NA 027

DIN Standards Committee Optics and Precision Mechanics

DIN EN ISO 10993-1 [CURRENT] references following documents:

Document number Edition Title
DIN EN ISO/IEC 17025 2018-03 General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2017); German and English version EN ISO/IEC 17025:2017 More 
ISO 10993-1 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process More 
ISO 13485 2016-03 Medical devices - Quality management systems - Requirements for regulatory purposes More 
ISO 7405 2018-10 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry More 
ISO 9000 2015-09 Quality management systems - Fundamentals and vocabulary More 
ISO 9001 2015-09 Quality management systems - Requirements More 
ISO 9004 2018-04 Quality management - Quality of an organization - Guidance to achieve sustained success More 
ISO/IEC 17025 2017-11 General requirements for the competence of testing and calibration laboratories More 
ISO/TR 10993-22 2017-07 Biological evaluation of medical devices - Part 22: Guidance on nanomaterials More 
ISO/TR 10993-33 2015-03 Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3 More