YY/T 0664-2020: Medical device software - Software life cycle processes

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Scope

This Standard describes PROCESSES that are intended to be applied to
software which executes on a processor or which is executed by other software
(for example an interpreter) which executes on a processor.
Compliance with this Standard is defined as implementing all of the
PROCESSES, ACTIVITIES, and TASKS identified in this Standard in
accordance with the software safety class.
2 Normative references
The following documents are indispensable for the application of this document.
For the dated references, only the editions with the dates indicated are
applicable to this document. For the undated references, the latest edition
(including all the amendments) are applicable to this document.
YY/T 0316 Medical devices - Application of risk management to medical
devices (YY/T 0316-2016, ISO 14971.2007 revised edition, IDT)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
4 General requirements
As an alternative to applying Clauses 5 through 9, compliance of LEGACY
SOFTWARE may be demonstrated as indicated in 4.4.2 to 4.4.5.
Based on the software safety class of the LEGACY SOFTWARE (see 4.3), the
MANUFACTURER shall perform a gap analysis of available DELIVERABLES
against those required according to 5.2, 5.3, 5.7, and Clause 7.

Basic Data

Standard ID	YY/T 0664-2020 (YY/T0664-2020)
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	11.040.01; 35.240.80
Word Count Estimation	64,687
Date of Issue	2020-09-27
Date of Implementation	2021-09-01
Older Standard (superseded by this standard)	YY/T 0664-2008
Regulation (derived from)	Announcement No. 108 (2020) of the National Medical Products Administration
Issuing agency(ies)	State Drug Administration