ANSI Z80 27:2001 pdf download.Ophthalmics一Aqueous Shunts for Glaucoma Application.
ANSI Z80 27 applies to the physical and mechanical properties and performance of finished aqueous shunts, their biocompatibility properties, and describes elements of a clinical protocol that may be used to assess the clinical performance of these devices for treatment of glaucoma.
2 Normative references
The following standards contain provisions that, through reference in this text, constitute provisions of this American National Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this American National Standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of the IEC and ISO maintain registers of currently valid International Standards.
ASTM D41 69-99, Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM D4332-89(1 994)el, Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing”
ISO 2248, Packaging – Complete, Filled Transport Packages – Vertical Impact Test by Dropping
ISO 8318, Packaging – Complete Filled Transport Packages – Vibration Tests with a Sinusoidal Variable Frequency
ISO 8597, Optics and Optical Instruments – Visual Acuity Testing – Method of Correlating Optotypes
3 Definitions
For the purpose of this standard, the following definitions apply:
3.1 antifibrotics/antimetabolites:
Substances (such as 5-fluorouracil (FU), mitomycin C) used to modulate wound healing.
3.2 aqueous shunt: This term will refer to any artificial aqueous drainage device used in the treatment of elevated intraocular pressure.
3.3 bleb: The fluid-filled space within the fibrous capsule surrounding the explant portion of an aqueous shunt.
3.4 device description: Aqueous shunts will be described in geometric terms (including top and cross-sectional or side views).
3.5 device material(s): The specific substances or compounds used to manufacture each portion of the aqueous shunt.
3.6 drainage tube: The connecting lumened tube between the ocular fluid space (anterior chamber or vitreous) and the explant portion of the drainage device.
3.7 explant: The extraocular part of an aqueous shunt, excluding tube.
3.8 explant surface area: The measured or calculated surface area in mm of the side in contact with the sclera.
3.9 flow restrictor: A component of the aqueous shunt that restricts flow (adds resistance) of aqueous out of the eye through the drainage tube.
3.10 hypertensive phase: A transient rise in intraocular pressure, after tube opening or installation, usually occurring 0 to 3 months postoperatively.
3.11 IOP (intraocular pressure): The pressure, measured in mm Hg, within the eye created by the balance between inflow and outflow of aqueous humor.
3.12 inside diameter (i.d.) of drainage tube:
The physical measurement in mm from one inside wall of the tube to the opposite.
3.13 normal aqueous inflow: The aqueous volume in uI/mm considered physiologic and normal for human eyes.ANSI Z80 27 pdf download.