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YY/T 0664-2020 PDF English

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YY/T 0664-2020: Medical device software - Software life cycle processes
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YY/T 0664: Evolution and historical versions

Standard IDContents [version]USDSTEP2[PDF] deliveryName of Chinese StandardStatus
YY/T 0664-2020English980 Add to Cart 0-9 seconds. Auto-delivery Medical device software - Software life cycle processes Valid
YY/T 0664-2008English500 Add to Cart 0-9 seconds. Auto-delivery Medical device software - Software life cycle processes Obsolete

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

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YY PHARMACEUTICAL INDUSTRY STANDARD ICS 11.040.01; 35.240.80 C 30 Replacing YY/T 0664-2008 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. This Standard shall be under the jurisdiction of National Technical Committee 221 on Quality Systems and Corresponding General Aspects for Medical Devices of Standardization Administration of China (SAC/TC 221). The previous editions of the standard replaced by this Standard were released as follows. - YY/T 0664-2008.

1 Scope

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.

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. 3.1 Activity A set of one or more interrelated or interacting TASKS. 3.2 Anomaly Any condition that deviates from the expected based on requirements specifications, design documents, standards, etc. or from someone's perceptions or experiences. ANOMALIES may be found during, but not limited to, the review, test, analysis, compilation, or use of MEDICAL DEVICE

4 General requirements

The MANUFACTURER shall document the software safety class assigned to each SOFTWARE SYSTEM in the RISK MANAGEMENT FILE. When a SOFTWARE SYSTEM is decomposed into SOFTWARE ITEMS, and when a SOFTWARE ITEM is decomposed into further SOFTWARE ITEMS, such SOFTWARE ITEMS shall inherit the software safety classification of the original SOFTWARE ITEM unless the MANUFACTURER documents a rationale for classification into a different software safety class. ......
Source: Above contents are excerpted from the full-copy PDF -- translated/reviewed by: www.ChineseStandard.net / Wayne Zheng et al.


      

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