KS C IEC60601-1-3: 의료용 전기기기-제1-3부: 기본 안전 및 필수 성능에 관한 일반 요구사항-보조표준

• 영문명: Amendment of the Inspection Standard for Diagnostic Radiation Equipment Applying IEC 60601-1-3: Medical Electrical Equipment – Part 1-3: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Radiation Protection in Diagnostic X-ray Equipment
• 발행기관: 대한방사선과학회(구 대한방사선기술학회)
• 저자명: 박혜민(Park Hye-Min) 김정민(Kim Jung-Min) 김정수(Kim Jung-Su) 김성옥(Kim Seong-Ok) 최영민(Choi Young-Min)
• 간행물 정보: 『방사선기술과학』방사선기술과학 제41권 제5호, 493~504쪽, 전체 12쪽
• 주제분류: 의약학 > 방사선과학
• 파일형태: PDF
• 발행일자: 2018.10.30

영문 초록

The diagnostic radiation equipment is managed in accordance with the 「Rules for Safety Management of Diagnostic Radiation Equipment 」 enacted in 1995. The equipments should be inspected before use and every three years after use in accordance with the [Appendix 1] of the same rule. The inspection standard has been maintained without particular revision since enacted. But, over the past two decades new types of equipments have been manufactured and used. So, it is necessary to revise [Appendix 1] by making inspection items and inspection standards. In this study, we revised the classification system of equipments and reviewed international standards of IEC 60601 series, IEC 61223 series and AAPM TG 18 On-line Report No.03. And identified the problem of current inspection standards. Through this, we revised, deleted and added the inspection items and inspection standard of each equipment to meet the domestic circumstances. As a result of the study, we reorganized the classification system of equipment which are current classified as 5 classes into 22 classes as X-ray system etc. (7 classes), CT system etc. (5 classes) and Dental X-ray system etc. (10 classes). And then, we developed 70 inspection items for 6 types of equipments according to the reorganized classification system of equipments. The inspection items and inspection standards derived from this study have been proposed to the KCDC and will be applied to the revision of the Rule’s [Appendix 1]. Therefore, we expect to be used as reference materials for domestic medical center, inspection institutions, and equipment manufacturing·import companies.

목차

Ⅰ. 서 론

Ⅱ. 대상 및 방법

Ⅲ. 결 과

Ⅳ. 고 찰

Ⅴ. 결 론

키워드

Diagnostic radiation equipment Regular inspection Inspection standard Safety management International harmonization 진단용 방사선 발생장치 정기검사 검사기준 안전관리 국제조화