当前位置：搜档网 › 《医疗器械临床试验质量管理规范》英文版

《医疗器械临床试验质量管理规范》英文版

State Food and Drug Administration

National Health and Family Planning Commission

Number twenty-fifth

< medical equipment specification for the quality control of clinical trial of > has been state food and Drug Administration in the executive meeting of the, national health and Family Planning Commission, director of the committee meeting examined and adopted, is hereby promulgated, since June 1, 2016 implementation.

Director Bi Jingquan

Director Li Bin

March 1, 2016

Standard for quality management of medical device clinical trials

Chapter one is the first chapter

The first is to strengthen the management of medical device clinical trials, the maintenance process for clinical trials of medical devices in rights and interests, and to guarantee the medical device clinical trials process specification, real results, science, reliable and traceable, according to < the supervision and administration of Medical Devices Regulations > formulated this specification.

Article 2 within the territory of the people's Republic of China to carry out the clinical trial of medical apparatus and instruments, shall comply with the specification. This specification covers the whole process of medical device clinical trials, including design of clinical trials, the implementation of, monitoring, verification, inspection, and data acquisition, record, and analyze the summarizing

and reporting.

The third section of this specification referred to in the clinical trial of medical apparatus and instruments, refers to in the accreditation of medical instrument clinical trial institution, intends to apply for the registration of medical device in the normal conditions of use is safe and effective for confirmation or verification

process.

Fourth clinical trials of medical devices shall comply with the principles of law,

ethical principles and scientific principles.

Article 5 at or above the provincial level food and drug supervision and management departments responsible for the supervision and management of medical device clinical trials. Health and family health department in charge, within its scope of functions and duties, strengthen the clinical trial of medical apparatus and instruments management. Food and drug supervision and management departments, health and family health departments should establish the medical quality of clinical trial management information reporting mechanism, strengthen the class III medical devices, included in the national configuration of large medical equipment quality management objective of medical apparatus and instruments to carry out examination and approval of clinical trials and the corresponding clinical trial supervision and management of data communications.

The second chapter is the preparation before clinical trial

Article 6 the clinical trial of medical apparatus and instruments shall have sufficient scientific basis and the clear purpose of the test, and weigh on expected and the

public health benefit and risk, expected benefit should exceed the possible damage. Article 7 before clinical trials, the sponsor shall test done in preclinical studies of medical apparatus and instruments, including product design (structure, working principle and mechanism of action, is expected to use and scope of application, the applicable technical requirements and quality inspection, animal testing and risk analysis and results should be able to support the clinical trial. Quality inspection results including self inspection report and a qualified inspection agency issued a year within the product registration inspection report.

Prior to the eighth clinical trials, the applicant should prepare adequate testing of medical equipment. The development of the test with medical equipment shall meet the applicable requirements of the medical device quality management

system.

The nine clinical trials of medical devices shall be in two or more than two medical device clinical trial institution. Selected testing institutions shall be without qualification accreditation of medical instrument clinical trial institution, and facilities and conditions shall meet the safety effectively clinical trial experience. Researchers should be able to bear the clinical trials of specialty, qualification and ability and trained. Qualification of medical instrument clinical trial institution identified management measures shall be formulated separately by the State Food and drug administration shall, jointly with the Ministry of health and Family

Planning Commission.

Article 10 before clinical trials, the sponsor and clinical trial institutions and

researchers should test design, test quality control, test the division of responsibilities, sponsor to bear the costs associated with the clinical trial and test in may occur damage dealing with principles to reach a written agreement.

Article 11 clinical trials should obtain consent of the clinical trial of medical apparatus and instruments institutional ethics committee. Included in the need for clinical trials and approval of class III medical devices directory, should also be approved by the State Food and drug administration.

Article 12 prior to clinical trials, the sponsor shall be to the location of provinces, autonomous regions, municipal food and drug supervision and management departments for the record. Accept filing of food and drug supervision and administration department shall record the situation informed clinical trial institution is located at the same level of food and drug supervision and management departments, as well as health and family health departments.

The third chapter is the protection of the rights and interests of the subjects Thirteenth clinical trials of medical devices shall comply with the ethical standards set by the Helsinki declaration of the world medical assembly.

The fourteenth ethical review and informed consent are the main measures to protect the rights and interests of the subjects. The parties involved in clinical trials should assume the corresponding ethical responsibilities according to their respective responsibilities.

Article 15 the sponsor should avoid undue influence or misleading to subjects, clinical trials and research and clinical trial participants or related party. Clinical trial

institutions and researchers should avoid undue influence or misleading to subjects, the sponsor and other participants in clinical trials or interested parties. Sixteenth applicants, clinical trials and researchers should not exaggerate the compensation measures involved in clinical trials, to mislead the participants to participate in clinical trials.

Seventeenth pre clinical trials, the applicant shall submit the following documents to the ethics committee by researchers and clinical trial institution of medical instrument clinical trial management: (a) clinical trial program; (two) researchers manual; (three) written informed consent document and any other available to participants (; four) recruiting subjects and procedural documents to its propaganda; (five) the case report form text; (six) self inspection report and product registration inspection report; (seven) researchers resume, professional expertise, skills, training and other documents to prove their qualifications; (eight) clinical trial institution the facilities and conditions to meet the test review; (nine) with the development of medical devices in accordance with the relevant requirements of medical quality management system for the test statement; (ten) other documents related to ethical review. Ethics committee shall uphold the principles of ethics and science, review and supervise the implementation of clinical trials.

Eighteenth one of the following circumstances occur in the course of clinical trials, researchers should report to the clinical trial institution of medical instrument clinical trial management department, and the timely notification of the applicant, the ethics committee report: (a) serious adverse events; (two) progress report,

including a summary of safety and deviation reports; (three) for any amendment has been approved by the ethics committee of the file, does not affect the rights and interests of the subjects, safety and health, non substantive changes without prior reports or clinical trials with the purpose or end not related, but afterwards shall notify in writing; (four) to suspend, terminate or suspend the request after the recovery of clinical trials (five;) affect the rights and interests of the subjects, from clinical trials or clinical trial safety and health science, including the deviation of request and report the deviation. For the protection of subjects Where a person's rights, security and health are not immediately reported in an emergency, it shall be reported in written form as soon as possible in accordance with the relevant provisions.

Article 19 in the process of clinical trials, as amended clinical trial protocols and informed consent documents, request deviation, resume a paused clinical trials should be can continue to implement until it obtain the written approval of the ethics committee.

It is good to the health article 20 should be avoided as far as possible selection of minors, pregnant women, elderly, persons with mental obstacle in life critical patients as subjects, that really need to be selected, it shall abide by the ethics committee of the additional requirement. In clinical trials for their health is specially designed, and should be.

article 20 should be avoided as far as possible selection of minors, pregnant women, elderly, persons with mental obstacle in life critical patients as subjects, that really need to be selected, it shall abide by the ethics committee of the additional requirement. In clinical trials

for their health is specially designed, and should be.

Article 21 in subjects in clinical trials, researchers should fully to subjects or no capacity for civil conduct, the guardian of the person of civil action competence limit that the details of the clinical trials, including the known, it can be predicted the risk and possible adverse events. After full and detailed explanation by the subjects or their guardians in informed consent Book sign your name and date, researchers also need to in informed consent Book sign your name and date.

Twenty-second general consent shall include the following contents and description of matters: (a) the researchers name and relevant information; (two) the name of clinical trial institution; (three) the name of the trial, purpose, method, content; (four) test process, test period; (five) the sources of funds and the possible conflicts of interest; (six) the expected participants may benefit and known, risk can be foreseen and adverse events may occur; (seven) alternative treatment subjects can obtain the information and its potential benefits and risks; (eight) when needed, that subjects may be assigned to different groups of experiments; (nine) subjects participated in the experiment should be voluntary, and at any stage of the test has the right to withdraw without discrimination or revenge, the medical treatment and The rights and interests are not affected; (ten) told the subjects in the study of personal data is confidential, but the ethics committee, food and drug supervision and management departments, health departments or sponsor at work when necessary in accordance with the prescribed procedures, can refer to the subjects in the study of personal data; (eleven) as happened with the related test the hurt, the subjects could get treatment and economic compensation; (twelve) the subjects can understand the related information during the test; (thirteen) free clinic project participants may be obtained during the test and other related subsidies. Informed consent shall be adopted by the subjects or guardians can understand the language and text. Informed consent shall not contain any cause subjects to give up the legitimate rights and interests and exemption from clinical trial institutions and researchers, the sponsor or The agent shall be responsible for the content.

Twenty-third obtain informed consent shall also meet the following requirements: (a) the subjects incapacitated, if the ethics committee agreed in principle, researchers believe that the subjects participating in a clinical trial with its own interests, can also enter clinical trials, but should try and marked by the Guardian Signature Date prior.; (two) the subjects or their guardians without reading ability, in the process of knowledge should have a witness present, after a detailed explanation of the informed consent, witnesses read the informed consent and oral informed content, agreed to by the subjects or their care population head, witnesses in informed consent the book of signature and date, signature

of witness and the researcher's signature should be on the same day.; (three) minors as subjects, should obtain the consent of the guardian and signed informed consent Department informed consent, minors on whether to participate in testing an intention, should also be their consent.; (IV) found relates to medical apparatus and instruments of important information or are expected to test the clinical impact of shall be of informed consent book content is modified, the modified informed consent by the ethics committee approval shall be by the test or its guardian re signature confirmation.

