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IEC 60601-2-91 Ed. 1.0:2026 (b)
医用電気機器-第2-91部:非熱プラズマ創傷治療装置の基本安全及び基本性能に関する個別要求事項
Medical electrical equipment - Part 2-91: Particular requirements for basic safety and essential performance of non-thermal plasma wound treatment equipment

発行年月日: 2026-06-19
状態: 有効
邦訳版: 無

規格概要
IEC 60601-2-91:2026 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES.
NON-THERMAL PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES are not intended to supply heat to the PATIENT. They are used to treat chronic and acute wounds and biological tissue as well as diverse skin and itching diseases.
HAZARDS inherent in the intended physiological function of PLASMA WOUND TREATMENT EQUIPMENT and NON-THERMAL PLASMA WOUND TREATMENT ACCESSORIES within the scope of this document are covered by specific requirements in 7.2.13 of IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020.
This document does not apply to ME EQUIPMENT intended for the haemostasis of biological tissue (see IEC 60601-2-2 and IEC 60601-2-76).
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TC TC 62/SC 62D
ICS 11.140
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