Health Care and Medical Devices

Origin: ISO
Close date: May 1, 2019
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This document specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package.

Origin: ISO
Close date: May 1, 2019
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This document defines terms in the field of the sterilization of health care products including related equipment and processes.

Origin: ISO
Close date: May 1, 2019
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This document specifies the particular requirements, including performance criteria for washer-disinfectors (WD) that are intended to be used for cleaning and chemical disinfection of thermolabile endoscopes.

Origin: ISO
Close date: May 1, 2019
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This International Standard specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices.

Origin: ISO
Close date: May 18, 2019
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This document specifies the requirements and methods for the clinical investigation of me equipment used for the intermittent non-invasive automated estimation of the arterial blood pressure by utilizing a cuff.

Origin: CSA
Close date: Jun 5, 2019
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This Standard provides requirements for the planning, design, construction, commissioning, operation, and maintenance of HVAC systems in HCFs. In general, these requirements are more stringent than those applied to non-health-care facilities.