ANSI Z80.27:2001 pdf free download – Aqueous Shunts for Glaucoma Application
4.1.1 Surface quality
All of the components of the aqueous shunt shall be essentially free from pits, scratches, cracking and crazing at a minimum of 6x magnification or visible to a trained observer without magnification.
4.1.2 Edge quality
The edges of the aqueous shunt shall appear smooth and free of burrs and flash when inspected at 6x magnification.
4.1.3 Dimensions
The overall dimensions of the aqueous shunt and the dimensions of the drainage area in terms of thickness, length, and width shall be within ± 5% of the design nominal. The inlet and discharge tubes will have an O.D. and I.D. within 15% of design nominal.
4.1.4 Physical stability
The functional and dimensional stability of the aqueous shunt shall be demonstrated to be stable with all test parameters within tolerance after immersion in distilled water for 14 days at a temperature of 37°C ± 2°C.
4.1.5 Pressure/flow characteristics
The resistance and pressure/flow characteristics of the device under physiological conditions shall be described. The opening and closing pressures of valved devices in an aqueous medium shall be described. The shunt shall be evaluated for unintended leaks; there shall be no observable unintended leaks. Annex A describes examples of test methods for determining the theoretical flow characteristics of these devices.
4.1.7 Sterility
The requirements for sterilization of nonactive surgical implants outlined in ISO 14630 shall apply. The recommendations for sterilization outlined in FDA’s ODE Guidance Memorandum #K90-1 should be evaluated for sterile devices. The aqueous shunt shall be provided sterile. Whenever possible, the product shall be terminally sterilized in its final container. However, if the device is provided non-sterile, the ODE Guidance “Labeling of Reusable Medical Devices for Reprocessing in Health Care Facilities: FDA Reviewer Guidance” should be consulted and the issues identified and addressed. The method used to sterilize the device should be validated with a method appropriate for the sterilization method. ANSI/AAMI/ISO 11134, 11135, and 11137 describe validation methods for moist heat, ethylene oxide, and gamma radiation sterilization, respectively.
4.2 Biocompatibility requirements
The aqueous shunt shall be evaluated for biological safety. The general requirements specified in ANSI/AAMI/ISO 10993-1 shall apply, together with the following particular requirements. These in vivo and in vitro tests shall be used to assess the biocompatibility of the aqueous shunt material and to quantify and evaluate the toxicity of biologically active chemical entities that may diffuse out of the finished device material. Literature demonstrating a long history (e.g., greater than five years) of acceptable clinical performance with a material in an ophthalmic application (or equivalent) may be used to satisfy the biocompatibility testing requirement in this standard.
4.2.3 Chemical testing
The levels of residual monomers and other contaminants should be determined and identified for the finished aqueous shunt (or material(s) of equivalent processing) using an exhaustive extraction method with an appropri- ate solvent to swell the device material. For shunt components composed of PMMA, the residual monomer levels should not exceed 1% by weight. A risk analysis should be performed to justify the levels of residual monomers.
4.2.4 Aqueous aging test
Aqueous shunt materials that are susceptible to hydrolytic degradation should be evaluated for monomer content, molecular weight, and identification and quantification of degradation products. A method that may be used to perform this test is described in ANSI/AAMI/ISO 11979-5, Annex A. Evaluate for changes in characteristics following aging. If adverse changes are found, additional biocompatibility tests should be performed following aging. The manufacturer should evaluate the significance of the changes in the material properties of the device within the context of the useful lifespan of the device.