Article 24 informed consent book shall be indicated in the formulation of date or revised versions of date. Such as informed consent in the test in the process of revision, revised version of the informed consent implement the book before again by the ethics committee agreed to. Revised edition of informed consent books clinical trial mechanism after, all before the end of the test process of the subjects were as affected by the shall signed the informed consent for the newly revised.

Twenty-fifth subjects have the right to withdraw from any stage of clinical trials and are not subject to any financial responsibility.

The fourth chapter clinical trial program

Twenty-sixth to carry out clinical trials of medical devices, the applicant should be in accordance with the categories of medical equipment testing, risk, intended use, and other organizations to develop scientific and rational clinical trials program.

Article 27 not inside and outside the approved the listing of new products, safety and performance has not been confirmed by medical, clinical trial design should first conduct a feasibility test for small samples, to be initially recognized for their safety, according to the statistical requirements to determine the sample size to carry out the following clinical trial.

Twenty-eighth clinical trials protocol should include the following: (a) general information; (two) the background data in clinical trials; (three) the purpose of the experiment; (four) experimental design; (five) safety evaluation method; (six) effectiveness evaluation method; (seven) statistical considerations; (eight) the provisions for clinical trials program; (nine) the provisions of adverse events and equipment defect report; (ten) direct access to the source data file; (eleven) clinical trials involving ethical issues and instructions and informed consent document; (twelve) data processing and record keeping; (thirteen) financial and insurance; (fourteen) agreement. The test results were published part of the contents can be included in other related documents such as project researchers. Handbook of clinical trials Specific information about the organization, the results of the trial published agreement, finance and insurance can be expressed in the test plan, you

can also make a separate agreement to be specified.

Twenty-ninth multi center clinical trial by a number of researchers in the same test program in clinical trials in different period. The design and implementation of the test plan shall at least include the following contents: (a) the test plan and the clinical trial institutions and researchers to discuss identified by the applicant organization, and a clear lead the unit of clinical trial institution for the coordination of researchers; (two) the researchers responsible for coordinating the work of coordination between the institution of clinical trial process of clinical trials, clinical trials in early, middle and late organization researchers meeting, responsible for the implementation and the sponsor of the whole test together; (three) the institution of clinical trial the principle should be carried out over the same period and the end of clinical trials; (four) the institution of clinical trial test sample size and distribution, with statistical analysis to For reason; (5) the sponsor and the clinical test units on experimental training plan and training records requirements; (VI) established test data transfer, management, query and verification procedure, especially clear requirements of the institution of clinical trial testing the data should be the lead unit centralized management and analysis; (7) after the end of the multi center clinical trials, each clinical trial institutions researchers should respectively issued a summary of clinical trials, together with a case report table in accordance with the provisions of the audited over by coordinating research summary report.

Fifth chapter ethics committee duties

Article 30 medical device clinical trial institution ethics committee shall be by at least five members, including medical professionals, medical professionals, which should be the members of the different gender. Non medical specialty committee at least a legal worker and a name for the clinical trial institution other than the personnel. The ethics committee should be with the assessment and evaluation of the clinical trials of science, medicine and ethics, and other aspects of qualification or experience. All members should be familiar with ethical guidelines for the clinical trial of medical apparatus and instruments and relevant regulations and abide by the ethics committee of the constitution. Article 31 medical ethics committee shall comply with the provisions of the < world medical assembly declaration of Helsinki > ethical standards and food and drug supervision and administration department and establish the corresponding working procedures and the formation of the file and work in accordance with the procedures perform their duties. The ethics committee independent to members of the researchers and the sponsor has the right to comment and participate in relevant test vote.

Article 32 The Ethics Committee meeting shall be notified in advance, to

participate in the review and the number of voting can not be less than five, make any decision should be by an ethics committee composed by more than half of the members. Researchers can provide information on any aspect of the relevant test, but should not participate in the review, vote or comment. Ethics committee in the review of some special test, can invite experts in related fields.

Thirty-third from the ethics committee shall safeguard the rights and interests of the subjects of the perspective of strict consideration test scheme and related documents, and shall focus on the following: (a) the researchers qualifications, experience and whether there is sufficient time to participate in the clinical trial. (two) clinical trial institution staffing and equipment conform to the test. (three) the subjects may suffer a degree of risk and benefit compared to the expected test is appropriate. (four) test program is fully considered the ethical principles, with scientific research purposes, including the appropriateness of subjects' rights are protected, other persons may suffer the risk and protection method participants are science. (five) subjects were selected to test the method, the relevant information of the subjects or their guardians provided The information is complete, whether the subjects could understand, obtaining informed consent is appropriate; when necessary, the ethics committee shall organize the participants on behalf of the level of understanding of the test data, the evaluation of informed consent is appropriate, the assessment results shall be the end of the 10 year written record and save to clinical trials (six.) subjects if the occurrence of clinical trial related injury or death, treatment and insurance measures for adequacy. (seven) whether the proposed amendments to the test scheme is acceptable. (eight) whether can be carried out in clinical trials in regular evaluation may harm to subjects from (nine). The test plan may affect the rights and interests of the subjects, safety and health, or affect the scientific nature, the integrity of the test, whether it can be accepted.

Ethical review thirty-fourth multicenter clinical trial should be led by the ethics committee responsible for the establishment of collaborative review procedures to ensure consistency and timeliness of the review work. The beginning of each clinical trial institution before the test should be led by the ethics committee responsible for examination and test scheme of ethical rationality and scientificity, participate in the test of other clinical trial institution ethics the Committee in the prerequisite of accepting the lead unit ethics committee review comments, can be used to review or file review, review the feasibility of the trials in this clinical trial institutions, including the qualification and experience of the equipment and conditions, generally no longer on the design scheme of the test proposed amendments, but not right approved test in clinical trials.

Article 35 The Ethics Committee receives the application of clinical trials of medical devices shall convene a meeting, discuss the review, issue a written opinion, seal, and attached to attend the meeting of the personnel list, professional and personal signature. The views of the ethics committee may be: (a) consent; (II) modifications necessary consent; (III) without consent; (IV), to suspend or terminate the test has been approved.

Article 36 The Ethics Committee shall be of clinical trials of this clinical trial institution tracking supervision, it is found that the subjects' rights and interests can not get security situation, can be in any time upon written request to suspend or terminate the trial. Clinical trials have been suspended, without the consent of the ethics committee should not be allowed to resume.

Thirty-seventh ethics committees shall retain all records relating to the completion of clinical trials for at least 10 years.

The sixth chapter is the responsibility of the applicant

Article 38 The sponsor is responsible for initiating, application, organization and monitoring of clinical trials and the authenticity of clinical trials, responsible for reliability. The sponsor is usually the medical device production enterprise. The sponsor for overseas institutions shall in accordance with the provisions within the territory of the people's Republic of China appointed agent.

Article 39 The sponsor is responsible for organizing the formulation and revision of the Handbook, the clinical trials protocol, informed consent, case report form, the standard operating procedures and other relevant documents and is responsible for organizing the training of clinical trials necessary.

Article 40 the sponsor should according to the characteristics of medical apparatus and instruments used for testing, in the accreditation of medical instrument clinical trial institution selection mechanism test and research were. The sponsor before the clinical trial agreement signed in clinical trial institution shall clinical trial institutions and researchers to provide the latest research manual and other relevant documents, for its decision whether they can afford the clinical trials. Article 41 the manual shall include the following main contents: (a) the applicant, researchers of information; (II) test summary of medical devices for; (III) support test medical devices expected overview of the use and clinical trial design in reason and evaluation; and (IV) test with medical device manufacturing with suitable medical equipment quality management system requirements of the statement.

Article forty-second the applicant in the organization of the development of clinical trials program may not exaggerate the mechanism and efficacy of medical devices.

Article 43 in clinical trials, the sponsor to get important information about clinical trials shall modify the Handbook of research and related documents in time, and through the clinical trial institution of medical instrument clinical trial management departments submit ethics review committee agreed.

Forty-fourth the applicant should with clinical trial institutions and researchers to reach a written agreement on the following issues: (a) clinical trial implementation in accordance with the relevant laws and regulations and the clinical trial program, and accept the inspection, verification and inspection; (two) according to the data recording and reporting procedures; (three) retain the basic documents and test the less than less than the statutory time, clinical trials and research institutions are no longer need to notice until the sponsor of the documents so far; (four) the applicant from the ethics committee approval, medical equipment is responsible to the clinical trial institutions and researchers to provide test, and determine the conditions of transport and storage conditions, storage time, period of validity; (five) test of medical devices should be qualified, it is easy to identify, the correct encoding and labeled "test" of the special logo, and according to the clinical test Program requirements for appropriate packaging and preservation; (6) the applicant shall formulate a clinical trial quality control related SOPs, transportation of medical devices such as test, receiving, storage, distribution, processing, recycling, clinical trials research organizations and donor follow.

