国务院


中华人民共和国标准化法实施条例(附英文)

1990年4月6日，国务院

第一章 总则
第一条 根据《中华人民共和国标准化法》（以下简称《标准化法》）的规定，制定本条例。
第二条 对下列需要统一的技术要求，应当制定标准：
（一）工业产品的品种、规格、质量、等级或者安全、卫生要求；
（二）工业产品的设计、生产、试验、检验、包装、储存、运输、使用的方法或者生产、储存、运输过程中的安全、卫生要求；
（三）有关环境保护的各项技术要求和检验方法；
（四）建设工程的勘察、设计、施工、验收的技术要求和方法；
（五）有关工业生产、工程建设和环境保护的技术术语、符号、代号、制图方法、互换配合要求；
（六）农业（含林业、牧业、渔业，下同）产品（含种子、种苗、种畜、种禽，下同）的品种、规格、质量、等级、检验、包装、储存、运输以及生产技术、管理技术的要求；
（七）信息、能源、资源、交通运输的技术要求。
第三条 国家有计划地发展标准化事业。标准化工作应当纳入各级国民经济和社会发展计划。
第四条 国家鼓励采用国际标准和国外先进标准，积极参与制定国际标准。

第二章 标准化工作的管理
第五条 标准化工作的任务是制定标准、组织实施标准和对标准的实施进行监督。
第六条 国务院标准化行政主管部门统一管理全国标准化工作，履行下列职责：
（一）组织贯彻国家有关标准化工作的法律、法规、方针、政策；
（二）组织制定全国标准化工作规划、计划；
（三）组织制定国家标准；
（四）指导国务院有关行政主管部门和省、自治区、直辖市人民政府标准化行政主管部门的标准化工作，协调和处理有关标准化工作问题；
（五）组织实施标准；
（六）对标准的实施情况进行监督检查；
（七）统一管理全国的产品质量认证工作；
（八）统一负责对有关国际标准化组织的业务联系。
第七条 国务院有关行政主管部门分工管理本部门、本行业的标准化工作，履行下列职责：
（一）贯彻国家标准化工作的法律、法规、方针、政策，并制定在本部门、本行业实施的具体办法；
（二）制定本部门、本行业的标准化工作规划、计划；
（三）承担国家下达的草拟国家标准的任务，组织制定行业标准；
（四）指导省、自治区、直辖市有关行政主管部门的标准化工作；
（五）组织本部门、本行业实施标准；
（六）对标准实施情况进行监督检查；
（七）经国务院标准化行政主管部门授权，分工管理本行业的产品质量认证工作。
第八条 省、自治区、直辖市人民政府标准化行政主管部门统一管理本行政区域的标准化工作，履行下列职责：
（一）贯彻国家标准化工作的法律、法规、方针、政策，并制定在本行政区域实施的具体办法；
（二）制定地方标准化工作规划、计划；
（三）组织制定地方标准；
（四）指导本行政区域有关行政主管部门的标准化工作，协调和处理有关标准化工作问题；
（五）在本行政区域组织实施标准；
（六）对标准实施情况进行监督检查。
第九条 省、自治区、直辖市有关行政主管部门分工管理本行政区域内本部门、本行业的标准化工作，履行下列职责：
（一）贯彻国家和本部门、本行业、本行政区域标准化工作的法律、法规、方针、政策，并制定实施的具体办法；
（二）制定本行政区域内本部门、本行业的标准化工作规划、计划；
（三）承担省、自治区、直辖市人民政府下达的草拟地方标准的任务；
（四）在本行政区域内组织本部门、本行业实施标准；
（五）对标准实施情况进行监督检查。
第十条 市、县标准化行政主管部门和有关行政主管部门的职责分工，由省、自治区、直辖市人民政府规定。

