GB/T 22275 "Requirements for the Implementation of Good Laboratory Practice" is divided into 7 parts, and this part is Part 4 of GB/T 22275. This part of GB/T 22275 specifies the organization and personnel of the test institution for field research, quality assurance plans, test facilities, instruments, raw materials, reagents, test systems, test samples and reference materials, standard operating procedures, reporting of research results, records, and storage and retention of materials. Except for explicit exemptions from national legislation, the good laboratory practice principles (hereinafter referred to as GLP principles) specified in this part apply to all non-clinical health and environmental safety studies required by regulations, including the registration or application for licenses for pharmaceuticals, pesticides, food additives and feed additives, cosmetics, veterinary drugs and similar products, as well as industrial chemical management. This part has made the following editorial changes: - The foreword and directory have been deleted. GB/T 22275.4-2008 Requirements for the implementation of good laboratory practice Part 4: Application of good laboratory practice principles in field studies GB/T22275.4-2008 standard download decompression password: www.bzxz.net
GB/T 22275 "Requirements for the implementation of good laboratory practice" is divided into 7 parts, this part is the 4th part of GB/T 22275. This part of GB/T 22275 specifies the organization and personnel of the test institution for field studies, quality assurance plans, test facilities, instruments, raw materials, reagents, test systems, test samples and reference materials, standard operating procedures, reporting of research results, records and storage and retention of materials. Except for explicit exemptions from national legislation, the good laboratory practice principles (hereinafter referred to as GLP principles) specified in this part apply to all non-clinical health and environmental safety studies required by regulations, including the registration or application for licenses of pharmaceuticals, pesticides, food additives and feed additives, cosmetics, veterinary drugs and similar products, and industrial chemical management. This part has been edited as follows: ——The foreword and the table of contents have been deleted.
class="f14" style="padding-top:10px; padding-left:12px; padding-bottom:10px;"> GB/T 22275 "Implementation requirements for good laboratory practice" is divided into 7 parts:
---Part 1: Quality assurance and good laboratory practice;
---Part 2: Tasks and responsibilities of project leaders in good laboratory practice studies;
---Part 3: Compliance of laboratory suppliers with good laboratory practice principles;
---Part 4: Application of good laboratory practice principles in field studies;
---Part 5: Application of good laboratory practice principles in short-term studies;
---Part 6: Application of good laboratory practice principles in computerized systems;
---Part 7: Application of good laboratory practice principles in the organization and management of multi-site studies.
This part is part 4 of GB/T 22275.
This part is equivalent to the Organization for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP) principles and compliance monitoring series document No. 6: "Application of GLP principles in field research" [ENV/JM/MONO (99) 22].
This part has been edited as follows:
--- The foreword and the contents have been deleted.
This part was proposed and managed by the National Technical Committee for the Administration of Hazardous Chemicals (SAC/TC251).
The drafting unit of this part: Shandong Entry-Exit Inspection and Quarantine Bureau. The
main drafters of this part: Wan Min, Huang Honghua, He Fei, Wang Xiaobing, Wang Huiyong.
The clauses in the following documents have become the clauses of this part through reference in this part of GB/T 22275. For dated references, all subsequent amendments (excluding errata) or revisions are not applicable to this part. However, parties to agreements based on this part are encouraged to study whether the latest versions of these documents can be used. For undated references, the latest versions apply to this part.
GB/T22275.1 Implementation requirements for good laboratory practice Part 1: Quality assurance and good laboratory practice
GB/T22278-2008 Principles of good laboratory practice

ICS 03. 120. 20
National Standard of the People's Republic of China
GB/T 22275.4—2008
Requirements of conduct for Good Laboratory Practice(GLP)-Part 4: The application of the GLP principles to field studies2008-08-04Published
General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of ChinaAdministration of Standardization of the People's Republic of China
Acid Code Defense
2009-04-01Implementation
GB/T22275 Requirements for the implementation of good laboratory practice are divided into 7 parts:Part 1: Quality assurance and good laboratory practice;Part 2: Tasks and responsibilities of the project leader in good laboratory practice studies! Part 3: Compliance of laboratory suppliers with the principles of good laboratory practice; Part 4: Application of the principles of good laboratory practice in field studies; Part 5: Application of the principles of good laboratory practice in short-term studies; Part 6: Application of the principles of good laboratory practice in computerized systems; Part 7: Application of the principles of good laboratory practice in the organization and management of multi-site studies. This part is Part 4 of GB/T 22275. GB/T 22275.4—2008
This part is equivalent to the Organization for Economic Cooperation and Development (OECD) Good Laboratory Practice (GLP) Principles and Conformity Monitoring Series Document No. 6: Application of GLP Principles in Field Studies [ENV/JM/MONO(99)22]. This part has made the following editorial changes:
- The foreword and the contents have been deleted.
