DIN 12980:2016-10

This document applies to safety cabinets for cytostatic drugs (abbreviated as SfZ) and isolators for cytostatic drugs (abbreviated as IfZ): (1) for the preparation of cytostatic drug preparations and preparations of other drugs with CMR or toxic potential within the scope of normal pharmacy operations; (2) for the preparation of ready-to-use cytostatic drugs and other CMR drugs. Requirements for SfZs and IfZs are specified, as well as the testing of these requirements. Within the scope of this document cytostatic drugs are generally understood to be antineoplastic drugs that have the properties of CMR drugs. The preparations may be parenterals and orals. CMR drugs are drugs with carcinogenic (cancerogenic), mutagenic or reprotoxic properties. The standard defines personal protection (for the operating personnel) and product protection (ultimately patient protection) and describes design measures with which these protection objectives can be achieved. With regard to the safety requirements and their testing, DIN 12980 is very closely based on the standard DIN EN 12469 (performance criteria for microbiological safety cabinets), to which reference is often made. DIN 12980 specifies four types of testing and their chronological sequence. Pharmacists, physicians, chemists and safety engineers participated in the preparation of the standard in Working Group "Cytostatic Safety Cabinets". The committee NA 055-02-04 AA "Sicherheitswerkbänke und Isolatoren" ("Safety cabinets and isolators") at DIN is responsible for this standard.