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

Nr. / Chapter: / Description / Reference to document/text position: / Verdict
1 / (4.2) / Definition of Risk management Process / Please identify the documents, the chapters and the pages ...
2 / (4.3) / Definition of Essential performance
3 / (4.4) / Expected service life
4 / (4.5) / Equivalent safety
5 / (4.6) / Parts contacting the patient
6 / (4.7) / Single Fault Condition for ME Equipment
7 / (4.8) / Components of ME Equipment
8 / (4.9) / Use of components with high-integrity characteristics in ME
9 / (5.1) / Type tests
10 / (5.4) / Other conditions
11 / (5.7) / Humidity preconditioning treatment
12 / (5.9.2.3) / Actuating mechanisms
13 / (7.1.1) / Usability of the identification, marking and documents
14 / (7.9.1) / General accompanying documents format.
15 / (8.1 b) / Fundamental rule of protection against electric shock
16 / (8.3 d) / Classification of applied parts
17 / (8.4.2 c) / Accessible parts including applied parts
18 / (8.5.2.2) / Type B applied parts
19 / (8.5.2.3) / PATIENT Leads
20 / (8.6.3) / Protective earthing of moving parts
21 / (8.8.4.1) / Mechanical strength and resistance to heat
22 / (8.10.1) / Fixing of components
23 / (8.10.2) / Fixing of wiring
24 / (8.10.5) / Mechanical protection of wiring
25 / (8.11.5) / Mains fuses and over-current releases
26 / (9.2.1) / Hazards associated with moving parts – General
27 / (9.2.2.4.3) / Movable guards
28 / (9.2.2.4.4) / Protective measures
29 / (9.2.2.5 c) / Continuous activation
30 / (9.2.2.6) / Speed of movement(s)
31 / (9.2.3.2) / Over travel
32 / (9.2.4) / Emergency stopping devices
33 / Release of patient ()
34 / (9.3) / Hazards associated with surfaces, corners and edges
35 / (9.4.2.4.3) / Movement over a threshold
36 / (9.5.1) / Protective means
37 / (9.6.1) / Acoustic energy – General
38 / (9.6.2.2) / Infrasound and ultrasound energy
39 / (9.7.2) / Pneumatic and hydraulic parts
40 / (9.7.4) / Pressure rating of ME equipment parts
41 / (9.7.6) / Pressure-control device
42 / (9.7.7) / Pressure-relief device
43 / (9.8.1) / Hazards associated with support systems – General
44 / (9.8.2) / Tensile safety factor
45 / (9.8.3.1) / Strength of patient or operator support or suspension systems – General
46 / (9.8.3.2 a&b) / Static forces due to lading from persons
47 / (9.8.4.1) / Systems with mechanical protective devices- General
48 / (9.8.4.3) / Mechanical protective device intended for single activation
49 / (9.8.5) / Systems without mechanical protective devices
50 / (10.1.2) / ME equipment intended to produce diagnostic or therapeutic X-radiation
51 / (10.2) / Alpha, beta, gamma, neutron and other particle radiation
52 / (10.3) / Microwave radiation
53 / (10.5) / Other visible electromagnetic radiation
54 / (10.6) / Infrared radiation
55 / (10.7) / Ultraviolet radiation
56 / (11.1.1) / Maximum temperature during normal use
57 / (11.1.2.1) / Applied parts intended to supply heat to a patient
58 / (11.1.2.2) / Applied parts not intended to supply heat to a patient
59 / (11.1.3) / Measurements
60 / (11.1.3 e) / Measurements
61 / (11.2.2.1 a&b) / Risk of fire in an oxygen rich environment
62 / (11.3) / Constructional requirements for fire enclosures of ME equipment
63 / (11.5) / ME equipment and ME systems intended for use in conjunction with flammable agents
64 / (11.6.3) / Spillage on ME equipment and ME system
65 / (11.6.6) / Cleaning and disinfection of ME equipment and ME systems
66 / (11.6.7) / Sterilization of ME equipment and ME systems
67 / (11.6.8) / Compatibility with substances used with the ME equipment
68 / (12.1) / Accuracy of controls and instruments
69 / (12.3) / Alarm systems
70 / (12.4.1) / Intentional exceeding of safety limits
71 / (12.4.2) / Indication of parameters relevant to safety
72 / (12.4.3) / Accidental selection of excessive output values
73 / (12.4.4) / Incorrect output
74 / (12.4.5.2) / Diagnostic X-ray equipment
75 / (12.4.5.3) / Radiotherapy equipment
76 / (12.4.5.4) / Other ME equipment producing diagnostic or therapeutic radiation
77 / (12.4.6) / Diagnostic or therapeutic acoustic pressure
78 / (13.2.6) / Leakage of liquid
79 / (14.1) / Programmable electrical medical systems – General
80 / (14.2) / Programmable electrical medical systems – Documentation
81 / (14.3) / Programmable electrical medical systems - Risk management plan
82 / (14.4) / PEMS Development Life Cycle
83 / (14.6.1) / Identification of known and foreseeable hazards
84 / (14.6.2) / Risk control
85 / (14.7) / Requirement specification
86 / (14.8) / Architecture
87 / (14.9) / Design and Implementation
88 / (14.10) / Verification
89 / (14.11) / Programmable electrical medical systems - PEMS validation
90 / (15.1) / Construction of ME equipment - Arrangements of controls and indicators of ME equipment
91 / (15.3.2) / Push test
92 / (15.3.3) / Impact test
93 / (15.3.4.2) / Portable ME equipment
94 / (15.3.5) / Rough handling test
95 / (15.4.1) / Construction of connectors
96 / (15.4.2.1 a-h) / Temperature and overload control devices -Application
97 / (15.4.3.1) / Housing
98 / (15.4.3.5) / Excessive current and voltage protection
99 / (15.4.5) / Pre-set controls
100 / (15.4.7.3 b) / Entry of liquids
101 / (16.1) / General Requirements for ME Systems
102 / (17) / Electromagnetic compatibility of ME equipment and ME systems

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