This part was proposed and managed by the National Technical Committee for Standardization of Hazardous Chemicals Management (SAC/TC251). The drafting unit of this part: Shandong Entry-Exit Inspection and Quarantine Bureau. The main drafters of this part are Fang Min, Huang Honghua, He Fei, Wang Xiaobing and Wang Huiyong. I
1 Scope
Requirements for the implementation of good laboratory practice
Part 4: Application of good laboratory practice principles in field research
GB/T 22275.4—2008
This part of GB/T 22275 specifies the organization and personnel of the test institution for field research, quality assurance plan, test facilities, instruments, raw materials, reagents, test systems, test samples and reference materials, standard operating procedures, reporting of research results, records and storage and retention of materials. Except for the explicit exemptions of national legislation, the good laboratory practice principles specified in this part (hereinafter referred to as GLP principles) apply to all non-clinical health and environmental safety studies required by regulations, including the registration or application for licenses of pharmaceuticals, pesticides, food additives and feed additives, cosmetics, veterinary drugs and similar products, as well as industrial chemical management. 2 Normative references
The clauses in the following documents become clauses of this part through reference in this part of GB/T 22275. For dated references, all subsequent amendments (excluding errata) or revisions are not applicable to this part. However, parties to agreements based on this part are encouraged to investigate whether the latest versions of these documents can be used. For undated references, the latest versions apply to this part.
GB/T 22275.1 Requirements for the implementation of good laboratory practice Part 1: Quality assurance and good laboratory practice GB/T 22278--2008 Principles of good laboratory practice 3 Terms and definitions
The terms and definitions in GB/T 22278-2008 apply to the technical part. 4 Main technical specifications
4.1 Background
In 1981, the Organization for Economic Cooperation and Development (OECD) adopted the GLP principles. In 1997, OECD revised it. The GLP principles provide recommended test management standards for a variety of studies conducted for regulatory purposes or other assessment-related purposes. The OECD expert group that developed the GLP principles in 1981 clearly listed the types of tests covered by the GLP principles in its report: a) Physical and chemical properties: b) Toxicological studies (long-term and short-term) for evaluating human health effects c) Ecotoxicological studies (long-term and short-term) for evaluating environmental effects; d) Ecological studies (transport, biodegradation and bioaccumulation) for evaluating the environmental fate of chemicals. The general category of ecological studies also includes tests for determining the characteristics and quantities of pesticide residues, metabolites and other compounds used for resistance and other dietary exposure. The GLP principles are used to cover more chemical products, including pesticides, drugs, cosmetics, veterinary food additives, feed additives, industrial chemicals, etc. The supervisory authorities of OECD member countries have gained most of their experience in GLP compliance monitoring in the field of (non-clinical) toxicology tests. This is because these studies have traditionally been considered the most important from the perspective of human health. Many of the established compliance monitoring programs in OECD member countries have been developed from the experience gained from toxicology laboratory space inspections. Compliance monitoring programs for laboratories conducting ecotoxicology studies are also well developed. The study planning, documentation, methods, techniques and development of field studies of pesticides or veterinary drugs (such as residue studies, metabolism studies and ecological studies) are significantly different from those associated with toxicology tests and most ecotoxicology tests based on laboratory space. This part proposes and explains some special issues related to field studies. The purpose is to further explain and guide GB/T 22278-2008. This part proposes issues that are considered to require further explanation. For more details, please refer to GB/T 22278-2008. 4.2 Explanation of terms and definitions related to field studies 4.2.1 Field studies
4.2.1.1 "Non-clinical health and environmental safety studies" in the definition of GB/T 22278-2008 are understood to include field studies. Field studies are studies that include test activities conducted outside conventional laboratories (such as in the field, in outdoor ponds or in greenhouses) and are often combined or associated with tests conducted in laboratories. 4.2.1.2 Field studies include, but are not limited to, studies on the following: Field studies are used to determine: a) Residues; b) Photodegradation; d) Plant metabolism; d) Soil metabolism; c) Uptake by crops; g) Effects on mesocosms; h) Bioaccumulation; i) Effects on non-target organisms. 