Latest Standards From ISO, IEC, CEN, CENELEC, ETSI Examples
Health informatics - Omics Markup Language (OML) (ISO 21393:2021)
EN ISO 21393 :2021
OML, or data exchanging format, is a way to exchange omics data across the globe without having to modify any database schemas.
- OML, from the Informatics perspective, is the data exchanging format based upon XML. The data exchanging format for messaging and communication is included in this scope. However, the database schema is not.
- All types of omics are under consideration from a biological point of view. The genomic sequence variations as well as the entire genome sequence are not covered in this document.
- Other than that, the annotations in clinical concerns and the relationship with other omics concern are included in this document.
Although omics can be found in many biological species, this document only covers human health-related species such as cell lines, preclinical animals, and humans. Other biological species are not included in this document.
- This document covers the clinical field, but not the basic research and other scientific fields.
This document covers clinical trials, drug discovery and other related areas. Our main focus is on human health, including clinical practice, preventive medicine and clinical researches. Have a look at this collection of latest standards from ISO, IEC, CEN, CENELEC, ETSI, and SIST.
Guidelines for the implementation BIM Execution Plans and Exchange Information Requirements at European level, based on EN ISO 19650-1 & -2
CEN/TR 1754:2021
BIM Execution Plans and Exchange Information requirements are key documents that complement each other to define information requirements and how they can be processed in collaborative BIM environments.
EIR is an exchange information requirement of an appointing Party. BEP, the BIM execution plan, describes how the parties will fulfill these requirements.
This work item will
* Examine and explain the requirements for Exchange Information Requirements and BIM execution Plans (BEP), based on EN/ISO 19650-1 & -2.
* Provide guidance on the implementation of EIR/BEP
* Templates for creating EIR and BEP
Part 2 of Health Software - Health and Wellness Apps - Quality & Reliability (ISO/TS 82304-2 :2021)
CEN ISO/TS 82304-2.2021
The European Technical Specification for Health and Wellness Apps will set out requirements that developers must meet in order to satisfy the needs of patients, doctors, carers, and the general public. It will contain a list of quality criteria. It covers the entire app development life cycle from the conception, testing, release, and updating of the app. This includes native, hybrid, and web-based apps, as well as apps that are associated with wearable, ambient, and other health devices. It will address fitness for purpose as well as monitoring usage. It will be used to inform the development and marketing of health and wellbeing apps, regardless of whether they are paid for. The specification does not include the criteria or processes that app developers or publishers use to determine whether an app for health and wellness is subject to regulatory oversight (e.g. As a medical device or related to information governance
Earth-moving machinery -- Product identification system
This document outlines the requirements, structure, and identification location for a product identification system for earth-moving machines as per ISOA 6165. NOTE: ISOA 10261 PIN is also applicable to other types of offroad work machines. It does not apply to identification of attachments or components.
Devices to connect luminaires for household or similar purposes - Part I: General requirements
EN 61995-1:2008/A11:2021
This prAA will amend EN61995-1. It will also provide the required Common Modifications for EN61995-1:2018/A1;2017 (PR=60113). Common Modifications were used to publish EN 61995-1. The Common Modifications introduced after the publication of the A1 European-level document are no longer authoritative. This project is aimed at reintroducing these Common Modifications.