1、BRITISH STANDARD BS ISO 15198:2004 Clinical laboratory medicine In vitro diagnostic medical devices Validation of user quality control procedures by the manufacturer ICS 11.100 BS ISO 15198:2004 This British Standard was published under the authority of the Standards Policy and Strategy Committee on
2、 26 July 2004 BSI 26 July 2004 ISBN 0 580 44155 5 National foreword This British Standard reproduces verbatim ISO 15198:2004 and implements it as the UK national standard. The UK participation in its preparation was entrusted to Technical Committee CH/212, IVDs, which has the responsibility to: A li
3、st of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement international publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspo
4、ndence Index”, or by using the “Search” facility of the BSI Electronic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Compliance with a British Standard does not of
5、itself confer immunity from legal obligations. aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments a
6、nd promulgate them in the UK. Summary of pages This document comprises a front cover, an inside front cover, the ISO title page, pages ii to iv, page 1 to 10, an inside back cover and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amend
7、ments issued since publication Amd. No. Date CommentsINTERNATIONAL STANDARD ISO 15198 First edition 2004-07-15 Reference number ISO 15198:2004(E) OSI 2004 Clinical laboratory medicine In vitro diagnostic medical devices Validation of user quality control procedures by the manufacturer Laboratoires d
8、analyses de biologie mdicale Dispositifs mdicaux de diagnostic in vitro Validation des recommandations du fabricant pour la matrise de la qualit par lutilisateurBSISO15198:2004ISO :89151(4002)E ii ISO 4002 All rithgs reresvde id FDPscalimer ThFDP si fam eliy ctnome niat deddebyepfa.sec In cacnadroci
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13、 02 Te.l 22 14 + 10 947 11 Fax + 22 14 0 9479 74 Eam-il ocpyrithgios.ogr Web wwwi.soo.rg Pubni dehsil Stiwrezldna BSISO15198:2004ISO 91514002:8)E( ISO 4002 r llAithgs reservde iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
14、 (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations,
15、governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/
16、IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the me
17、mber bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 15198 was prepared by Technical Committee ISO/TC 212, Clinical labora
18、tory testing and in vitro diagnostic test systems. BSISO15198:2004ISO :89151(4002)E iv ISO 4002 All rithgs reresvde Introduction Manufacturers of IVD medical devices often include quality control (QC) procedures in their instructions for use. These quality control procedures are intended to provide
19、users with assurance that the device is performing within specifications, and therefore the results are suitable for their intended diagnostic use. For some devices, QC procedures can be an essential risk control measure. Depending on the design of the device, these quality control procedures can he
20、lp users ensure the quality of results by: a) verifying the suitability of analytical systems (sample, reagents, instruments, and/or users); b) monitoring the precision and trueness of measurement results; c) preventing false-negative and false-positive results; d) identifying fault conditions that
21、could lead to inaccurate results; and/or e) troubleshooting problems that require corrective action. In addition, manufacturers often design IVD medical devices with the ability to detect potential failures and alert users to take corrective action. Such internal control systems could potentially re
22、duce or even eliminate the need for users to run quality control samples to monitor the performance of the device. This International Standard is written for manufacturers of in vitro diagnostic (IVD) medical devices as part of their design control and risk management programs. It will also enable m
23、anufacturers to provide validated quality control procedures for users in clinical diagnostic laboratories. This International Standard describes how manufacturers can validate quality control procedures for their devices. Validation ensures that quality control procedures will perform as intended b
24、y the manufacturers and that manufacturers recommendations fit the needs of particular devices, such as discrete systems, products with built-in electronic controls, and products with “on board” chemical and/or biological controls. Information about the validated quality control procedures increases
25、 users understanding of devices overall quality assurance requirements so that informed choices regarding suitable control procedures can be made. Although laboratory directors have the ultimate responsibility for determining appropriate quality control procedures for their laboratories, manufacture
26、rs of IVD medical devices are responsible for providing adequate information to users about performance of devices as well as a means to control risks and to verify performance within specifications. Thus, in practice, quality control is a shared responsibility of IVD medical device manufacturers an
27、d users. No single quality control procedure can cover all IVD medical devices, neither now, nor in the future, since the devices may differ fundamentally in design, technology, function and intended use. Quality control practices that developed over the years have provided laboratories with some de
28、gree of assurance that results are valid. Although widely accepted by laboratories, government agencies and accrediting organizations, these practices originated when laboratory analyses were performed manually and laboratories prepared their own reagents. They may not always be optimal for current
29、IVD medical devices. Therefore, when quality control procedures are required, the manufacturer has the responsibility to design and validate quality control procedures appropriate for the device. Quality system standards for medical device manufacturers have also evolved over time. Design control an
