ISO/IEC 17025:2005
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General requirements for the competence of testing and calibration laboratories |
ISO 11137-1:2006
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Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
ISO 14160:2011
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Sterilization of health care products Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives Requirements for characterization, development, validation and routine control of a sterilization process for medical devices |
DIN EN ISO 13485:2016-08
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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
ISO 11737-2:2009
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Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes |
ISO 14937:2009
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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 |
DIN EN ISO 11137-1:2015-11
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STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 1: REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11137-1:2006, INCLUDING AMD 1:2013) |
DIN EN ISO 11137-3:2015-08 (Draft)
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STERILIZATION OF HEALTH CARE PRODUCTS - RADIATION - PART 3: GUIDANCE ON DOSIMETRIC ASPECTS OF DEVELOPMENT, VALIDATION AND ROUTINE CONTROL (ISO 11137-3:2017) |
DIN EN ISO 11138-2:2015-10 (Draft)
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STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES (ISO 11138-2:2017) |
ISO 11138-2:2017
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Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes |
ISO/TS 11139:2006
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Sterilization of health care products Vocabulary |
ISO 11137-3:2017
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Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects of development, validation and routine control |
DIN EN ISO 11737-2:2010-04
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STERILIZATION OF MEDICAL DEVICES - MICROBIOLOGICAL METHODS - PART 2: TESTS OF STERILITY PERFORMED IN THE DEFINITION, VALIDATION AND MAINTENANCE OF A STERILIZATION PROCESS |
ISO 11137-2:2013
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Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
DIN EN ISO 9000:2015-11
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QUALITY MANAGEMENT SYSTEMS - FUNDAMENTALS AND VOCABULARY (ISO 9000:2015) |
ISO 10012:2003
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Measurement management systems — Requirements for measurement processes and measuring equipment |
ISO 9000:2015
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Quality management systems — Fundamentals and vocabulary |
DIN EN ISO 14160:2011-10
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Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2011) |
ISO/TR 7871:1997
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Cumulative sum charts Guidance on quality control and data analysis using CUSUM techniques |
ISO 17665-1:2006
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Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |