医疗器械专业英语（第2版/高专临床/配增值）

绪论 专业英语文体特点与翻译技巧
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
Chapter 4 Medical device standards and practices
Section 1 Medical device standards
Text 1 ISO 1 0993—5：Test for in vitro cytotoxicity
Text 2 Heavy metals impurities test methods in United States pharmacopeia
Text 3 IEC 60601—1-2—2014：Medical electrical equipment-General requirements for basic safety and essential performance
Section 2 Appl ication cases
Text 1 Classes and types of medical electrical equipment
Text 2 The AK 96 dialysis machine
Text 3 Maintenance manual of the AK 96 dialysis machine
Chapter 5 Medical device marketing and management
Section 1 Business etiquette
Text 1 Business etiquette tips everyone should follow
Text 2 Customer service etiquette
Section 2 Marketing
Text 1 Medical device sales jobs
Text 2 How medical device companies can strategically sell products to customers?
Section 3 Business negotiation
Text 1 How to win price negotiations?
Text 2 Meet goals in negotiation
Chapter 6 Industrial communication
Section 1 Job hunting
Text 1 Resume for employment
Text 2 Job—hunting 1etter
Text 3 Interview skl]Is
Section 2 Technica]cOmmunlcatlOn
Text 1 How to become a successful medical device sales representatlve?
Text 2 The Internet-where the customers are?
参考文献
目标检测参考答案（Learning Test部分）
医疗器械专业英语课程标准