Hi friends!!!
In our previous blogs, we have discussed about the following topics.
IEC 62304 Software Architectural & Detailed Design
IEC 62304 Software Requirements Analysis
IEC 62304 Software Development Planning
IEC 62304 Overview & Definitions
IEC 60601-1 Classification of Medical Electrical Equipment
IEC 60601-1 General Requirements for Testing Medical Electrical Equipment
IEC 60601-1 Medical Electrical Systems
IEC 60601-1 Protection against unwanted and excessive radiation hazards
IEC 60601-1 General Requirements
IEC 60601-1 Programmable Electrical Medical Systems
IEC 60601-1 Hazardous situations and fault condition
IEC 60601-1 Construction of Medical Electrical Equipment
IEC 60601-1 Leakage Currents and Patient Auxiliary Currents
IEC 60601-1 Creepage Distance and Air Clearance
IEC 60601-1 Components and Wiring
IEC 60601-1 Mechanical Hazards Moving Parts
IEC 60601-1 Excessive Temperatures
IEC 60601-1 Markings on the Outside of Medical Electrical Equipment
IEC 60601-1 Markings on the Inside of Medical Electrical Equipment
IEC 60601-1 Instability Hazards
IEC 60601-1 Separation of Parts
EU MDR Timeline, Annex, Chapter
EU MDR Post Market Surveillance
EU MDR Technical Documentation – Part 1
EU MDR Technical Documentation – Part 2
EU MDR General Safety and Performance Requirement
EU MDR Information on the Label
EU MDR Post Market Clinical Follow Up
EU MDR Unique Device Identification – Part 1
EU MDR Unique Device Identification – Part 2
EU MDR Chapter & Articles – Part 1
EU MDR Chapter & Articles – Part 2
In today’s blog, we are going to discuss about IEC 62304.
IEC 62304 states the requirements for Medical Device Software. Satisfying the requirements of IEC 62304 is an important task in order to ensure the safety of patients and efficacy of software used in treating the patients.
Therefore, it is important for Medical Device QA/RA Professionals to understand about Software Unit Implementation, Integration & Integration Testing requirements as per Clause 5.5 & 5.6 of IEC 62304.
Software Unit
As per IEC 62304, the Software Items which cannot be further decomposed are called as Software Units.
Software Unit Implementation:
The Manufacturer of the medical device software shall implement each software units. This requirement is applicable for Class A, B, C, medical device software.
The procedures, strategies and methods shall be established by the manufacturer of medical device software for verifying the software units. If the verification of software unit is done by testing, the adequacy of the test method shall be evaluated by the manufacturer. This requirement is applicable for Class B & C, medical device software.
Prior to integrating the software units with larger software items, the manufacturer of the medical device software shall establish the acceptance criteria for each software units and shall ensure that the software unit meets the acceptance criteria. This requirement is applicable for Class B & C medical device software.
The following factors can be considered for acceptance
criteria:
The software code implements adequate risk control measures, free from contraindications with respect to the interface design, comply to applicable programming or coding standards.
The software unit verification shall be performed by the manufacturer of medical device software and results shall be documented. The software unit verification means verifying the software unit implementation against the software unit design. This requirement is applicable for Class B & C medical device software.
Software Unit Integration and Integration Testing:
The manufacturer of medical device software shall integrate each software units. The integration of software units with software items and/or software system shall be verified by the manufacturer according to the software integration plan and evidence of such verification shall be retained. This requirement is applicable for Class B & C, medical device software.
The integrated software items shall be tested by the manufacturer of medical device software according to the software integration plan and the results shall be documented. Such integration testing procedures shall be evaluated for adequacy. This requirement is applicable for Class B & C, medical device software.
The intended performance of the integrated software items shall be addressed by the manufacturer of medical device software during the software integration testing. This requirement is applicable for Class B & C, medical device software.
The following factors can be considered during software integration testing:
The functionality of the software.
Appropriate implementation of risk control measures.
Specified timing and other behavior of the software.
Specified functioning of internal and external interfaces of the software.
The software can be tested under abnormal conditions including foreseeable misuse.
The manufacturer of medical device software shall conduct the regression testing when software items are integrated, to ensure that no defect have been introduced into previously integrated software. This requirement is applicable for Class B & C, medical device software.
The software problem resolution process shall be used by the manufacturer of medical device software to enter details about the anomalies found during integration and integration testing. This requirement is applicable for Class B & C, medical device software.
The integration test records shall document the test results, identify the tester, have adequate details like equipment’s used for testing, environmental conditions, test case specifications etc., to enable the test to be repeated.
Now I hope you have acquired some basic knowledge about Software Unit Implementation, Integration & Integration Testing as per Clause 5.5 & 5.6 of IEC 62304. We will meet again with another valuable topic related to Biomedical Engineering, Medical Device, Healthcare.
NOTE: Dear friends!!!… Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.
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