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Pattern Approval of Measuring Instrument

in China

Yibo Ye Grace Lin Zhenlu Li


Legal Technology Division Grace Compliance Specilist LLC Department of Metrology
National Institute of Metrology New Jersey, USA AQSIQ
Beijing, P.R. China gracelin@graspllc.com Beijing, P.R. China
yeyb@nim.ac.cn lizl@aqsiq.gov.cn

Abstract—China’s market has lured many manufacturers and • calorimeters


companies globally. This paper provides readers with a
communication channel to help people understand and follow the • flow meters (including water meters, geometers)
regulations, thus speeding up the approval process of measuring
• pressure meters (including sphygmomanometers)
instrument imported into China.
• thermometers
Keywords-AQSIQ, China, NIM, Meauring Instrument, Pattern
Approval • digital voltmeters
• field strength measuring instruments
I. INTRODUCTION
• electrocardiographs, electroencephalographs
China’s compulsory product certification system (CPCS)
[1] covers regulatory requirements for most of products. Some • monitors of harmful gas, dust, water contamination
products are covered by other compliance schemes [2] such as
the pattern approval, network access license approval, etc. This • ionizing radiation protectors
paper addresses compliance requirements for measuring • spectrophotometers (including UV, IR and visual
instruments. spectrophotometers)
China’s regulatory agency for measuring instruments is the • gas and liquid chromatographs
General Administration of Quality Supervision, Inspection and
Quarantine of the People’s Republic of China (AQSIQ). The • humid meters, moisture measuring instruments
“Metrology Law of the People’s Republic of China” took effect
July 1, 1986. “Rules for the implementation of the Metrology For a large system including regulated measurement
Law of the People’s Republic of China” gives a detail instruments, if the name/description of the system is listed
implementation of the metrology law. The “Act for the above, the system is subject to pattern approval. In addition to
Supervision and Management of Imported Measuring the pattern approval, electrocardiographs are subject to
Instruments of the People’s Republic of China” governs compulsory certification under the CPCS. Both
imported measuring instruments. The “Rules for the electrocardiographs and electroencephalographs are subject to
implementation of the Act of the Supervision and Management medical device registration under the State Food and Drug
of Imported Measuring Instruments of the People’s Republic of Administration (SFDA).
China” gives the detail requirements, clarification, and
interpretation of the Act. II. APPROVAL PROCESS
China’s compliance approval process for measuring The Pattern Approval process includes the following steps.
instruments is the pattern approval. The imported measuring A flow chart is shown in Fig. 1.
instruments subject to pattern approval are: • Submitting an Application
• weighing instruments (including balances) • Initial Review
• transducers (sensors, load cells) • Type Testing.
• sound level meters • Final Review
• three-coordinate measuring machines • Issuance of Certificate
• roughness measuring instruments An application for pattern approval is submitted to:
• geodetic instruments AQSIQ - Department of Metrology

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No. 9, Madian East Road, Haidian District receiving an application. The initial review observes the
Beijing 100088, P. R. China product in order to:
• Make sure it follows the international system of unit
AQSIQ performs initial review within two weeks after (SI), which is used in China
• See if the product is restricted by the State Council
An applicant or its agent
• Confirm the product meets other metrological
requirements required by law/regulations
Submitting an application to the
Dept. of Metrology, AQSIQ Type test includes examining the exterior look of the
product and testing metrological functions, safety, environment
Initial Review
immunity, reliability or life cycle, etc. Typically, the quantity
of test samples required is three (3). For large and/or expensive
products, the quantity of test samples can be reduced to two or
No
one. For extra large products, witness testing is an option. If
Pass
submitted test samples fail the type test, an applicant can re-
submit test samples within three months. If test samples pass
Yes the tests, three types of reports are issued by the laboratory
engineer: test registration form (stating basic product
AQSIQ authorizes a test lab information, including product exterior photos), test plan, and
(NIM) to conduct test. The
test report. If re-submitted test samples fail tests, test
application is forwarded to
the lab. registration form is not issued.
To avoid the responsibility for mishandling of certificates
Lab notifies applicant for during delivery, AQSIQ does not mail certificates out to an
test samples

Applicant submits test


samples to the lab

Lab conducts test(s)

No Applicant modifies
Pass tests? test samples

Lab conducts test(s)


Yes

Lab engineer prepares test/


evaluation reports to AQSIQ

Final review by AQSIQ

AQSIQ issues a certificate

Applicant picks up a certificate

End

Figure 1. Pattern Approval Process Figure 2 Pattern Approval Certificate

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applicant or its agent. Certificates must be picked up from the
AQSIQ office. An example of a certificate is shown in Fig. 2. TABLE I. TYPE DESIGNATOR OF CPA MARK

