Narrow Your Results
This document enables the advancement of interoperability from the data/information exchange paradigm to knowledge sharing at decreasing level of abstraction, starting at IT concept level (semantic coordination) through business domain concept level (agreed service function level...
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices...
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process described in this document intends to assist manufacturers of medical devices...
This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and...
This document defines the core data set for a patient summary document that supports continuity of care for a person and coordination of their healthcare. It is specifically aimed at supporting the use case' scenario for 'unplanned, cross border care' and is intended to be an international patient...
This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination,
NOTE 1 There is guidance or rationale for this Clause contained in Clause A.2. This document specifies the requirements for information supplied by the manufacturer for a medical device or by the manufacturer for an accessory, as defined in 3.1. This document includes the generally applicable...
This document provides an overview of security and privacy considerations for Electronic Health Records (EHR) in a cloud computing service that users can leverage when selecting a service provider.
This document applies to the basic safety and essential performance of a high-frequency ventilator (HFV) in combination with its accessories, hereafter referred to as ME equipment: - intended for use in an environment that provides specialized care for patients whose conditions can be...
This document provides lists of reference standards which contain general information, implant device or application-specific
Inclusions This document provides guidance for bioburden testing and tests of sterility for biologics and tissue-based products, where this testing is in relation to product sterilization. NOTE This document is intended to be used in conjunction with ISO 11737-1 and ISO 11737-2....
This document specifies the requirements for the evaluation of absorbable medical devices during a biological risk assessment based on ISO 10993-1, including a clarification of the terms "absorb", "degrade" and other related terms (see Annex A).
This document gives guidelines for certificate management issues involved in deploying digital certificates in healthcare. It specifies a structure and minimum requirements for certificate policies, as well as a structure for associated certification practice statements. This document also...
This document lists examples of and defines categories of use cases for machine learning in medicine for clinical practice. The developments and applications of machine learning technologies for artificial intelligence consist of 1) data collection and curation, 2) pre-processing, 3) model...
This document provides the principles, concepts, terms and definitions for health software and health IT systems, key properties of safety, effectiveness and security, across the full life cycle, from concept to decommissioning, as represented in Figure 1. It also identifies the transition...
