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.