Type of Measuring Instrument Type Designator


III. APPLICATION PACKAGE FOR PATTERN APPROVAL
Length L
A. Application Form Thermodynamics, Temperature T
Dynamics F
An application form, in both Chinese and English, can be
downloaded from the NIM (National Institute of Metrology) Electromagnetic E
web site at www.nim.ac.cn; it includes five pages. The Radio, Microwave R
required information in the application form includes, but is not
limited to: name of applicant, contact name, manufacturer, date Time, Frequency K
of application, and product information. Acoustics S

B. Application Fees Optics O


The application fee must be paid before a certificate is Ionization A
issued. Chinese currency is Reminbi Yuan (RMB¥, US$1.00 ≅ Chemistry C
RMB¥8.30).
In addition to the application fee, the applicant is measuring instrument, is in the format of YYYY-ZNNN.
responsible for the cost of testing. YYYY standards for the year a certificate is issued. Z is a
character designating the type of product. TABLE I lists type
C. Application Documents designators. NNN stands for serial number. CPA mark can be
Three copies of the following documents must accompany affixed to product and its package.
an application:
VI. VALIDITY OF A CERTIFICATE
1) Product Photographs: A complete set of product
photographs, including extenal and internal views, is required. The validity of a certificate, under pattern approval, is not
2) Assembly Drawings, Schematics, Block Diagrams: specified. As long as the Metrology Law and its related rules
provide when applicable are followed, a certificate is valid.
3) Technical Standard(s) and Examination Method(s): AQSIQ reserves the right to withdraw the certificate(s) for
describe or provide a list of product standard(s) for which the outdated (from technical point of view) products.
product is designed
4) Test report(s) issued by the manufacturer: provide test VII. TEMPORARY PATTERN APPROVAL
report(s) obtained during product development Under the following circumstances, a temporary certificate
5) Operation Manual: The operation manual must be in can be issued:
Chinese
• Urgent Need
IV. PATTERN APPROVAL TIME FRAME
• Small Quantity
The average approval time for an application is about four
months (sixteen weeks). This time frame includes two weeks • For those products that China’s test lab(s) temporarily
of initial review, twelve weeks of testing, and two weeks of have no capability to perform tests on
final review. Lag time caused by the applicant is not included. • For display and sale during business show

V. PATTERN APPROVAL CERTIFICATION MARK • Other special need


Pattern approval certification mark is the CPA An application for display products needs to be submitted
(Certification of Pattern Approval) mark. This mark includes a to a metrological office of provincial government where the
CPA logo and an identification number. The logo of the mark exhibition is located. An application for all other purposes
is shown in Fig. 3. The identification number, for imported needs to be submitted to the AQSIQ.
The validity of a temporary certificate is up to one year, and
is only valid for the quantity applied.

VIII. SERIES PRODUCT FILING


“Series” product filing is the method used when seeking
approval for a product family. It must be included in the
Figure 3. CPA Logo primary filing.

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TABLE II. COMMONLY USED EMC, SAFETY, AND ENVIRONMENTAL TEST STANDARDS

