国务院办公厅


国务院办公厅转发国家旅游局关于加强旅游工作意见的通知(附英文)
国务院办公厅


国家旅游局《关于加强旅游工作的意见》已经国务院同意，现转发给你们，请结合本地区、本部门的实际情况贯彻执行。 旅游业是一项综合性事业，涉及航空、交通、文化、建设、轻工、纺织、商业等许多部门，各有关部门要积极配合和支持，共同努力，推动我国旅游事业更加健康
、协调地发展。关于加强旅游工作的意见 党的十一届三中全会以来，在改革、开放方针的指引下，我国旅游事业迅速发展，在增加我国非贸易外汇收入、促进对外经济贸易和文化交流、增进同世界各国人民的相互了解和友谊等方面发挥了积极作用。目前我国旅游业的发展已具备了相当的
基础和进一步加快发展的基本条件，国际旅游业持续稳定发展的大趋势也有利于我们把旅游事业搞上去。为进一步加强对旅游工作的协调管理，争取我国旅游业有一个更大的发展，现提出如下意见：
一、加强旅游管理工作，搞好各级旅游管理机构改革。各省、自治区、直辖市人民政府及旅游重点城市，特别是旅游资源比较丰富的热点地区，要按照党政分开、政企分开和精简、统一的原则，从当地情况和发展国际国内旅游业的需要出发，结合地方机构改革，统筹安排，建立健全旅
游管理机构。各级旅游管理部门要切实转变职能，划清职责范围，合理配置机构。为切实搞好政企分开，需做到：（一）旅游部门主管领导不得兼任地方旅游公司、旅行社或饭店的经理；（二）旅游局与其直属企业要在人、财、物管理方面完全分开，使旅游企业真正做到自主经营、自负盈
亏；（三）各级旅游管理部门开展旅游业务的费用，由各级财政安排。为了加强旅游管理部门与旅游经营单位之间的联系，国家旅游局将根据工作需要，适当调整“中国旅游协会”、“中国旅游饭店协会”，成立“中国国内旅游协会”，协助旅游主管部门协调与各有关部门的关系，研究指
导国内旅游业发展中的有关事宜。
二、进一步明确国家旅游局的行业管理范围和管理权限，建立分级管理的办法和制度。全国所有的旅游企业事业单位，包括旅游院校和科研单位，经营国际、国内旅游业务的旅行社，各类旅游涉外饭店、宾馆、餐馆及旅游车船公司，对外开放的重点旅游风景区、游览点、旅游商品经销
店以及派驻国外的旅游办事机构、国外在华开设的旅游办事机构等，其隶属关系均不变，但旅游局要按照国家的有关规定，实行行业管理和检查监督。各级旅游管理部门对各级各类旅游企业，要一视同仁。国家旅游局要按此原则，会同有关部门研究制定分级管理办法，并严格旅游企业审批
制度。所有旅游企事业单位都要接受行业管理和监督。
三、全面深化改革，实行承包经营责任制。各级旅游管理部门和办有旅游企业的部门，可结合本地区、本部门的具体情况，根据国家有关规定，研究提出在国营、集体旅游企业实行承包经营责任制的具体计划和实施步骤，并使之配套、完善和深化。在实行承包经营责任制中，可根据不
同工作性质（旅行社、旅游涉外饭店、旅游车船队等）和不同经营情况（盈利企业、还贷企业、亏损企业等），采取不同的承包经营方式。凡是有外汇收入的企业，要承包创汇指标，并制定相应的结汇管理办法。有条件的企业，可以逐步建立企业风险基金。要采取招标招聘等多种形式，通
过竞争确定承包者。承包合同期限，一般不应少于3年。承包合同一经确定，承发包双方都要严格履行，不得违反。实行承包经营责任制，要和改进企业管理、促进企业内部管理制度的改革紧密结合起来，按照责、权、利相结合的原则，进一步改革和完善企业的劳动工资制度，严格考核和
奖罚制度。
四、改革旅行社管理体制。鼓励、支持国旅、中旅、青旅三大骨干旅行社向建立企业联合体和企业集团的方向发展。对已开办的各类旅行社，国家旅游局和地方旅游管理部门要按照《旅行社管理暂行条例》和《旅行社管理暂行条例实施细则》进行考核和整顿。各类旅行社都要切实搞好
企业内部改革，进一步挖掘潜力，促进经营管理水平和服务质量的提高。
五、加强旅游对外宣传招徕工作，努力开拓国际客源市场。国家旅游局要进一步加强对国际客源市场的调查研究，制定开拓国际市场的具体规划并组织实施。驻外旅游办事处要搞好国际旅游市场调研和宣传招徕，负责各外联单位在外宣传招徕的管理工作，积极开展与驻在国有关机构、
旅行社和旅游批发商等的联系，并注意搜集和反馈有关信息。各驻外办事机构在驻在国法律许可的范围内，也可酌情开展一些有偿服务或经营性活动。各外联单位在对外推销旅游线路时，要互相配合，顾全大局，不得低于保护价竞销或相互贬低。鼓励提倡各外联单位自愿组织起来，开展对
外联合推销。对于违反外联纪律的，国家旅游局和地方旅游管理部门要根据情节轻重给予行政处分或经济处罚。为适应我国旅游业发展的需要，旅游宣传推销经费可逐年有所增加。今后各外联单位开展对外联合推销活动，可采取收费的办法，凡参加及受益单位均需缴纳一定费用。
六、加强对新建旅游涉外饭店的宏观管理，推进饭店管理制度改革。各级旅游管理部门要认真贯彻执行今年9月22日国务院发布的《楼堂馆所建设管理暂行条例》，会同当地计划部门，对本地区旅游涉外饭店项目进行认真清理。今后，各地一般不要再建设高档旅游涉外饭店。温冷点
地区可根据旅游客源市场需求，酌建中低档饭店（可视需要在中档饭店内设若干高档房间）。北京、上海、广州、桂林、西安、杭州等旅游热点城市，原则上不再批准中外合资或合作建造饭店。要按照国办发〔1988〕17号文件精神，加快建立我国自己的饭店管理公司。对确需新建中
外合资、合作饭店的，必须按照国发〔1986〕101号和国办发〔1988〕32号文件有关规定办理。对于由国家旅游局投资或参与投资建设的旅游风景区和游览点，地方旅游管理部门要参与领导和管理。推进饭店管理制度的改革。全国旅游涉外饭店星级评定工作，已有具体标准和
实施办法，要抓紧进行，争取明年底完成。要逐步建立旅游涉外饭店（包括各类旅行社和旅游车船公司）营业许可证发放和吊销制度。旅游主管部门对有严重违法乱纪行为的旅游企业，可建议工商行政管理部门吊销其营业执照。
七、审慎进行旅游价格方面的改革，加强对旅游外汇收支及结汇的管理。旅游价格问题直接关系到国家的利益和声誉，要不断进行调查研究，作出审慎的改革，并按规定报批。要充分考虑适应国际竞争需要，根据不同旅游路线、不同季节等特点，改革价格结构模式，更加科学、合理地
制定价格（国家旅游局和国家物价局今后主要是制定最高限价和最低保护价）。价格原则一经确定，各级、各类旅游企业都应严格执行。对于违反价格纪律的，要严肃处理。 国家旅游局要会同国家统计局、国家外汇管理局、财政部、中国银行等部门，在加强对旅游外汇收支统计工作的同
时，进一步加强对旅游外汇的收支管理，建立旅游外汇结汇制度，并纳入计划；要研究制定《旅游外汇管理办法》和《旅游外汇财务管理办法》，报国务院批准后实施，以尽快扭转目前旅游外汇收入流失严重的状况。
八、大力发展旅游商品、旅游纪念品的生产和销售，进一步提高我国旅游业的创汇水平和经济效益。搞好旅游商品、旅游纪念品的生产和销售是旅游业一个重要组成部分，也是为国家创汇的重要途径之一。要逐步建立起全国旅游商品、旅游纪念品的生产和销售网络。要以国家旅游局所
属的“中国旅游服务公司”系统、轻工部现有的“中国旅游产品生产供应公司”系统、商业部现有的“中国友谊服务公司”系统为基础，发挥其主导作用，进一步扩大业务，形成各具特色、经营不同旅游商品和旅游纪念品的企业体系。这些企业系统，可以有计划地兴办一批旅游纪念品生产
基地和研究国际旅游商品、旅游纪念品市场行情、开发新产品的科研单位，逐步使科研开发与产供销紧密结合。要鼓励各地特别是旅游重点地区大力发展具有民族风格、地方特色的旅游商品和旅游纪念品的生产，增加花色品种，广开货源渠道，改善销售服务，加强市场管理。要落实国务院
早已确定的“旅游商品创汇视同外贸出口创汇”的规定，并研究制定具体办法；对外贸出口中属于非实行出口许可证管理的商品，要进一步扩大对国外旅游者的销售；旅游商品、旅游纪念品的销售价格，要根据不同商品的货源情况、国际市场行情和经贸部门的具体销售方针，灵活掌握；发
展旅游商品、旅游纪念品生产所需国内紧缺的专用原材料，各级物资部门要纳入供货渠道；必须由国家统一进口的原材料，要纳入国家进口计划；对所需进口的专用原材料，按国办发〔1987〕16号文件有关规定执行。北京、上海、广州是海外旅游者出入境的三大口岸，要逐步建设成
为亚洲地区有一定规模和声誉的旅游购物城市。 目前一些旅游涉外饭店用大量外汇进口内装修材料、卫生洁具、机电设备和零部件，为尽快改变这种状况，今后对凡属于国内已能生产的产品，价格合理，质量、交货期等方面又能保证需要的，应一律停止进口。建议由有关部门提出限制进
口的产品目录，并由行业归口管理部门进行审批。
九、加强旅游从业人员的队伍建设，抓好职业道德和职业纪律教育。要进一步抓好旅游院校教育工作和从业人员的培训工作，大力培养不同层次、不同类别的旅游专业人才。要强化职业道德和职业纪律教育，不断提高旅游从业人员的政治、业务素质，树立旅游职业的光荣感和责任感，
反对各种不正之风，进一步提高旅游服务质量，搞好优质服务，使我国旅游业在国际上建立良好的信誉和形象。
十、加强与各有关部门的协调配合。旅游业是一项综合性事业，其发展不仅取决于旅游部门本身的工作，而且与航空、交通、城建、园林、文物、文化、轻工、纺织、商业、宗教事务等很多部门的工作紧密相关。旅游业又是一项跨地区的行业，大量的组织工作和实际工作要靠地方去做
，需要协调一致。各级旅游管理部门要进一步与有关部门密切配合，共同努力，促进我国旅游事业更加健康协调地发展。

