YY/T 0664-2020Medical device software—Software life cycle processes (English PDF)

Foreword

This standard was 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, apart from editorial changes, the main technical changes are as follows:

- the amendments of IEC 62304:2006/AMD1:2015 have been incorporated, marked by a double vertical line in the outer margin. The main amendments are: the term "software product" (3.26 of the 2008 edition) has been deleted and replaced by "medical device software" (see 3.11); the terms and definitions of hazardous situation (3.33), legacy software (3.34), release (3.35), residual risk (3.36), risk estimation (3.37) and risk evaluation (3.38) have been added; the requirements for software safety classification have been modified and Figure 3, Assigning software safety classification, added (see 4.3); requirements for legacy software (4.4) and for identification and avoidance of common software defects (5.1.12) have been added; the requirements for verifying software integration (5.6.2), the software safety classes to which provisions apply, the evaluation and record contents of software system testing (5.7.4, 5.7.5) and the preparation of problem reports (9.1) have been modified; the requirements to document the sequence of events (7.1.5 and 7.3.2 of the 2008 edition) have been deleted; the guidance on software safety classification (B.4.3) has been modified and guidance on legacy software (B.4.4) added;

- the Chinese wording of the terms anomaly (3.2), hazard (3.9), safety (3.20) and serious injury (3.22) has been modified;

- some content has been modified because of translation.

This standard uses the redrafting method to adopt IEC 62304:2015, Medical device software - Software life cycle processes, with modifications, marked by a single vertical line in the outer margin. The main technical differences are: the normative references have been adjusted to China's technical conditions, ISO 14971 being replaced by YY/T 0316, its identical adoption; terms, clauses or items marked "not used" have been deleted and renumbered in accordance with GB/T 1.1; the definition of manufacturer (3.10) has been aligned with YY/T 0287-2017; the term medical device has been deleted, being defined in the medical device regulations and in YY/T 0287-2017; and the definitions of process (3.13) and verification (3.31) have been modified.

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 dated references, only the edition cited applies. For undated references, the latest edition (including all amendments) applies.

YY/T 0316, Medical devices - Application of risk management to medical devices (YY/T 0316-2016, ISO 14971:2007 corrected version, 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. Note: anomalies may be found during, but not limited to, the review, test, analysis, compilation or use of medical device software or applicable documentation.