EN ISO 20072-2013 en Aerosol drug delivery device design verification - Requirements and test methods《气溶胶药物输送装置设计验证 需求和测试方法》.pdf

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1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 20072:2013Aerosol drug deliverydevice design verification Requirements and testmethods (ISO 20072:2009)BS EN ISO 20072:2013 BRITISH STANDARDNational forewordThis Britis

2、h Standard is the UK implementation of EN ISO 20072:2013. It is identical to ISO 20072:2009. It supersedes BS EN ISO 20072:2010, which is withdrawn.The UK participation in its preparation was entrusted to T e c h n i c a l C o m m i t t e e C H / 8 4 , C a t h e t e r s a n d s y r i n g e s .A list

3、 of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2013. Published by BSI Standards L

4、imited 2013.ISBN 978 0 580 82254 4 ICS 11.040.10 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 28 February 2013.Amendments issued since publicationDate T e x t

5、 a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 20072 February 2013 ICS 11.040.10 Supersedes EN ISO 20072:2010English Version Aerosol drug delivery device design verification - Requirements and test methods (ISO 20072:2009) Vrification de la conception dun dispositif dadmini

6、stration de mdicament sous forme darosol - Exigences et mthodes dessai (ISO 20072:2009) Ausfhrungsverifizierung von Inhalationsgerten - Anforderungen und Prfverfahren (ISO 20072:2009) This European Standard was approved by CEN on 8 January 2013. CEN members are bound to comply with the CEN/CENELEC I

7、nternal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to

8、any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official

9、 versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Nor

10、way, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2013 CEN All rights of exploitation in

11、any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 20072:2013: EBS EN ISO 20072:2013 EN ISO 20072:2013 (E) 3 Foreword The text of ISO 20072:2009 has been prepared by Technical Committee ISO/TC 84 “Devices foradministration of medicinal products and intravascular c

12、atheters” of the International Organization forStandardization (ISO) and has been taken over as EN ISO 20072:2013 by Technical Committee CEN/TC 205“Non-active medical devices” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by

13、publication of an identicaltext or by endorsement, at the latest by August 2013, and conflicting national standards shall be withdrawn atthe latest by August 2013. Attention is drawn to the possibility that some of the elements of this document may be the subject of patentrights. CEN and/or CENELEC

14、shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 20072:2010. This document has been prepared under a mandate given to CEN by the European Commission and theEuropean Free Trade Association, and supports essential requirements of EU Directive

15、. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the followingcountries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cro

16、atia, Cyprus, CzechRepublic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece,Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the

17、 United Kingdom. Endorsement notice The text of ISO 20072:2009 has been approved by CEN as EN ISO 20072:2013 without any modification. BS EN ISO 20072:2013EN ISO 20072:2013 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements ofEU Directive 93/42/EE

18、C on Medical Devices This European Standard has been prepared under a mandate given to CEN by the European Commissionand the European Free Trade Association to provide a means of conforming to Essential Requirements of theNew Approach Directive 93/42/EEC on Medical Devices. Once this standard is cit

19、ed in the Official Journal of the European Union under that Directive and has beenimplemented as a national standard in at least one Member State, compliance with the clauses of thisstandard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption ofconformity with

20、 the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 93/42/EEC onMedical Devices Clause(s)/subclause(s) of thisEN Essential Requirements (ERs)of Directive 93/42/EEC Qualifying remarks/Notes

21、 5.1, parts h, i, j, l and 5.2 7 5.1, parts h, i, j, l and 5.2 8 5.1 part d and 5.6 9 5.1, 5.5, 6.4.2, 6.4.3, 6.4.4, 8.2 105.1, parts k, m, n and 5.6.8 128 (all parts) 13 The parts of ER 13.3 a) relatingto the address of manufacturerand to the authorizedrepresentative are notaddressed. ERs 13.3 f) a

22、nd 13.6 h) relatingto single-use are not addressed. ER 13.6 q) is not addressed. WARNING Other requirements and other EU Directives may be applicable to the product(s) fallingwithin the scope of this standard. BS EN ISO 20072:2013ISO 20072:2009(E) ISO 2009 All rights reserved iiiContents PageForewor

23、d ivIntroduction v1Scope12Normative references13Terms and definitions .24Symbols and abbreviated terms 65Requirements.75.1 General75.2Risk assessment requirements85.3Device functionality profile.85.4 System verification test 85.5 Uncertainty of measurements and conformance with specification95.6 Tes

24、t requirements96Test methods116.1 General116.2Test procedures.126.3Test conditions166.4 Test evaluations.177Test report198Information supplied by the manufacturer .198.1General198.2 Marking.198.3 Instructions for use.20Annex A (informative) Rationale for requirements22Annex B (informative) Further g

25、uidance and clarification of the device functionality profile24Annex C (informative) Rationale for test methods.26Annex D (informative) Two-sided tolerance limit factors ( k ).29Annex E (informative) Alternative acceptance criteria for the device functionality profile evaluation.35Bibliography42BS E

26、N ISO 20072:2013ISO 20072:2009(E)iv ISO 2009 All rights reservedForeword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical co

27、mmittees. Each member bodyinterested in a subject for which a technical committee has beenestablished has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closelywith the I

