陳秋蘭主編的《醫療器械專業英語（第2版）》是
針對高等職業教育醫療器械類專業學生和從業人員，
為提高專業英語水平，熟練運用醫療器械行業英語的
需求而編寫。全書共分六個章節，內容涉及面廣，涵
蓋了專業英語文體特點與翻譯技巧、專業基礎知識介
紹、典型產品介紹、監管法規、產品標準與應用案例
、市場營銷和行業交流等七方面的內容。結構上力求
突出實踐性和職業性，強化職業能力的培養，以滿足
高職高專學生在學習和將來從業中對英語素養的需求
。
通過本教材的學習可以掌握大量的專業英語詞彙
、句法和表達方法等，從而提高醫療器械專業英語的
閱讀能力、理解能力、翻譯能力，為從事醫療器械相
關工作打下堅實的基礎。

緒論 專業英語文體特點與翻譯技巧
Chapter 1 Fundamentals of medical devices
Section 1 Basic Introduction to medica]devices
Text 1 Introduct，ion to medica]devices
Text 2 FDA：definition and classification of medica]devices
Text 3 Globa]medical device market
Section 2 Fundamentals of medical devices
Text 1 A brief Introduction to electronic basics
Text 2 A brief introduction to biological basics
Text 3 A brief introduction to mlcr00rganlsms
Chapter 2 Introduction to typical products
Section 1 Consumer products
Text 1 Contact 1enses
Text 2 Blood pressure meters
Text 3 Glucose meters
Text 4 Hearing aids
Section 2 Electrocardlograph(ECG)monitors
Text 1 Introduction to e]ectrocardlograph(ECG)monitors
Text 2 How an ECG monitor works
Section 3 Ultrasound 1maging
Text 1 Introduction to ultrasound imaging
Text 2 Fundamentals of ultrasound imaging
Section 4 X-ray imaging
Text 1 Introduction to medical X-ray imaging
Text 2 Radiography(Plain X-rays)
Text 3 Computed tomography(CT)
Section 5 Magnetic resonance imaging(MRI)
Text 1 Introduction to magnetic resonance imaglng(MRI)
Text 2 Physics of magnetic resonance imaging(MRI)
Section 6 Clinical laboratory equipment
Text 1 Hematology analyzer
Text 2 Biochemistry analyzer
Text 3 Urine analyzer
Section 7 Biomateria ls
Text 1 Medical dressing materials
Text 2 Dental materials
Text 3 Metallic biomaterials in orthopaedic surgery
Chapter 3 Medical devices regulations
Section 1 Globa]medical device regulatory harmonization
Text 1 Global regulations of medical devices
Text 2 Global harmonization of medical devices
Section 2 US FDA regulations
Text 1 How to market your medical devices in U．S．?
Text 2 FDA：Premarket notification(PMN)510(k)
Section 3 NMPA regulations
Text 1 Regulations on supervisory management of medical devices
Text 2 Provisions for medical device registration
Section 4 Quality management system(QMS)for medical device
Text 1 Quality management system(QMS)for medical devices
Text 2 ISO 1 3485：2003 Medical devices-quality management systems-requirements for regulatory purposes