Presentation on theme: "Provided By:. Federal, State and Local Guideline, Laws and Regulation for the Fabrication of Eyewear. Note: Reflects 2010 ANSI regulations, guidelines."— Presentation transcript:
Federal, State and Local Guideline, Laws and Regulation for the Fabrication of Eyewear. Note: Reflects 2010 ANSI regulations, guidelines and standards
The Organizations ANSI – American National Standards Institute ASTM – American society for Testing Material OSHA – Occupational Safety and Health Administration FDA – Federal Drug Administration FTC – Federal Trade Commission
ASTM –The American Society for Testing Materials sets standards for sports-related products. Standard F803 sets standards for safety eyewear used in sports. ANSI – The American National Standards Institute is a private agency who purpose is to set commercial and industrial standards. Standard Z80.1 sets standard Recommendations for Prescription Ophthalmic Lenses. OSHA – The Occupational Safety and Health Administration is a federal government agency established for the purpose of reducing deaths, injury, and illnesses in the workplace. FDA – The Food and Drug Administration is a federal government agency whose function is to enforce laws related to the production and labeling of food, drugs, and cosmetics. Contact lenses and eyeglasses are considered medical devices and fall under the jurisdiction of the FDA. Standards Publications of Interest to Opticians ANSI Z80.1 - 2005 Ophthalmics - Prescription Ophthalmic Lenses - Recommendations ANSI Z80.3 - 2001 Ophthalmics - Non-Prescription Sunglasses and Fashion Eyewear - Requirements ANSI Z80.5 - 2004 Ophthalmics - Requirements for Ophthalmic Frames ANSI Z80.9 - 2004 Ophthalmics - Devices for Low Vision ANSI Z80.10 - 2003 Ophthalmic Instruments - Tonometers ANSI Z80.12 - 2007 Multifocal Intraocular Lenses ANSI Z80.17 - 2001 Ophthalmics - Focimeters ANSI Z80.18 - 2003 Contact Lens Care Products: Vocabulary, Performance, Specifications and Test Methodology ANSI Z80.20 - 2004 Ophthalmics - Contact Lenses - Standard Terminology, Tolerances, Measurements, and Physicochemical Properties ANSI Z80.21 - 1992 Ophthalmics - Instruments - General-Purpose Clinical Visual
ANSI Provides guidelines (voluntary standards) for dress and safety eyewear. ANSI Z87.1 is the standard for occupational and safety eyewear ANSI Z80.1 is the standard for prescription ophthalmic lenses
Safety Eyewear ANSI Z 87.1 and Z 87.1+ 2010 Two levels of impact resistance: Non Impact rated (Previously called Basic Impact): Z 87.1 1” ball dropped 50” (Drop Ball Test) http://www.fda.gov/MedicalDevices/DeviceRegulationandGuid ance/GuidanceDocuments/ucm150003.htm http://www.fda.gov/MedicalDevices/DeviceRegulationandGuid ance/GuidanceDocuments/ucm150003.htm Frame front marking A, DBL, Z 87, Mfg. I.D. Temple marking Length, Z 87, Mfg. I.D. 3.0 lens thickness with 2.5 edge on high plus lenses Sandblasted mfg. I.D. (additional marks for tinted, photochromic or special purpose lenses)
Impact rated (Previously called High Impact): Z 87.1+ High Velocity Test Must withstand a 1.4” metal ball traveling 150 feet per second(High Velocity Test) http://www.youtube.com/watch?v=ZWHJmFBKcMw http://www.youtube.com/watch?v=ZWHJmFBKcMw Sandblasted mfg. I.D. and “+” Note: The high mass pointed projectile is pointed and weighs 500 grams and is dropped from a height of 50 inches. Safety Eyewear ANSI Z 87.1 and Z 87.1+ 2010 Lenses
Impact rated (Previously called High Impact): Z 87.2+ Basic and High Impact frames must meet High Impact Standard Frame front marking A, DBL, Z 87.2+, Mfg. I.D. Temple marking Length, Z 87.2+, Mfg. I.D. Note: The high mass pointed projectile is pointed and weighs 500 grams and is dropped from a height of 50 inches. Safety Eyewear ANSI Z 87.2+ 2010 Frames
The following special lenses must be impact resistant but are exempt from testing: raised multifocal lenses shall be impact resistant but need not be tested beyond initial design testing prism segment multifocal slab-off prism lenticular cataract iseikonic depressed segment one-piece multifocal biconcave myodisc and minus lenticular, custom laminate and cemented assembly lenses shall be impact resistant but need not be subjected to impact testing.” (21 CFR 801.410(c)(3)) Safety Eyewear ANSI Z 87.1 and Z 87.1+ 2010
SV and Multi Focal Sphere Power Tolerance 0.00 to 6.50D +/- 0.13D Above 6.50D +/- 0.15D PAL 0.00 to 8.00D +/- 0.16 Above 8.00D +/- 2% Distance Refractive Power Tolerance ANSI Z80.1 2010 Note: ANSI 2010 Tolerances are in effect however if studying for the ABO Exam the question may refer to 2005 Highest Meridian power instead of sphere. The Tolerance values are the same so answers will be the same.
