DIN EN ISO 11607-1:2014-11
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PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 1: REQUIREMENTS FOR MATERIALS, STERILE BARRIER SYSTEMS AND PACKAGING SYSTEMS (ISO 11607-1:2006 + AMD 1.:2014) |
ISO 6507-1:2005
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Metallic materials Vickers hardness test Part 1: Test method |
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 |
DIN ISO 8601:2006-09
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DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES |
DIN EN ISO 6507-1:2016-08 (Draft)
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METALLIC MATERIALS - VICKERS HARDNESS TEST - PART 1: TEST METHOD |
ISO 11607-2:2006
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Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
DIN EN ISO 13485:2016-08
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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) |
ISO 14155-2:2003
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Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
DIN EN ISO 10993-7:2009-02
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Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals (ISO 10993-7:2008) |
DIN EN ISO 14405-2:2012-03
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GEOMETRICAL PRODUCT SPECIFICATIONS (GPS) - DIMENSIONAL TOLERANCING - PART 2: DIMENSIONS OTHER THAN LINEAR SIZES (ISO 14405-2:2011) |
DIN EN ISO 17664:2016-06 (Draft)
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PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES (ISO 17664:2017) |
ISO 6892-1:2016
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Metallic materials Tensile testing Part 1: Method of test at room temperature |
ISO 5832-3:2016
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Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloy |
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 14801:2008-02
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DENTISTRY - IMPLANTS - DYNAMIC LOADING TEST FOR ENDOSSEOUS DENTAL IMPLANTS (ISO 14801:2016) |
ISO 14155-1:2003
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Clinical investigation of medical devices for human subjects Part 1: General requirements |
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 14971:2013-04
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MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007) |
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) |
ISO 7405:2008
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Dentistry Evaluation of biocompatibility of medical devices used in dentistry |
DIN EN ISO 6892-1:2017-02
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METALLIC MATERIALS - TENSILE TESTING - PART 1: METHOD OF TEST AT ROOM TEMPERATURE (ISO 6892-1:2016) |
ISO 13356:2015
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Implants for surgery — Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) |
ISO 11135-1:2007
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Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
DIN EN ISO 17665-1:2006-11
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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 (ISO 17665-1:2006) |
DIN EN ISO 14155-1:2009-11
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CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 1: GENERAL REQUIREMENTS |
ISO 6474-1:2010
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Implants for surgery Ceramic materials Part 1: Ceramic materials based on high purity alumina |
ISO 8601:2004
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Data elements and interchange formats Information interchange Representation of dates and times |
ISO 1942:2009
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Dentistry 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 11607-2:2014-11
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PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: VALIDATION REQUIREMENTS FOR FORMING, SEALING AND ASSEMBLY PROCESSES (ISO 11607-2:2006 + AMD 1.:2014) |
DIN EN ISO 11135-1:2007-08
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STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
ISO 10993-7:2008
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Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
ISO 11137-2:2013
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Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
ISO 10993-1:2009
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Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
ISO 5832-2:1999
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Implants for surgery Metallic materials Part 2: Unalloyed titanium |
ISO 9001:2015
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Quality management systems — Requirements |
ISO 129-1:2004
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Technical drawings Indication of dimensions and tolerances Part 1: General principles |
ISO 10993-9:2009
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Biological evaluation of medical devices Part 9: Framework for identification and quantification of potential degradation products |
ISO 14801:2016
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Dentistry Implants Dynamic loading test for endosseous dental implants |
DIN EN ISO 9001:2015-11
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QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (ISO 9001:2015) |
DIN EN ISO 7405:2013-12
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DENTISTRY - EVALUATION OF BIOCOMPATIBILITY OF MEDICAL DEVICES USED IN DENTISTRY (ISO 7405:2008 + AMD. 1:2013) |
DIN EN ISO 1942:2011-03
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Dentistry - Vocabulary (ISO 1942:2009, Corrected version 2010-03-01) |
ISO/TS 11135-2:2008
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Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1 |
ISO 14971:2007
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Medical devices Application of risk management to medical devices |
ISO 11607-1:2006
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Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
DIN ISO/TS 11135-2:2010-01
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STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1 |
DIN EN ISO 14155-2:2009-11
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CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - PART 2: CLINICAL INVESTIGATION PLANS |
ISO 178:2010
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Plastics Determination of flexural properties |
ISO 17664:2017
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Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices |
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 |
DIN EN ISO 10993-9:2010-04
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Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2009) |
ISO/TS 22911:2016
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Dentistry Preclinical evaluation of dental implant systems Animal test methods |