Article 45 the sponsor to test with medical device in clinical trials of the security responsibility. When found may influence test implementation may change the ethics committee approval test continues to, the sponsor shall immediately notify all clinical testing machine structure and study their safety or test, and make corresponding processing.

Article 46 the sponsor decided to suspension or termination of the clinical trials, it shall notify all clinical trial institution of medical device clinical trial management department in 55 days, and explain the reasons in written form. Clinical trials clinical trials of medical devices management department shall timely notify the corresponding research and ethics committee. The suspension of clinical trials, without the consent of the ethics committee and shall not resume. After the end of the trial, the applicant shall be informed in writing of the province where the, autonomous regions and municipalities food and drug supervision and administration department.

Article 47 the applicant shall ensure the implementation of all researchers in clinical trials, strictly follow the scheme of clinical trials, clinical trials and found that does not comply with the relevant laws and regulations, this specification and the clinical trial protocol, it shall timely pointed out and corrected, if severe or sustained do not

change shall be termination of the trial, and to clinical trial institution, the seat of the provincial, autonomous regions and municipalities food and drug supervision and management departments and the State Food and drug administration report.

Article 48 the sponsor shall occur and clinical trials related to the injury or death of subjects who bear the cost of treatment and the corresponding economic compensation, but damage caused by medical institutions and medical personnel and the fault in the medical activities except.

Article 49 The sponsor shall bear the liability for the monitoring of clinical trials, and choose to comply with the requirements of the arbitrator to perform the duty of monitoring. Monitoring of the number of members and the monitoring times depending on the complexity of clinical trials and trial participation institution of clinical trial number.

Article 50 the arbitrator shall have corresponding clinical medical, pharmaceutical, biomedical engineering, statistics and other related professional background and after the necessary training, familiar with relevant laws and regulations and the rules, tests are related to familiar with non clinical and similar products in the clinical information of medical devices and clinical trial protocol and related documents.

Sixtieth clinical trials should be in accordance with the terms of the applicant's agreement to properly preserve the clinical trial records and basic documents.

Study on the sixty-first responsible for clinical trials should meet the following conditions: (a) associate professor is deputy director of the physician, in the clinical trial institution, associate deputy high above the relevant professional titles and qualifications; (two) with professional knowledge and experience test for medical instruments required, when necessary, shall be subject to relevant training; (three) familiar with the applicant and the requirements related to clinical trial data, documents; (four) the ability to coordinate, personnel and equipment of the test of control and use, and have the ability to deal with adverse events of medical test and other related events; (five) familiar the relevant national laws, regulations and the code.

Sixty-second clinical trials, clinical trials of medical device clinical trials management department should cooperate with the applicant to apply to the ethics committee, and in accordance with the provisions of the relevant documents submitted.

Article 63 researchers should ensure that participating in the trial of the relevant staff familiar with the test with the principle of medical apparatus and instruments, scope of application, product performance,

methods of operation, installation requirements and technical indicators, understanding the test medical devices pre clinical study data and safety information, master clinical trials can produce risk prevention and emergency treatment.

Article 64 researchers should ensure that all clinical trial participants fully understand the clinical trial protocol, relevant regulations, test characteristics of medical apparatus and instruments and duties associated with clinical trials, and to ensure that a sufficient number and in accordance with the inclusion criteria of a clinical trial program by participants in clinical trials, to ensure that the trial period as stipulated in the agreement of enough time and in accordance with the relevant provisions of the safe implementation and completion of clinical trials.

Sixty-fifth researchers should ensure that the trial use of medical devices only for the clinical trial of subjects, and shall not charge any fees.

Article 66 researchers should strictly follow the clinical trial protocol, without the consent of the sponsor and the ethics committee, or not in accordance with the provisions approved by the State Food and drug administration, shall not deviate from the plan or substantive changes in the program. But in the subjects face direct risk to immediately eliminate the emergency can also be afterwards report in written form. Article 67 the researchers responsible for recruiting subjects, and subjects or their guardians conversation. Researchers have the responsibility to the subjects that test medical devices and clinical trials related details, informed subjects may benefit and known, foreseeable risks and obtain subjects or their guardians signed and dated informed consent.

Sixty-eighth researchers or other people who participated in the test should not be forced or induced by other unfair means to participate in the trial.

Article 69 researchers in clinical trials found that test medical devices expected adverse events should be and bid together on informed consent related content to modify, in accordance with the procedures ethics review committee agreed, by the affected subjects or their guardians to modify after informed consent was re signed.

Article 70 researchers responsible for make and clinical trials related to medical decision, in the clinical trial related adverse events occurred, the clinical trial institutions and researchers should guarantee to provide enough, timely treatment and processing subjects. When subjects appear concurrent disease in need of treatment and treatment, researchers should timely inform the subjects.

Article 71 in clinical trials appear serious adverse events, researchers should take appropriate treatment measures on the subjects immediately,

also submit a written report to the medical devices in clinical trial institution of clinical trial management department, and after the written notice to the applicant. Medical appliance and clinical trial management departments should be in within 24 hours of a written report to the corresponding ethics committee, and clinical trial institution of the province where the, autonomous regions, municipal food and drug supervision and management departments and health meter health departments. To death and clinical trial institutions and researchers should when to the ethics committee and the applicant to provide all the information needed.

Article 72 researchers should record of all adverse events occurring in the process of clinical trials and found the device defects, and bid with the common analysis cause of the incident, to form a written analysis reports, put forward to continue, suspension or termination of the trial, the clinical trial institution of medical device clinical trial management department, be submitted to the ethical review committee. Article 73 researchers should ensure that the clinical trial data will exact, complete, clear, timely loading case report form. Case report table name by the signature of the researchers, any data change shall by researchers and signed and dated, while retaining the original records, the original records should be clearly identifiable.

Seventy-fourth clinical trials and researchers should ensure that the data, documentation and records of clinical trials are true, accurate, clear, and secure.

Article 75 clinical trials and research should accept the sponsor of the monitoring, verification and the ethics committee of supervision and provide required related to test all the records. Food and drug supervision and management departments, health and family supervisor Department inspectors to carry out inspection and clinical trial institutions and researchers should be fit.

Article 76 clinical trial institutions and researchers found that risk than may benefit, or have been drawn to determine test medical devices safety and validity of the results, need to suspend or terminate clinical trials shall be notified by subjects, and secure the appropriate treatment and follow-up of subjects, and in accordance with the provisions of the report and provide detailed written explanation. When necessary, report to the local province, autonomous regions, municipal food and drug supervision and administration department. Researchers received a bid or ethics committee to pause and notice of termination of clinical trials shall promptly notify the subjects, and secure the appropriate treatment and follow-up of subjects.

Article 77 clinical trial institutions and researchers for sponsor violation of relevant provisions or request to change the test data, the conclusion should be to bid for the seat of the provincial, autonomous

regions and municipalities food and drug supervision and administration department or the State Food and drug administration report.

Article 78 at the end of the clinical trial, the researchers should ensure the completion of the record report. At the same time, researchers should also ensure that the received test medical devices and the, abandoned or return the number of consistent to ensure that the remaining test medical devices properly good treatment and record keeping.

Article 79 researchers can according to the need of clinical trials, authorization relevant personnel of the subjects were recruited, and sustained communication, clinical trial data record test with medical equipment management. Researchers should authorize the staff for training and the formation of the corresponding file.

The eighth chapter records and reports

Medical records of medical test in Article 80 clinical trials, researchers should ensure that any observation and findings are correct and complete to be recorded, and carefully fill in the case report form. Records shall at least include: (a) the use of medical equipment information, including name, models, specifications, receiving date, batch number or serial number, etc.; (II) each subjects related to the history and the progress of the disease and other medical records, nursing records; (III) for each subject using test equipment, including each use the date, time, test equipment, etc.; (IV) records the signature and date.

Article 81 clinical trial records as raw materials, shall not be arbitrarily changed. Where it is really necessary to make the change shall explain the reasons, signed and dated. To deviate significantly from the clinical trials protocol or beyond the range of acceptable clinical data should be verified, by researchers as a necessary explanation.

Article 82 the sponsor shall be accurate and complete records and clinical trial related information, including: (a) test medical devices shipping and handling records, includes the name, models, specifications, batch number or serial number, the recipient's name, address, the delivery date, returned to the maintenance or after the clinical trial of medical devices sample recovery and disposal date causes and treatment methods; (II) and clinical trial institution signed the agreement; (III) audit reports, verification report; and (IV) serious adverse events and may lead to serious adverse events of equipment defect records and reports. Article 83 researchers should be in accordance with the requirements of the clinical trials protocol design, verification or validation test with safety and effectiveness of medical equipment and complete clinical trials report. The multi center clinical trial reported in clinical trials should contains the center of the sub clinical trials of small nodes. Article 84 for multi center clinical trial, the summary of the center of the sub clinical trials should include at least the general situation of

clinical trials, clinical data test with medical devices and control information of medical equipment is used to describe, safety and efficacy data sets, adverse events and treatment, regimen deviated from the account of the circumstances and attached case report form.

