放射性药品管理办法(附英文)
国务院
放射性药品管理办法(附英文)
1989年1月13日，国务院
第一章 总 则
第一条 为了加强放射性药品的管理，根据《中华人民共和国药品管理法》（以下称《药品管理法》）的规定，制定本办法。
第二条 放射性药品是指用于临床诊断或者治疗的放射性核素制剂或者其标记药物。
第三条 凡在中华人民共和国领域内进行放射性药品的研究、生产、经营、运输、使用、检验、监督管理的单位和个人都必须遵守本办法。
第四条 卫生部主管全国放射性药品监督管理工作。能源部主管放射性药品生产、经营管理工作。
第二章 放射性新药的研制、临床研究和审批
第五条 放射性新药是指我国首次生产的放射性药品。药品研制单位的放射性新药年度研制计划，应当报送能源部备案，并报所在地的省、自治区、直辖市卫生行政部门，经卫生行政部门汇总后，报卫生部备案。
第六条 放射性新药的研制内容，包括工艺路线、质量标准、临床前药理及临床研究。研制单位在制订新药工艺路线的同时，必须研究该药的理化性能、纯度（包括核素纯度）及检验方法、药理、毒理、动物药代动力学、放射性比活度、剂量、剂型、稳定性等。
研制单位对放射免疫分析药盒必须进行可测限度、范围、待异性、准确度、精密度、稳定性等方法学的研究。
放射性新药的分类，按新药审批办法的规定办理。
第七条 研制单位研制的放射性新药，在进行临床试验或者验证前，应当向卫生部提出申请，按新药审批办法的规定报送资料及样品，经卫生部审批同意后，在卫生部指定的医院进行临床研究。
第八条 研制单位在放射性新药临床研究结束后，向卫生部提出申请，经卫生部审核批准，发给新药证书。卫生部在审核批准时，应当征求能源部的意见。
第九条 放射性新药投入生产，需由生产单位或者取得放射性药品生产许可证的研制单位，凭新药证书（副本）向卫生部提出生产该药的申请，并提供样品，由卫生部审核发给批准文号。
第三章 放射性药品的生产、经营和进出口
第十条 放射性药品生产、经营企业，必须向能源部报送年度生产、经营计划，并抄报卫生部。
第十一条 国家根据需要，对放射性药品实行合理布局，定点生产。申请开办放射性药品生产、经营的企业，应征得能源部的同意后，方可按照有关规定办理筹建手续。
第十二条 开办放射性药品生产、经营企业，必须具备《药品管理法》第五条规定的条件，符合国家的放射卫生防护基本标准，并履行环境影响报告的审批手续，经能源部审查同意，卫生部审核批准后，由所在省、自治区、直辖市卫生行政部门发给《放射性药品生产企业许可证》、《派湫砸┢肪笠敌砜芍ぁ贰Ｎ扌砜芍さ纳⒕笠担宦刹蛔忌⑾鄯派湫砸┢贰?
