Thoughts on eyepiece mirror piece (biological safety)

Updated: July 2024, 3

In today's busy life, the number of people using eyeglasses has greatly increased.
Especially since it is a change in people's way of life, and the creation of eyeglasses that can be used is the best choice for movement and outside activities.

Is there a demand for bell-shaped eyeglasses?

There are many types of eyeglasses, among which there are many types of glasses that can be used for accurate viewing and weight.
　
The general definition is as shown below.
　

Required for the purchase of a mirror, the customer acquired "first category medical equipment manufacturing purchase approval", and the above-mentioned products received "medical equipment manufacturing purchase approval". In addition, we hope that the BtoC model electronics service will be used by general consumers, and the demand for "highly managed medical equipment can be purchased".
　
Please refer to the detailed information and reference board contents for "First-class medical equipment manufacturing software" and "Highly managed medical equipment manufacturing tools" This is the content of this offer.
　
At the beginning of the day, how to understand the production of eyeglasses and the introduction of medical equipment into the market, ensuring the demand for safety and effectiveness. Under the current circumstances, please select the following standard manufactured goods, proceed with examination,
　

• JIS B 7183, Mirror measurement amount
• JIS K 7361-1, Method for measuring the total luminous flux of transparent plastic materials - Part 1: Single luminous flux method
• JIS K 7127, Test method for plastic elongation performance - Part 3: Test conditions for thin film Japanese material
• JIS K 7161-1, Plastics – Determination method for elongation performance – Part 1: General description
• JIS K 7142, Plastics - refractive index determination method
• JIS K 7209, Plastics - Water absorption measurement method
• JIS T 0993-1, Medical and Mechanical Biology Examination – Part 1: Window Management Examination
• JIS Z 8722, Color-based measurement method – Reflection sum and transmitted object color
• ISO 9394, Ophthalmic optics - Ophthalmological optics - Ophthalmology for general use Ophthalmic research confirmed Biocompatibility
• ISO 11987, Ophthalmic optics - Eyeglasses - Determining the maintenance period
• ISO 18369-3, Ophthalmic optics - Eyeglasses - Part 3: Measurement methods
• ISO 18369-4, Ophthalmic optics - Eyeglasses - Part 4: Physical and chemical properties of eyeglasses materials
• 《Manufacturing (Production) Approval of Disinfectants for Useful Eyeglasses and Disinfectant Glasses》 (March 11, 3 Medical Examination No. 31) (hereinafter referred to as ``Material Procedures'') ”)
• 《Basics of biological safety guidelines for medical equipment production, approval, etc.》 (March 24, 3, 药食机发1No. 0301) (hereinafter referred to as ``Basics of biological safety guidelines'') Thoughts”)

　
The requirements of ISO 18369-3 and ISO 18369-4 are particularly high.
The functions of the eyeglass shield are well-equipped in all aspects, such as the basis of the standard, the demand determination, the refraction rate, visual transparency, the optical transmission system, and the numerical strength of the optical system. In addition, the production of skin-based or membrane-contact medical instruments does not meet the above requirements, and the requirements of the biology requirements are met.

Is this a biosafety standard?

For the time being, medical and mechanical biosafety compliance JIS T 0993-1 and international standard ISO 10993 “Medical and mechanical biosafety certification” series.
　
Is it necessary to have a biological safety review?
　
This is to ensure that the medical instrument is used during the period of use, and its safety characteristics are mutually exclusive.

Biological safety medium “hazard” “wa” “wind”

●harm:Possible development, poor human anatomy, factors such as toxicity, sensitivity, chronic systemic toxicity, etc.

●windrisk　: Approximate degree of harm to human health.

　
Unfortunately, the term safety is not the same, but the product, the physical contact area, the contact time, and the standard of contact are also different. The details are categorized below.
　

• Classification of rubbing contact areas
• Non-contact
• Body surface contact: skin, mucous membranes, injured surfaces
• Body internal and external connections: Blood flow path, structure/bone/fang, blood circulation
• In-body implantation: Structure/bone, blood
• Classification of contact time　
• Time of contact: repeated or multiple use, cumulative contact time not exceeding 24 hours
• Medium- and short-term contact: single or multiple use, cumulative contact time 24 hours to 30 days
• Long-term contact: continuous or multiple use, cumulative contact time exceeds 30 days.

　
The above specifications are not the same, and the demand factors are also different. However, in the next review of the eyeglasses, the requirements are based on ISO 10993-1, detailed examination of toxicity, skin examination, and examination of acute toxicity.