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New Laboratory Medicine Standards for the 4th Quarter 2014

Kyle Bach

Document Center Inc. is pleased to announce that the following New Standards on Laboratory Medicine are now available:


  • BS EN ISO 10993-3, 2014 Edition, Biological evaluation of medical devices. Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • BS EN ISO 15189, Corrigendum 1 for the 2012 Edition, Medical laboratories. Requirements for quality and competence
  • CLSI GP39, 6th Edition, Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard
  • DIN EN ISO 10993-10, 2014 Edition, Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
  • ISO 10993-3, Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
  • ISO 15189, 3rd Edition Reprint, Medical laboratories – Requirements for quality and competence
  • ISO 17822-1, 1st Edition, In vitro diagnostic test systems – Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens – Part 1: General requirements, terms and definitions
  • NCCLS H01, Renumbered CLSI GP39, Tubes and Additives for Venous and Capillary Blood Specimen Collection; Approved Standard
  • SS EN ISO 10993-3, 2014 Edition, Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014) – English language edition



For more standards like these, please see our Document Center List of Standards on Laboratory Medicine.  There are additional links there to various sub-topics.

And you’ll also want to take a look at my previous posting: