GB 45184-2024Optometry products - Safety technical specifications for components (English PDF)
眼视光产品 元件安全技术规范
Open the GB 45184-2024 preview as PDF
This is a limited preview
Buy now to download the full PDF (34 pages)
Issued by
State Administration for Market Regulation; Standardization Administration of China
Level / Type
National · Mandatory
Issue date
December 31, 2024
Implementation date
January 1, 2026
Scope
GB 45184-2024 is the English-translated version of 眼视光产品 元件安全技术规范.
China's mandatory safety specification for the components of optometry products - the lenses, frames, temples, bridges, nose pads and fittings from which spectacles are made, regulated at the component level so that a compliant pair cannot be assembled from non-compliant parts. It is the companion of GB 45185, which covers the finished spectacles. It specifies the safety technical requirements for the components of optometry products, together with the corresponding test methods. Spectacles are a medical device worn against the face for most of the waking day, usually for years, and the risks are of two kinds. The first is mechanical: a lens or a frame that breaks can injure the eye it was meant to serve, so the standard sets the impact resistance of the lenses, the strength of the frame and its joints, the security of the lens in the rim, and the freedom from sharp edges and protruding parts. The second is chemical, and it is the reason a component standard exists separately: the frame is in prolonged contact with the skin, so the standard limits the nickel release from the metal parts, which is the commonest cause of contact dermatitis from spectacles, together with the heavy metals - lead, cadmium, chromium - the restricted azo colourants in the plastics and coatings, and the other substances that migrate out of a material worn against the skin for years. To those are added the optical requirements the component must meet for the finished pair to be correct, and the marking that lets a manufacturer, and an inspector, know what a component is and what it was made from. Issued on 31 December 2024 and in force since 1 January 2026.
Document preview — GB 45184-2024
National Standard of the People's Republic of China
- ICS
- 11.040.70
- Classification
- Y89
Issued by: State Administration for Market Regulation; Standardization Administration of China
Contents
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Safety technical requirements
- 4.1 General...
- 4.2 Optical properties
- 4.2.1 Vertex power
- 4.3 Transmission performance...
- 4.3.4 Applicable requirements for walking and driving
- 4.4 Lens strength...
- 4.5 Sweat-resistance of frames...
- 4.6 Mechanical stability of frames...
- 4.7 Nickel release...
- 5 Test methods
- 5.1 Test conditions...
- 5.2 Optical properties
- 5.2.1 Vertex power
- 5.3 Transmission performance
- 5.4 Lens strength...
- 5.5 Sweat-resistance of frames
- 5.5.1 Apparatus and reagents
- 5.5.2 Procedures
- 5.5.2.4 After standing for
- 5.6 Mechanical stability of frames
1 Scope
China's mandatory safety specification for the components of optometry products - the lenses, frames, temples, bridges, nose pads and fittings from which spectacles are made, regulated at the component level so that a compliant pair cannot be assembled from non-compliant parts. It is the companion of GB 45185, which covers the finished spectacles. It specifies the safety technical requirements for the components of optometry products, together with the corresponding test methods. Spectacles are a medical device worn against the face for most of the waking day, usually for years, and the risks are of two kinds. The first is mechanical: a lens or a frame that breaks can injure the eye it was meant to serve, so the standard sets the impact resistance of the lenses, the strength of the frame and its joints, the security of the lens in the rim, and the freedom from sharp edges and protruding parts. The second is chemical, and it is the reason a component standard exists separately: the frame is in prolonged contact with the skin, so the standard limits the nickel release from the metal parts, which is the commonest cause of contact dermatitis from spectacles, together with the heavy metals - lead, cadmium, chromium - the restricted azo colourants in the plastics and coatings, and the other substances that migrate out of a material worn against the skin for years. To those are added the optical requirements the component must meet for the finished pair to be correct, and the marking that lets a manufacturer, and an inspector, know what a component is and what it was made from. Issued on 31 December 2024 and in force since 1 January 2026.
This document defines the terms and definitions of optometry product components, specifies safety technical requirements, and describes the corresponding test methods. This document applies to components of optometry products.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 6682, Water for analytical laboratory use - Specification and test methods
GB/T 26397, Ophthalmic optics - Terminology
GB/T 38009, Spectacle frames - Requirement and method for the detection of nickel release
ISO 13666, Ophthalmic optics - Spectacle lenses - Vocabulary
3 Terms and definitions
For the purposes of this document, the following terms and definitions, as well as those given in GB/T 26397 and ISO 13666, apply.
3.1 finished spectacles Various types of glasses that can be used directly.
Note. Types generally refer to ordinary spectacles, partially enclosed or fully enclosed eye masks, flip-up or detachable additional lenses, etc. Common finished spectacles include custom-made glasses, presbyopia glasses, sunglare filters, swimming goggles, glasses for alpine snow use, special glasses for motor vehicle driving, polarized three-dimensional glasses, etc. Sunglare filter with a nominal vertex power of zero.
