1、BS EN ISO21649:2009ICS 11.040.20NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBRITISH STANDARDNeedle-free injectorsfor medical use Requirements andtest methods (ISO21649:2006)This British Standardwas published underthe authority of theStandards Policy andStrategy Committee on
2、 30November 2009. BSI 2009ISBN 978 0 580 67782 3Amendments/corrigenda issued since publicationDate CommentsBS EN ISO 21649:2009National forewordThis British Standard is the UK implementation of EN ISO 21649:2009.It is identical to ISO 21649:2006. It supersedes BS EN ISO 21649:2006which is withdrawn.
3、The UK participation in its preparation was entrusted to TechnicalCommittee CH/84, Catheters and syringes.A list of organizations represented on this committee can be obtained onrequest to its secretary.This publication does not purport to include all the necessary provisionsof a contract. Users are
4、 responsible for its correct application.Compliance with a British Standard cannot confer immunityfrom legal obligations.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 21649 September 2009 ICS 11.040.20 Supersedes EN ISO 21649:2006English Version Needle-free injectors for medical use - Req
5、uirements and test methods (ISO 21649:2006) Injecteurs sans aiguille usage mdical - Exigences et mthodes dessai (ISO 21649:2006) Kanlenlose Injektionsgerte zur medizinischen Anwendung - Anforderungen und Prfverfahren (ISO 21649:2006) This European Standard was approved by CEN on 24 August 2009. CEN
6、members are bound to comply with the CEN/CENELEC Internal 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 appli
7、cation to the CEN 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 translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre h
8、as the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, P
9、ortugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2009 CEN All rights of exploitation in any form and by any me
10、ans reserved worldwide for CEN national Members. Ref. No. EN ISO 21649:2009: EBS EN ISO 21649:2009EN ISO 21649:2009 (E) 3 Foreword The text of ISO 21649:2006 has been prepared by Technical Committee ISO/TC 84 “Devices for administration of medicinal products and intravascular catheters” of the Inter
11、national Organization for Standardization (ISO) and has been taken over as EN ISO 21649:2009. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by March 2010, and conflicting national standards shall b
12、e withdrawn at the latest by March 2010. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 21649:2006. T
13、his document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. According to
14、the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithu
15、ania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 21649:2006 has been approved by CEN as a EN ISO 21649:2009 without any modification. BS EN ISO 21649:2009EN ISO 21649:200
16、9 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a
17、 means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the
18、clauses of this standard given in table ZA.1 confers, within the limits of the scope of this standard, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between this European Standard and Directive 9
19、3/42/EEC on medical devices Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 5.1 7.1, 8.1, 8.3, 8.4, 12.7.3, 12.8.1, 12.8.2 5.3 12.8 5.4 10, 12.8, 12.9 5.5 1, 2, 3, 4, 6, 6 a Ergonomic requirements in ERs 1 are only partly covered in sta
20、ndard by subclauses 5.1 7thparagraph and 5.5.2 Note 5.6.1 4, 9.2, 10.1, 12.8.1 5.6.2 5 5.6.35.6.45.6.5 4, 12.7.1 5.6.6 4, 12.7.1, 12.7.2 5.6.7 9.2, 12,56.1, 6.2 1, 3, 4, 5 General conditions for performing tests. Ergonomic requirements in ERs 1 are only partly covered in standard by subclauses 5.1 7
21、thparagraph and 5.5.2 Note 6.2.2 4, 9.2 6.2.3 5 6.2.46.2.56.2.6 4, 9.1, 12.7.1 BS EN ISO 21649:2009EN ISO 21649:2009 (E) 5 Table ZA.1 (continued) Clause(s)/sub-clause(s) of this EN Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 6.2.7 4, 9.2, 12.7.1 6.2.8 9.2 6.3 4, 56.4
22、.1 3, 4, 12.8 6.4.2 3, 4, 5, 10.2, 12.9, 13.1, 13.2 7 All applicable ERs Report on tests 8.1 13.1 8.2 13.1, 13.3, 13.4, 13.5 Except 13.3 (f) (regarding indication of single-use and consistent across community) and 13.3(a) (regarding representative in the Community) 8.3 13.6 Except 13.6 (h) (regardin
23、g if the device bears indication of single use, information on known characteristics and technical factors known to manufacturer that could pose a risk if reused) and 13.6 (q) (regarding date of issue or latest revision of instructions for use) NOTE 12.1 a Software requirements are not covered in th
24、is standard WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 21649:2009ISO 21649:2006(E) ISO 2006 All rights reserved iiiContents Page Foreword iv Introduction v 1 Scope . 1 2 Normative references . 1 3 Terms
25、and definitions. 2 4 Symbols and abbreviated terms . 4 5 Requirements 5 5.1 General requirements. 5 5.2 Noise requirements 6 5.3 Dose specification requirements 6 5.4 Uncertainty of measurements and conformance with specifications. 7 5.5 Performance profile requirements 7 5.6 Test requirements. 7 6
26、Test methods. 10 6.1 General. 10 6.2 Test procedures 11 6.3 Test conditions . 18 6.4 Test evaluations 19 7 Test report . 20 8 Information supplied by the manufacturer 21 8.1 General. 21 8.2 Marking 21 8.3 Instructions for use 22 Annex A (informative) Two-sided tolerance limit factors (k) 23 Annex B
27、(informative) Examples of accuracy limit calculations and random settings 28 Annex C (informative) Correspondence between ISO/IEC standards and EN standards. 29 Annex ZA (informative) Relationship between this International Standard and the Essential Requirements of EU Directive 93/42/EEC. 30 Biblio
