1* Scope and Object
1.1 Scope
This standard applies to the safety of MEDICAL ELECTRICAL EQUIPMENT (as defined in Sub-clause 2.2.15).
Although this standard is primarily concerned with safety, it contains some requirements regarding reliable operation where this is connected with safety.
SAFETY HAZARDS resulting from the intended physiological function of EQUIPMENT covered by this standard are not considered.
Annexes in this standard are not mandatory unless made so by an explicit statement in the main text.
1.2 Object
The object of this standard is to specify general requirements for the safety of MEDICAL ELECTRICAL EQUIPMENT and to serve as the basis for the safety requirements of Particular Standards
*1.3 Particular standards
A requirement of a Particular Standard takes priority over the corresponding requirement of this General Standard.
1.4 Environmental conditions
See Section Two.
1.5 Collateral standards
Among series standards for MEDICAL ELECTRICAL EQUIPMENT, general requirements for safety specified in collateral standards shall apply to:
——A set of MEDICAL ELECTRICAL EQUIPMENT (e.g.: irradiation EQUIPMENT);
——A certain characteristic (e.g. electromagnetic compatibility) of all MEDICAL ELECTRICAL EQUIPMENT not sufficiently indicated in general safety standards.
If a certain collateral standard is applicable to a certain particular standard, the latter is preferred.
2 Terminology and Definitions
For the purpose of this standard, the following shall apply:
——Where the terms "voltage" and "current"' are used, they mean the r.m.s. values of an alternating direct or composite voltage or current.
——The auxiliary verb
"shall" means that compliance with a requirement or a test is mandatory for compliance with this standard.
"should" means that compliance with a requirement or a test is recommended but is not mandatory for compliance with this standard.
"may" is used to describe a permissible way to achieve compliance with a requirement or test.
2.1 EQUIPMENT parts, auxiliaries and ACCESSORIES
2.1.1
access cover
Part of an ENCLOSURE or guard providing the possibility of access to EQUIPMENT parts for the purpose of adjustment, inspection, replacement or repair.
2.1.2
accessible metal part
Metal part of EQUIPMENT which can be touched without the use of a TOOL. See also Sub-clause 2.1.22.
2.1.3
accessory
Optional component necessary and/or suitable to be used with EQUIPMENT in order to enable, facilitate or improve the intended use of EQUIPMENT or to integrate additional functions.
2.1.4
accompanying documents
Documents accompanying EQUIPMENT or an ACCESSORY and containing all important information for USER, OPERATOR, installer or assembler of EQUIPMENT, particularly regarding safety.
2.1.5*
applied part
A part of EQUIPMENT in NORMAL USE:
——Part of EQUIPMENT which contacts the PATIENT body for need of realizing its function; or
——Part which may contact the PATIENT; or
——Part need to be touched by PATIENT.
2.1.6
enclosure
Exterior surface of EQUIPMENT including:
——all ACCESSIBLE METAL PARTS, knobs, grips and the like;
——accessible shafts;
——for the purpose of tests, metal foil, with specified dimensions, applied in contact with parts of the exterior surface made of material with low conductivity or made of insulating material.
2.1.7
F-type isolated (floating) applied part (hereinafter referred to as F-TYPE APPLIED PART)
APPLIED PART isolated from all other parts of the EQUIPMENT to such an insulation degree that the PATIENT LEAKAGE CURRENT allowable in SINGLE FAULT CONDITION is not exceeded when external unintended voltage is connected to PATIENT and therefore applied to between the APPLIED PART and earth.
F-TYPE APPLIED PART is either TYPE BF APPLIED PART or TYPE CF APPLIED PART.
2.1.8
Not used.
2.1.9
internal electrical power source
Power source intended to provide the electrical power necessary to operate EQUIPMENT and which is incorporated in that EQUIPMENT.
2.1.10
live
State of a part which, when connection is made to that part, can cause a current exceeding the allowable LEAKAGE CURRENT (specified in Sub-clause 19.3) for the part concerned to flow from that part to earth or from that part to an ACCESSIBLE PART of the same EQUIPMENT.
2.1.11
Not used.
