables, Centrifuges, Vital Psylogical monitors, Home Healthcare Products, and so on.
Across the Globe, IEC 60601 helps ensure the safety of electrical and electronic medical devices. Our expertise in helping ensure that your medical devices and products comply with IEC 60601 standards and are ready for export to global markets. We can help you at any stage of your medical device project, ensuring the best certification option for your product, markets, and business.
IEC60601 supports electrical and electronic equipment security around the world. Our experience will help you ensure that your medical devices meet IEC 60601 specifications and can be exported to international markets. We will assist you at any point in your project to ensure that the right certification requirements are based on your application, industry.
Some of our IEC 60601 Medical Safety Testing services include, not limited to, CE Marking class I, IIa, IIb, and III devices.
- Risk management and integrated quality system (ISO 13485 and/or ISO 14971) assessments
- Software and usability assessments to support various IEC 60601 clauses
We offer impartial third-party support in all aspects of the consultation, full product safety testing, and completion of a Declaration of Conformity (DoC) to Technical File compilation and review. Compliance with ISO 14971 is a crucial requirement for IEC 60601
Applying risk management to medical devices is a mandatory requirement when demonstrating compliance to 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
More information about Risk Analysis as per ISO 14971,
I3Cglobal provides you with guidance through every step of the CE Marking process for medical devices, ensuring successful and efficient product launches.