DIN EN ISO 11608-1:2012-12

ISO 11608-1 covers needle-based injection systems (referred to as NISs) primarily intended for human use. It provides performance requirements regarding essential aspects so that variations of design are not unnecessarily restricted. It specifies requirements and test methods for pen-injectors intended to be used with needles and with replaceable or non-replaceable cartridges. Non-electrically powered pen-injectors, which are equipped with electronic components, are covered by this standard. High-pressure injectors and electrically powered injectors are not covered by this 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 underlying standard ISO 11608-1:2012 has been prepared by Technical Committee ISO/TC 84 "Devices for administration of medicinal products and intravascular catheters" in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices" with the collaboration 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 the Medical Standards Committee (NAMed).