Health Care and Medical Devices

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.

This document defines terms in the field of the sterilization of health care products including related equipment and processes.

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.

This International Standard specifies requirements for the development, validation and routine control of a dry heat sterilization process for medical devices.

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.

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.