IEC 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 |
ISO 15883-1:2006
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Washer-disinfectors Part 1: General requirements, terms and definitions and tests |
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) |
ISO 11607-2:2006
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Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
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 |
ISO 11138-3:2017
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Sterilization of health care products — Biological indicators — Part 3: Biological indicators for moist heat sterilization processes |
EN 13445-5 : 2014 COR 2017
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UNFIRED PRESSURE VESSELS - PART 5: INSPECTION AND TESTING |
EN 61508-1:2010
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Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements |
ISO 4126-1:2013
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Safety devices for protection against excessive pressure — Part 1: Safety valves |
EN 60584-2:1993
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Thermocouples - Part 2: Tolerances |
EN 285:2015
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Sterilization - Steam sterilizers - Large sterilizers |
IEC 60073:2002
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Basic and safety principles for man-machine interface, marking and identification - Coding principles for indicators and actuators |
EN 60073:2002
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Basic and safety principles for man-machine interface, marking and identification - Coding principles for indicators and actuators |
EN 764-1:2015+A1:2016
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Pressure equipment - Part 1: Vocabulary |
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) |
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 |
ISO 4017:2014
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Fasteners Hexagon head screws Product grades A and B |
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 |
EN 62304:2006/A1:2015
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MEDICAL DEVICE SOFTWARE - SOFTWARE LIFE-CYCLE PROCESSES (IEC 62304:2006/A1:2015) |
ISO 12100:2010
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Safety of machinery — General principles for design — Risk assessment and risk reduction |
PREN 285 : DRAFT 2013
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STERILIZATION - STEAM STERILIZERS - LARGE STERILIZERS |
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) |
EN 61326-1:2013
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Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements |
EN ISO 11140-1:2014
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Sterilization of health care products - Chemical indicators - Part 1: General requirements (ISO 11140-1:2014) |
ISO 11140-1:2014
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Sterilization of health care products Chemical indicators Part 1: General requirements |
EN 1041:2008+A1:2013
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Information supplied by the manufacturer of medical devices |
ISO/IEC Guide 51:2014
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Safety aspects Guidelines for their inclusion in standards |
IEC 62304:2006+AMD1:2015 CSV
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Medical device software - Software life cycle processes |
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 |
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) |
EN 60751:2008
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INDUSTRIAL PLATINUM RESISTANCE THERMOMETERS AND PLATINUM TEMPERATURE SENSORS |
ISO/TS 11139:2006
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Sterilization of health care products Vocabulary |
IEC 60529:1989+AMD1:1999+AMD2:2013 CSV
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Degrees of protection provided by enclosures (IP Code) |
EN 62061:2005/A2:2015
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SAFETY OF MACHINERY - FUNCTIONAL SAFETY OF SAFETY-RELATED ELECTRICAL, ELECTRONIC AND PROGRAMMABLE ELECTRONIC CONTROL SYSTEMS (IEC 62061:2005/A2:2015) |
IEC 60751:2008
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Industrial platinum resistance thermometers and platinum temperature sensors |
EN ISO 4017:2014
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Fasteners - Hexagon head screws - Product grades A and B (ISO 4017:2014) |
EN ISO 12100:2010
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Safety of machinery - General principles for design - Risk assessment and risk reduction (ISO 12100:2010) |
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) |
ISO 9000:2015
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Quality management systems — Fundamentals and vocabulary |
EN ISO 15883-1:2009/A1:2014
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WASHER-DISINFECTORS - PART 1: GENERAL REQUIREMENTS, TERMS AND DEFINITIONS AND TESTS (ISO 15883-1:2006/AMD 1:2014) |
EN 61010-1:2010
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Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
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) |
IEC 61508-1:2010
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Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 1: General requirements (see Functional Safety and IEC 61508) |
ISO 14971:2007
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Medical devices Application of risk management to medical devices |
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) |
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 |
IEC 62061:2005+AMD1:2012+AMD2:2015 CSV
|
Safety of machinery - Functional safety of safety-related electrical, electronic and programmable electronic control systems |
IEC 61010-1:2010+AMD1:2016 CSV
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Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements |
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 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 |
EN ISO 9000:2015
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Quality management systems - Fundamentals and vocabulary (ISO 9000:2015) |
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) |
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 |
EN 10088-1:2014
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Stainless steels - Part 1: List of stainless steels |
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 |