体外诊断试剂IVD欧盟EN13612性能评估部分中英文13页精选文档文档格式.docx

1、在运用观察法组织活动时，我着眼观察于观察对象的选择，着力于观察过程的指导，着重于幼儿观察能力和语言表达能力的提高。 The manufacturer takes the responsibility for the initiation and/or the conduct of a performance evaluation study. He shall define the responsibility and the interrelation of all personnel who manage单靠“死”记还不行,还得“活”用,姑且称之为“先死后活”吧。让学生把一周看到或听到的新

2、鲜事记下来,摒弃那些假话套话空话,写出自己的真情实感,篇幅可长可短,并要求运用积累的成语、名言警句等,定期检查点评,选择优秀篇目在班里朗读或展出。这样,即巩固了所学的材料,又锻炼了学生的写作能力,同时还培养了学生的观察能力、思维能力等等,达到“一石多鸟”的效果。 and conduct the performance evaluation of IVD MDs, particularly for personnel who need theorganisational freedom and authority toa） assess the validity of test results

3、and data already available;b） specify performance claims which shall be further examined or confirmed;c） specify and document the evaluation plan and the test procedures;d） prepare the evaluation report.The manufacturer shall appoint a co-ordinator with overall responsibility of the performance eval

4、uationstudy. The co-ordinator shall himself assure that adequate resources are available. The investigatorshall ensure that the evaluation plan is followed at his location and that the study is appropriatelyreviewed from an ethical point of view.3.2 DocumentationThe documentation of the performance

5、evaluation study shall contain the files relating to clauses 3 to7 of this standard and shall be part of the technical documentation of the IVD MD.3.3 Final assessment and reviewThe co-ordinator shall assess and document which performance claims are met, state whether claimsare not met and give reco

6、mmendations for corrective actions, where necessary.The responsible management of the manufacturer shall make sure that the results of the performanceevaluation study and the recommendations for corrective actions are carefully considered and properlydocumented before issuing a declaration of confor

7、mity.4 Organisation of a performance evaluation study4.1 PreconditionsBefore starting a performance evaluation study it shall be ensured by the co-ordinator thata） the performance claims of the IVD MD which are the subject of the study are specified;b） the IVD MD has been manufactured under controll

8、ed production processes and conditions;c） the IVD MD to be evaluated meets the quality control release specifications;d） a sufficient number of samples of the IVD MD can be provided during the entire period of theperformance evaluation study;e） all legal requirements for performance evaluation studi

9、es are met;f） the investigator（s） is （are） adequately skilled and trained to conduct the study and the necessaryresources are available.4.2 Evaluation planThe evaluation plan shall state the purpose on scientific, technical or medical grounds, the scope ofthe evaluation, the structure and organizati

10、on of the study and the number of devices concerned.Defining the objective of the study, the co-ordinator shall have assessed which performance claimsare already verified by data or scientific literature.The evaluation plan shall be designed to minimise the requirements for invasive sampling. In the

11、 caseof IVD MDs for self-testing it shall be ensured that the evaluation plan is appropriate and acceptable tousers and the information provided shall be clear and easily understood.The evaluation plan shall specifya） that the investigator（s） is （are） adequately skilled and trained to use the IVD MD

12、;b） the list of laboratories or other institutions taking part in the performance evaluation study; for selftesting,the location and number of lay persons involved;c） the time-table;d） the necessary minimum number of probands from whom specimens are collected by invasiveprocedures in order to adequa

13、tely assess the performance of the IVD MD;e） instructions for use including a description of the conditions of use;f） the performance claims （e.g. analytical sensitivity, diagnostic sensitivity, analytical specificity,diagnostic specificity, accuracy, repeatability, reproducibility） to be validated;

14、g） the format of performance study records.4.3 Sites and resourcesIn general, the performance study procedure（s） shall be carried out under conditions reflecting therelevant intended conditions of use.The co-ordinator shall take the responsibility for the proper conduct of the performance evaluation

