1、January 2010DEUTSCHE NORM English price group 17No part of this standard may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).ICS 11.040.20!$t_“1568160w
2、ww.din.deDDIN EN ISO 21649Needle-free injectors for medical use Requirements and test methods (ISO 21649:2006)English version of DIN EN ISO 21649:2010-01Kanlenlose Injektionsgerte zur medizinischen Anwendung Anforderungen und Prfverfahren (ISO 21649:2006)Englische Fassung DIN EN ISO 21649:2010-01Sup
3、ersedesDIN EN ISO 21649:2006-09www.beuth.deDocument comprises 40 pagesDIN EN ISO 21649:2010-01 2 Start of validity This standard takes effect on 1 January 2010. National foreword This standard has been prepared by Technical Committee ISO/TC 84 “Devices for administration of medicinal products and in
4、travascular catheters” in collaboration with Technical Committee CEN/SS S03 “Syringes” (Secretariat: CMC). The responsible German body involved in its preparation was the Normenausschuss Medizin (Medical Standards Committee), Working Committee NA 063-02-01 AA Injektionssysteme. The DIN Standards cor
5、responding to the International Standards referred to in clause 2 of this document are as follows: ISO 3746 DIN EN ISO 3746 ISO 10993 DIN EN ISO 10993 ISO 11201 DIN EN ISO 11201 ISO 11202 DIN EN ISO 11202 ISO 11204 DIN EN ISO 11204 ISO 14155-1 DIN EN ISO 14155-1 ISO 14155-2 DIN EN ISO 14155-2 ISO 14
6、253-1 DIN EN ISO 14253-1 IEC 60068-2-27 DIN EN 60068-2-27 IEC 60068-2-32 withdrawn, replaced by: IEC 60068-2-31 DIN EN 60068-2-31 IEC 60068-2-64 DIN EN 60068-2-64 IEC 60601-1-1 DIN EN 60601-1-1 IEC 60721-3-7 DIN EN 60721-3-7 IEC 61672-1 DIN EN 61672-1 Amendments This standard differs from DIN EN ISO
7、 21649:2006-09 as follows: a) Annex ZA (informative) concerning the relationship between this European Standard and the essential requirements of EU Directive 93/42/EEC on medical devices has been updated on the basis of EU Directive 2007/47/EC of the European Parliament and of the Council of 5 Sept
8、ember 2007 amending Council Directives 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices and 93/42/EEC on medical devices and EU Directive 98/8/EC on the placing on the market of biocidal products. Previous editions DIN EN ISO 21649: 2006
9、-09 DIN EN ISO 21649:2010-01 3 National Annex NA (informative) Bibliography DIN EN ISO 3746, Acoustics Determination of sound power levels of noise sources using sound pres-sure Survey method using an enveloping measurement surface over a reflecting plane DIN EN ISO 10993 (all parts), Biological eva
10、luation of medical devices DIN EN ISO 11201, 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 DIN EN ISO 11202, Acoustics Noise e
11、mitted by machinery and equipment Measurement of emission sound pressure levels at a work station and at other specified positions applying approximate environmental corrections DIN EN ISO 11204, Acoustics Noise emitted by machinery and equipment Measurement of emission sound pressure levels at a wo
12、rk station and at other specified positions Method requiring environmental corrections DIN EN ISO 14155-1, Clinical investigation of medical devices for human subjects Part 1: General requirements DIN EN ISO 14155-2, Clinical investigation of medical devices for human subjects Part 2: Clinical inves
13、tigation plans DIN EN ISO 14253-1, Geometrical product specifications (GPS) Inspection by measurement of workpieces and measuring equipment Part 1: Decision rules for proving conformance or non-conformance with specifications DIN EN 60068-2-27, Environmental testing Part 2-27: Tests Test Ea and guid
14、ance: Shock DIN EN 60068-2-31, Environmental testing Part 2-31: Tests Test Ec: Rough handling shocks, primarily for equipment-type specimens DIN EN 60068-2-64, Environmental testing Part 2-64: Tests Test Fh: Vibration, broadband random and guidance DIN EN 60601-1-1, Medical electrical equipment Part
15、 1-1: General requirements for safety Collateral standard: Safety requirements for medical electrical systems DIN EN 60721-3-7, Classification of environmental conditions Part 3: Classification of groups of environmental parameters and their severities Section 7: Portable and non-stationary use DIN
16、EN 61672-1, Electroacoustics Sound level meters Part 1: Specifications DIN EN ISO 21649:2010-01 4 This page is intentionally blank 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
17、 use - Requirements 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
18、2009. CEN 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 obtaine
19、d on application 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 Managemen
20、t Centre has 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,
21、 Poland, Portugal, 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
22、 by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 21649:2009: EContents EN ISO 21649:2009 (E) DIN EN ISO 21649:2010-01 2 Page Foreword .3 Introduction.4 1 Scope5 2 Normative references5 3 Terms and definitions .6 4 Symbols and abbreviated terms 8 5 Requirements.9 5.1 General