第三章 标准的制定
第十一条 对需要在全国范围内统一的下列技术要求，应当制定国家标准（含标准样品的制作）：
（一）互换配合、通用技术语言要求；
（二）保障人体健康和人身、财产安全的技术要求；
（三）基本原料、燃料、材料的技术要求；
（四）通用基础件的技术要求；
（五）通用的试验、检验方法；
（六）通用的管理技术要求；
（七）工程建设的重要技术要求；
（八）国家需要控制的其他重要产品的技术要求。
第十二条 国家标准由国务院标准化行政主管部门编制计划，组织草拟，统一审批、编号、发布。
工程建设、药品、食品卫生、兽药、环境保护的国家标准，分别由国务院工程建设主管部门、卫生主管部门、农业主管部门、环境保护主管部门组织草拟、审批；其编号、发布办法由国务院标准化行政主管部门会同国务院有关行政主管部门制定。
法律对国家标准的制定另有规定的，依照法律的规定执行。
第十三条 对没有国家标准而又需要在全国某个行业范围内统一的技术要求，可以制定行业标准（含标准样品的制作）。制定行业标准的项目由国务院有关行政主管部门确定。
第十四条 行业标准由国务院有关行政主管部门编制计划，组织草拟，统一审批、编号、发布，并报国务院标准化行政主管部门备案。
行业标准在相应的国家标准实施后，自行废止。
第十五条 对没有国家标准和行业标准而又需要在省、自治区、直辖市范围内统一的工业产品的安全、卫生要求，可以制定地方标准。制定地方标准的项目，由省、自治区、直辖市人民政府标准化行政主管部门确定。
第十六条 地方标准由省、自治区、直辖市人民政府标准化行政主管部门编制计划，组织草拟，统一审批、编号、发布，并报国务院标准化行政主管部门和国务院有关行政主管部门备案。
法律对地方标准的制定另有规定的，依照法律的规定执行。
地方标准在相应的国家标准或行业标准实施后，自行废止。
第十七条 企业生产的产品没有国家标准、行业标准和地方标准的，应当制定相应的企业标准，作为组织生产的依据。企业标准由企业组织制定（农业企业标准制定办法另定），并按省、自治区、直辖市人民政府的规定备案。
对已有国家标准、行业标准或者地方标准的，鼓励企业制定严于国家标准、行业标准或者地方标准要求的企业标准，在企业内部适用。
第十八条 国家标准、行业标准分为强制性标准和推荐性标准。
下列标准属于强制性标准：
（一）药品标准，食品卫生标准，兽药标准；
（二）产品及产品生产、储运和使用中的安全、卫生标准，劳动安全、卫生标准，运输安全标准；
（三）工程建设的质量、安全、卫生标准及国家需要控制的其他工程建设标准；
（四）环境保护的污染物排放标准和环境质量标准；
（五）重要的通用技术术语、符号、代号和制图方法；
（六）通用的试验、检验方法标准；
（七）互换配合标准；
（八）国家需要控制的重要产品质量标准。
国家需要控制的重要产品目录由国务院标准化行政主管部门会同国务院有关行政主管部门确定。
强制性标准以外的标准是推荐性标准。
省、自治区、直辖市人民政府标准化行政主管部门制定的工业产品的安全、卫生要求的地方标准，在本行政区域内是强制性标准。
第十九条 制定标准应当发挥行业协会、科学技术研究机构和学术团体的作用。
制定国家标准、行业标准和地方标准的部门应当组织由用户、生产单位、行业协会、科学技术研究机构、学术团体及有关部门的专家组成标准化技术委员会，负责标准草拟和参加标准草案的技术审查工作。未组成标准化技术委员会的，可以由标准化技术归口单位负责标准草拟和参加标准草案的技术审查工作。
制定企业标准应当充分听取使用单位、科学技术研究机构的意见。
第二十条 标准实施后，制定标准的部门应当根据科学技术的发展和经济建设的需要适时进行复审。标准复审周期一般不超过五年。
第二十一条 国家标准、行业标准和地方标准的代号、编号办法，由国务院标准化行政主管部门统一规定。
企业标准的代号、编号方法，由国务院标准化行政主管部门会同国务院有关行政主管部门规定。
第二十二条 标准的出版、发行办法，由制定标准的部门规定。

