logo

Standards Manage Your Business

We Manage Your Standards

IEC

IEC 62304:2006+AMD1:2015 CSV

Medical device software - Software life cycle processes

Standard Details

IEC 62304:2006+A1:2015 Defines the life cycle requirements for medical device software. The set of processes, activities, and tasks described in this standard establishes a common framework for medical device software life cycle processes. Applies to the development and maintenance of medical device software when software is itself a medical device or when software is an embedded or integral part of the final medical device. This standard does not cover validation and final release of the medical device, even when the medical device consists entirely of software. This consolidated version consists of the first edition (2006) and its amendment 1 (2015). Therefore, no need to order amendment in addition to this publication.

General Information

Status : ACTIVE
Standard Type: Main
Document No: IEC 62304:2006+AMD1:2015 CSV
Document Year: 2015
Pages: 170
Edition: 1.1
  • Section Volume:
  • TC 62.SC 62A Common aspects of electrical equipment used in medical practice

Life Cycle

Currently Viewing

ACTIVE
IEC 62304:2006+AMD1:2015 CSV
Knowledge Corner

Expand Your Knowledge and Unlock Your Learning Potential - Your One-Stop Source for Information!

© Copyright 2024 BSB Edge Private Limited.

Enquire now +