4 Safety technical requirements
4.1 General The refractive performance of lens shall be measured using a focimeter or equivalent method. The optical parameters of the lens shall be measured at the reference points. If the manufacturer explicitly states that the vertex power value of the wearing position will be corrected, it shall be tested against the calibration vertex power, and the corresponding calibration vertex power deviation shall comply with the provisions of Tables 1 ~
5.The manufacturer's declared calibration vertex power for the wearing position shall be indicated on the packaging or attachments.
4.2.1 Vertex power
4.2.1.1 Measure according to the method described in 5.2.1.The deviation of the vertex power of each principal meridian plane of the lens and the deviation of vertex power of the cylindrical lens shall comply with the requirements of Table 1 or Table 2. upper and lower limits of the classification; for categories 3 and 4, there shall be no overlap. -- If the manufacturer marks the visible light transmittance value, for categories 0 ~ 3, the absolute deviation of the visible light transmittance shall not exceed ±3%; for category 4, the relative deviation of the visible light transmittance shall not exceed ±30%.
4.3.2 Visible light transmittance uniformity Measured according to the method described in 5.3.4, the visible light transmittance uniformity (DeltaF) of the plano sunglare filter shall comply with. -- Category 0 ~ 3 lenses. DeltaF <=10%; -- Category 4 lenses. DeltaF <=20%. The visible light transmittance uniformity (DeltaP) of unmounted binocular plano sunglare filter shall not be greater than 15%.
Note. Not including changes in visible light transmittance due to thickness variations in lens design.
4.3.3 Scattered light Measured according to the method described in 5.3.5, the haze value of plano sunglare filter shall not be greater than 3%.
4.3 Transmission performance...
4.3.4 Applicable requirements for walking and driving
4.3.4.1 Daytime driving Measured according to the method described in 5.3.2, the visible light transmittance tauV of the lens shall not be less than 8%.
4.3.4.2 Driving at dawn, dusk and night Measured according to the method described in 5.3.2, the visible light transmittance tauV of the lens shall not be less than 75%.
4.3.4.3 Spectral transmittance Measured according to the method described in 5.3.2, the spectral transmittance of the lens, within the range of 475 nm ~ 650 nm, shall not be less than 0.2 tauV.
4.3.4.4 Traffic light identification Measured according to the method described in 5.3.2, the relative visual attenuation factor (Q) of the lens shall comply with the following requirements.
4.7 Nickel release For metal frames and metal parts of hybrid frames that are in direct contact with the wearer's skin for a long time, the nickel release shall not be greater than 0.5 µg/(cm2·week) when tested according to the method described in 5.7. Parts to be tested include.
b) nose bridge, crossbar, and other nose-supporting surfaces, including metal nose pads;
c) temples (excluding the hinges, the area around the hinges and the area protected by the plastic sleeve).
5 Test methods
5.1 Test conditions The test environment temperature is 23 °C ± 5 °C.
5.2.1 Vertex power
5.2.1.1 Lens Place the back surface of the lens on the focimeter holder and center it; measure at the reference point of the lens.
5.2.1.2 Plano sunglare filter 5.2.1.2.1 General Measure using the finite telescope method. Or use other equivalent measurement methods, such as focimeter, etc. If there is a discrepancy between the measurement results of the finite telescope method and those of the focimeter, the finite telescope method shall prevail. 5.2.1.2.2 Finite telescope method 5.2.1.2.2.1 Test apparatus The test apparatus for the finite telescope method is shown in Figure 2. -- For multifocal lenses, determine the horizontal reference line as described in
5.2.2.2 and measure the horizontal and vertical components at the distance reference point.
5.2.4.2 Power-variation lens Align the prism reference point of the lens; use the permanent mounting reference provided by the manufacturer to determine the horizontal reference line; measure the horizontal and vertical prismatic power. The measurement can also be performed using a prism compensation device that is in the opposite direction to the base of the prismatic power being measured.
5.2.4.3 Plano sunglare filter 5.2.4.3.1 General Measure using the finite telescope method. Or use other equivalent measurement methods, such as focimeter, etc. If there is a discrepancy between the measurement results of the finite telescope method and those of the focimeter, the finite telescope method shall prevail. 5.2.4.3.2 Finite telescope method Place the sample as described in 5.2.1.2.4.2 and observe through the telescope the relative position of the crosshairs in the eyepiece on the standard measuring plate. If the crosshairs fall on the outer edge of the large circle, the prismatic power is equal to
0.25 cm/m; if the crosshairs fall on the inner edge of the small circle, the prismatic power is equal to
0.12 cm/m.
5.3 Transmission performance
5.3.1 Sample Samples shall be carefully cleaned before measurement. Because lenses usually have vertex power, when using transmittance measuring equipment such as spectrometers, attention shall be paid to the possible impact of changes in lens thickness on the measurement results.
5.3.2 Visible light transmittance tauV and relative visual attenuation factor Q value When measuring the visible light transmittance tauV, the spectral distribution function of the standard light source D65 and the spectral luminous efficiency function under daylight shall be used for calculation. The wavelength sampling interval of the spectral transmittance shall not be greater than 5 nm. Linear interpolation is allowed for wavelengths less than 5 nm.
