DIN Standards Committee Health Technologies
DIN EN 1041
Information supplied by the manufacturer of medical devices; German version EN 1041:2008+A1:2013
Bereitstellung von Informationen durch den Hersteller von Medizinprodukten; Deutsche Fassung EN 1041:2008+A1:2013
Overview
This standard (EN 1041:2008+A1:2013) contains the amendments to EN 1041:2008 which have been prepared by Technical Committee CEN/CLC/TC 3 "Quality management and corresponding general aspects for medical devices". The responsible German committee is NA 063-01-13 AA "Qualitätsmanagement und entsprechende allgemeine Aspekte für Medizinprodukte" ("Quality management and corresponding general aspects for medical devices") at the Medical Standards Committee, NAMed. The amendment mainly contains specifications regarding the provision of information required in clause 5, and an update of the Bibliography.
Document: references other documents
Document: referenced in other documents
Responsible national committee
NA 176-01-02 AA - Quality management and corresponding general aspects for medical devices
Responsible european committee
CEN/CLC/JTC 3 - Quality management and corresponding general aspects for medical devices