ISO-21649-2006.pdf
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1、 Reference number ISO 21649:2006(E) ISO 2006 INTERNATIONAL STANDARD ISO 21649 First edition 2006-06-01 Needle-free injectors for medical use Requirements and test methods Injecteurs sans aiguille usage mdical Exigences et mthodes dessai ISO 21649:2006(E) PDF disclaimer This PDF file may contain embe
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4、were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below. ISO 2006 All rights reserved. Unless otherwise spec
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6、ase postale 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in Switzerland ii ISO 2006 All rights reserved ISO 21649:2006(E) ISO 2006 All rights reserved iii Contents Page Foreword iv Introduction v 1 Scope . 1 2 Normative reference
7、s. 1 3 Terms 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 requi
8、rements. 7 6 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
9、) 23 Annex B (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/E
10、EC. 30 Bibliography. 32 -,-,- ISO 21649:2006(E) iv ISO 2006 All rights reserved Foreword 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
11、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 collaborates
12、 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.
13、 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
14、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. ISO 21649:2006(E) ISO 2006 All rights
15、reserved v Introduction 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 more as a “horizontal”
16、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 of this nature inte
17、ntionally 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 compartments thereof (e.g., in
18、tramuscular, 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 products. Such standards
19、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 potential risks of inadve
20、rtent 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 selected for this Internati
21、onal 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 quality systems, includ
22、ing lot release, which appear in standards on quality systems, e.g. the ISO 9000 series or ISO 13485. INTERNATIONAL STANDARD ISO 21649:2006(E) ISO 2006 All rights reserved 1 Needle-free injectors for medical use Requirements and test methods 1 Scope This International Standard applies to safety and
23、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 replaced after either a si
24、ngle 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 claimed life of the device. Excl
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