HC352 - Regulation and standards

This course deals with regulations and standards developed for the biomedical engineering field. Two main families of standards will be presented: IEC standards and ISO standards, mainly IEC60601, IEC62353, ISO13485, IEC61010, ISO14971. In addition, the classification of safety standards will also be presented (Typ A, Typ B and Typ C).

In addition, a basic architecture design where safety standards are implemented will be presented. Thus, a comparison between basic biomedical systems, where safety is not taken into account, and advanced systems, where safety and redundancy at the level of sensors, processing unit and communication interfaces are present, will be proposed. Some examples related to life applications will be presented during the course.

EN:

This course deals with the regulations and standards developed for the biomedical engineering domain. Two main standards families will be presented: the IEC and the ISO standards, mainly IEC60601, IEC62353, ISO13485, IEC61010, ISO14971. Added to that, the safety standards classification will be also presented (Typ A, Typ B and Typ C).

Added to that, some basic architecture design where safety standards are implemented will be presented. Thus, a comparison between basic biomedical systems, where safety is not taken into consideration, and advanced systems, where safety and redundancy at the level of the sensors, the processing unit and the communication interfaces is present, will be proposed. Some examples related to life-application will be shown during this course.

By the end of this course, students will have acquired basic information on safety standards for biomedical devices. In addition to this, they will be able to identify basic system failures due to unsafe architecture design. Thus, they should be able to design a safe system while taking into account sensor/communication interface/memory/processing unit redundancy.

Tags:
- Safety system
- Safety standards applied to medical devices
- Designing a safe medical device

Remarks :

Although this module has a large theoretical component, many examples will be introduced to enrich the idea of safety architecture. An important point for students to focus on is to differentiate between the application of safety (which is a property of biomedical systems, mainly those aimed at helping humans) and the design of safety.

The evaluation could be based in part on a section devoted to the above topics in the project report.

EN:

At the end of this course, the students should have acquired basic information about the safety standards in biomedical devices. Added to that, they should identify the basic failures in system due to unsafe architecture design. Thus, they must be able to design a safe system while taking into consideration the redundancy of the sensors/communication interfaces/memory/processing unit.

Keywords:
* Safety Systems
* Safety Standards applied to medical devices
* Design of a safe medical device

Comments:

Although this module has a large theoretical part, one will introduce many examples to enhance the idea of safety architecture. A main point that the students have to focus on is to differentiate between safety application (which is a property of the biomedical systems, mainly the ones aiming to help humans) and safety design.

Evaluation might be partly based on a section dedicated to the aforementioned topics in the realization project report.

Plan:

Chapter A - Introduction to medical device regulations

Chapter B1 - Overview
- A simple design...
- Definition of a medical device
- Standards & regulations
* History
* Definition
* When, who and how?
- Effect of electricity on the body
- Electrical risks associated with medical equipment
- Construction of medical equipment
- Safety testing and inspection of medical equipment
- Other equipment in the patient's environment
- Medical electrical systems
- Networked medical devices
- Software

Chapter B2 - Safety System Architecture
- Some definitions
- Reliability
- Functional safety in cyber-physical medical systems (CPMS)
* Risks and hazards
- Types of failure
- Reliability enhancement in CPMS
- Calculations
* CPMS without redundancy
* M out of N system architecture
- Software error/security in CPMS
- Diagnostics and test classification in CPMS
- Future CPMS architectures

EN:

Outline:

Chapter A - Introduction to medical device regulation

Chapter B1 - General Overview
- A simple design...
- Definition of Medical Device
- Standards & Regulations
* History
* Definition
* When, Who and How?
- Effect of Electricity on the body
- Electrical Hazards from Medical Equipment
- Construction of Medical Equipment
- Medical Equipment Safety Testing and Inspection
- Other equipment in the patient environment
- Medical Electrical Systems
- Networked Medical Devices
- Software

Chapter B2 - Safety System Architecture
- Some definitions
- Reliability
- Functional Safety in Cyber Physical Medical Systems
* Risks and Hazards
* Types of failures
- Improving reliability in CPMS
- Calculations
* CPMS without redundancy
* M out of N system architecture
- Software Error/Safety in CPMS
- Diagnostics and Tests Classification in CPMS
- Future Architectures for CPMS