Medical equipment in general

This Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as ME EQUIPMENT. (Published Document (JS))

This Particular Standard applies to the safety of EQUIPMENT FOR EXTRACORPOREALLY INDUCED LITHOTRIPSY as defined in 2.1.101. The applicability of this Particular Standard is limited to components directly involved in the LITHOTRIPSY treatment, such as, but not limited to, the generator of the PRESSURE PULSE, PATIENT support device, and their interactions with imaging and monitoring devices. (Published Document (JS))

This Standard applies to the reduction of adverse ENVIRONMENTAL IMPACTS of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. MEDICAL ELECTRICAL SYSTEMS are excluded from the scope of this collateral standard. (Published Document (JS))

This 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, which are intended by their MANUFACTURER for use in the HOME HEALTHCARE ENVIRONMENT, as defined in 3.2, regardless of whether the ME EQUIPMENT or ME SYSTEM is intended for use by a LAY OPERATOR (Published Document (JS))

This 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. This collateral standard applies to ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS. (Published Document (JS))

This 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. If a clause or subclause is specifically intended to be applicable to ME EQUIPMENT only, or to ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the case, (Published Document (JS))

This 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. This collateral standard specifies requirements for ALARM SYSTEMS and ALARM SIGNALS in ME EQUIPMENT and ME SYSTEMS. It also provides guidance for the application of ALARM SYSTEMS. (Published Document (JS))

This Standard specifies a PROCESS for a MANUFACTURER to analyse, specify, design, VERIFY and VALIDATE USABILITY, as it relates to BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT, hereafter referred to as ME EQUIPMENT. This USABILITY ENGINEERING PROCESS assesses and mitigates RISKS caused by USABILITY problems associated with CORRECT USE and USE ERRORS, i.e., (Published Document (JS))

This standard applies to the safety of MEDICAL ELECTRICAL SYSTEMS, as defined in 2.201. It describes the safety requirements necessary to provide protection for the PATIENT, the OPERATOR and surroundings. (Published Document (JS))

This Collateral Standard applies to the SAFETY of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS incorporating PROGRAMMABLE ELECTRONIC SUBSYSTEMS (PESS), hereinafter referred to as PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS). (Published Document (JS))

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. This collateral standard specifies requirements for the development (analysis, design, VERIFICATION and VALIDATION) of a PHYSIOLOGIC CLOSED-LOOP CONTROLLER (PCLC) as part of a PHYSIOLOGIC (Published Document (JS))

This part 2-15 of JS 61558 applies to stationary, single-phase or polyphase, air-cooled (natural or forced) isolating transformers for the supply of group II medical locations, designed to be permanently connected to the fixed wiring and intended to form the IT system on the secondary side, having a rated supply voltage not exceeding AC 1 kV and rated frequency not exceeding 500 Hz. (Published Document (JS))

Applies for the purpose of safety of medical equipment and contains some requirements regarding relibale operation of it where this is connected with safety (Withdrawn Document)