28、nternational Electrotechnical Com mission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordancewith the rules given in the ISO/IEC Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft International

29、 Standardsadopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval byat least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the su

30、bject of patent rights. ISO shall not be held responsible for identifying an y or all such patent rights. ISO20072 was prepared by Technical Committee ISO/TC84, Devices for administration of medicinal products and intravascular catheters . BS EN ISO 20072:2013ISO 20072:2009(E) ISO 2009 All rights re

31、served vIntroduction This International Standard applies to hand-held aerosol drug deliveryd evices (ADDD) intended to administer medication to humans. To avoid unnecessarily restricting innovation, given the broad variation in devicedesigns, this International Standard addresses the more general de

32、sign/labelling requirements rather thanspecific physical and prescriptive design requirements. However, this International Standard does require the elaboration of a device functionality profile (DFP) specific to the ADDD in question. This International Standard also addresses ADDD design requiremen

33、ts from both the user interface and safetyperspectives.An ADDD is used as part of a system consisting of the ADDD, the container, the medication and the labelling, including the instructions for use. Therefore, design verification of the ADDD includes a final systemverification test conducted in acc

34、ordance with the instructions for use. From a regulatory perspective, the ADDD system maybe reviewed and approved as part of a drug product (combination of ADDD and medication) or as a device by itself. For the purposes of this InternationalStandard, such regulatory distinctions do not alter the int

35、ent of the design verification process describedherein. As an example, in the European Union (EU), if an ADDD is placed on the market in such a way that the ADDD and the medication form a single integral product (i.e. the system) that is intended exclusively foruse in the given combination and which

36、 is not refillable, that single product shall be governed by Directive2001/83/EEC. However, the relevant essential requirements of Annex I of the Medical Device Directive (93/42/EEC) shall apply as far as safety and performance-related ADDD features are concerned, which is the specific objective of

37、this design verification standard. Regardless of the distinctions (“drug” or “device,” pre-filled or refillable), it is recognised that ADDD design verification is an important component of the overall validation process. Moreover, design verification isiterative, to be conducted at various phases t

38、hroughout the ADDDs development and subsequent ADDDpost-approval modifications. In all instances, design verification is conducted using the phase-appropriate instructions for use. It is understood thatin the early phases of ADDD development an appropriate subset ofthe requirements contained herein

39、might apply, but that all of the requirements will be satisfied as part of thefinal design verification exercise. Furthermore, design verification should be considered a minimumrequirement for the safe and effective use of the ADDD, and in many instances additional testing maybeappropriate as indica

40、ted by a risk assessment that shall alsobe conducted. This International Standard introduces the requirement for developers and/or manufacturers to create a devicefunctionality profile (DFP) for a given ADDD based on the ISO Standard for device risk assessment (as a part of ISO14971). The device fun

41、ctionality profile defines the parameters and tolerance intervals used to verifythe ADDDs ability to meet the manufacturers design specifications during in-use conditions and following environmental and electromechanical extreme use conditions. This International Standard also includes a system veri

42、fication test conducted at standard atmosphere and nominal flow rate as a simple bridge betweenthe device design and the patient interface. The purpose of this International Standard is to ensure a method and guide for independent testing of therepeatability and reproducibility of ADDD functionality

43、 that verifies compliance with its design specification.The design verification processmay include use ofapplicable regulatory agency requirements and/or testmethods. The sampling plans for this International Standard are intended to verifythe design at a highconfidence level. They do not replace th

44、e more general manufacturing quality systems, including lot release,which appear in standards on quality systems (e.g. the ISO 9000 series or ISO 13485). Figure 1 illustrates the process this International Standard advises to use in order to assess and verifywhether a design meets the determined DFP

45、. BS EN ISO 20072:2013ISO 20072:2009(E)vi ISO 2009 All rights reservedFigure 1 ADDD designverification process This International Standard specifically addresses the most basic elements regarding the safe and effectiveuse of ADDD in humans. It does not define the pharmaceutical or clinical performan

46、ce of an ADDD. Anylabelling indicating ADDD use to deliver medication to specific regions of the respiratorytract falls under the authority of national governments or regional agencies regulating the manufacture and marketing of medicaldevices and pharmaceutical products. In some countries national

47、regulations exist, and their requirements cansupersede or complement this International Standard. For a given manufacturer, existing marketed products and those currentlyunder development might not fulfilsome of the requirements. However, manufacturers should comply with this International Standard

48、whenimproving the functional design of existing ADDDs or developing newADDDs to obtain an even higher level ofquality.Annex A describes the reasoning for establishing the various requirements in this International Standard. BS EN ISO 20072:2013INTERNATIONAL STANDA RD ISO 20072:2009(E) ISO 2009 All r

49、ights reserved 1Aerosol drug delivery device design verification Requirements and test methods1 Scope This International Standard applies to the design, labelling, instructions for use and testing requirements forhand-held single- and multi-use aerosol drug delivery devices (ADDDs) intended to deliver a metered or pre-metered aerosolized medication to or by means of the human respiratorytract (including nasal, oral, tracheal,bronchial and alveolar sites). This International Standard applies to both refillable and disposable devices intended f