第四章 标准的实施与监督
第二十三条 从事科研、生产、经营的单位和个人，必须严格执行强制性标准。不符合强制性标准的产品，禁止生产、销售和进口。
第二十四条 企业生产执行国家标准、行业标准、地方标准或企业标准，应当在产品或其说明书、包装物上标注所执行标准的代号、编号、名称。
第二十五条 出口产品的技术要求由合同双方约定。
出口产品在国内销售时，属于我国强制性标准管理范围的，必须符合强制性标准的要求。
第二十六条 企业研制新产品、改进产品、进行技术改造，应当符合标准化要求。
第二十七条 国务院标准化行政主管部门组织或授权国务院有关行政主管部门建立行业认证机构，进行产品质量认证工作。
第二十八条 国务院标准化行政主管部门统一负责全国标准实施的监督。国务院有关行政主管部门分工负责本部门、本行业的标准实施的监督。
省、自治区、直辖市标准化行政主管部门统一负责本行政区域内的标准实施的监督。省、自治区、直辖市人民政府有关行政主管部门分工负责本行政区域内本部门、本行业的标准实施的监督。
市、县标准化行政主管部门和有关行政主管部门，按照省、自治区、直辖市人民政府规定的各自的职责，负责本行政区域内的标准实施的监督。
第二十九条 县级以上人民政府标准化行政主管部门，可以根据需要设置检验机构，或者授权其他单位的检验机构，对产品是否符合标准进行检验和承担其他标准实施的监督检验任务。检验机构的设置应当合理布局，充分利用现有力量。
国家检验机构由国务院标准化行政主管部门会同国务院有关行政主管部门规划、审查。地方检验机构由省、自治区、直辖市人民政府标准化行政主管部门会同省级有关行政主管部门规划、审查。
处理有关产品是否符合标准的争议，以本条规定的检验机构的检验数据为准。
第三十条 国务院有关行政主管部门可以根据需要和国家有关规定设立检验机构，负责本行业、本部门的检验工作。
第三十一条 国家机关、社会团体、企业事业单位及全体公民均有权检举、揭发违反强制性标准的行为。

第五章 法律责任
第三十二条 违反《标准化法》和本条例有关规定，有下列情形之一的，由标准化行政主管部门或有关行政主管部门在各自的职权范围内责令限期改进，并可通报批评或给予责任者行政处分：
（一）企业未按规定制定标准作为组织生产依据的；
（二）企业未按规定要求将产品标准上报备案的；
（三）企业的产品未按规定附有标识或与其标识不符的；
（四）企业研制新产品、改进产品、进行技术改造，不符合标准化要求的；
（五）科研、设计、生产中违反有关强制性标准规定的。
第三十三条 生产不符合强制性标准的产品的，应当责令其停止生产，并没收产品，监督销毁或作必要技术处理；处以该批产品货值金额百分之二十至百分之五十的罚款；对有关责任者处以五千元以下罚款。
销售不符合强制性标准的商品的，应当责令其停止销售，并限期追回已售出的商品，监督销毁或作必要技术处理；没收违法所得；处以该批商品货值金额百分之十至百分之二十的罚款；对有关责任者处以五千元以下罚款。
进口不符合强制性标准的产品的，应当封存并没收该产品，监督销毁或作必要技术处理；处以进口产品货值金额百分之二十至百分之五十的罚款；对有关责任者给予行政处分，并可处以五千元以下罚款。
本条规定的责令停止生产、行政处分，由有关行政主管部门决定；其他行政处罚由标准化行政主管部门和工商行政管理部门依据职权决定。
第三十四条 生产、销售、进口不符合强制性标准的产品，造成严重后果，构成犯罪的，由司法机关依法追究直接责任人员的刑事责任。
第三十五条 获得认证证书的产品不符合认证标准而使用认证标志出厂销售的，由标准化行政主管部门责令其停止销售，并处以违法所得二倍以下的罚款；情节严重的，由认证部门撤销其认证证书。
第三十六条 产品未经认证或者认证不合格而擅自使用认证标志出厂销售的，由标准化行政主管部门责令其停止销售，处以违法所得三倍以下的罚款，并对单位负责人处以五千元以下罚款。
第三十七条 当事人对没收产品、没收违法所得和罚款的处罚不服的，可以在接到处罚通知之日起十五日内，向作出处罚决定的机关的上一级机关申请复议；对复议决定不服的，可以在接到复议决定之日起十五日内，向人民法院起诉。当事人也可以在接到处罚通知之日起十五日内，直接向人民法院起诉。当事人逾期不申请复议或者不向人民法院起诉又不履行处罚决定的，由作出处罚决定的机关申请人民法院强制执行。
第三十八条 本条例第三十二条至第三十六条规定的处罚不免除由此产生的对他人的损害赔偿责任。受到损害的有权要求责任人赔偿损失。赔偿责任和赔偿金额纠纷可以由有关行政主管部门处理，当事人也可以直接向人民法院起诉。
第三十九条 标准化工作的监督、检验、管理人员有下列行为之一的，由有关主管部门给予行政处分，构成犯罪的，由司法机关依法追究刑事责任：
（一）违反本条例规定，工作失误，造成损失的；
（二）伪造、篡改检验数据的；
（三）徇私舞弊、滥用职权、索贿受贿的。
第四十条 罚没收入全部上缴财政。对单位的罚款，一律从其自有资金中支付，不得列入成本。对责任人的罚款，不得从公款中核销。