CIRCULAR OF THE GENERAL OFFICE UNDER THE STATE COUNCIL ON THEAPPROVAL AND TRANSMISSION OF A REPORT SUBMITTED BY THE NATIONAL TOURISMADMINISTRATION CONCERNING THE STRENGTHENING OF TOURIST WORK

Important Notice: (注意事项)

英文本源自中华人民共和国务院法制局编译, 中国法制出版社出版的《中华人民共和国涉外法规汇编》(1991年7月版).
当发生歧意时, 应以法律法规颁布单位发布的中文原文为准.
This English document is coming from the "LAWS AND REGULATIONS OF THE
PEOPLE'S REPUBLIC OF CHINA GOVERNING FOREIGN-RELATED MATTERS" (1991.7)
which is compiled by the Brueau of Legislative Affairs of the State
Council of the People's Republic of China, and is published by the China
Legal System Publishing House.
In case of discrepancy, the original version in Chinese shall prevail.

Whole Document (法规全文)

CIRCULAR OF THE GENERAL OFFICE UNDER THE STATE COUNCIL ON THE
APPROVAL AND TRANSMISSION OF A REPORT SUBMITTED BY THE NATIONAL TOURISM
ADMINISTRATION CONCERNING THE STRENGTHENING OF TOURIST WORK
(December 21, 1988)
The Report, "Suggestions Concerning the Strengthening of Tourist Work",
submitted by the National Tourism Administration, has been approved by the
State Council and is hereby transmitted to you for implementation in the
light of the actual conditions of the respective localities and
departments.
The tourist industry is a comprehensive undertaking which involves
departments such as aviation, communications, culture, construction, light
industry, textile industry, and commerce. All the departments concerned
shall coordinate and support each other and make joint efforts to promote
the sound and coordinated development of tourism in our country.
SUGGESTIONS CONCERNING THE STRENGTHENING OF TOURIST WORK
Since the conclusion of the Third Plenary Session of the Eleventh Central
Committee of the Communist Party of China, under the guidance of the
policy of reform and opening to the outside world, tourism has been
developing very rapidly in our country; and it has played an active part
in increasing our country's non-trade foreign exchange earnings, in
boosting international trade and cultural exchange, and in promoting the
mutual understanding and friendship between peoples throughout the world.
At present, our country possesses a fairly good foundation for the
development of tourism and the necessary conditions for speeding up such
development. The general trend of continuous and steady development of the
international tourism is also favourable to us for promoting our tourist
industry. In order to further strengthen the coordinated administration of
tourist work and strive for a greater development of our tourist industry,
we hereby advance the following suggestions:

1. Strengthening the administration of the tourist industry and doing a
good job in the reform of tourism administration organs at various levels.
The people's governments of various provinces, autonomous regions, and
municipalities directly under the Central Government, as well as tourist
cities, especially those favourite haunts with relatively rich tourist
resources, shall, in accordance with the principles of "separating Party
organs from government organs", "separating government organs from
enterprises", and "simplified and unified administration", and in the
light of local conditions and needs of the development of international
and domestic tourism, set up and improve the tourism administration organs
by combining them with the reform of local setups and making overall
arrangements. The tourism administration departments at various levels
shall make timely and specific adjustments to their responsibilities,
clearly define their scope of duties, and rationally deploy their
organizations. In order to effect the separation of government organs from
enterprises, it is imperative to lay stress on the following measures:
(1) The persons in charge of the tourism administration departments shall
not assume concurrently posts of manager of local tourist companies,
tourist agencies, or hotels;
(2) The tourism bureaus shall be completely separated from the enterprises
directly under them in the administration of such aspects as personnel,
finance, and materials, so that the tourist enterprises shall carry on
their business operations independently, and assume sole responsibility
for their profits and losses;
(3) The expenses for the tourism administration departments at various
levels to conduct tourist business operations shall be appropriated by the
finance departments at various levels. In order to strengthen the
connections between tourism administration departments and tourist opera-
ting units, the National Tourism Administration shall, in accordance with
the requirements of work, make necessary adjustments with regard to the
"China Association of Tourism" and the "China Association of Tourist
Hotels", and establish thereby the "China Association of Domestic
Tourism", which shall assist the competent authorities for tourism in
coordinating relations with other departments concerned and in studying
and providing guidance to the development of domestic tourism.