Eighty-fifth clinical trials report should be consistent, and the clinical trial program include: (a) general information; (two) abstract; (three) introduction; (four) clinical trial; (five) clinical trial methods; (six) clinical trial; (seven) clinical data; (eight) test medical equipment and medical equipment control or control treatment; (nine) statistical analysis methods and evaluation methods; (ten) clinical evaluation criteria; (eleven) clinical trial organization; (twelve) ethical situation; (thirteen) clinical trial results; (fourteen) adverse events found in clinical trials and its treatment; (fifteen) analysis, the results of clinical trials are discussed, especially the indications, contraindications and precautions scope. Items; (sixteen) clinical trial conclusions; (seventeen) the problems and suggestions for improvement; (eighteen) the list of test personnel; (nineteen) the other needs to be explained.

Article 86 clinical test report shall be signed by the researchers, dated, the clinical trial institution of medical device clinical trials management audit opinions issued, dated and stamped with the seal of the institution of clinical trial after the sponsor. Multi center clinical trials, various heart clinical summary of the experiment should be by researchers in the center signed and dated, through the center of the medical device clinical trials management audit, indicating date and shall be affixed with the seal of the institution of clinical trial after the lead unit.

In the ninth chapter, the management of medical equipment

Eighty-seventh applicants should refer to the provisions of the State Food and Drug Administration on medical device specifications and label management, the test of medical equipment for appropriate labeling, and marked the "test".

Article 88 test records of medical apparatus and instruments including the production date, product batch number, serial number and other records related to production, quality and stability of products and related inspection records, transportation, maintenance, delivery of the institution of clinical trial records, and after the test back with the date of disposal and other aspects of information collection.

Article 89 the test with the use of medical devices by clinical trial institutions and researchers responsible for, the researchers should ensure all test for medical use only for the clinical trial subjects. During the test in accordance with the requirements of storage and custody trials with a medical instrument, in clinical test in accordance with the relevant provisions of the state and the sponsor agreement to test for

medical equipment for processing. The process required by the person responsible for the record and. Researchers not to test medical devices to transmit any not participating in the clinical trial.

The tenth chapter basic document management

Article 90 institution of clinical trial, the researchers, the sponsor shall establish the basic file system. The basic documents of clinical trials according to the clinical trial stage divided into three parts: document preparation stage, to document and termination or after the completion of the file.

Article ninety-first clinical trial institutions shall keep clinical trials data to 10 years after the end of the clinical trial. The applicant shall keep the clinical trial data to be used without the use of the medical device.

Article 92 clinical test basic file can be used to assess the applicant and execution of clinical study institutions and researchers to the relevant requirements of this specification and food and drug supervision and management departments, food and drug supervision and management departments can check on the basic documents of clinical trials.

The eleventh chapter

Ninety-third of the following terms used in this specification: the meaning of clinical trials of medical institutions, refers to the State Food and Drug Administration in conjunction with the national health and family planning commission that bear the medical device clinical trials of medical institutions. If no special instructions, the specification of "clinical trial institution" refers to "the medical institution of clinical trial" for testing of medical devices, refers to the clinical trials on its safety, confirmation or medical intends to apply for registration verification of the effectiveness of the sponsor, refers to the clinical trials initiated, management and provide financial support to institutions or organizations. The researchers, is responsible for the implementation of clinical trials in clinical trials in person. If in clinical trial institution is composed of a group of personnel to carry out the test, then the researchers refer to the person in charge of the group, also known as the main The researchers. The ethics committee refers to the review of the clinical trial setting mechanism of clinical trial project medical science and ethics of independent institutions. Medical clinical trial management department, is responsible for the clinical medical settings clinical trial institution test management and quality control departments or offices. The center of clinical trials, is in accordance with the same clinical trial program, in more than three (including three) clinical trial implementation of clinical trial institution. The subjects were enrolled, refers to the medical device clinical trials. Informed consent is the subjects to inform clinical trials, by the subjects voluntarily participate in the confirmation

process of the trial, should be dated and signed informed consent documents. As informed consent, refers to the subjects Said that documents voluntarily participate in clinical trials. Audit refers to the sponsor for clinical trials to ensure development can follow the clinical test plan, standard operating procedures, requirements of this specification and applicable management, send specialized personnel of institution of clinical trial, researchers evaluated investigation, verification and recording and reporting activities the clinical test data. The arbitrator, refers to the specialized personnel of the sponsor selected clinical trial program of medical audit. Verification refers to the system of independent inspection by the applicant organization of clinical trial related activities and documents, to determine the type of execution, data recording, analysis and report whether it meets the clinical test plan, standard operating procedures, requirements of this specification and applicable management. Inspectors, refers to the sponsor of the Medical Commission Device clinical trial project verification personnel. Inspection refers to the supervision department of the relevant documents, to the clinical trial facilities, records and other aspects of the supervision and management activities. The inspector, refers to the supervision department appointed to inspect the clinical trial project of medical personnel. Deviation refers to intentionally or unintentionally, did not follow the requirements the clinical trial protocol. Case report form, refers to the clinical trial scheme specified in the design documents, all the information and data obtained for each record in the process of test subjects. The end is used for assessment of clinical trial hypothesis index. The data source, refers to the clinical clinical trials found that the original record of observation and other activities as well as its information by all certified copies of the test can be used for clinical reconstruction and evaluation. The source file, Refers to the printed document contains the source data, video files or electronic documents. Adverse events, refers to the adverse medical events occur in the course of clinical trials, regardless of whether the test and medical instruments. Serious adverse events, refers to cause death or serious deterioration of the health status of clinical trials, including fatal the illness or injury, permanent defect body structure or body function, requiring hospitalization or prolonged hospitalization, the need for medical or surgical intervention to avoid the structure of the body or body function caused permanent defects; cause of fetal distress, fetal death or congenital abnormalities, congenital defect. Event refers to the equipment defects. Clinical trials of medical devices exist unreasonable risks that may endanger human health and life safety under the condition of normal use, such as Label error and quality problems, fault and so on. Standard operating procedures, is refers to the clinical trials in each work of the proposed standards and detailed

written procedures to effectively implement and complete. Clinical data is obtained in the clinical use of relevant documents or medical device safety performance information.

Ninety-fourth medical device clinical trials of ethical review of the application for examination and approval form template by the State Food and drug administration shall be formulated separately.

Ninety-fifth this specification does not apply to in accordance with the medical device management of in vitro diagnostic reagents.

Ninety-sixth this specification since June 1, 2016 the implementation of the.2004 January 17th release of the medical device clinical trials (the State Food and drug administration order No. fifth) was repealed simultaneously.

5部bbc史诗级纪录片不可不看

5部BBC 史诗级纪录片，不可不看！从小伴随你长大的节目有哪些呢？《人与自然》？《动物世界》？每次母上大人不让看电视的时候，我们就可以理直气壮地说：“我们在学习知识！”这话绝对没！毛！病！我们确实在学知识。自从生命中有了小U，我们升级成了在英语中学知识！今天小U 为大家准备了 5 部BBC 史诗级纪录片！涨姿势又学英语，U粉儿们接着读下去吧?《人类星球》 Human Planet Human Planet is an 8-part British television documentary series. 《人类星球》是一部英国电视纪录片系列，分为8 个部分。It describes the human species and its relationship with the natural world by showing the remarkable ways humans have adapted to life in every environment on Earth. 它描述了人类物种及其与自然世界的关系，展示了人类在地球的各种环境中，适应生活的非凡方式。豆瓣评分9.8 部极其特别的自然纪录片，说是讲地球，其实是在从社会学的角度讲人类；但说是讲人类的纪录片，它又是以自然生态地理环境等要素为载体来讲述。视点新颖，内容丰富，把自然和人文结合得天衣无缝。 IMDb 评分9.8 Like all life forms, humanity partially adapts to types of

natural environment, yet also tends to change them. 像所有的生命形式一样，人类部分地适应不同类型的自然环境，但也倾向于改变它们。Each episode examines how life differs for men and nature in some type of environment, from Arctic to desert and jungle, from coasts to mountains. 每一集都考察了在不同类型的环境中，从北极到沙漠到丛林、从海岸到山脉，人们的生活是如何的不同。《人类星球》生命》Life Life is a British nature documentary series created and produced by the BBC in association with The Open University. 《生命》是由英国广播公司与开放大学联合创作和制作的英国自然纪录片系列。The series takes a global view of the specialized strategies and extreme behavior that living things have developed in order to survive; what Charles Darwin termed 'the struggle for existence'. 该系列以一种全球性的观点来看待那些为了生存而发展的特殊策略和极端行为。查尔斯?达尔文称之为“为生存而斗争”。豆瓣评分9.7 人类看完足以无地自容的片子，哪怕只是地穴里一只微不足道的小虫子，每天也在上演生存的史诗。为了吃饭，为了繁衍，为了活下去，无数精彩甚至悲壮的生物行为，在这个生生不息的地球上无限地演绎下去，地球也因此而不朽。 IMDb 评分9.1 David Attenborough's legendary BBC crew explains and shows wildlife all over pl anet earth in 10 epi sodes. 大卫?爱登堡的传奇BBC 制作团队，在10 集的时间内解释和说明了全世界的野生动物。The first is an overview of the challenges facing life, the others are dedicated to hunting, the deep sea and various major evolutionary groups of creatures: plants, primates and other large sections of other vertebrates and invertebrates. 此片首先是概述了生活面临的挑战，其它则致力于狩猎，深海和各种主要进化群体的生物：植物，灵长类动物和大量其他的脊椎动物和无脊椎动物。《生命》

