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NEMA/MITA CSP 1 - CYBERSECURITY FOR MEDICAL IMAGING Organization: NEMA
Date: 2016-01-01
Description: NEMA recently published a similar white paper that identifies a set of best practices and guidelines that electrical equipment and medical imaging manufacturers can implement during product development to minimize the possibility that bugs, malware, viruses, or other exploits can be used to negatively impact product operation.
DS/EN 62274 - MEDICAL ELECTRICAL EQUIPMENT - SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS Organization: DS
Date: 2005-07-15
Description: It does, however, address certain specifi aspects of the connection of the RVS to a network or to other radiotherapy equipment, and the communication protocol to be used.
IEC 62274 - MEDICAL ELECTRICAL EQUIPMENT SAFETY OF RADIOTHERAPY RECORD AND VERIFY SYSTEMS - EDITION 1.0 Organization: IEC
Date: 2005-05-01
Description: It does, however, address certain specific aspects of the connection of the RVS to a network or to other radiotherapy equipment, and the communication protocol to be used.
IEC/TR 80001-2-2 - APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES – PART 2-2: GUIDANCE FOR THE DISCLOSURE AND COMMUNICATION OF MEDICAL DEVICE SECURITY NEEDS, RISKS AND CONTROLS - EDITION 1.0 Organization: IEC
Date: 2012-07-01
Description: This part of IEC 80001 creates a framework for the disclosure of security-related capabilities and RISKS necessary for managing the RISK in connecting MEDICAL DEVICES to IT-NETWORKS and for the security dialog that surrounds the IEC 80001-1 RISK MANAGEMENT of IT-NETWORK connection.
AAMI TIR80001-2-2 - APPLICATION OF RISK MANAGEMENT FOR IT-NETWORKS INCORPORATING MEDICAL DEVICES - PART 2-2: GUIDANCE FOR THE DISCLOSURE AND COMMUNICATION OF MEDICAL DEVICE SECURITY NEEDS, RISKS AND CONTROLS Organization: AAMI
Date: 2012-01-01
Description: This part of IEC 80001 creates a framework for the disclosure of security-related capabilities and RISKS necessary for managing the RISK in connecting MEDICAL DEVICES to IT-NETWORKS and for the security dialog that surrounds the IEC 80001-1 RISK MANAGEMENT of IT-NETWORK connection.
AAMI - 60601-2-25 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-25: PARTICULAR REQUIREMENTS FOR THE BASIC SAFETY AND ESSENTIAL PERFORMANCE OF ELECTROCARDIOGRAPHS Organization: AAMI
Date: 2011-01-01
Description: 1 The general standard is IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
DSF/FPREN 62949 - PARTICULAR SAFETY REQUIREMENTS FOR EQUIPMENT TO BE CONNECTED TO INFORMATION AND COMMUNICATION NETWORKS Organization: DS
Description: This Standard applies to the interface of equipment designed and intended to be connected as a communication terminal to an information and communication technology (ICT) network termination. This Standard does not apply to: – equipment covered by IEC 62368-1; and – interfaces to other networks.
IEC 62949 - PARTICULAR SAFETY REQUIREMENTS FOR EQUIPMENT TO BE CONNECTED TO INFORMATION AND COMMUNICATION NETWORKS - EDITION 1.0 Organization: IEC
Date: 2017-01-01
Description: The following requirements are not covered by this document: • functional safety of equipment; • functional reliability of equipment; • communication facilities with remote supply using hazardous voltage; • protection of equipment connected to ICT networks from functional damage.
DSF/EN 60601-1-10/FPRA1 - MEDICAL ELECTRICAL EQUIPMENT -- PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS Organization: DS
Description: Specifies requirements for the development (analysis, design, verification and validation) of a physiologic closed-loop controller (PCLC) as part of a physiologic closed-loop control system (PCLCS) in medical electrical equipment and medical electrical systems to control a physiologic variable.
DS/EN 60601-1-10 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS Organization: DS
Date: 2015-06-04
Description: Specifies requirements for the development (analysis, design, verification and validation) of a physiologic closed-loop controller (PCLC) as part of a physiologic closed-loop control system (PCLCS) in medical electrical equipment and medical electrical systems to control a physiologic variable.
DSF/EN 60601-1-10/FPRA1 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS Organization: DS
Description: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.
DS/EN 60601-1-10 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS Organization: DS
Date: 2008-06-09
Description: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE ofMEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.
IEC 60601-1-10 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE – COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS - EDITION 1.1 CONSOLIDATED REPRINT Organization: IEC
Date: 2013-11-01
Description: This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.
