Medical electrical equipment -
Recurrent test and test after repair of medical electrical equipment
1 Scope
This document specifies the requirements for testing of medical electrical equipment and medical electrical systems, hereafter referred to as ME equipment and ME systems, or parts of such equipment or systems, which comply with GB 9706.1, before putting into service, during maintenance, inspection, after repair and in other service or recurrent tests.
This document does not define requirements for repair, exchange of components and modification of ME equipment or ME systems.
This document is applicable to GB 9706.1 compliant ME devices and ME systems and their components.
This document is not suitable to assess whether ME equipment or ME systems or any other equipment comply with the relevant standards for their design.
This document is not applicable to the assembly of ME systems. For assembling ME systems see Clause 1 6 of GB 9706.1-2020.
Note: In this document, GB 9706.1 without the version specified refers to GB 9706.1-1995, GB 9706.1-2007 or GB 9706.1-2020.
2 Normative references
The following documents contain requirements which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB 4793.1 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements (GB 4793.1-2007; IEC 61010-1: 2001, IDT)
GB 4793.5 Safety requirements for electrical equipment for measurement control and laboratory use - Part 5: Safety requirements for hand-held probe assemblies for electrical measurement and test (GB 4793.5-2008; IEC 61010-031: 2002, IDT)
GB 9706.1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (GB 9706.1-2020; IEC 60601-1: 2012, MOD)
GB/T 17045 Protection against electric shock - Common aspects for installation and equipment (GB/T 17045-2020; IEC 61140: 2016, IDT)
GB/T 18216.1 Electrical safety in low voltage distribution systems up to 1000 V a.c. and 1500 V d.c. - Equipment for testing,measuring or monitoring of protective measures - Part 1: General requirements (GB/T 18216.1-2021; IEC 61557-1: 2019, IDT)
GB/T 18216.2 Electrical safety in low voltage distribution systems up to 1000 V a.c.and 1500 V d.c. - Equipment for testing,measuring or monitoring of protective measures - Part 2:Insulation resistance (GB/T 18216.2-2021; IEC 61557-2: 2019, IDT)
GB/T 18216.4 Electrical safety in low voltage distribution systems up to 1000 V a.c and 1500 V d.c - Equipment for testing,measuring or monitoring of protective measures - Part 4:Resistance of earth connection and equipotential bonding (GB/T 18216.4-2021; IEC 61557-4: 2019, IDT)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
Note: Some of the definitions are necessarily different from those in GB 9706.1, as different measuring methods are used.
3.1
accessible conductive part
an electrically conductive part of the ME equipment other than an applied part, which is accessible to the patient or to the operator in contact with the patient or can come in contact with the patient
3.2
accessory
additional part for use with equipment in order to:
——–achieve the intended use,
——–adapt it to some special use,
——–facilitate its use,
——–enhance its performance, or
——–enable its functions to be integrated with those of other equipment
[Source: GB 9706.1-2020, 3.3]
3.3
accompanying document
document accompanying ME equipment, an ME system, equipment or an accessory and containing information for the responsible organization or operator, particularly regarding basic safety and essential performance
[Source: GB 9706.1-2020, 3.4]
3.4
applied part
part of ME equipment that in normal use necessarily comes into physical contact with the patient for ME equipment or an ME system to perform its function
[Source: GB 9706.1-2020, 3.8, modified]
3.5
applied part leakage current
current flowing between an F-type applied part and all of the following as applicable:
——mains part and
——accessible conductive parts of the enclosure;
caused by an external voltage on the F-type applied part.
3.6
class I
term referring to electrical equipment in which protection against electric shock does not rely on basic insulation only, but which includes an additional safety precaution in that means are provided for accessible parts of metal or internal parts of metal to be protectively earthed
[Source: GB 9706.1-2020, 3.13]
3.7
class II
term referring to electrical equipment in which protection against electric shock does not rely on basic insulation only, but in which additional safety precautions such as double insulation or reinforced insulation are provided, there being no provision for protective earthing or reliance upon installation conditions
Note: Class II ME equipment can be provided with a functional earth terminal or a functional earth conductor.
[Source: GB 9706.1-2020, 3.14]
3.8
configuration
term that refers to software settings or hardware settings of ME equipment , or the arrangement and interconnection of ME equipment and any other equipment that form an ME system, that are appropriate for an intended clinical application
3.9
detachable power supply cord
flexible cord intended to be connected to electrical equipment by means of a suitable appliance coupler for mains supply purposes
[Source: GB 9706.1-2020, 3.21]
3.10
earth leakage current
current flowing from the mains part through or across the insulation into the protective earth conductor
[Source: GB 9706.1-2020, 3.25, modified]
3.11
electrical safety
status of protective measures within an equipment/system designed and produced in accordance with GB 9706.1 which limit the effects of electrical current on a patient, user or other individuals in accordance with this standard
Note: Safety is defined as freedom from unacceptable risk (refer to YY/T 0316-2016, definition 2.24).
