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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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ISO/IEC 17025:2005
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General requirements for the competence of testing and calibration laboratories
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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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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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DIN EN ISO 6507-1:2016-08 (Draft)
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METALLIC MATERIALS - VICKERS HARDNESS TEST - PART 1: TEST METHOD
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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 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
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DIN EN ISO 13485:2016-08
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Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016)
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DIN EN ISO 10993-2:2006-10
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Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006)
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ISO 5840:2005
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Cardiovascular implants Cardiac valve prostheses
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ASTM F 2503 : 2013 : REDLINE
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Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
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DIN EN 62366 : 2016
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MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014)
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ISO 13485:2016
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Medical devices Quality management systems Requirements for regulatory purposes
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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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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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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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ISO 10993-2:2006
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Biological evaluation of medical devices — Part 2: Animal welfare requirements
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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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|
ISO 25539-1:2017
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Cardiovascular implants — Endovascular devices — Part 1: Endovascular prostheses
|
|
ISO 22442-1:2015
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Medical devices utilizing animal tissues and their derivatives Part 1: Application of risk management
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|
IEC 62366:2007+AMD1:2014 CSV
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Medical devices - Application of usability engineering to medical devices
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|
ISO 11135-1:2007
|
Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
|
|
ISO 14630:2012
|
Non-active surgical implants General requirements
|
|
VDE 0750-241 : 2016
|
MEDICAL DEVICES - APPLICATION OF USABILITY ENGINEERING TO MEDICAL DEVICES (IEC 62366:2007 + A1:2014)
|
|
DIN EN ISO 5832-3:2015-06 (Draft)
|
IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 3: WROUGHT TITANIUM 6-ALUMINIUM 4-VANADIUM ALLOY (ISO 5832-3:2016)
|
|
ASTM F 2052 : 2015 : REDLINE
|
Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
|
|
ISO 8601:2004
|
Data elements and interchange formats Information interchange Representation of dates and times
|
|
DIN EN ISO 14630:2013-03
|
Non-active surgical implants - General requirements (ISO 14630:2012)
|
|
ISO/TS 11139:2006
|
Sterilization of health care products Vocabulary
|
|
ISO 11137-3:2017
|
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
|
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
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 1: REQUIREMENTS FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
|
|
DIN ISO 5832-4:2015-12
|
IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 4: COBALT-CHROMIUM-MOLYBDENUM CASTING ALLOY (ISO 5832-4:2014)
|
|
ASTM F 2213 : 2017 : REDLINE
|
Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment
|
|
ISO 11137-2:2013
|
Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
|
|
DIN EN ISO 22442-2:2016-05
|
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015)
|
|
DIN EN ISO 61:2000-01
|
Plastics - Determination of apparent density of moulding material that cannot be poured from a specified funnel (ISO 61:1976); English version of DIN EN ISO 61
|
|
ISO 10993-1:2009
|
Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
|
|
DIN EN ISO 14155:2012-01
|
CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS - GOOD CLINICAL PRACTICE (ISO 14155:2011 + COR. 1:2011)
|
|
ISO 10555-1:2013
|
Intravascular catheters — Sterile and single-use catheters — Part 1: General requirements
|
|
ISO 22442-2:2015
|
Medical devices utilizing animal tissues and their derivatives Part 2: Controls on sourcing, collection and handling
|
|
DIN EN ISO 22442-3:2008-03
|
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 3: VALIDATION OF THE ELIMINATION AND/OR INACTIVATION OF VIRUSES AND TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHY (TSE) AGENTS
|
|
DIN EN ISO 13934-1:2013-08
|
TEXTILES - TENSILE PROPERTIES OF FABRICS - PART 1: DETERMINATION OF MAXIMUM FORCE AND ELONGATION AT MAXIMUM FORCE USING THE STRIP METHOD (ISO 13934-1:2013)
|
|
DIN EN ISO 25539-1:2015-07 (Draft)
|
CARDIOVASCULAR IMPLANTS - ENDOVASCULAR DEVICES - PART 1: ENDOVASCULAR PROSTHESES (ISO 25539-1:2017)
|
|
ISO 14155:2011
|
Clinical investigation of medical devices for human subjects Good clinical practice
|
|
DIN EN ISO 6721-2:2008-09
|
PLASTICS - DETERMINATION OF DYNAMIC MECHANICAL PROPERTIES - PART 2: TORSION-PENDULUM METHOD
|
|
DIN EN ISO 6721-1:2011-08
|
PLASTICS - DETERMINATION OF DYNAMIC MECHANICAL PROPERTIES - PART 1: GENERAL PRINCIPLES
|
|
ISO 22442-3:2007
|
Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
|
|
DIN EN ISO 14160:2011-10
|
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/TS 11135-2:2008
|
Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1
|
|
ISO 14971:2007
|
Medical devices Application of risk management to medical devices
|
|
ISO 11607-1:2006
|
Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems
|
|
DIN EN ISO 10555-1:2013-11
|
INTRAVASCULAR CATHETERS - STERILE AND SINGLE-USE CATHETERS - PART 1: GENERAL REQUIREMENTS (ISO 10555-1:2013 + AMD 1:2017)
|
|
DIN ISO/TS 11135-2:2010-01
|
STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - PART 2: GUIDANCE ON THE APPLICATION OF ISO 11135-1
|
|
DIN EN ISO 5832-2:2012-08
|
IMPLANTS FOR SURGERY - METALLIC MATERIALS - PART 2: UNALLOYED TITANIUM (ISO 5832-2:1999)
|
|
DIN EN ISO 604:2003-12
|
PLASTICS - DETERMINATION OF COMPRESSIVE PROPERTIES
|
|
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
|
|
DIN EN ISO 22442-1:2016-05
|
Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015)
|
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