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This Standard is intended to address the safe, effective, and reliable reprocessing of reusable medical devices at each phase of the reprocessing workflow, including a) establishing a QMS for the MDRD, including i) key performance indicators; ii) policies and procedures; iii)...
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This third edition provides a substantial comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure a company's design control program evolves in accordance with current industry practice. It assists in the development of an effective design...
Purpose and Scope This monograph contains voluntary guidance for design, construction and labeling of general-purpose, reusable textile face coverings for adults. Guidance in this document applies to general-purpose face coverings intended for daily use by asymptomatic individuals. Face coverings...
This Standard covers the protection from lightning of a) recreational, residential, institutional, medical, agricultural, industrial, commercial, military, and telecommunications buildings and structures; b) tall, slender structures such as smokestacks, silos, tanks, towers, masts, and...
4.1 Implantable medical device labeling often results in a variety of label formats and information prioritization. This variability can be seen not only across different manufacturers but also across different implant types.3 At present label design and layout is developed by a given...
This Standard applies to the decommissioning of nuclear facilities and other locations where nuclear substances are managed, possessed, or stored. Notes: 1) Users are responsible for determining the extent to which this Standard applies to a given facility or location and for consulting the...
General This Standard covers the test requirements used to measure battery charger energy consumption for battery chargers intended to be operated from 115 V ac, 60 Hz line voltage connected by plug to wall receptacles or existing dc sources (such as automotive power jacks or USB ports)....
General This Standard specifies the minimum requirements and best practices for the development, validation, and use of laboratory-developed