28、graphy . 32 BS EN ISO 21649:2009ISO 21649:2006(E) iv ISO 2006 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
29、 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, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborate
30、s 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/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards
31、. 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 member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this
32、 document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. ISO 21649 was prepared by Technical Committee ISO/TC 84, Devices for administration of medicinal products and intravascular catheters. BS EN ISO 21649:2009ISO 21649:2006(E)
33、 ISO 2006 All rights reserved vIntroduction This International Standard applies to needle-free injectors primarily intended to administer medicinal products to humans. Because of the anticipated variation in the designs of such a broad array of devices, this International Standard is promulgated mor
34、e as a “horizontal” rather than a “vertical” one. Thus, it will tend to specify the results of the design effort instead of the physical and construction requirements used as the basis for device design, so that innovation in achieving the intended purposes is not unnecessarily restricted. Standards
35、 of this nature intentionally avoid addressing more than the most basic elements regarding the safety and performance of needle-free injector devices in humans. Any intended labelling of such devices indicating their use to deliver medicinal products into the body or into specified tissue compartmen
36、ts thereof (e.g., intramuscular, subcutaneous or intradermal), or for the administration of specific pharmaceutical drugs or vaccines, shall fall under the authority of national governments or supranational agencies regulating the manufacture and marketing of medical devices and pharmaceutical produ
37、cts. Such standards are expected to be supplemented by additional requirements and may occasionally be superseded by such regulatory authorities. Despite certain advantages for intentional interchangeability for dose chambers designed for different needle-free injection systems, as well as the poten
38、tial risks of inadvertent interchangeability, these standards avoid setting forth design specifications for the uniform size, shape and interface of such dose chambers. This issue is left for future initiatives to build upon the standards promulgated herein. The sampling plans for inspection selecte
39、d for this International Standard are intended to verify the design, at a high confidence level, i.e., the manufacturers ability to manufacture one “lot” of needle-free injectors, which conforms to the critical product attributes. The sampling plan does not replace the more general manufacturing qua
40、lity systems, including lot release, which appear in standards on quality systems, e.g. the ISO 9000 series or ISO 13485. BS EN ISO 21649:2009BS EN ISO 21649:2009INTERNATIONAL STANDARD ISO 21649:2006(E) ISO 2006 All rights reserved 1Needle-free injectors for medical use Requirements and test methods
41、 1 Scope This International Standard applies to safety and performance and testing requirements for single-use and multiple-use needle-free injection systems intended for human use in clinics and other medical settings and for personal use by patients. The dose chamber of the injection system is oft
42、en disposable and intended to be replaced after either a single use or a limited number of uses. It is sometimes separable from the injection mechanism and often termed a “cartridge”, “ampoule”, “syringe”, “capsule” or “disc”. In contrast, the dose chamber also may be a permanent internal chamber de
43、signed to last through the claimed life of the device. Excluded from this International Standard are drug delivery methods which: involve penetration of a part of the device itself into or through skin or mucous membranes (such as needles, tines, micro-needles, implantable slow-release drug devices)
44、; generate aerosols, droplets, powders or other formulations for inhalation, insufflation, intranasal or oral deposition (such as sprays, inhalers, misters); deposit liquids, powders, or other substances on the surface of skin or mucosal surfaces for passive diffusion or ingestion into the body (suc
45、h as transdermal patches, liquid drops); apply sonic or electromagnetic energy (such as ultrasonic or iontophoretic devices); infusion systems for adding or metering medication into or through systems of artificial tubes, catheters, and/or needles which themselves enter the body. 2 Normative referen
46、ces The following referenced 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 3207:1975, Statistical interpretation of
47、data Determination of a statistical tolerance interval ISO 3746:1995, Acoustics Determination of sound power levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane ISO 10993 (all parts), Biological evaluation of medical devices ISO
48、11201:1995, Acoustics Noise emitted by machinery and equipment Measurement of emission sound pressure levels at a work station and at other specified positions Engineering method in an essentially free field over a reflecting plane ISO 11202:1995, Acoustics Noise emitted by machinery and equipment M
49、easurement of emission sound pressure levels at a work station and at other specified positions Survey method in situ BS EN ISO 21649:2009ISO 21649:2006(E) 2 ISO 2006 All rights reservedISO 11204:1995, Acoustics Noise emitted by machinery and equipment Measurement of emission sound pressure levels at a work station and at other specified positions Method requiring environmental corrections ISO 14155-1:2003, Clinical investigation of medical devices for human subjects Part 1: General requirements ISO 14155-2:2003,