2.1.12
mains part
Entirety of all parts of EQUIPMENT intended to have a CONDUCTIVE CONNECTION with the SUPPLY MAINS. For the purpose of this definition, the PROTECTIVE EARTH CONDUCTOR is not regarded as a part of the MAINS PART (see Figure 1).
2.1.13
Not used.
2.1.14
Not used.
2.1.15*
patient circuit
Any circuit containing one or more PATIENT CONNECTION(S).
PATIENT CIRCUIT includes conductive components with insulation failing to reach dielectric strength requirements (see Chapter 20),or with isolation failing to reach CREEP DISTANCE and ELECTRICAL CLEARANCE requirements (see Sub-clause 57.10), where under PATIENT CONNECTION.
ontents
Foreword i
SECTION ONE GENERAL
1* Scope and Object
2 Terminology and Definitions
3 General Requirements
4* General Requirements for Tests
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 No General Requirements
12 No General Requirements
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 (Previous Title: Insulation and Protective Impedances)
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 USE
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 Ultra-sonics)
36* Electromagnetic Compatibility
SECTION SIX PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES
37 Locations and Basic Requirements
38 Marking, 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 and Disinfection
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 HAZARDOUS 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 LAYOUT
58 Protective Earthing - Terminals and Connections
59 Construction and Layout
Annex A (Informative) General Guidance and Rationale
Annex B (Informative) Testing during Manufacture and/or Installation
Annex C (Informative) Sequence of Testing
Annex D (Normative) Symbols on Marking
Annex E (Informative) Survey of Insulation Paths and Test Circuits
Annex F (Informative) Test Apparatus for Flammable Mixtures
Annex G (Normative) Impact-Test Apparatus
Annex H (Informative) Screwed Terminal Connections
Annex J (Informative) Mains Supply Transformers
Annex K (Normative) Examples of the Connection of the Applied Part for Measurement of the Patient Leakage Current (See Chapter 19)
Annex L (Normative) Normative References
Table 1 Specified Atmospheric Conditions
Table 2 Marking on the Outside of EQUIPMENT
Table 3 Recommended Colors of Indicator Lights and Their Meaning for EQUIPMENT
Table 4 Allowable Values of Continuous LEAKAGE and PATIENT AUXILIARY CURRENTS*
Table 5 Test Voltages
Table 8 Drop Height
Table 9 Gas-tightness of Cord Inlets
Table 10a) Allowable Maximum Temperatures1)
Table 10b) Allowable Maximum Temperatures1)
Table 11 Maximum Temperatures under Fault Conditions
Table 12 Temperature Limits of Motor Windings, in℃
Table 13 Test Torques for Rotating Controls
Table 15 NOMINAL CROSS-SECTIONAL AREA of POWER SUPPLY CORDS
Table 18 Testing of Cord Anchorages
Table 19 Maximum Allowable Temperatures at 25℃ Ambient Temperature of Mains Supply Transformer Windings under Overload and Short-circuit Conditions
Table 20 Test Current for Mains Supply Transformers
Table161) CREEPAGE DISTANCES and AIR CLEARANCES
Figure 1 Example of the Defined Terminals and Conductors (see Chapter 2)
Figure 2 Example of a Class I EQUIPMENT (see Sub-clause 2.2.4)
Figure 3 Example of A Metal-enclosed Class II EQUIPMENT (See Sub-clause 2.2.5)
Figure 4 No General Requirements
Figure 5 Detachable Mains Connection (See Chapter 2)
Figure 6 No General Requirements
Figure 7 Standard Test Finger (See Chapter 16)
Figure 8 Test Pin (See Chapter 16)
Figure 9 Test Hook (See Chapter 16)
Figure 10 Measuring Supply Circuit with One Side of the SUPPLY MAINS at (Approximately) Earth Voltage [See Sub-clause 19.4b)]
Figure 11 Measuring Supply Circuit with the SUPPLY MAINS Approximately Symmetrical to Earth [See Sub-clause 19.4b)]
