SUMMARY
Of the
SINO-US Workshop on Standards and Conformity Assessment
Held in Beijing
March 10-12, 1999

The second workshop under the auspices of the U.S. - China Joint Commission on Commerce and Trade, co-chaired by Secretary Daley of the U.S. Department of Commerce (USDOC) and Minister Shi of China’s Ministry of Foreign Trade and Economic Cooperation (MOFTEC) took place in Beijing, China March 10-12, 1999. Over three hundred and fifty, including forty-four US industry and government representatives from the United States were in attendance during these three days. The workshop continued the important dialogue initiated at the earlier successful workshop held in Washington DC in February 1998. In addition to continuing the dialogue in the areas of electrical safety and boilers and pressure vessels, standards and conformity assessment matters were addressed relative to the areas of medical devices, telecommunications, information technology, automotive and off-road vehicular equipment, and building construction codes and standards.

The Workshop consisted of an opening and closing plenary session; the remaining two days were comprised of concurrent sessions covering the seven market sectors of interest. It was especially noteworthy during the opening plenary that the requirements for foreign interests (those exporting to China) relative to standards, testing and certification reside with the State Administration for Entry-Exit Inspection and Quarantine (SAIQ) of the PRC, including those technical regulations developed by various Ministries. The China State Bureau of Quality and Technical Supervision (CSBTS) of the PRC is the national standards body, responsible for documentary standards and their development, metrology, quality management systems, and the administration of the required WTO "Inquiry Point" as well as technical requirements relative to boilers and pressure vessels and electro-magnetic compatibility and interference. It was apparent that the responsibilities between these two entities reporting to the State Council have not been completely defined as a result of China’s restructuring of its Government agencies last year. Both claimed similar responsibilities.

The Workshop has already resulted in several additional follow up activities under development, including:

• a workshop to take place at NIST with other Government agencies and US industry this Fall on Construction Codes and Conformity Assessment with near twenty key China agency representatives participating,
• a bilateral meeting with ASME International and CSBTS representatives in New York City this summer to work on the procedures for defining joint audits
• a visit to NIST by CSBTS staff this spring to learn how to develop the required "Inquiry Point" under the Agreement on Technical Barriers to Trade Agreement (TBT) of the World Trade Organization (WTO) – i.e., the information exchange center for coordinating all notifications with the WTO Secretariat in Geneva on national proposed technical regulations and related conformance requirements
• an agreement for the information technology interests to further review cooperative arrangements such as those in progress under the Asian Pacific Economic Cooperation (APEC)
• and bilateral discussions this fall among the automotive interests to further explore participation in Working Party 29 of the United Nations Economic Commission for Europe (UNECE).

Highlights of the Break-Out Sessions

Electrical Safety Systems:

Chinese speakers noted that electromagnetic compatibility and interference (EMC) requirements had been imposed on six product categories effective January 1999 including personal computers, switching equipment, printers, monitors, audio equipment, and televisions. China still requires having two certification marks. One can apply to either the China Commission for Conformity Certification of Electrical Equipment (CCEE) for the "CCEE" mark or the State Administration for Entry-Exit Inspection and Quarantine (SAIQ) for the "CCIB" mark, however both marks can be obtained with one application, one test and one fee from either agency. However, the factory inspections are co-audited by both CCEE & SAIQ staff.

It was noted that:

• China’s Audio/Video equipment standard GB8980-97 is equivalent to IEC60065 Fifth Edition, including amendment three and national differences.
• China’s information technology (IT) equipment standard is equivalent to IEC950 and that China participates in IEC TC74. Components used in equipment must also conform to the applicable China GB standard and China’s National Electrical Wiring Standards.
• The EMI/EMC standards GB9254-1998 and GB/T17618-1998 for IT products used in China are equivalent to CISPR22 and CISPR24 respectively, or IEC standards.
• China’s household appliance requirements and standards are equivalent to IEC335 series standards. (China’s deviations from IEC335 are due to electrical equipment already in place and environmental conditions in China.
• Most of China’s component standards are also equivalent to IEC standards. e.g. IEC 775; IEC 1008; IEC 1009; IEC 898; IEC 947; IEC 269; IEC 439; IEC 934; IEC 1095; and IEC 61540.

Chinese representatives were made aware that the U.S. Department of Labor’s Occupational Safety and Health Administration (OSHA) accredits 17 Nationally Recognized Testing Laboratories (NRTL) and that all NRTLs are capable of issuing electrical safety approval on products used in the US.