第六章 附则
第四十一条 军用标准化管理条例，由国务院、中央军委另行制定。
第四十二条 工程建设标准化管理规定，由国务院工程建设主管部门依据《标准化法》和本条例的有关规定另行制定，报国务院批准后实施。
第四十三条 本条例由国家技术监督局负责解释。
第四十四条 本条例自发布之日起施行。(附英文)

REGULATIONS FOR THE IMPLEMENTATION OF THE STANDARDIZATION LAW OFTHE PEOPLE'S REPUBLIC OF CHINA

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)
REGULATIONS FOR THE IMPLEMENTATION OF THE STANDARDIZATION LAW OF
THE PEOPLE'S REPUBLIC OF CHINA
(Promulgated by Decree No. 53 of the State Council of the People's
Republic of China on April 6, 1990 and effective as of the date of
promulgation)

Chapter I General Provisions
Article 1
These Regulations are formulated in accordance with the provisions of the
Standardization Law of the People's Republic of China (hereinafter
referred to as the Standardization Law).
Article 2
Standards should be formulated for the following technical requirements
that need to be unified:
(1) varieties, specifications, quality and grades of industrial products
or requirements pertinent to safety and hygiene;
(2) methods for design, production, experimentation, examination, packing,
storage, transportation and utilization of industrial products or
requirements pertinent to safety and hygiene in the course of production,
storage and transportation;
(3) various technical requirements and methods for examination concerning
environmental protection;
(4) technical requirements and methods for surveying, designing,
construction and examination and acceptance in building projects;
(5) technical terms, symbols, codes, drafting methods and requirements for
conversion and coordination concerning industrial production, project
construction and environmental protection;
(6) varieties, specifications, quality, grades, examination, packing,
storage, transportation and requirements for production technology and
management expertise concerning agricultural products (including seeds,
seedlings, breeding stock and breeding poultry and those in forestry,
animal husbandry and fishery; the same below);
(7) technical requirements concerning information, energy, resources, and
transport.
Article 3
The State develops standardization undertakings in a planned way.
Standardization work should be included in the plans for national economic
and social development at the various levels.
Article 4
The State encourages the adoption of international standards and advanced
standards abroad and takes an active part in the formulation of
international standards.

