DIN EN ISO 1135-3:2017-05

This part of ISO 1135 specifies requirements for types of blood-taking sets for medical use in order to ensure functional interchangeability of transfusion equipment. It is applicable to sterilized blood-taking sets intended for single use only. This standard also aims to provide a) specifications relating to the quality and performance of materials used in transfusion equipment, and b) a unified presentation of terms for such equipment. On the basis of DIN 58372:1979 Transfusion, infusion; taking sets for blood, concepts, requirements, test, the corresponding, identical standard ISO 1135-3 was published in 1986. This ISO Standard has been adopted as DIN ISO 1153-3:1987 and replaces DIN 58372 to formally only have one standard for blood-taking sets. Because applications of blood-taking sets according to DIN ISO 1135-3 dealt with blood donations in glass bottles, and collapsible plastic containers have been used for blood donation in Germany for several years, DIN ISO 1135-3 was withdrawn without replacement in 2004. ISO 1135-3 was still valid then, although applications based on this standard declined on the international level. When revising the applications, it was identified that blood-taking sets according to ISO 1153-3 are also still used in some fields in Germany - for example, for therapeutic blood-taking or ozone therapy. For this reason, the responsible ISO Working Group decided to revise the ISO Standard and to adapt it to the current state of the art. A parallel panel on the European level showed that there was a specific interest in converting this standard into a European Standard. In light of the CEN framework agreement, this standard has been adopted as a German Standard and replaces DIN ISO 1135-3:1987 which was withdrawn in 2004. This document has been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use" (secretariat: DIN, Germany) in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices" (secretariat: DIN, Germany) with the participation of German experts. The responsible national standardization committee is Working Committee NA 063-02-02 AA "Transfusions-/Infusionsbehältnisse und geräte aus Kunststoffen und Einmalprobengefäße für die In-vitro-Diagnostik" ("Transfusion/infusion containers and equipment made from plastics and disposable sample containers for the in-vitro diagnostics") at DIN Standards Committee Medicine (NAMed).