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ISO SYSTEM
- ISO13485 In Vitro Diagnostic/ Medical Devices
- ISO 22716 Cosmetics
- ISO 27001 Information Security
- ISO 27701 Privacy Information Management
- ISO 45001 Occupational Health and Safety
- ISO 15378 Primary Packaging Materials
- ISO 22000 Food Safety
- ISO 9001 Quality Management
- ISO 14001 Environmental Management
- ISO 10002 Customer Satisfaction
- ISO 22301 Business Continuity
- ISO 37001 Anti-bribery Management
- TRAINING CENTER
- ACHIEVEMENT
- ICMC NEWS & LIBRARY
- NOTICE
- CUSTOMER
- ABOUT ICMC
- DOMESTIC RA
- GLOBAL RA
-
ISO SYSTEM
- ISO13485 In Vitro Diagnostic/ Medical Devices
- ISO 22716 Cosmetics
- ISO 27001 Information Security
- ISO 27701 Privacy Information Management
- ISO 45001 Occupational Health and Safety
- ISO 15378 Primary Packaging Materials
- ISO 22000 Food Safety
- ISO 9001 Quality Management
- ISO 14001 Environmental Management
- ISO 10002 Customer Satisfaction
- ISO 22301 Business Continuity
- ISO 37001 Anti-bribery Management
- TRAINING CENTER
- ACHIEVEMENT
- ICMC NEWS & LIBRARY
- NOTICE
ICMC NEWS & LIBRARY
ICMC (International Certification Management Center Co., Ltd.)
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유럽에서의 X-ray 장비의 의료기기 분류
- Admin Hits:1316
- 2011-04-26 18:38:00
ANNEX IX(부속서 IX)
분류 기준
III. 분류
3. 작동 기기에 적용되는 추가 규칙
3.2 규칙 10
전리 방사선을 방출하도록 의도된 능동 기
기와 진단 및 치료 중재 방사선을 위해 의도된 능동 기기는, 그들 기기를 통제 또는
감시하기 위한 기기 또는 그들의 성과에 직
접적인 영향을 끼치기 위한 기기를 포함하
여, Class IIb이다.
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- Company : ICMC (International Certification Management Center Co., Ltd.)
- CEO : Bong Ju Kim
- Address: 16 Digital-ro 32-ga-gil, Guro-gu, Seoul (Guro-dong) Partner Tower 2nd Room 1001.
- TEL : +82-2-851-3111
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