2. Further clarifying the scope of responsibility and the limits of powers
of the tourist administration bureaus, and establishing a system of graded
administration. The subordinative relationship of all the tourist
enterprises and tourist institutions throughout the country-including
institutes and schools of tourism, research institutes of tourism, tourist
agencies that are engaged in the international and domestic tourist
industries; various categories of tourist hotels, guest houses,
restaurants, and tourist automobile and vessels companies for the
reception of foreign tourists; key tourist scenic spots, tourist
attractions, and shops selling tourist goods that are open to foreigners;
tourist representative offices abroad, as well as the tourist
representative offices established in China by foreign tourist agencies-to
the competent administrative authorities directly over them shall remain
unchanged; but the tourist bureau shall, in accordance with the provisions
of the State, implement the system of trade administration, inspection,
and supervision. The tourism administration departments at various levels
shall treat tourist enterprises of various categories equally without
discrimination. The National Tourism Administration shall, in accordance
with the aforesaid principle, and working in coordination with other
departments concerned, make a study of, and work out, ways to implement
the system of graded administration and effect a stricter procedure in
examining and approving the establishment of tourist enterprises. All the
tourist enterprises and tourist institutions shall, without exception,
subject themselves to trade administration and supervision.

3. Deepening the reform in a comprehensive way and implementing the
responsibility system of contracted business operations. The tourism
administration departments at various levels and the departments that run
tourist enterprises shall, taking into consideration the actual conditions
of the local areas and of their own departments, and in accordance with
the pertinent provisions of the State, make a study of, and submit a
report on, a specific plan and practicable procedures for the
implementation of the responsibility system of contracted business
operations in state-run and collectively-run tourist enterprises and, at
the same time, formulate other provisions to perfect such a system. In the
course of implementing the aforesaid responsibility system of contracted
business operations, different forms of contracted business operations may
be adopted, in accordance with the differences in the nature of business
operations (tourists agencies, tourist hotels specialized in receiving
foreign guests, fleets of tourist automobiles and vessels) and business
operations of different conditions (enterprises with profits, enterprises
that have to repay loans, enterprises suffering losses and with a
deficit). All those enterprises that have foreign exchange earnings shall
carry out a contracted target for earning foreign exchange, and work out a
corresponding method for the administration of the settlement of the
exchange. Enterprises, which possess the necessary conditions, may
gradually set up risk funds for themselves. The contractor shall be
finally determined, through various kinds of competition, such as by
inviting tenders, or by advertising for employment. The contract period
shall, in principle, be no shorter than 3 years. Once a contract is
confirmed and signed, the two parties, the contractor and the party
awarding the contract, shall execute the contract strictly, and under no
circumstances shall it be violated. The implementation of the
responsibility system of contracted business operations calls for a close
integration of the improvement of enterprise management and the promotion
of reform in the internal administration system of enterprises, and for
further efforts in reforming and improving the labour wage system and the
policy of reward and punishment, in accordance with the principle of
combining responsibility, power, and profit.

4. Reforming the administration system of tourist agencies. The three
backbone travel services-China International Travel Service, China Travel
Service, and China Youth Travel Service-shall be encouraged and supported
to develop towards the establishment of an integrated complex or
enterprise group.
With respect to those tourist agencies of various categories that have
already been set up, the National Tourism Administration and local tourism
administration departments shall carry out assessment and rectification in
accordance with the provisions in Interim Regulations on the
Administration of Tourist Agencies and Rules of Implementation for Interim
Regulations on the Administration of Tourist Agencies. Tourist agencies of
various categories shall all carry out effectively the reform in the
internal work of their respective tourist agencies, further tap their
potentials, so as to raise standard of their operation and administration,
and to improve the quality of their services.

5. Strengthening overseas tourist publicity and the endeavouring for
soliciting tourists, and striving to expand the international market for
foreign tourists. The National Tourism Administration shall make further
efforts in investigating and analyzing the market for international
tourists, work out specific plans for the expansion of the said
international market, and take measures to put it into practice. Our
resident representative tourist offices abroad shall try their best to
investigate into the market for international tourists and carry out
publicity work for soliciting visiting tourists, take the responsibility
to supervise the publicity and soliciting endeavour carried out abroad by
units in charge of liaison work with foreign countries, actively make
contacts with the institutions concerned, tourist agencies and tourist
wholesalers in countries where our representative tourist offices are
resident, and pay attention to collecting and feeding back relevant
information. Various resident representative tourist offices abroad may,
within the scope of law of the respective countries where they are
resident, and at their discretion, undertake some paid services or other
business operational activities.
Various units in charge of liaison work with foreign countries, while
canvassing among foreigners for tourists itineraries, shall work in close
coordination and take the interests of the whole country into account.
They may not play down the others and compete against them by offering
prices lower than the protective price. Various units in charge of liaison
work with foreign countries shall be encouraged to collaborate on a
voluntary basis to canvass jointly among foreigners. With respect to those
who have violated external liaison disciplines, the National Tourism
Administration and the local tourism administration departments shall,
depending on the seriousness of the cases, impose disciplinary sanctions,
or economic penalty, on the violators. In order to meet the needs of the
development of the tourist industry in our country, the outlay for
conducting tourist publicity and canvassing abroad may be increased with
each passing year. From now on, various units in charge of liaison work
with foreign countries, when canvassing jointly among foreigners may
collect service charges: all units that take part in the canvassing
activities and derive benefits there from shall pay the charges.

6. Strengthening the macro-administration of those newly-built tourist
hotels that specialize in receiving foreign guests and promoting the
reform of hotel administration system. The tourism administration
departments at various levels shall conscientiously implement Interim
Regulations on the Construction and Administration of Storied Buildings,
Halls, Hotels and Guest Houses, promulgated by the State Council on
September 22, 1988, and, working in coordination with the local planning
departments, carry out a checking-up on the projects of local tourist
hotels that specialize in receiving foreign guests. From now on, in
principle, no more high-grade tourist hotels that specialize in receiving
foreign guests shall be built in any place. In areas less frequented than
favourite tourist haunts, medium-and low-grade hotels may be built, in
accordance with the tourist market's demand, and depending on the actual
circumstances, (a number of highgrade rooms may be provided in a
medium-grade hotel, if necessary). In such highly frequented tourist
cities as Beijing, Shanghai, Guangzhou, Guilin, Xi'an, and Hangzhou, no
new hotel construction projects with Chinese-foreign joint investment or
by Chinese-foreign cooperation shall, in principle, be approved. In
accordance with the guideline of Document No. 17 (1988) issued by the
General Office under the State Council, it shall be imperative to speed up
the establishment of the hotel administration company of our own country.
In cases where necessity arises for the building of new hotels in form of
Chinese-foreign joint ventures or Chinese-foreign contractual joint
venture, the cases shall be handled in accordance with the provisions in
Document No. 101 (1986) and Document No. 32 (1988), issued by the General
Office under the State Council. As regards the tourist scenic spots and
tourist attraction, built and facilitated with, or partly with the
investment of the National Tourism Administration, the local tourism
administration departments shall take part in the leadership and
administration of the aforesaid tourist places.
Promoting the reform in the hotel administration system. There are now
specific standards for the "star-rating" of the country's tourist hotels
that specialize in receiving foreign guests; the rating process shall be
speeded up and strive to complete the task by the end of next year. The
system for issuing and revoking business licence for tourist hotels that
specialize in receiving foreign guests (including various categories of
tourist agencies and tourist automobiles and vessels companies) shall be
gradually set up. With respect to those tourist enterprises that have
committed serious illegal acts, the competent authorities for tourism may
suggest to the relevant administrative departments for industry and
commerce that the business licences of the aforesaid enterprises be
revoked.

