NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 15378 [CURRENT] references following documents:

Document number Edition Title
DIN EN ISO 14937 2010-03 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2009); German version EN ISO 14937:2009 More 
DIN EN ISO 9000 2015-11 Quality management systems - Fundamentals and vocabulary (ISO 9000:2015); German and English version EN ISO 9000:2015 More 
DIN EN ISO 9001 2015-11 Quality management systems - Requirements (ISO 9001:2015); German and English version EN ISO 9001:2015 More 
DIN EN 45020 2007-03 Standardization and related activities - General vocabulary (ISO/IEC Guide 2:2004); Trilingual version EN 45020:2006 More 
DIN EN 60300-1 2015-01 Dependability management - Part 1: Guidance for management and application (IEC 60300-1:2014); German version EN 60300-1:2014 More 
DIN EN 60812 2006-11 Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) (IEC 60812:2006); German version EN 60812:2006 More 
DIN EN 61025 2007-08 Fault tree analysis (FTA) (IEC 61025:2006); German version EN 61025:2007 More 
DIN EN 61160 2006-06 Design review (IEC 61160:2005); German version EN 61160:2005 More 
DIN EN 61882 ; VDE 0050-8:2017-02 2017-02 Hazard and operability studies (HAZOP studies) - Application guide (IEC 61882:2016); German version EN 61882:2016 More 
DIN ISO 37500 2015-08 Guidance on Outsourcing (ISO 37500:2014) More