ADD Sphere Power Tolerance Up to 4.00 +/- 0.12D Above 4.00D +/- 0.18 ANSI Z80.1 2010 ADD Power Tolerance Single Vision
PRISM ≤ 0.33 ∆ at PRP (Prism Reference Point) PRP location ≤ 1.0mm from specified PRP ANSI Z80.1 2010 Prism Power Tolerance Edged or uncut-Per Lens
Base Curve ±.075D When specified ANSI Z80.1 2010 Base Curve Tolerance Edged or uncut-Per Lens
ANSI Z80.1 2010 Prism Power Tolerance Mounted SV or Multi ∆ Imbalance Vertical PowerTolerance ≥0.00 to ≤ ±3.37D ≤ 0.33 ∆ > ±3.37 ≤ 1mm height difference at PRP ∆Imbalance Horizontal PowerTolerance ≥ 0.00D, ≤ ±2.75D ≤0.67 ∆
ANSI Z80.1 2010 Prism Imbalance Tolerance Mounted PAL – Difference between lenses ∆ Imbalance Vertical PowerTolerance ≥0.00D to ≤ ±3.375 D ≤ 0.33 ∆ > ±3.375 D ≤ 1mm height difference at PRP ∆Imbalance Horizontal PowerTolerance ≥ 0.00D, ≤ ±3.375D ≤0.67 ∆ > ±3.375D ≤ 1mm height difference at PRP
ANSI Z80.1 2010 Segment Tilt Tolerance Mounted SV or Multi Segment Segment Tilt ± 2% Vertical Location ± 1.0 mm Vertical Difference ± 1.0 mm Horizontal Difference ± 2.5 mm
ANSI Z80.1 2010 Fitting Point Tolerance Mounted PAL Fitting Point Vertical Location ± 1.0 mm per lens Vertical Difference ± 1.0 mm between lenses Horizontal Location ± 1.0 mm from specified mono PD Horizontal Axis Tilt ± 2 degrees use horizontal reference mark
ANSI Z80.1 2010 Misc. Misc. Center Thickness ± 0.3 mm when specified Segment Size ± 0.5 mm Warpage ± 1.00 D Cylinder induced on front
Single Vision Cyl Power Tolerance Less than 2.00D +/- 0.13D 2.00 to 4.50D +/- 0.15D Greater than 4.50D 4% Cylinder Power Tolerance Single Vision Distance Refractive Power Tolerance ANSI Z80.1 2010
Progressive Cyl Power Tolerance Less than 2.00D +/- 0.16D 2.00 to 3.50D +/- 0.18D Greater than 3.50D 5% Cylinder Power Tolerance Progressive Distance Refractive Power Tolerance ANSI Z80.1 2010
+/14 ° 0.00 to 0.25D +/7 ° 0.26 to 0.50D +/5 ° 0.51 to 0.75D +/3 ° 0.76 to 1.50D 2% 1.51 or greater Cylinder Axis Tolerance (SV or PAL) Cylinder Power Degrees of Tolerance Distance Refractive Power Tolerance ANSI Z80.1 2010
ASTM American society for Testing Material ASTM test many of safety devices used in sports. Must be marked with: (review with patient before removal) Manufacturers I.D. Model ID Date of mfg. (week and year) Label or tag with instructions or warnings F803 - Eye Protectors in Racquet Sports F910 - Baseball F513 - Hockey
OSHA Occupational Safety and Health Administration Regulates safety practices in the workplace. Has adopted Z87.1 standards for educational settings and workplace. Can issue fines to companies where all employees not wearing safety eyewear at inspection.
OSHA Occupational Safety and Health Administration Regulates safety practices in the workplace. Has adopted Z87.1 standards for educational settings and workplace. Requires that MSDS safety booklet be posted to provide workers and emergency personnel with procedure for handling particular substances Can issue fines to companies where all employees not wearing safety eyewear at inspection.
OSHA Occupational Safety and Health Administration Forms that employers must have in workplace OSHA form 300,300A and 301 Log, summary and incident report of work related injuries and illnesses OSHA workplace poster – pub 3165-english- You Have a Right to a Safe and Healthful Workplace Note: Must follow OSHA guidelines for disposal of manufacturing waste products such as edger waste, coolants, used tint dyes and UV solution. Maintain and reference MSDS sheet for proper disposal.
FDA Federal Drug Administration First agency to require impact resistance testing. Records must be kept for three years. Impact resistance: 5/8” (15.9mm) steel ball weighing.56 oz. (16g) dropped 50” (127cm)