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AAMI IEC 80601-2-78 pdf free download

AAMI IEC 80601-2-78 pdf free download.Medical electrical equipment—Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation.
201.6 Classification of ME EQUIPMENT and ME SYSTEMS Clause 6 of the general standard applies. 201.7 M E EQUIPMENT identification, marking and documents Clause 7 of the general standard applies, except as follows: 201 .7.2.4 A CCESSORIES Replacement: If misidentification of ACCESSORIES results in an unacceptable RISK , the MANUFACTURER shall follow 6.2 of ISO 14971:2007 and the stated priorities for RISK CONTROL . A CCESSORIES shall be marked as has been identified in the RISK MANAGEMENT PROCESS , but at least with  the name or trademark of their manufacturer,  a model or type reference,  a serial number or lot or batch identifier, if applicable, and  the date of manufacture or use-by date, if applicable. NOTE 1 See ISO 15223-1 for symbols for MANUFACTURER , serial number, lot or batch, year of manufacture and use by date. NOTE 2 The serial number, lot or batch identifier, and the date of manufacture can be provided in a human readable code or through automatic identification technology, such as barcodes or radio-frequency identification. Where no marking of the ACCESSORIES is practicable, these markings may be affixed to the individual packaging.201 .9.2 M ECHANICAL HAZARDS associated with moving parts 201 .9.2.1 General Addition: A RACA ROBOT , especially if it is BODY – WORN or WALKING , can move in its environment and contact objects in the environment, such as walls, different walking surfaces, chairs or tables, while performing its INTENDED USE . If applicable, the MANUFACTURER shall consider these aspects in the RISK MANAGEMENT process. If applicable, information for safety shall be given to reduce RISKS . NOTE 101 ISO 13482:2014, 5.10.8, can be helpful for the MANUFACTURER to consider RISK CONTROL measures (ISO 13482 describes RISK CONTROL as RISK reduction) related to collision with objects in the environment (ISO 13482 uses the term “safety-related obstacles”). To fulfil their INTENDED USE , RACA ROBOT s move one or more PATIENT body parts, therefore different stopping procedures (see Table 201.102), including automatic stopping procedures, should be considered inthe RISK MANAGEMENT PROCESS .201.11 Protection against excessive temperatures and other HAZARDS Clause 11 of the general standard applies. 201.12 Accuracy of controls and instruments and protection against hazardous outputs Clause 12 of the general standard applies, except as follows. Additional subclauses: 201 .1 2.1 01 Movement or force/torque of RACA ROBOT The MANUFACTURER , through the RISK MANAGEMENT PROCESS , shall identify foreseeable HAZARDS related to loss or degradation of movements or force/torque of the ACTUATED APPLIED PARTS of the RACA ROBOT . If the movement or force/torque is a CLINICAL FUNCTION , then the MANUFACTURER shall define performance limits considering both NORMAL CONDITION and SINGLE FAULT CONDITION . If characteristics of movement or force/torque outside of the performance limits lead to an unacceptable RISK , then movement or force/torque is an ESSENTIAL PERFORMANCE . In this case, the MANUFACTURER shall implement RISK CONTROL measures to reduce the RISK to an acceptable level. NOTE Characteristics of movement or force/torque can depend on many different factors, such as: spatial coordination, timing, speed, stability, range, pressure, fitting/misalignment, installation and other relevant factors. Compliance is checked by inspection of the design documents/performance limits, the ACCOMPANYING DOCUMENTS , the RISK MANAGEMENT FILE and by functional tests as necessary.AAMI IEC 80601-2-78 pdf download.

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