4.2.2 Experimental Establishments for Field Studies Experimental establishments for field studies may include several test sites at one or more geographical locations where a phase or component of a single overall study is conducted. The different test sites may include, but are not limited to: a) research laboratories where characterization of the test sample/reference material is performed (including determination of identity, purity/concentration, stability and other relevant properties); b) one or more agricultural or indoor or outdoor sites (e.g. greenhouses) where the test sample or reference material is applied to the test system; in some cases, processing equipment where harvested products are prepared into other samples (e.g. processing tomatoes into soups, soups, pastes or sauces); d) one or more laboratories where collected samples (including samples from processing processes) are analyzed for chemical or biological residues or otherwise evaluated. 4.2.3 Project Leader and Project Representative for Field Studies In field studies that may involve multiple sites, some of the responsibilities of the Project Leader may be delegated. When the Project Leader is unable to exercise direct management at each test site, the study process may be controlled by certain individuals, called Project Representatives. Project Representatives are individuals who are responsible for managing a certain phase of the study on behalf of the Project Leader. The responsibilities of the project representative are detailed in 4.3.3 and 3.1.3 of GB/T22278-2008.
4.2.4 Non-clinical health and environmental safety research In field research at one or more test sites, non-clinical health and environmental safety research can include two phases, field and laboratory phases, but only belong to one research plan. 4.2.5 Test system
Field research also includes complex ecosystems. 4.2.6 Test samples
Test samples for field studies include, but are not limited to, chemical substances or mixtures, radiolabeled compounds, biogenic materials or processing wastes. In the case of field residue or environmental studies, the test sample is either an active ingredient or a mixture (formulation) containing the active ingredient and one or more reactive ingredients (such as emulsifiers). Other field studies on plant and soil metabolism are used to study the fate of test samples and use radiolabeled chemicals. Test samples can be analytical or technical grade raw materials, which can be prepared on site at any time before application. 4.2.7 According to
GB/T 22275.4—2008
For field studies, reference materials can also be understood to include analytical standards. Depending on the type of study, the characteristics of the reference material should be fully described and this description should be recorded in the study plan. 4.2.8 Medium
In field studies, medium generally refers to the diluent, which is often used to dilute the test sample (usually a pesticide formulation or tank mix). The medium also includes any additional solvents, surfactants, or other chemicals added to enhance solubility or application properties.
4.3 Organization and Personnel of the Study Site
4.3.1 Responsibilities of the Study Site Manager
4.3.1.1 From the perspective of GLP principles, management has several meanings and may involve multiple personnel from several study sites. Management, to whom the project manager reports, has ultimate responsibility for ensuring that the organization is operated in accordance with GLP principles. A field study may also have several study site management entities, who are primarily responsible for the personnel, facilities, equipment, and materials at each study site and who formally assure the project manager (in writing) that these requirements are met at the appropriate stage of each study. The study site manager should also assure the project manager that the site complies with the provisions of GLP principles. 4.3.1.2 The site manager should ensure to the study leader and the study leader's manager that appropriately qualified personnel (project representatives) are available at the site and that the project representative is able to effectively perform the phase of the study for which he or she is responsible in accordance with the study plan, appropriate standard operating procedures, GLP principles, and specific technical requirements. The general manager should fully understand and reach agreement with the site manager on how and by whom the quality assurance program will be implemented. 4.3.1.3 Where multiple levels of management exist, there should be clear boundaries of authority, information exchange, and assigned responsibilities between researchers and quality assurance program personnel, especially between them, so that the study leader can effectively perform his or her GLP duties. This should be documented in writing. The general manager has the responsibility to ensure that clear channels of communication exist. 4.3.1.4 At some sites, certain aspects of the study may be performed directly or indirectly by temporary employees. When these individuals generate and enter raw data or perform other activities related to the study that are unsupervised, records of their qualifications, training, and experience should be maintained. When these personnel perform routine maintenance operations, such as thinning, weeding, and fertilizing, under the supervision of more highly qualified personnel, it is not necessary to keep records of these personnel. 4.3.2 Responsibilities of the Project Leader
