Astute Labs Pvt. Ltd.
Pune, Maharashtra, India
+91 96899 44877Sr. No. 82/1, Bajirao Dhawade Patil Industrial Estate, NDA Road, Shivane, Pune, Maharashtra, 411023, India
About
Astute Labs, incorporated in March 2012 and based at the Bajirao Dhawade Patil Industrial Estate on NDA Road in Shivane, south-west Pune, is a NABL-accredited laboratory whose centre of gravity is medical device compliance. Its regulatory footing is unusually complete for the Indian medical sector: NABL accreditation to ISO/IEC 17025, recognition by the Bureau of Indian Standards, approval by the Central Drugs Standard Control Organisation (CDSCO) - which is what allows its reports to support Indian medical device registration - and QAI recognition. The core work pairs electrical safety testing to IEC 60601-1 with electromagnetic compatibility to IEC 60601-1-2, the combination a medical device manufacturer needs in a single engagement, and customers single out the laboratory's strength in exactly that pairing. Beyond medical devices it tests IT and audio-video products and performs RoHS substance analysis, and it offers shielding effectiveness measurement as a discrete service. The company also presents itself as an EMC equipment manufacturer alongside its testing business, so test fixtures and jigs can be built in-house. Specialisations are medical and connected medical device EMC and safety, IEC 60601-1 and 60601-1-2 programmes, CDSCO and BIS registration support, IT and audio-video products, and RoHS compliance.
Accreditations
| Accreditation |
|---|
| ISO/IEC 17025 |
| NABL |
Testing Services
| Test Type | Applicable Standards |
|---|---|
| Radiated Emissions | CISPR 11, CISPR 32, EN 55032, IEC 60601-1-2, IEC 61000-6-3, IEC 61000-6-4 |
| Conducted Emissions | CISPR 11, CISPR 32, EN 55032, IEC 60601-1-2, IEC 61000-6-3, IEC 61000-6-4 |
| Radiated Immunity | IEC 61000-4-3, EN 61000-4-3, IEC 60601-1-2, CISPR 35, IEC 61000-6-1, IEC 61000-6-2 |
| Conducted Immunity | IEC 61000-4-6, EN 61000-4-6, IEC 60601-1-2, CISPR 35, IEC 61000-6-1, IEC 61000-6-2 |
| ESD | IEC 61000-4-2, EN 61000-4-2, IEC 60601-1-2 |
| EFT/Burst | IEC 61000-4-4, EN 61000-4-4, IEC 60601-1-2 |
| Surge Immunity | IEC 61000-4-5, EN 61000-4-5, IEC 60601-1-2 |
| Harmonics & Flicker | IEC 61000-3-2, EN 61000-3-2, IEC 61000-3-3, EN 61000-3-3 |
| Voltage Dips/Interrupts | IEC 61000-4-11, EN 61000-4-11, IEC 60601-1-2 |
| Power Frequency Magnetic Field | IEC 61000-4-8, EN 61000-4-8, IEC 60601-1-2, IEC 61000-4-39 |
| Pre-Compliance Testing | IEC 60601-1-2, CISPR 32, IEC 61000-4-3 |
| Medical Device EMC | IEC 60601-1-2, EN 60601-1-2, IEC 60601-1-11, IEC 61326-2-6 |
| Medical Device Regulatory | CDSCO Medical Device Rules 2017, IEC 60601-1, ISO 13485, IEC 62304 |
| Product Safety | IEC 60601-1, IEC 62368-1, IEC 61010-1, IS 13252 |
Certifications / Marks
| Certification |
|---|
| CDSCO |
| BIS |
| CE |
Industries Served
| Industry |
|---|
| Medical Devices |
| Information Technology |
| Consumer Electronics |
| Multimedia |
| Industrial Equipment |
| Radio & Wireless |
Major Equipment
| Equipment |
|---|
| EMC test chamber |
| Shielded enclosure |
| EMI receiver |
| Spectrum analyser |
| LISN |
| CDN |
| ESD simulator |
| EFT/burst generator |
| Surge generator |
| Harmonics and flicker analyser |
| Magnetic field immunity coils |
| RF immunity amplifier and antennas |
| Shielding effectiveness measurement set |
| IEC 60601-1 electrical safety and leakage current benches |
| RoHS / XRF substance analysis equipment |
| In-house test fixture and jig fabrication |
