Tacro medical device inspection institute was established in accordance with ISO 17025, RB/T 214 and the requirements national food and drug administration key laboratory, and now has received CMA certificate from Certification and Accreditation Administration of the People's Republic of China. Based on years of domestic and international medical device regulatory services experience and deep understanding of the medical device technical problems and testing difficulties, five laboratories were built during first-stage project, which are EMC Lab., General Electrical Safety Lab., Environment Reliable Lab., Clean Room Inspection Lab., Package Verification Test Lab.
Test items: Radiated emission, radiated susceptibility, conducted emission, harmonic current, voltage flicker, electrostatic discharge, EFT, SURGE, CS, power frequency magnetic field, DIPS.
Covering YY 0505/IEC 60601-1-2, GB 4824/CISPR11, GB/T 18268/IEC 61326, GB 9254/EN 55022, GB 4343/EN 55014, EN 61000-6, GB/T 17626/EN 61000, etc. standards.
Test items: Safety label durability, capacitor charge and discharge, circuit stability, grounding impedance, dielectric strength, leakage current, stress release, fire, moisture, torsion, external stress, equipment temperature rise, ball pressure, withstand voltage and other tests。
Applicable product: Laser equipment, ultrasonic equipment, monitoring equipment, high-frequency surgery equipment, optical equipment, rehabilitation equipment, laboratory (IVD) equipment, also include information equipment, lighting equipment, household appliances and other products.
Environment Reliable Laboratory
|
Test item |
Standard |
|
High temperature |
GB/T 2423.2-2008, GB 14710-2009 |
| Low temperature |
GB 2423.1-2008, GB/T 2421.1, GB 14710-2009 |
|
Constant damp heat |
GB/T 2423.3-2016, GB/T 2423.50-2012, GB 14710-2009 |
|
Humidity & temperature change |
GB/T 2423.22-2012, GB/T 2423.4-2008, GB/T 2423.34-2012 |
|
Waterproof |
GB/T 4208-2017, GB/T 2423.38-2008 |
|
Vibration |
GB/T 2423.10-2008, GB 14710-2009 |
|
Drop |
GB/T 4857.5-1992, ISO 2248-1972(E), JISZ 0202-87, GB 14710-2009 |
|
Collision |
GB/T 2423.6-1995, IEC 68-2-29, GB 14710-2009 |
| Transportation simulation |
GB 14710-2009, EN71 ANSI, UL, ASTM, ISTA, etc. |
Clean Room Inspection Laboratory
Test items：Planktonic bacteria, settlement of bacteria, temperature, humidity, noise, intensity of illumination, suspended particles, wind speed, air changes, etc.
Applicable situations: sterile clean plant, IVD clean plant, medicine&cosmetics&food clean plant, operating room, hospital consulting room, Animal Laboratory, biohazard safety equipment, etc.
Package Verification Test Laboratory
Test items: Vacuum leak test, dye leakage test, AGAR attack test, sealing strip test, accelerated aging test, seal strength test, burst/creep stress test, ink and coating chemical evaluation, rub test, internal pressure test, visual test, sterile validation.
Applicable products: co-extrusion film, coated film, nonwovens, plastic aluminum film, etc.
