Medical electrical equipment - Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices Ingestion-build-71203 8 Common elements

8 Common elements

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Guidance on the failure modes and effects analysis (FMEA) and failure modes

Medical electrical equipment - Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices Ingestion-build-71203 8 Common elements201. 1 Scope, object and related standards Clause 1 of the general standard1) applies, except as follows: 201. 1. 1 Scope Replacement: This international standard applies to the basic safety and essential performance of mammographic X ray equipment including equipment for mammographic tomosynthesis and mammographic stereotactic devices, hereafter also referred to as me equipment. NOTE 1 This includes mammographic X ray equipment using integrated