ANSI Z80.29-2015 pdf free download

ANSI Z80.29-2015 pdf free download.Ophthalmics – Accommodative Intraocular Lenses.
1 Scope and purpose This standard applies to any ocular implant whose primary indication is the correction of aphakia and is designed to provide vision over a continuous range of distances by affecting a change in the vergence power of the eye resulting from the implant design that changes eye optical power or implant position in response to a stimulus. For the purposes of this standard, these implants are referred to as accommodative intraocular lenses (AIOLs). This standard addresses specific requirements for AIOLs that are not addressed in the normative references, and include vocabulary, optical properties and test methods, mechanical properties and test methods, labeling, biocompatibility, sterility, shelf-life and transport stability, and clinical investigations necessary for this type of device. As with any standard, alternative validated test methods may be used. 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. ANSI Z80.7, Ophthalmics – Intraocular lenses ISO 10993-2, Biological evaluation of medical devices – Part 2: Animal welfare requirements ISO 10993-6, Biological evaluation of medical devices – Part 6: Tests for local effects after implantation ISO 11979-1, Ophthalmic implants – Intraocular lenses – Part 1: Vocabulary ISO 11979-2, Ophthalmic implants – Intraocular lenses – Part 2: Optical properties and test methods ISO 11979-3, Ophthalmic implants – Intraocular lenses – Part 3: Mechanical properties and test methods
3 Definitions For the purpose of this standard, the definitions given below and in ISO 11979-1, ISO 14155-1, and ISO 14155-2 apply. Definitions in ISO 11979-1 apply with the following modification: substitute the term “AIOL” for “IOL” in any occurrence in a definition. 3.1 far power: minimum effective power of the AIOL assembly that provides an in-focus retinal image of a distant object. 3.2 far power configuration: configuration of the AIOL in the eye that results in the far power. 3.3 near power: maximum effective power of the AIOL assembly that provides an in-focus retinal image of a near object. 3.4 near power configuration: configuration of the AIOL in the eye that results in the near power. 3.5 best case subjects: subjects with no preoperative ocular pathology or macular degeneration detected at any time, and no previous surgery for the correction of refractive errors. 3.6 optical power of the eye: vergence power of the eye. 3.7 accommodative amplitude: difference in refractive power between the near point and the far point (of the eye). 3.8 near point: plane of best focus when the AIOL is in the near power configuration. 3.9 far point: plane of best focus when the AIOL is in the far power configuration.
4.2.1 Tolerances and dimensions The requirements in 4.2 of ANSI Z80.7 shall apply, together with the following additional requirements. Addition: The manufacturer shall establish appropriate additional physical requirements unique to the mechanism of action that affect the optical function or surgical placement of the AIOL. 5 Optical requirements 5.1 Scope This section applies to the optical properties and performance requirements of AIOLs in their final form, as intended for implantation in the human eye. 5.2 Requirements Optical and mechanical testing shall be performed over a range that includes the clinical function of the device and intended claim(s). 5.2.1 Optical characterization Tests that shall be performed to characterize the AIOL optical performance are described in Annex A. 5.2.2 Dioptric power The power associated with the far power configuration of an AIOL shall be determined by one of the methods in ISO 11979-2. When determined by one of these methods, the dioptric power tolerances specified in ISO 11979-2 shall apply to the power associated with the far power configuration of the AIOL. NOTE – The tolerances specified in ISO 11979-2 represent the combined manufacturing and measurement tolerances around the nominal power. 5.2.3 Imaging quality The requirements given in 4.3 of ISO 11979-2 shall apply at the far power configuration and all configurations over a range that includes the clinical function of the device and intended claim(s). The manufacturer shall demonstrate that all available labeled powers of an AIOL meet this specification.