第十三条 《放射性药品生产企业许可证》、《放射性药品经营企业许可证》的有效期为五年，期满前六个月，放射性药品生产、经营企业应当分别向原发证的卫生行政部门重新提出申请，按第十二条审批程序批准后，换发新证。
第十四条 放射性药品生产企业生产已有国家标准的放射性药品，必须经卫生部征求能源部意见后审核批准，并发给批准文号。凡是改变卫生部已批准的生产工艺路线和药品标准的，生产单位必须按原报批程序经卫生部批准后方能生产。
第十五条 放射性药品生产、经营企业，必须配备与生产、经营放射性药品相适应的专业技术人员。具有安全、防护和废气、废物、废水处理等设施。并建立严格的质量管理制度。
第十六条 放射性药品生产、经营企业，必须建立质量检验机构，严格实行生产全过程的质量控制和检验。产品出厂前，须经质量检验。符合国家药品标准的产品方可出厂，不符合标准的产品一律不准出厂。
经卫生部审核批准的含有短半衰期放射性核素的药品，可以边检验边出厂，但发现质量不符合国家药品标准时，该药品的生产企业应当立即停止生产、销售，并立即通知使用单位停止使用，同时报告卫生部和能源部。
第十七条 放射性药品的生产、供销业务由能源部统一管理。放射性药品的生产、经营单位和医疗单位凭省、自治区、直辖市卫生行政部门发给的《放射性药品生产企业许可证》、《放射性药品经营企业许可证》，医疗单位凭省、自治区、直辖市公安、环保和卫生行政部门联合发给的《放射性药品使用许可证》，申请办理订货。
第十八条 放射性药品的进出口业务，由对外经济贸易部指定的单位，按照国家有关对外贸易的规定办理。
进出口放射性药品，应当报卫生部审批同意后，方得办理进出口手续。
进口的放射性药品品种，必须符合我国的药品标准或者其他药用要求。
第十九条 进口放射性药品，必须经中国药品生物制品检定所或者卫生部授权的药品检验所抽样检验；检验合格的，方准进口。
对于经卫生部审核批准的短半衰期放射性核素的药品，在保证安全使用的情况下，可以采取边进口检验，边投入使用的办法。进口检验单位发现药品质量不符合要求时，应当立即通知使用单位停止使用，并报告卫生部和能源部。
第四章 放射性药品的包装和运输
第二十条 放射性药品的包装必须安全实用，符合放射性药品质量要求，具有与放射性剂量相适应的防护装置。包装必须分内包装和外包装两部分，外包装必须贴有商标、标签、说明书和放射性药品标志，内包装必须贴有标签。
标签必须注明药品品名、放射性比活度、装量。
说明书除注明前款内容外，还须注明生产单位、批准文号、批号、主要成份、出厂日期、放射性核素半衰期、适应症、用法、用量、禁忌症、有效期和注意事项等。
第二十一条 放射性药品的运输，按国家运输、邮政等部门制订的有关规定执行。
严禁任何单位和个人随身携带放射性药品乘坐公共交通运输工具。
第二十二条 医疗单位设置核医学科、室（同位素室），必须配备与其医疗任务相适应的并经核医学枝术培训的技术人员。非核医学专业技术人员未经培训，不得从事放射性药品使用工作。
第二十三条 医疗单位使用放射性药品，必须符合国家放射性同位素卫生防护管理的有关规定。所在地的省、自治区、直辖市的公安、环保和卫生行政部门，应当根据医疗单位核医疗技术人员的水平、设备条件，核发相应等级的《放射性药品使用许可证》，无许可证的医疗单位不得临床使用放射性药品。
《放射性药品使用许可证》有效期为五年，期满前六个月，医疗单位应当向原发证的行政部门重新提出申请，经审核批准后，换发新证。
第二十四条 持有《放射性药品使用许可证》的医疗单位，在研究配制放射性制剂并进行临床验证前，应当根据放射性药品的持点，提出该制剂的药理、毒性等资料，由省、自治区、直辖市卫生行政部门批准，并报卫生部备案。该制剂只限本单位内使用。
第二十五条 持有《放射性药品使用许可证》的医疗单位，必须负责对使用的放射性药品进行临床质量检验，收集药品不良反应等项工作，并定期向所在地卫生行政部门报告。由省、自治区、直辖市卫生行政部门汇总后报卫生部。
第二十六条 放射性药品使用后的废物（包括患者排出物），必须按国家有关规定妥善处置。
第五章 放射性药品标准和检验
第二十七条 放射性药品的国家标准，由卫生部药典委员会负责制定和修订，报卫生部审批颁发。
第二十八条 放射性药品的检验由中国药品生物制品检定所或者卫生部授权的药品检验所承担。
第六章 附 则
第二十九条 对违反本办法规定的单位或者个人，由县以上卫生行政部门，按照《药品管理法》和有关法规的规定处罚。
第三十条 本办法由卫生部负责解释。
第三十一条 本办法自发布之日起施行。
MEASURES FOR THE CONTROL OF RADIOACTIVE DRUGS
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)
MEASURES FOR THE CONTROL OF RADIOACTIVE DRUGS
(Promulgated by Decree No. 25 of the State Council of the People's
Republic of China on January 13, 1989 and effective as of the date of
promulgation)
Chapter I General Provisions
Article 1
These Measures are formulated to strengthen the control of radioactive
drugs in accordance with Pharmaceutical Administration Law of the People's
Republic of China (hereinafter referred to as the Pharmaceutical
Administration Law)
Article 2
"Radioactive drugs" refer to any forms of radionuclide or their tagged
drugs that are used for clinical diagnosis or in radiotherapy.