船舶结构与设备知识点知识学习

船舶结构与设备特点： 1、知识点多、杂。考点知识多为书本原文，计算、思考等题目较少； 2、与货运、避碰同考，所占比例较小。其中货运160道题目，结构占20-30道题； 3、后期新题更新不多； 4、难点不多，需记忆。如船舶种类及特点、轻型吊杆、舵设备等。

第一章船舶常识（结构货运）第一节船舶的基本组成与主要标志一、船舶基本组成由主船体、上层建筑及其他各种配套设备等组成。 1、主船体船底：分单层底、双层底。舭部 ★舷侧：首/尾部船首/尾甲板：上甲板、平台甲板（注：强力甲板、遮蔽甲板、量吨甲板、舱壁甲板定义见“甲板结构”）、甲板命名舱壁：按方向分横舱壁、纵舱壁（其他分类方式见“舱壁结构”）。★船底、舷侧、舭部构成船壳板 2、上层建筑定义：分类：长上层建筑、短上层建筑（定义）组成：首楼、尾楼、桥楼（位置、作用）、甲板室（长甲板室、短甲板室） ★桅屋属于短甲板室上层建筑各层甲板：艇甲板、罗经甲板 3、舱室名称机舱、货舱、压载舱、深舱（定义）、其他舱室 ★隔离空舱（干隔舱）：仅有一个肋骨间距的空舱二、船舶主要标志

1、球鼻首和首侧推器标志：位置（前、后） 2、吃水标志：公制/英制（10cm/6英尺），★读取 3、甲板线标志：尺寸（300mm×25mm）、★位置 ★4、载重线标志：位置、堪划要求、字母涵义、丈量最小干舷 5、其他标志：船名船籍港标志：船名字高比船首字高小10%-20%；船籍港字高为船名字高60%-70% 烟囱标志：位置分舱与顶推位置标志：位置、形状引航员登离船标志：上白下红船舶识别号：100总吨及以上客船/300总吨及以上货船，位置公司名称标志：第二节船舶尺度与船舶吨位一、船舶尺度分为：最大尺度、船型尺度、登记尺度

《船舶结构与设备》_第四章_题库

《船舶结构与设备》第四章题库第四章系泊设备题库与答案 1)大型船舶的导缆钳多用________。 A．闭式和开式 B．单柱式 C．双滚轮或三滚轮式 D．单滚式答案：C 2)下列属于植物纤维绳的有________。 ①白棕绳；②马尼拉绳；③油麻绳；④尼龙绳；⑤涤纶绳；⑥椰棕绳。 A．①～③⑥ B．①～⑥ C．①③⑤⑥ D．①②⑥ 答案：A 3)下列类型的钢丝绳中________是半硬钢丝绳。 A．7×7 B．7×19 C．6×24 D．6×19 答案：D 4)在英制中，各种缆绳的大小尺寸是以________来表示的。 A．半径 B．周径 C．直径 D．以上均可答案：B 5)钢丝缆绳每百米重量W（kg）计算公式为＝0.35D2，其公式中D的单位是________。A．mm B．cm C．in D．dm 答案：A 6)钢丝缆绳每米的重量计算公式W（kg）＝0.35d2，其公式中d的单位是________。A．mm B．cm C．in D．dm 答案：B 7)各种不同规格钢丝绳的重量可用公式W＝0.35D2估算，其中"W"的含义是________。A．每200m钢丝绳重（kg）

B．每10m钢丝绳重量（kg） C．每50m钢丝绳重量（kg） D．每100m钢丝绳重量（kg）答案：D 8)7×19的钢丝绳为________钢丝绳。 A．硬 B．软 C．半硬 D．A、C都对答案：A 9)化纤缆的规格用直径表示时单位为________，用周径表示时单位为________。A．mm；in B．in；mm C．mm；mm D．in；in 答案：A 10)半硬钢丝绳常用于做________。 A．静索 B．拖缆或系船缆 C．绑扎 D．大桅支索答案：B 11)钢丝缆中油麻心的作用是________。 ①使缆绳变软便于操作；②起软垫作用减少缆绳内部摩擦；③防锈和润滑缆绳内部；④减轻缆绳重量。 A．①②③ B．②③④ C．①③④ D．①②③④ 答案：A 12)各种不同规格钢丝缆的重量可用公式W＝0.0035d2估算，其中W的含义是________。A．每米钢丝缆的重量（kg） B．每10m钢丝缆的重量（kg） C．每50m钢丝缆的重量（kg） D．每100m钢丝缆的重量（kg）答案：A 13)缆绳的长度一般以每捆220m计算，但也有每捆以________计算的。 A．100m B．200m C．300m D．500m 答案：D 14)缆绳的粗细一般以________来衡量的。 A．直径 B．周径 C．半径

航海概论教学大纲

《航海概论》课程教学大纲一、本课程的性质和目的《航海概论》课程是一门理性和实践性很强的综合性学科，涉及的内容及其广泛。本书针对船舶驾驶专业所必须了解和掌握的航海基本原理和基础知识进行介绍，力求简明扼要，由浅入深，内容新颖，重点突出，篇幅适中，使读者易于接受，便于掌握。本课程是根据高等海运院校船舶驾驶专业的特点和需要而设置的，是船舶驾驶专业了解航海的船员组织、职责和船舶常识及航行的特点、操纵要点的主要途径，是船舶驾驶专业学生必备的知识。本课程也做为其它有关专业学生了解航海知识的一门选修课。二、课程简介本书共分为五章节。第一章讲述船员组织、船员职责和船员的职业资格；第二章讲述船舶常识、船舶设备和船舶的航行性能；第三章讲述航海基础知识，包括地理坐标、航向与方位、能见距离、航速和航程、时间系统、航标、航海图书资料以及气象与海况；第四章讲述船舶航行中的航行计划、值班、通信、定位、操纵与避碰以及特殊航行方法；第五章讲述海上运输和船舶营运方式、主要货运单证、货物配载和装卸以及航行途中货物的保管等。三、课程教学内容第一章船员第一节船员组织第二节船员的职责第三节船员的职业资格第二章船舶

第一节船舶常识第二节船舶设备第三节船舶的航行性能第三章航海基础知识第一节地理坐标第二节航向与方位第三节能见距离第四节航速与航程第五节时间系统第六节航标第七节航海图书资料第八节气象与海况第四章船舶航行第一节航行计划第二节航行值班第三节船舶通信第四节船舶定位第五节船舶操纵和避碰第六节特殊航行方法第五章海上运输业务第一节海上运输和船舶营运方式第二节海上主要货运单证第三节货物配载和装卸第四节航行途中的货物保管

BBC纪录片《中国新年》笔记精华

2016 is the Year of the Monkey and Kate goes in search of the extremely rare Snub-Nosed Monkeys of Yunnan. She goes on a 'poo hunt', looking for monkey faeces to test for their health. Jing experiences the spectacular showers of sparks from ancient fireworks made from liquid metal by Mr. Xue, the last practitioner of this dying craft - his only protection is a sheepskin coat and straw hat. Ant finds out how an entire ice city is made from just frozen river water, sculpted to make full-sized buildings that are illuminated beautifully at night. 2016年是猴年，凯特来到云南寻找稀少的狮鼻猴。她进行了一场“便便搜索之旅”，寻找到猴子的排泄物并检验他们是否健康。Jing观看了一场由薛先生用液态金属制作的绚烂烟火，这样的做法非常古老。薛先生是这一即将失传技艺的最后传人，期间他仅有的保护措施就是一件羊皮外套和一顶草帽。安特则探索了整个冰城是如何从整条冰冻的河建造而来，在灯光的照射下，整座冰城在夜间熠熠生辉。Meanwhile, the Hairy Bikers, Dave and Si, join the largest motorbike flotilla on earth, as thousands of migrant workers in Guangzhou province head for home as New Year approaches. It’s an extraordinary scene as workers from the city go back to their home villages, often for the only time in a year. The Bikers join the volunteers helping the motorcyclists as they head carefully back home on bikes loaded high with people and presents. 同时，毛毛骑手戴维和Si加入了地球上最大规模的摩托迁徙大队，春节将近之时，成千上万的民工从广州省骑摩托车回家过节。多么壮观的场面，众多工人从城市骑车回到农村，一年中他们只有在春节才回家。戴维和Si加入了志愿者团队，去帮助这些一心想骑车回家的摩托骑手们，他们的摩托车上坐着很多人，载满礼物. 第一集重点笔记整理 1.词汇篇春节Chinese New Year=the Spring Festival 中国丰富的文化the richness of Chinese culture 农历lunar calendar 聚集到城市flock to the cities 惨不忍睹的eye-watering 对…爱发牢骚enjoy a good old moan about… 管理这么大的车流量manage this flow of vehicles 保持交通顺畅keep the traffic flowing 春运期间during the New Year rush 全家福have a family portrait 精密的运营require precision organization 入境旅客，接机家属arriving passengers and waiting families 与家人团聚reunite with their families 顽强的意志iron will 摩托车大军motorbike flotilla 巍然直立stand proud in the sky 需要对细节的一丝不苟demand meticulous attention to detail 中国生肖Chinese zodiac 犯太岁offend the God of Taisui 少数民族ethnic minority 2.句型篇中国食物丰富和多样绝世无双。Chinese food is as rich and varied as any on earth. 使用的是中国本土生长的食材。Use a host of ingredients grown right across the vast nation. 在春节时,千百万人会涌出城市前往他们位于全国各地的家乡。 At Chinese New Year, millions floods out of the city and head to their home towns across China. 在整个中国，春节期间会有惊人的五千四百万次航空旅行。 Across China, a staggering 54 million trips are by air during the festival. 红帽子的工作深受乘客欢迎。Red Caps truly got their work cut out for them. 它将哈尔滨升级为本地区的工商业中心。 It transformed this city into the beating heart of commerce and industry in this region.