Chinese Standards Reference Standards Title


Safety requirements for electrical equipment for measurement, control, and laboratory
GB 4793.1 – 1995 IEC 1010-1: 1990
use Part 1: General requirements
GB 4793.x – 2001 IEC 61010-2-0xx: 1994 Safety requirements for electrical equipment for measurement, control and laboratory
(x = 2, 3, 4, 5, 6, 7) (xx = 32, 51, 41, 31, 10, 20) use
GB 11500 - 1989 ISO 5-2: 1985 Geometric conditions for measuring transmission density
GB 11501 - 1989 ISO 5-3: 1984 Spectral conditions for measuring photography density
GB/T 3978 - 1994 CIE S001: 1986 Standard illuminants and illuminating-viewing conditions
GB/T 6585 - 1996 IEC 351-1: 1976 General specification for cathode-ray oscilloscopes
GB/T 9317 - 1988 IEC 469: 1974 The specifications of pulse signal generators
GB/T 9318 - 1988 IEC 469-2: 1974 Test method of pulse signal generators
GB/T 6587.2 - 1986 --- Temperature tests for electronic measuring instruments
GB/T 6587.3 - 1986 --- Humility tests for electronic measuring instruments
GB/T 6587.4 - 1986 --- Vibration tests for electronic measuring instruments
GB/T 6587.5 - 1986 --- Shock tests for electronic measuring instruments
GB/T 6593 - 1996 --- Quality inspection provisions for electronic measuring instruments
GB/T 11461 - 1989 IEC 714: 1981 Generic specification of spectrum analyzers
GB/T 11462 - 1989 IEC 714: 1981 Test methods of spectrum analyzers
GB/T 11463 - 1989 --- Reliability test for electronic measuring instruments
GB/T 12114 - 1989 IEC 716: 1981 Generic specification of high frequency signal generators
GB/T 12115 - 1989 --- Measuring methods for high frequency signal generators
GB/T 12116 - 1989 --- Generic specification for electronic analog voltmeters
GB/T 12117 - 1989 --- Measuring methods for electronic analog voltmeters
GB/T 12179 - 1990 --- General specifications of noise generators
GB/T 12180 - 1990 --- Test methods for general purpose low frequency signal generators
GB/T 12181 - 1990 IEC 716: 1981 General purpose specification of low frequency signal generators
GB/T 12280 - 1990 --- Test methods for noise generator
GB/T 12822 - 1991 ISO 5-4: 1983 Geometric conditions for photographic reflection density measurement
GB/T 15151.1 - 1994 --- Generic specification for frequency counters
GB/T 15151.2 - 1994 --- Measuring methods for frequency counters
Electromagnetic compatibility – Testing and measurement techniques –Electrostatic
GB/T 17626.2 - 1998 IEC 61000-4-2: 1995
discharge immunity test
Electromagnetic compatibility(EMC) Testing and measurement techniques Radiated,
GB/T 17626.3 - 1998 IEC 61000-4-3: 1995
radio-frequency, electromagnetic field immunity test
Electromagnetic compatibility(EMC) Testing and measurement techniques Electrical
GB/T 17626.4 - 1998 IEC 61000-4-4: 1995
fast transient/burst immunity test
Electromagnetic compatibility – Testing and measurement techniques – Surge
GB/T 17626.5 - 1999 IEC 61000-4-5: 1995
immunity test
Electromagnetic compatibility – Testing and measurement techniques – Immunity to
GB/T 17626.6 - 1998 IEC 61000-4-6: 1996
conducted disturbances, induced by radio-frequency fields
Electromagnetic compatibility – Testing and measurement techniques – Power
GB/T 17626.8 - 1998 IEC 61000-4-8: 1993
frequency magnetic field immunity test
Electromagnetic compatibility – Testing and measurement techniques – Voltage dips,
GB/T 17626.11 - 1999 IEC 61000-4-11: 1994
short interruptions and voltage variations immunity test

If none of China’s standards apply to the product for testing,


IX. COMPLIANCE REQUIREMENTS FOR SPARE/REPAIR PARTS international standard(s) or specifications in the contract can be
There is no special compliance requirement under pattern used.
approval for spare parts. TABLE II lists commonly used electromagnetic
compatibility (EMC), safety, and environmental test standards.
X. TEST STANDARDS Please note this table does not include product standards for
China’s national standards are GB (Guo Biao) or GB/T each product type. Not all the products need to meet all the test
standards. If there is no GB or GB/T standard available, standards listed in the table. Test standards are determined by
professional standard(s) or enterprise standard(s) may be used. the laboratory engineer during product evaluation.

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XI. LABORATORY ACCREDIATION • Order to compensate for losses
Currently, the National Institute of Metrology (NIM) is • Withdrawal of certificate(s)
accredited for the testing of measuring instruments. NIM is a
state level of research, development, calibration and test center • Confiscation of illegal gains, measuring instruments,
of metrology in China. defective spare parts of measuring instruments, and an
illegal verification stamp(s) and a certificate(s)
XII. MUTUAL RECOGNITION • Imposition of fines
Mutual recognition is a way to avoid the same or similar In addition to administrative sanctions, if the circumstances
tests to satisfy all of the various requirements worldwide. At are serious, the individual or the person in charge shall be
the time of this writing, China has signed mutual recognition investigated for criminal responsibility according to the crimes
agreement/arrangement with Germany and Holland in regards of swindling or speculation.
to the mutual acceptance of a test report for pattern approval.
REFERENCES
XIII. LEGAL OBLIGATIONS
Manufacturing, selling, and importing unapproved [1] G. Lin, “EMC in China,” Symposium Record, 2002 IEEE International
regulated measurement instruments violate Chinese law. Symposium on EMC, pp. 782-787
Punishment of violations are based on the “Rules for the [2] G. Lin, “China’s Compliance Management System,” Symposium
Punishment of Violations against Metrological Law and Acts” Record, 2003 IEEE International Symposium on EMC, pp. 102-107
promulgated August 25, 1990. Administrative sanctions for [3] JJF 1015-2002, “General Norm for Pattern Evaluation and Pattern
the violations against metrological law include: Approval of Measuring Instruments”
[4] www.aqsiq.gov.cn
• Order to make a correction(s) [5] www.nim.ac.cn
• Order to stop manufacture, business, delivery, repair,
marketing , use, verification, testing, inspection, and
import

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