Article 3
All units or individuals in the People's Republic of China are required to
abide by these Measures when they are engaged in research work,
production, business, transportation, consumption, examination,
supervision and administration work related to radioactive drugs.
Article 4
The Ministry of Public Health is in charge of the supervisory and
administrative work of radioactive drugs while the Ministry of Energy is
in charge of the administration work concerning the production and sale of
radioactive drugs.
Chapter II Examination and Approval for the Development and Cli- nical Research of New Radioactive Drugs
Article 5
"New radioactive drugs" refer to those radioactive drugs that are made in
China for the first time. The annual plan of any drug research units for
the development of new radioactive drugs must be submitted to both the
Ministry of Energy for the record and to the health administration
department at the provincial, autonomous regional or municipal (directly
under the Central Government) level. Then an itemized plan made by the
latter shall be presented to the Ministry of Public Health for the record.
Article 6
The development of a new kind of radioactive drug includes the research
work in its technological process, quality requirements,
preclinicopharmacological study and clinical study;
The research unit, when designing the technological process for a new
drug, must study the physical and chemical properties, purity (including
pureness of radionuclide), testing method, pharmacology, toxicity, nuclein
animal dynamics, radiospecific activity, dosage, pharmaceutical forms and
stability of that radioactive drug. Furthermore, the research unit must
make a study of radio-immunity analysis container with respect to its
scalability, range, specificity, accuracy, precision and stability.
New kinds of radioactive drugs shall be classified in accordance with the
provisions for the examination and approval of new pharmaceuticals.
Article 7
Before the newly developed radioactive drug is put to clinical test or
verification, an application together with the data and sample must be
submitted to the Ministry of Public Health in accordance with the
provisions for the examination and approval of new pharmaceuticals.
The newly developed radioactive drug may be used for clinical study at an
appointed hospital only after its application has been examined and
approved by the Ministry of Public Health.
Article 8
After completion of clinical study of a newly developed radioactive drug,
the research unit must submit an application to the Ministry of Public
Health for examination and approval.
The latter shall consult the Ministry of Energy before granting a New Drug
License.
Article 9
Before a newly developed radioactive drug is put to production, the
production unit or the research unit that holds a license for the
production of radioactive drugs must submit an application together with a
copy of New Drug License and sample to the Ministry of Public Health.
After examination and verification, the Ministry of Public Health shall
issue them document of approval.
Chapter III The Production, Sales, Import and Export of Radio- active Drugs
Article 10
The enterprises that produce or sell radioactive drugs are required to
submit their production plan and business plan to the Ministry of Energy
and a duplicate to the Ministry of Public Health.
Article 11
The State shall, according to the actual conditions, make sure that
radioactive drugs be produced at designated pharmaceutical factories which
shall be located rationally over the country. Applications for the setting
up of any enterprises to produce or sell radioactive drugs must be
approved by the Ministry of Energy before the preparations start in
accordance with related provisions.