15、study at all sites. All investigators shall be named.The co-ordinator shall ensure adequate competence and skill at all sites involved and that thenecessary resources are available.Where lay persons are involved in a performance evaluation study of an IVD MD for self-testing, thelocation of the stud

16、y and the number of persons shall be given. The co-ordinator shall specify thecriteria for the selection of a representative panel.Especially for studies involving lay persons it shall be ensured that these persons do not receiveadditional information on the use of the IVD MD apart from that which i

17、s provided with the IVD MDwhen it is placed on the market because the comprehension of the manufacturers instructions for useis one of the important aspects of the study. lt shall also be ensured that the untrained person（s） donot receive any additional information or help, e. g. from a tutor, other

18、 than the training specified andprovided by the manufacturer in the instructions for use.4.4 Basic design informationThe co-ordinator shall provide the investigator（s） with sufficient information in order to understand thefunction and application of the IVD MD and, where necessary, the investigator

19、shall make himselffamiliar with the IVD MD and its application. The information provided shall include a statement thatthe device in question conforms with the requirements of the Directive 98/79/EC apart from those to beevaluated.4.5 Experimental designThe experimental procedures to validate each p

20、erformance claim subject to the performanceevaluation study shall be documented in the evaluation plan.Special consideration in performance evaluation studies of reagents/kits shall be given, whereapplicable, to the following: specification of type （e.g. serum, plasma, urine） and properties （e.g. co

21、ncentration range, ageand sex of the proband population） of specimens appropriate to the intended use; probands to be enrolled; suitability, stability and volume of specimens and specimen exclusion criteria; blind procedures, where necessary; reagent stability; inclusion of common interfering factor

22、s, caused by specimen condition or thepathological/physiological status of the specimen donor or treatment; conditions for use which can be reasonably anticipated; special attention shall be paid to theconditions of use by lay persons; selection of an appropriate reference measurement procedure and

23、reference material ofhigher order, where available; determination of the status of specimens （for qualitative tests with a nominal or ordinal scale）; calibration procedures, including traceability, where appropriate; appropriate means of control; limitations of the test; criteria for re-examination

24、and data exclusion; availability of additional information concerning the specimen or donor if follow-up ofunexpected results is required; appropriate measures to reduce risk of infection to the user.Where the study is intended to validate the performance claims of an instrument special consideratio

25、nshall be given additionally to the following: maintenance and cleaning; carry-over effects; software validation.NOTE For the investigation of the technical aspects of instruments, other standards can be relevant.4.6 Performance study recordsThe performance study records shall refer to the experimen

26、tal procedures in the evaluation plan; be unequivocally identifiable; contain or refer to all results and related relevant data; be part of the technical documentation of the IVD MD.The protection of all confidential data shall be ensured.4.7 Observations and unexpected outcomesSpecial attention sha

27、ll be paid to observations and unexpected outcomes, e. g. drop outs, outliers,instability of sample or reagent signal etc., non-reproducibility, non-correlation of results to thereference or to the diagnostic pattern, defects or breakdowns, software errors, or error signals.Any deviation from the de

28、fined procedures shall be recorded. In the case of IVD MDs for self-testing,the investigator or tutor shall duly note any difficulty or question a user may have and any deviationfrom the mode of application of the IVD MD as described by the manufacturer.Any such observation shall be properly recorde

29、d. The co-ordinator shall, together with the investigator,trace the cause whenever possible. The result shall be recorded and shall be part of the evaluationreport.Where the validity of the examinations already performed may be questionable because of anidentified source of error the tests shall be

30、repeated after exclusion of that cause.Where a misuse or misinterpretation of the instructions for use has been the cause and where anunexpected risk inherent to the product design or the mode of application has been identified this shallbe clearly stated.The proposals of the investigator（s） and the co-ordinator for any improvement of the IVD MD and/or itsapplication shall be recorded.4.8 Evaluation reportThe co-ordinator shall establish an evaluation report. It shall contain a descript