钢结构规范及图集

钢结构规范及图集【国家标准】 1、GB-50017-2003《钢结构设计规范》 2、GB50018-2002冷弯薄壁型钢结构技术规范》 3、GB-50205-2001《钢结构结构施工质量验收规范》 4、GB50191-93构筑物抗震设计规范》 5、GBJ135-90高耸结构设计规范》 6、GB500046《工业建筑防腐蚀设计规范》 7、GB8923-88《涂装前钢材表面锈蚀等级和涂装等级》 8、GB14907-2002《钢结构防火涂料通用技术条件》 9、GB-50009-2001《建筑结构荷载规范》 10、GBT-50105-2001《建筑结构制图标准》 11、GB-50045-95《高层民用建筑设计防火规范》(2001年修订版) 12、GB-50187-93 《工业企业总平面设计规范》【行业标准】 1、JGJ138-2001/J130-2001型钢混凝土组合结构技术规程 2、JGJ7-1991网架结构设计与施工规程 3、JGJ61-2003/J258-2003网壳结构技术规程 4、JGJ99-1998高层民用建筑钢结构技术规程(正修订) 5、JGJ82-91钢结构高强度螺栓连接的设计、施工及验收规程 6、JGJ81-2002/J218-2002建筑钢结构焊接技术规程 7、DL/T5085-1999钢－混凝土组合结构设计规程 8、JCJ01-89钢管混凝土结构设计与施工规程

9、YB9238-92钢－混凝土组合楼盖结构设计与施工规程 10、YB9082-1997钢骨混凝土结构技术规程11、YBJ216-88压型金属钢板设计施工规程(正修订)12、YB/T9256-96钢结构、管道涂装技术规程13、YB9081-97冶金建筑抗震设计规范14、CECS102:2002门式刚架轻型房屋钢结构技术规程15、CECS77：96钢结构加固技术规范16、YB9257-96钢结构检测评定及加固技术规范17、CECS28：90钢管混凝土结构设计与施工规程18、YB9254-1995钢结构制作安装施工规程19、CECS159：2004矩形钢管混凝土结构技术规程20、CECS24:90钢结构防火涂料应用技术规范21、CECS158：2004索膜结构技术规程22、CECS23:90钢货架结构设计规范23、CECS78:96塔桅钢结构施工及验收规程24、CECS167:2004拱形波纹钢屋盖结构技术规程25、JGJ85-92预应力筋用锚具、夹具和连接器应用技术规程26、CECS多、高层建筑钢－混凝土混合结构设计规程27、CECS热轧H型钢构件技术规程28、CECS钢结构住宅建筑设计技术规程29、CECS建筑拱形钢结构技术规程30、CECS钢龙骨结构技术规程31、CECS 轻型房屋钢结构技术规程32、CECS冷弯型钢受力蒙皮结构技术规程33、CECS混凝土钢管叠合柱技术规程34、CECS钢管结构技术规程35、CECS预应力钢结构技术规程36、CECS 建筑用铸钢节点技术规程37、CECS钢结构抗火设计规程【地方标准】1、DB29-57-2003/J10297-2003天津市钢结构住宅设计规程2、DBJ13-51-2003/J10279-2003钢管混凝土结构技术规程（福建省）3、DBJ13-61-2004/J10429-2004钢－混凝土混合结构技术规程（福建省）4、DG/T08-008-2000/J10041-2000建筑钢结构防火技术规程（上海市）5、DBJ08-68-97轻型钢结构设计规程（上海市）6、DBJ01-616-2004/J10411-2004建筑防火涂料（板）工程设计、施工与验收规程（北京市）7、DBJ08-32-92高层建筑钢结构设计暂行规定（上

英国BBC 《中国新年》

英国BBC 《中国新年》无论是“欲扬先抑”的《中国创造》，还是摆脱高级黑路线，直接一键黑到底的《中国的秘密》， BBC纪录片的中国话题，总有那么点吃不到葡萄说葡萄酸的味道。但是！ “昨天的我你爱理不理，如今的我你高攀不起。” 给力的中国各种实力打脸，引得全世界都想知道，这个有品位的暴发户，到底在想啥？于是，BBC坐不住了，发挥“识时务者为俊杰”的优良传统， 2016年年初发了一个大招，推出纪录片《中国新年2016》，满满正能量画风。不过说来惭愧，好些传统，身为中国人的非凡君都不知道（捂脸）。从南到北，从城市到农村，从冰雪之城到热闹花街，

几位外国主持人春节期间，随着返乡大潮，好好体验了一把热闹的中国新年。哈尔冰的冰雪之城，有极限温度下孕育而出的虔诚，以冰雪塑造长城，用霓虹灯点开新年的炫彩，美，在于通透，在于明妍，在于天地万物之间。新年的钟声按时敲响返乡的人们，也都开始动身了，统计之后的35亿次出行，带着回家心切的震撼。而支撑在这些匆匆的脚步背后的，是繁忙而高效的交通网。还有些职业，专为春运而生，比如北京车站的红帽子。（为了工作，两年没回家的小伙）经过了多少次别离，依旧惮于别离，经过了多少次重逢，依旧感怀于重逢。(小侄子长得都快举不动了)中国人好客，而且越淳朴的地方越好客，邀请外国人过年，觥筹交错间，

同一个世界，都是新的一年。欢庆是全国的事，但每个地方都有自己的花样，这也是非凡君最爱中国的一点，和而不同，当是社会的哲学。查干湖自然少不了渔网，只是撒下去的，是数百年的生生不息，收上来的，是千万人的勃勃生机。河北蔚县，这个应该为众人熟知的地点，记着，如果每年只能开一朵花，便只能是这老汉手里，洒向老城墙的铁花。即使春节，云南金丝猴的保护员也在工作，他认识保护区的每一只猴子，每一只都上帝的杰作。如何真正融入中国人的生活呢？想走捷径的话，只能和我们共舞一场了。（反正老了都要跳）百年前，鸦片敲开中国的国门，百年后，辣条攻陷全世界的心门，说到底，还是中国强。（别傻啦，辣条是老少通吃）春晚上演着最初也是最后的大戏，

十字板剪切试验

十字板剪切试验十字板剪切试验定义和适用范围十字板剪切试验是用插入软粘土中的十字板头以一定的速率旋转测出土的抵抗力矩换算其抗剪强度它相当于摩擦角时的粘聚力值十字板剪切试验按力的传递方式分为电测式和机械式两类本规程适用于原位测定饱和软粘土的不排水总强度和灵敏度引用标准现场十字板剪切仪土工仪器的基本参数及通用技术条件第二篇原位测试仪器电测式十字板剪切试验仪器设备压入主机应能将十字板头垂直压入土中可采用触探主机或其它压入设备十字板头基本参数应符合表的规定其机械和材料要求应符合该标准和的规定扭力量测仪表传感器和量测仪表应符合表及和的规定扭力装置由蜗轮蜗杆变速齿轮钻杆夹具和手柄组成其他钻杆水平尺管钳等仪器设备的检定和校准测力传感器通过施加扭矩的圆盘和误差不大于的专用砖码参照负荷传感器试行检定规程的方法进行检定其结果应满足本规程的要求操作步骤在试验点两旁将地锚旋入土中安装和固定压入主机用分度值为的水平尺校平并安装好施加扭力的装置将十字板头接在扭力传感器上并拧紧把穿好电缆的钻杆插入扭力装置的钻杆夹具孔内将传感器的电缆插头与穿过钻杆的电缆插座连接并进行防水处理接通量测仪表然后拧紧钻杆钻杆应平直接头要拧紧宜在十字板以上的钻杆接头处加扩孔器将十字板头压入土中预定的试验深度后调整机架使钻杆位于机架面板导孔中心拧紧扭力装置上的钻杆夹具并将量测仪表调零或读取初读数顺时针方向转动扭力装置上的手摇柄当量测仪表读数开始增大时即开动秒表以的速率旋转钻杆每转测记读数次应在内测得峰值当读数出现峰值或稳定值后再继续旋转测记峰值或稳定值作为原状土剪切破坏时的读数松开钻杆夹具用板手或管钳快速将钻杆顺时针方向旋转圈使十字板头周围的土充分扰动后立即拧紧钻杆夹具按本规程的规定测记重塑土剪切破坏时的读数重塑土的抗剪强度试验视工程需要而定一般情况下可酌情减少试验次数如需继续进行试验可松开钻杆夹具将十字板头压至下一个试验深度

