Friday, May 19, 2023

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 Development Planning requirements as per Clause 5.1 of IEC 62304.

Let's get into the topic.

Software Development Planning

The Software Development Planning is an important part of Software Development Process. The Software Development Planning shall consider the following details as per IEC 62304.

Software Development Plan:

The Software Development Plan shall address the following:

The information about the process used in the development of Software System shall be provided.

The Information about the deliverables or documentation for each activity and tasks in Software Development Process shall be provided.

The information about the Traceability between System requirements, Software Requirements, Software System Testing and Risk Control Measures implemented shall be provided.

The information about the Configuration of the Software & Change Management shall be provided. It shall also include information about SOUP Configuration Items and other Software’s used to support the Software development process.

The information about the Problem Resolution process of software shall be provided for handling problems in the Software products, deliverables and activities during each stage of Software Life Cycle.

Update to Software Development Plan:

The Software Development Plan shall be updated as necessarily during the Software Development Life Cycle process with appropriate version controls.

Reference to System Design and Development:

System Requirements Document, other procedures for coordinating the Software Development activity and Design & Development validation activity shall be referenced in the Software Development Plan.

Standards, Methods and Tools:

The Standards, Methods & Tools used in the Software Development Process shall be referenced in the Software Development Plan.

Software Integration and Integration Testing planning:

A plan to integrate multiple software items and testing that needs to be performed during the integration shall be referenced in the Software Development Plan.

Software Verification planning:

There shall be information about the deliverables requiring verification and acceptance criteria for the verification of deliverables in the Software Development Plan.

Software Risk Management planning:

The Plans related to tasks and activities of Software Risk Management Process shall be addressed in Software Development Plan. The information related to managing the risks of SOUP shall also be addressed in Software Development Plan.

Documentation planning:

The information about the documents that needs to be produced during the Software Development Life Cycle shall be referenced in Software Development Plan.

The Documents shall have an appropriate Title, Name, Purpose, information about the Intended Audience of the document, Procedures and Responsibilities for development, review, approval and modifications of the document.

Software Configuration management planning:

The information about the Software Configuration Management shall be referenced in Software Development Plan. The information shall have details about, but not limited to the following:

The Activities and Tasks in Software Configuration Management.

The Class, type, category or list of items that needs to be controlled.

The Responsible Persons and Designations for performing Software Configuration management activities.

Impact or relationship of the configuration with the other functions of the organisations such as development and maintenance.

Details about when the item needs to be placed under configuration management and when the problem resolution process shall be used.

Control of Configuration items before verification:

There shall be a plan specified by the manufacturer of Software to place the configuration items under documented configuration management control before they are verified.

Now I hope you have acquired some basic knowledge about Software Development Planning requirements as per Clause 5.1 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.

Check out for this blog about Computed Tomography, X ray, MRI scan, ECG.

Generations of CT Scanners

COMPUTED TOMOGRAPHY|TECHNOLOGY|ARTIFACTS

x ray machine working principle

components of x ray tube

MRI scan

MRI With Contrast

Brain MRI

Types of MRI scanners

ELECTROCARDIOGRAM

12 Lead ECG Placement

HOW TO READ AN ECG

Holter Monitor

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Friday, April 28, 2023

IEC 62304 Overview & Definitions

Hi friends!!!

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

IEC 60601-1 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 Assessment Routes

EU MDR Timeline, Annex, Chapter

EU MDR Post Market Surveillance

EU MDR Clinical Evaluation

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 Classification Rules

EU MDR EUDAMED

EU MDR Economic Operators

EU MDR Chapter & Articles - Part 1

EU MDR Chapter & Articles - Part 2

In today's blog, we are going to discuss about IEC 62304.

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.

Check out for this blog about Computed Tomography, X ray, MRI scan, ECG.

Generations of CT Scanners

COMPUTED TOMOGRAPHY|TECHNOLOGY|ARTIFACTS

x ray machine working principle

components of x ray tube

MRI scan

MRI With Contrast

Brain MRI

Types of MRI scanners

ELECTROCARDIOGRAM

12 Lead ECG Placement

HOW TO READ AN ECG

Holter Monitor

DON’T FORGET TO FOLLOW THIS BLOG PAGE

DROP YOUR MAIL ID TO GET IMMEDIATE UPDATES

If you find this blog post knowledgeable,

comment & share it with a friend!

