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YY/T 1837-2022: Medical electrical equipment - General requirements for reliability
YY/T 1837-2022
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.010
CCS C 30
Medical electrical equipment - General requirements for
reliability
ISSUED ON: MAY 18, 2022
IMPLEMENTED ON: JUNE 01, 2023
Issued by: National Medical Items Administration
Table of Contents
Foreword ... 4
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 5
4 General ... 9
4.1 Goals of reliability work ... 9
4.2 Basic principles of reliability work ... 9
4.3 Coordination of reliability work and other related work ... 10
4.4 Classification of reliability work ... 10
4.5 Description of reliability work requirements ... 10
4.6 Compliance guidelines ... 12
5 Reliability requirements analysis and requirements determination ... 12
5.1 User needs analysis ... 13
5.2 Environmental profile analysis... 13
5.3 Determination of reliability indicators ... 14
6 Reliability design and analysis ... 15
6.1 Establishment of reliability models ... 15
6.2 Reliability assignment ... 15
6.3 Reliability prediction ... 16
6.4 Design failure modes and effects analysis (DFMEA) ... 16
6.5 Failure tree analysis (FTA) ... 17
6.6 Development of reliability design criteria ... 18
6.7 Identification of reliability key parts ... 19
6.8 Selection and control of materials, components and parts ... 19
6.9 Finite element analysis ... 20
6.10 Derating analysis ... 20
6.11 Circuit tolerance analysis ... 21
6.12 Durability analysis ... 21
6.13 Reliability review ... 21
7 Reliability test and evaluation ... 22
7.1 Reliability R and D test ... 22
7.2 Reliability verification and evaluation ... 23
8 Manufacturing process reliability ... 25
8.1 Process failure mode and effects analysis (PFMEA) ... 25
8.2 Verification of manufacturing process reliability ... 25
8.3 Environmental stress screening ... 26
9 Collection and evaluation of use reliability information ... 26
Annex A (informative) Description of principle ... 27
Annex B (informative) Reliability requirements analysis ... 47
Annex C (informative) Environmental profile analysis ... 48
Annex D (informative) Reliability modeling ... 49
Annex E (informative) DFMEA form template ... 55
Annex F (informative) Failure tree FTA examples ... 57
Annex G (informative) Reliability evaluation of components and parts selection ... 60
Annex H (informative) Finite element analysis ... 61
Annex I (informative) Derating analysis method ... 62
Annex J (informative) Method and program of circuit tolerance analysis ... 66
Annex K (informative) Reference template for design review form ... 72
Annex L (informative) Growth test with known growth model ... 73
Annex M (informative) Reliability index verification - Examples of conventional test
and accelerated test methods ... 80
Annex N (informative) Examples of item failures introduced by the manufacturing
process ... 84
Annex O (informative) Environmental stress screening ... 85
Bibliography ... 88
Medical electrical equipment - General requirements for
reliability
1 Scope
This document specifies the general requirements and basic methods for carrying out
reliability work during the life cycle of medical electrical equipment (hereinafter
referred to as ME equipment) and medical electrical systems (hereinafter referred to as
ME system).
This document is applicable to the reliability work of various types of ME equipment
or ME system. This document does not contain relevant requirements and methods
specific to software reliability.
NOTE: All chapters and clauses in the main text of this document have corresponding relevant
principle explanations in Annex A.
2 Normative references
The following referenced documents are indispensable for the application of this
document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
GB/T 2900.1-2008, Electrotechnical terminology - Fundamental terms
GB 9706.1-2020, Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance
YY/T 0316-2016, Medical devices - Application of risk management to medical
devices
YY/T 1813, Methods for operational reliability information collection and
evaluation of medical electrical equipment
3 Terms and definitions
For the purposes of this document, the terms and definitions defined in GB/T 2900.1-
2008, GB 9706.1-2020, YY/T 0316-2016 as well as the followings apply.
3.1 safety
An analysis technology that analyzes the potential failure modes in the process of
manufacturing, assembly and logistics and their impact on items and upper-level items
and classifies and analyzes them according to the severity of the impact of the failure
modes, so as to ensure that the produced items meet the design.
[Source: GB/T 2900.99-2016, 192-11-05, modified]
3.9 environment profile
A sequential description of the various main environmental parameters that the ME
equipment or ME system will encounter during storage, transport, use.
3.10 accelerated test
To shorten the test time or find item defects, under the condition of not changing the
failure mode and failure mechanism, the test that is carried out by means of stress
increase or time compression or event compression.
[Source: GB/T 2900.99-2016, 192-09-08, modified]
3.11 reliability
The ability of ME equipment or ME system to perform a specified function under
specified conditions and within a specified time.
NOTE: The ability to perform specified functions includes at least the ability of ME equipment or
ME system to meet safety and effectiveness requirements.
[Source: GB/T 2900.99-2016, 192-01-24, modified]
3.12 reliability key parts
Parts that will seriously affect the safety and effectiveness of ME equipment or ME
system in the event of failure, or are highly complex, or have high technological content,
or are expensive, or have a high failure rate.
3.13 reliability work
A series of technical work to determine and meet the reliability requirements of ME
equipment or ME system.
3.14 reliability diagram
A logical, graphical representation of the system, revealing how the reliability of the
system's sub-items (represented by boxes) and their combinations affect system
reliability.
[Source: GB/T 2900.99-2016, 192-11-03]
3.15 reliability model
Establish the reliability block diagram and mathematical expression of the failure logic
relationship between the system and the unit. The model that is established for the
distribution, prediction, analysis or estimation of the reliability of the item.
[Source: GB/T 2900.99-2016, 192-11-02, modified]
3.16 operational reliability
The demonstrated reliability of ME equipment or ME system under actual conditions
of use. It reflects the comprehensive influence of item design, manufacturing,
installation, use, maintenance, environment and other factors.