4.3.2.1 The designation of a Project Leader is key to ensuring that a study is conducted in accordance with GLP principles. Broadly speaking, the term "responsible for the overall execution and final reporting of the study" is understood to mean that the Project Leader may be geographically located far from the actual test site for most field studies. As a result, the Project Leader can only rely primarily on his or her designated project representatives and relevant technical personnel at each test site to ensure technical reliability and compliance with GLP principles. The responsibilities of these personnel should be clearly defined in writing. 4.3.2.2 The Project Leader and all relevant personnel should establish and maintain effective communication to ensure that the study plan, standard operating procedures are followed, and all other GLP principles are met. Communication between the Project Leader and the quality assurance program personnel is also very important to ensure that they understand the activities at key stages and the quality assurance program inspection reports. can be communicated promptly and corrective actions can be implemented as soon as possible.
4.3.2.3 As part of his or her duties, the project leader has the responsibility to ensure that: a) there are adequate characterized test samples and reference materials at the test site; b) for the analysis of this, there is adequate coordination between the field (or treatment site) and the analytical experiments; and c) the data from the field, treatment site and laboratory sites are fully compared and archived. 4.3.3 Responsibilities of the Project Representative
4.3.3.1 When the project leader is unable to provide on-site supervision and management for any particular stage of the study, a project representative will be identified/recommended to represent the project leader in charge of certain specific stages of the study. 4.3.3.2 Designate the project representative in the study plan or its revised document , state the research phase for which the project representative is responsible. The project representative will be a person with appropriate qualifications and experience so that he or she can directly supervise the appropriate phase of the study. 4.3.3.3 The project representative, representing the project leader, will ensure that the relevant research phase is carried out in accordance with the requirements of the research plan, relevant standard operating procedures and GLP principles. The responsibilities of the project representative should include, but are not limited to the following aspects. They should: a) Work with the project leader and other research scientists to draft the research plan. b) Ensure that researchers are appropriately appointed, the appointment should be recorded, and ensure that researchers can obtain copies of the research plan and relevant standard operating procedures as needed. c) Ensure that all experimental data are accurately recorded d) Ensure that deviations from the study plan and standard operating procedures that occur during the study are detected and, if necessary, corrective actions are taken immediately and recorded in the original data. The project leader is informed of these deviations as soon as possible. However, changes to the study plan (complete changes, modifications or amendments) should be approved in writing by the project leader. e) Ensure that all relevant original data and records are retained to ensure the integrity of the data and that the original data and records are promptly delivered to the project leader or in accordance with the provisions of the study plan. Ensure that all samples and specimens of the relevant study phase are adequately protected and prevented from confusion and damage during handling and storage, and that these samples and specimens are transported in an appropriate manner. g) Sign and date the relevant phase report to certify that the report accurately reflects all the work done and all the results obtained, and that the work was carried out in accordance with the principles of GLP. This report should include sufficient instructions to enable the project leader to write a final report covering the entire study. The project representative should provide the report to the project leader. The project representative may submit the original data as his or her report, and the report should include a statement of compliance with GLP, if appropriate. 4.4 Quality Assurance Plan
4.4.1 Usually, a single person cannot complete the quality assurance work of field research, but multiple people are required. These people may be employed by a single department (such as from the research sponsor) or belong to different departments (such as some from the research sponsor and some from the contractor). Detailed and true information exchange should be maintained between different quality assurance personnel and the responsible trial site manager, the responsible project representative, the project leader responsible for the overall execution of the study, the project leader's manager and their quality assurance plan. In order to inform the key activities of the study, it is also necessary to ensure that effective communication is established between the project leader and (or) project representative and the quality assurance personnel: 4.4.2 Based on the complexity of field research, similar activities may be involved in different sites, or the exact time of an activity depends on local weather or other conditions. Field research may require a flexible quality assurance plan. See GB/T22275.1 for details. 4.4.3 Given the geographical dispersion of trial sites, quality assurance personnel also need to cope with language differences so that they can communicate with local researchers, project sponsors, project representatives and trial site managers. 4.4.4 Regardless of the location of the test site, written reports from quality assurance personnel should be provided to both the manager and the project leader. The actual receipt of the report by the manager and the project leader should be recorded in the original data. 4.5 Facilities
