GB/T 12519-2021 PDF English
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General specification of analytical instruments
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GB/T 12519-2021: PDF in English (GBT 12519-2021) GB/T 12519-2021
GB
NATIONAL STANDARD OF THE
PEOPLE’S REPUBLIC OF CHINA
ICS 71.040.10
CCS N 53
GB/T 12519-2021
Replacing GB/T 12519-2010
General specification of analytical instruments
ISSUED ON. OCTOBER 11, 2021
IMPLEMENTED ON. MAY 01, 2022
Issued by. State Administration for Market Regulation;
Standardization Administration of the People’s Republic of China.
Table of Contents
Foreword... 3
1 Scope... 5
2 Normative references... 5
3 Terms and definitions... 6
4 Instrument classification and naming... 7
5 Requirements... 8
6 Test method... 10
7 Inspection rules... 12
8 Marking, packaging, transportation, storage... 12
Bibliography... 14
General specification of analytical instruments
1 Scope
This document specifies the terms and definitions, instrument classification and naming,
requirements, test methods, inspection rules and marking, packaging, transportation and
storage of analytical instruments.
This document applies to various types of analytical instruments.
This document also applies to sample processing, preparation, signal processing and
transmission, and auxiliary analysis devices that are used with instruments or form
independent products.
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 191-2008 Packaging - Pictorial marking for handling of goods
GB/T 6592 Electrical and electronic measurement equipment - Expression of
performance
GB/T 9969 General principles for preparation of instructions for use of industrial
products
GB/T 11606-2007 Methods of environmental test for analytical instruments
GB/T 13384 General specifications for packing of mechanical and electrical product
GB/T 13966 Terminology for analytical instruments
GB/T 18268.1-2010 Electrical equipment for measurement, control and laboratory
use - EMC requirements - Part 1.General requirements
GB/T 18403.1 Expression of performance of gas analyzers - Part 1.General
GB/T 20245.1 Expression of performance of electrochemical analyzers - Part 1.
General
GB/T 25472 Quality inspection provisions for analyzers
GB/T 34042 General specification for on-line analyzer systems
mean time between failure; MTBF
The average time between two adjacent failures.
NOTE. It reflects the time quality of the instrument, is an indicator for measuring the reliability of
the instrument, and reflects the ability of the instrument to maintain the required performance and
function within the specified time, and the unit is “h”.
4 Instrument classification and naming
4.1 Classification
4.1.1 Classification by test principle
According to the test principle, it is divided into electrochemical instruments, optical
instruments, chromatographic instruments, mass spectrometers, spectral instruments,
energy spectrum and radiation instruments, thermal instruments, etc.
4.1.2 Classification by application occasions
According to the application occasions, it is divided into laboratory instruments,
portable or mobile instruments, online or process instruments, etc.
4.2 Naming
4.2.1 Naming principles
The naming of analytical instrument products mainly considers the test principle and
the measuring object, and appropriately takes into account the habits.
4.2.2 Naming of instruments
The meaning and naming method of “meter”, “analyzer”, “microscope”, “system” and
“instrument” are as follows.
a) Special analytical instruments that measure the mass of a single substance
(excluding gas) and assign values should be called “meter”, such as pH meter,
salt meter, viscometer, etc.;
b) Instruments that measure gas can be called “analyzer”, such as carbon monoxide
analyzer, carbon dioxide analyzer, etc.;
c) Analytical instruments that study the morphology of the surface of substances by
analyzing images can be called “microscopes”, such as transmission electron
microscopes, scanning electron microscopes, etc.;
d) Analytical instruments that are composed of sample processing, analytical
instruments, data management and auxiliary facilities, etc. (or parts) to achieve
the whole process from sample extraction to output of analytical results are
generally called “systems”, such as air quality monitoring systems, water quality
monitoring systems, etc.;
e) Analytical instruments other than a), b), c) and d) are usually (or generally) called
“instruments”;
f) Safety alarm instruments that only have sound and light warnings are generally
called “alarms”; those with other display methods are generally called “explosion
detectors, testers, and detectors.”
5 Requirements
5.1 Working conditions of instruments
The working conditions of instruments include. normal working conditions, reference
working conditions, and extreme working conditions.
The conditions of use are as follows.
a) According to the design and use conditions of the instrument, refer to the
environmental conditions given in Table 1 of GB/T 11606-2007, and select all
quantities that will have a non-negligible impact on the quality characteristics of
the instrument and their reference values or reference value ranges as normal
working conditions. When it is not possible to fully comply with the provisions
of GB/T 11606-2007, the differences shall be indicated in the document.
b) When the evaluation of certain quality characteristics of the instrument needs to
exclude the influence of environmental factors, reference working conditions
shall be given (see Table 2 in GB/T 11606-2007).
c) If necessary, extreme working conditions shall be given.