CENELEC - EN 60601-1-10 - MEDICAL ELECTRICAL EQUIPMENT - PART 1-10: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: REQUIREMENTS FOR THE DEVELOPMENT OF PHYSIOLOGIC CLOSED-LOOP CONTROLLERS - INCORPORATES AMENDMENT A1: 2015 Organization: CENELEC
Date: 2008-04-01
Description: This I nternational Standard a pplies to t he BASIC SAFETY a nd ESSENTIAL PERFORMANCE o f MEDICAL ELECTRICAL E QUIPMENT and MEDICAL ELECTRICAL S YSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS.
ETSI - EN 303 203 - SHORT RANGE DEVICES (SRD); MEDICAL BODY AREA NETWORK SYSTEMS (MBANSS) OPERATING IN THE 2 483,5 MHZ TO 2 500 MHZ RANGE; HARMONISED STANDARD COVERING THE ESSENTIAL REQUIREMENTS OF ARTICLE 3.2 OF THE DIRECTIVE 2014/53/EU - V2.1.1 Organization: ETSI
Date: 2015-11-01
Description: The present document contains requirements to demonstrate that Medical Body Area Network System (MBANS) “…shall be so constructed that it both effectively uses and supports the efficient use of radio spectrum in order to avoid harmful interference” (article 3.2 of the Directive 2014/53/EU) [i.3].
ETSI - EN 303 203-1 - ELECTROMAGNETIC COMPATIBILITY AND RADIO SPECTRUM MATTERS (ERM); SHORT RANGE DEVICES (SRD); MEDICAL BODY AREA NETWORK SYSTEMS (MBANSS) OPERATING IN THE 2 483,5 MHZ TO 2 500 MHZ RANGE; PART 1: TECHNICAL CHARACTERISTICS AND TEST METHODS - V1.1.1 Organization: ETSI
Date: 2014-11-01
Description: The present document covers the minimum characteristics of Medical Body Area Network System (MBANS), including the spectrum monitoring and access requirements, considered necessary in order to make the best use of the available spectrum within the 2 483,5 MHz to2 500 MHz frequency range and to avoid harmful interference between MBANS and other users of this band.
CEN - EN ISO 11073-30200 - HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 30200: TRANSPORT PROFILE - CABLE CONNECTED - INCORPORATES AMENDMENT A1: 2015 Organization: CEN
Date: 2005-08-01
Description: The term “legacy devices” refers to equipment that is - Already in use in clinical facilities - In active production at the facilities of medical device manufacturers, or - Beyond the initial stages of engineering development In each of these cases, the degree of effort to add a standardized communications capability might normally be prohibitive, unless special care is taken in developing a suitable standard.
ETSI - EN 303 203-2 - ELECTROMAGNETIC COMPATIBILITY AND RADIO SPECTRUM MATTERS (ERM); SHORT RANGE DEVICES (SRD); MEDICAL BODY AREA NETWORK SYSTEMS (MBANSS) OPERATING IN THE 2 483,5 MHZ TO 2 500 MHZ RANGE; PART 2: HARMONIZED EN COVERING THE ESSENTIAL REQUIREMENTS OF ARTICLE 3.2 OF THE R&TTE DIRECTIVE - V1.1.1 Organization: ETSI
Date: 2014-11-01
Description: The present document covers the minimum characteristics of Medical Body Area Network System (MBANS), including the spectrum monitoring and access requirements, considered necessary in order to make the best use of the available spectrum within the 2 483,5 to 2 500 MHz frequency range and to avoid harmful interference between MBANS and other users of this band.
NBN - EN ISO 11073-30200 - HEALTH INFORMATICS - POINT-OF-CARE MEDICAL DEVICE COMMUNICATION - PART 30200: TRANSPORT PROFILE - CABLE CONNECTED (ISO/IEEE 11073-30200:2004) Organization: NBN
Date: 2005-09-30
Description: ISO/IEEE 11073-30200:2004 describes an IrDA-based, cable-connected local area network (LAN) for the interconnection of computers and medical devices and is suitable for new device designs, but is particularly targeted to modifications of legacy devices.
IEC 62103 - ELECTRONIC EQUIPMENT FOR USE IN POWER INSTALLATIONS - EDITION 1.0 Organization: IEC
Date: 2003-07-01
Description: This standard does not cover the following applications: Electrical accessories and electrical appliances for household and similar purposes, medical equipment, electric railway equipment, data processing without control on systems and processes, public and private non-industrial telecommunication and radio communication equipment and networks, protection relays, residual-current-operated protective devices, uninterruptible power supplies, lighting equipment and public charging equipment for electrical vehicles.

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