GB 18871-2002 PDF in English
GB 18871-2002 (GB18871-2002) PDF English
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Basic standards for protection against ionizing radiation and for the safety of radiation sources
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Standards related to (historical): GB 18871-2002
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GB 18871-2002: PDF in English GB 18871-2002
National Standard of the People’s Republic of China
ICS 13.280
F 73
Replacing GB4792−1984, GB8703−1988
Basic Standards for Protection Against Ionizing Radiation and for
the Safety of Radiation Sources
ISSUE ON: OCTOBER 8, 2002
IMPLEMENTED ON: APRIL 1, 2003
Issued by: General Administration of Quality Supervision, Inspection and Quarantine
of the People’s Republic of China
Table of Contents
Foreword..... 3
1 Scope ..... 4
2 Definitions .... 4
3 General Requirements ..... 4
4 Major Requirement for Practice ......... 7
5 Major Requirement for Intervention ....... 14
6 Control of Occupational Exposure .... 16
7 Control of Medical Exposure ...... 24
8 Control of Public Exposure ......... 32
9 Control of Potential Exposure -- Safety of Source ....... 37
10 Intervention of Emergency Exposure Condition ....... 43
11 Intervention of Prolonged Exposure Condition... 47
Appendix A (Normative) Exemptions ..... 50
Appendix B (Normative) Dose Limits and Control Level of Surface Contamination ..... 58
Appendix C (Normative) Classification of Working Spaces with Unsealed Sources ..... 194
Appendix D (Normative) Toxicity Grouping of Radionuclides ..... 195
Appendix E (Normative) Dose Level of Expected Intervention in Any Case and the Intervention
Level and Action Level Under Emergency Exposure Condition ......... 198
Appendix F (Normative) Sign and Warning Sign of Ionizing Radiation ... 201
Appendix G (Informative) Guidance Level for Medical Exposure of Radiodiagnosis and Nuclear
Medicine Diagnosis ..... 202
Appendix H (Informative) Action Level Under Prolonged Exposure Condition .... 206
Appendix J (Normative) Terms and Definitions ....... 207
Basic Standards for Protection Against Ionizing Radiation and for the
Safety of Radiation Sources
1 Scope
This standard specifies the basic requirements of ionizing radiation protection and radiation
source safety (hereinafter referred to as “protection and safety”).
This standard is applicable to the protection of ionizing radiation exposure received by personnel
in practice and intervention as well as source safety in practice.
This standard is not applicable to the protection for detriment to personnel possibly caused by
nonionizing radiation (such as microwave, ultraviolet, visible light and infrared radiation).
2 Definitions
See Appendix J (Normative) for the terms and definitions adopted by this standard.
3 General Requirements
3.1 Application
3.1.1 Practice
The practice applicable to this standard shall include:
a) Source production and radiation or radioactive substance application in medical, industry,
agriculture or teaching and research, including various activities related to application involved or
possibly involved in radiation or radioactive substance exposure;
b) Generation of nuclear energy, including various activities involved or possibly involved in
radiation or radioactive substance exposure in nuclear fuel cycle;
c) Practice involved in natural source exposure and controlled according to regulatory authority
specification;
d) Other practices specified by regulatory authority.
3.1.2 Source
3.1.2.1 The source applicable to the requirements of this standard for practice shall include:
a) Radioactive substance and component containing radioactive substance or generating radiation,
including consumer product, sealed source, unsealed source and radiation generator;
b) Device and facility with radioactive substance and equipment generating radiation, including
irradiation installations, mine or mill processing radioactive ores, installation processing radioactive
substances, nuclear installation and radioactive waste management facility;
c) Other sources specified by regulatory authority.
3.1.2.2 The requirements of this standard shall be applied to each radiation source in device or
facility; if necessary, the requirements of this standard shall be applied to whole device or facility
considered as single source according to regulatory authority specification.
3.1.3 Exposure
3.1.3.1 It shall be the exposure applicable to the requirements of this standard for practice, and shall
refer to occupational exposure, medical exposure or public exposure caused by relevant practice or
source in practice, including normal exposure and potential exposure.
3.1.3.2 Under general condition, the natural source exposure shall be considered as a kind of prolonged
exposure; if necessary, the requirements for intervention of this standard shall be followed. Under the
following various conditions, the requirements for intervention of this standard shall be followed if it
is not eliminated or the relevant practice or source is not exempted:
a) Public exposure caused by discharge of effluent generated by practice of natural sources or
radioactive waste disposal;
b) Occupational exposure of worker caused by exposure of natural sources under the following
conditions:
1) Radon exposure of worker owing to working demand or direct relation with working,
regardless if the exposure is higher or lower than the action level of remedial action under
prolonged exposure condition of radon in working space [see Appendix H (Informative)];
2) Though the radon exposure of worker during working is not regular, the exposure size
is higher than the action level of remedial action under prolonged exposure condition of
radon in working space [see Appendix H (Informative)];
3) Exposure of natural sources received by operating personnel during jet airplane flight
process;
c) Exposure of other natural sources specified by regulatory authority and needed to follow the
requirements of this standard for practice.
3.1.4 Intervention
3.1.4.1 The intervention conditions applicable to this standard shall be:
a) Emergency exposure condition requiring adopting protective action, including:
1) Accident conditions and emergency circumstances have implemented emergency plan
or emergence program;
2) Other any emergency exposure condition having the justifiable reason to carry out
intervention confirmed by regulatory authority or intervening organization;
b) Prolonged exposure condition requiring adopting remedial action, including:
1) Exposure of natural sources, such as radon exposure in building and working space;
2) Exposure of radioactive survivor caused by departed incident and exposure of radioactive
survivor caused by departed practice and source utilization without notification and
approval system control (see 4.2.1 and 4.2.2);
3) Other any prolonged exposure condition having the justifiable reason to carry out
intervention confirmed by regulatory authority or intervening organization.
3.2 Excluding
Any exposure condition essentially incapable control for size or possibility of exposure through
this standard requirement implementation, such as the exposure caused by 40K in human body and
cosmic ray reaching earth surface shall not be applicable this standard, and shall be excluded in the
application scope of this standard.
3.3 Responsible Party of Implementation and Responsibility
3.3.1 Responsible party
3.3.1.1 The responsible party (hereinafter referred to as “main responsible party) undertaking main
responsibility for the implementation of this standard shall be:
a) Registrant and licensee;
b) Employer.
3.3.1.2 Other related parties shall undertake the respective corresponding responsibility for the
implementation of this standard, and other related parties may include:
a) Supplier;
b) Worker;
c) Radiation protection officer;
d) Medical practitioner;
e) Health professional;
f) Qualified expert;
g) Any other parties entrusted with specific responsibility by main responsible party.
3.3.2 Responsibility
3.3.2.1 Each responsible party shall undertake general responsibility and specific responsibility
specified in the relevant chapters and articles of this standard.
3.3.2.2 The general responsibility undertaken by main responsible party shall be:
a) Establishing protection and safety target meeting relevant requirements of this standard;
b) Establishing and implementing written protection and safety outline, and this outline shall be
corresponding with risk property and degree of responsible practice and intervention, and sufficiently
guarantee to meet the relevant requirements of this standard. This outline shall:
1) Determine measures and resources required by realizing protection and safety target,
and guarantee to correctly implement these measures and provide these resources;
2) Maintain the regular examination for these measures and resources, and periodically
check the realization of protection and safety target;
3) Identify any invalidity or defect of protection and safety measures and resources, and
take steps to rectify and prevent secondary occurrence;
4) Work out various arrangements convenient for consultation and cooperation of related
parties according to protection and safety demand;
5) Preserve relevant records of responsibility fulfillment.
3.4 Supervision and Administration of Implementation
3.4.1 The implementation of this standard and supervision and administration implemented by this
standard shall be charged by regulatory authority; for intervention condition, the intervening organization
shall be in charge of main responsibility for relevant requirements of this standard.
