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1、,MARKET RESEARCH REPORT,MEDICAL DEVICE SENSORS:TECHNOLOGIES AND GLOBAL,MARKETS,HLC080A,Jim Wilson,Project Analyst,BCC Research,35 Walnut Street,Wellesley,MA 02481,Phone:866-285-7215(sales),Web Address:,E-mail:,ISBN:1-59623-567-5,ii,HLC080A Medical Device Sensors:Technologies and Global Markets,TABLE
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10、2009 by BCC Research Wellesley,MA 02481.,Reproduction of any material in this report is strictly forbidden without express permission of thePublisher.,To receive a complete catalog of BCC studies,please visit our Web site at,FEBRUARY 2010,Copyright BCC Research,Wellesley,MA USA,Web:,iii,HLC080A Medi
11、cal Device Sensors:Technologies and Global Markets,TABLE OF CONTENTS,CHAPTER ONE:INTRODUCTION.1STUDY GOAL AND OBJECTIVES.1REASONS FOR DOING THE STUDY.1INTENDED AUDIENCE.2SCOPE OF REPORT.2SCOPE OF REPORT(CONTINUED).3SCOPE OF REPORT(CONTINUED).4METHODOLOGY.4INFORMATION SOURCES.5THE ANALYSTS CREDENTIAL
12、S.5RELATED BCC RESEARCH REPORTS.5BCC ONLINE SERVICES.6DISCLAIMER.6CHAPTER TWO:SUMMARY.7,SMMARY TABLE GLOBAL REQUIREMENTS FOR MEDICAL DEVICESENSORS,THROUGH 2014($MILLIONS,CLASS II AND CLASS,III DEVICES).7,SUMMARY FIGURE GLOBAL MARKET FOR MEDICAL DEVICES,SENSORS BY TECHNOLOGY,2007-2014($MILLIONS).8CHA
13、PTER THREE:THE MEDICAL SENSORS INDUSTRY IN 2009.9,THE MEDICAL SENSORS INDUSTRY IN 2009(CONTINUED).9THREE INDUSTRY-DRIVING TRENDS.10THREE INDUSTRY-DRIVING TRENDS(CONTINUED).11THREE INDUSTRY-DRIVING TRENDS(CONTINUED).11CHAPTER FOUR:SENSORS USED IN MEDICAL DEVICES.12DIGITAL CONVERSION IS NOW COMPLETE.1
14、2SENSORS FOR MEDICAL DEVICES.13TEMPERATURE SENSORS.13POSITION SENSORS.14PRESSURE SENSORS AND TRANSDUCERS.14Pressure Sensors(Continued).15CHEMICAL SENSORS.16FORCE AND LOAD SENSORS AND TRANSDUCERS.17FLOW SENSORS.18LEVEL SENSORS.18TABLE 1 LEVEL SENSOR TECHNOLOGIES LISTED BY SENSING,FUNCTION.,SPINTRONIC
15、S.19,Spintronics(Continued).20,Copyright BCC Research,Wellesley,MA USA,Web:,iv,HLC080A Medical Device Sensors:Technologies and Global Markets,TABLE OF CONTENTS,CHAPTER FIVE:STANDARDS AND REGULATIONS.21GOVERNMENT REGULATORY AUTHORITIES.21CONSENSUS STANDARDS ORGANIZATIONS.22BROAD INTEREST ORGANIZATION
16、S.23,Association for the Advancement of Medical Instruments(AAMI).23American National Standards Institute(ANSI).23American Society for Quality(ASQ).23ASTM International(ASTM).24European Committee for Standardization(CEN).25,TABLE 2 CEN MEMBER COUNTRIES.,Electrostatic Discharge(ESD)Association.26Inte
