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YY/T 1813-2022: Methods for operational reliability information collection and evaluation of medical electrical equipment
YY/T 1813-2022
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040
CCS C 30
Method for Operational Reliability Information Collection
and Evaluation of Medical Electrical Equipment
ISSUED ON: MAY 18, 2022
IMPLEMENTED ON: JUNE 01, 2023
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Terms and Definitions ... 4
4 Collection of Operational Reliability Information of ME Equipment and ME Systems
... 8
4.1 Sources of operational reliability information ... 8
4.2 Contents of operational reliability information ... 9
4.3 Fault judgment and record ... 12
5 Assessment of Operational Reliability of ME Equipment and ME Systems ... 14
5.1 Overview ... 14
5.2 Determining the assessment indicators of operational reliability ... 14
5.3 Determination of samples ... 14
5.4 Preliminary collation of operational reliability information ... 15
5.5 Inspection method of distribution type ... 16
5.6 Parameter estimation for continuous distributions ... 16
5.7 Preparation of assessment report of operational reliability ... 16
Appendix A (Informative) Collection Form of Operational Reliability Information of
ME Equipment and ME Systems ... 17
Appendix B (Informative) Description of Other Relevant Operational Reliability
Parameters for ME Equipment and ME Systems ... 19
Appendix C (Informative) Introduction to Relevant Distribution Models ... 24
Appendix D (informative) Inspection of Relevant Distribution Type ... 27
Bibliography ... 29
Method for Operational Reliability Information Collection
and Evaluation of Medical Electrical Equipment
1 Scope
This Document specifies the methods for collecting operational reliability information and
assessing the operational reliability of medical electrical equipment and medical electrical
systems (hereinafter referred to as ME equipment and ME systems) within the period of use
specified by the manufacturer.
This Document is applicable to the collection of operational reliability information and
assessment of operational reliability assessment of ME equipment and ME systems.
2 Normative References
The provisions in following documents become the essential provisions of this Document
through reference in this Document. For the dated documents, only the versions with the dates
indicated are applicable to this Document; for the undated documents, only the latest version
(including all the amendments) is applicable to this Document.
GB 9706.1-2020 Medical Electrical Equipment - Part 1: General Requirements for Basic
Safety and Essential Performance
YY/T 1837-2022 Medical Electrical Equipment - General Requirements for Reliability
3 Terms and Definitions
For the purposes of this Document, the terms and definitions given in GB 9706.1-2020 and
YY/T 1837-2022 and the following apply.
3.1 Parameter estimation
Infer unknown total distribution parameters from a sample.
The process of estimating parameters or parameter functions used to characterize reliability
indicators in the analysis of operational reliability data of ME equipment and ME systems.
[SOURCE: GB/T 17560-1998, 3.1.1, modified]
At different times, the reliability shall have different reliability levels r. When the reliability of
the ME equipment and the ME systems drop to a given reliability level r, this time is called the
reliable life of the ME equipment and the ME systems, denoted as tr.
For example, the median life refers to the time corresponding to the reliability level r=0.5, that
is, R (t0.5) = 0.5.
3.12 Useful life
The period of time between ME equipment and ME systems from their first use until they no
longer meet the user's requirements due to economics of operation and maintenance or
obsolescence.
[SOURCE: GB/T 2900.99-2016, 192-02-27, modified]
3.13 Life unit
Use duration units of measure for ME equipment and ME systems. Such as hours, kilometers,
times, etc.
3.14 Mean time between failures; MTBF; TBF
A basic reliability parameter for repairable ME equipment and ME systems. Its measurement
method is: the ratio of the total number life units to the total number of failures of ME
equipment and ME systems under specified conditions and within a specified period.
3.15 Mean time between critical failures; MTBCF; TBCF
A reliability parameter that is related to a task. Its measurement method is: in a series of
specified task profiles, the ratio of the total task time to the total number of critical faults of ME
equipment and ME systems. Formerly known as task time between fatal faults.
3.16 Mean time between maintenances; MITBM; TBM
A reliability parameter that is related to maintenance policy. Its measurement method is: under
specified conditions and within a specified time, the ratio of the total number of life units to the
total number of planned/unplanned maintenance events of the ME equipment and ME systems.
3.17 Failure distribution density function
It is used to characterize the change of failure distribution with time interval. When the ME
equipment and the ME systems work until the time t, the ratio between the number of failures
per unit time and the total number is recorded as f(t).
4.2 Contents of operational reliability information
4.2.1 ME equipment and ME systems information
Names, model specifications, serial numbers, production batch numbers, and other information
of equipment, systems, components, and accessories.
4.2.2 User information
After obtaining the relevant authorization, the relevant information of the user can be collected:
a) address of use;
b) User organization information;
c) The frequency of movement within the place where the equipment and system are used,
such as the location is fixed and basically does not move, and it moves every time it is
used, etc.;
d) Information such as operators and operating habits.
4.2.3 Environmental condition information
Environmental conditions for ME equipment and ME systems include temperature, humidity,
atmospheric pressure, etc. The following factors also need to be recorded if they affect the
reliability of ME equipment and ME system.
a) Climate environment:
1) For ME equipment and ME systems working in a controlled environment, the climate
environment factors mainly refer to the following information:
● Salt spray factor;
● Illumination and radiation factors: indirect solar radiation, ultraviolet lamp
irradiation, incandescent lamp irradiation, etc.
2) For ME equipment and ME systems working in an uncontrolled environment, the
climate environment factors may include the following aspects in addition to the
above points:
● Acid rain factors: pH value, type, etc.;
● water factor;
● direct solar radiation;
● Air pollution factors: particle size and nature of dust and smog.
b) biochemical environment:
1) Insects, microorganisms, rodents, etc.;
2) Chemical atmosphere: cleaning agents, disinfectants, body fluids, excrement,
chemical reagents, etc.
c) Mechanical environment:
1) Vibration factor: whether it is at or close to the vibration source;
2) Mechanical shock factor;
3) Noise factor.
d) Power supply and electromagnetic field:
1) Information such as power supply quality, power load capacity, and power outages,
etc.;
2) Non-ionizing electromagnetic radiation disturbance.
e) High-energy radiation environment: ionizing radiation.
Refer to Appendix A for the ...