钢结构工程施工质量验收规范最新版

钢结构工程施工质量验收规范最新版篇一：GB50205-2001 钢结构工程施工质量验收规范《钢结构工程施工质量验收规范》（GB50205-2001）目录 0、关于发布国家标准《钢结构结构施工质量验收规范》的通知-------0 0、前言----------------------------------------------------0 1、总则----------------------------------------------------0 2、术语、符号-----------------------------------------------0 3、基本规定------------------------------------------------0 4、原材料及成品进场----------------------------------------0 4.1一般规定-------------------------------------------0 4.2钢材-----------------------------------------------0 4.3焊接材料-------------------------------------------0 4.4连接用紧固标准件-----------------------------------0 4.5焊接球--------------------------------------------0 4.6螺栓球--------------------------------------------0

武汉理工大学船舶结构与设备期末考试重点

“船舶结构与设备”课程应知应会知识 1、主船体内包含的舱室有哪些？7 包含下列舱室:机舱、货舱、液舱（燃油舱、滑油舱、污油舱、淡水舱、压载水舱、深舱）、隔离空舱、锚链舱、轴隧、舵机间、应急消防泵舱等。 2、简述吃水标志的作用、标记方法，如何读取船舶吃水？7 吃水标志的作用标示船舶不同部位的吃水，勘划在船舶船首、船中、船尾两侧船壳上，以醒目颜色标示。水尺标志有公制水尺和英制水尺两种，公制水尺用阿拉伯数字标绘，每个数字高10cm，上下字间距也是10cm；英制水尺用阿拉伯数字或罗马数字标绘，每个数字高6英寸，上下字间距也是6英寸读取水尺时以数字下缘为准。读取吃水根据水线在数字中的位置，按比例读取，有波浪时应取几次读取的最高值和最低值的平均数。 3、集装箱船的主要特点是什么？6 集装箱船的特点如下：货舱和甲板均可装载集装箱；多为单层甲板，舱口长而宽，采用双层船壳结构；为使集装箱堆放和稳固，在货舱内设置箱轨、立柱、水平桁等，组成固定集装箱用的蜂窝状格珊，在甲板上设置固定集装箱的专用设施；主机马力大，航速高，多为两部主机、双螺旋桨，方形系数小；

通常不设装卸设备，利用码头上的专用设备装卸。 4、国际航行不装木材的船舶载重线标志识图。10

CS——中国船级社 TF——热带淡水载重线 F——夏季淡水载重线 T——热带载重线 S——夏季载重线 W——冬季载重线 WNA——北大西洋冬季载重线还需标出船首向、甲板线、载重线圈位置。

5、何谓船舶纵、横骨架式，各有什么特点？8 橫骨架式船体结构是上甲板、船底、舷侧结构中，横向构件尺寸相对较小、数目多、排列密，纵向构件尺寸大、数目少、排列疏的船体结构。其特点是：横向强度和局部强度好，结构简单，容易建造，舱容利用率是高，空船重量大；通常在中小型船采用。纵骨架式船体结构是上甲板、船底、舷侧结构中，纵向构件尺寸相对较小、数目多、排列密，横向构件尺寸大、数目少、排列疏的船体结构。其特点是：总纵强度大，结构复杂，焊接工作量大，舱容利用率低，空船重量小。通常在大型油船和矿砂船上采用。 6、双层底的作用和主要构件。8 双层底的作用是：增加船体的总纵强度的船底的局部强度，可以作为燃油舱、滑油舱和淡水舱，提高船舶的抗沉性，对也货船提高了其抗泄漏能力，作为压载舱水舱，能调节船舶的吃水和纵横倾，改善船舶航行性能，在矿砂船上有提高船舶重心高度的作用。主要组成部分：纵向构件：中桁材、旁桁材、箱型中桁材、纵骨；横向构件：水密肋板、实肋板、组合肋板、轻型肋板、舭肘板。 7、船舶压载管系的作用和主要组成部分有哪些？6 压载管系的作用是将压载水打入或排出压载舱或将压载水在压

钢结构施工验收规范强制性条文汇总

钢结构有关规范目录门式刚架轻型房屋钢结构技术规程版）冷弯薄壁型钢结构技术规程GB50018-2002 钢结构焊接规范GB50661-2011 钢结构工程施工质量验收规范GB50205-2001 钢结构工程施工规范GB50755-2012 钢结构高强度螺栓连接技术规程JGJ82-2011 门式刚架轻型房屋钢构件JG 144-2002 波浪腹板钢结构应用技术规程CECS 290-2011 钢结构工程施工质量验收规范 GB50205-2001 强制性条文 4.2.1 钢材、钢铸件的品种、规格、性能等应符合现行国家产品标准和设计要求。进口钢材产品的质量应符合设计和合同规定标准的要求。检查数量：全数检查。

检验方法：检查质量合格证明文件、中文标志及检验报告等。 4.3.1 焊接材料的品种、规格、性能等应符合现行国家产品标准和设计要求。检查数量：全数检查。检验方法：检查焊接材料的质量合格证明文件、中文标志及检验报告等。 4.4.1 钢结构连接用高强度大六角头螺栓连接副、扭剪型高强度螺栓连接副、钢网架用高强度螺栓、普通螺、铆钉、自攻钉、拉铆钉、射钉、锚栓（机械型和化学试剂型）、地脚锚栓等紧固标准件及螺母、垫圈等标准配件，其品种、规格、性能等应符合现行国家产品标准和设计要求。高强度大六角头螺栓连接副和扭剪型高强度螺栓连接副出厂时应分别随箱带有扭矩系数和坚固轴力（预拉力）的检验报告。检查数量：全数检查。检查方法：检查产品的质量合格证明文件、中文标志及检验报告等。 5.2.2 焊工必须经考试合格并取得合格证书.持证焊工必须在其考试合格项目及其认可范围内焊施。检查数量：全数检查。检验方法：检查焊工合格证及其认可范围、有效期。 5.2.4设计要求全焊透的一、二级焊缝采用超声波探伤进行内部缺陷的检验，超声波探伤不能对缺陷作出判断时，应采用射线探伤，其内部缺陷分级及探伤方法应符合现行国家标准《钢焊缝手工超声波探伤方法和探伤结果分级法》GB11345或《钢熔化焊对接接头射线照相和质量分级》GB3323的规定。焊接球节点网架焊缝、螺栓球节点网架焊缝及圆管T、K、Y形节点相关线焊缝，其内部缺陷分级及探伤方法应分别符合国家现行标准《焊接球节点钢网架焊缝超声波探伤方法及质量分级法》JBJ/、《螺栓球节点钢网架焊缝超声波探伤方法及质量分级法》JBJ/T3034。2、《建筑钢结构焊接技术规程》JGJ81的规定。一级、二级焊缝的质量等级及缺陷分级应符合表5.2.4的规定。检查数量：全数检查。检验方法：检查超声波或射线探伤记录。一、二级焊缝质量等级或射线探伤记录表5.2.4

十字板剪切试验报告

十字板剪切试验 1.1试验的目的及意义（1）测定原应力条件下软粘性土的不排水抗剪强度；（2）评定软粘性土的灵敏度；（3）计算地基的承载力；（4）判断软粘性土的固结历史。 1.2试验的适用范围原位测定饱水软粘土的抗剪强度，所测得的抗剪强度值，相当于试验深度处于天然土层，在原位压力下固结的不排水抗剪强度。 1.3试验的仪器设备本次实验采用的是机械式十字板剪切仪（1）十字板头：矩形，高度为10公分，直径为5公分。（2）轴杆：使用的轴杆直径为20mm，轴杆与十字板头连接的采用离合器装置，使轴杆和十字板头能够离合，以便分别作十字板总剪应力试验和轴杆摩擦校正试验。（3）测力装置：采用开口钢环测力装置。

1.4实验原理十字板剪切试验的原理，即在钻孔某深度的软粘土中插入规定形状和尺寸的十字板头，施加扭转力矩，将土体剪切破坏，测定土体抵抗扭损的最大力矩，通过换算得到土体不排水抗剪强度u c 值（假定0≈?）。十字板头旋转过程中假定在土体产生一个高度为H （十字板头的高度）、直径为D （十字板头的直径）的圆柱状剪损面，并假定该剪损面的侧面和上、下底面上每一点土的抗剪强度都相等。在剪损过程中土体产生的最大抵抗力矩M 由圆柱侧表面的抵抗力矩1M 和圆柱上、下底面的抵抗力矩2M 两部分组成，即21M M M +=。其中： 2 1D DH c M u ? =π3 226 1 232412D c D D c M u u ππ=???=)3 (2161223H D D c D c D DH c M u u u +=+? =πππ