3.12
equipment leakage current
total current flowing from mains parts to earth via
a) the protective earth conductor and accessible conductive parts of the enclosure and applied parts (differential and alternative method), or
b) the accessible conductive parts of the enclosure and applied parts (direct method).
3.13
F-type isolated (floating) applied part (F-type applied part)
applied part in which the patient connections are isolated from other parts of the ME equipment to such a degree that no current higher than the allowable patient leakage current flows if an unintended voltage originating from an external source is connected to the patient, and thereby applied between the patient connection and earth
Note: F-type applied parts are either type BF applied parts or type CF applied parts.
[Source: GB 9706.1-2020, 3.29]
3.14
functional connection
connection, electrical or otherwise, including those intended to transfer signals, data, power or substances
Note: Connection to a fixed supply mains socket-outlet, whether single or multiple, is not considered to result in a functional connection.
[Source: GB 9706.1-2020, 3.33]
3.15
inspection
combination of all means for verification and assessment of a status quo
3.16
internal electrical power source
electrical power source for operating equipment that is a part of the equipment and which produces electrical current from some other form of energy
Example: Chemical, mechanical, solar, or nuclear
Note: An internal electrical power source can be inside the principal part of equipment, attached to the outside, or contained in a separate enclosure.
[Source: GB 9706.1-2020, 3.45]
3.17
line-to-earth voltage
voltage between a line conductor and earth/ground
[Source: IEC 60050-195: 1998, 195-05-03, modified]
3.18
mains part
part of electrical equipment forming a circuit that is intended to be connected to the supply mains
Notes:
1 The mains part includes all conductive parts that are not separated from the supply mains by at least one means of protection.
2 For the purpose of this definition, the protective earth conductor is not regarded as a part of the mains part.
[Source: GB 9706.1-2020, 3.49]
3.19
mains plug
part, integral with or intended to be attached to a power supply cord of electrical equipment, to be inserted into a mains socket-outlet
[Source: GB 9706.1-2020, 3.50, modified]
3.20
mains voltage
voltage of a supply mains between two line conductors of a polyphase system or voltage between the line conductor and the neutral conductor of a single-phase system
[Source: GB 9706.1-2020, 3.54]
3.21
maintenance
combination of all technical and administrative means, including supervisory ones, to keep ME equipment or an ME system in a normal working condition or restored to normal working condition
3.22
manufacturer
natural or legal person with responsibility for the design, manufacture, packaging, or labelling of ME equipment, assembling an ME system, or adapting ME equipment or an ME system, regardless of whether these operations are performed by that person or on that person's behalf by a third party
Notes:
1 ISO 13485 defines “labelling” as written, printed or graphic matter
——affixed to a medical device or any of its containers or wrappers, or
——accompanying a medical device,
related to identification, technical description, and use of the medical device, but excluding shipping documents. In this standard, that material is described as markings and accompanying documents.
2 “Adapting” includes making substantial modifications to ME equipment or an ME system already in use.
3 In some jurisdictions, the responsible organization can be considered a manufacturer when involved in the activities described.
4 Adapted from YY/T 0316-2016, definition 2.8.
[Source: GB 9706.1-2020, 3.55]
3.23
medical electrical equipment (ME equipment)
electrical equipment having an applied part or transferring energy to or from the patient or detecting such energy transfer to or from the patient and which is:
a) provided with not more than one connection to a particular supply mains; and
b) intended by its manufacturer to be used:
1) in the diagnosis, treatment, or monitoring of a patient, or
2) for compensation or alleviation of disease, injury or disability
Notes:
Foreword i
Introduction iii
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
4.1 *General requirements
4.2 Testing before putting into service , after modifications , and after repair
4.3 *Recurrent test
5 *Tests
5.1 General
5.2 Visual inspection
5.3 Measurements
5.4 Functional test
6 Results of test and evaluation
6.1 Reporting of results
6.2 Evaluation
Annex A (Informative) General guidance and rationale
Annex B (Informative) Sequence of testing
Annex C (Informative) Requirements for the measurement equipment and for measurement circuits for protective earth resistance and leakage currents
Annex D (Informative) Patient environment
Annex E (Informative) Allowable values for leakage currents from GB 9706.1
Annex F (Informative) Testing intervals
Annex G (Informative) Example of test documentation
Annex H (Informative) Notes on testing ME systems
Bibliography
