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
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
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.
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.
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