Figure 12 Measuring Supply Circuit for Poly-phase EQUIPMENT Specified for Connection to A Poly-phase SUPPLY MAINS [See Sub-clause 19.4b)]
Figure 13 Measuring Supply Circuit for Single-phase EQUIPMENT Specified for Connection to A Poly-phase SUPPLY MAINS [See Sub-clause19.4b)]
Figure 14 Measuring Supply Circuit for Either EQUIPMENT Supplied from A Specified Class I Single-phase Power Supply or for EQUIPMENT Supplied from A Specified Class II Single-phase Power Supply
Figure 15 Example of A Measuring Device and Its Frequency Characteristic [See Sub-clause 19.4e)]
Figure 16 Measuring Circuit for the EARTH LEAKAGE CURRENT of Class I EQUIPMENT, with or without APPLIED PART [See Sub-clause 19.4 f) and Notes to Table 4]
Figure 17 Measuring Circuit for the EARTH LEAKAGE CURRENT of EQUIPMENT, with or without APPLIED PART, Specified for Use with A Specified Class I Single-phase Power Supply [See Sub-clause 19.4 f) and Notes of Table 4]
Figure 18 Measuring Circuit for the ENCLOSURE LEAKAGE CURRENT
Figure 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
Figure 20 Measuring Circuit for the PATIENT LEAKAGE CURRENT from the APPLIED PART to Earth
Figure 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
Figure 22 Measuring Circuit for the PATIENT LEAKAGE CURRENT from the APPLIED PART to Earth Caused by An External Voltage on a SIGNAL INPUT or a SIGNAL OUTPUT PART
Figure 23 Measuring Circuit for the PATIENT LEAKAGE CURRENT from the APPLIED PART to the ENCLOSURE of INTERNALLY POWERED EQUIPMENT [See Sub-clause 19.4h)]
Figure 24 Measuring Circuit for the PATIENT LEAKAGE CURRENT Via an F-TYPE APPLIED PART to the ENCLOSURE of INTERNALLY POWERED EQUIPMENT [See Sub-clause 19.4h)]
Figure 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 or SIGNAL OUTPUT PART [See Sub-clause 19.4h)]
Figure 26 Measuring Circuit for the PATIENT AUXILIARY CURRENT
Figure 27 Measuring Circuit for the PATIENT AUXILIARY CURRENT of INTERNALLY POWERED EQUIPMENT ([See Sub-clause 19.4j)]
Figure 28 Example of A Circuit for Dielectric Strength Test at Operating Temperature for Heating Elements (See Sub-clause 20.4)
Figure 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 Vapor with Air (See Sub-clause 40.3)
Figure 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 Vapor with Air (See Sub-clause 40.3)
Figure 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 Vapor with Air (See Sub-clause 40.3)
Figure 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 Vapor with Oxygen (See Sub-clause 41.3)
Figure 33 Maximum Allowable Voltage UZC as A Function of the Capacity Cmax, Measured in A Capacitive Circuit with the Most Readily Flammable Mixture of Ether Vapor with Oxygen (See Sub-clause 41.3)
Figure 34 Maximum Allowable Current Izl as A Function of the Inductance Lmax, Measured in An Inductive Circuit with the Most Readily Flammable Mixture of Ether Vapor with Oxygen (See Sub-clause 41.3)
Figure 35 No General Requirements
Figure 36 No General Requirements
Figure 37 No General Requirements
Figure 38 Ratio between HYDRAULIC TEST PRESSURE and MAXIMUM PERMISSIBLE WORKING PRESSURE (see Sub-clause 45.2)
Figure 39 Example 1 (See Sub-clause 57.10)
Figure 40 Example 2 (See Sub-clause 57.10)
Figure 41 Example 3 (See Sub-clause 57.10)
Figure 42 Example 4 (See Sub-clause 57.10)
Figure 43 Example 5 (See Sub-clause 57.10)
Figure 44 Example 6 (See Sub-clause 57.10)
Figure 45 Example 7 (see Sub-clause 57.10)
Figure 46 Example 8 (See Sub-clause 57.10)
Figure 47 Example 9 (See Sub-clause 57.10)
Figure 48 Ball-pressure Test Apparatus [See Sub-clause 59.2]
Figure 49 No General Requirements
Figure 50 Test Voltage Applied to Patient Connection Bridged by Defibrillation-proof APPLIED PART (See 17h)
Figure 51 Test Voltage Applied to Single Patient Connection Bridged by Defibrillation-proof Applied Part (See 17h)
