недоступно на русском языке

Тезис Предпросмотр

IEC TR 80002-3:2014 which is a technical report (TR), provides the description of software life cycle processes for medical devices. The medical device software life cycle processes are derived from IEC 62304:2006, with corresponding safety classes. They have been aligned with the software development life cycle processes of ISO/IEC 12207:2008 and are presented herein in full compliance with ISO/IEC 24774:2010. The content of these three standards provides the foundation of this TR. This TR does not:
- address areas already covered by existing related standards, e.g. the international standards that relate to the four standards used to build this TR (see Bibliography);
- FDA guidance documents; or
- software development tools. This TR describes the process reference model for medical device software development and is limited in scope to the life cycle processes described in IEC 62304:2006. The process names correspond to those of IEC 62304:2006. The mappings provided in Annex B are essential for the alignment between IEC 62304:2006 (which is based on ISO/IEC 12207:1995) and ISO/IEC 12207:2008, developed to address the detailed normative relationship between the two standards. This technical report is not intended to be used as the basis of regulatory inspection or certification assessment activities.


Общая информация

  • Текущий статус :  Published
    Дата публикации : 2014-06
  • Версия : 1
    Число страниц : 23
  • :
    ISO/TC 210
    Quality management and corresponding general aspects for medical devices
  • 11.040.01
    Medical equipment in general
    35.240.80
    IT applications in health care technology

Приобрести данный стандарт

Формат Язык
PDF
Бумажный
  • CHF170

Жизненны цикл

Стандарт, который пересматривается каждые 5 лет



Изменения / Исправления

  • Сейчас
    IEC/TR 80002-3:2014

Появились вопросы?

Ознакомьтесь с FAQ

Работа с клиентами
+41 22 749 08 88

Часы работы:
Понедельник – пятница: 09:00-12:00, 14:00-17:00 (UTC+1)

Будьте в курсе актуальных новостей ИСО

Подписывайтесь на наши новости, обзоры, а также на информацию о продуктах