7. Carrying out, with caution, the reform in tourist prices, and
strengthening the administration of the receipts and expenditures in
foreign exchange as well as the settlement of exchange relating to tourist
enterprises. The problem of tourist prices has a direct bearing on the
interests and reputation of the State; therefore it is imperative to
conduct careful investigation and studies before taking cautious steps in
the reform, and submit the reform plan to higher authorities for approval.
It is necessary to reform the price structure so as to fix the tourist
prices more scientifically and reasonably by taking into full
consideration the necessity to meet the challenge of international
competition, and in accordance with the special features of different
tourist itineraries and different seasons (from now on, the National
Tourism Administration and the State Administration for Commodity Prices
shall chiefly fix the ceiling price and the floor price - the protective
price). Once the price principles are determined, the tourist enterprises
at various levels and of various categories shall execute them strictly.
Those who have violated the price discipline shall be dealt with
seriously.
The National Tourism Administration shall, working in coordination with
such departments as the State Statistical Bureau, the State Administration
of Foreign Exchange Control, the Ministry of Finance, and the Bank of
China, strengthen the statistical work on the tourist enterprises'
receipts and expenditures, and tighten the control of the foreign exchange
receipts and expenditures of the tourist enterprises, establish the system
for the settlement of tourist foreign exchange, and bring this work into
line with the State plan. It is imperative to formulate, through studies,
the Measures for Foreign Exchange Control in Tourism and the Measures for
the Financial Administration of Foreign Exchange in Tourism, and submit
these two documents to the State Council for approval before
implementation so as to reverse as early as possible the present situation
of serious drain on foreign exchange earnings from tourism.

8. Developing vigorously the manufacture and marketing of tourist goods
and tourist souvenirs, increasing the volume of the foreign exchange
earning from tourism in our country and improving its economic results.
The manufacture and marketing of tourist goods and tourist souvenirs
constitute an important component part of the tourist industry, and is
also an important channel for earning foreign exchange for the State. It
is imperative to establish gradually a nationwide network for the
production and marketing of tourist goods and tourist souvenirs. For the
aforesaid purpose, the "China Tourist Services Company" under the National
Tourism Administration, the "China Tourist Products Production and Supply
Company" under the Ministry of Light Industry, and the "China Friendship
Services Company" under the Ministry of Commerce shall be taken as the
foundation; their leading role shall be brought into full play, and their
businesses shall be further expanded so that they shall grow into
complexes of enterprises specialized in different lines of business,
handling different assortments of tourist goods and tourist souvenirs.
These complexes of enterprises may establish, in a planned way, a number
of production bases for the production of tourist souvenirs, and a number
of research institutes for carrying on studies in the marketing quotations
of international tourist goods and tourist souvenirs and for developing
new products, so that scientific research and product development will be
combined in the integrated process of production-supply-marketing. It is
necessary to encourage various places, especially the key tourist areas,
to vigorously develop the production of tourist goods and tourist
souvenirs that are of national style with various local colours, to
increase designs and varieties, to expand channels for sources of goods,
to improve sales service, and to strengthen market administration. It is
imperative to implement conscientiously the provisions approved long ago
by the State Council: "the foreign exchange earned through the sales of
tourist goods shall be deemed as the foreign exchange earned by foreign
trade" and to formulate, through studies, specific measures for carrying
out the said provisions; with respect to those export goods which do not
come under the licence control, it is important to expand their sales to
foreign tourists; the selling prices of tourist goods and tourist
souvenirs shall be handled flexibly in accordance with the different
conditions of goods supply, the international market quotations, and the
specific marketing policy pursued by the economic and trade departments.

The special raw and processed materials which are needed for the
development of the production of tourist goods and tourist souvenirs and
are in short supply in the country, shall be brought into the goods supply
channels handled by the departments of goods and materials at various
levels; those raw and processed materials that are imported solely by the
State shall be brought into the plan for importation executed by the
State; the special imported raw and processed materials needed shall be
handled in accordance with the pertinent provisions in Document No. 16
(1987) issued by the General Office under the State Council. As Beijing,
Shanghai, and Guangzhou are the three main ports of entry and exit for
overseas tourists, they shall be turned into cities with sizable tourist
shopping centres and good reputation in Asia. At present, some tourist
hotels that specialize in receiving foreign guests spend a large amount of
foreign exchange in importing fitting-up materials, sanitary utensils,
machinery and electrical equipment, and spare and component parts. In
order to change this situation without delay, from now on, all similar
products which can already be manufactured in our country and reasonably
priced and whose quality and delivery time can be guaranteed shall cease
to be imported. We suggest that a catalogue of products to be restricted
in importation be put forward by the departments concerned and the
importation of the aforesaid products shall be examined and approved by
the administrative departments of the trades concerned.

9. Strengthening the building of a contingent of tourist personnel and
paying close attention to the education in professional ethics and
professional discipline. It is imperative to improve the educational work
in schools and institutes of tourism and the professional training of
tourist personnel, especially the training of qualified specialized
personnel at various levels and of different categories. It is also
imperative to intensify the education in professional ethics and
professional discipline, so as to improve the political and professional
quality of tourist personnel, to foster a sense of honour and
responsibility, to oppose all kinds of unhealthy tendencies, to improve
the quality of tourist services and offer high-quality services, thus
enabling our tourist industry to establish good international reputation
and image.

10. Strengthening the coordination between different departments
concerned. The tourist industry is a comprehensive undertaking, the
development of which relies not only on its own work, but also on the
close coordination with such organizations as the departments of aviation,
communications, city construction, gardens and parks, historical relics,
culture, light industry, textile industry, commerce, and religious
affairs. The tourist industry is also a trans-regional trade, and a large
amount of organizational work shall be done by the local departments; a
harmonious coordination is thus indispensable. Tourist departments at
various levels shall strengthen their coordination with other departments
concerned and make joint efforts in promoting a sound and co-ordinated
development of the tourist industry in our country.



1988年12月21日
国家药监局


国家药品监督管理局关于印发一九九九年医疗器械标准项目制定、修订计划的通知
国家药品监督管理局




各省、自治区、直辖市药品监督管理局或医药管理部门，各医疗器械标准化技术委员
会：
为进一步做好医疗器械标准工作，根据各医疗器械标准化技术委员会报送的标准制定、修订计划，经研究，现将1999年医疗器械标准项目制定、修订计划（其中，强制性医疗器械标准36项、推荐性医疗器械标准20项）印发给你们（见附件），请各有关单位遵照计划要求，加强
测试验证和技术复核工作。按时按质地完成所承担的起草项目。
特此通知

