DIN EN ISO 11608-1:2015-04

This International Standard covers needle-based injection systems (referred to as NISs) primarily intended for human use. Requirements and test methods for NISs intended for use with syringes and replaceable and non-replaceable cartridges are specified. NISs which are not electrically operated but which are equipped with electronic components are covered by this International Standard. Manufacturers are expected to follow a risk-based approach during the design, development and manufacture of the product. Given the specific medicinal product and intended use, this might result in product-specific requirements and test methods that differ from what is outlined in this part of ISO 11608. The international committee experienced after the publication in 2012 that corrections of the terms NIS and user packaging, modified system designations as well as of a lower temperature range shall take place. In order to correct these points and open questions it was suggested to do so by "minor revision". The underlying ISO 11608-1:2014 has been prepared by Technical Committee CEN/TC 205 "Non-active medical devices" (secretariat: DIN) with the participation of German experts. At DIN, the German Institute for Standardization e. V., the responsible committee is Working Committee NA 063-02-01 AA "Injektionssysteme" ("Injection systems") at DIN Standards Committee Medicine (NAMed).