(1) Reasons for Proposal

This amendment aims to strengthen the safety standards for mask-type medical beam irradiators in accordance with the recommendations of the Consumer Policy Committee under the Framework Act on Consumers and adjust the minimum thickness standard for medical use gloves in consideration of international standards.

(2) Major Provisions

A. Revise the standards for “medical beam irradiator” (attached Table 2-34) 

Require LED mask-type products to be tested at short distances considering the actual use environment and products using wavelengths below blue light (400 ∼ 500 nm) to have an eye protection device.

B. Revise standards and specifications for “medical use gloves” (attached Table 3-3) 

Change the minimum thickness standard for medical use gloves made of nitrile rubber latex from 0.08 mm or more to 0.05 mm or more.