附件1：一九九九年制定、修订 强制性医疗器械标准 项目计划汇总表（ＹＹ）

－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－
｜序 ｜ 标准项目名称 ｜标准｜制定或修订 ｜ 起止年限 ｜主管部门 ｜技术委员会或｜主要负责起草单位
｜号 ｜ ｜类别｜ ｜ ｜ ｜技术归口单位｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－｜－－－－－－－－
｜1 ｜红外乳腺诊断仪 ｜产品｜制定 ｜1999-2000 ｜国家药品 ｜全国医用光学｜浙江海鹰企业集团
｜ ｜ ｜ ｜ ｜ ｜监督管理 ｜和仪器标准化｜
｜ ｜ ｜ ｜ ｜ ｜局 ｜分技术委员会｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－｜－－－－－－－－
｜2 ｜裂隙灯显微镜 ｜产品｜修订 ｜1999.7- ｜ ｜ ｜苏州医疗器械厂
｜ ｜ ｜ ｜YY0065-92 ｜2000.7 ｜ 同上 ｜ 同上 ｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－｜－－－－－－－－
｜3 ｜氦氖激光血管内照射治 ｜产品｜修订 ｜1999-2000 ｜ ｜ ｜国家药品监督管理
｜ ｜疗仪通用技术条件 ｜ ｜YY0284- ｜ ｜ 同上 ｜ 同上 ｜局杭州医疗器械质
｜ ｜ ｜ ｜1996 ｜ ｜ ｜ ｜量监督检验中心
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－｜－－－－－－－－
｜4 ｜连续波掺钕钆铝石榴石 ｜产品｜修订 ｜1999-2000 ｜ ｜ ｜
｜ ｜激光治疗机通用技术条 ｜ ｜YY0307- ｜ ｜ 同上 ｜ 同上 ｜ 同上
｜ ｜件 ｜ ｜1998 ｜ ｜ ｜ ｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－｜－－－－－－－－
｜5 ｜用于牙科的医疗器械生 ｜基础｜修订 ｜1999年9月 ｜ ｜ ｜国家药品监督管理
｜ ｜物性能临床前评价 第 ｜ ｜YY0268- ｜ 至 ｜ 同上 ｜ 同上 ｜局北医医疗器械质
｜ ｜一单元：导则 ｜ ｜1995 ｜2000年12月 ｜ ｜ ｜量监督检验中心
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－｜－－－－－－－－
｜6 ｜400ｍＡ医用诊断Ｘ射线｜产品｜修订 ｜1999年 ｜ ｜全国医用Ｘ线｜国家药品监督管理
｜ ｜机 ｜ ｜GB10150-88 ｜ ｜ 同上 ｜设备及用具标｜局沈阳医疗器械质
｜ ｜ ｜ ｜ ｜ ｜ ｜准化分技术委｜量监督检验中心
｜ ｜ ｜ ｜ ｜ ｜ ｜员会 ｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－｜－－－－－－－－
｜7 ｜医用诊断Ｘ射线辐射防 ｜产品｜制定 ｜1999年 ｜ ｜全国医用Ｘ线｜
｜ ｜护器具第3部分：防护 ｜ ｜ ｜ ｜ 同上 ｜设备及用具标｜ 同上
｜ ｜衣和防护器具 ｜ ｜ ｜ ｜ ｜准化分技术委｜
｜ ｜ ｜ ｜ ｜ ｜ ｜员会 ｜
－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－

－－－－－－－－－－－－－－－－－－－
｜采用国际标准或国｜ 备 注 ｜
｜外先进标准编号 ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜
｜ ｜ ｜
｜ ｜ ｜
｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜
｜IS010939-1998 ｜ ｜
｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜
｜ ｜ ｜
｜ ｜ ｜
｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜
｜ ｜ ｜
｜ ｜ ｜
｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜
｜IS07405-1997 ｜ ｜
｜(E) ｜ ｜
｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜
｜ ｜ ｜
｜ ｜ ｜
｜ ｜ ｜
｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜
｜IS01331-3(1998) ｜ ｜
｜ ｜ ｜
｜ ｜ ｜
｜ ｜ ｜
－－－－－－－－－－－－－－－－－－－
一九九九年制定、修订 强制性医疗器械标准 项目计划汇总表（ＹＹ）
－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－
｜序 ｜ 标准项目名称 ｜标准｜制定或修订 ｜ 起止年限 ｜主管部门 ｜技术委员会或｜主要负责起草单位
｜号 ｜ ｜类别｜ ｜ ｜ ｜技术归口单位｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－｜－－－－－－－－
｜8 ｜可吸收缝合线标准 ｜产品｜制定 ｜1999.7- ｜国家药品 ｜全国外科器械｜
｜ ｜ ｜ ｜ ｜2000.7 ｜监督管理 ｜标准化技术委｜
｜ ｜ ｜ ｜ ｜ ｜局 ｜员会 ｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－｜－－－－－－－－
｜9 ｜人工乳房通用技术条件 ｜产品｜制定 ｜1999.7- ｜同上 ｜ ｜国家药品监督管理
｜ ｜ ｜ ｜ ｜2000.7 ｜ ｜ ｜局中检所医疗器械
｜ ｜ ｜ ｜ ｜ ｜ ｜ ｜质量监督检验中心
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－｜－－－－－－－－
｜10｜埋植式给药装置标准 ｜产品｜制定 ｜1999.7- ｜同上 ｜全国输液器具｜
｜ ｜ ｜ ｜ ｜2000.7 ｜ ｜标委会 ｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－｜－－－－－－－－
｜11｜无菌医用无损伤缝合针 ｜产品｜修订 ｜1999-2000 ｜同上 ｜全国外科器械｜江苏省淮阴医疗器
｜ ｜ ｜ ｜YY0044-91 ｜ ｜ ｜标准化技术委｜械厂
｜ ｜ ｜ ｜YY0166-94 ｜ ｜ ｜员会 ｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－｜－－－－－－－－
｜12｜手提式压力蒸汽灭菌器 ｜产品｜修订 ｜1999-2000 ｜同上 ｜全国消毒技术｜国家药品监督管理
｜ ｜ ｜ ｜GB4027.1-83 ｜ ｜ ｜与设备标准化｜局广州医疗器械质
｜ ｜ ｜ ｜WS2-84-83 ｜ ｜ ｜技术委员会 ｜量监督检验中心
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－｜－－－－－－－－
｜13｜立式压力蒸汽灭菌器 ｜产品｜修订 ｜1999-2000 ｜同上 ｜同上 ｜同上
｜ ｜ ｜ ｜GB4027.2-83 ｜ ｜ ｜ ｜
｜ ｜ ｜ ｜WS2-85-83 ｜ ｜ ｜ ｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－｜－－－－－－－－
｜14｜卧式圆形压力蒸汽灭菌 ｜产品｜修订 ｜1999-2000 ｜同上 ｜同上 ｜同上
｜ ｜器 ｜ ｜GB4027.3-83 ｜ ｜ ｜ ｜
｜ ｜ ｜ ｜WS2-86-83 ｜ ｜ ｜ ｜
－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－

