SN EN 60601-1 : 2006 AMD 11 2011

National Foreword
Committees responsible
SECTION ONE - GENERAL
1 Scope and Object
2 Terminology and definitions
3 General Requirements
4 General requirements for test
5 Classification
6 Identification, marking and documents
7 Power input
SECTION TWO - ENVIRONMENTAL CONDITIONS
8 Basic safety categories
9 Removable protective means
10 Environmental conditions
11 Not Used
12 Not Used
SECTION THREE - PROTECTION AGAINST ELECTRIC SHOCK HAZARDS
13 General
14 Requirements related to classification
15 Limitation of voltage and/or energy
16 ENCLOSURES AND PROTECTIVE COVERS
17 Separation
18 Protective earthing, functional earthing and potential
    equalization
19 Continuous LEAKAGE CURRENTS AND PATIENT AUXILIARY CURRENTS
20 Dielectric strength
SECTION FOUR - PROTECTION AGAINST MECHANICAL HAZARDS
21 Mechanical strength
22 Moving parts
23 Surfaces, corners and edges
24 Stability in NORMAL LIFE
25 Expelled parts
26 Vibration and noise
27 Pneumatic and hydraulic power
28 Suspended masses
SECTION FIVE - PROTECTION AGAINST HAZARDS FROM UNWANTED OR
EXCESSIVE RADIATION
29 X-Radiation
30 Alpha, beta, gamma, neutron radiation and other particle
    radiation
31 Microwave radiation
32 Light radiation (including lasers)
33 Infra-red radiation
34 Ultraviolet radiation
35 Acoustical energy (including ultrasonics)
36 Electromagnetic compatibility
SECTION SIX - PROTECTION AGAINST HAZARDS OF IGNITION OF
FLAMMABLE ANAESTHETIC MIXTURES
37 Locations and basic requirements
38 Marking and ACCOMPANYING DOCUMENTS
39 Common requirements for CATEGORY AP AND CATEGORY APG
    EQUIPMENT
40 Requirements and tests for CATEGORY AP EQUIPMENT, parts
    and components thereof
41 Requirements and tests for CATEGORY APG EQUIPMENT, parts
    and components thereof
SECTION SEVEN - PROTECTION AGAINST EXCESSIVE TEMPERATURES
AND OTHER SAFETY HAZARDS
42 Excessive temperatures
43 Fire prevention
44 Overflow, spillage, leakage, humidity, ingress of liquids,
    cleaning, sterilization, disinfection and compatibility
45 Pressure vessels and parts subject to PRESSURE
46 Human errors
47 Electrostatic charges
48 Biocompatibility
49 Interruption of the power supply
SECTION EIGHT - ACCURACY OF OPERATING DATA AND PROTECTION
AGAINST HAZARDING OUTPUT
50 Accuracy of operating data
51 Protection against hazardous output
SECTION NINE - ABNORMAL OPERATION AND FAULT CONDITIONS -
ENVIRONMENTAL TESTS
52 Abnormal operation and fault conditions
53 Environmental tests
SECTION TEN - CONSTRUCTIONAL REQUIREMENTS
54 General
55 ENCLOSURES and covers
56 Components and general assembly
57 MAINS PARTS, components and layouts
58 Protective earthing - Terminals and connections
59 Construction and layout
TABLES
I Specified atmospheric conditions
II Marking on the outside of EQUIPMENT
III Recommended colours of indicator lights and their
       meaning for EQUIPMENT
IV Allowable values of continuous LEAKAGE AND PATIENT
       AUXILIARY CURRENTS, in milliamperes
V Test voltages
VI Not used
VII Not used
VIII Drop height
IX Gas-tightness of cord inlets
Xa Allowable maximum temperatures
Xb Allowable maximum temperatures
XI Maximum temperatures under fault conditions
XII Temperature limits of motor windings in Deg C
XIII Test torques for rotating controls
XIV Not used
XV NOMINAL cross-sectional area of POWER SUPPLY CORDS
XVI CREEPAGE DISTANCES AND AIR CLEARANCES in millimetres
XVII Not used. See note in Table XVI
XVIII Testing of cord anchorages
XIX Maximum allowable temperatures at 25 deg C ambient
       temperature of mains supply transformer windings
       under overload and short-circuit conditions
XX Test current for mains supply transformers
FIGURES
1 Example of the defined teminals and conductors
2 Example of a CLASS 1 Equipment
3 Example of a metal-enclosed CLASS II EQUIPMENT
4 Not used
5 Detachable mains connection
6 Not used
7 Standard test finger
8 Test pin
9 Test hook
10 Measuring supply circuit with the SUPPLY MAINS at
   (approximately) earth voltage