Article 12
Requirements for the setting up of enterprises to produce or sell
radioactive drugs are that they must have the necessary conditions as
stipulated in Article 5 of the Pharmaceutical Administration Law and that
they must meet the essential standard of radio hygiene protection set by
the State. They are also required to submit a report on environment impact
to the Ministry of Energy and the Ministry of Public Health for
examination and approval and then the health administration department in
their province, autonomous region or municipality directly under the
Central Government shall issue them "License for the Production Enterprise
of Radioactive Drugs", "License for the Business Enterprise of Radioactive
Drugs". No enterprises without the license shall be permitted to engage in
the production or sale of radioactive drugs.
Article 13
The term of validity of "License for the Production Enterprise of
Radioactive Drugs" and "License for the Business Enterprise of Radioactive
Drugs" is five years. If needed, the enterprises engaged in the production
or sale of radioactive drugs shall make a new application six months
before the expiration to the health administration department which shall,
in accordance with Article 12 of these Provisions, issue them a new
license.
Article 14
Before an approved pharmaceutical enterprise produces radioactive drugs
with specifications already set by the State, it must forward an
application which has to be examined and approved by the Ministry of
Public Health in conjunction with the Ministry of Energy. If any changes
in the technological process and specifications of the drugs previously
approved by the Ministry of Public Health are to be made, the
pharmaceutical factory shall be required to go through the same procedures
for approval.
Article 15
The production and business enterprises of radioactive drugs are required
to employ technical personnel who are qualified for the work and to have
safety and protection facilities as well as waste gas, liquid and material
disposal facilities. They must also have a strict quality control system.
Article 16
The production and business enterprises of radioactive drugs are required
to set up quality inspection offices. The entire process of production
must be put under strict qualify control and inspection.
All radioactive drugs are subject to quality testing. Only the products
that meet the State pharmaceutical standard shall be allowed to be shipped
out from the factories. Products that are not up to the standard are not
allowed out of the factory. As for the drugs with short half-life
radionuclide previously approved by the Ministry of Public Health, they
may be shipped out from the factory while having sample testing. If the
drugs are found to be below the State pharmaceutical standard, the factory
must stop the production and sale of the drugs immediately and inform
consuming units to stop using the drugs without delay. A report about the
case must be submitted to both the Ministry of Public Health and the
Ministry of Energy.
Article 17
The production, supply and sale of radioactive drugs are under the unified
administration of the Ministry of Energy.
When ordering these stuff, the pharmaceutical factory must furnish a
License for the Production Enterprise of Radioactive Drugs while the
business unit must present a License for the Business Enterprise of
Radioactive Drugs issued by the health administration department at the
provincial, autonomous regional or municipal (directly under the Central
Government) level. As for the medical treatment unit, they must order
these drugs with a License for the Use of Radioactive Drugs jointly issued
by the public security department, the environment protection department
and health administration department at the provincial, autonomous
regional or the municipal (directly under the Central Government) level.
Article 18
The import and export business of radioactive drugs shall be handled by
the units appointed by the Ministry of Foreign Economic Relations and
Trade in accordance with the State provisions related to foreign trade.
Prior to the import or export of radioactive drugs, an application must be
made and be examined and approved by the Ministry of Public Health.
Imported radioactive drugs are required to meet the State standards for
pharmaceuticals or other medical requirements.
Article 19
Imported radioactive drugs are subject to sample examination by the State
Administration for the Inspection and Testing of Pharmaceuticals and
Biological Products or by an inspection and testing institution of
pharmaceuticals authorized by the Ministry of Public Health. Only those
drugs that have met the State standards are allowed to be imported. As for
the drugs with short half-life radionuclide previously approved by the
Ministry of Public Health, they may be put to use upon being shipped in
while having import inspection. If the import inspection unit finds the
quality of imported drugs not up to the standard, they must inform the
consuming units promptly to stop using the drugs. A report about the
quality problem must be submitted to both the Ministry of Public Health
and the Ministry of Energy.