－－－－－－－－－－－－－－－－－－－
｜采用国际标准或国｜ 备 注 ｜
｜外先进标准编号 ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜
｜美国药典标准 ｜ ｜
｜ ｜ ｜
｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜
｜美国ASTM ｜ ｜
｜F703-96 ｜ ｜
｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜
｜德国企业标准 ｜ ｜
｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜
｜ ｜ ｜
｜ ｜ ｜
｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜
｜ISO11134-1994 ｜参加单位：山 ｜
｜ ｜东新华医疗 ｜
｜ ｜器械厂 ｜
｜－－－－－－－－｜－－－－－－－－｜
｜ISO11134-1994 ｜参加单位：上 ｜
｜ ｜海医用核子 ｜
｜ ｜仪器厂 ｜
｜－－－－－－－－｜－－－－－－－－｜
｜ISO11134-1994 ｜参加单位：上 ｜
｜ ｜海医用核子 ｜
｜ ｜仪器厂 ｜
－－－－－－－－－－－－－－－－－－－
一九九九年制定、修订 强制性医疗器械标准 项目计划汇总表（ＹＹ）
－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－
｜序 ｜ 标准项目名称 ｜标准｜制定或修订 ｜ 起止年限 ｜主管部门 ｜技术委员会或｜主要负责起草单位
｜号 ｜ ｜类别｜ ｜ ｜ ｜技术归口单位｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－｜－－－－－－－－
｜15｜卧室矩形压力蒸汽 ｜产品｜修订 ｜1999-2000 ｜国家药品监｜全国消毒技术｜国家药品监督管理
｜ ｜灭菌器 ｜ ｜GB4027.4-83 ｜ ｜督管理局 ｜与设备标准化｜局广州医疗器械质
｜ ｜ ｜ ｜WS2-232-83 ｜ ｜ ｜技术委员会 ｜量监督检验中心
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－｜－－－－－－－－
｜16｜环氧乙烷灭菌器 ｜产品｜制定 ｜1999.6-2000 ｜同上 ｜同上 ｜国家药品监督管理
｜ ｜ ｜ ｜ ｜ ｜ ｜ ｜局广州医疗器械质
｜ ｜ ｜ ｜ ｜ ｜ ｜ ｜量监督检验中心、
｜ ｜ ｜ ｜ ｜ ｜ ｜ ｜杭州电达消毒设备
｜ ｜ ｜ ｜ ｜ ｜ ｜ ｜厂
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－｜－－－－－－－－
｜17｜外科不锈钢植入物 ｜方法｜制定 ｜98.11-99.10 ｜同上 ｜全国外科植入｜国家药品监督管理
｜ ｜点蚀电位试验方法 ｜ ｜ ｜ ｜ ｜物和矫形器械｜局天津医疗器械质
｜ ｜ ｜ ｜ ｜ ｜ ｜标委会 ｜量监督检验中心
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－｜－－－－－－－－
｜18｜外科植入物－无损 ｜方法｜制定 ｜98.11-99.10 ｜同上 ｜同上 ｜同上
｜ ｜检验－液体渗透检 ｜ ｜ ｜ ｜ ｜ ｜
｜ ｜验方法 ｜ ｜ ｜ ｜ ｜ ｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－｜－－－－－－－－
｜19｜金属接骨板 ｜产品｜制定 ｜98.11-99.10 ｜同上 ｜同上 ｜上海手术器械厂
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－｜－－－－－－－－
｜20｜金属接骨螺钉 ｜产品｜修订 ｜98.11-99.10 ｜同上 ｜同上 ｜江苏金鹿集团
｜ ｜ ｜ ｜YY0018-90 ｜ ｜ ｜ ｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－｜－－－－－－－－
｜21｜骨针 ｜产品｜制定 ｜98.11-99.10 ｜同上 ｜同上 ｜天津骨科医疗器械
｜ ｜ ｜ ｜ ｜ ｜ ｜ ｜厂
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－｜－－－－－－－－
｜22｜金属矫形用钉 ｜产品｜修订 ｜98.11-99.10 ｜同上 ｜同上 ｜江苏宏宝集团
｜ ｜ ｜ ｜YY0119-93 ｜ ｜ ｜ ｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－｜－－－－－－－－
｜23｜金属矫形用棒 ｜产品｜修订 ｜98.11-99.10 ｜同上 ｜同上 ｜江苏宏宝集团
｜ ｜ ｜ ｜YY0120-93 ｜ ｜ ｜ ｜
－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－

－－－－－－－－－－－－－－－－－－－
｜采用国际标准或国｜ 备 注 ｜
｜外先进标准编号 ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜
｜ISO11134-1994 ｜参加单位：山东新｜
｜ ｜华医疗器械厂 ｜
｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜
｜JIST7323-1989 ｜参考标准 ｜
｜JIST7325-1989 ｜ISO11135-1994 ｜
｜ ｜ISO10993- ｜
｜ ｜7:1995 ｜
｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜
｜ ｜ ｜
｜ ｜ ｜
｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜
｜ISO9583:1993 ｜等效采用 ｜
｜ ｜ ｜
｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜
｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜
｜ ｜ ｜
｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜
｜ ｜ ｜
｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜
｜ ｜ ｜
｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜
｜ ｜ ｜
｜ ｜ ｜
－－－－－－－－－－－－－－－－－－－
制定、修订 强制性医疗器械标准 项目计划汇总表（ＹＹ）
－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－
｜序 ｜ 标准项目名称 ｜标准｜制定或修订 ｜ 起止年限 ｜主管部门 ｜技术委员会或技术
｜号 ｜ ｜类别｜ ｜ ｜ ｜ 归口单位
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－－－
｜24｜髋关节假体 ｜产品｜修订 ｜99.8-2000.10｜国家药品监｜全国外科植入物和
｜ ｜ ｜ ｜YY0118-93 ｜ ｜督管理局 ｜矫形器械标委会
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－－－
｜25｜外科植入物－髋关节 ｜产品｜修订 ｜99.8-2000.10｜同上 ｜同上
｜ ｜锻、铸件 ｜ ｜YY0117.1-93 ｜ ｜ ｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－－－
｜26｜外科植入物－无损检 ｜方法｜制定 ｜99.8-2000.10｜同上 ｜同上
｜ ｜验－铸造金属外科植 ｜ ｜ ｜ ｜ ｜
｜ ｜入物Ｘ射线检验方法 ｜ ｜ ｜ ｜ ｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－－－
｜27｜接骨板弯曲强度和刚 ｜方法｜制定 ｜99.8-2000.10｜同上 ｜同上
｜ ｜度试验方法 ｜ ｜ ｜ ｜ ｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－－－
｜28｜骨钻通用技术条件 ｜产品｜制定 ｜99.8-2000.10｜同上 ｜同上
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－－－
｜29｜骨锯通用技术条件 ｜产品｜制定 ｜99.8-2000.10｜同上 ｜同上
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－－－
｜30｜红外治疗设备专用安 ｜安全｜制定 ｜99年底 ｜同上 ｜全国医用电器标准
｜ ｜全要求 ｜ ｜ ｜ ｜ ｜化技术委员会物理
｜ ｜ ｜ ｜ ｜ ｜ ｜治疗设备标准化分
｜ ｜ ｜ ｜ ｜ ｜ ｜技术委员会
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－－－
｜31｜电子血压计 ｜产品｜制定 ｜99.2-99.12 ｜同上 ｜同上
｜ ｜ ｜ ｜ ｜ ｜ ｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－－－
｜32｜医用磁疗器具通用技 ｜产品｜制定 ｜1999-2000 ｜同上 ｜同上
｜ ｜术条件 ｜ ｜ ｜ ｜ ｜
｜ ｜ ｜ ｜ ｜ ｜ ｜
｜ ｜ ｜ ｜ ｜ ｜ ｜
－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－