At the previous workshop ASME International and the Occupational Health & Safety and Boiler & Pressure Vessel Supervision Administration (OSBPV - formerly of the Ministry of Labor – now under CSTBS) signed a Memorandum of Understanding (MOU). They pledged to strive toward a system of joint conformity assessment activities for manufacturers of boilers and pressure vessels. The MOU calls for the development of a system of joint conformity assessment activities to be achieved by:

This workshop served to further the goals of the MOU and its implementing steps. Differences and similarities in the laws, regulations and administrative structures in the US and China were discussed. The international use of the ASME Boiler and Pressure Vessel Code, and the roles of the National Board of Boiler and Pressure Vessel Inspectors and jurisdictional inspectors were reviewed. The global acceptance of US water heater standards was addressed. It was agreed to develop specific procedures in another ASME International meeting to take place this year for observers to participate on each other’s assessments. This should lead to fulfillment of the goal of joint assessments.

The main points of the sessions were:

• A new regulation will be passed shortly by the State Council, which will increase the China State Drug Administration’s (SDA) authority over medical devices.
• All medical devices sold in China, whether imported or produced domestically, must be registered with the SDA. Devices, which have been approved, for sale in the country of manufacturing origin will not require clinical testing or type testing in China. The one exception is Class III implantables, which require a quality systems audit by SDA officials.
• Like the US Food and Drug Administration (USFDA), the SDA will endeavor to emphasize market supervision, including audits of manufacturing facilities, institution of an accident reporting system and product sampling for compliance.
• The SDA will accept third party test data. The SDA's laboratories are independent, and are open to forming cooperative relationships with foreign laboratories.
• The SDA will use international standards in its approval processes, and gives strong merit to the Global Harmonization Task Force, the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).
• There is currently a prohibition against the importation of second-hand, refurbished or remanufactured electro-mechanical equipment in China, including medical devices. Such equipment may be bought and sold within China. The SDA does not have authority over this law.
• In addition to registration with the SDA, the State Administration for Quarantine Inspection requires its Great Wall Mark, based on a quality systems audit, for the following products:

• Medical diagnostic x-ray equipment
• Hemodialysis equipment
• Hollow fiber dialysers
• Extracorporeal blood circuit for blood
• Purification equipment
• Movable pressure vessels (sterilizers)
• Electrocardiographs
• Ultrasonic diagnosis equipment and ultrasonic therapy equipment
• Implantable cardiac pacemakers

China has four standards categories with a grading by level. They are in the order of grading, highest to lowest; i.e., national standards to professional (or industry) standards to local standards to enterprise (or company) standards. No duplication or contradiction is allowed among them. National standards are of the greatest significance since they have major impact on national economic and technical development. National standards are unified and applicable throughout China. Once a national standard is approved all redundant professional and local standards are canceled. The mark of a national standard is "GB" and national standards contain both recommended (voluntary) and compulsory (mandatory) standards.

Professional standards (we believe these are like industry standards) are developed as unified requirements in a professional (or sector) field throughout China. These are intended to compliment the national standards and are more technical and sector specific. Such standards for the telecommunications are distinguished by the "YD" designation. Ultimately, professional standards become candidates for national standards.

Local standards are also developed as unified requirements for safety and hygiene within a province or municipality where national or professional standards are non-existent for issues in question. Local standards are always mandatory but apply only within the specific local jurisdiction for which they were developed. Enterprise (or company) standards are those developed within a company. In general these standards are more technically complete and stricter than the other three levels of standards.

To the extent possible, the Chinese indicated that ITU recommendations are given high consideration for national standards and the FCC requirements are given weight for the professional standards. China claims that about 40 percent of their national standards are from international standards. The Chinese also indicated that the standards development include both industry and government participation.

Beginning this year, Chinese regulations were established for approval of all types of telecommunications equipment for use in either the public or private network. The technical requirements and product approval requirements apply both to infrastructure and customer premises equipment. It appears that the Chinese technical requirements go well beyond what we specify in the U.S. Specifically, the Chinese technical requirements address interworking and interoperability, that is to say they include performance based requirements and include network equipment.

In order to sell or import telecommunications products into the China market, the products must have a network entry mark issued by the Ministry of Information and Industry (MII). The approval process depends on which category the equipment is assigned; there are two categories: regular equipment; or new or important equipment. In both categories, the preexamination, sampling and quality system process approvals are essentially the same. The new or important equipment must also go through a 3-month technical evaluation trial operation in either a test bed or in network operation.

