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IEC 80601-2-78 Ed. 1.0:2019 (b)
医用電気機器-第2-78部:リハビリテーション,アセスメント,補償又は緩和のための医療ロボットの基礎安全及び基本性能の特定要求事項
Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

発行年月日: 2019-07-09
状態: 有効
邦訳版: 無

規格概要
IEC 80601-2-78:2019 applies to the general requirements for BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ROBOTS that physically interact with a PATIENT with an IMPAIRMENT to support or perform REHABILITATION, ASSESSMENT, COMPENSATION or ALLEVIATION related to the PATIENT S MOVEMENT FUNCTIONS, as intended by the MANUFACTURER.
IEC 80601-2-78:2019 does not apply to
external limb prosthetic devices (use ISO 22523),
electric wheelchairs (use ISO 7176 (all parts)),
diagnostic imaging equipment (e.g. MRI, use IEC 60601-2-33), and
personal care ROBOTS (use ISO 13482).
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TC TC 62/SC 62D
ICS 11.040.01
備考
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