－－－－－－－－－－－－－－－－－－－－－－－－－－－－
｜主要负责起草单位｜采用国际标准或国｜ 备 注 ｜
｜ ｜外先进标准编号 ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜－－－－－－－－｜
｜北京京航公司 ｜ ｜ ｜
｜ ｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜－－－－－－－－｜
｜北京京航公司 ｜ ｜ ｜
｜ ｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜－－－－－－－－｜
｜国家药品监督管理｜ISO9584: ｜等效采用 ｜
｜局天津医疗器械质｜1993-10-15 ｜ ｜
｜量监督检验中心 ｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜－－－－－－－－｜
｜同上 ｜ISO9585: ｜等效采用 ｜
｜ ｜1990-12-15 ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜－－－－－－－－｜
｜上海手术器械厂 ｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜－－－－－－－－｜
｜天津骨科器械二厂｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜－－－－－－－－｜
｜国家药品监督管理｜ ｜ ｜
｜局天津医疗器械质｜ ｜ ｜
｜量监督检验中心 ｜ ｜ ｜
｜ ｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜－－－－－－－－｜
｜柯顿（天津）电工｜IEC601-2-30 ｜ ｜
｜电器有限公司 ｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜－－－－－－－－｜
｜国家药品监督管理｜ ｜ ｜
｜局天津医疗器械质｜ ｜ ｜
｜量监督检验中心、｜ ｜ ｜
｜哈慈股份有限公司｜ ｜ ｜
－－－－－－－－－－－－－－－－－－－－－－－－－－－－
一九九九年制定、修订 强制性医疗器械标准 项目计划汇总表（ＹＹ）
－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－
｜序 ｜ 标准项目名称 ｜标准｜制定或修订 ｜ 起止年限 ｜主管部门 ｜技术委员会或技术
｜号 ｜ ｜类别｜ ｜ ｜ ｜ 归口单位
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－－－
｜33｜一次性使用去白细胞 ｜产品｜制定 ｜1999-2000 ｜国家药品监｜全国医用输液器具
｜ ｜输血过滤器 ｜ ｜ ｜ ｜督管理局 ｜标准化技术委员会
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－－－
｜34｜一次性使用血浆分离 ｜产品｜制定 ｜1999-2000 ｜同上 ｜同上
｜ ｜器 离心式 ｜ ｜ ｜ ｜ ｜
｜ ｜ ｜ ｜ ｜ ｜ ｜
｜ ｜ ｜ ｜ ｜ ｜ ｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－－－
｜35｜卫生材料通用技术条 ｜产品｜制定 ｜1999-2000 ｜同上 ｜
｜ ｜件 ｜ ｜ ｜ ｜ ｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－－－
｜36｜医用电气设备漏电流 ｜产品｜制定 ｜1999-2000 ｜同上 ｜
｜ ｜仪技术规范 ｜ ｜ ｜ ｜ ｜
｜ ｜ ｜ ｜ ｜ ｜ ｜
－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－

－－－－－－－－－－－－－－－－－－－－－－－－－－－－
｜主要负责起草单位｜采用国际标准或国｜ 备 注 ｜
｜ ｜外先进标准编号 ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜－－－－－－－－｜
｜上海血液中心 ｜ ｜ ｜
｜ ｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜－－－－－－－－｜
｜国家药品监督管理｜ ｜ ｜
｜局上海医疗器械质｜ ｜ ｜
｜量监督检验中心、｜ ｜ ｜
｜上海血液中心 ｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜－－－－－－－－｜
｜ ｜ ｜ ｜
｜ ｜ ｜ ｜
｜－－－－－－－－｜－－－－－－－－｜－－－－－－－－｜
｜北京医疗器械研究｜ ｜ ｜
｜所、中国计量科学｜ ｜ ｜
｜研究院 ｜ ｜ ｜
－－－－－－－－－－－－－－－－－－－－－－－－－－－－

附件2：一九九九年制定、修订 推荐性医疗器械标准 项目计划汇总表（ＹＹ／Ｔ）

－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－
｜序 ｜ 标准项目名称 ｜标准｜制定或修订 ｜ 起止年限 ｜主管部门 ｜技术委员会或技
｜号 ｜ ｜类别｜ ｜ ｜ ｜ 术归口单位
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－－－
｜1 ｜齿科手机－齿科用低 ｜产品｜制定 ｜1999 ｜国家药品 ｜全国口腔材料和
｜ ｜压电动机 ｜ ｜ ｜ ｜监督管理 ｜器械设备标准化
｜ ｜ ｜ ｜ ｜ ｜局 ｜技术委员会
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－－－
｜2 ｜齿科手机－齿科用气 ｜产品｜制定 ｜1999 ｜同上 ｜同上
｜ ｜动马达 ｜ ｜ ｜ ｜ ｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－－－
｜3 ｜牙医师座椅 ｜产品｜制定 ｜1999 ｜同上 ｜同上
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－－－
｜4 ｜口腔材料生物试验方 ｜方法｜制定 ｜1999.9- ｜同上 ｜同上
｜ ｜法：盖髓和切髓试验 ｜ ｜ ｜2000.12 ｜ ｜
｜ ｜ ｜ ｜ ｜ ｜ ｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－－－
｜5 ｜口腔材料生物试验方 ｜方法｜修订 ｜1999.9- ｜同上 ｜同上
｜ ｜法：溶血试验 ｜ ｜YY/T0127.1 ｜2000.12 ｜ ｜
｜ ｜ ｜ ｜-93 ｜ ｜ ｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－－－
｜6 ｜口腔材料生物试验方 ｜方法｜修订 ｜1999.9- ｜同上 ｜全国口腔材料和
｜ ｜法：静脉注射急性全 ｜ ｜YY/T0127.2 ｜2000.12 ｜ ｜器械设备标准化
｜ ｜身毒性试验 ｜ ｜-93 ｜ ｜ ｜技术委员会
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－－－
｜7 ｜血流多普勒超声体模 ｜产品｜制定 ｜1999-2000 ｜北京市医 ｜医用超声设备标
｜ ｜的技术要求 ｜ ｜ ｜ ｜药管理局 ｜准化分委员会
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－－－
｜8 ｜医用诊断Ｘ射线微型 ｜产品｜制定 ｜1998年 ｜国家药品 ｜全国医用Ｘ线设
｜ ｜机 ｜ ｜ ｜ ｜监督管理 ｜备及用具标准化
｜ ｜ ｜ ｜ ｜ ｜局 ｜分技术委员会
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－｜－－－－－｜－－－－－－－－
｜9 ｜医用Ｘ射线设备标 ｜基础｜修订 ｜1999年 ｜同上 ｜同上
｜ ｜志、包装、运输和储 ｜ ｜ ｜ ｜ ｜
｜ ｜存 ｜ ｜ ｜ ｜ ｜
－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－