Chapter II Administration of Standardization Work
Article 5
The task for those who are in charge of standardization work is:
formulating standards, organizing the implementation of standards and
exercising supervision over the implementation of standards.
Article 6
The competent department in charge of standardization under the State
Council exercises unified leadership over the standardization work
throughout the country, and it performs the following duties:
(1) organizing the implementation of the State's laws, regulations,
policies and measures concerning standardization;
(2) organizing the formulation of programmes and plans concerning
standardization work in the whole country;
(3) organizing the formulation of national standards;
(4) providing guidance to the relevant competent departments under the
State Council and administrative departments for standardization work in
the people's governments in the provinces, autonomous regions and the
municipalities directly under the Central Government in their
standardization work, and coordinating work in this field and dealing with
problems arising therein;
(5) organizing the implementation of standards;
(6) conducting supervision over and inspection on the implementation of
standards;
(7) exercising unified leadership over attestation of product quality in
the whole country;
(8) taking overall responsibility for professional contacts with the
relevant international standardization organizations.
Article 7
The relevant competent departments under the State Council are responsible
for the standardization work in their own departments or trades. They
shall perform the following duties:
(1) implementing the State's laws, regulations, policies and measures
concerning standardization work and formulating specific procedures for
their implementation in their departments and trades;
(2) formulating programmes and plans concerning standardization work in
their departments and trades;
(3) undertaking tasks assigned by the State of drafting state standards
and organizing the formulation of the standards in their respective
trades;
(4) providing guidance to the relevant competent authorities in the
provinces, autonomous regions and municipalities directly under the
Central Government in their standardization work;
(5) organizing the implementation of the standards in their departments
and trades;
(6) conducting supervision over and inspection on the implementation of
standards;
(7) taking charge of attestation of product quality in their own trades on
the authorization from the competent department in charge of
standardization under the State Council.
Article 8
The administrative departments for standardization in the people's
governments in the provinces, autonomous regions and municipalities
directly under the Central Government exercise unified leadership over
standardization work in their respective administrative regions, and shall
perform the following duties:
(1) implementing the State's laws, regulations, policies and measures
concerning standardization work and formulating specific procedures for
their implementation in their respective administrative regions;
(2) formulating local programmes and plans concerning standardization
work;
(3) organizing the formulation of local standards;
(4) providing guidance to the relevant administrative authorities in their
own administrative regions in their standardization work, and coordinating
work in this field and dealing with problems arising therein;
(5) organizing the implementation of the standards in their respective
administrative regions;
(6) conducting supervision over and inspection on the implementation of
the standards.
Article 9
The relevant competent administrative authorities in the provinces,
autonomous regions and municipalities directly under the Central
Government are responsible for the standardization work in their own
departments and trades in the respective administrative regions, and shall
perform the following duties:
(1) implementing the laws, regulations, policies and measures concerning
standardization work formulated by the State and their respective
departments, trades and administrative regions and formulating specific
procedures for their implementation;
(2) formulating programmes and plans concerning standardization work for
their own departments and trades in the respective administrative regions;
(3) undertaking the tasks of drafting local standards assigned by the
people's governments in the provinces, autonomous regions and
municipalities directly under the Central Government;
(4) organizing the implementation of the standards in their own
departments and trades in the respective administrative regions;
(5) conducting supervision over and inspection on the implementation of
the standards.
Article 10
The division of the duties of the administrative departments in charge of
standardization and the relevant competent administrative authorities in
municipalities and counties shall be stipulated by the people's
governments in the provinces, autonomous regions and municipalities
directly under the Central Government.

Chapter III The Formulation of Standards
Article 11
National standards (including making sample standards) should be
formulated for the following technical requirements that need to be
unified throughout the country:
(1) requirements for standardizing commonly used technical terms;
(2) technical requirements for guaranteeing human health and personal and
property safety;
(3) technical requirements for essential raw materials, fuels and
processed materials;
(4) technical requirements for commonly used basic spare parts;
(5) commonly used methods of experimentation and examination;
(6) technical requirements for commonly used management expertise;
(7) important technical requirements in project construction;
(8) technical requirements for the other important products that must be
controlled by the State.
Article 12
In formulating national standards, the administrative department in charge
of standardization under the State Council shall be responsible for making
plans, organizing drafting, examination and approval, numbering and
promulgation. In formulating national standards for project construction,
pharmaceuticals, food hygiene, veterinary medicine and environmental
protection, the competent departments in charge of project construction,
public health, agriculture and environmental protection under the State
Council shall be responsible for organizing drafting and examination and
approval in their respective departments. The procedures for numbering and
promulgation shall be formulated by the administrative department in
charge of standardization under the State Council in conjunction with the
relevant competent departments under the State Council.
Where there are, in law, provisions different from those above for the
formulation of national standards, those provisions in law shall prevail.
Article 13
If there are no national standards for those technical requirements which
need to be standardized for certain trades throughout the country, trade
standards (including the making of sample standards) may be formulated.
Items of trade standards to be formulated shall be determined by the
relevant competent administrative departments under the State Council.
Article 14
In formulating trade standards, the relevant competent administrative
departments under the State Council shall be responsible for drawing up
plans, organizing drafting, examination and approval, numbering and
promulgation and they should report to the administrative department in
charge of standardization under the State Council for the record.
Trade standards shall be null and void automatically after the
corresponding national standards have taken effect.
Article 15
Local standards may be formulated for the safety and sanitation
requirements for industrial goods which need to be unified in the
provinces, autonomous regions and municipalities directly under the
Central Government, in the absence of national standards or trade
standards for them. Items of local standards to be formulated shall be
determined by the administrative departments for standardization of the
people's governments in the provinces, autonomous regions and
municipalities directly under the Central Government.
Article 16
In formulating local standards, the administrative departments for
standardization of the people's governments in the provinces, autonomous
regions and municipalities directly under the Central Government shall be
responsible for drawing up plans, organizing drafting, examination and
approval, numbering and promulgation, and they should report to the
administrative department in charge of standardization under the State
Council and the relevant competent departments under the Council for the
record. Where there are, in law, provisions different from those above
for the formulation of local standards, those provisions in law shall
prevail.
Local standards shall be null and void automatically after the
corresponding national standards or trade standards go into effect.
Article 17
In the absence of national standards, trade standards and local standards
for certain products, the enterprises producing such products shall
formulate their own standards as the basis for organizing production.
Enterprise standards shall be formulated by the relevant enterprises
themselves (procedures for formulating standards for agricultural
enterprises shall be provided for separately), and shall be filed for the
record in accordance with the provisions of the people's governments in
the provinces, autonomous regions and municipalities directly under the
Central Government.
Where there are already national standards, trade standards and local
standards, enterprises should be encouraged to formulate enterprise
standards which are stricter than the corresponding national, trade or
local standards and apply them within their enterprises.
Article 18
National standards and trade standards are divided into compulsory
standards and recommendatory standards.
The following standards belong in the compulsory category:
(1) standards for pharmaceuticals, food hygiene and veterinary medicine;
(2) safety and hygiene standards for products and the production, storage
and transportation and utilization of products; standards for the safety
of labour and hygiene standards and safety standards for transportation;
(3) quality, safety and sanitation standards for project construction and
other standards for project construction that must be controlled by the
State;
(4) standards for the discharge of pollutants concerning environmental
protection and standards for environmental quality;
(5) important technical terms, symbols, codes and drafting methods in
common use;
(6) standards for commonly used methods of experimentation and
examination;
(7) standards for conversion and coordination;
(8) quality standards for the important products which need to be
controlled by the State. The catalogue of the important products which
need to be controlled by the State shall be fixed by the administrative
department for standardization under the State Council in conjunction with
the relevant competent administrative departments under the State Council.
Those standards which are not compulsory are recommendatory standards.
The local standards for safety and hygiene requirements for industrial
products formulated by the administrative departments in charge of
standardization of the people's governments in the provinces, autonomous
regions and municipalities directly under the Central Government are
compulsory standards in their respective administrative regions.
Article 19
Trade associations, research institutions for science and technology, and
academic organizations should be given a role to play in formulating
standards. The departments responsible for formulating national, trade
and local standards should set up standardization technical committees
consisting of experts from users, production units, trade associations,
research institutions for science and technology, academic organizations
and the departments concerned, which shall be responsible for drafting
standards and examining the technical aspects of the drafts. Where
standardization technical committees have not been set up, the units
charged with specific responsibility for standardization technology may
take charge of drafting standards and examining the technical aspects of
the drafts.
It is necessary to heed fully the opinions of the users and research
institutions for science and technology in formulating enterprise
standards.
Article 20
After standards go into effect, the departments which formulated the
standards shall carry out timely reexaminations in light of the
development of science and technology and the needs of economic
construction. Normally, reexamination should be conducted every five
years, at the longest.
Article 21
The procedures of coding and numbering for national, trade and local
standards shall be provided for by the administrative department in charge
of standardization under the State Council.
The procedures of coding and numbering for enterprise standards shall be
provided for by the administrative department in charge of standardization
under the State Council in conjunction with the relevant competent
administrative departments under the State Council.
Article 22
The procedures of publication and distribution of standards shall be
stipulated by the departments which have formulated the standards.