11 Measuring supply circuit with the SUPPLY MAINS
   approximately symmetrical to earth
12 Measuring supply circuit for polyphase EQUIPMENT
   specified for connection to a polyphase SUPPLY MAINS
13 Measuring supply circuit for single-phase EQUIPMENT
   specified for connection to a polyphase SUPPLY MAINS
14 MEASURING SUPPLY CIRCUIT FOR EITHER equipment supplied from
   a specified CLASS 1 single-phase power supply or for
   EQUIPMENT supplied from a specified CLASS II single-phase
   power supply, in this case not using the protective earth
   earth connection and S8
15 Example of a measuring device and its frequency characteristics
16 Measuring circuit for the EARTH LEAKAGE CURRENT OF
   EQUIPMENT, with or without APPLIED PART, specified
   for use with a specified clas I single-phase power
   supply using the measuring supply circuit of Figure 14
17 Measuring circuit for the EARTH LEAKAGE CURRENT OF
   EQUIPMENT, with or without APPLIED PART, specified for
   use with a specified clas I single-phase power supply
   using the measuring supply circuit of figure 14
18 Measuring circuit for the ENCLOSURE LEAKAGE CURRENT.
   Example with the measuring supply circuit of Figure 10
19 Measuring circuit for the ENCLOSURE LEAKAGE CURRENT of
   EQUIPMENT with or without APPLIED PART, intended only
   for use with a specified single-phase power supply
20 Measuring circuit for the PATIENT LEAKAGE CURRENT from
   the APPLIED PART to earth
21 Measuring circuit for the PATIENT LEAKAGE CURRENT via
   an F-TYPE APPLIED PART to earth caused by an external
   voltage on the APPLIED PART
22 Measuring circuit for the PATIENT LEAKAGE CURRENT from
   the APPLIED PART to earth caused by an external
   voltage on a SIGNAL INPUT PART or a SIGNAL OUTPUT PART
23 Measuring circuit for the PATIENT LEAKAGE CURRENT
   from the APPLIED PART to the ENCLOSURE OF INTERNALLY
   POWERED EQUIPMENT
24 Measuring circuit for the PATIENT LEAKAGE CURRENT via
   F-TYPE APPLIED PART to the ENCLOSURE OF INTERNALLY
   POWERED EQUIPMENT
25 Measuring circuit for the PATIENT LEAKAGE CURRENT from
   the APPLIED PART to earth of INTERNALLY POWERED
   EQUIPMENT, caused by an external voltage on a SIGNAL
   INPUT PART OR SIGNAL OUTPUT PART
26 Measuring circuit for the PATIENT AUXILIARY CURRENT
27 Measuring circuit for the PATIENT AUXILIARY CURRENT of
   INTERNALLY POWERED EQUIPMENT
28 Example of a circuit for dielectric strength test at
   operating temperature for heating elements
29 Maximum allowable current Izr as a function of the
   maximum allowable voltage UZR measured in a purely
   resistive circuit with the most readily flammable
   mixture of ether vapour with air
30 Maximum allowable voltage UZC as a function of the
   capacitance Cmax measured in a capacitive circuit with
   the most readily flammable mixture of ether vapour with air
31 Maximum allowable current IZL as a function of the
   inductance Lmax measured in an inductive circuit with the
   most readily flammable mixture of ether vapour with air
32 Maximum allowable current IZR as a function of the maximum
   allowable voltage UZR, measured in a purely resistive
   circuit with the most readily flammable mixture of ether
   vapour with oxygen
33 Maximum allowable voltage UZC as a function of the
   capitance Cmax measured in a capacitive circuit with the
   most readily flammable mixture of ether vapour with oxygen
34 Maximum allowable current IZL as a function of the inductance
   Lmax, circuit with the most readily flammable mixture
   of ether vapour with oxygen
35-37, 39-47, 49 Not used
38 Ratio between hydraulic test pressure and maximum
   permissible working pressure
48 Ball-pressure test apparatus
50 Application of test voltage to bridged PATIENT CONNECTIONS
   for DEFIBRILLATION-PROOF APPLIED PARTS
51 Application of test voltage to individual PATIENT CONNECTIONS
   FOR DEFIBRILLATION-PROOF APPLIED PARTS
Appendix A - Appendix L
INDEX OF DEFINED TERMS
Annex ZA - ZD

Applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.