S2W2

 Assigned testing: 

Brinkley 

  1. ISO 11135:2014 - Sterilization of healthcare products

    1. Specifications: 

      1. Needs to be documented 

    2. Tests:

      1. Products will be sterilized using the sterilizer and making sure that it meets the appropriate standards. 

    3. Assigned to:

      1. Brinkley

  2. Aqueous testing

    1. Specifications: 

      1. Materials should be monomer content, molecular weight, identification, and quantification. It must also be able to sustain the degradation of the product aging. 

    2. Test: 

      1. The valve will have fluid pass through it about 60 times with 1-50µl/min flowing through. 

    3. Assigned to: 

      1. Brinkley 

  3. Must have waste disposal protocol 

    1. Specification: 

      1. Must be environmental friendly 

    2. Test: 

      1. Ensure to use materials that have lower impact on environment can be checked by looking up sources on different materials 

    3. Assigned to: 

      1. Brinkley 

  4. Device needs to have shelf life of of about 7 years with success rates of 80% or more 

    1. Specifications 

      1. Must be aged 7 years to test shelf life 

    2. Test 

      1. Age in oven to ensure shelf life and success rate of flow rate

    3. Assign to: 

      1. Brinkley 

  5. Chemical Testing - silicones

    1. Specifications: 

      1. Should have the basic form of any volatile elements reduced by no greater than 1.0wt% 

    2. Tests: 

      1. Test the silicones using the FDA guidelines ensuring they pass the biocompatibility standards. It must pass the cytotoxicity test making sure that it has no toxic effects on cells. It must also pass the hemocompatibility test. 

      2. Silicone Biocompatibility for Medical Components - Miwo (miwosilicone.com) 

    3. Assigned to: 

      1. Brinkley 

Alex

  1. 21 CER Part 801 - labeling requirements for medical devices

    1. Specifications: 

      1. Labeling will be made for the product, ensuring that the name and place of business, the warnings, the intended use, and specific directions will be placed on the product and not have false or misleading statements

    2. Test: 

      1. Comparison of the standards to our product will be made, ensuring that our labeling abides by the standards.

    3. Assigned to: 

      1. Alex


  1. ISO 10993 - biological evaluation of medical devices, biocompatibility

    1. Specifications: 

      1. Data must be collected on the materials that are used to ensure that they are in the context of biological safety. 

    2. Tests 

      1. It must pass the 10993-18 standard tests to ensure that it is biocompatible. 

    3. Assigned to: 

      1. Alex 

        1. Ensuring the material purchased for the final product is biocompatible

  2. Pressure/flow characteristics

    1. Specifications: 

      1. Under physiological conditions should be equivalent to a predicate device 

      2. Appendix A tells how it should be tested  

    2. Test 

      1. Must pass proof pressure of 40mmHg and burst pressure of 60mmHg.

    3. Assigned to: 

      1. Alex 


  1. Physical stability

    1. Specifications: 

      1. functional and dimensional properties of the aqueous shunt should be demonstrated to be stable with all test parameters within tolerance after immersion in distilled water for 14 days temp 37℃ +/-2 ℃

    2. Tests:

      1. Product will be submerged in distilled water 2-3 in weeks in 37℃ +/-2 ℃ temperature. 

    3. Assigned to: 

      1. Alex 

  2. Structural integrity: 

    1. Specifications: 

      1. The shunt should be able to withstand force of 0.5N without breaking or leakage

    2. Tests 

      1. The shunt will go through push and pull testing ensuring that it can withstand 0.7N without it breaking or leaking. 

    3. Assigned to:

      1. Alex 

  3. Packaging 

    1. Specifications: 

      1. Provide adequate protection to the shunt 

      2. Should have a shelf life 

    2. Tests: 

      1. Will be aged in the oven to determine shelf life and packaging will go through several durability tests to ensure protection of the product. 

    3. Assigned to:

      1. Alex

  4. Flow can be changed throughout time 

    1. Specifications 

      1. Must be able to change linearly over time 

    2. Test 

      1. Test high medium and low pressure rates and ensure that it changes linearly (proportionally)

    3. Assign to: 

      1. Fady and Alex 

Kierstin 

  1. 21 CFR Part 803 - medical device reporting

    1. Specifications: 

      1. When reporting the medical device, it will be ensured that the user facilities, importers, manufacturers, and distributors will be reported along with the report of incidents and the things it may cause, such as death or serious injuries. 

    2. Tests

      1. Comparison of our device reporting versus the standard device reporting. 

    3. Assigned to:

      1. Kierstin 

  2. Shape must be safe to patient. 

    1. Specification 

      1. Must not have sharp corners. 

    2. Tests 

      1. Analysis can be done by viewing for no sharp corners 

    3. Assigned to: 

      1. Kierstin 

  3. Product must lower or keep surgical complexity 

    1. Specifications: 

      1. Surgeon must be able to implant it with more ease or with similar complexity of ahmed valve 

    2. Test 

      1. Compare surgical procedure with the Ahmed valve. 

    3. Assigned to: 

      1. Kierstin 

  4. Project completion date

    1. specification : 

      1. project must be completed by April 2023

    2. Test 

      1. Will be ensured by meeting small goals consistently until overall goal is met

    3. Assigned to: 

      1. Kierstin 

  5. Device must be portable

    1. Specifications 

      1. Device to switch must be portable and wearable for the customer

    2. Test

      1. Use the device and ensure that it can be used for day to day wear . 

    3. Assign to: 

      1. Kierstin 

Fady

  1. Must sustain healthy eye pressure 

    1. Specification 

      1. Hold pressure at 10 to 21mmHg 

    2. Test

      1. It should pass proof and burst tests of around 60mmHg. 

    3. Assigned to: 

      1. Fady 

  2. Design must reliable and consistent 

    1. specification : 

      1. Must allow different flow rates to keep healthy eye pressure through a one way valve 

    2. Tests 

      1. Tests fluid flow through clear tubing and observe for backflow and the different pressure performance. 

    3. Assigned to: 

      1. Fady 

  3. Flow can be changed throughout time 

    1. Specifications 

      1. Must be able to change linearly over time 

    2. Test 

      1. Test high medium and low pressure rates and ensure that it changes linearly (proportionally)

    3. Assign to: 

      1. Fady and Alex 

  4. Must have appropriate noise levels 

    1. Specifications: 

      1. Must not exceed on 40dB 

    2. Test 

      1. Will do noise testing to ensure to not exceed 40dB.

    3. Assigned to: 

      1. Fady

  5. Dimensional and surface quality

    1. Specifications: 

      1. Free from pits, scratches, cracking, and crazing at a minimum of 6x magnification 

      2. ANSI Z80.7 - 1994 Annex A performed 

      3. Should be stable in all tests 

    2. Test: 

      1. Must be within the Ahmed Dimensions of thickness: 2.1mm width 13.0mm length: 16.0mm surface area: 184.0mm^2. Must also be made of medical-grade silicone. Will be tested through measuring and passing through different durability tests. 

    3. Assigned to:  Fady 


Looked up bio medical biocompatible code:


labeling 


pressure 

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