5.4.2.2 Adjustment There is a cylindrical groove in the steel structure support. Place a piece of white paper on the flat bottom of the groove and cover it with a piece of carbon paper; adjust the position of the white paper and the carbon paper to be
1.5 mm below the plane where the rubber ring contacts the rear surface of the sample and parallel to this contact surface (assuming the contact surface is flat). If the rear surface of the sample is not rotationally symmetrical, the position of the white paper and the carbon paper shall be
1.5 mm lower than the lowest point of contact between the rubber ring and the rear surface of the sample.
5.4.2.3 Load application Apply a load to the sample at a rate of 350 mm/min ± 50 mm/min; maintain a pressure of 100 N ± 2 N for 10 s ± 2 s; then release the load.
5.4.2.4 Sample inspection Remove the lens and observe its condition.
5.5.1 Apparatus and reagents
5.5.1.1 Heating box. capable of providing a test temperature of 55 °C ± 5 °C.
5.5.1.2 Container. glass or inert plastic, at least 200 mm wide and 90 mm high, capable of being closed.
5.5.1.3 Volumetric flask. 1 L, measurement grade A.
5.5.1.4 Water. conform to the requirements for Grade III water in GB/T 6682.
5.5.1.5 Artificial sweat contains the following ingredients.
a) Lactic acid. rho =
1.21 g/mL, purity > 85%;
b) Sodium chloride. analytical grade >=99%;
c) Water (5.5.1.4). Weigh
0.1 g of lactic acid and 100.0 g ±
0.1 g of sodium chloride; dissolve them in 900 mL of water; then use a volumetric flask to prepare 1 L of solution.
5.5.1.6 Sample holder. Glass or inert plastic, placed in the container to support the sample and keep it above the artificial sweat. See Figure A.1 in Appendix A. The holder can be designed to allow multiple samples to be stacked or placed side by side, but the samples shall not touch each other.
5.5.2 Procedures
5.5.2.1 Add artificial sweat to a depth of at least 10 mm into the container. The lowest point of the sample (including when layered) must be at least 12 mm from the liquid surface.
5.5.2.2 Place the sample on the holder, with the temples naturally open (the spring holders are opened to the maximum position where no external force is applied to the spring device). Place the lower edges of the temples on the holder, ensuring that there is no contact between the samples or between the samples and the container wall.
5.5.2.3 Close the container and place it in a heating cabinet, maintaining the temperature at 55 °C ± 5 °C.
5.5.2.4 After standing for
0.5 h, remove the sample and immediately rinse with water; then use a soft cloth without friction to dry it. Within
0.5 h, examine each sample without the aid of a magnifying glass and record any corrosion spots or color changes by comparing it with a pair of samples that have not been subjected to this test.
5.5.2.5 Place the sample back into the container; close the container; maintain the temperature at 55 °C ± 5 °C for
0.5 h. After completing the second test phase, remove the samples; immediately rinse with water and dry the samples; then inspect the areas of each sample that are likely to come into contact with the wearer's skin for extended periods of time; record any corrosion, surface discoloration, or coating shedding.
5.6 Mechanical stability of frames
5.6.1 Device The test device mainly consists of two parts. a ring clamp and a pressure rod, including a linear measuring tool with a minimum graduation value of no more than
0.1 mm. The ring clamp can fix the frame without twisting or slipping. The diameter of the clamp is 25 mm ± 2 mm, and its two contact surfaces (E1 and E2) are made of elastic material (such as nylon). The diameter of the pressure rod is 10 mm ± 1 mm, and it can move at least 10 mm upward and at least 8 mm downward. The contact surface is approximately hemispherical, as shown in Figure
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 34 pages — is available in the English PDF.
Referenced standards
Normative references
GB/T 26397 · GB/T 38009 · ISO 13666
Similar standards
GB 45185-2024|GB/T 14214|GB 10810.1|GB/T 19940|GB 18401-2010|GB/T 17592
How to Buy GB 45184-2024
- 1Add to cart. Click the "Buy GB 45184-2024" button on this page. You can add more standards before checkout.
- 2Checkout. Enter your email and billing details. Payment is processed securely by Stripe (cards, Apple Pay, Google Pay supported).
- 3Instant delivery (0–9 sec). Delivery is automatic: within seconds of payment you'll receive an email with a secure download link. The link stays valid for 72 hours.
- 4Invoice included. A tax invoice is attached to the confirmation email. Need a custom invoice? Contact us.
Related Standards
GB/T 6682-2008 — Water for analytical laboratory use - Specification and test methods
GB 11118-2026 — Hydraulic fluids (L-HL, L-HM, L-HV, L-HS and L-HG type)
GB 11557-2026 — Provisions for protecting drivers from injury by the steering mechanism of motor vehicles
Secure payment via Stripe
Payments accepted
GB 45184-2024
$365.00