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DIN EN ISO 11135:2014-10
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STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES (ISO 11135:2014)
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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)
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DIN EN ISO 80000-1:2013-08
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Quantities and units - Part 1: General (ISO 80000-1:2009 + Cor 1:2011)
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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
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ISO 15883-1:2006
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Washer-disinfectors Part 1: General requirements, terms and definitions and tests
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DIN ISO 8601:2006-09
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DATA ELEMENTS AND INTERCHANGE FORMATS - INFORMATION INTERCHANGE - REPRESENTATION OF DATES AND TIMES
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ISO 5832-1:2016
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Implants for surgery — Metallic materials — Part 1: Wrought stainless steel
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ISO 11607-2:2006
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Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes
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ISO 5832-11:2014
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Implants for surgery — Metallic materials — Part 11: Wrought titanium 6-aluminium 7-niobium alloy
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ISO 11138-3:2017
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Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes
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IEC 60068-2-27:2008
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Environmental testing - Part 2-27: Tests - Test Ea and guidance: Shock
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ISO 15882:2008
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Sterilization of health care products — Chemical indicators — Guidance for selection, use and interpretation of results
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ISO 11135:2014
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Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
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ISO 10993-13:2010
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Biological evaluation of medical devices — Part 13: Identification and quantification of degradation products from polymeric medical devices
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ISO 5832-6:1997
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Implants for surgery Metallic materials Part 6: Wrought cobalt-nickel-chromium-molybdenum alloy
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ISO 7151:1988
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Surgical instruments Non-cutting, articulated instruments General requirements and test methods
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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
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ISO 11737-1:2006
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Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on products
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ISO 5832-5:2005
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Implants for surgery Metallic materials Part 5: Wrought cobalt-chromium-tungsten-nickel alloy
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ISO 15883-3:2006
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Washer-disinfectors Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste containers
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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)
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ISO 5832-3:2016
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Implants for surgery Metallic materials Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
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ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes
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EN 2318:1992
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Aerospace series - Aluminium alloy AL-P2024-T3511 - Extruded bars and sections 1,2 mm < or = a or D < or = 150 mm
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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
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EN 2326 : 1992
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AEROSPACE SERIES - ALUMINIUM ALLOY AL-P6082-T6 EXTRUDED BARS AND SECTIONS A OR D <= 200 MM
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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)
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ISO/TR 14969:2004
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Medical devices Quality management systems Guidance on the application of ISO 13485: 2003
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ISO 4957:1999
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Tool steels
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ISO 11140-3:2007
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Sterilization of health care products — Chemical indicators — Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
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DIN EN ISO 14971:2013-04
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MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES (ISO 14971:2007)
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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)
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EN 2127:1992
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Aerospace series - Aluminium alloy AL-P7075-T73511 - Extruded bars and sections a or D < or = 100 mm
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IEC 60068-2-31:2008
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Environmental testing - Part 2-31: Tests - Test Ec: Rough handling shocks, primarily for equipment-type specimens
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ISO 5832-8:1997
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Implants for surgery Metallic materials Part 8: Wrought cobalt-nickel-chromium-molybdenum- tungsten-iron alloy
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ISO 11138-2:2017
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Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
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ISO 10993-14:2001
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Biological evaluation of medical devices — Part 14: Identification and quantification of degradation products from ceramics
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ISO 11140-1:2014
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Sterilization of health care products Chemical indicators Part 1: General requirements
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ISO 5832-4:2014
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Implants for surgery — Metallic materials — Part 4: Cobalt-chromium-molybdenum casting alloy
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ISO 10993-18:2005
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Biological evaluation of medical devices Part 18: Chemical characterization of materials
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|
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)
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ISO/TS 10993-19:2006
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Biological evaluation of medical devices Part 19: Physico-chemical, morphological and topographical characterization of materials
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ISO 18472:2006
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Sterilization of health care products Biological and chemical indicators Test equipment
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IEC 60068-2-47:2005
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Environmental testing - Part 2-47: Test - Mounting of specimens for vibration, impact and similar dynamic tests
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|
ISO 11140-4:2007
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Sterilization of health care products — Chemical indicators — Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration
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ISO 8601:2004
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Data elements and interchange formats Information interchange Representation of dates and times
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ISO 13408-1:2008
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Aseptic processing of health care products — Part 1: General requirements
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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
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|
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)
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ISO 10993-12:2012
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Biological evaluation of medical devices Part 12: Sample preparation and reference materials
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|
ISO 10993-7:2008
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Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
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|
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 80000-1:2009
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Quantities and units — Part 1: General
|
|
ISO 5832-2:1999
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Implants for surgery Metallic materials Part 2: Unalloyed titanium
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|
DIN EN ISO 14155:2012-01
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CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011 + COR. 1:2011)
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ISO 7153-1:2016
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Surgical instruments Materials Part 1: Metals
|
|
ISO 5832-7:2016
|
Implants for surgery — Metallic materials — Part 7: Forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy
|
|
ISO 7740:1985
|
Instruments for surgery Scalpels with detachable blades Fitting dimensions
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|
EN 2100 : 1992
|
AEROSPACE SERIES - ALUMINIUM ALLOY AL-P2014A-T4511 EXTRUDED BARS AND SECTIONS A OR D <= 200 MM
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|
ISO 8319-2:1986
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Orthopaedic instruments — Drive connections — Part 2: Screwdrivers for single slot head screws, screws with cruciate slot and cross-recessed head screws
|
|
ISO 11140-5:2007
|
Sterilization of health care products — Chemical indicators — Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
|
|
ISO 14155:2011
|
Clinical investigation of medical devices for human subjects Good clinical practice
|
|
ISO 11138-1:2017
|
Sterilization of health care products — Biological indicators — Part 1: General requirements
|
|
ISO 14971:2007
|
Medical devices Application of risk management to medical devices
|
|
ISO 7000:2014
|
Graphical symbols for use on equipment Registered symbols
|
|
ISO 11607-1:2006
|
Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
|
|
EN 2128 : 1992
|
AEROSPACE SERIES - ALUMINIUM ALLOY AL-P7075-T7351 - DRAWN BARS 6 MM <= A OR D <= 75 MM
|
|
ISO 14161:2009
|
Sterilization of health care products Biological indicators Guidance for the selection, use and interpretation of results
|
|
ISO 15223-1:2016
|
Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
|
|
EN 2384 : 1992
|
AEROSPACE SERIES - ALUMINIUM ALLOY AL-P2014A-T6511 EXTRUDED BARS AND SECTIONS A OR D <= 150 MM
|
|
ISO 15883-2:2006
|
Washer-disinfectors Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.
|
|
ISO 5832-12:2007
|
Implants for surgery Metallic materials Part 12: Wrought cobalt-chromium-molybdenum alloy
|
|
ISO 17664:2017
|
Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
|
|
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 5832-9:2007
|
Implants for surgery Metallic materials Part 9: Wrought high nitrogen stainless steel
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