23、 requirements .9 5.2 Noise requirements.10 5.3 Dose specification requirements.10 5.4 Uncertainty of measurements and conformance with specifications .11 5.5 Performance profile requirements.11 5.6 Test requirements .11 6 Test methods .14 6.1 General .14 6.2 Test procedures.15 6.3 Test conditions 22
24、 6.4 Test evaluations 23 7 Test report24 8 Information supplied by the manufacturer .25 8.1 General .25 8.2 Marking.25 8.3 Instructions for use.26 Annex A (informative) Two-sided tolerance limit factors (k) 27 Annex B (informative) Examples of accuracy limit calculations and random settings.32 Annex
25、 C (informative) Correspondence between ISO/IEC standards and EN standards .33 Bibliography34 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices .35 Foreword The text of ISO 21649:2006 has been prepared by Te
26、chnical Committee ISO/TC 84 “Devices for administration of medicinal products and intravascular catheters” of the International 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 publ
27、ication of an identical text or by endorsement, at the latest by March 2010, and conflicting national standards shall be 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 sha
28、ll not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 21649:2006. This 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.
29、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 following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Cypr
30、us, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 21
31、649:2006 has been approved by CEN as a EN ISO 21649:2009 without any modification. EN ISO 21649:2009 (E) DIN EN ISO 1:2010-01 3 Introduction This International Standard applies to needle-free injectors primarily intended to administer medicinal products to humans. Because of the anticipated variatio
32、n in the designs of such a broad array of devices, this International Standard is promulgated more 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,
33、 so that innovation in achieving the intended purposes is not unnecessarily restricted. Standards 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 ind
34、icating their use to deliver medicinal products into the body or into specified tissue compartments 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 supranatio
35、nal agencies regulating the manufacture and marketing of medical devices and pharmaceutical products. Such standards are expected to be supplemented by additional requirements and may occasionally be superseded by such regulatory authorities. Despite certain advantages for intentional interchangeabi
36、lity for dose chambers designed for different needle-free injection systems, as well as the potential 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 init
37、iatives to build upon the standards promulgated herein. The sampling plans for inspection selected 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 c
38、ritical product attributes. The sampling plan does not replace the more general manufacturing quality systems, including lot release, which appear in standards on quality systems, e.g. the ISO 9000 series or ISO 13485. EN ISO 21649:2009 (E) DIN EN ISO 21649:2010-01 4 1 Scope This International Stand
39、ard 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 often disposable and intended to be
40、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 designed to last through the claime
41、d 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); generate aerosols, droplets, po
42、wders 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 (such as transdermal patches, liquid
43、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 references The following referenced docu
44、ments 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 data Determination of a statistic
45、al 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 11201:1995, Acoustics Noise emitt
46、ed 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 Measurement of emission sound pres
47、sure levels at a work station and at other specified positions Survey method in situ EN ISO 21649:2009 (E) DIN EN ISO 3:2010-01 5 ISO 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
48、 requiring environmental corrections ISO 14155-1:2003, Clinical investigation of medical devices for human subjects Part 1: General requirements ISO 14155-2:2003, Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans ISO 14253-1:1998, Geometrical Product S
49、pecifications (GPS) Inspection by measurement of workpieces and measuring equipment Part 1: Decision rules for proving conformance or non-conformance with specifications IEC 60068-2-27:1987, Environmental testing Part 2: Tests. Test Ea and guidance: Shock IEC 60068-2-30:2005, Environmental testing Part 2-30: Tests. Test Db and guidance: Damp heat, cyclic (12 h + 12 h cycle) IEC 60068-2-32:1975, Environmental testing Part 2: Tests. Test Ed: Free fall IEC