NOTE: It mainly refers to the reliability of ME equipment or ME system after delivery.
3.17 design failure modes and effects analysis; DFMEA
An analytical technique that, in the design phase, ANALYZES each possible failure
mode of the item and its impact on the item and the upper item, and CLASSIFIES and
ANALYZES the solution according to the severity of the impact of the failure mode, so
as to ensure that potential failure modes and their associated causes or mechanisms of
failure are considered and addressed as far as possible before the item is delivered to
production.
[Source: GB/T 2900.99-2016, 192-11-05, modified]
3.18 medical electrical equipment; ME equipment
Electrical equipment having an applied part or delivering or receiving energy to a
patient or detecting such delivered or received energy. Such electrical equipment:
a) has not more than one connection to a designated supply network; and
b) its manufacturer intends to use it for:
1) diagnosis, treatment or monitoring of patients; or
2) elimination or alleviation of disease, injury or disability.
[Source: GB 9706.1-2020, 3.63]
3.19 medical electrical system (ME system)
As specified by the manufacturer, a combination consisting of several devices that are
functionally connected or connected to each other using a multi-socket socket. At least
one of the combinations is ME equipment.
[Source: GB 9706.1-2020, 3.64]
determination
5.1 User needs analysis
User needs analysis shall be carried out as early as possible in the early phase of ME
equipment or ME system R and D project approval. Provide information for the
determination of reliability requirements to meet the actual use needs of ME equipment
or ME system.
It can be developed from the following:
a) The frequency of clinical use of ME equipment or ME system or parts within a
specified period of time can be the times of use, continuous working hours.
Ergonomics can be used to identify scene factors (such as user behavior patterns,
medical environments, places, and work patterns) and their impact on user needs
and expected uses, as well as the habits, strength, and direction of different user
groups operating and contacting the interface.
b) User needs research activities can be implemented using structured methods, such
as customer feedback, through interviews, on-site investigations and collections.
c) Refer to Annex B for the reliability requirements analysis.
5.2 Environmental profile analysis
Various environmental factors that may affect the equipment during the equipment life
cycle shall be determined according to the characteristics of the ME equipment or ME
system. Determine the main environmental parameters by analyzing the collected
information. At the same time, the comprehensive effect of various environmental
factors is considered, so as to obtain the environmental profile of the ME equipment or
ME system. Environmental profile analysis can be used as input for ME equipment or
ME system development and design. It can provide reference for reliability test.
If applicable, mainly collect and analyze information on the following environmental
factors.
a) The climate environment mainly includes the following factors:
- Temperature and humidity: investigate the temperature and humidity ranges
inside and outside each place during the storage, transportation, turnover,
installation, use, and maintenance of ME equipment or ME system.
- Atmospheric pressure: the range of atmospheric pressure in the area where the
ME equipment or ME system is intended to be used.
- Salt spray.
- Acid rain.
- Air pollution: dust/haze; dust: particle size/dispersion/property
(organic/inorganic/mixed); haze: particle size/property/occurrence frequency.
- Light radiation factors: direct or indirect solar radiation, ultraviolet lamp
exposure, incandescent lamp exposure, etc.
b) Mechanical environment:
ME equipment or ME system may encounter mechanical environmental factors
such as vibration, impact, wall collision and bumping during storage,
transportation, turnover, installation, use and maintenance. Investigate the
vibration amplitude/frequency/period, impact number/intensity/waveform that
ME equipment or ME system may experience.
c) Electromagnetic environment:
ME equipment or ME system may be subjected to levels of electromagnetic
disturbance that exceed those defined in ISO 9706.102.
d) Biochemical environment mainly includes the following factors:
- Corrosive fluids in the process of cleaning, disinfection, sterilization, such as
alcohol, ozone, sulfide, chloride and other corrosive liquids or gases.
- Body fluids, such as sweat, urine, blood.
- Microorganisms, such as mold.
- Small animals, such as mice, spiders, cockroaches.
e) High energy radiation environment: ionizing radiation.
For environmental profile analysis, refer to Annex C.
5.3 Determination of reliability indicators
Reliability quantitative indicators suitable for ME equipment or ME system
characteristics shall be determined, such as mean time between failures (MTBF), mean
time to failure (MTTF), failure rate, reliability. The work of determining the reliability
indicators of ME equipment or ME system shall pay attention to the following:
a) When determining the reliability indicator requirements, factors such as the use
requirements, cost, progress, technical level and reliability level of similar ME
equipment or ME system shall be considered comprehensively.
completed, the responsibility for the indicators shall be assigned to the relevant design
department. The general workflow and precautions for reliability assignment are as
follows:
a) First determine the level of ME equipment or ME system that requires assignment.
b) According to the reliability model established in 6.1, assign the reliability
quantitative requirements to the specified ME equipment or ME system level. Use
as a basis for reliability design and for proposing reliability quantitative
requirements for outsourced and outsourced parts.
c) The specific reliability assignment value shall be included in the corresponding
ME equipment or ME system R and D indicator requirements.
d) When assigning the reliability indicators, factors such as the complexity, technical
level, working hours and environmental conditions of the ME equipment or ME
system level to be assigned shall be fully considered to allocate the reliability
indicators quantitatively.
6.3 Reliability prediction
The reliability indicator of ME equipment or ME system shall be estimated. Whether
the proposed design scheme can meet the specified reliability quantitative requirements
shall be evaluated. The general procedures, methods and precautions for reliability
prediction work are as follows:
a) Carry out Reliability prediction for each level specified by ME equipment or ME
system.
b) Use the reliability model established in 6.1 when predicting. Relevant estimation
methods and data are given priority to the information obtained by the enterprise
itself in the ...