Chapter IV The Packaging and Shipment of Radioactive Drugs
Article 20
The packaging of radioactive drugs must be safe and reliable, and up to
the standards for the quality requirements of radioactive drug. There must
be protection devices that will match different radio dosages. The
packaging is required to consist of packing and inner packaging. There
must be trade mark, label, specifications and marker of radioactive drugs
on the packing and a label on the inner packaging. On the label there must
be name of the drug, radiospecific activity and packings.
The specifications must indicate the name of the producer, license number,
batch number, main composition, date of manufacture, half-life of
radionuclide, indications, administration, dosage, contraindication,
expiry date and precautions in addition to name of the drug, radioapecific
activity and packings.
Article 21
The shipment of radioactive drugs shall be handled in accordance with the
rules formulated by the State transportation and postal departments. No
unit or person shall be allowed to carry along radioactive drugs on any
means of public transportation.
Chapter V The Use of Radioactive Drugs
Article 22
If a medical treatment unit desires to set up a radiologic department or a
radioisotope department, it is required to employ technical personnel who
are qualified for radiotherapeutic work after special technical training.
Without prior technical training no personnel shall be allowed to use the
drugs in radiotherapy.
Article 23
When a medical treatment unit uses radioactive drugs, it must observe the
rules formulated by the State concerning radioisotope hygiene and
protection. The health administration department, the public security
department and the environment protection department at provincial,
autonomous regional or municipal (directly under the Central Government)
level shall issue a certain grade of License for the Use of Radioactive
Drugs according to technical skill and professional level of the
radiological personnel and equipment of the medical treatment unit. No
medical treatment unit without a license is allowed to use radioactive
drugs clinically.
The term of validity of a License for the Use of Radioactive Drugs is 5
years. If needed, the medical treatment unit must make a new application 6
months before the expiration of its license to the health administration
department which, after examination and verification shall issue it a new
license.
Article 24
Before a medical treatment unit holding a License for the Use of
Radioactive Drugs starts the preparation of any forms of radioactive drug
for clinical use, it is required to submit an application with the data
concerning pharmacology and toxicity of the radioactive drug, according to
the characteristics of the radioactive drug, to the health administration
department at the provincial, autonomous regional or municipal (directly
under the Central Government) level for approval and to the Ministry of
Public Health for the record. That form of radioactive drug can be used
only in the medical treatment unit.
Article 25
The medical treatment units that hold a License for the Use of Radioactive
Drugs are required to conduct clinical quality testing of the radioactive
drugs and find out their undesirable reactions and submit regular reports
to the health administration department. The health administration
department at the provincial, autonomous regional or municipal (directly
under the Central Government) level shall then present an itemized report
to the Ministry of Public Health.
Article 26
Waste material of radioactive drugs (including patients' excrement) must
be properly disposed of in accordance with the State regulations.
Chapter VI The Standards for Radioactive Drugs and Their Testing
Article 27
The Pharmacopoeia Commission under the Ministry of Public Health is
entrusted to formulate and revise the State standards for radioactive
drugs and then submit it to the Ministry of Public Health for examination
and approval before it is promulgated.
Article 28
The State Administration for the Inspection and Testing of Pharmaceuticals
and Biological Products or an inspection and testing institution of
pharmaceuticals authorized by the Ministry of Public Health is entrusted
to inspect and examine radioactive drugs.
Chapter VII Supplementary Provisions
Article 29
Any unit or individual that violates these Measures shall be penalized by
the health administration department at or above the county level in
accordance with the Pharmaceutical Administration Law and other rules and
regulations.
Article 30
The right to interpret these Measures resides in the Ministry of Public
Health.
Article 31
These Measures shall go into effect as of the date of promulgation.