The pretesting includes a test report prepared by an accredited/approved test center (probably includes a laboratory). The test center prepares an application with the test report and the application along with a test sample is submitted to Telecommunications Administration Bureau (TAB), a government agency. The agency (or TAB) evaluates the application and may even do some sample testing. Once this portion of the process is complete, the agency will evaluate the applicants quality control system. Regular equipment is issued its network entry mark at this stage. For new or important equipment, the 3 month-trial begins.

Manufacturers who have ISO 9000, 9001, 9002 or other quality systems approval with TAB confirmation can receive quality system evaluation exemptions. Also, manufacturers who have passed quality system evaluations and have a stable product history can do acceptance testing themselves. In this case, the manufacturer may still be required to provide samples with its application.

Entry marks have a 3-year life. To renew, the manufacturer needs to submit the product to Chinese authorities for reapproval. Entry marks must be attached to all equipment. While not clear from the workshop, EMC and electrical safety seem to require separate approvals. However, TAB indicated that they could do all evaluations so as to avoid overlapping tests.

World regulatory requirements for IT equipment were discussed in view of the differences in practices in both China and the US. Of particular note was the need for global acceptance of requirements in products where the technology is moving rapidly. The concept of "One Standard – One Test, Supplier’s Declaration of Conformity" to achieve cost-effective international trade (http://www.itic.org) served as the basis for session discussions.

In particular, the application of safety standards such as IEC 60950 and electromagnetic interference requirements such as those detailed in CISPR 22 were reviewed. The value of moving new technology based products rapidly through reducing non-tariff related trade barriers, such as redundant testing and the requirement for third party certification was expounded upon in some detail. Included in these discussions were the value of internationally developed standards and the harmonization of national and regional standards with international standards. The WTO Information Technology Agreement was reviewed for its applicability and merit.

Additionally, many of the matters under the Electrical Safety session were also reviewed as being relative to the acceptance of IT equipment; including the acceptance of tests reports under the IECEE CB scheme, and the recognition of ISO9000 quality registrations/certifications from other nations participating in the ISO and IEC.

Participants discussed mechanisms for the international harmonization of standards and technical requirements. This could be advanced by full participation within the United Nations - ECE Working Party 29 forums in Geneva (1958 Amended Geneva Agreement), and by being signatories to the 1998 Global Technical Agreement. It was noted that adoption of ECE Regulations at appropriate levels and appropriate points in time should occur when ongoing measurement processes are in place to support the objectives of the regulation. This is particularly important in environmental requirements where vehicle emissions regulations should not precede appropriate fuel specifications and service infrastructure.

Consideration to accept alternative standards from other geographic regions was deemed "functionally equivalent" to adopted UNECE Regulations. A major benefit to adopting ECE regulations and participating in the international standards and regulatory development process, is the recognition and opportunity to certify and issue ECE certificates. These certificates are accepted in all countries that have adopted the same ECE regulations.

It was also pointed out that under the principles prescribed in the Agreement on Technical Barriers to Trade (TBT) of the World Trade Organization (WTO) that advance notification for comments on technical regulations allows all interested signatories to offer their suggestions on proposed rules. In addition, the value of advanced notice on the effective implementation dates of future regulations allows manufacturers adequate time to prepare and deliver appropriately equipped vehicles to meet the regulation.

The Chinese described the governmental standards system for engineering construction, and, current and future engineering construction standardization. The US described the privatized standards writing system, how certain standards became mandatory and finally, how conformity assessment was utilized in building construction control. The differences between a government administered standards process in China and the privatized standards system in the United States, and, how the standards are used in construction quickly came into focus for discussion.

Chinese concerns were directed to voluntary and mandatory US standards and how they became enforceable by law. This in turn pointed to the US political system of local government control for building construction. China is not alone in questioning how this system functions with privatized construction codes and conformity assessment systems. US delegation questions focused on the regulations of various ministries that could affect building product recognition in China. Laboratory accreditation, product quality, import requirements, environmental considerations and safety rules as they relate to the appropriate ministry or agency was of concern.

The consensus was (1) there is need for better understanding of each country’s building standards, codes and conformity assessment systems before significant effort can be effectively initiated to achieve technical understanding, and (2) that there should be harmonization of national product safety and performance standards with international standards. The current practice and benefits of manufacturer's self-declaration of conformity (also known as "self-certification") were also noted.

Please view the workshop agenda and related information.