EN ISO 11138-1:2017
Sterilization of health care products - Biological indicators - Part 1: General requirements

Standard No.
EN ISO 11138-1:2017
Release Date
2017
Published By
European Committee for Standardization (CEN)
Latest
EN ISO 11138-1:2017
Replace
FprEN ISO 11138-1:2016

EN ISO 11138-1:2017 Referenced Document

  • IEC 60027-1:1992 Letter symbols to be used in electrical technology; part 1: general
  • IEC 60027-2:2005 Letter symbols to be used in electrical technology - Part 2: Telecommunications and electronics
  • IEC 60027-3:2002 Letter symbols to be used in electrical technology - Part 3: Logarithmic and related quantities, and their units
  • IEC 60027-4:2006 Letter symbols to be used in electrical technology - Part 4: Rotating electric machines
  • IEC 60027-6:2006 Letter symbols to be used in electrical technology - Part 6: Control technology
  • IEC 60027-7:2010 Letter symbols to be used in electrical technology - Part 7: Power generation, transmission and distribution
  • ISO ISO IEC 27001-2013 cor2-2015 technical errata*2023-12-23 Update
  • ISO 11135:2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
  • ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements
  • ISO 11737-1:2006 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
  • ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
  • ISO 14161:2009 Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
  • ISO 14937:2009 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 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
  • ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
  • ISO 18472:2006 Sterilization of health care products - Biological and chemical indicators - Test equipment
  • ISO 80000-1:2009 Quantities and units - Part 1: General
  • ISO 80000-2:2009 Quantities and units - Part 2: Mathematical signs and symbols to be used in the natural sciences and technology
  • ISO 80000-3:2006 Quantities and units - Part 3: Space and time
  • ISO 80000-4:2006 Quantities and units - Part 4: Mechanics
  • ISO 80000-5:2007 Quantities and units - Part 5: Thermodynamics
  • ISO 80000-7:2008 Quantities and units - Part 7: Light
  • ISO 8601:2004 Data elements and interchange formats - Information interchange - Representation of dates and times
  • ISO/TS 11139:2006 Sterilization of health care products - Vocabulary

EN ISO 11138-1:2017 history

  • 2017 EN ISO 11138-1:2017 Sterilization of health care products - Biological indicators - Part 1: General requirements
  • 2006 EN ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements



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