Chapter IV Implementation and Supervision Concerning Standards
Article 23
Any units and individuals that are engaged in scientific research,
production and operation must strictly implement compulsory standards. The
products which do not measure up to compulsory standards may not be
allowed to be produced, marketed or imported.
Article 24
Enterprises may go by the national, trade and local standards or
enterprise standards in production. The codes, serial numbers and names of
the standards should be marked on their products, or written in the
technical manuals or on the packages.
Article 25
The technical requirements for export products shall be agreed upon by the
two contracting parties.
When those export products which should be subject to compulsory standards
of China are sold at domestic markets, they must meet the requirements of
the relevant compulsory standards.
Article 26
Enterprises should meet standardization requirements in developing new
products, improving products or carrying out technical innovations.
Article 27
The administrative department in charge of standardization under the State
Council organizes or authorizes the relevant competent departments under
the State Council to set up trade attestation agencies for carrying out
product quality attestation.
Article 28
The administrative department in charge of standardization under the State
Council shall be responsible for the supervision over the implementation
of standards throughout the country. The relevant administrative
departments under the State Council shall be responsible for the
supervision over the implementation of the standards in their respective
departments and trades.
The administration departments for standardization in the provinces,
autonomous regions and municipalities directly under the Central
Government shall be responsible for the supervision over the
implementation of the standards in their respective administrative areas.
The relevant administrative authorities in the people's governments in the
provinces, autonomous regions and municipalities directly under the
Central Government shall be responsible for the supervision over the
implementation of the standards in their departments and trades in the
respective administrative areas.
The administrative departments for standardization and the relevant
administrative authorities in municipalities and counties shall be
responsible for the supervision over the implementation of the standards
in their respective administrative areas according to the duties assigned
to them by the people's governments of the provinces, autonomous regions
and municipalities directly under the Central Government.
Article 29
The administrative departments in charge of standardization in the
people's governments above county level may, according to their needs, set
up examination agencies or authorize the examination agencies of other
units to ensure products are up to the standards and undertake other tasks
of supervision and examination concerning the implementation of standards
in setting up examination agencies, attention should be paid to a rational
geographical allocation and making full use of the available personnel and
facilities.
The establishment of state examination agencies shall be planned and
examined by the administrative department in charge of standardization
under the State Council in conjunction with the relevant administrative
departments under the State Council. The establishment of local
examination agencies shall be planned and examined by the administrative
departments in charge of standardization in the people's governments of
the provinces, autonomous regions and municipalities directly under the
Central Government in conjunction with the relevant administrative
authorities at provincial level. The data provided by the examination
agencies stipulated in this Article shall be taken as the criterion in
solving disputes over whether certain products are up to the relevant

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卫生部办公厅


卫生部办公厅关于加强非结核分枝杆菌医院感染预防与控制工作的通知

卫办医政发〔2010〕88号


各省、自治区、直辖市卫生厅局，新疆生产建设兵团卫生局：

非结核分枝杆菌是自然界中广泛存在的一种条件致病菌，存在于水、土壤和气溶胶中，可以导致免疫力低下的患者发生感染。近年来，部分基层医疗机构发生因手术器械、注射器具及医疗用水等灭菌不合格、使用不规范造成患者手术切口、注射部位非结核分枝杆菌感染暴发事件，对患者健康造成危害，对社会造成不良影响。为进一步加强非结核分枝杆菌医院感染的预防与控制工作，保障医疗安全，现将有关要求通知如下：

一、高度重视非结核分枝杆菌医院感染预防与控制工作

医疗机构应当高度重视非结核分枝杆菌医院感染的预防与控制工作，加强组织领导，强化安全意识，严格执行《医院感染管理办法》及有关医院感染控制的技术和标准，明确并落实各部门预防和控制医院感染的职责，建立医院感染管理责任制。针对非结核分枝杆菌流行病学特点及医院感染预防与控制的各个环节，制定并完善相应的规章制度和工作规范，切实从管理及技术等方面采取有效措施，加强管理。

二、采取有效措施预防和控制非结核分枝杆菌医院感染

（一）加强重点部门的医院感染控制工作。医疗机构应当加大对重症监护病房（ICU）、手术室、新生儿室、血液透析室、内镜诊疗中心（室）、消毒供应中心、治疗室等医院感染重点部门的管理。贯彻落实《重症医学科建设与管理指南（试行）》、《医院手术部（室）管理规范（试行）》、《新生儿病室建设与管理指南（试行）》、《医疗机构血液透析室管理规范》、《医院消毒供应中心管理规范》等有关技术规范和标准，健全规章制度、细化工作规范、落实各项措施，保证医疗安全。

（二）加强手术器械等医疗用品的消毒灭菌工作。消毒灭菌是预防和控制非结核分枝杆菌医院感染的重要措施。医疗机构要按照《医院感染管理办法》、《消毒管理办法》等有关规定，切实做好手术器械、注射器具及其他侵入性医疗用品的消毒灭菌工作。对耐高温、耐高湿的医疗器械、器具和用品应当首选压力蒸汽灭菌，尽量避免使用液体化学消毒剂进行浸泡灭菌。使用的消毒药械、一次性医疗器械、器具和用品应当符合国家有关规定。一次性使用的医疗器械、器具和用品不得重复使用。进入人体组织和无菌器官的相关医疗器械、器具及用品必须达到灭菌水平，接触皮肤、粘膜的相关医疗器械、器具及用品必须达到消毒水平。

（三）规范使用医疗用水、无菌液体和液体化学消毒剂。医疗机构应当遵循无菌技术操作规程，规范使用医疗用水、无菌液体和液体化学消毒剂等，防止二次污染。氧气湿化瓶、雾化器、呼吸机、婴儿暖箱的湿化装置应当使用无菌水。各种抽吸的输注药液或者溶媒等开启后应当注明时间，规范使用，并避免患者共用。无菌液体开启后超过24小时不得使用。需要使用液体化学消毒剂时，要保证其使用方法、浓度、消毒时间等符合有关规定。同时加强对使用中的液体化学消毒剂的浓度监测。

（四）严格执行无菌技术操作规程。医疗机构医务人员实施手术、注射、插管及其他侵入性诊疗操作技术时，应当严格遵守无菌技术操作规程和手卫生规范，避免因医务人员行为不规范导致患者发生感染，降低因医疗用水、医疗器械和器具使用及环境和物体表面污染导致的医院感染。

（五）加强医院感染监测工作。医疗机构要加强重点部门（重症监护病房（ICU）、手术室、新生儿室、血液透析室、内镜诊疗中心（室）、消毒供应中心等），重点部位（导管相关性血流感染、外科手术部位感染等）以及关键环节（各种手术、注射、插管、内镜诊疗操作等）医院感染监测工作，及时发现、早期诊断感染病例。特别是医疗机构发生聚集性、难治性手术部位或注射部位感染时，应当及时进行非结核分枝杆菌的病原学检测及抗菌药物敏感性、耐药模式的监测，根据监测结果指导临床及时应用抗菌药物，有效控制非结核分枝杆菌医院感染。

医疗机构发生非结核分枝杆菌感染的暴发时，应当按照《医院感染管理办法》、《医院感染暴发报告及处置管理规范》等有关规定进行报告。

三、加强对医务人员的培训

医疗机构应当加强对全体医务人员医院感染预防与控制知识的培训，特别要加大对一线医务人员非结核分枝杆菌医院感染预防与控制措施的培训力度，强化防控意识，加大对消毒灭菌、无菌技术操作、手卫生及隔离等措施的落实力度，提高医务人员有效预防和控制医院感染的工作能力和处置能力，切实保障医疗安全。

四、加强对医疗机构的管理

地方各级卫生行政部门应当高度重视非结核分枝杆菌医院感染预防与控制工作，加强对各级各类医疗机构特别是基层医疗机构的管理、检查和指导，加大对医务人员特别是一线医务人员的培训力度，保证医疗机构预防、控制医院感染的各项工作措施落到实处，保障医疗安全。

各省级卫生行政部门医院感染质量控制中心及相关机构要协助卫生行政部门对辖区内医疗机构非结核分枝杆菌医院感染预防与控制进行质量评估和检查指导，促进医院感染预防与控制工作持续改进。

二Ｏ一Ｏ年五月二十二日