Laboratory Test Request Description

Medical Device Manufacturer needs medical device laboratory for sterilization validation of device sterilization process.
1.¬ ¬Sterilization method: ¬ We will supply instr¬uctions for a method ¬with step by step ins-tructions and we need¬ to get the steriliza¬tion validation ? the¬y will be autoclaved Yes it is correct but you should validate your steam sterilization parameters, temperature,duration,pressure etc. After you sterilize your products according to your set values. you confirm with sterility test that No Microbial Contamination on products.
Cleaning and Sterilization Instructions
Spring FG Diamond Burs are non-STERILE, but should be cleaned and sterilized before use and subsequent reuse.

Ultrasonic Cleaning Procedure
Prepare a fresh pH-neutral cleaning solution; place the Diamond Bur in the dedicated instrument block (if applicable) and then place in a sonication unit. Follow the agent manufacturers' instructions for correct concentration, exposure time, temperature, and water quality. Completely submerge the device in the cleaning solution and sonicate for at least fifteen (15) minutes.
Perform a final thorough rinse of the device and instrument block (if applicable) under running warm tap water for at least (1) minute. Visually inspect to confirm the removal of debris. Repeat the cycle if needed. Dry the device using a non-shedding wipe or clean compressed air.

inspection Testing 1. Carefully inspect each device to ensure that all debris has been removed. 2. Visually inspect the device for damage/ wear that would prevent proper operation. a. Do not use if the tip is broken. b. Do not use if there are missing or worn diamond particles. c. Do not use if there is evidence of corrosion. Packaging Singly: Pack the Diamond Bur in pouches validated for sterilization In Sets: Place the Diamond Bur in the dedicated instrument block. Sterilization Use the following cycles for steam sterilization Cycle Type Minimum Sterilization Exposure Time (minutes) Minimum Sterilization Exposure Temperature Minimum Dry Time (minutes) Gravity 10 135°C (275°F) 30 Pre-vacuum (4 Pulses) 3 134°C (273°F) 30 Ensure that the sterilizer manufacturer?s maximum load is not exceeded. Storage The Diamond Bur should be stored in the sterilization pouch (or instrument block) until required. Additional Information These processes have been validated as being capable of preparing Spring Diamond Burs for reuse. Any deviation from these instructions should be properly validated for effectiveness and potential adverse results.

2.¬ ¬Cleaning Validation¬
There are two steps
1) cleaning residual on products coming from Production-, grease(oil) from machining and cleaning material residual on piece...

2) decreasing bio burden level...
So you validate and find optimum values for ultrasonic cleaning machine parameters (time,temperature etc) based on criteria Limit above Cleaning
1. If you choose to reprocess burs, avoid delaying following use as this increases the chance of debris drying on the working area. If debris does dry on the burs, they must be cleaned manually with a brush.
2. Burs can be ultrasonically cleaned when inserted in bur blocks or holders to prevent damage from rubbing or vibrating against each other or hard surfaces. An ultrasonic cycle of 5 minutes using a neutral-pH ultrasonic cleaner is recommended.
3. After the ultrasonic cycle, use a brush to remove any remaining debris and rinse under running water.
4. Immediately dry the burs thoroughly with an absorbent towel or paper tissue.
5. After the cleaning process, inspect and discard any burs that show signs of damage or corrosion.\

3.¬ ¬Corrosion Test
Corrosion resistance for metal and alloy products as per ISO 9227
ISO/DIS 10271 1998 Dental Metallic Materials - Corrosion Test Methods (Rev


Number: 16-01384

Industry: Medical Devices

Interested in learning more about this
Medical Devices Laboratory Test Request?

Unlock more information about this
Laboratory Test Request

Other medical devices laboratory services.

Other Medical Devices testing, analysis, scientific research and development, inspection, certification, engineering, failure investigation, and product development needs include :

