standards final

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standards final
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2010-12-09 14:42:52
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  1. path of standard traceability hiearchy + standard
    • ISO31/1000
    • international bureau of weights & measures
    • national institute of standards
    • reference laboratory
    • measurement device
  2. def'n: biomedical engineering
    application of math & physics to biological and medical problems
  3. code of professional practice (7)
    • patient/user safety
    • protection of environment
    • know one's own limitations
    • confidentiality
    • continuing education
    • conflict of interest
    • fairness/credit
  4. life cycle of medical device
    • research
    • development
    • evaluation
    • marketing
    • manufacturing
    • procurement
    • utilization
    • disposal
  5. why standards (4)
    • a reference
    • desirable attributes of a product, process, or system
    • define safety, protection of environment, conflict of interest; professional practice
    • legal protection
  6. physical standards traceability (more defined)
    • national or international standards (NRC/NIST)
    • 10 standard (national level)
    • reference standards/transfer standards
    • working standards
    • client test equipment, shop/level standards, 20 standards
  7. instrument calibration involves:
    • condition of receive & return
    • date/env of calibration
    • expiration
    • standards/equip'ts used
    • certificate of traceability
  8. def'n: safety & effectiveness (9)
    • identify risks inherent to device, eliminate/reduce risk, provide protection against those risks, provide info related to risks that remain
    • not compromise clinical safety condition
    • conforms to safety principles
    • performance over life time
    • transport & storage requirements
    • material compatible
    • safe sterilization method
    • software performance validation
    • appropriate training manuals
  9. def'n: process standards + standards
    • control manufacture process
    • ISO9000-2003 (General QA) ~ ISO13485 (Medical QA) ~ 21CFR820 (Quality System Requirements)
    • ISO14971-2000 (Risk Management)
  10. def'n: collateral/horizontal standards
    general, many types of equipments e.g. CISPR.11
  11. def'n: particular/vertical standards
    • device specific
    • e.g. AAMI EC12-1991
  12. Technical Standards def'n + examples
    • technical requirements & test methods
    • CSA-Z32-99 (electrical safety & essential electrical system in health care facilities) e.g. backup power requirements
    • IEC 60601-2: Particular requirements for safety
    • IEC 60601-1: General req'ts for basic safety & essential performance
  13. def'n: consensus/voluntary standards
    • derived by standard organizations
    • not part of gov't body
    • not created by treaty
    • most standards
    • IEC, ANSI, CISPR
  14. standards sources
    • notified bodies:
    • - CSA (Canadian Standards Assoc)
    • - Underwriters Laboratory (U.S. version of CSA)
    • associations:
    • - AAMI (Association for the Advancement of Medical Instrumentation)
    • - ANSI (American National Standards Institute)
    • - ISO (International Standard Organization)
    • - ECRI
  15. contents of standards
    • scope (disclaimer, what is covered & not)
    • purpose (intended or desired result)
    • definitions
    • requirements
    • test methods (how requirements verified)
    • appendixes
  16. Table of diff standards & jurisdictions
  17. standard compliance
    • self certification, regulatory body right to audit
    • third party certification, gives certificate
    • diff jurisdiction, diff certification requirements
    • CSA Certification Program: certifies process & device (>1)
    • CSA Special Inspection Program: certifies 1 particular device (only 1)
  18. def'n: calibration control system
    • ensures measurement, test, and process-control equip'ts & materials are calibrated and maintained w/in tolerance limits sufficient for individual tasks to meet regulatory & quality requirements
    • ensures control of environmental conditions to get accurate results
  19. def'n: macroshock
    high current (mA), low density, transcutaneous
  20. def'n: microshock
    low current (uA), high density, introduced to heart
  21. how do electric effects cause human harm?