4.5.1 General
4.5.1.1 Field research facilities generally consist of agricultural or cultivated land, forest land, microecological environments, or other outdoor test areas in whole or in part. These outdoor test areas usually have less or no control over environmental conditions than those in closed laboratories or greenhouses. Similarly, safety controls and supervision of operations and facilities are not as easy to manage as laboratory research. 4.5.1.2 For field studies of pesticides, there is a problem of potential contamination of the test area by spray drift or overspray from pesticides used in adjacent areas, especially when the test area is located in the middle of or adjacent to agricultural land: in this case, the test site should be selected to minimize interference from external locations. As far as possible, the selected area should be free of chemicals that may cause interference or where the use of pesticides (including research applications and normal use) has been recorded. 4.5.1.3 Pesticide residue analysis performed in the laboratory should pay special attention to potential contamination of samples and reference standards. The receiving and storage areas for samples should be separated from the storage areas for pesticides and other test samples or reference materials. The areas used for samples and sample preparation, instrument operation, spray calibration, preparation of reference standards and cleaning of glass instruments should be completely separated from each other and should be separated from other functional areas of the laboratory that may cause contamination. bZxz.net
GB/T22275.4—2008
4.5.2 Facilities for handling test samples and reference materials If necessary, environmental monitoring should be carried out in the storage areas of test samples and reference materials in all test sites to ensure that the stability limits of these materials are met, if necessary. Test samples and reference materials should not be placed in the same storage containers as test system samples and other low-concentration raw materials collected for transportation to analytical laboratories or other archiving institutions. Adequate facilities should be provided for the storage and treatment of pesticides and related wastes to prevent potential cross-contamination between test systems, test samples, reference materials or collected samples. 4.5.3 Waste treatment
For field studies, the storage and disposal of excess pesticide dilutions (or tank mixes) should be taken seriously, and the minimum amount of pesticide should be prepared for release. In addition to ensuring that these potentially hazardous wastes do not cause harm to human health or the environment, these materials should also be controlled in a reasonable manner to avoid affecting the test system, samples, other materials or equipment used in the study. Test and reference materials used in the study should be returned to the sponsor or supplier or disposed of in a legal and reliable manner. 4.6 Apparatus, Materials, Reagents
4.6.1 During the field phase, the frequency of operations such as inspection, cleaning, maintenance and calibration may take into account the possible transportation of equipment (e.g., moving a balance from one site to another). These operations should be described in standard operating procedures. 4.6.2 Equipment used in a specific study (e.g., equipment temporarily rented or a nebulizer with a specific configuration for a study) may not have records of regular inspection, cleaning, maintenance and calibration. In this case, this information can be recorded in the original records for this specific study. If it is not feasible to include the relevant procedures as standard operating procedures, they can be included in the study plan together with a reference to the manual. 4.6.3 Materials and reagents should be shown to be free of interference by adequate blank analysis. 4.7 Test Systems
4.7.1 The test system used in a field study may consist of a complex ecosystem. Such an ecosystem is difficult to describe and identify or, on the other hand, difficult to record to the extent of a traditional test system. More complex test systems should be described in the study plan by location and characteristics, as far as possible; actual test areas may be identified by markings, symbols or other means. Plants, seeds, soils and other materials used as test systems should be described and recorded by source, date of acquisition, species, strain, variety or other appropriate identifying characteristics. Soils should be characterized to the extent necessary and their suitability for use in field studies documented. 4.7.2 Test systems for pesticides should be free from external interference, particularly spray drift or overspray from adjacent areas, as noted in the facility. The need for analysis of prepared or pre-treated control samples should be discussed in the study plan, as appropriate. Control areas and buffer zones should be used to the extent necessary to address or minimize potential interference or other forms of study bias. 4.8 Test Samples and Reference Materials
