Hi friends!!!

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

In today's blog, we are going to discuss about IEC 60601-1.

IEC 60601-1 states the Basic safety requirements for Medical Electrical Equipment's. Satisfying the requirements of IEC 60601-1 is an important task in order to commercialize the Medical Electrical Equipment's

Therefore, it is important for Medical Device QA/RA Professionals to know in detail about Clause 14: Programmable Electrical Medical Systems as per IEC 60601-1.

Let's get into the topic.

Clause 14 – Programmable Electrical Medical Systems

The Clause 14 of IEC 60601-1 states the requirements of Programmable Electrical Medical Systems. The following are the Sub-Clauses.

General

Documentation

Risk Management plan

PEMS Development Life-Cycle

Problem resolution

Risk Management Process

Requirement specification

Architecture

Design and implementation

Verification

PEMS Validation

Modification

PEMS intended to be incorporated into an IT-Network

Let’s discuss in detail about Important requirements of above-mentioned Sub Clauses.

Risk Management Plan:

The PEMS Validation Plan shall be referenced in Risk Management Plan.

PEMS Development Life-Cycle:

Milestones shall be defined at each stage of PEMS Development Life-Cycle. Each milestone shall have the details of verification methods and activities to be completed. Each activity listed in the milestone shall have details about its input and output. The PEMS Development Life-Cycle shall follow risk-based approach.

The PEMS Development Life-Cycle has certain attributes. All the activities in PEMS Life-Cycle shall be grouped into decomposition process and integration process.

Requirement Specification:

Each Subsystem of PEMS shall have requirement specification document. The requirement specification shall have details about essential performance of Subsystem and risk controls implemented.

Architecture:

Each Subsystem of PEMS shall have architecture which satisfies the requirement specification.

The architecture shall be framed to reduce the risk to an acceptable level by making use of Components with High Integrity, fail safe functions, redundancy, defensive design, test interval duration & diagnostic coverage, protection from reasonably foreseeable misuse, etc.

Design and Implementation:

Each Subsystems of PEMS shall have a Design and Test Specification.

Verification:

Each function which ensures basic safety, essential performance, and risk control measures shall be verified. The Verification shall be performed for each function at each milestone. A Verification Plan shall be created to decide on the strategies and methods of verification. The strategies and methods of verification shall include Statistical Techniques, Inspections, Dynamic Analysis etc.

The Verification shall be performed as per the plan and the results shall be documented.

Validation:

The Person responsible for overall validation shall be independent from the Design Team. No member of the design team shall perform PEMS Validation of their own design. The rationale for the level of independence shall be given by the manufacturer.

The Validation shall be performed as per the plan and the results shall be documented.

Programmable Electrical Medical Systems intended to be incorporated into an IT-Network:

If the PEMS is intended to be incorporated into an IT-Network which is not validated by Manufacturer. The instructions for implementing such connection shall be made available by the manufacturer which shall include the following:

The purpose of the Programmable Electrical Medical Systems connection to an IT-Network shall be available.

The required characteristics and configuration of the IT-Network incorporating the PEMS.

The technical and security specifications of the network shall be available.

During the incorporation of PEMS to IT Network, there will be subsequent changes in the IT Network which can introduce new risks and raises the requirement to perform additional analysis.

The changes to the IT Network shall include the following:

The change in the configuration of IT Network.

Disconnection of items from the IT Network.

The update of equipment connected to the IT Network

Now I hope you have acquired some knowledge about IEC 60601-1 Clause 14: Programmable Electrical Medical Systems. 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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