17、rnational Electrotechnical Commission(IEC).27International Organization for Standardization(ISO).28,International Organization(Continued).29TABLE 3 STANDARDS FOR GENERAL USE MEDICAL DEVICES.30TABLE 3(CONTINUED).31TABLE 3(CONTINUED).32HOSPITAL USE DEVICES.32UNITED STATES PHARMACOPEIAL CONVENTION(USP)
18、.33TABLE 4 STANDARDS FOR DEVICES USED BY HOSPITALS.33TABLE 4(CONTINUED).34TABLE 4(CONTINUED).35TABLE 4(CONTINUED).36TABLE 4(CONTINUED).37TABLE 4(CONTINUED).38,IN VITRO TESTING STANDARDS.39,Clinical Laboratory Standards Institute(CLSI).39National Committee for Clinical Laboratory Standards,(NCCLS).40
19、TABLE 5 IN VITRO MEDICAL DEVICE STANDARDS.40TABLE 5(CONTINUED).41TABLE 5(CONTINUED).42TABLE 5(CONTINUED).43TABLE 5(CONTINUED).44TABLE 5(CONTINUED).45,MATERIALS-RELATED STANDARDS.45,TABLE 6 ASTM STANDARDS FOR MATERIALS USED IN,MEDICAL DEVICES.46TABLE 6(CONTINUED).47TABLE 6(CONTINUED).48,Copyright BCC
20、 Research,Wellesley,MA USA,Web:,v,HLC080A Medical Device Sensors:Technologies and Global Markets,TABLE OF CONTENTS,TABLE 6(CONTINUED).49TABLE 7 ISO STANDARDS FOR MATERIALS USED IN MEDICAL,DEVICES.50,BIOCOMPATABILITY.50TABLE 8 STANDARDS RELATED TO BIOCOMPATABILITY.51TABLE 8(CONTINUED).52TABLE 8(CONTI
21、NUED).53TABLE 9 STANDARDS RELATED TO TISSUE ENGINEERING.53TABLE 9(CONTINUED).54MANUFACTURING-RELATED CONSENSUS STANDARDS.54STERILITY.54ASSOCIATION OF ANALYTICAL COMMUNITIES,INTERNATIONAL(AOAC).55TABLE 10 MEDICAL DEVICE STERILIZATION STANDARDS.56TABLE 10(CONTINUED).57TABLE 10(CONTINUED).58TABLE 10(CO
22、NTINUED).59TABLE 10(CONTINUED).60TABLE 10(CONTINUED).61TABLE 10(CONTINUED).62INFORMATION TECHNOLOGYRELATED STANDARDS.62UNDERWRITERS LABORATORIES(UL).63TABLE 11 INFORMATION TECHNOLOGY RELATED STANDARDS.63TABLE 11(CONTINUED).64PRACTICE-ORIENTED DEVICE STANDARDS.65ANESTHESIA DEVICES.65Standards Austral
23、ia(AS).65American Society of Mechanical Engineers(ASME).66Compressed Gas Association(CGA).67,Compressed Gas(Continued).68National Fire Protection Association(NFPA).69TABLE 12 STANDARDS PERTAINING TO ANESTHESIA DEVICES.69TABLE 12(CONTINUED).70,CARDIOVASCULAR.71TABLE 13 STANDARDS PERTAINING TO CARDIOL
24、OGY DEVICES.71TABLE 13(CONTINUED).72,EAR,NOSE,AND THROAT DEVICES.73,Acoustical Society of America(ASA).73Institute of Electrical and Electronic Engineers(IEEE).73,TABLE 14 STANDARDS FOR MEDICAL DEVICES USED IN EAR,NOSE,AND THROAT PRACTICES.74,Copyright BCC Research,Wellesley,MA USA,Web:,vi,HLC080A M
25、edical Device Sensors:Technologies and Global Markets,TABLE OF CONTENTS,GASTROENTEROLOGY AND UROLOGY DEVICES.74,TABLE 15 STANDARDS FOR MEDICAL DEVICE USED IN,GASTROENTEROLOGY AND UROLOGY.75TABLE 15(CONTINUED).76,NEUROLOGY DEVICES.76,TABLE 16 STANDARDS FOR MEDICAL DEVICES USED IN,NEUROLOGY.76TABLE 16