档案管理规范编写规则
机械部
档案管理规范编写规则
1994年5月4日，机械部
本规则参照ＧＢ1．1一87《标准化工作导则 标准编写的基本规定》结合我部档案管理规范编写的实际情况制定的。
1 主题内容与适用范围
本规则规定了档案管理规范编写的基本要求、规则的构成、 条文的编排。
本规则适用于编写机械行业、企业、事业单位的档案管理规范。
2 引用标准
ＧＢ1．1《标准化工作导则 标准编写的基本规定》
3 档案管理规范编写的基本要求
3．1 贯彻国家有关政策，法令和法规，与同级有关标准相协调， 下级标准不得与上级标准相抵触。
3．2 规范的文字表达应准确、简明、易懂、逻辑严谨， 避免产生不易理解或不同理解的可能性。标准的图样、表格、 数值和其他管理内容应正确无误。
3．3 规范中的术语、符号、代号应统一，并与其他的有关标准一致。同一术语应表达同一概念，同一概念应采用同一术语来表达。 类似部分应采用相同的表达形式与措词。
4 档案管理规范的构成
档案管理规范的一般构成和编写顺序如下：
┍━ 封面与首页（见5．1条）
概述部分━━━┥ 目次（见5．2条）
│ 规范名称（见5．3条）
┕━ 引言（见5．4条）
┍━主题内容与适用范围（见6．1条）
│ 引用标准及法规文件（见6．2条）
正文部分 ━━━┥ 术语、符号、代号（见6．3条）
│ 管理规范内容（见6．4条）
┕━检查与考核（见6．5条）
┍━附录（见7．1条）
补充部分 ━━━┥
┕━附加说明（见7．2条）
上述构成部分不是任何一项档案管理规范都需要全部包括的。 一项档案管理规范究竟应包括其中的哪些部分，可根据实际情况确定。
5 概述部分
5．1 封面与首页
规范的封面、首页及内页应符合ＧＢ1．2的规定， 当规范的印刷为合订本时、可设封面。
5．2 目次
5．2．1 当规范的内容较长、结构复杂、条文较多（一般印刷在15页以上）时应编写目次。
5．2．2 目次的内容包括篇、章和附录的编号、标题以及所在页码。标题及页码之间用符号“……连接。
5．2．3 目次中所引标准正文标题的页码应加圆括号。目次应另编页码，不与规范正文的页码连续。
5．3．1 规范名称应简短明确地反映规范化对象或规范的主题。必要时，应在规范化对象前加说明部分以明确其他相类似标准的区别。
例：科学技术档案案卷构成的一般要求
（说明部分）
5．3．2 规范名称一般由规范化对象的名称和所规定的管理特征两部分组成，如果两部分连起来不通顺，可在两者之间留一字的位置，不用破折号，在封面和首页可写成两行。
例：标准化工作导则 标准编写的基本规定
5．3．3 规范化对象的名称过长时，在规范正文的叙述中可用简称，但在第一次出现全称时用括号加以说明。
例：《工业企业档案分类试行规则》（以下简称“规则”）。
5．4 引言
引言一般不写标题，也不编号。其内容包括：制定规范的依据，目的，执行本规范的原则和需要在引言中表述的其他内容。 如这些内容不需说明时，引言可省略。
6 正文部分
6．1 主题内容与适用范围
6．1．1 主题内容
简明说明规范的主要内容（一般在50字以下）
一般采用下列典型用语：
“本规范规定了……。”
6．1．2 适用范围
主要规定了规范适用范围或应用领域，必要时， 还应明确写出不适用范围或领域。
“本规范适用于……。”
“本规范适用于……，……可参照使用。”
“本规范适用于……也适用于……。”
“本规范不适用于……。”
6．2 引用标准与法规文件
说明档案管理规范中直接引用和必须配合使用的标准。 应写明标准号和名称，必须遵照的法规文件应写明发文机关、发文字号及题名。