5.2 Appearance and structure
The appearance and structure of the instrument shall meet the following requirements.
a) The appearance shall be neat, the color shall be uniform, and there shall be no
burrs;
b) The nameplate and logo shall be durable and clear, and the content shall comply
with the requirements of relevant laws and standards;
c) The fasteners shall not be loose, the various adjustment parts shall be flexible, and
the functions shall be normal;
d) The detachable parts of the instrument shall be easy to disassemble and assemble.
5.7.2 Special requirements
If necessary, special environmental requirements such as low pressure, mold, salt spray,
explosion-proof, etc. shall be specified by the product standard.
5.7.3 Transportation, transportation and storage
The circulation conditions shall be specified in the product standard. After testing in
accordance with the requirements of Clause 8, Clause 15, Clause 16, Clause 17 and
Clause 18 of GB/T 11606-2007, the packaging box shall not have large deformation
and damage, and the tested instrument shall not have mechanical damage such as
deformation, loosening, and peeling of the coating layer, and its performance
characteristics shall comply with the provisions of the product standard.
5.8 Reliability
If necessary, reliability indicators such as the mean time between failures shall be
specified.
5.9 Electromagnetic compatibility
If necessary, electromagnetic compatibility requirements shall be specified.
The instrument immunity and emission requirements shall be in accordance with GB/T
18268.1-2010.
5.10 Completeness
The completeness of the instrument and its accessories shall be specified in the product
standard.
6 Test method
6.1 Test conditions
6.1.1 Test working conditions
The instrument shall be tested under the following test conditions.
a) It shall clearly specify the various environmental conditions during the test;
b) When there are special requirements, it shall specify reference conditions.
6.1.2 Test equipment
6.1.2.1 The uncertainty (or maximum allowable error) of the measuring equipment,
standard substances (or physical standard samples, working standard samples), etc.
used in the test shall be better than the uncertainty (or maximum allowable error) of the
tested instrument and shall be within the validity period of verification or calibration.
6.1.2.2 The uncertainty of the measuring equipment, standard substances (or physical
standard samples, working standard samples), etc. used in the test shall not exceed one-
third of the indication error specified by the instrument. At this time, the error generated
by the measurement test can be ignored.
6.1.2.3 When the uncertainty of the measuring equipment, standard substances (or
physical standard samples, working standard samples), etc. used in the test is greater
than one-third of the absolute value of the maximum allowable error of the instrument,
the error generated by the measurement test cannot be ignored and shall be handled
according to the following principles.
a) If an instrument is rated with a limit uncertainty of ±e % for a given performance
characteristic, and the uncertainty of the instrument used by the manufacturer for
test is ±n %, the tested uncertainty shall be kept within the limit of ±(e + n) %;
b) Similarly, if the uncertainty of the customer using another test instrument to
measure the same instrument is ±m %, and the uncertainty obtained by the
instrument exceeds the limit of ±e %, it shall still be kept within the limit of ±(e
+ m) %;
c) If a standard substance (or physical standard sample, working standard sample)
with a confidence level of 95 % and an uncertainty of ±m % is used to test the
instrument, its uncertainty shall be within ±(e + m) %.
6.1.3 Tested instrument status
For instruments that have preheating requirements or stabilization time requirements
after power is turned on, formal measurements and observations shall be carried out
after the specified preheating requirements or stabilization time.
6.1.4 Test sequence
If the test sequence has a non-negligible impact on the test results, it shall be specified.
6.2 Appearance and structure
Visual and manual inspection.
6.3 Functional inspection
According to the product standards, the implementation of each function can be
checked during the performance characteristics test.
6.4 Performance characteristics test
d) manufacturing date;
e) technical parameters that must be marked;
f) other information specified in relevant laws and regulations.
8.2 Packaging
8.2.1 The instrument packaging shall comply with the provisions of GB/T 13384.
8.2.2 The markings on the packaging box shall be clear and firm, and the contents are
as follows.
a) manufacturer name, address, and contact information;
b) instrument name, model, and specifications;
c) overall dimensions. length × width × height, in millimeters (mm); gross weight
and net weight, in kilograms (kg);
d) factory-exit number, packaging box serial number, quantity, and factory-exit date;
e) pictorial marking for handling of goods on packaging. “FRAGILE”, “THIS WAY
UP”, “KEEP AWAY FROM RAIN”, etc. shall comply with the provisions of
GB/T 191-2008.
8.2.3 Accompanying documents, including.
a) packing list;
b) product certificate;
c) instructions for use, in accordance with GB/T 9969, for safety warnings, see
Clause 5 of GB 4793.1-2007;
d) spare parts list, etc.
8.3 Transportation
For instruments with special requirements for transportation, their transportation
requirements shall be specified, and they shall generally be protected from strong
impact, rain, and exposure.
8.4 Storage
The instrument shall be stored at a temperature of 0 °C to 40 °C, with a relative humidity
of no more than 85%, and no acid, alkali or corrosive gases in the room. If necessary,
special provisions may be made in the product standard.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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