4.8.1 Receipt, Handling, Sampling, Storage
The following relevant documents shall be kept at the test site: a) Origin, e.g. commercial formulation, special formulation, etc.; b) Mode of transport, including retained shipping documents; c) Date of receipt;
State of the material upon receipt;
e) Storage location and conditions;
f) Complete distribution log, indicating the total number of test samples and the number of final dispositions. 4.8.2 Characterization
4.8.2.1 It is not necessary to keep all characterization records and data at every test site. Sufficient information shall be provided to ensure that all test samples and reference materials are fully characterized. This generally includes: chemical name (e.g. CAS number, code name, name, etc.), batch or lot number, amount of active ingredient, location where analysis was performed, location of archive of relevant raw data, storage stability and transport stability (e.g. shelf life, temperature range), and safety precautions. 4.8.2.2 Product chemistry data obtained from different laboratory tests usually indicate the stability of the medium mixture of the test sample within a certain range of pH, temperature and hardness. If these limitations are known, the study plan can specify the appropriate application range and record the actual values, preparation time and termination time in the original data. 5
GB/T22275.4—2008
4.8.2.3 The manufacturer should provide sample homogeneity data to show that there is no stratification after the sample is mixed at different times under specific conditions. 4.8.2.4 For the analysis of canned mixture samples, the study plan should state the necessary conditions, as well as the sampling and analysis methods. 4.9 Standard Operating Procedures
4.9.1 Key procedures for field studies include test sample storage, field data collection, application equipment calibration, test sample application, sample collection and delivery, and should be given special attention.
4.9.2 The study plan should also include all methods used for sample analysis. If the methods were not fully developed or validated when the original study plan was signed, this may require approval of a study plan amendment. The study plan should also specify all specialized analytical methods, such as validation procedures.
4.10 Study Implementation
4.10.1 Study Plan
4.10.1.1 Because of the unpredictable conditions of field studies, the possibility of using loaner equipment, special arrangements for specimen care, storage, and delivery, and other special conditions, the study plan for most field studies should reflect more flexibility than a traditional laboratory study. Rather than citing specific dates in the study plan to describe key stages (e.g., application of test specimens, incubation operations, and specimen collection), it is more practical to describe the development stages of these activities as far as possible and to give general time frames. 4.10.1.2 To allow for timely and efficient approval of study plan amendments, special communication procedures should be established between the study leader and site personnel if they are not in the same location. 4.10.2 Execution of the Study
4.10.2.1 Given the importance of quality control measures in residue and environmental analyses, quality control measures should be documented in the standard operating procedures and/or study plan. Procedures for reproducibility assessment, interference avoidance, and analytical qualification confirmation should also be included in the standard operating procedures and/or study plan.
4.10.2.2 Original data, including copies of all worksheets, records, memoranda, notes, original observations, and results of study activities, are essential for the reconstruction and evaluation of study reports. If the original data have been accurately backed up, accurate copies or transcripts may be used as original data in place of the original data. Original data include: photographs, microfilm or microfilm, computer printouts, magnetic media, including oral observations, and data recorded by automated equipment. 4.10.2.3 It is recommended that all entries be written in indelible ink. In some cases, it may be unavoidable to use pencil. If pencil is necessary, verified copies should be made whenever possible. The use of pencil or color-coded items should be identifiable on the verification copy. In addition, the reason for using pencil should be clearly stated in the study record. 4.11 Report on study results
The project sponsor should attach the project representative's report as an annex to the general study report, see item g) of 4.3.3.3 on the representative's responsibilities.
4.12 Storage and retention of records and materials
A potential problem in remote test sites is that records and materials during the study need to be temporarily stored until they are transferred to an archiving agency at the end of the study. Temporary storage facilities at all test sites should be sufficient to ensure the integrity of the study materials. 6
GB/T 22275.4-2008
People's Republic of China
National Standard Promotion
Good Laboratory Practice Implementation Requirements
Part 4: Application of Good Laboratory Practice Principles in Field Research
GB/T22275.4—2008
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