The following chart highlights the distribution of testing categories. All 8 models listed below have passed relevant test standards.下圖展示了本次認證所涵蓋的三大核心技術標準分佈。以下列出的 8 款型號均已通過相關測試標準。
P5070ZB
P5070NB
P5070SB
P5070ZA
P5070NA
P5070SA
P2070NA
P2070SA
1
Medical Device Directive (MDD)醫療器材指令 (MDD)
Compliance with 93/42/EEC framework, ensuring core safety for clinical use.符合 93/42/EEC 指令框架，確保專業醫療環境使用的基礎安全性。
EN 60601-1-2 medical grade EMC certification provides a foundation for flexible deployment. Below are five key scenarios where the HMI utilizes its high stability.EN 60601-1-2 醫療級 EMC 認證賦予了 FATEK P5/P2 系列靈活部署的技術基礎。以下是該 HMI 發揮其高穩定性與電磁靜默特性的五大關鍵醫療場景。
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Precision Diagnosis精密監測與診斷
Maintains data purity by avoiding interference when capturing weak physiological signals or high-resolution images.在捕捉微弱生理訊號或高精細影像時，確保介面運作不產生干擾，維持資訊純淨度。
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High-Frequency Areas高頻強干擾環境
Strong immunity ensures stable interface response in operating rooms or ICUs, keeping critical controls uninterrupted.於手術室或重症護理區，強大的抗擾度能維持介面穩定回應，確保關鍵控制不中斷。
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Lab Automation自動化檢驗分析
Resists power noise from laboratory electromechanical equipment, ensuring continuity and consistency in workflows.抵禦實驗室周邊機電設備的電源雜訊，確保高強度自動化流程的連續性與一致性。
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Home Care Safety居家與非臨床安全
Provides reliable monitoring in locations with unstable power quality, protecting the safety of home care.在電力品質不穩的場所，依然提供可靠監控，保障復健與居家護理的日常安全。
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Mobile Medical Units移動醫療與通訊場域
Exhibits excellent compatibility in cramped ambulance environments, coexisting harmoniously with rescue gear and comms.在空間狹小的救護環境中，能與高能量救護器材及通訊設備和諧共存，展現極佳相容性。
MDD 93/42/EEC Compliance歐盟醫療器材指令合規性
This section outlines the primary regulatory framework under which the HMI is certified for CE Marking.本章節概述了 HMI 通過 CE 標記認證所遵循的主要法規框架。
CE
MDD 93/42/EEC
The product conforms to the Medical Device Directive for CE Marking, a mandatory requirement for Placing medical devices on the market in the EEA.該產品符合醫療器材指令 (MDD) 之 CE 標記規範。這是將醫療器材投放於歐洲經濟區 (EEA) 市場的強制性要求。
Official Ref:官方引用編號:HA269015-CE
Electromagnetic Emission Testing電磁發射測試標準
Testing ensures that the HMI operates with "Electromagnetic Silence," protecting precision equipment.測試確保 HMI 以「電磁靜默」狀態運行，保護周遭精密設備不受干擾。
EN 60601-1-2:2015+A1:2021
Overarching standards for medical electrical equipment EMC safety.醫療電氣設備電磁相容性 (EMC) 安全的總體標準。
DETAILS詳解
CISPR 11:2024
Group 1Class A
Disturbance characteristics for industrial, scientific and medical equipment.工業、科學及醫療設備的電磁干擾特性規範。