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YY/T 0664-2020: Medical device software -- Software life cycle processes
YY/T 0664-2020
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.01; 35.240.80
C 30
Replacing YY/T 0664-2008
Medical device software - Software life cycle
processes
(IEC 62304:2015, MOD)
ISSUED ON: SEPTEMBER 27, 2020
IMPLEMENTED ON: SEPTEMBER 01, 2021
Issued by: National Medical Products Administration
Table of Contents
Foreword ... 4 
Introduction ... 8 
1 Scope ... 11 
1.1 * Purpose ... 11 
1.2 * Field of application ... 11 
1.3 Relationship to other standards ... 12 
1.4 Compliance ... 12 
2 * Normative references ... 12 
3 * Terms and definitions ... 13 
4 * General requirements ... 22 
4.1 * Quality management system ... 22 
4.2 * RISK MANAGEMENT ... 23 
4.3 * Software safety classification ... 23 
4.4 * LEGACY SOFTWARE ... 25 
5 Software development PROCESS ... 27 
5.1 * Software development planning ... 27 
5.2 * Software requirements analysis ... 31 
5.3 * Software ARCHITECTURAL design ... 34 
5.4 * Software detailed design ... 35 
5.5 * SOFTWARE UNIT implementation ... 36 
5.6 * Software integration and integration testing... 37 
5.7 * SOFTWARE SYSTEM testing ... 39 
5.8 * Software RELEASE for utilization at a SYSTEM level ... 41 
6 Software maintenance PROCESS ... 42 
6.1 * Establish software maintenance plan ... 42 
6.2 * Problem and modification analysis ... 43 
6.3 * Modification implementation ... 45 
7 * Software RISK MANAGEMENT PROCESS ... 45 
7.1 * Analysis of software contributing to hazardous situations ... 45 
7.2 RISK CONTROL measures ... 46 
7.3 VERIFICATION of RISK CONTROL measures ... 47 
7.4 RISK MANAGEMENT of software changes ... 47 
8 * Software configuration management PROCESS ... 48 
8.1 * Configuration identification ... 48 
8.2 * Change control ... 49 
8.3 * Configuration status accounting ... 50 
9 * Software problem resolution PROCESS ... 50 
9.1 Prepare PROBLEM REPORTS ... 50 
9.2 Investigate the problem ... 50 
9.3 Advise relevant parties ... 50 
9.4 Use change control process ... 51 
9.5 Maintain records ... 51 
9.6 Analyse problems for trends ... 51 
9.7 Verify software problem resolution ... 51 
9.8 Test documentation contents ... 51 
Annex A (Informative) Rationale for the requirements of this Standard ... 53 
Annex B (Informative) Guidance on the provisions of this Standard ... 56 
Annex C (Informative) Relationship to other standards ... 82 
Annex D (Informative) Implementation ... 104 
Bibliography ... 107 
Foreword
This Standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This Standard replaces YY/T 0664-2008 "Medical device software - Software
life cycle processes". Compared with YY/T 0664-2008, in addition to editorial
changes, the main technical changes are as follows:
- Incorporate the amendments of the international standard IEC
62304:2006/AMD1:2015. The clauses and subclauses involved in these
amendments have been marked by a vertical double line (||) on the outer
margins. The main amendments include:
 Delete the term "software product" (3.26 of the 2008 edition); replace
"software product" with "medical device software" (see 3.11);
 ADD the terms and definitions of "hazardous situation" (see 3.33),
"legacy software" (see 3.34), "release" (see 3.35), "residual risk" (see
3.36), "risk estimation" (see 3.37), and "risk evaluation" (see 3.38);
 Modify the requirements of "Software safety classification" (see 4.3; 4.3
of the 2008 edition);
 ADD "Figure 3 Assigning software safety classification" (see 4.3);
 ADD the requirements of "LEGACY SOFTWARE" (see 4.4);
 ADD the requirements of "Identification and avoidance of common
software defects" (see 5.1.12);
 Modify the requirements of "Verify software integration" (see 5.6.2;
5.6.2 of the 2008 edition);
 Modify the software safety class to which the provisions apply (see
5.7.1, 5.7.2, 5.7.3, 5.8.1, 5.8.2, 5.8.7, 5.8.8; 5.7.1, 5.7.2, 5.7.3, 5.8.1,
5.8.2, 5.8.7, 5.8.8 of the 2008 edition);
 Modify the requirements of "Evaluate SOFTWARE SYSTEM testing"
(see 5.7.4; 5.7.4 of the 2008 edition);
 Modify "SOFTWARE SYSTEM test record contents" (see 5.7.5; 5.7.5
of the 2008 edition);
 Delete the requirements of "Document the sequence of events" (7.1.5
of the 2008 edition);
 Delete the requirements of "Document any new sequence of events"
(7.3.2 of the 2008 edition);
 Modify the requirements of "Prepare PROBLEM REPORTS" (see 9.1;
9.1 of the 2008 edition);
 Modify the guidance on "Software safety classification" (see Annex
B.4.3; Annex B.4.3 of the 2008 edition);
 ADD the guidance on "LEGACY SOFTWARE" (see Annex B.4.4).