30、d risk management requirements, for example, are included in ISO 13485:2003 as well as in most contemporary regulatory schemes. Design controls require a risk analysis of the design, and, prior to introduction to the marketplace, require that the design be validated with respect to user requirements
31、 and intended use. Quality control procedures in the instructions for use should be viewed as an integral part of the design of an IVD medical device; and thus are subject to design validation requirements. BSISO15198:2004ANRETNIITOTS LANDNADRA ISO 91514002:8)E( ISO 4002 r llAithgs reservde 1 Clinic
32、al laboratory medicine In vitro diagnostic medical devices Validation of user quality control procedures by the manufacturer 1S c o p e This International Standard describes a process for manufacturers of in vitro diagnostic medical devices to validate quality control procedures they recommend to th
33、eir users. These quality control procedures are intended to provide users with assurance that device performance is consistent with its intended use and the manufacturers claims. This International Standard applies to all in vitro diagnostic medical devices. 2 Normative references The following refe
34、renced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 3534-1, Statistics Vocabulary and symbols Part 1: Probability a
35、nd general statistical terms ISO 5725-1, Accuracy (trueness and precision) of measurement methods and results Part 1: General principles and definitions ISO 13485:2003, Medical devices Quality management systems Requirements for regulatory purposes ISO 14971, Medical devices Application of risk mana
36、gement to medical devices International vocabulary of basic and general terms in metrology (VIM). BIPM, IEC, IFCC, ISO, IUPAC, IUPAP , OIML, 2nd ed. 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 3534-1, ISO 5725-1, ISO 13485, ISO 14971, the VIM and
37、 the following apply. For the convenience of the user, some of the terms and definitions have been reproduced below. 3.1 accuracy closeness of agreement between a test result and the accepted reference value ISO 3534-1 NOTE The term accuracy, when applied to a set of test results, involves a combina
38、tion of random error components and a common systematic error or bias (3.2) component. See the VIM. 3.2 bias difference between the expectation of the test results and an accepted reference value ISO 5725-1 BSISO15198:2004ISO :89151(4002)E 2 ISO 4002 All rithgs reresvde 3.3 commutability of a materi
39、al ability of a material to yield the same numerical relationships between results of measurements by a given set of measurement procedures, purporting to measure the same quantity, as those between the expectations of the relationship obtained when the same procedures are applied to other relevant
40、types of materials ISO 15194 3.4 control material substance, material or article used to verify the performance characteristics of an in vitro diagnostic medical device EN 375 3.5 control procedure activities at the point of use to monitor the performance of an IVD medical device NOTE 1 In the IVD m
41、edical device industry and in many laboratories that use IVD medical devices, these activities are commonly referred to as quality control. NOTE 2 Quality control may monitor all or part of the measurement procedure, from the collection of samples to reporting the result of the measurement. 3.6 exam
42、ination set of operations having the object of determining the value of a property NOTE In the IVD medical device industry and in many laboratories that use IVD medical devices, examination of an analyte in a biological sample is commonly referred to as a test, assay or analysis. 3.7 examination pro
43、cedure set of operations, described specifically, used in the performance of examinations according to a given method NOTE In the IVDmedical device industry and in many laboratories that use IVDmedical devices, an examination procedure for an analyte in a biological sample is commonly referred to as
44、 an analytical method, analytical procedure or test procedure. 3.8 information supplied by the manufacturer with the medical device all written, printed, or graphic matter on a medical device or any of its containers or wrappers, or accompanying a medical device, relating to the identification, tech
45、nical description and use of the medical device, but excluding shipping documentation and promotional material NOTE 1 Adapted from EN 1041. NOTE 2 In some countries, information supplied by the manufacturer is called “labelling”. 3.9 instructions for use information supplied by the manufacturer with
46、 an in vitro diagnostic medical device concerning the safe and proper use of the reagent or the safe and correct operation, maintenance and basic troubleshooting of the instrument NOTE Adapted from EN 375 and EN 591. BSISO15198:2004ISO 91514002:8)E( ISO 4002 r llAithgs reservde 3 3.10 intermediate p
47、recision precision under conditions intermediate between reproducibility conditions (3.20) and repeatability conditions (3.18) NOTE The concept of intermediate levels of precision is described in ISO 5725-3. 3.11 intermediate precision conditions conditions where independent test results are obtaine
48、d with the same method on identical test items in the same laboratory or location, but where other variables such as operators, equipment, calibration, environmental conditions and/or time intervals differ NOTE Intended to measure precision in conditions leading to variability representative of actu
49、al use. Quantitative measures of intermediate precision depend on the stipulated conditions. 3.12 lot batch one or more components or finished devices that consist of a simple type, model, class, size, composition or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits 3.13 manufacturer natural or legal person with
