컬러콘택트렌즈 기준규격에 관한 국가 간 비교 및 고찰
Comparison and Investigation of the National Standards for Tinted Contact Lenses between Various Countries
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목적: 국가 간 컬러콘택트렌즈 기준규격에 대한 비교를 통하여 국내 기준규격의 안전성을 제고하고자 한다. 대상과 방법: 국제표준화기구(International Organization for Standardization, ISO), 미국의 식품의약국(Food and Drug Administration, FDA), 일본의 후생노동성(Ministry of Health, Labor and Welfare, MHLW), 국내 식품의약품안전처(Ministry of Food and Drug Safety, MFDS)에서 고시하는 형상 및 외관, 지름, 두께, 곡률반경, 정점/원주 굴절력 및 원주축, 가시광선/자외선/산소 투과율, 함수율, 추출물질의 양, 용출물시험, 세포독성/감작성/안자극 시험, 급성전신/아만성/아급성/유전 독성시험, 토끼 눈을 이용한 생체적합성, 무균시험에 대해 비교하였다. 결과: ISO, FDA, MFDS는 일반콘택트렌즈와 컬러콘택트렌즈가 동등한 기준규격을 가지고 있으나, 일본 MHLW는 따로 분류하여, 중심부 6 mm에서 측정한 가시광선 투과율이 80% 이상 유지 및 컬러 착색이 산소투과율에 유의한 영향을 미치지 않아야 한다. 국내외기준규격 중 물리적 특성(형상 및 외관, 지름, 두께, 곡률반경, 함수율)과 성능/광학적 특성(정점/원주 굴절력 및 원주축, 가시광선/자외선/산소 투과율)은 ISO와 동등한 기준규격을 가지나 화학적 특성(추출물질의 양, 용출물시험)과 생물학적 안정성(세포독성/감작성/ 안자극 시험, 급성전신/아만성/아급성/유전 독성시험, 토끼 눈을 이용한 생체적합성, 무균시험)은 차이가 있으며, 용출물시험의 경우국내만 포함된다. 결론: 국내만 포함되는 용출물시험의 유용성에 대한 고찰이 필요하며, 주사 및 원자현미경을 이용한 광학부 크기, 색소층 위치 및거칠기 정도를 포함한 컬러콘택트렌즈만의 규격이 고안되어야 할 것이다.
Abstract
Purpose: In this study we investigated the safety level of the national standard for tinted soft contact lenses by comparing the standards in various countries. Methods: To evaluate the current guidelines for tinted soft contact lenses such as form and appearance, diameter, curvature radius, vertex power, cylindrical refractivity and cylindrical axis, luminous/ultraviolet ray (UV) transmittance, moisture content, oxygen permeability coefficient, extractables, elution test, cytotoxicity, sensitization, eye irritation test, acute systemic/subchronic/subacute toxicity, genotoxicity and biocompatibility safety test using rabbit eyes and sterility test. We compared the standards of International Organization for Standardization (ISO), Food and Drug Administration (FDA) of the United States, Ministry of Health, Labor and Welfare (MHLW) of Japan and Ministry of Food and Drug Safety (MFDS) of Korea. Results: The guidelines for tinted soft contact lenses of ISO, FDA and MFDS are similar to soft contact lenses but MHLW of Japan classifies these lenses and sets specific guidelines. First, the oxygen permeability coefficient measured at 6mm from the center should be maintained over 80%. Also, coloring should not affect the oxygen permeability coefficient significantly. Regarding the physical (form and appearance, diameter, curvature radius, moisture content) and optical (vertex power, cylindrical refractivity and cylindrical axis, luminous/UV transmittance, oxygen permeability coefficient) characteristics, no differences were found between ISO and MFDS. However, several differences were found in chemical characteristics (extractables, elution test) and biological stability (cytotoxicity, sensitization, eye irritation test, acute systemic/subchronic/subacute toxicity test, genotoxicity, biocompatibility safety test using rabbit eyes, sterility test). For example, the elution test is required only by MFDS. Conclusions: The reinvestigation into the effectiveness of the elution test is needed and new evaluation measures including scanning electron microscopy and atomic force microscopy designed for tinted soft contact lenses to evaluate the size of the optical area, the location and roughness of the pigmented layer are required.
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