6．3 术语、符号、代号
管理规范中使用的术语、符号、代号， 必要时应同时写明其定义或说明。
6．4 管理规范内容
6．4．1 管理规范的内容，应根据各类档案管理规范对象的特点和需要进行编写。
6．4．2 应明确规定该规范涉及的管理职能及业务范围，写明所管理的事项由哪些部门主管，其他部门或基层单位应负责哪些工作。
6．4．3 应明确档案管理工作的数量、质量、期限、程序、方法的要求以及有关责任单位的协作方式和互相制约的关系、制约方式， 工作中遇有矛盾的处理方式等。需要信息管理反馈时，应规定信息反馈的渠道、 内容、方式和处理程序。
6．5 检查与考核
规定有关部门完成的期限、数量和质量检查与考核的方法。
7 补充部分
7．1 附录
7．1．1 根据实际需要编制档案管理规范附录。附录分为“补充件”和“参考件”两种，按补充件在前，参考件在后顺序编排， 并分别在目次中、条文中和附录标题下方写明。
7．1．2 “补充件”附录，主要是指对管理标准内容所作的补充，相当于管理内容的一个组成部分。能直接写入正文的尽量不编写附录。
7．1．3 “参考件”附录，主要是帮助理解管理规范的内容。以便正确掌握和使用规范。
“参考件”附录。主要内容包括：
Ａ．规范中重要规定的依据和有关问题的系统介绍；
Ｂ．规范中有关条文的参考性资料或推荐性方法；
Ｃ．正确使用规范的说明等。
7．2 附加说明
“附加说明”分段写在规范终结线的下面。主要内容如下：
本规范由××单位提出。
本规范主要起草人或单位。
本规范由××单位负责解释。
8 档案管理规范条文的编排及编号
8．1 档案管理规范按其内容分为若干章。第一层次为章， 以下层次统为条。层次划分一般不超过四节。
8．2 章．条层次的编号方法采用阿拉伯数字， 每两个层次之间加圆点。圆点加在数字右下角，编号方法加附录一（补充件）所示。
8．3 章，条的编号应左起顶格书写。有标题时， 在编号后空一十字的位置再写标题，另起一行写具体内容。无标题时， 在编号之后空一个字的位置再写具体内容。
8．4 标准条文的编排及编号格式如附册二（补充件）所示。
9 终结线
在附加说明前，版面的中间划一条粗实线作为终结线。 其长度约为版面宽度的1／4。
附录一 档案管理规范层次编号示例（补充件）
┍━ ┍ 1 ┍6.4.3.1
│ │ 2 ┍6.1 │6.4.3.2
│ │ 3 │6.2 ┍6.4.1 │6.4.3.3
│ │ 4 │6.3 │6.4.2 │6.4.3.4
│ │ 5 │6.4━┥6.4.3━┥6.4.3.5
│ │ 6 ┥6.5 │6.4.4 │6.4.3.6
│第一篇━┥ 7 │ ┕6.4.5 │6.4.3.7
│ │ 8 ┕6.6 ┕6.4.3.8
│ │
│ ┕ 9
│
正文部分┥ ┍12.3.1 ┍12.3.5.1
│ ┍10 │12.3.2 │12.3.5.2
│ │11 ┍12.1 │12.3.3 │12.3.5.3
│ │ │12.2 │12.3.4 │12.3.5.4
│ │12━┥12.3━┥12.3.5━┥12.3.5.5
│第二篇━┥13 │12.4 │12.3.6 │12.3.5.6
│ │14 ┕12.5 │12.3.7 ┕12.3.5.7
│ │15 ┕12.3.8
│ ┕16
┕━
┍附录A ┍B1 ┍B2.1 ┍B2.2.1
补充部分━┥附录B━┥B2━┥ │B2.2.2
┕附录C ┕B3 ┕B2.2━┥B2.2.3 ┍B2.2.4.1
│B2.2.4━┥B2.2.4.2