    • P = I2R --> burns tissue
    • evokes action potential
    • heart fibrillation
    • current threshold for macroshock
  22. Current perception with 60 Hz
    • 1 mA: threshold of perception
    • 5 mA: max harmless current
    • 10-20 mA: can't let go, sustained muscular contraction
    • 50 mA: pain, faint, exhaustion
    • 100-300 mA: ventricular fibrillation start
    • 6 A: temporary respiratory paralysis, burns, myocardial contraction
  23. def'n: leakage current
    inherent flow of current from an energized cct to conductors
  24. purpose of ground wires
    • drain leakage currents
    • create short cct in case of fault
    • min. unwanted noise
  25. def'n isolated power
    electrical system in which no cct conductor is connected directly to ground
  26. advantages of isolated power
    • no spark at ground fault
    • SF fault to ground no shock occurs
    • fault does not affect operation of device
  27. def'n: LIM
    • line isolation monitoring system
    • displays current that would flow if there's direct fault to ground to the equipotential grounding system
    • impedance measuring device
    • indicate degree of isolation from ground to isolated portion
    • trig at ~2mA
  28. def'n: GFCI
    • Ground Fault Circuit Interrupter
    • interrupts power if Ileak >= 5 mA or when Iin >> Iout
    • protection against macroshock
    • not for OR use b/c power shuts down
  29. def'n: equipotential ground
    • if long distance to panel can have voltage drop
    • green-yellow wire insulation
    • ensure all same length
  30. Gas safety (10)
    • proper ID: color, label, PISS (pin index safety system), DISS (diameter index safety system)
    • storage & transportation of gas containers: valve protection cap, chains
    • leaks: fire hazard
    • oil/grease free environment: high pressure O2 + oil/grease = burning/explosion hazard
    • sparks: explosion hazard
    • ventilation: accumulation of gases in enclosed areas
    • relieve valve location & air intake
    • cryogenic burns
    • shock-waves: no 1/4 turn valves with high pressure systems
    • dust contamination
  31. def'n: problem solving
    process to find answers in engineering design, design improvement, and troubleshooting
  32. problem solving tools (6)
    • brainstorming
    • reverse engineering
    • decision tree
    • PMI
    • SWOT
    • Critical Path / Gantt
  33. troubleshooting tools (4)
    • troubleshooting flowchart
    • fault tree analysis
    • half-split analysis
    • identical systems analysis
  34. troubleshooting in BMET includes:
    • clinical considerations
    • documentation
    • incident reporting
  35. Rayleigh resolution
    • Rrayleigh = h {1.22 x lambda / (2 x NA) }
    • distance between peaks of 2 light spreads
    • point spread function, defines the design of the lens
    • higher resolution have higher Rrayleigh
  36. steps in problem solving
    • 1. problem definition: understand/verify problem
    • 2. background research
    • 3. high level approach: problem isolation
    • 4. idea generation: possible causes
    • 5. idea formulation: test & measurement methods
    • 6. idea evaluation and implementation: test & measure
    • 7. verification/validation: follow-up document
  37. def'n: design problem definition (5)
    • summary of device and intended use
    • general operational specifications/initial requirements
    • functional specifications: performance
    • non-functional specifications: safety & standard compliance
    • packaging & cost
  38. brainstorming in problem solving
    • method for developing creative solutions to problems
    • encourages lateral & creative thinking
    • no criticism
    • choose best solution with decision making tools
    • individual or group
  39. def'n: reverse engineering
    • adopt ideas from similar systems, processes, or problems and modify to suit our needs
    • consider intellectual property issues & give credit where it's due
  40. steps to construct a decision tree
    • 1. assign value/cost to outcomes
    • 2. assign probability to each branch according to effort
    • 3. calculate value to next higher level
    • 4. select path with highest value
  41. def'n: PMI
    • Plus-Minus-Interesting
    • plus: pros
    • minus: cons
    • interesting: implications & possible outcomes for taking action
  42. def'n: SWOT
    • Strength: what it does well
    • weakness: what it does less well
    • opportunity: what current trends favour it ssuccess?
    • threats: what obstacles exist to its success?