3.4.2 The main responsible party shall receive the supervision for protection and safety with approved
practice of personnel formally authorized by regulatory authority, including inspection of protection
and safety record.
3.4.3 When the condition against relevant requirements this standard happens, the main responsible
party shall:
a) Investigate the reason and of violation behavior;
b) Adopt corresponding action to rectify and prevent secondary occurrence of similar violation
incident;
c) Report the violation reason, adopted or preparing to be adopted rectification action or
protective action to regulatory authority;
d) Adopt other necessary actions according to the requirements of this standard.
3.4.4 The main responsible party shall timely report violation incident. If the standard violation has
performed or is about to be performed to emergency exposure condition, it shall be reported timely.
3.4.5 After standard violation incident occurrence, if the main responsible party is incapable of
adopting rectification or improvement action within the stipulated time limit according to national relevant
regulations, the regulatory authority shall revise, suspend or cancel issued registration certificate, license
or other approval documents.
4 Major Requirement for Practice
4.1 Basic Principles
4.1.1 Introduction, implementation, interruption or stopping of any practice and exploitation, mill,
processing, design, manufacture, construction, assembling, procurement, import, export, sales, sell out,
lending, lease, receiving, installation, positioning, debugging, holding, use, operation, maintenance, repair,
transfer, decommission, disassembly, transportation, storage or disposal of any source in practice shall
be carried out according to relevant requirements of this standard; unless the exposure generated by
relevant practice or source is excluded or the relevant practice or source is exempted by the
requirements of this standard.
4.1.2 For any practice applicable to this standard, any source in practice or any activity specified in
4.1.1, the implementation of each relevant requirement of this standard shall be corresponding with
characteristic of this practice or source and size and possibility of its caused exposure, and shall meet
specified relevant requirements by regulatory authority.
4.1.3 The transportation of radioactive material shall follow the requirements of national relevant
safety transportation laws and regulations of radioactive substance.
4.2 Management Requirements
4.2.1 Notification
4.2.1.1 Any legal person intended to carry out some item practice or any activity specified in 4.1.l of
this standard shall submit notification to regulatory authority to explain the purpose and plan, and
shall only explain the plan in such aspects as manufacture, assembling, import and sales for consumer
product.
4.2.1.2 If the practice or activity meets the following conditions and is confirmed by regulatory
authority, only the notification procedure shall be fulfilled, if not, the corresponding approval procedure
shall be fulfilled according to the requirements of 4.2.2:
a) The caused normal exposure unlikely exceeds a certain small share of specified relevant
limit by regulatory authority;
b) The possibility and size of accompanied potential exposure may be neglected.
c) Any other accompanied possible detriment consequence may also be neglected.
4.2.2 Approval: registration or licensing
4.2.2.1 Any legal person responsible for any sealed source, unsealed source or radiation generator
shall propose application to regulatory authority to obtain approval unless the responsible source is
exempt. Whether adopt registration mode or licensing mode for this approval shall be determined by
regulatory authority according to source or practice property utilizing this source and size and possibility
of caused exposure. The practice suitable for approval with registration mode shall be provided with
the following characteristics:
a) Guarantee safety to a great extent through the design of installation and equipment;
b) Simple and easy working procedure;
c) Extremely low requirements for safety training;
d) Hardly any safety problem in history run.
4.2.2.2 The legal person responsible for any following source shall submit application to regulatory
authority to obtain approval, and the approval for this source shall be adopted with licensing mode:
a) Irradiation installations;
b) Mine or mill processing radioactive ores;
c) Installation processing radioactive substances;
d) Nuclear installation;
e) Radioactive waste management facility;
f) Other any source that is non-exempt and the regulatory authority has not designated approval
suitable for registration mode.
4.2.2.3 Any applicant shall:
a) Submit relevant data for supporting the application to regulatory authority;
b) Explain the analysis on property, size and possibility of caused exposure by responsible
source in submitted application information, and explain various measures used to plan to adopt for
protecting worker, public and environment.
c) If the exposure may be larger than some level specified by regulatory authority, the
corresponding safety assessment and environmental impact assessment shall be carried out, and shall
be taken as one part of application form to submit to regulatory authority;
d) Any activity specified in 4.1.1 of this standard shall not be carried out before regulatory
authority issuing registration certificate or license.
