Ophthalmic Industry Standards Flashcards
What does these stand for? ANSI ASTM FDA OSHA
American National Standards Institute
American Society for testing and materials
Food and drug admin
Occupational safety and health administration
Role of FDA in optometry
Protects public health. Ensuring safe medical devices such as glasses, lenses and CLs.
They write the impact resistance standards!
Who writes the impact resistance standards?
FDA
Drop ball test
- When did it start
- requirements
- by who?
1972
FDA
5/8 inch steel ball weighing 0.56 Oz, dropped from 50 inches.
Lens must not fracture!
Who writes the ophthalmic lens “paper sleeve”
FDA Code of federal regulations. Title 21
Federal trade commission mission
To prevent business practices that are unfair to consumers. Enhance informed customer choice and public understanding.
Who created the eyeglass rule? What is it?
Requires that optometrists provide patients a copy of their prescription after eye exam without extra cost. Prohibits requirement that pt buys glasses from them.
Created by the FTC (federal trade commission)
ANSI mission
Facilitates/promotes statements on products. They APPROVE many standards for many products in multiple industries.
VOLUNTARY industry based industry. Non-governmental.
Legally, it can be seen as the standard of care. Sometimes, OSHA will adopt ANSI standard as regulation. In that case, it is no longer voluntary.
ANSI standards we need to know.
Prescription ophthalmic lenses Z80.1-2015
-Impact resistance requirement CFR801.410
Non prescription sunglasses and fashion eyewear Z80.3-2018
**occupational and educational eye and face protective devices Z87.1-2020
laser Safety Z136.1-2014
According to ANSI guidelines, they should be updated when
Every 5 years.
Ansi Z80.1-2015 prescription ophthalmic lenses recommendations
Each variable of a spec lens Rx has a range of tolerance.
Sphere
- under 6.50D +/- 0.13D
- Above 6.50D +/- 2%
Cyl power
- Under 2.00DC +/- 0.13D
- 2.00 to 4.50 DC +/- 0.15
- Greater than 2.50DC +/- 4%
Cyl axis- as cyl goes up, tolerance goes down.
Add power
- under 4.00D +/-0.12 D
- Above 4.00D +/- 0.18 D
Ansi Z80.1-2015 prescription ophthalmic lenses tolerance for axis
0-0.25: 14 degree
- 25-0.50: 7 degree
- 50-0.75: 5 degree
- 75-1.50: 3 degree
- 50 or more: 2 degree
Requirements for polarization axis location
Within 3 degrees
OSHA mission
Creates and enforces regulations.
To ensure safe and healthful working conditions for men/women by setting and enforcing standards. Provide training, education.
Has the power to make regulations- make standards mandatory
Diff between ANSI and OSHA
ANSI is voluntary. Not required unless adopted by OSHA.
OSHA makes regulations- mandatory.
Who is subject to OSHA?
Most employers
What department is OSHA within?
Department of Labor
Why do we need OSHA?
Worker death in america is down from 38 per day to 13 per day.
72% reduction in injuries and illnesses.
NIOSH stands for what and what is their mission
national institute for occupational safety and health
Promote safe and healthy work places
Not a legal enforcement agency
Pushes forward scientific field of occupational safety
What department is NIOSH within?
Center for disease control and prevention (CDC)
ASTM stands for
American society for testing and materials
ASTM goal
Establishes standards for sports eyewear.
***ANSI does not have sports standards!
Global standard associations - ISO and IEC
International organization for standardization
International electrotechnical commission
ISO is similar to ANSI- promotes accepted standards
ANSI is the official representative for the US to the
ISO and IEC
Other standards/markings:
CSA
AS/NZS
CE
CSA - Canadian standard.
AS/NZS- australia/ new zealand standards
CE- Funny looking CE on any ophthalmic product. Conformite Europeenne.
CE (DIN EN 166)
Funny looking CE on any ophthalmic product.
Conformite Europeenne
Administrative marking that indicates conformity with health safety.
50 countries within the EY. If you have the CE marking, then a product can move between these countries without having to be approve each time it crosses a boarder.
Facilitates trade, free movement and convenience.
