Tham khảo tài liệu 'six sigma for medical device design by jose justiniano and venky gopalaswamy_3', kinh doanh - tiếp thị, quản trị kinh doanh phục vụ nhu cầu học tập, nghiên cứu và làm việc hiệu quả | 18 Six Sigma for Medical Device Design Table Design input examples Potential design input Examples Intended use Specific vs. general surgery instrumentation. Endoscopic or open surgery Screening or final abused drug immunoassay. Beating or still-heart surgery. User s Installer maintenance technician trainer nurse physician clinician patient. What is the current familiarity of all potential users with this technology a Performance requirements Highly sensitive immunoassay or with a very broad dynamic range. How long will the surgical procedure last b Is there a potential complication with very big very small obese skinny very ill very old very young patients Frequency of calibration longer than a month for a diagnostic assay. Is it part of a typical battery of assays . T4 T3 and TSH Software user interface requirements. Software requirement specifications. Chemical environmental characteristics Compatibility with user s Sterility Biodegradable packaging. Biocompatibility and toxicity. Pyrogen-free. Sterile. Is it to be used within the sterile field in surgery Compatibility with accessories ancillary equipment IV bag spike or other standard connectors. Electrical power . . vs. South America . Open architecture for computer systems networking. Is it to be used with an endoscope Which channel size s Labeling packaging Languages special conditions special warnings . C 60601-1 states several warning symbols . Heat protection. Vibration protection. Fragility level. Shipping and storage conditions Ergonomicsc and human factors Bulk shipments or final package. Humidity and temperature ranges. International vs. domestic considerations. Fool proof. continued 2005 by CRC Press Chapter two Design Control roadmap 19 Table Design input examples continued Potential design input Examples Physical facilities dimensions Power cables for electrosurgical generators may need to be longer in Europe than in . operating rooms. The same would apply to devices that .
