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Checklist Risk Management / Usabillity IEC 60601-1 3rd edition

Nr. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 (9.3) (9.4.2.4.3) (9.5.1) (9.6.1) Chapter: (4.2) (4.3) (4.4) (4.5) (4.6) (4.7) (4.8) (4.9) (5.1) (5.4) (5.7) (5.9.2.3) (7.1.1) (7.9.1) (8.1 b) (8.3 d) (8.4.2 c) (8.5.2.2) (8.5.2.3) (8.6.3) (8.8.4.1) (8.10.1) (8.10.2) (8.10.5) (8.11.5) (9.2.1) (9.2.2.4.3) (9.2.2.4.4) (9.2.2.5 c) (9.2.2.6) (9.2.3.2) (9.2.4) Description Definition of Risk management Process Definition of Essential performance Expected service life Equivalent safety Parts contacting the patient Single Fault Condition for ME Equipment Components of ME Equipment Use of components with highintegrity characteristics in ME Type tests Other conditions Humidity preconditioning treatment Actuating mechanisms Usability of the identification, marking and documents General accompanying documents format. Fundamental rule of protection against electric shock Classification of applied parts Accessible parts including applied parts Type B applied parts PATIENT Leads Protective earthing of moving parts Mechanical strength and resistance to heat Fixing of components Fixing of wiring Mechanical protection of wiring Mains fuses and over-current releases Hazards associated with moving parts General Movable guards Protective measures Continuous activation Speed of movement(s) Over travel Emergency stopping devices Release of patient () Hazards associated with surfaces, corners and edges Movement over a threshold Protective means Acoustic energy General Reference to document/text position:

38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70

(9.6.2.2) (9.7.2) (9.7.4) (9.7.6) (9.7.7) (9.8.1) (9.8.2) (9.8.3.1) (9.8.3.2 a&b) (9.8.4.1) (9.8.4.3) (9.8.5) (10.1.2) (10.2) (10.3) (10.5) (10.6) (10.7) (11.1.1) (11.1.2.1) (11.1.2.2) (11.1.3) (11.1.3 e) (11.2.2.1 a&b) (11.3) (11.5) (11.6.3) (11.6.6) (11.6.7) (11.6.8) (12.1) (12.3) (12.4.1)

Infrasound and ultrasound energy Pneumatic and hydraulic parts Pressure rating of ME equipment parts Pressure-control device Pressure-relief device Hazards associated with support systems General Tensile safety factor Strength of patient or operator support or suspension systems General Static forces due to lading from persons Systems with mechanical protective devices- General Mechanical protective device intended for single activation Systems without mechanical protective devices ME equipment intended to produce diagnostic or therapeutic X-radiation Alpha, beta, gamma, neutron and other particle radiation Microwave radiation Other visible electromagnetic radiation Infrared radiation Ultraviolet radiation Maximum temperature during normal use Applied parts intended to supply heat to a patient Applied parts not intended to supply heat to a patient Measurements Measurements Risk of fire in an oxygen rich environment Constructional requirements for fire enclosures of ME equipment ME equipment and ME systems intended for use in conjunction with flammable agents Spillage on ME equipment and ME system Cleaning and disinfection of ME equipment and ME systems Sterilization of ME equipment and ME systems Compatibility with substances used with the ME equipment Accuracy of controls and instruments Alarm systems Intentional exceeding of safety limits

71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99 100 101 102

(12.4.2) (12.4.3) (12.4.4) (12.4.5.2) (12.4.5.3) (12.4.5.4) (12.4.6) (13.2.6) (14.1) (14.2) (14.3) (14.4) (14.6.1) (14.6.2) (14.7) (14.8) (14.9) (14.10) (14.11) (15.1) (15.3.2) (15.3.3) (15.3.4.2) (15.3.5) (15.4.1) (15.4.2.1 a-h) (15.4.3.1) (15.4.3.5) (15.4.5) (15.4.7.3 b) (16.1) (17)

Indication of parameters relevant to safety Accidental selection of excessive output values Incorrect output Diagnostic X-ray equipment Radiotherapy equipment Other ME equipment producing diagnostic or therapeutic radiation Diagnostic or therapeutic acoustic pressure Leakage of liquid Programmable electrical medical systems General Programmable electrical medical systems Documentation Programmable electrical medical systems - Risk management plan PEMS Development Life Cycle Identification of known and foreseeable hazards Risk control Requirement specification Architecture Design and Implementation Verification Programmable electrical medical systems - PEMS validation Construction of ME equipment Arrangements of controls and indicators of ME equipment Push test Impact test Portable ME equipment Rough handling test Construction of connectors Temperature and overload control devices -Application Housing Excessive current and voltage protection Pre-set controls Entry of liquids General Requirements for ME Systems Electromagnetic compatibility of ME equipment and ME systems

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