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DS/EN 60601-2-1 - MEDICAL ELECTRICAL EQUIPMENT – PART 2-1: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTRON ACCELERATORS IN THE RANGE 1 MEV TO 50 MEV Organization: DS
Date: 2016-08-25
Description: Its purpose is to identify those features of design that are regarded, at the present time, as essential for the safe operation of such medical electrical equipment. It places limits on the degradation of medical electrical equipment performance beyond which it can be presumed that a fault condition exists and where an interlock then operates to prevent continued operation of the me equipment.
DSF/EN 60601-2-52;2010_FPRA1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-52: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL BEDS (IEC 60601-2-52:2009) Organization: DS
Description: IEC 60601-2-52:2009 is the realization of much work in alignment, and scope adjustment between IEC 60601-2-38, EN 1970, and the third edition of IEC 60601-1.
DSF/EN 60601-2-52/FPRA1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-52: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL BEDS (IEC 60601-2-52:2009) Organization: DS
Description: IEC 60601-2-52:2009 is the realization of much work in alignment, and scope adjustment between IEC 60601-2-38, EN 1970, and the third edition of IEC 60601-1.
DS/EN 60601-2-18 - MEDICAL ELECTRICAL EQUIPMENT – PART 2-18: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ENDOSCOPIC EQUIPMENT Organization: DS
Date: 2016-08-25
Description: The main changes with respect to the previous edition include: – alignment of requirements with IEC 60601-1:2005; – inclusion of essential performance requirements; – the inclusion of energized endoscopes and energized endotherapy devices used through second and subsequent punctures within the scope of the standard; – reference to IEC 60601-2-2 for the dielectric strength testing of HF energized endotherapy devices, rather than defining different tests.
DS/EN 62220-1-1 - MEDICAL ELECTRICAL EQUIPMENT - CHARACTERISTICS OF DIGITAL X-RAY IMAGING DEVICES - PART 1-1: DETERMINATION OF THE DETECTIVE QUANTUM EFFICIENCY - DETECTORS USED IN RADIOGRAPHIC IMAGING Organization: DS
Date: 2015-07-01
Description: It constitutes a technical revision of IEC 62220-1:2003 and assures a better alignment with the other parts of the IEC 62220 series. The main changes are as follows: - necessary modifications have been applied as a consequence of taking into account IEC 61267:2005.
DS/EN 80601-2-30 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS Organization: DS
Date: 2010-10-05
Description: This edition constitutes a major technical revision as well as an alignment with the third edition of IEC 60601-1. Specific technical changes include: expansion of the scope to include all automated sphygmomanometers including those where the patient is the operator, identification of essential performance, new clinical accuracy requirements, additional mechanical strength requirements and prohibition of operator accessible 'Luer' connectors in the pneumatic system.
DSF/EN 80601-2-30/FPRA1 - MEDICAL ELECTRICAL EQUIPMENT -- PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS Organization: DS
Description: This edition constitutes a major technical revision as well as an alignment with the third edition of IEC 60601-1. Specific technical changes include: expansion of the scope to include all automated sphygmomanometers including those where the patient is the operator, identification of essential performance, new clinical accuracy requirements, additional mechanical strength requirements and prohibition of operator accessible 'Luer' connectors in the pneumatic system.
DSF/EN 80601-2-30/FPRA1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS Organization: DS
Description: This edition constitutes a major technical revision as well as an alignment with the third edition of IEC 60601-1. Specific technical changes include: expansion of the scope to include all automated sphygmomanometers including those where the patient is the operator, identification of essential performance, new clinical accuracy requirements, additional mechanical strength requirements and prohibition of operator accessible 'Luer' connectors in the pneumatic system.
DS/EN 80601-2-30/A1 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-30: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF AUTOMATED NON-INVASIVE SPHYGMOMANOMETERS Organization: DS
Date: 2015-06-04
Description: This edition constitutes a major technical revision as well as an alignment with the third edition of IEC 60601-1. Specific technical changes include: expansion of the scope to include all automated sphygmomanometers including those where the patient is the operator, identification of essential performance, new clinical accuracy requirements, additional mechanical strength requirements and prohibition of operator accessible 'Luer' connectors in the pneumatic system.
DS/EN 50104 - ELECTRICAL APPARATUS FOR THE DETECTION AND MEASUREMENT OF OXYGEN - PERFORMANCE REQUIREMENTS AND TEST METHODS Organization: DS
Date: 2010-08-30
Description: The additional tests shall be agreed between the manufacturer and test laboratory and identified and described in the test report.This European Standard is applicable to oxygen alarm apparatus intended to measure reliably the oxygen concentration, to provide an indication, alarm or other output function, the purpose of which is to give a warning of a potential hazard and, in some cases, to initiate automatic or manual protective action(s), whenever the level exceeds or falls below a preselected alarm concentration.This standard is applicable to apparatus, including integral sampling systems of aspirated apparatus, intended to be used for commercial, industrial and non-residential safety applications.This standard does not apply to external sampling systems, or to apparatus of laboratory or scientific type, or to medical equipment, or to apparatus used only for process control purposes.
CENELEC - EN 50104 - ELECTRICAL APPARATUS FOR THE DETECTION AND MEASUREMENT OF OXYGEN - PERFORMANCE REQUIREMENTS AND TEST METHODS Organization: CENELEC
Date: 2010-06-01
Description: This standard does not apply to external sampling systems, or to apparatus of laboratory or scientific type, or to medical equipment, or to apparatus used only for process control purposes.

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