BS EN ISO 21649 is the British Standard applicable 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 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 claimed life of the device.
BS EN ISO 21649 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 BS EN ISO 21649 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, 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 indicating 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 supranational 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Such standards are expected to be supplemented by additional requirements and may occasionally be superseded by such regulatory authorities.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 interchangeability 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 initiatives to build upon the standards promulgated herein.
The sampling plans for inspection selected for BS EN ISO21669 are intended to verify the design, at a high confidence level, i.e., the manufacturer's 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, including lot release, which appear in standards on quality systems, e.g. the ISO 9000 series or ISO 13485.
The following are not covered, drug delivery methods that:
BS EN ISO 21649 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.
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 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.
BS EN ISO 21649:2009 supersedes EN ISO 21649:2006 which has been withdrawn.
EN ISO 21649:2009
ISO 21649:2006