  • Biomaterials Testing
  • of Tissues Testing
  • Bone and Joint Computer Modeling Testing
  • Ethylene Oxide Biological Indicators Performance Testing
  • GHG Emissions Testing
  • Implantable Medical Device Testing
  • In-Vitro Diagnostic Testing
  • Precision Testing
  • Sensitivity Testing
  • Specificity Testing
  • Medical Device AATCC and ASTM Antimicrobial Testing
  • Medical Device ASTM Extractable Testing
  • Medical Device Barrier Testing
  • Medical Device Bioburden Testing
  • Total Aerobes Testing
  • Total Coliforms Testing
  • Total Fungi Testing
  • Medical Device Biodegradation Subchronic Toxicity Studies Testing
  • Medical Device Biomaterial Extracts Protein Assays Testing
  • Medical Device Carcinogenicity Testing
  • Medical Device Compliance Testing
  • Medical Device Container/Closure Testing
  • Medical Device Contamination Testing
  • Medical Device Design and Modeling of Systems Medical Device Environmental Monitoring Testing
  • Medical Device Ex-Vivo Hemocompatibility Studies Medical Device Finished Product Quality Control Testing
  • Medical Device Genotoxicity Ames Testing
  • Medical Device Genotoxicity Chromosomal Aberration Testing
  • Medical Device Histopathology Testing
  • Medical Device ISO 10993-1 (FDA GP 95-1) Biological Safety Testing
  • Medical Device In-Vitro Biocompatibility Studies Testing
  • Medical Device In-Vivo Biocompatibility Studies Medical Device In-Vivo Hemocompatibility Studies Testing
  • Medical Device Irritation Studies Testing
  • Medical Device Leachable Testing
  • Medical Device Microbial Identifications Testing
  • Medical Device Mutagenicity Testing
  • Medical Device Particles Analysis Testing
  • Medical Device Particulate Testing
  • Medical Device Physical Testing
  • Medical Device Preclinical Testing
  • Medical Device Product Inoculations Testing
  • Medical Device Product Safety Testing
  • Medical Device Radiological Testing
  • Medical Device Sensitization Testing
  • Medical Device Shipping Validations and Shipping Testing
  • Medical Devices Impact Resistance Testing
  • Simulated Use Testing
  • Medical Device Stability Studies Testing
  • Medical Devices Accelerated Aging Stability Studies Medical Devices Real Time Stability Studies Medical Device Sterility Testing
  • Medical Device Sterilization Dose Validation Medical Device Sterilization Validation Medical Device Tensile Testing
  • Medical Device Thermal Analysis Testing
  • Medical Device USP Implantation Studies Medical Device USP Microbial Limits Testing
  • Medical Device USP and EP Plastics and Container Testing
  • Medical Device USP Glass Container Testing
  • Medical Device USP Polyethylene Container Testing
  • Medical Device USP Testing
  • AAMI Testing
  • EP Bacteriostasis/Fungistasis Testing
  • Medical Devices Analytical Chemistry Testing
  • Medical Devices Bacterial Endotoxin Testing
  • - Gel Clot Testing
  • Medical Devices Bacterial Endotoxin Testing
  • - Limulus Amebocyte Lysate LAL Testing
  • Medical Devices Biomaterials Testing
  • Medical Devices Biomechanical Platform Testing
  • Medical Devices Biomechanical Testing
  • Medical Devices Biomedical Testing
  • Medical Devices Biomedical Testing
  • Medical Devices Biophysical Characterization Testing
  • Medical Devices Biophysical Properties Testing
  • Medical Devices Biophysical Testing
  • Medical Devices Cleaning Validation Testing
  • Medical Devices Conformity Assessments Testing
  • Medical Devices Cytotoxicity Testing
  • Medical Devices Electrical Safety Testing
  • Medical Devices Electromagnetic Compatibility Testing
  • EMC Testing
  • Medical Devices Ethylene Oxide Residuals Testing
  • Medical Devices Failure Analysis Testing
  • Medical Devices Fatigue Testing
  • Medical Devices Fatigue Testing
  • Medical Devices Foreign Materials Testing
  • Medical Devices In-Vivo USP Testing
  • JP Testing
  • EP Pyrogen Testing
  • Medical Devices Leak Testing
  • Medical Devices Materials Characterization Testing
  • Medical Devices Methods Development and Validation Testing
  • Medical Devices Microbiology Testing
  • Medical Devices Packaging Studies and Testing
  • Medical Device Package Integrity Testing
  • Medical Device Packaging Burst Testing
  • Medical Device Packaging Creep Testing
  • Medical Device Packaging Dye Penetration Testing
  • Medical Device Packaging Peel Testing
  • Medical Device Packaging Vacuum Leak Testing
  • Medical Devices Safety Evaluations Testing
  • Medical Devices Toxicology Testing
  • Medical Devices Transportation Simulation Testing
  • Medical Devices Vibration Testing
  • Medical Products Re-engineering Testing
  • Medical Products Reverse Engineering Testing
  • Reusable Device Studies Testing
  • Reusable Medical Devices Testing
  • RoHS Testing
  • Steam Biological Indicators Performance Testing
  • USP Purified Water Testing
  • USP Water for Injection Testing
  • WEEE Testing

Learn more about medical devices testing and research

Need Medical Devices Testing or Scientific Research?

Save time and money searching. Simply, submit a Medical Devices request to find the laboratories or lab suppliers that best meet your needs.

Submit Laboratory Request

Test Request: 20-00286

Medical Device Laboratory needed ISO dead-space testing on manually powered resuscitation ISO spec 10651-4:200... view

Test Request: 20-00242

Contract Analytical Laboratory needed for quantifying the amount Trisodium Phosphatein in water samples The samples we w... view

Test Request: 20-00240

URGENT - BUDGET APPROVED East Coast USA Packaging Laboratory needed for ASTM torque testing for bottle caps samples view