4.2.2.4 The medical exposure practice and source applicant shall include the following contents in
the application form:
a) Explain the qualification of medical practitioner in radiation protection; or
b) Promise that only the medical practitioner with professional qualification of radiation protection
specified in relevant regulations or written in license can allow issuing source inspection application
form or treatment prescription.
4.2.3 Authorized legal person: registrant and licensee
4.2.3.1 The registrant and licensee shall be responsible for establishing and implementing each
necessary technique and organization measure to ensure the protection and safety of authorized source;
they can entrust other parties to complete certain relevant activities or tasks, but they still undertake
the main responsibility for these activities or tasks. The registrant and licensee shall employ qualified
personnel according to demand and ensure to meet this standard.
4.2.3.2 If the registrant and licensee are intended to revise the authorized practice or source, and the
proposed revision may have important impact for protection or safety, the revision plan shall be
noticed to regulatory authority, and this revision shall not be carried out before obtaining regulatory
authority recognition.
4.2.4 Exemptions
4.2.4.1 If the source meets one of the following conditions and is confirmed and agreed by regulatory
authority, this source or practice utilizing this source may be exempted by the requirements of this
standard:
a) Meeting the exemption requirements specified in Appendix A (Normative) of this standard;
b) Meeting the exemption level determined by regulatory authority according to exemption
criteria specified in Appendix A (Normative) of this standard.
4.2.4.2 The practice has not been proved as justifiable practice shall not be exempted.
4.2.5 Clearance
4.2.5.1 If the source (including substances, materials and articles) in noticed or approved practice
meets the clearance levels specified by regulatory authority, it may be carried out with clearance
without following the requirements of this standard after regulatory authority recognition.
4.2.5.2 Unless otherwise stated by regulatory authority, the determination of clearance levels shall
be considered with exemption criteria specified in Appendix A (Normative) of this standard, and the
clearance levels shall not be higher than the exemption level specified in Appendix A (Normative) of
this standard or established by regulatory authority according to specified criteria of this Appendix.
4.3 Radiation Protection Requirements
4.3.1 Justifiability of practice
4.3.1.1 If the interest for radiated individual or social brought by one practice can sufficiently make
up possibly caused radiation hazard after considering social, economy and other relevant factors, this
practice is justifiable. The practice without justifiability and the source in this practice shall not be
approved.
4.3.1.2 The justifiability judgment related to practice of medical exposure shall follow the detail
requirements specified in Chapter 7.
4.3.1.3 In addition to the practice judged as justifiable and related to medical exposure, it is not
justifiable by addition of radioactive substance or increasing radioactivity in relevant daily commodities
or products through activation in the following practices:
a) Practice involved in food, drink, cosmetics or other any goods or product for eating, suction,
skin intake or skin application;
b) Practice involved in insignificant application of radiation or radioactive substance in daily
commodities or products (such as toys).
4.3.2 Dose limit and potential exposure risk limit
4.3.2.1 The normal exposure received by individual shall be limited to guarantee individual total
effective dose and total equivalent dose of relevant organs or tissues caused by comprehensive
exposure of each approved practice not exceeding corresponding dose limit specified in Appendix B
(Normative) except the particular case specified in 6.2.2 of this standard. The dose limit shall not be
applied to medical exposure in approved practice.
4.3.2.2 The potential exposure risk received by individual shall be limited to make individual risk
caused by all potential exposure in each approved practice and health risk corresponding to normal
exposure dose limit in the same quantity level.
4.3.3 Optimization of protection and safety
4.3.3.1 For the exposure of any specific source in one item practice, the protection and safety shall
be optimized to keep individual exposure dose size, exposed people number and exposed possibility
in reasonably reached low level after considering economy and social factors; this optimization shall
take the personal dose caused by this source and potential exposure risk respectively less than dose
constraint and potential exposure risk constraint as the prior condition (except medical exposure of
treatment).