26、(CONTINUED).77,OB-GYN DEVICES.77TABLE 17 OBSTETRIC-GYNECOLOGY DEVICE STANDARDS.77TABLE 17(CONTINUED).78TABLE 17(CONTINUED).79,OPHTHALMIC DEVICES.80TABLE 18 OPHTHALMIC DEVICE STANDARDS.80TABLE 18(CONTINUED).81,ORTHOPEDIC DEVICES.82TABLE 19 ORTHOPEDIC DEVICE STANDARDS.82TABLE 19(CONTINUED).83TABLE 19(
27、CONTINUED).84,PHYSICAL MEDICINE DEVICES.84,Rehabilitation Engineering and Assistive Technology,Society(RESNA).84Rehabilitation Engineering(Continued).85Rehabilitation Engineering(Continued).86,TABLE 20 STANDARDS FOR MEDICAL DEVICES USED IN PHYSICALMEDICINE.87TABLE 20(CONTINUED).88,RADIOLOGICAL DEVIC
28、ES.89,American Institute of Ultrasound in Medicine(AIUM).89Health Physics Society(HPS).89National Electrical Manufacturers Association(NEMA).90Illuminating Engineering Society of North America,(IESNA).90TABLE 21 RADIOLOGICAL MEDICAL DEVICE STANDARDS.91TABLE 21(CONTINUED).92TABLE 21(CONTINUED).93TABL
29、E 21(CONTINUED).94TABLE 21(CONTINUED).95TABLE 21(CONTINUED).96TABLE 21(CONTINUED).97TABLE 21(CONTINUED).98,Copyright BCC Research,Wellesley,MA USA,Web:,vii,HLC080A Medical Device Sensors:Technologies and Global Markets,TABLE OF CONTENTS,SURGICAL DEVICES.98TABLE 22 SURGICAL DEVICES.98TABLE 22(CONTINU
30、ED).99TABLE 22(CONTINUED).100TABLE 22(CONTINUED).101TABLE 22(CONTINUED).102TABLE 22(CONTINUED).103,CHAPTER SIX:FORECASTS.104FORECASTS.104FORECASTS(CONTINUED).105TABLE 23 GLOBAL REQUIREMENT FOR MEDICAL DEVICE SENSORS,BY MEDICAL SPECIALTY AND DEMAND,THROUGH 2014($,MILLIONS).106,TABLE 24 GLOBAL REQUIRE
31、MENT FOR MEDICAL DEVICE,SENSORS,BY GROWTH RATE,THROUGH 2014($MILLIONS).107FORECASTING MEDICAL SENSOR TECHNOLOGY.107TABLE 25 GLOBAL REQUIREMENT FOR SENSOR,BY TECHNOLOGY,THROUGH 2014($MILLIONS).108SENSOR REQUIREMENTS BY DEVICE OEMS.108TABLE 26 GLOBAL REQUIREMENT FOR SENSORS BY ORIGINAL,EQUIPMENT MANUF
32、ACTURER,THROUGH 2014($MILLIONS).109OEM REQUIREMENTS BY TECHNOLOGY.110TABLE 27 GLOBAL REQUIREMENT FOR SENSORS BY ANALYTICALLABORATORY INSTRUMENT MANUFACTURERS,THROUGH 2014($MILLIONS).110,TABLE 28 GLOBAL REQUIREMENT FOR SENSORS BY,ELECTROMEDICAL AND ELECTROTHERAPEUTIC APPARATUS,MANUFACTURERS,THROUGH 2
33、014($MILLIONS).111,TABLE 29 GLOBAL REQUIREMENT FOR SENSORS BY SURGICALAND MEDICAL INSTRUMENT MANUFACTURERS,THROUGH 2014,($MILLIONS).111TABLE 30 GLOBAL REQUIREMENT FOR SENSORS BY LABORATORYAPPARATUS AND FURNITURE MANUFACTURERS,THROUGH 2014($MILLIONS).111TABLE 31 GLOBAL REQUIREMENT FOR SENSORS BY OPHT
