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분야 | TC 62/SC 62D : Particular medical equipment, software, and systems |
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적용범위 | IEC TR 61289:2019 contains guidelines for medical and nursing personnel regarding the safe and effective operation of HIGH FREQUENCY SURGICAL EQUIPMENT and HIGH FREQUENCY SURGICAL ACCESSORIES (also referred to as HF SURGICAL EQUIPMENT in this document). It is also of use to scientific/technical staff who have responsibility for the maintenance of this equipment. The application guidelines in this document deal with the safe operation of HIGH FREQUENCY SURGICAL EQUIPMENT constructed according to the safety requirements of IEC 60601-1 and IEC 60601-2-2. Not all existing HIGH FREQUENCY SURGICAL EQUIPMENT meets the minimum requirements of current international standards, however, the guidelines in this document is still helpful in utilizing these devices. IEC TR 61289:2019 cancels and replaces the first edition published in 2011. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) general adaption to IEC 60601-2-2:2017; b) refinement and additions to the defined terms; c) separation of HF SURGICAL EQUIPMENT and HF SURGICAL ACCESSORIES; d) consideration of the HIGH CURRENT MODE; e) update of symbols. |
국제분류(ICS)코드 | 11.040.01 : 일반 의료장비 |
페이지수 | 28 |
Edition | 2.0 |
No. | 표준번호 | 표준명 | 발행일 | 상태 |
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1 | IEC TR 61289:2019 | High frequency surgical equipment and high frequency surgical accessories - Operation and maintenance | 2019-05-10 | 표준 |
2 | IEC TR 61289:2019 RLV | High frequency surgical equipment and high frequency surgical accessories - Operation and maintenance | 2019-05-10 | 표준 |
3 | IEC TR 61289:2011 | High frequency surgical equipment - Operation and maintenance | 2011-11-22 | 구판 |
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