Contract Laboratory has received the following Medical Devices Laboratory Test Requests which need to be fulfilled! These Laboratory Test Requests are received from a variety of sources ranging from start-up companies to large, multinational Fortune 500 corporations, international organizations, well-respected universities and government agencies that are actively seeking Independent, Third-Party Medical Devices Laboratories to perform their Medical Devices Testing, Analysis, Assays, Product Development, Scientific Research Experiments, Inspections, Certifications, and Engineering Projects. If you are a Medical Devices laboratory that would like more information on these Medical Devices projects, please visit our registration page or call toll us free 1-855-377-6821.
Test Request 17-01943
Medical Device Laboratory needed for ASTM Testing of Protective Clothing to the following standards: ASTM F1670/F1670M Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood, ASTM F1671/ F1671M Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System, ASTM D882 Standard Test Methods for Tensile Properties of Thin Plastic Sheeting, ASTM F1342/ F1342M Standard Test Method for Protective Clothing Material Resistance to Puncture, ASTM D1004 Standard Test Method for Tear Resistance (Graves Tear) of Plastic Film and Sheeting
Test Request 17-01888
Medical Device Laboratory needed for cleaning and validation studies to support our class II medical device 510(k) submissions to the FDA- will need to go over specific instructions for use, the level of disinfection and the type of microorganisms chosen for the test.
Test Request 17-01830
Medical Device Laboratory needed for testing of a filter developed for a medical application. The filter consists of a pleated element to trap particulates and a carbon-based filter to trap VOC's. The following testing is required:
1 - A trace showing the % retention of 1u, 2u, 3u particles over time @ 9 liters/min initial flow, and flow decrease over time.
2 - In a smoke-filled environment, trace flow decrease vs. time starting at 9 l/min to 6 l/min to 0 flow.
3 - Evaluate filter behavior in a humid environment - 98.6 deg F @ 95% humidity
4 - Evaluate the filter's removal of noxious odors
5 - In a smoke-filled chamber, evaluate the filter's particulate removal in recycle mode as a function of time (perhaps via light scattering and Beer's Law?).
Service Request 17-01813
LONG-TERM SERVICES Contract Sterilizer needed for steam sterilization services for titanium medical devices, batches of 100-1000 peel-packs max 10 x 20 cm. ISO 13485
Autoclaves should comply with the requirements of, and be validated,
maintained and checked in accordance with EN 285/EN 13060, EN ISO 17665
Test Request 17-01773
LONG-TERM TESTING Medical Device Microbiology laboratory of Bioburden and sterility testing for implantable medical device. WE will send product for testing after sterilization using gamma radiation as the method of sterilization. 20 samples/ product family (4 families) every quarter.
Test Request 17-01681
Healthcare manufacturer needs Microbiology Laboratory for Bacterial Suspension Testing using P. aeruginosa. Specifications are: Suspensions diluted to 10^-6 and 10^-7 in sterile saline, pour plated in 0.2 ml amounts in Trypticase Soy Agar and incubated 24-48 hours at 33C to 37C. T0: 4.3 x 10^7 -- 7.6 x 10^8 CFU/ml
T6: 4.6 x 10^7 -- 7.6 x 10^8 CFU/ml
Test Request 17-01619
Medical Devices Laboratory needed for performance and microbiology testing of medical textiles to EN 13795: 2011 A1: 2013 including Tensile strength - dry and wet - EN 29073-3:1992 Burst strength - dry and wet - EN 13938-1Resistance to fluid penetration - EN 20811Cleanliness microbial - EN 1174 (replaced by EN ISO 11737)Cleanliness particulate matter - ISO 9073-10Linting - ISO 9073-10 Resistance to microbial penetration - dry - ISO 22612Resistance to microbial penetration - wet - ISO 22610.My main question is, if you are able to perform such tests?
Test Request 17-01459
Medical Device laboratory needed for surgery simulation and functional testing of sterile surgical packs after sterilization including on:
- aged samples (2 years past used by date) for: appearance (noting any signs of discolouration)
- functionality (whether the components within the pack show no adverse affect on the brittleness of the plastics, bungs breaking up in syringes etc).
Test Request 17-01448
Business Request 17-01423
Company interested in acquiring an analytical laboratory in Saudi Arabia for the testing for quality assurance, testing, inspection, and certification of Agrochemicals & Pesticides, Basic & Industrial Chemicals, Dyes & Detergents, Lubricants & Greases, Nano materials, Petrochemicals, Polymers & Plastic , Food, Medical Devices, Pharmaceuticals, Beauty & Personal Care Products
Test Request 17-01355
Medical device laboratory needed for drug compatiblity testing and testing of parenteral IV containers to ISO 15747:2010 which contains requirements that relate to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.
ISO 15747:2010 is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.
On the same lines I need to collaborate to test the following in my products:
(i) Ideal Uniform Self Collapsibility
(ii) logarithmic volume measurement for infused volume
(iii) No Exchange of Hazardous Contaminants with Environment
(iv) Residual Volume in Container
(v) No Suck Back in the container
(vi) No Contamination during Admixing
(vii) Drug Compatibility
Medical Device Laboratory needed for conducting safety and efficacy study of ear candle which assists with ear wax removal. The study should show that the ear candles do not cause burns, do not produce a suction or vacuum in the ear and do not introduce any contamination into the ear.
Test Request 17-01327
FDA Medical device microbiology laboratory needed to perform multi-use testing assay on a liquid bandage medical device product. This assay is similar to USP51 testing and will use the 5 specified microbes, but it must have repetitious bioburdens applied to simulate a multi-use, (ie. ~50 uses) environment for the non-sterile liquid bandage product. The produc unit and the applicator with which bioburden contamination will occur is a propylene brush.
Test Request 17-01283
Test Request 17-01246
FDA Medical Device Laboratory needed for ISO VOC, particulate, CO and CO2 testing for ventilator components with dry gas pathway contact for emergency and transport ventilator to ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Test Request 17-01218
FDA GLP Medical Device Laboratory needed for performance testing of medical resuscitator to ISO 10651-4 Manual Resuscitator. The test to be performed include:
Delivered O2 concentration
- Expiratory resistance
- Inspiratory resistance
- Patient valve
- (Dead space
- Tidal Volume
Test Request 17-01178
Clinical laboratory needed to perform clinical study of product that lowers your blood alcohol content with 150 people with 100 being given the product and 50 a placebo. The test subjects will have to drink three 1.5 ounces of vodka in an hour. Their blood alcohol will need to be tested with 20 individual DOT certified breathalyzers every half hour. The study will need to last 3 hours from beginning to end.
Test Request 17-01173
Medical device laboratory needed for cleaning validation study of the water cleaning cycle of a plastic covered electronic tracking device . Simulation of the a 150C temperature water cleaning cycle for 30 minutes over a 500 cycles tis needed to ensure that this product can withstand the temperature, time and cycles. I would provide a fixture with 10 units for this test
Test Request 17-01152
Medical Device laboratory needed for ISO pre-compliance filter testing on medical ventilation module in accordance with ISO 23328-1:2008 standard, Breathing system filters for anaesthetic and respiratory use -- Part 1: Salt test method to assess filtration performance
The standard specifies a salt (NaCl) filtration challenge.
Test Request 17-01131
Medical electrical laboratory needed for IEC testing of sterile electrosurgical products to IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance and IEC 60601-2-2 Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories