Hi friends!!!

In our previous blogs, we have discussed about the following topics.

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 have basic understanding about IEC 62304 & it’s important definitions.

Let’s get into the topic.

IEC 62304 Overview:

IEC
62304 is an International Standard which provides framework for processes,
activities and tasks that occur throughout the product life cycle. The product
life cycle here refers to the software life cycle when a software alone is used
as a medical device (SAMD), a software is used as a component of a medical
device or is used in the production of a medical device.

IEC
62304 does not define a specific life cycle model which needs to be followed. The
requirements in IEC 62304 shall be followed in order to ensure the safety of
patients and efficacy of software used in treating the patients.

IEC 62304 classifies
the medical device software as following:

Class A: No injury or
damage to health is possible.
Class B: Injury is
possible, but not serious.
Class C: Death or
serious injury is possible.

Higher the
classification of the medical device software (Class C), more stringent are the
requirements that needs to be satisfied as per IEC 62304. Class B medical
device software will have some exemptions in the requirements. Class A medical
device software will have more exemptions in the requirements when compared to
Class B.

Clauses of
IEC 62304:

Clause 5:
States the requirements for Software Development Process from Software Planning
Phase to Software Release Phase.

Clause 6:
States the requirements for Maintenance Process of Software once it is released
into the market.

Clause 7:
States the requirements for Risk Management Process in the Medical Device
Software.

Clause 8:
States the requirements for Configuration Management Process of the Medical
Device Software.

Clause 9: States the requirements for Problem Resolution
Process of the Medical Device Software.

Important Definitions:

Architecture:

The Architecture means an organizational structure of a
system or a component.

Configuration Item:

The Configuration item is an entity which can be identified
at a given reference point.

Medical Device Software:

The Medical Device Software is a software system which is
intended for use as a Medical Device or that has been developed for being
incorporated into the Medical Device.

Security:

Security means a protection of information and data such
that it cannot be modified or read by the unauthorized persons or systems.

Software Item:

A Software item means any identifiable part of the computer
programs. Eg: Source code.

A Software can be decomposed into three categories:
Software System, Software Items, Software Units. The top level is Software
system and the bottom level which cannot be further decomposed is called
Software Units. A Software System can be composed of one or more Software
Items, a Software Item can be composed of one or more Software Units or
decomposable Software Items.

Software Product:

A Software product means a set of computer programs,
procedures and possibly associated documentation and data.

Software System:

Software System means an integrated collection of Software
Items which are organized to accomplish a specific function or set of functions.

Software of Unknown Provenance (SOUP):

SOUP means a generally available Software Item which was
already developed but not developed for the purpose of being incorporated in
the medical device. Such previously developed software may not have adequate
evidence for the software development process.

Version:

Version means an identified instance of a Configuration
Item.

Now I hope you have acquired some basic knowledge about IEC 62304 & it’s important definitions. 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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