SIST EN 13975:2003

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Sampling procedures used for acceptance testing of in vitro diagnostic medical devices - Statistical aspectsProcédures d'échantillonnage utilisées pour l'acceptation des essais des dispositifs médicaux de diagnostic in vitro - Aspects statistiquesProbenahmeverfahren für die Annahmeprüfung von In-vitro-Diagnostika - Statistische AspekteTa slovenski standard je istoveten z:EN 13975:2003SIST EN 13975:2003en11.100.10In vitro diagnostic test systemsICS:SLOVENSKI
STANDARDSIST EN 13975:200301-september-2003







EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 13975March 2003ICS 11.100English versionSampling procedures used for acceptance testing of in vitrodiagnostic medical devices - Statistical aspectsProcédures d'échantillonnage utilisées pour l'acceptationdes essais des dispositifs médicaux de diagnostic in vitro -Aspects statistiquesProbenahmeverfahren für die Annahmeprüfung von In-vitro-Diagnostika - Statistische AspekteThis European Standard was approved by CEN on 14 November 2002.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Management Centre or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and UnitedKingdom.EUROPEAN COMMITTEE FOR STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2003 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 13975:2003 E



EN 13975:2003 (E)2ForewordThis document (EN 13975:2003) has been prepared by Technical Committee CEN /TC 140, "In vitro diagnosticmedical devices" the secretariat of which is held by DIN.This European Standard shall be given the status of a national standard, either by publication of an identical text orby endorsement, at the latest by September 2003, and conflicting national standards shall be withdrawn at thelatest by September 2003.This document has been prepared under a mandate given to CEN by the European Commission and the EuropeanFree Trade Association, and supports requirements of EU Directive(s).For relationship with EU Directive(s), see informative annex ZA, which is an integral part of this document.Annex A is informative.According to the CEN/CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland,France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal,Slovakia, Spain, Sweden, Switzerland and the United Kingdom.



EN 13975:2003 (E)3IntroductionThis European Standard relates to Annex VI "EC VERIFICATION" of the Directive 98/79/EC of the EuropeanParliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, setting out requirementsfor sampling procedures used for acceptance testing of in vitro diagnostic medical devices by a notified body.In Annex VI three provisions for verification are described:¾ Section 5 provides for verification by examination and testing of every finished device;¾ Section 6.3 provides for verification based on statistical control by attributes and/or variables;¾ Section 2.2 provides for alternative conformity assessment procedures for those situations where statisticalverification as specified in Section 6.3 is considered to be not appropriate.The first provision is not considered in the present standard since the associated sampling plan requires nostatistical considerations.The second provision is applied when sufficient certainty on the result of such verification on finished devices canbe gained by a sampling plan established on a statistical basis. For this purpose existing standards on acceptancetesting can be applied.The third provision is addressed in Section 2.2 of Annex VI which states that:"To the extent that for certain aspects the final testing according to Section 6.3 is not appropriate, adequatein-process testing, monitoring and control methods shall be established by the manufacturer with the approval ofthe notified body. The provision of Annex IV, Section 5, shall apply accordingly in relation to the above mentionedapproved procedures."Annex IV, Section 5, prescribes surveillance and approval of a manufacturer's quality system.It is current state of the art that inspection and verification of the finished devices is complementary to processcontrol and final testing performed by the manufacturer. Performance verification is generally performed bymeasurements on defined control materials or a defined panel of reference specimens (e.g. sera).Valid conclusions can only be drawn from a limited number of units of the final product, if adequate in-processtesting, monitoring and control procedures ensure the homogeneity of the final product batch and its components atthe intermediate stage(s) of manufacture as well as the suitability of the process applied. Any sampling plan usedfor final testing of in vitro diagnostic medical devices is based on statistical considerations. This does notnecessarily mean that a large number of units is sampled and tested. In many cases using very small sample sizes(sometimes equal to one unit) can be an acceptable approach, provided that an adequate level of conformity hasbeen demonstrated by other appropriate means.Following this last approach, this standard can also be used for establishing sampling procedures when annex III orIV or VII is applied.



