EN 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 (ISO 14937:2009)
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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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EN 61010-2-040:2015
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Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 2-040 Particular requirements for sterilizers and washer-disinfectors used to treat medical materials
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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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ISO 4126-1:2013
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Safety devices for protection against excessive pressure Part 1: Safety valves
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EN 60584-2:1993
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Thermocouples - Part 2: Tolerances
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EN 285:2015
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Sterilization - Steam sterilizers - Large sterilizers
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IEC 60073:2002
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Basic and safety principles for man-machine interface, marking and identification - Coding principles for indicators and actuators
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EN 60073:2002
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Basic and safety principles for man-machine interface, marking and identification - Coding principles for indicators and actuators
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EN 868-5:2009
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Packaging for terminally sterilized medical devices - Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods
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EN 868-4:2017
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Packaging for terminally sterilized medical devices - Part 4: Paper bags - Requirements and test methods
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EN 764-1:2015+A1:2016
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Pressure equipment - Part 1: Vocabulary
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EN ISO 11138-3:2017
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Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017)
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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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ISO 4017:2014
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Fasteners Hexagon head screws Product grades A and B
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EN 867-5:2001
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Non-biological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S
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EN 868-6:2017
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Packaging for terminally sterilized medical devices - Part 6: Paper for low temperature sterilization processes - Requirements and test methods
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EN 868-2:2017
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Packaging for terminally sterilized medical devices - Part 2: Sterilization wrap - Requirements and test methods
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EN ISO 228-1:2003
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Pipe threads where pressure-tight joints are not made on the threads - Part 1: Dimensions, tolerances and designation (ISO 228-1:2000)
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ISO/IEC Guide 99:2007
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International vocabulary of metrology Basic and general concepts and associated terms (VIM)
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EN 61326-1:2013
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Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
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EN 868-3:2017
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Packaging for terminally sterilized medical devices - Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5) - Requirements and test methods
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EN ISO 11140-1:2014
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Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014)
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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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EN 1041:2008+A1:2013
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Information supplied by the manufacturer of medical devices
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ISO 3746:2010
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Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Survey method using an enveloping measurement surface over a reflecting plane
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EN ISO 3746:2010
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Acoustics - Determination of sound power levels and sound energy levels of noise sources using sound pressure - Survey method using an enveloping measurement surface over a reflecting plane (ISO 3746:2010)
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EN 60751:2008
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INDUSTRIAL PLATINUM RESISTANCE THERMOMETERS AND PLATINUM TEMPERATURE SENSORS
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ISO/TS 11139:2006
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Sterilization of health care products Vocabulary
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IEC 60751:2008
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Industrial platinum resistance thermometers and platinum temperature sensors
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EN ISO 4017:2014
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Fasteners - Hexagon head screws - Product grades A and B (ISO 4017:2014)
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EN ISO 14971:2012
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Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
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EN 61010-1:2010
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Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements
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EN 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 (ISO 17665-1:2006)
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EN 60529:1991/AC:2016-12
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DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE) (IEC 60529 EDITION 2.2 CORRIGENDUM 2:2015)
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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
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EN 868-7:2017
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Packaging for terminally sterilized medical devices - Part 7: Adhesive coated paper for low temperature sterilization processes - Requirements and test methods
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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
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ISO 228-1:2000
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Pipe threads where pressure-tight joints are not made on the threads Part 1: Dimensions, tolerances and designation
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EN ISO 4126-1:2013/A1:2016
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SAFETY DEVICES FOR PROTECTION AGAINST EXCESSIVE PRESSURE - PART 1: SAFETY VALVES (ISO 4126-1:2013/AMD 1:2016)
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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
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EN 10088-1:2014
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Stainless steels - Part 1: List of stainless steels
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1997/23/EC : 1997
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DIRECTIVE 97/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 29 MAY 1997 ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES CONCERNING PRESSURE EQUIPMENT
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