Medical Device Testing
We are reputed as one of the most trusted medical device testing laboratories in India accredited by BIS, NABL, CDSCO & QAI. We conduct tests as per IEC/IS & multiple Particular Standards. Our knowledge of products & standards translates to faster time-to-market for your next innovation.
Medical Equipment Testing
In-Vitro Diagnostics Equipment Testing
Packaging Validation Testing
Accelerated Ageing Testing
RoHS
Biocompatibility Toxicology Tests
Precision testing for medical equipment
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Medical Equipment Testing
We can test products as per IEC 60601-1 / IS 13450 Part 1 Sec 1 , IEC 60601-1-2 / IS 13450 Part 1 Sec 2, IEC 60601-1-6, IEC 60601-1-8 and Particular Standards like:
- IEC 60601-1 / IS 13450
- IEC 60601-2-2 / IS 13450-2-2
- IEC 60601-2-4 / IS13450-2-4
- IEC 13450-2-12 / ISO 80601-2-12
- IEC 60601-2-13 / IS 13450-2-13
- IEC 60601-2-18 / IS 13450-2-18
- IEC 60601-2-19 / ISO 13450-2-19
- IEC 60601-2-21 / ISO 13450-2-21
- IEC 60601-2-24 / ISO 13450-2-24
- IEC 60601-2-25 / ISO 13450-2-25
- IEC 60601-2-27 / ISO 13450-2-27
- IS / IEC 80601-2-30
- IEC 60601-2-34 / ISO 13450-2-34
- IS / IEC 80601-2-49
- IEC 60601-2-50 / ISO 13450-2-50
In-Vitro Diagnostics Equipment Testing
The In Vitro Diagnostics Directive (IVDD) 98/79/EC is a set of regulatory requirements that medical device manufacturers must comply with in order to place CE marking to their product for European markets.
In Vitro Diagnostics (IVDs) are medical devices and accessories used to perform tests on samples, (e.g., blood, urine, tissue, etc.) in order to:
- Help detect infection
- Diagnose a medical condition
- Prevent disease
- Monitor drug therapies
We can test products as per IEC/ EN 61010-2-101, IEC/ EN 61326-2-6, IEC/ EN 62304, and IEC/ EN 62366.
Accelerated Ageing Testing
Astute labs Pvt Ltd offers real-time and accelerated ageing study of the medical devices based on the shelf life of the product. The purpose of this test is to validate the different packaging types for the effectiveness.
It includes:
- Dimensional inspection
- Functional inspection
- Visual inspection
- Tests related to packaging integrity
Packaging Validation Testing
At Astute Labs, we offer comprehensive packaging validation services that include testing of packaging materials, drop tests on fully packed medical devices, and additional evaluations. The aim is to simulate all the conditions of handling, storage, and transportation of medical devices to ensure their safety and performance remain uncompromised.
Additionally, we conduct comprehensive assessments including vibration analysis, environmental stress simulations, and compression strength evaluations to guarantee robust performance throughout the entire distribution process.
Biocompatibility Toxicology Tests
Astute labs Pvt Ltd offer testing services for the medical devices as per ISO 10993 series of standards:
- EN ISO 10993-5 In vitro cytotoxicity in L929
- EN ISO 10993-10 Intracutaneous reaction in rabbits
- EN ISO 10993-11 Systemic injection test in mice
- EN ISO 10993-10 Primary Skin Irritation test
- EN ISO 10993-10 Primary Skin Irritation test
- EN ISO 10993-10 Mucous Membrane Irritation test
- EN ISO 10993-6 Acute implantation test in rabbits
- EN ISO 10993-4 Hemocompatibility test
- EN ISO 11737-1 Bio Burden test
- EN ISO 11737-1 Sterility test
- EN ISO 10993 Part 9 Irritation
- EN ISO 10993 Part 10 Irritation
- EEN ISO 10993-11 Systemic injection test in mice with polar and non-polar extract
- EN ISO 10993-11 Systemic injection test in mice with polar and non-polar extract
- EN ISO 10993-1 Mucous membrane irritation test with polar and non-polar extract
- EN ISO 10993-10 Skin sensitization test with polar & non-polar extract in guinea pigs
- EN ISO 10993-6 Subacute implantation in rabbits…30 days
- EN ISO 10993-6 Subacute implantation in rabbits …90 days
- EN ISO 10993-10 Skin sensitization test in guinea pigs
- EN ISO 10993 Part 10 Intracutaneous reactivity
- EN ISO 10993-3 Genotoxicity Test option 1 of ISO 10993-3 : a. AME’S Test b. In Vitro Genotoxicity Test OECD 473 c. In Vitro Genotoxicity Test OECD 476
Our Way of Working
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FAQs
Frequently asked questions
01. Which international standards do you follow for testing medical devices and equipment?
Our testing services cover a broad spectrum of international standards. For instance, we conduct IEC/EN 60601 testing for electrical safety, IVDD Compliance Testing for in-vitro diagnostic equipment, and ISO 10993 testing for biocompatibility. We also provide specialized tests like RoHS analysis and accelerated ageing studies, ensuring that every aspect of your product’s performance and safety is thoroughly validated.
02. What types of medical devices and equipment can you test?
Our comprehensive testing portfolio spans a wide range of products including medical devices, medical equipment, and in-vitro diagnostics. Whether your product requires precision testing, functional performance assessments, or packaging validation, our lab is equipped to handle diverse testing needs—from IEC/EN 60601 and in-vitro diagnostic testing to biocompatibility toxicology and accelerated ageing tests.
03. How do your testing services ensure the safety and efficacy of my medical device?
By integrating a multi-faceted approach, our testing services address every critical component of device safety and performance. We perform rigorous electrical safety tests, biocompatibility assessments, and functional evaluations under conditions that mimic real-world usage. This thorough testing regimen not only meets but often exceeds industry and regulatory standards, ensuring that your product is safe for both patients and healthcare providers.
04. How can partnering with Astute Labs accelerate my product’s market approval?
Our expert-driven, accredited testing services streamline the regulatory process by identifying potential issues early and providing detailed, actionable insights. With our fast turnaround on comprehensive tests—from packaging validation to RoHS and biocompatibility testing—you can reduce development delays, confidently meet regulatory requirements, and accelerate your product’s journey to market.