式中 —十字板抗剪强度；—u c —十字板头直径；—D —十字板头高度。—H 对于普通十字板仪，上式中的M 值应等于试验测得的总力矩减去轴杆与土体间的摩擦力矩和仪器机械摩阻力矩，即 R f p M f ）（-= 式中剪损土体的总作用力；——f p —施力转盘半径。—R 代入得：上式右端第一个因子，对一定规格（D 和H 均为十字板几何尺寸）的十字板仪为一常数，称为十字板常数k 即）（H D D M c u += 3 22π杆脱离进行测定；与轴试验时通过使十字板仪力和仪器机械阻力，在—轴杆与土体间的摩擦—f ) ()3 (22f p H D D R c f u -+= π) 3 (22H D D R k += π

船舶结构与设备题库(及答案)

第一章船舶常识 (C)1、下列有关主船体描述正确的是：①、是船舶的主体部分；②、由船底、舷侧、内底及首尾等结构组成；③、由上甲板、内底板、舷侧、首尾及横舱壁等结构组成； ④、是指上甲板及以下由船底、舷侧、甲板、首尾及舱壁等结构所组成的水密空心结构 A.①、② B.①、③ C.①、④ D.①、③、④ (D)2、船底板与舷侧板之间的圆弧过渡部分称之为： A.舭肘板 B.舭龙骨 C.舭列板 D.舭部 (B)3、主船体两舷舷侧在过渡至船舶前后两端并最终会拢的会拢段部分分别称之为： A.首舷和尾舷 B.船首和船尾 C.首部和尾部 D.首端和尾端 (C)4、主船体两舷舷侧在前部的线型弯曲部分称之为: A.船首(船端) B.船头 C.首舷(首部) D.首端 (C)5、主船体两舷舷侧在后部的线型弯曲部分称之为： A.船尾(尾端) B.船头 C.尾舷(尾部) D.船端 (A)6、船首两侧船壳弯曲处称： A.首舷 B.首楼 C.舭部 D.胯部 (D)7、船舶外板(又称船壳板)是指主船体中的： A.船底板 B.舷侧外板 C.舭部 D.构成船底、舷侧及舭部外壳的板 (A)8、就普通货船而言，下列有关主船体中甲板描述正确的是：①、为主船体垂向上成上下层并沿船长方向水平布置的大型纵向连续板架；②、上甲板为船体的最高一层全通甲板；③、平台甲板沿船长方向布置并计入船体总纵强度 A.①、② B.①、③ C.②、③ D.①、②、③ (B)9、上层连续甲板是指： A.船体的最高一层甲板 B.船体的最高一层全通甲板 C.水密横舱壁上伸到达的连续甲板 C.平台甲板 (A)10、平台甲板是指： A.沿船长方向布置并不计入船体总纵强度的不连续甲板 B.沿船长方向布置并计入船体总纵强度的连续甲板 C.沿船长方向布置并计入船体总纵强度的不连续甲板 D.沿船长方向布置并不计入船体总纵强度的连续甲板 (B)11、上甲板以下的第二层连续甲板常称为： A.二层甲板 B.三层甲板 C.主甲板 D.干舷甲板 (B)12、上甲板以下的第一层甲板常称为： A.一层甲板 B.二层甲板 C.舱内甲板 D.下甲板 (A)13、上甲板以上由一舷伸至另一舷的围蔽建筑称之为： A.上层建筑 B.甲板室

钢结构施工的技术要求

钢结构施工技术要求目录 1总则 (2) 2规范与标准 (3) 3钢板材料技术要求 (3) 4焊接材料 (6) 5制造工艺设计技术要求 (7) 6制造加工准备 (8) 7各部位构件、零部件按加工技术要求的分类 (8) 8零件加工 (10) 9零件组装、节段组装 (11) 10构件变形的控制 (12) 11构件尺寸允许公差 (13) 12焊接工艺评定和焊工考核 (13) 13焊接制造质量、焊接工艺和抗裂要求 (14) 14工厂内焊接 (18) 15工地焊接 (19) 16焊缝的检验与无损检测 (20) 17构件的工厂试组装 (22) 18构件成品的验收、存放、运输 (23) 19现场安装和焊接 (24) 20竣工主要文件 (25) 21钢结构制造加工精度要求 (25) 22钢结构防腐涂装技术要求 (33)

xxx一期工程跨运河桥梁，主桥为三跨连续钢桁梁结构，主跨为双层钢桁梁结构，边跨为单层钢双主梁结构，跨径组合40+80+40=160m。主桥跨越运河，为V级航道，通航净宽45m，通航净高5m，最高通航水位2.4m。 1总则 1.1本要求适用于运河桥梁主桥钢结构加工制造。 1.2本要求所列规范与标准应以最新版本为准。 1.3当各规范和标准与本要求的内容有差异时，按照较高要求执行。 1.4本桥钢结构施工方案为节段工厂预制，现场安装。因此钢结构加工单位除应考虑加工运输问题，还应结合现场施工方法和条件，制定高效合理的施工组织方案与施工工艺。 1.5施工预拱度由设计、施工监控、施工单位根据确定的施工组织方案与施工工艺共同确定。本桥应严格按照施工预拱度进行加工，在工厂内自重状态下进行预拼装，精度满足设计要求后，方能运输至现场。 1.6钢结构的主要杆件在正式加工前，应先进行相应的首件试制。在加工、组装、焊接、矫正、验收合格后，再正式投入大批量生产，以利及时积累数据发现与处理问题，使在以后批量生产中予以改进。各构件的相应首件的编号选取，由业主、设计、加工、施工、监理共同商定。 1.7加工单位必须先对到货供应的钢材和选定的焊接材料，进行完整、系统的试验，提前进行工艺评定试验；尤其应对工地现场焊接的各种环焊缝，进行工艺试验和评定，取得资料和参数，指导实施部件的加工与拼装。 1.8钢结构在加工制造中，必须对关键性零件、构件的半成品和成品进行检查、验收，并做好加工及检查记录以备跟踪和查考。 1.9制造和检验所使用的量具、仪器、仪表等必须由二级以上计量机构检验合格后方可使用。工厂与工地用尺必须由总包统一发放，防止出现系统交互误差。 1.10本桥钢结构加工制造，必须严格进行施工过程中的全面质量控制和管理，以确保质量，不留隐患。

船舶结构与货运课程改革总结

《船舶结构与货运》课程教学改革工作总结一、课程改革背景《船舶结构与货运》课程是航海技术专业的核心课程之一，是国家海事局无限航区三副适任考试必考科目。本门课程我院于2005年开设以来的10年间大致经历了四个阶段，最初阶段（2005-2007年），课程理论性强，实践内容少，教学方式以课堂讲授为主。学生普遍反映难学、难懂，用人单位也反映学生普遍动手能力不足；探索阶段（2007-2009年），本阶段对课程进行尝试性的改革，降低课程理论难度，加大实操课程时间，提高学生实际操作能力；改革阶段（2009-2011年），该阶段的课程围绕着航海技术专业“三岗递进、课证融合”的模式，以“保证货物运输安全”的能力目标全面采用“工学结合”教学模式，对课程内容、课程目标、教学组织等方面进行了较为全面的改革。修改完善阶段（2011年-至今），STCW公约马尼拉修正案（以下简称“新公约”）于2012 年1月1日生效以来，国际海事组织对于船员的职业素质提出了更高的要求，同时高职教育的改革如雨后春笋般不断涌现，各种项目化教学改革、教学做一体的教学模式，工学结合的教育教学手段，微课、慕课、翻转课堂的开发和应用，在线课堂、信息化课堂的建设都为高职教育的改革提供了方向和思路，这些模式和手段的应用改变了传统的教学模式，为高职学生技术应用能力的提高提供了平台，本课程以此为契机，近三年来进一步修改和完善课程改革方案并加以实施，至目前为止，课程改革已初见成效。二、课程改革思路与措施 1.课程改革目标：以校企对接为基础，通过调研分析新公约下国际航运界对船员能力的需求，确定课程的岗位适任能力，最终以学生的岗位适任为目标，查找以往课程体系中存在的不足，对课程结构体系、课程内容、课程教学模式等方面进行全面的改革和完善。 2.课程改革思路与措施： 1）校企合作，共同确定课程目标：校企对接，共同分析新公约下国际航运界对船员海上货物运输能力的需求，确定本课程的岗位适任能力，根据岗位适任能力重新确定课程的知识目标、能力目标和素质目标。 2）依据课程目标对课程结构及内容进行全面重组：根据校企共同确定的课程目标，按的人才培养方案，将海上货物运输课程模块重组为“三岗递进、课证融合”照航海技术专业能力递进的课程体系，按海上货物运输的能力要求确定出实际的货运工作流程，按照工作流程选取典型的工作任务作为教学内容，实现工学结合下课程体系和课程内容的重建。 3）以提高教学效果为目标，改革教学模式及考核方式：根据重新构建的课程体系和课程教学内容选取并确定合适的课程教学模式、教学手段以及相应的考核方式，不盲目追求教学模式的改革形式，而真正注重实际应用的效果和学生职业素质和可持续发展能力的提升。 4）为满足教学做一体化的需要，创造并改善教学资源和教学条件：以实际的教学做一体化需要为出发点，与企业联合，对已有的教学条件进行改善，同时为满足相应的教学模式开发并创造有利的信息化教学资源，为学生提供全面立体的学习环境和有效的学习平台。