4.3.3.2 The process of protection and safety optimization may range from visualized qualitative
analysis to quantitative analysis using aid decision making technique, but all relevant factors shall be
considered with some proper methods to realize the following targets:
a) Determine optimized protection and safety measures for leading condition, and the protection
and safety selection for utilization, property, size and possibility of exposure shall be considered during
determining these measures;
b) Establish corresponding criteria according to optimization result, and limit the size and
possibility of exposure according to the measures adopting accident prevention and relieving accident
consequence.
4.3.4 Dose constraint and potential exposure risk constraint
4.3.4.1 In addition to medical exposure, for any specific source in one item practice, the dose
constraint and potential exposure risk constraint shall not be larger than specified or approved value
for this source by regulatory authority, and shall not be larger than the value possibly causing to
exceed dose limit and potential exposure risk limit;
4.3.4.2 For any source possibly releasing radioactive substance to environment, the dose constraint
shall still limit the released cumulative effect of this source in pass years to make the received
effective dose of any member of the public (including progeny) in any one year not exceeding the
corresponding dose limit after considering all release accumulation and exposure possibly caused by
other relevant practices and sources.
4.3.5 Guidance level of medical exposure
The guidance level for medical exposure used for medical practitioner shall be established. This
guidance level shall:
a) Be established according to detail requirements of Chapter 7 and referring to Appendix G
(Informative);
b) Be a kind of reasonable dose indication for medium-size body;
c) Provide guide for medical practice may be accomplished by currently good medical skill
(instead of optimal medical skill);
d) May flexibly apply in need of reliable clinical judgment indication, namely allow implementing
higher exposure;
e) Be revised with improvement of technology and technique.
4.4 Operating Management Requirements
4.4.1 Sense of safety culture
Cultivate and maintain good sense of safety culture, encourage adopting thinking, research and
modesty learning attitude for protection and safety matters and oppose complacency, and guarantee:
a) Establish the policy and procedure regarding protection and safety as higher than all;
b) Timely investigate and rectify the problems impacting protection and safety, and make
adopted method corresponding with problem significance;
c) Define the responsibility of each relevant personnel (including higher management) for
protection and safety, and each relevant personnel shall be provided with proper training and
corresponding qualifications;
d) Define authority and responsibility relation for protection and safety decision;
e) Work out organization arrangement and establish effective communication channel, maintain
smooth protection and safety information in all-level departments of registrant or licensee and between
departments.
4.4.2 Quality assurance
Establish and implement quality assurance program, and this outline shall:
a) Provide adequate assurance for meeting each specific requirement involved in protection and
safety;
b) Provide quality control mechanism and procedure for comprehensive effectiveness of examination
and assessment measures for protection and safety.
4.4.3 Human factors
The measures shall be adopted to meet the following requirements to reduce the possibility of
human error resulting in accident and incident as much as possible:
a) All relevant personnel of protection and safety shall be provided with proper training and
corresponding qualifications to understand their own responsibility and can correctly judge and fulfill
responsibility according to established procedure;
b) Design equipment and establish operation procedure according to tried and true human
engineering principle to make equipment operation or application as simple as possible and minimize
accident probability owing to operation mistake, and reduce misunderstanding possibility of indication
signal under normal and abnormal operation condition;
c) Install proper equipment, safety system and controlling procedure, and work out other
necessary specifications to:
1) Reduce the possibility of personnel accident exposure owing to human error as much as
possible;
2) Provide the means of discovering and rectifying or making up human error;
3) Be convenient for intervention during invalidity of safety system or other protective
measures.
4.4.4 Qualified expert
4.4.4.1 The registrant and licensee shall employ qualified expert to provide consultation for implementing
this standard as required.
4.4.4.2 The registrant and licensee shall inform the arrangement for qualified expert employment to
regulatory authority. The provided information during notification shall include occupation or profession
range of employed expert.
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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