This International Standard establishes a classification and terminology of assistive products, especially produced or generally available, for persons with disability. Assistive products used by a person with disability, but which require the assistance of another person for their operation, are...
ISO 9999:2016 establishes a classification and terminology of assistive products, especially produced or generally available, for persons with disability. Assistive products used by a person with disability, but which require the assistance of another person for their operation, are included in the...
This International Standard establishes a classification and terminology of assistive products, especially produced or generally available, for persons with disability. Assistive products used by a person with disability, but which require the assistance of another person for their operation, are...
ISO/TS 13131:2014 provides advice and recommendations on how to develop quality objectives and guidelines for telehealth services that that use information and communications technologies (ICTs) to deliver healthcare over both long and short distances by using a risk management process. The...
This specification is concerned with the safety of patients and gives guidance on the analysis and categorisation of hazards and risks to patients from health informatics products, to allow any product to be assigned to one of five risk classes. It applies to hazards and risks which could cause...
This International Standard establishes a classification and terminology of assistive products, especially produced or generally available, for persons with disability. Assistive products used by a person with disability, but which require the assistance of another person for their operation, are...
This International Standard establishes a classification and terminology of assistive products, especially produced or generally available, for persons with disability. Assistive products used by a person with disability, but which require the assistance of another person for their operation, are...
Validation is an important and mandatory activity for laboratories that fall under regulatory agency review. Such laboratories produce data upon which the government depends to enforce laws and make decisions in the public interest. Examples include data to support approval of new drugs, prove...
This Technical Specification is concerned with the safety of patients and gives guidance on the analysis and categorization of hazards and risks to patients from health software products, in order to allow any product to be assigned to one of five risk classes. It applies to hazards and risks which...
1.1 This guide covers a framework for the protection of healthcare information. It addresses both storage and transmission of information. It describes existing standards used for information security which can be used in many cases, and describes which (healthcare-specific) standards are needed to...
1. Scope 1.1 This provisional guide covers a framework for the protection of healthcare information. It addresses both storage and transmission of information. It describes existing standards used for information security which can be used in many cases, and describes which (healthcare-specific)...
The purpose of this document to provide processes that can be used to analyze the risks to the quality and safety of healthcare and continuity of care when telehealth services are used to support healthcare activities. This document provides advice and recommendations on how to develop quality...
A growing number of initiatives in various countries around the world, most of them small-scale, are described as telehealth or telemedicine or m-health projects. It is not yet clear when the term telehealth or telemedicine should be used to describe such initiatives, because these terms can be...
This Technical Specification is concerned with QoS as it applies to interactions between components of distributed healthcare IT systems. The scope is not limited to network infrastructures; it includes the QoS requirements of information storage and processing IT systems. The related areas of...
Background: Effective health care delivery requires an efficient information base. A standard description is needed regarding the capabilities of Registration-Admission, Discharge, Transfer (R-ADT) Systems in both automated hospital and ambulatory care information systems. This practice is intended...
4.1 This guide provides recommendations for the local or regional AHJ to use in dealing with persons with disabilities who reside within their area of responsibility or jurisdiction. It provides information that can support development of procedures and protocols in preparing for the impact of...
5.1 Measurement of mycobacterial cell count densities is an important step in establishing a possible relationship between mycobacteria and occupational health-related allergic responses, for example, hypersensitivity pneumonitis (HP) in persons exposed to aerosols of metalworking fluids. It is...
4.1 This practice specifies an in-vivo measurement of CWA decontamination on the skin. 4.2 CWA skin decontaminants will have different modes of action including absorption, adsorption, removal, chemical neutralization or some combination of the above. There is, therefore, no single representative...
4.1 This practice is a guideline for short-term and long-term assessment of skeletal muscle and bone tissue responses to long-term implant materials. For testing of final finished medical devices, the test article for implantation shall be as for intended use, including packaging and sterilization....
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