EN 13975:2003 (E)41 ScopeThis European Standard specifies sampling procedure requirements for acceptance testing of finished in vitrodiagnostic medical devices, which require EC verification by a notified body.Two different provisions are addressed:a) verification by testing attributes and/or variables on a statistical basis;b) verification by testing a homogeneous batch which has been defined by appropriate means of processvalidation and in-process control.This standard specifies requirements and criteria for testing procedures to establish and verify the homogeneity ofprocesses and products. This standard is also applicable for drawing up sampling plans for finished productsaccording to the requirements laid down for manufacturers' product certification and production quality systems.2 Normative referencesThis European Standard incorporates by dated or undated reference provisions from other publications. Thesenormative references are cited at the appropriate places in the text and the publications are listed hereafter. Fordated references, subsequent amendments to, or revisions of, any of these publications apply to this EuropeanStandard only when incorporated in it by amendment or revision. For undated references the latest edition of thepublication referred to applies (including amendments).ISO 2859-1, Sampling procedures for inspection by attributes — Part 1: Sampling plans indexed by acceptablequality level (AQL) for lot-by-lot inspection.ISO 2859-2, Sampling procedures for inspection by attributes — Part 2: Sampling plans indexed by limiting quality(LQ) for isolated lot inspection.ISO 2859-3, Sampling procedures for inspection by attributes — Part 3: Skip-lot sampling procedures.ISO 3951, Sampling procedures and charts for inspection by variables for percent nonconforming.3 Terms and definitionsFor the purposes of this European Standard, the following terms and definitions apply.3.1acceptable quality levelAQLquality level that for the purpose of sampling inspection of a continuous series of batches is the limit of asatisfactory process average3.2acceptance testingsampling inspectionprocess of inspecting a sample of the units of product that make up a batch for the purpose of accepting orrejecting the entire batch, as prescribed in the associated pre-established sampling plan



EN 13975:2003 (E)53.3batchlotdefined amount of material, either starting material, intermediate or finished product which is uniform in itsproperties and has been produced in one process or series of processes[EN 375:2001]3.4batch acceptanceprocedure of establishing conformity of a batch with the device specifications3.5in vitro diagnostic medical deviceIVD MDany medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus,equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro forthe examination of specimens, including blood and tissue donations, derived from the human body, solely orprincipally for the purpose of providing information concerning a physiological or pathological state, or concerningcongenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitortherapeutic measures[Directive 98/79/EC]NOTE 1A specimen receptacle, whether vacuum-type or not, is considered to be an in vitro diagnostic medical device whenit is specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the humanbody for the purpose of in vitro diagnostic examination.NOTE 2Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of theirproperties, are specifically intended by their manufacturer to be used for in vitro diagnostic examination.3.6inspection by attributesinspection method whereby the unit of product is classified simply as conforming or nonconforming with respect toa given requirement or set of requirements3.7inspection by variablesinspection method whereby a specified quantitative property
is measured in a sample of units of product, eithercomponents or finished devices, to establish statistically the acceptability of a batch3.8limiting qualityLQwhen a batch is considered in isolation, a quality level which for the purposes of sampling inspection is limited to alow probability of acceptance[ISO 2859-1:1999]3.9sampleone or more units of product, either components or finished devices, drawn from a batch without regard to thequality of the units3.10sample sizenumber of units of product in the sample3.11sampling planplan that indicates the number of units of product, either components or finished devices, from each batch which isto be drawn for inspection and the associated criteria for determining the acceptability of the batch



EN 13975:2003 (E)6NOTEA sampling plan either contains or refers to instructions for the sampling strategy.3.12sampling strategyestablished method for obtaining an adequate sampleEXAMPLERandom selection, stratified, with stated frequency, rational sub-grouping.3.13validationconfirmation, through the provision of objective evidence, that the requirements for a specific intended use orapplication have been fulfilled[EN ISO 9000:2000]NOTE 1Process validation means establishing by objective evidence that a process consistently produces a result orproduct meeting its predetermined specifications.NOTE 2Design validation means establishing by objective evidence that device specifications conform with user needs andintended use(s).3.14verificationconfirmation, through the provision of objective evidence, that specified requirements have been fulfilled[EN ISO 9000:2000]4 Procedures4.1 GeneralSampling procedures used for batch acceptance testing shall be an integral part of the operational quality controlstrategy for any particular in vitro diagnostic medical device and shall take the nature of that product and possibleconsequences of nonconformity into account, i.e. ensure a high level of safety and performance according to thestate of the art.Batch acceptance shall be based on, either:¾ verification by examination and testing of every unit of product (finished devices);¾ statistical verification of a batch of finished devices;¾ process control, complemented, where appropriate, by
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