┕B2.2.5 ┕B2.2.4.3
注：
1．引言部分可有可无。
2．当规范不设篇时，去掉篇的编号，即为不设篇的规范的层次编号。
附录二 档案管理规范条文排列格式示例
（补充件）
┍━━━━━━━━━━━━━━━━━━━━━━━┑
│ （引言） │
┕━━━━━━━━━━━━━━━━━━━━━━━┙
1 （章的标题）
┍━━━━━━━━━━━━━━━━━━━━━━━┑
┕━━━━━━━━━━━━━━━━━━━━━━━┙
┍━━━━━━━━━━┑
┕━━━━━━━━━━┙
1．1（条的标题）
┍━━━━━━━━━━━━━━━━━━━━━━━┑
┕━━━━━━━━━━━━━━━━━━━━━━━┙
┍━━━━━━━━━━┑
┕━━━━━━━━━━┙
1．2（条的标题）
1．2．1 ┍━━━━━━━━━━━━━━━━━━━━━━┑
┕━━━━━━━━━━━━━━━━━━━━━━┙
┍━━━━━━━━━━┑
┕━━━━━━━━━━┙
1．2．2┍━━━━━━━━━━━━━━━━━━━━━━┑
┕━━━━━━━━━━━━━━━━━━━━━━┙
1．2．2．1┍━━━━━━━━━━━━━━━━━━━━┑
┕━━━━━━━━━━━━━━━━━━━━┙
┍━━━━━━━━━━━┑
┕━━━━━━━━━━━┙
1．2．2．2
┍━━━━━━━━━━━━━━━━━━━━━━━━━━━┑
┕━━━━━━━━━━━━━━━━━━━━━━━━━━━┙
2（章的标题）
2．1（条的标题）
2．1．1（条的标题）
┍━━━━━━━━━━━━━━━━━━━━━━━┑
┕━━━━━━━━━━━━━━━━━━━━━━━┙
┍━━━━━━━━━━━━━━━┑
┕━━━━━━━━━━━━━━━┙
2．1．2（条的标题）
┍━━━━━━━━━━━━━━━━━━━━┑
┕━━━━━━━━━━━━━━━━━━━━┙
2．2（条的标题）
2．2．1┍━━━━━━━━━━━━━━━━━━━━━━┑
┕━━━━━━━━━━━━━━━━━━━━━━┙
┍━━━━━━━━━━━━━━┑
┕━━━━━━━━━━━━━━┙
2．2．2┍━━━━━━━━━━━━━━━━━━━━━━┑
┕━━━━━━━━━━━━━━━━━━━━━━┙
2．3（条的标题）
┍━━━━━━━━━━━━━━━━━━━━━━━━━┑
┕━━━━━━━━━━━━━━━━━━━━━━━━━┙
┍━━━━━━━━━━━━━━━┑
┕━━━━━━━━━━━━━━━┙
注：①┍━━━━━━━━━┑
┕━━━━━━━━━┙
②┍━━━━━━━━━┑
┕━━━━━━━━━┙
1） ┍━━━━━━━━━┑
┕━━━━━━━━━┙
3（章的标题）
3．1（条的标题）
┍━━━━━━━━━━━━━━━━━━━━━━━┑
┕━━━━━━━━━━━━━━━━━━━━━━━┙
┍━━━━━━━━┑
┕━━━━━━━━┙
ａ．┍━━━━━━━━━━━━━━━━━━━━━━━━┑
┕━━━━━━━━━━━━━━━━━━━━━━━━┙
ｂ．┍━━━━━━━━━━━━━━━━━━━━━━━━┑
┕━━━━━━━━━━━━━━━━━━━━━━━━┙
┍━━━━━━━┑
┕━━━━━━━┙
3．2（条的标题）
┍━━━━━━━━━━━━━━━━━━━━━━━━━━┑
┕━━━━━━━━━━━━━━━━━━━━━━━━━━┙
━━━━━━━━━━━━━━━━
附加说明：
本规范由机械部办公厅档案处组织起草
本规范主要起草人：傅代秀、郭建平、刘文义、黄建德