- Modify the Chinese expression of the term "anomaly" (see 3.2; 3.2 of the
2008 edition).
- Modify the Chinese expression of the term "hazard" (see 3.9; 3.9 of the
2008 edition).
- Modify the Chinese expression of the term "safety" (see 3.20; 3.21 of the
2008 edition); USE the changed expression throughout the text instead.
- Modify the Chinese expression of the term "serious injury" (see 3.22; 3.23
of the 2008 edition).
- Modifications to part of the content due to translation.
This Standard uses the redraft law to modify and adopt IEC 62304:2015
"Medical device software - Software life cycle processes".
There are technical differences between this Standard and IEC 62304:2015. 
The provisions involved in these differences have been marked by a single
vertical line (|) on the outer margins. The main technical differences and
reasons are as follows:
- As for the normative references, this Standard has adjusted the technical
differences, to adapt to the technical conditions of China. The adjustments
are mainly reflected in Clause 2 “Normative references”. The specific
adjustments are as follows:
 Replace ISO 14971 with YY/T 0316 which is identical to the
international standard.
- For deleted terms, clauses, or items that involve "not used", change the
corresponding serial numbers (including table serial numbers), to comply
with the provisions of GB/T 1.1, to ensure the determination of technical
content and the harmonization of the text structure;
- Modify the definition of the term "manufacturer (see 3.10)", to be consistent
with the YY/T 0287-2017 standard;
- Delete the term "medical device". Because medical device regulations and
YY/T 0287-2017 both have a definition of "medical device", this Standard
does not repeat it;
- Modify the definitions of the terms "process (see 3.13)" and "verification
(see 3.31)", to be consistent with GB/T 19000-2016;
- Modify the definition of the term "regression testing" (see 3.14), to be
consistent with ISO/IEC/IEEE 90003:2018;
- Modify the Chinese expression of the term "harm" (see 3.8; 3.8 of the 2008
edition); and modify the definition to be consistent with YY/T 0316-2016;
- Modify the Chinese expression of the term "security" (see 3.21; 3.22 of the
2008 edition); and modify the definition to be consistent with ISO/IEC/IEEE
12207:2017;
- Uniformly modify "RISK CONTROL measures external to the software",
"RISK CONTROL measures external to the software system", "RISK
CONTROL measures not implemented within (external to) the software
system", and "RISK CONTROL measures external to the (software
system)" TO "external RISK CONTROL measures” (see 4.3 and Figure 3),
in order to be consistent with regulations;
- CHANGE the 8.2.2 note/8.2.3 note "5.1.1 e)" to "5.1.1 d)". Based on the
standard context, editorial errors are corrected;
- ADD Annex B.4.5 Regulatory perspective, in order to understand standards’
and regulatory requirements;
- Delete the IEC mark in Figure 3. The content in the figure has technical
changes with IEC 62304:2015;
- Modify Table C.1 and Table C.2 in Annex C, to be consistent with YY/T
0287-2017 and YY/T 0316-2016 respectively;
- Delete Annex C.4.7, because IEC 60601-1-4 has been abolished;
- Delete the index of the terms defined in Clause 3, which is not used.
Attention is drawn to the possibility that some of the elements of this document
may be the subject of patent rights. The issuing authority of this document shall
not be held responsible for identifying any or all such patent rights.
This Standard was proposed by National Medical Products Administration.
Medical device software - Software life cycle
processes
1 Scope
1.1 * Purpose
This Standard 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.
1.2 * Field of application
This Standard 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.
Note 1: This Standard can be used in the development and maintenance of software that
is itself a medical device. However, additional development activities are needed
at the system level before this type of software can be placed into service. These
system activities are not covered by this Standard, but can be found in IEC 82304-
1 [11].
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.
This Standard applies regardless of the persistent storage device(s) used to
store the software (for example: hard disk, optical disk, permanent or flash
memory).
This Standard applies regardless of the method of delivery of the software (for
example: transmission by network or email, or physical transfer by optical disk,
flash memory or EEPROM). The method of software delivery itself is not
considered MEDICAL DEVICE SOFTWARE.
This Standard does not cover validation and final release of the MEDICAL
DEVICE, even when the MEDICAL DEVICE consists entirely of software.
Note 2: If a medical device incorporates embedded software intended to be executed on
a processor, the requirements of this Standard apply to the software, including the
requirements concerning software of unknown provenance (see 8.1.2).