  43. Critical Path Analysis and Gantt Chart
    • Planning of an activity/project
    • sub-dividing problems into more manageable tasks
    • resource assignment
    • budgeting
    • determine critical paths & tasks
  44. Troubleshooting Flow Chart
  45. Fault Tree
    • typically provided by manufacturer in manual under troubleshooting section
    • lists problems, provides typical possible causes and corresponding remedies
  46. Half Split Analysis
    • start with system block diagram or flowchart
    • define input & faulty output
    • split diagram into half or at a convenient boundary
    • continue to split until problem is isolated & part, code, or process can be replaced
  47. Identical System Analysis
    • 2 identical systems are available & 1 works
    • troubleshoot by swapping suspicious components
  48. Troubleshooting picture
    • know the equipment: patient/user, function, env't
    • resources: manual, manufacture, databases, ECP
    • back to basics: common faults (age, user error, misuse, power interruption), replaceable parts, analysis
    • communication: documentation (logbook, ECP)
  49. medical device reporting + standard
    • 21CFR803
    • report if caused or contributed to death or serious injury
    • submit annual report, event file, incident report w/in 5, 10, and 30 days
    • reporting procedures must be developed, implemented, and maintained
  50. policy on managing the investigation of incidents
    • initial response: secure the scene, stop dmg spread, know seq of events
    • gather incident info
    • remedial action
    • coroner's inquests: if death unexpected, will be investigated
    • internal communication and documentation: report to supervisor
    • external communication: FDA, Health Canada
  51. scope of research
    • scientific/clinical investigations
    • technical feasibility
    • device classifications
    • market assessment / requirements
    • risk assessment
    • knowledge of basic properties and functional requirements
    • competitive analysis
    • customer service plan
    • regulatory and clinical strategy
    • develop business case
  52. scope of development
    • product definition
    • intellectual property generation & strategy
    • requirements
    • high-lvl product and process design
    • product design, verification and validation
    • process development
    • supply-chain development
    • clinical studies/trials and regulatory submissions/approval
    • product certification
    • risk assessment & mitigation
    • develop & update business plan
    • commercialization strategy & marketing plans
    • design transfer design
  53. scope of operations
    • pilot production
    • production
    • market rollout
    • distribution channel management
    • maintenance and service
    • continuous improvement programs
    • pos-market clinical studies
    • market feedback
    • disposal
  54. rational for QSR (8)
    • encourage safety & effectiveness
    • encourage a systematic, structured, and documented process
    • encourage customer based development
    • encourage continuous improvement
    • enforce risk management development & operation
    • enforce planning and evidence-based development, manufacturing, and operation
    • enforce definition and verification/validation of requirements
    • encourage proactive organizations
  55. proactive vs. reactive company
    • proactive: keeps changing design, start slow, but less problems in the future
    • reactive: high productivity in the beginning, lots problems later
  56. def'n: 1-10-100 rule
    • 1: cost of preventing defect before it occurs
    • 10: cost of correcting a defect before it reaches the customer
    • 100: cost of correcting after it reaches the customer
  57. Types of Device Classifications
    • Regulatory: HBFB, FDA, MDD, etc
    • Electrical: IEC60601, degree of protection against electrical shock, types B, BF, CF
    • Electrical: IEC60601, type of protection against shock, class I (relaxed insulation), class II (enhanced insulation)
    • Laser: eye safety, aversion response, wavelength and output power, class I, II, IIA, IIIa, IIIb, and IV (old); 1, 1M, 2, 2M, 3R, 3B, and 4
  58. Medical Device Classes in relation to design conrtrol
    • ISO13485 - design controls
    • Canada - I (no need), II, III, IV
    • U.S. - I (only need for software), II, III
    • EU - I, IIa, IIb, III
  59. Canadian Classification
    • Rule-Based Classification
    • active device: source of nrg other than human body or gravity
    • active diagnostic device: info for the purpose of detection or monitoring
    • active therapeutic device: supports, modifies, replaces, restores
    • invasive device: contact with eye or penetrate
    • Particular rules apply to particular devices.
  60. FDA Device Classification
    • Substantial Equivalence: same intended use AND tech characteristics OR same intended use AND FDA does not raise new questions of safety & effectiveness
    • Class I: general controls, min potential for harm
    • Class II: special controls, general controls insufficient
    • Class III: premarket approval, special controls insufficient
  61. contents of 21CFR800-898
    • labelling
    • medical device reporting
    • investigational device exception (IDE): get this for pre-approved device before allowed to get clinical test data
    • market clearance
    • premarket approval of medical devices
    • QSR (quality system regulation)
    • medical device classification and groups
  62. ISO13485 and 21CFR820 elements (20)
    • management responsibility
    • ID & traceability
    • document control
    • customer-supplied product
    • tool control
    • non-conforming material (lock up so nobody uses it)
    • quality records
    • corrective & preventive action
    • handling, storage & packaging
    • quality system
    • design control
    • purchasing
    • contract review
    • testing
    • labelling
    • internal audits: "say what you do, do what you say"
    • training
    • statistical analysis
    • servicing
  63. why need design control
    • ensure safety & efficacy through controlled design process
    • ensure successful & efficient implementation
    • U.S. 21CFR820.30 required for classes II, III
    • Canada ISO13485 section 4.4 required for classes III, IV
  64. waterfall model
    • output feeds into input
    • separate overlapping phases
    • risk management is a 'separate' parallel process
    • documentation part of design process
    • not realistic b/c design process not linear but iterative
    • usually limited on time
  65. documentation process in design control
    DHF (design history file) contains DMR (device master record, everything needed to know about service & manufacturing device) + DHR (device history record, this is what i did, materials that i used)
  66. elements of QA
    • design control: planning, input/output, verification & validation, hazard analysis, review
    • documentation & documentation control
    • corrective/preventive action
    • consistency of process
    • management commitment
    • proactive rather than reactive

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