Tuesday, March 28, 2023

IEC 60601-1 Separation of Parts

Hi friends!!!

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

IEC 60601-1 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

EU MDR Assessment Routes

EU MDR Timeline, Annex, Chapter

EU MDR Post Market Surveillance

EU MDR Clinical Evaluation

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 Classification Rules

EU MDR EUDAMED

EU MDR Economic Operators

EU MDR Chapter & Articles - Part 1

EU MDR Chapter & Articles - Part 2

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 Sub Clause 8.5: Separation of Parts as per IEC 60601-1.

Let's get into the topic.

Separation of Parts

Means of Protection:

General:

The Applied Parts & Accessible Parts of Medical Electrical Equipment shall have two means of protection to prevent from exceeding the limits specified in “Section 8.4 Limitation of voltage, current or energy” of IEC 60601-1.

The Two Means of Protection are following:

Means of Patient Protection (MOPP):

MOPP reduces risk of electric shock to patients.

Means of Operator Protection (MOOP):

MOOP reduces risk of electric shock to persons other than the patients.

The following shall not be regarded as a Means of Protection:

Varnishing

Enamelling

Oxidation

Similar protective finishes

Means of Patient Protection (MOPP) & Means of Operator Protection (MOOP):

The following are the requirements of MOPP & MOOP:

Dielectric Strength Test according to Section 8.8 of IEC 60601-1 shall be complied for Solid Insulation forming a Means of Patient Protection or Means of Operator Protection in Medical Electrical Equipment.

The Limits specified in “Table 12 – Minimum Creepage Distances and Air Clearances providing Means of Patient Protection” of IEC 60601-1 shall be complied for Creepage Distances and Air Clearances forming a Means of Patient Protection in Medical Electrical Equipment.

The Limits specified in “Table 13 – Table 16” shall be complied for Creepage Distances and Air Clearances forming a Means of Operator Protection in Medical Electrical Equipment.

The requirements of Section 8.6 of IEC 60601-1 shall be complied for Protective Earth Connections forming a Means of Patient Protection or Means of Operator Protection in Medical Electrical Equipment.

Separation of Patient Connections:

F Type Applied Parts:

The Patient Connections of any F-Type Applied Part shall be separated from all other parts of the Medical Electrical Equipment, including the Patient Connections of other Applied Part, by one Means of Patient Protection for the Working Voltage equal to the Maximum Mains Voltage. The One Means of patient Protection shall also comply with the specified Patient Leakage Current limits of 110% of the Maximum Mains Voltage.

There might be multiple functions in a single F Type Applied Part. In this case, it is not required to have a separation between such functions.

If the Patient Connections does not have an electrical separation between the same or another function, then these Patient Connections are considered as one Applied Part.

The Type BF, Type CF or Defibrillation-Proof classifications applies to the whole of one Applied Part.

B Type Applied Parts:

In Medical Electrical Equipment, the Patient Connections of a Type B Applied Part which are not Protectively Earthed shall be separated from metal Accessible Parts which are not Protectively Earthed by one Means of Patient Protection.

The above-mentioned requirement shall not be necessary if the risk of metal Accessible Part making contact with the source of voltage or Leakage Current above permitted limits is acceptably low and if the metal Accessible Part is physically touching the Applied Part and can be considered as a part of the Applied Part.

Patient Leads or Patient Cables:

Any connector for electrical connections to the patient lead which is connected at the end of the lead or cable that is remote distal from the patient shall be constructed so that the said part cannot become connected to earth or possible hazardous voltage while the Patient Connections contact the Patient.

Likewise, any connector for electrical connections to the patient lead which contains a conductive part that is not separated from all Patient Connections by one Means of Patient Protection for a Working Voltage equal to the Maximum Mains Voltage, shall be constructed so that the said part cannot become connected to earth or possible hazardous voltage while the Patient Connections contact the Patient.

Now I hope you have acquired some knowledge about IEC 60601-1 Sub Clause 8.5: Separation of Parts. 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.

Check out for this blog about Computed Tomography, X ray, MRI scan, ECG.

Generations of CT Scanners

COMPUTED TOMOGRAPHY|TECHNOLOGY|ARTIFACTS

x ray machine working principle

components of x ray tube

MRI scan

MRI With Contrast

Brain MRI

Types of MRI scanners

ELECTROCARDIOGRAM

12 Lead ECG Placement