Transcript ANSI - Primary Eye Care

Provided By:
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
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)
Safety Eyewear
ANSI Z 87.1 and Z 87.1+ 2010
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
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 87.2+ 2010
Frames
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 87.1 and Z 87.1+ 2010
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))
PAL
SV and Multi Focal
Distance Refractive Power Tolerance
ANSI Z80.1 2010
Sphere Power
Tolerance
0.00 to 6.50D
+/- 0.13D
Above 6.50D
+/- 0.15D
0.00 to 8.00D
+/- 0.16
Above 8.00D
+/- 2%
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.
ANSI Z80.1 2010
ADD
ADD Power Tolerance Single Vision
Sphere
Power
Tolerance
Up to 4.00
+/- 0.12D
Above 4.00D
+/- 0.18
ANSI Z80.1 2010
PRISM
≤ 0.33∆ at PRP (Prism
Reference Point)
PRP location
Prism Power Tolerance
Edged or uncut-Per Lens
≤ 1.0mm from specified PRP
ANSI Z80.1 2010
Base Curve
Base Curve Tolerance
Edged or uncut-Per Lens
±.075D
When specified
ANSI Z80.1 2010
∆Imbalance
∆ Imbalance
Prism Power Tolerance
Mounted SV or Multi
Vertical
Power
Tolerance
≥0.00 to ≤ ±3.37D
≤ 0.33∆
> ±3.37
≤ 1mm height
difference at PRP
Power
Tolerance
≥ 0.00D, ≤ ±2.75D
≤0.67∆
Horizontal
ANSI Z80.1 2010
∆Imbalance
∆ Imbalance
Prism Imbalance Tolerance
Mounted PAL – Difference between lenses
Vertical
Horizontal
Power
Tolerance
≥0.00D to ≤
±3.375 D
≤ 0.33∆
> ±3.375 D
≤ 1mm height
difference at PRP
Power
Tolerance
≥ 0.00D, ≤
±3.375D
≤0.67∆
> ±3.375D
≤ 1mm height
difference at PRP
ANSI Z80.1 2010
Segment
Segment Tilt Tolerance
Mounted SV or Multi
Segment Tilt
± 2%
Vertical Location
± 1.0 mm
Vertical
Difference
± 1.0 mm
Horizontal
Difference
± 2.5 mm
ANSI Z80.1 2010
Fitting Point
Fitting Point Tolerance
Mounted PAL
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
Distance Refractive Power Tolerance
ANSI Z80.1 2010
Single Vision
Cylinder Power Tolerance Single Vision
Cyl Power
Tolerance
Less than 2.00D
+/- 0.13D
2.00 to 4.50D
+/- 0.15D
Greater than
4.50D
4%
Distance Refractive Power Tolerance
ANSI Z80.1 2010
Progressive
Cylinder Power Tolerance Progressive
Cyl Power
Tolerance
Less than 2.00D
+/- 0.16D
2.00 to 3.50D
+/- 0.18D
Greater than
3.50D
5%
Distance Refractive Power Tolerance
ANSI Z80.1 2010
Cylinder Axis Tolerance (SV or PAL)
Cylinder Power
Degrees of
Tolerance
• 0.00 to 0.25D
+/14°
• 0.26 to 0.50D
+/7°
• 0.51 to 0.75D
+/5°
• 0.76 to 1.50D
+/3°
• 1.51 or greater
2%
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)
FTC
Federal Trade Commission