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Safety Test


Scope

OBCM can perform product safety testing within the scope of the following product safety series of standards:
  • IEC 60601 Series, Electrical Medical Equipment; 
  • IEC 61010 Series, Electrical Equipment for Measurement, Control, and Laboratory Use; 
  • IEC 60950, Information Technology Equipment; and 
  • IEC 60204, Machinery 

Our focus is testing of medical and in vitro diagnostic (IVD) devices to IEC 60601 and IEC 61010. We can conduct gap analysis and test reports to the 3rd edition for legacy devices. Or we can conduct simultaneous 3rd and 2nd edition test reports for new devices.

We perform IEC 61010, IEC 60950, and IEC 60204 testing beyond this scope only when it's related to a medical or IVD system, or under special arrangement.

Or we can perform partial testing of early prototypes, where verification testing of early design options can assist early design decisions. We can perform testing to appropriate safety and performance consensus standards, or we can help you tailor a test procedure and test form for your specialized verification needs. Examples of testing we're ideally suited to deliver include:
  • Insulation and earthing alternatives can be compared for suitability with earthing, dielectric strength, and leakage current requirements.
  • Duty cycle alternatives can be compared for suitability with temperature limits.
  • Thermal sensor or over-current protection rating and location alternatives can be assessed.
  • Insulation and energy absorption alternatives for suitability with defibrillation-proof test requirements.
  • Mechanical stability and loading tests

Our Equipment 

Our test equipment includes for general safety testing:
  • 5 kVA, 0-280 V, 60 Hz power source
  • 2.5 kVA, 0-280 V, 50-400 Hz power source
  • 2 Environmental chambers, 8 ft3, -41 C to 190 C, 5 to 95 %RH
  • Oscilloscope, 500 MHz, 5 GS/s, with probes for
  • 40 kV, to uV,
  • nom. 60 Hz V and I,
  • 500 MHz V, 60 MHz I, and
  • differential V
  • Electrical Multimeters
  • Temperature Meters, ample Type K Thermocouples
  • Dielectric Voltage Tester, 10,000 Vac, 6000 Vdc
  • Ground Impedance Tester, 45 A
  • Defibrillation simulator, 5 kVp, 360 J
  • Force Gauge, 250 kg
  • Torque Meter, 15 kgcm
  • 50 mm, 1 kg impact ball
  • Ball pressure apparatus
  • IPx1 or 2 drip apparatus, IPx7 or 8 submersion apparatus
  • Peristaltic pump
  • Time and Environmental Meters
  • Distance measuring devices
  • Weight scale, 68 kg
  • Light meter, lux
  • Sound Meter, dBA

For patient monitoring safety and performance testing:
  • Clinical heart arrhythmia waveshape databases
  • Arbitrary function generator and ECG simulation circuitry
  • Pulse Oximeter simulator
  • Noninvasive blood pressure simulator
  • Refrigerated circulating bath, 6 L, -25 to 150 C
  • 400 W, 2x 0-30 Vdc, 6 A; 5 Vdc, 5 A power source

For HF generator and accessory safety testing:
  • 300 VA, 400 kHz, HF surgical power supply, max 9000 Vpp, crest factors 1.4 to 8, 
  • HF noninductive resistive loads, 10 to 50 kOhm, for up to 250 W

Loading for abnormal output testing of isolation transformers and power supplies:
  • Up to 5 kVA in ac resistive loads
  • 3x dc resistive loading, 0.1 to 600 Ohm, for up to 2 kW

All test equipment is state of the art, purchased new, and maintained with annual calibrations by an accredited IEC 17025 calibration service.

Our Test Reports

We can provide quick spreadsheet type test reports of data with conclusions, or IECEE CB style test report forms that are the global format for providing data. Test methods and results professionally documented with engineer, site, environment, list of calibrated meters, photos, temperature charts, and oscilloscope screenshots; and where compliance is found, Certificates of Compliance.

Our Data Acceptance

FDA Submissions and CE Technical Files

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ce mark
Test Reports and Certificates of Compliance issued by OBCM are considered part of your verification documentation for FDA approvals/clearances, CE Marking declarations, and other 1st-party declarations to customs officials, regulators, and customers, provided OBCM is accepted by your supplier qualification process, as a competent test laboratory for device safety requirements. Quality and competency criteria should include that OBCM operate under a quality management system in compliance with ISO/IEC 17025, and have staff with suitable experience and training.

TUV Partner Test Laboratory

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We are an accredited Partner Test Laboratory for TUV Rheinland, allowing tight and cost effective integration of our test services into their US and Canadian certification services (OSHA NRTL and SCC).TUV Rheinland is an excellent source for US and Canadian certifications, as they're also a well respected certifier of regulatory quality management systems for the European Union and Canada.  They are a 3rd party reviewer for FDA 510(k) reviews.  We feel TUV Rheinland offers an excellent one-stop service package for medical device manufacturers.

UL Witness Testing

Tests conducted at OBCM and witnessed by engineering staff of Underwriters Laboratories (UL) are routinely used for fulfilling UL's US and Canadian certification programs.


Our Facility

Our office suite comprises 2500 ft2 space for laboratory, conference rooms and our offices.

The laboratory has 240 V, 60 Hz, 1 phase, 15 kVA dedicated for equipment under test. Our office suite has individual control of heat, and air conditioning. Our laboratory can control humidity to maintain min. 30% RH.

Testing at Manufacturer's Premises

If you're located within 2 hours of Boston, we can bring our power regulation, loads, and calibrated test equipment to your facility. We'll need a suitable 208 or 240 V, 60 Hz, minimum 15 A power source, or more. if appropriate for your equipment. We have miscellaneous plug caps for connecting to any 1 or 3 phase receptacle. We have suitable extension cords, and power taps. We perform the necessary validation of your facility for our quality system.