34、HALMICGOODS MANUFACTURERS,THROUGH 2014($MILLIONS).112,TABLE 32 GLOBAL REQUIREMENT FOR SENSORS BY OPTICALINSTRUMENT AND LENS MANUFACTURERS,THROUGH 2014($,MILLIONS).112,Copyright BCC Research,Wellesley,MA USA,Web:,viii,HLC080A Medical Device Sensors:Technologies and Global Markets,TABLE OF CONTENTS,TA
35、BLE 33 GLOBAL REQUIREMENT FOR SENSORS BY IRRADIATIONAPPARATUS MANUFACTURERS,THROUGH 2014($MILLIONS).112,TABLE 34 GLOBAL REQUIREMENT FOR SENSORS BY SURGICALAPPLIANCE AND SUPPLIES MANUFACTURERS,THROUGH 2014($MILLIONS).113,CHAPTER SEVEN:OEM-LEVEL MEDICAL DEVICE SENSOR,FORECASTS.114OEM-LEVEL MEDICAL DEV
36、ICE SENSOR FORECASTS.114ANESTHESIOLOGY AND RESPIRATORY THERAPY.115,TABLE 35 TEN MOST COMMONLY PERFORMED PROCEDURESREQUIRING ANESTHESIOLOGY OR RESPIRATORY THERAPY,DEVICES.115TABLE 36 CLASS II ANESTHESIOLOGY DEVICES.115TABLE 36(CONTINUED).116TABLE 36(CONTINUED).117TABLE 37 CLASS III ANESTHESIOLOGY DEV
37、ICES.117,SENSOR REQUIREMENTS BY ANESTHESIOLOGY DEVICEOEMS.118TABLE 38 GLOBAL REQUIREMENT FOR SENSORS FOR,ANESTHESIOLOGY AND RESPIRATORY THERAPY DEVICES,BY,TYPE OF OEM($MILLIONS).118,SENSOR REQUIREMENTS BY TECHNOLOGY.118,TABLE 39 GLOBAL REQUIREMENT FOR SENSORS FOR,ANESTHESIOLOGY DEVICES,THROUGH 2014(
38、$MILLIONS).118,TABLE 40 ANALYTICAL LABORATORY INSTRUMENT OEMSREQUIREMENT FOR SENSORS FOR ANESTHESIOLOGY DEVICES,THROUGH 2014($MILLIONS).119,TABLE 41 ELECTROMEDICAL AND ELECTROTHERAPEUTICAPPARATUS OEMS REQUIREMENT FOR SENSORS FOR,ANESTHESIOLOGY DEVICES,THROUGH 2014($MILLIONS).119,TABLE 42 SURGICAL AN
39、D MEDICAL INSTRUMENT OEMS,REQUIREMENT FOR SENSORS FOR ANESTHESIOLOGY DEVICES,THROUGH 2014($MILLIONS).119,TABLE 43 LABORATORY APPARATUS AND FURNITUREMANUFACTURERS REQUIREMENT FOR SENSORS FOR,ANESTHESIOLOGY DEVICES,THROUGH 2014($MILLIONS).120,TABLE 44 OPHTHALMIC GOODS OEMS REQUIREMENT FORSENSORS FOR A
40、NESTHESIOLOGY DEVICES,THROUGH 2014($,MILLIONS).120,Copyright BCC Research,Wellesley,MA USA,Web:,ix,HLC080A Medical Device Sensors:Technologies and Global Markets,TABLE OF CONTENTS,TABLE 45 OPTICAL INSTRUMENT AND LENS MANUFACTURERSREQUIREMENT FOR SENSORS FOR ANESTHESIOLOGY DEVICES,THROUGH 2014($MILLI
41、ONS).120,TABLE 46 IRRADIATION APPARATUS MANUFACTURERS,REQUIREMENT FOR SENSORS FOR ANESTHESIOLOGY DEVICES,THROUGH 2014($MILLIONS).121,TABLE 47 SURGICAL APPLIANCE AND SUPPLIESMANUFACTURERSREQUIREMENT FOR SENSORS FOR,ANESTHESIOLOGY DEVICES,THROUGH 2014($MILLIONS).121CARDIOLOGY.121,TABLE 48 TEN MOST COM
42、MONLY PERFORMED CARDIAC,PROCEDURES REQUIRING MEDICAL DEVICES.121TABLE 48(CONTINUED).122TABLE 49 CLASS II CARDIOLOGY DEVICES.122TABLE 49(CONTINUED).123TABLE 49(CONTINUED).124TABLE 50 CLASS III CARDIOLOGY DEVICES THAT MAKE,SIGNIFICANT USE OF SENSORS.124TABLE 50(CONTINUED).125,SENSOR REQUIREMENTS BY OE
