The MDE NPRM proposed to permit the use of alternative designs or technologies that are substantially equivalent to or provide greater accessibility and usability than strict...
Search Results "Risk Analysis"
Commonly Searched Documents
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M101.4 Equivalent Facilitation (Section-by-Section Analysis)
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M101.6 Dimensional Tolerances (Section-by-Section Analysis)
The MDE NPRM proposed that dimensions were to be subject to conventional industry tolerances for manufacturing processes, material properties, and field conditions. In the preamble...
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M101.7 Units of Measurement (Section-by-Section Analysis)
In the MDE NPRM there was no explanation of the units of measurement used throughout the rule text. In order to avoid confusion and to align this final rule with the other...
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M201.2 General Exception (Section-by-Section Analysis)
The MDE NPRM did not propose a general exception for diagnostic equipment that was not capable of meeting the MDE Standards. As described in Section IV.A.1. (Significant Changes –...
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M301.2.2 Sunset Provision (Section-by-Section Analysis)
As discussed in Section IV.B.1.a. (Significant Changes – Transfer Surface Adjustability), this is a new provision that was added to the final rule in conjunction with the new...
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M305.2 Transfer Supports (Section-by-Section Analysis)
This is an introductory section. As discussed above in Section IV.E.1. (Significant Changes – Transfer Supports), the Access Board strengthened the transfer support requirements and...
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M302.2.4 Transfer Sides (Section-by-Section Analysis)
In the MDE NPRM, the transfer side provision for diagnostic equipment used by patients in the seated position required transfer surfaces to have the option to transfer from a...
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M302.3.1 Transfer Supports (Section-by-Section Analysis)
In the MDE NPRM the Access Board proposed that transfer supports must be provided for use with transfer sides on diagnostic equipment used by patients in the seated position, and...
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M302.3.2 Leg Supports (Section-by-Section Analysis)
The MDE NPRM did not propose to require stirrups to provide a method of supporting, positioning, and securing the patient’s legs for diagnostic equipment used by patients in the...
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M305.3 Standing Supports (Section-by-Section Analysis)
M305.3 provides the technical requirements for standing supports which are required on diagnostic equipment covered by M304. This provision has been reorganized in the final rule...
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M307 Operable Parts (Section-by-Section Analysis)
M307 in the final rule provides the technical criteria for operable parts used by patients to activate, deactivate, or adjust the diagnostic equipment. For example, equipment used...
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M307.4 Operating Force (Section-by-Section Analysis)
The MDE NPRM proposed to restrict the force required to activate operable parts to 5 pounds. The Access Board sought public input on this provision in question 42 on whether the...
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M304.2 Standing Surface (Section-by-Section Analysis)
The MDE NPRM proposed to require that the standing surface on which patients stand be slip resistant. In preparing the final rule, the Board has determined that as previously drafted...
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M304.2.2 Standing Supports (Section-by-Section Analysis)
The MDE NPRM proposed requiring standing supports on each side of the standing surface of diagnostic equipment used by patients in the standing position, and compliance with the...
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M305.2.6 Gripping Surfaces (Section-by-Section Analysis)
The proposed rule did not provide any specific requirements regarding gripping surfaces on transfer supports. However, in the MDE NPRM preamble the Access Board repeatedly noted that...
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M305.2.5 Surface Hazards (Section-by-Section Analysis)
The proposed rule did not provide any specific restrictions regarding surface hazards around the transfer supports. No public comments were submitted on this issue, but the MDE...
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M303.2.4 Equipment Clearances (Section-by-Section Analysis)
The MDE NPRM proposed knee and toe clearance for diagnostic equipment used by patients seated in wheelchairs to allow for components in the wheelchair space which the patient could...
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M301.4.1 Clearance in Base (Section-by-Section Analysis)
The MDE NPRM proposed certain clearance requirements beneath the diagnostic equipment to allow sufficient space for the legs of a portable patient lift to fit underneath the...
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M307.2 Tactilely Discernible (Section-by-Section Analysis)
The MDE NPRM proposed that operable parts intended for patient use be tactilely discernible without activation. Patients who are blind or have low vision have difficulty...
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M102.2 Undefined Terms (Section-by-Section Analysis)
The MDE NPRM proposed that the meaning of terms not defined in proposed M102.1 or in regulations or policies issued by an enforcing authority, be defined by collegiate dictionaries...
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M301.3.1 Transfer Supports (Section-by-Section Analysis)
The MDE NPRM proposed to require transfer supports to be provided for use with transfer sides on diagnostic equipment used by patients in the supine, prone, or side-lying position,...
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M301.2.4 Unobstructed Transfer (Section-by-Section Analysis)
In the MDE NPRM the Access Board proposed that each transfer side provide unobstructed access to the transfer surface, with an exception to permit temporary obstructions as long as...
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M301.4 Lift Compatibility (Section-by-Section Analysis)
The MDE NPRM proposed to require that diagnostic equipment used by patients in the supine, prone, or side-lying position be usable with a patient lift and comply with either the...
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M201.1 Enforcing Authority (Section-by-Section Analysis)
The MDE NPRM proposed to explain that the enforcing authority would specify the minimum number of types of accessible diagnostic equipment that would be required to comply with the...