ISO 11607, all parts: Packaging for terminally sterilized medical devices20 laboratories in Germany are accredited by DAKKS for at least one part of ISO 11607. Each lab card shows which parts it holds. These labs commonly handle Plastics matrices. From the accredited scope text: “ISO 11607-1: 2020-05 Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte – Teil 1: Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO 11607-1:2019) DI” “ISO 11607-1 : 2020-05 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019) DIN EN ISO 11607-1 / A1” “ISO 11607-2 Leitlinie für die Validierung der Verpackungsprozesse nach DIN EN ISO 11607-2 (Revision 2020) der Deutschen Gesellschaft für Sterilgutversorgung (DGSV e.V.) FDA Guidance Medical Washers an” “ISO 11607-2: 2020-05 Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2: Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des Zusammenstellens DIN EN”
This page is a fixed slice of the register: every ISO 11607 scope we hold for Germany. Search narrows it further by city, accreditation body, or a term from the scope text itself.
ISO/IEC 17025 is the international standard for the competence of testing and calibration laboratories. Accreditation to this standard provides independent confirmation that a laboratory operates a quality management system and is technically competent to produce valid results within its declared scope.