Protection Class in Accordance with IEC 60601-1
The protection classes in accordance with IEC 60601-1 specify the protective measures that manufacturers of medical electrical equipment must implement.
Systems engineering aims to systematically develop systems – in this context, medical devices – in the planned time and quality.
Content
This page helps manufacturers of medical devices and their service providers to gain an overview of systems engineering and to find further articles on the subject:
- Articles on processes and activities in the device life-cycle
- Articles on the IEC 60601-1 family and physical safety
- Articles on biocompatibility, sterility, and reprocessing
Definition of systems engineering
According to the ISO/IEC 15940 definition, systems engineering is …
… interdisciplinary approach governing the total technical and managerial effort required to transform a set of customer needs, expectations, and constraints into a solution and to support that solution throughout its life.
Wikipedia has also adopted this definition of systems engineering.
ISO/IEC/IEEE 21841 speaks of a process of planning, analysis, organization, development, and integration.
1. Articles on processes and activities
a) Processes
The V-model is a well-known model for the development process. It is suitable as a documentation model for the (agile) development of medical devices.
As part of this process, manufacturers carry out various activities for which further articles provide guidance. They can set up their development team for these activities and/or have activities carried out by third parties.
In the latter case, these articles are relevant:
- Outsourcing in medical technology
- Engineering service providers: successfully outsourcing development?
b) Formulate intended purpose and requirements
- Formulate intended use and purpose
- Stakeholder requirements, such as user requirements and regulatory requirements
- Create requirements specification and functional specification (be careful with this)
- Derive System Requirements or System Specification (SRS)
c) Designing systems
- Creating a system architecture for medical devices, ideally not a layered architecture
- Creating safety concepts to achieve functional safety
- Using modeling languages such as the Unified Modeling Language (UML)
- Creating designs using Computer-based Modeling & Simulation (CM&S)
- Performing threat modeling for systems that contain software for IT security
- Carrying out a design validation
- Developing software in compliance with the law
d) Verifying and validating systems
- Verification and validation: difference & definitions
- Verification and validation of IVD
- Combinatorial testing
- Clinical evaluation
e) Further phases in the life-cycle
- Design transfer to production
- Post-market phase, including post-market surveillance
- Subsequent design changes
- Recycling and disposal of medical devices
Notes and further information
Usability engineering and, thus, the verification and validation of usability are also part of systems engineering. You can find further information on systems engineering by clicking on this link.
Risk management is a special feature of systems engineering for medical devices. You will find an overview of articles on risk management by clicking on this link.
2. Articles on the IEC 60601-1 family and physical safety
a) Regulatory requirements
The regulatory requirements are based on EU regulations and directives:
- EU Regulation for Medical Devices MDR
- EU Regulation for In Vitro Diagnostic Medical Devices IVDR
- EU Machinery Directive
- EU Radio Equipment Directive
- EU Battery Regulation
The central standard is IEC 60601-1, which was extended by a 2nd amendment in 2019. IEC 61010-1 is relevant for IVDs.
The concepts of the standard(s) include:
- Basic safety, essential performance
- Functional safety
- MOPP, MOOP, MOP, and the IEC 60601 arithmetic
In addition to the basic standard, the particular standards are also relevant:
- IEC 60601-1-2: New edition on EMC of medical devices
- IEC 60601-1-8: Back to conformity in 12 steps
- IEC 60601-1-11 AMD1:2020 (2.1) – Medical devices in the home environment
Many manufacturers rely on the CB Reports to provide evidence.
b) Implementation of requirements for specific systems and situations
- Systems, devices
- Medical device software PC: Software manufacturers take note!
- Closed-loop systems for medical devices
- Autonomous systems: 4 advantages for medical device manufacturers
- Combination of medical devices: Legal and economic considerations
- Components, parts
- PESS: Programmable electronic subsystems
- Multiple socket-outlets for medical devices
- Critical components/parts
3. Articles on biocompatibility, sterility, and reprocessing
There are special standards for devices that are intended to come into contact with the human body:
- ISO 10993 on biocompatibility
- ISO 10993-5 on cytotoxicity testing
- ISO 18562 on the biocompatibility evaluation of breathing gas pathways in healthcare applications
ISO 17664 is relevant for the reprocessing of medical devices.
Please also refer to our article on substance-based medical devices.
Do you still have questions about your medical device’s development, inspection, and approval? Then, please take advantage of our free micro-consulting service.
Would you like support in developing your medical devices in compliance with the law, testing, and authorizing their safety? The Johner Institute team will be happy to help! Contact us!
Sterilization of medical devices: A quick overview
Because the quality of medical device sterilization is crucial to the safety of these medical devices, the selection and validation of the sterilization process are regularly subject to audits and inspections. This article provides a quick overview of the various sterilization processes and regulatory requirements for medical devices and offers best practices for successfully passing…
DetailsASCA: Accreditation Scheme for Conformity Assessment
ASCA stands for Accreditation Scheme for Conformity Assessment. The procedure is intended to accelerate conformity assessments and, thus, approval procedures. However, it is not applicable to all devices or all markets. This article explains who benefits from ASCA and how the procedure works.
DetailsIntended purpose and intended use: More consequences than you think!
The correct and precise formulation of the intended purpose of medical devices and in vitro diagnostic medical devices (IVD) is crucial for their successful development and approval. However, even the definitions of terms and the connection between intended purpose and intended use make it difficult to achieve clarity and precision. This article reveals how to…
DetailsIEC 61010-1 and IEC 61010-2-101: Requirements for IVD medical devices
The IEC 61010 series of standards specifies safety requirements for electrical equipment used for measurement, control, regulation, and laboratory use. The general standard IEC 61010-1 and the particular standards of the IEC 61010-2 series describe the state of the art and thus serve IVD manufacturers as a means of demonstrating compliance with the general safety…
DetailsClosed-loop systems in medical devices
Medical devices are increasingly based on closed-loop systems. These “closed-loop systems” are already mentioned in the Medical Device Regulation (MDR). One example is a system consisting of an insulin pump controlled by a device with a glucose sensor. In this article, you will learn what closed-loop systems are, where they are used in medicine, and what…
DetailsDesign verification of medical products and standalone software
The “design verification” requirement is not just a requirement of the FDA. This article describes what “design verification” means and which regulatory requirements medical device manufacturers should fulfill.
Design validation: What you need to demonstrate
Most medical device manufacturers associate the term “design validation” with the FDA. However, not only the FDA but also European regulations, particularly ISO 13485, require design and development validation. Nevertheless, design validation and validation of the design should not be confused. This article shows how the two differ and which regulatory requirements must be observed.
DetailsSystem architecture (not only) for medical devices
The system architecture describes the components of a (medical) device and how these components interact with each other via interfaces. For standalone software, the system architecture and software architecture coincide.
Verification and validation: Differences and definitions
What is the difference between verification and validation, and how are these terms defined? Even standards and regulations use the terms incorrectly or misleadingly. This article
Details