43、MS.125TABLE 51 GLOBAL REQUIREMENT FOR SENSORS IN CARDIOLOGYDEVICES,BY TYPE OF OEM,THROUGH 2014($MILLIONS).125,SENSOR REQUIREMENTS BY TECHNOLOGY.126TABLE 52 GLOBAL REQUIREMENT FOR SENSORS FOR CARDIOLOGYDEVICES,THROUGH 2014($MILLIONS).126,TABLE 53 ANALYTICAL LABORATORY INSTRUMENT OEMSREQUIREMENT FOR S
44、ENSORS FOR CARDIOLOGY DEVICES,THROUGH 2014($MILLIONS).126,TABLE 54 ELECTROMEDICAL AND ELECTROTHERAPEUTICAPPARATUS OEMS REQUIREMENT FOR SENSORS FOR,CARDIOLOGY DEVICES,THROUGH 2014($MILLIONS).126,TABLE 55 SURGICAL AND MEDICAL INSTRUMENT OEMSREQUIREMENT FOR SENSORS FOR CARDIOLOGY DEVICES,THROUGH 2014($
45、MILLIONS).127,TABLE 56 LABORATORY APPARATUS AND FURNITUREMANUFACTURERS REQUIREMENT FOR SENSORS FOR,CARDIOLOGY DEVICES,THROUGH 2014($MILLIONS).127,TABLE 57 OPHTHALMIC GOODS OEMS REQUIREMENT FORSENSORS FOR CARDIOLOGY DEVICES,THROUGH 2014($,MILLIONS).127,Copyright BCC Research,Wellesley,MA USA,Web:,x,H
46、LC080A Medical Device Sensors:Technologies and Global Markets,TABLE OF CONTENTS,TABLE 58 OPTICAL INSTRUMENT AND LENS MANUFACTURERSREQUIREMENT FOR SENSORS FOR CARDIOLOGY DEVICES,THROUGH 2014($MILLIONS).128,TABLE 59 IRRADIATION APPARATUS MANUFACTURERSREQUIREMENT FOR SENSORS FOR CARDIOLOGY DEVICES,THRO
47、UGH 2014($MILLIONS).128TABLE 60 SURGICAL APPLIANCE AND SUPPLIES MANUFACTURERS,REQUIREMENT FOR SENSORS FOR CARDIOLOGY DEVICES,THROUGH 2014($MILLIONS).128CLINICAL CHEMISTRY.129,TABLE 61 TEN MOST COMMONLY PERFORMED PROCEDURES,REQUIRING CLINICAL CHEMISTRY DEVICES.129TABLE 62 CLASS II CLINICAL CHEMISTRY
48、DEVICES(INCLUDINGTOXICOLOGY INSTRUMENTS).129TABLE 62(CONTINUED).130TABLE 63 CLASS III CLINICAL CHEMISTRY DEVICES.130,SENSOR REQUIREMENTS BY OEMS.130TABLE 64 GLOBAL REQUIREMENT FOR SENSORS IN CLINICALCHEMISTRY INSTRUMENTS AND DEVICES,BY TYPE OF OEM,THROUGH 2014($MILLIONS).130,SENSOR REQUIREMENTS BY T
49、ECHNOLOGY.131TABLE 65 GLOBAL REQUIREMENT FOR SENSORS FOR CLINICALCHEMISTRY DEVICES,THROUGH 2014($MILLIONS).131,TABLE 66 ANALYTICAL LABORATORY INSTRUMENT OEMSREQUIREMENT FOR SENSORS FOR CLINICAL CHEMISTRY,DEVICES,THROUGH 2014($MILLIONS).131,TABLE 67 ELECTROMEDICAL AND ELECTROTHERAPEUTICAPPARATUS OEMS
50、 REQUIREMENT FOR SENSORS FOR CLINICALCHEMISTRY DEVICES,THROUGH 2014($MILLIONS).132,TABLE 68 SURGICAL AND MEDICAL INSTRUMENT OEMSREQUIREMENT FOR SENSORS FOR CLINICAL CHEMISTRY,DEVICES,THROUGH 2014($MILLIONS).132,TABLE 69 LABORATORY APPARATUS AND FURNITURE,MANUFACTURERS REQUIREMENT FOR SENSORS FOR CLI