－－－－－－－－－－－－－－－－－－－－－－－－－－－－－
｜主要负责起草单位 ｜采用国际标准或国外先｜ 备 注 ｜
｜ ｜ 进标准编号 ｜ ｜
｜－－－－－－－－－｜－－－－－－－－－－｜－－－－－－｜
｜上海齿科医疗器械厂｜ISO11498-1997 ｜ ｜
｜ ｜ ｜ ｜
｜ ｜ ｜ ｜
｜－－－－－－－－－｜－－－－－－－－－－｜－－－－－－｜
｜上海齿科医疗器械厂｜ISO13294-1997 ｜ ｜
｜ ｜ ｜ ｜
｜－－－－－－－－－｜－－－－－－－－－－｜－－－－－－｜
｜上海齿科医疗器械厂｜ISO6875-1995 ｜ ｜
｜－－－－－－－－－｜－－－－－－－－－－｜－－－－－－｜
｜国家药品监督管理局｜ISO7405-1997(E) ｜ ｜
｜北医医疗器械质量监｜ ｜ ｜
｜督检验中心 ｜ ｜ ｜
｜－－－－－－－－－｜－－－－－－－－－－｜－－－－－－｜
｜ ｜ISO7405-1997(E) ｜ ｜
｜ 同上 ｜ ｜ ｜
｜ ｜ ｜ ｜
｜－－－－－－－－－｜－－－－－－－－－－｜－－－－－－｜
｜ ｜ISO7405-1997(E) ｜ ｜
｜ 同上 ｜ ｜ ｜
｜ ｜ ｜ ｜
｜－－－－－－－－－｜－－－－－－－－－－｜－－－－－－｜
｜中国科学院声学研究｜参照IEC1685/CD ｜ ｜
｜所 ｜ ｜ ｜
｜－－－－－－－－－｜－－－－－－－－－－｜－－－－－－｜
｜国家药品监督管理局｜ ｜接 转 ｜
｜沈阳医疗器械质量监｜ ｜（98） ｜
｜督检验中心 ｜ ｜ ｜
｜－－－－－－－－－｜－－－－－－－－－－｜－－－－－－｜
｜国家药品监督管理局｜ ｜调为行标 ｜
｜沈阳医疗器械质量监｜ ｜ ｜
｜督检验中心 ｜ ｜ ｜
－－－－－－－－－－－－－－－－－－－－－－－－－－－－－
一九九九年制定、修订 推荐性医疗器械标准 项目计划汇总表（ＹＹ／Ｔ）
－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－
｜序 ｜ 标准项目名称 ｜标准｜ 制订或修 ｜ 起止年限 ｜主管部门 ｜技术委员会或技
｜号 ｜ ｜类别｜ 订 ｜ ｜ ｜ 术归口单位
｜ ｜ ｜ ｜ ｜ ｜ ｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－－｜－－－－－｜－－－－－－－－
｜10｜医疗器械－与医疗器械 ｜基础｜制定 ｜1999.5-2000.2 ｜国家药品 ｜CSBTS/TC221
｜ ｜标签、作标记和提供信息 ｜ ｜ ｜ ｜监督管理 ｜
｜ ｜一起使用的符号 ｜ ｜ ｜ ｜局 ｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－－｜－－－－－｜－－－－－－－－
｜11｜医疗器械－医疗器械安 ｜基础｜制定 ｜1999.6-2000.4 ｜同上 ｜CSBTS/TC221
｜ ｜全和性能的公认基本原 ｜ ｜ ｜ ｜ ｜
｜ ｜则的保障标准选用指南 ｜ ｜ ｜ ｜ ｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－－｜－－－－－｜－－－－－－－－
｜12｜手术器械标志 ｜基础｜修订 ｜1999-2000 ｜同上 ｜全国外科器械标
｜ ｜ ｜ ｜ZBC30001 ｜ ｜ ｜准化技术委员会
｜ ｜ ｜ ｜-84 ｜ ｜ ｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－－｜－－－－－｜－－－－－－－－
｜13｜血液分析专用试剂－ ｜产品｜制订 ｜1999.4- ｜同上 ｜全国医用临床检
｜ ｜1、溶血剂 ｜ ｜ ｜2000.12 ｜ ｜验实验室和体外
｜ ｜2、稀释剂 ｜ ｜ ｜ ｜ ｜诊断系统标准化
｜ ｜3、清洗 ｜ ｜ ｜ ｜ ｜技术委员会
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－－｜－－－－－｜－－－－－－－－
｜14｜诊断试剂分类管理目录 ｜产品｜制定 ｜1999.4-2000.6 ｜同上 ｜同上
｜ ｜ ｜ ｜ ｜ ｜ ｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－－｜－－－－－｜－－－－－－－－
｜15｜中频治疗仪 ｜产品｜ZBC42002 ｜99年底 ｜同上 ｜全国医用电器标
｜ ｜ ｜ ｜-89 ｜ ｜ ｜准化技术委员会
｜ ｜ ｜ ｜ ｜ ｜ ｜物理治疗设备标
｜ ｜ ｜ ｜ ｜ ｜ ｜准化分技术委员
｜ ｜ ｜ ｜ ｜ ｜ ｜会
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－－｜－－－－－｜－－－－－－－－
｜16｜肌电生物反馈仪 ｜产品｜ZBC42002 ｜99年底 ｜同上 ｜同上
｜ ｜ ｜ ｜-89 ｜ ｜ ｜
－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－

－－－－－－－－－－－－－－－－－－－－－－－－－－－－－
｜主要负责起草单位 ｜采用国际标准 ｜ 备 注 ｜
｜ ｜或国外先进标 ｜ ｜
｜ ｜ 准编号 ｜ ｜
｜－－－－－－－－－｜－－－－－－－－｜－－－－－－－－｜
｜中国医疗器械质量 ｜ISO/DIS 15223 ｜采用快速程 ｜
｜认证中心 ｜ ｜序 ｜
｜ ｜ ｜ ｜
｜－－－－－－－－－｜－－－－－－－－｜－－－－－－－－｜
｜中国医疗器械质量 ｜ISO/DIS 16142 ｜采用快速程 ｜
｜认证中心 ｜ ｜序 ｜
｜ ｜ ｜ ｜
｜－－－－－－－－－｜－－－－－－－－｜－－－－－－－－｜
｜国家药品监督管理 ｜ ｜ ｜
｜局上海医疗器械质 ｜ ｜ ｜
｜量监督检验中心 ｜ ｜ ｜
｜－－－－－－－－－｜－－－－－－－－｜－－－－－－－－｜
｜国家药品监督管理 ｜ ｜ ｜
｜局北京医疗器械质 ｜ ｜ ｜
｜量监督检验中心 ｜ ｜ ｜
｜ ｜ ｜ ｜
｜－－－－－－－－－｜－－－－－－－－｜－－－－－－－－｜
｜ ｜ ｜快速程序 ｜
｜ 同上 ｜ ｜ ｜
｜－－－－－－－－－｜－－－－－－－－｜－－－－－－－－｜
｜国家药品监督管理 ｜ ｜ ｜
｜局天津医疗器械质 ｜ ｜ ｜
｜量监督检验中心 ｜ ｜ ｜
｜ ｜ ｜ ｜
｜ ｜ ｜ ｜
｜－－－－－－－－－｜－－－－－－－－｜－－－－－－－－｜
｜同上 ｜ ｜ ｜
｜ ｜ ｜ ｜
－－－－－－－－－－－－－－－－－－－－－－－－－－－－－
一九九九年制定、修订 推荐性医疗器械标准 项目计划汇总表（ＹＹ／Ｔ）
－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－
｜序 ｜ 标准项目名称 ｜标准｜ 制定或修订｜ 起止年限 ｜主管部门 ｜技术委员会或技
｜号 ｜ ｜类别｜ ｜ ｜ ｜ 术归口单位
｜ ｜ ｜ ｜ ｜ ｜ ｜
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－－｜－－－－－｜－－－－－－－－
｜17｜温度生物反馈仪 ｜产品｜ZBC42005- ｜99年底 ｜国家药品 ｜全国医用电器标
｜ ｜ ｜ ｜89 ｜ ｜监督管理 ｜准化技术委员会
｜ ｜ ｜ ｜ ｜ ｜局 ｜物理治疗设备标
｜ ｜ ｜ ｜ ｜ ｜ ｜准化分技术委员
｜ ｜ ｜ ｜ ｜ ｜ ｜会
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－－｜－－－－－｜－－－－－－－－
｜18｜热垫式治疗仪 ｜产品｜YY0165-94 ｜99年底 ｜同上 ｜同上
｜－－｜－－－－－－－－－－－－｜－－｜－－－－－－｜－－－－－－－｜－－－－－｜－－－－－－－－
｜19｜电动按摩椅 ｜产品｜修订 ｜99年底 ｜同上 ｜同上
｜ ｜ ｜ ｜ZBC42006- ｜ ｜ ｜
｜ ｜ ｜ ｜90 ｜ ｜ ｜
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｜20｜硬膜外麻醉包 ｜产品｜制定 ｜1999-2000 ｜同上 ｜全国麻醉和呼吸
｜ ｜ ｜ ｜ ｜ ｜ ｜设备标准化技术
｜ ｜ ｜ ｜ ｜ ｜ ｜委员会
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｜主要负责起草单位 ｜采用国际标准 ｜ 备 注 ｜

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