YY/T 0664-2008: Medical device software - Software life cycle processes

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Scope

1.1 Purpose
This standard specifies the life cycle requirements for medical device software. A set of processes, activities, and tasks described in this standard
Mechanical software life cycle process establishes a common framework.
This standard applies to the development and maintenance of medical device software.
When the software itself is a medical device, or when the software is an embedded part or component of the final medical device, this standard applies to that medical device
Development and maintenance of instrument software.
This standard does not cover the identification and final release of medical devices, even when the medical device consists entirely of software.
1.3 Relationship with other standards
When developing medical devices, this medical device software life cycle standard is used in conjunction with other applicable standards. This standard and other related
The relationship between relevant standards is shown in Appendix C.
1.4 compliance
Compliance with this standard means that all processes, activities, and tasks identified in this standard are implemented in accordance with the software security level.
Note. The software security level assigned to each requirement is determined in the text following the standard requirements.
Check all documents required by this standard (including risk management documents and processes, activities, and tasks required for software security levels).
Service assessment) to determine compliance. See Appendix D.
Note 1.This assessment can be achieved by internal or external audits.
NOTE 2 Even if the processes, activities and tasks to be completed are specified, the implementation of these processes and the methods for performing these activities and tasks are flexible.
Note 3.When any requirement that includes "as appropriate" is not completed, it is necessary for this assessment to document for reasons.
Note 4.Where the term "compliance" is used in this standard, the term "conformance" is used in GB/T 8566.

Basic Data

Standard ID	YY/T 0664-2008 (YY/T0664-2008)
Description (Translated English)	Medical device software - Software life cycle processes
Sector / Industry	Medical Device and Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040
Word Count Estimation	60,694
Date of Issue	2008-04-25
Date of Implementation	2009-06-01
Quoted Standard	YY/T 0316
Adopted Standard	IEC 62034-2006, IDT
Regulation (derived from)	SFDA [2008] No. 192
Issuing agency(ies)	State Food and Drug Administration
Summary	This standard specifies the medical device software life cycle requirements. In this standard describes a set of processes, activities and tasks for medical device software life cycle processes to establish a common framework. This standard applies to medical device software development and maintenance.