magnifying icon Basket
1 item ^

Basket is empty
Login

Login

LOGGED AS

Help

Satisfaction enquiry

SATISFACTION ENQUIRY

Newsletter

Free of charge lifelong learning "Standardization"

FREE OF CHARGE LIFELONG LEARNING "STANDARDIZATION"

Standardisation

Draft standards in public enquiry

DRAFT STANDARDS IN PUBLIC ENQUIRY

Standards organizations

STANDARDS ORGANIZATIONS

  • National standards

  • European standards

  • International standards


Deliverable

 
Free preview
Price
Language
 
CEN ISO/TS 82304-2:2021 Edition 08/2021
Health software - Part 2: Health and wellness apps - Quality and reliability (ISO/TS 82304-2:2021)
  •   
  •   
  •  
  • 91.8 / copy
  •  
 

Abstract

This document provides quality requirements for health apps and defines a health app quality label in order to visualize the quality and reliability of health apps. This document is applicable to health apps, which are a special form of health software. It covers the entire life cycle of health apps. This document is intended for use by app manufacturers as well as app assessment organizations in order to communicate the quality and reliability of a health app. Consumers, patients, carers, health care professionals and their organizations, health authorities, health insurers and the wider public can use the health app quality label and report when recommending or selecting a health app for use, or for adoption in care guidelines, care pathways and care contracts. NOTE 1   Health apps can be subject to national legislation, such as for medical devices. NOTE 2   See Annex C for additional details on the scope. Outside the scope of this document are guidelines to comply to the medical device regulation.

Status

Standard - Active

Origin

Technical Committee :
CEN/TC 251 : Health informatics

Implementation

start of the vote on the project      date of ratification (dor)    28/06/2021
end of the vote on the project      date of anouncement (doa)    30/11/2021
start of the vote on the final project    04/03/2021   date of publication (dop)   
end of the vote on the final project    27/05/2021   date of withdrawal (dow)   


Publication Official Journal
of the Grand-Duchy of Luxembourg
Reference

Relations

Relations to international standards
ISO/TS 82304-2 
ISO/TS 82304-2:2021 

International Classification for Standards (ICS codes) :

35.080 : Software
35.240.80 : IT applications in health care technology

magnifying icon Basket
1 item ^

Basket is empty


Warning:
DIN standards can be downloaded only once! After downloading, they are no longer available in the eLibrary.
Begin download?