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Keyword: IEC 60601-1: Medical electrical equipment
The IEC 60601-1 is the standard for medical electrical equipment.
The norm is called General specifications for safety including the essential performance characteristics.
Here you will find an overview of IEC 60601-1, its most important requirements and tips on how to meet them.
Applicability of IEC 60601-1
The IEC 60601-1 (available here) may also be of interest to software manufacturers because the IEC 62304 does not contain any requirements for the validation of the software and "leaves" the specifications for this to the IEC 60601-1. However, we recommend IEC 62366 for stand-alone software in order to get “guidance” for validation, specifically for validating usability.
However, the IEC 60601 is only for devices with a Application part applicable, that by definition a Part of the ME device [is] which, when used as intended, inevitably comes into physical contact with the patient so that the ME device or an ME system can fulfill its function.
Read more about the applicability of IEC 60601-1 here
Read more about IEC 61010-1, the pendent to IEC 60601-1 for IVD.
Requirements of IEC 60601-1
- regulates how that electric security of medical devices must be guaranteed and checked,
- makes demands on themechanical security of medical devices,
- determines the Marking and labeling of medical electrical devices,
- demands one Life cycle process for programmable electrical medical systems (PEMS),
- regulates how risks through electromagnetic radiation and excessive temperatures should be minimized,
- defines the requirements of the medical devices with regard to electromagnetic compatibility have to meet
For this purpose, IEC 60601-1 defines a large number of terms such as
Timeline and Appendix A1: 2013
Since 01.01.2016, EN 60601-1: 2006 can no longer be used as proof of conformity for the basic requirements of Directive 93/42 / EEC. Since then, manufacturers have had to apply EN 60601-1: 2006 + A1: 2013 (Edition 3.1).
Examples of changes
Version 3.1 of the standard contains more than a hundred other changes compared to version 3.0, in addition to clarifications of the essential performance characteristics and the elimination of difficulties in meeting the requirements for risk management.
- Normative reference in Appendix ZA to EN ISO 14917: 2012. The wording of ISO 14971: 2012 applies. That means the risk must:
- “As far as possible”, “to a minimum”, “to the lowest possible level”,
- "Minimized" or "fixed".
- Definition of own acceptance criteria in accordance with the risk policy and the risk management plan
- Exclusion of the applicability of EN 14971 in the monitoring of production and the production phases
- Clarifications in handling and the determination of essential performance characteristics
- Revised and new definitions of terms
- Electrical hazards, changes to the tests and revised requirements (e.g. clearances and creepage distances)
- General requirements for testing ME systems
"Z attachments": changes and ambiguities
The CENELEC has added the two annexes ZA and ZZ to the current edition of EN 60601-1. The annexes are binding for the EU. Appendix ZA contains a list of normative references to standards that are valid when used in the EU. In Appendix ZA, the EMC standard is listed in version EN 60601-1-2: 2007.
Unfortunately, there are still some ambiguities with Appendix ZA:
- Section 4.2.2 of the standard requires the use of ISO 14971: 2007
- Annexes ZA / ZZ require application of EN ISO 14971: 2012 (ZA / ZZ Annex only valid for EU) Problem is simultaneous applicability of ISO and EN ISO
Appendix ZA contains a normative reference to the 3rd edition of the EMC standard (EN 60601-1-2: 2007). When the 4th edition is published, how should it be brought into the scope of EN 60601-1 from 2013?
We support you in planning and carrying out the necessary steps:
- GAP analysis device designs
- Creation of an EMC test plan according to the 4th edition
- Review risk analysis or risk management file
- Determination of the "essential performance characteristics"
Please do not hesitate to contact our specialists.
IEC 60601-1 and validation
The requirements of IEC 60601-1 for validation - you will find excerpts listed below - are very general and therefore do not provide any specific information or assistance. We therefore recommend that you read the article on validation of medical devices or watch the video.
questions and answers
Question 1: Intended use and validation
The norm says
"52.210.1. The VALIDATION of the SECURITY of the PEMS must be carried out for the intended purpose. "
What does "carried out for the intended purpose" mean? Does that mean it should be validated within the intended use? Isn't the intended use itself actually being validated?
Here we are dealing with a suboptimal translation. The English wording makes it a little clearer what it is about.
"VALIDATION of the SAFETY of PEMS under the conditions of the intended use shall be carried out."
In other words: It must be validated under the same conditions as the product is later to be used according to its intended purpose. If the intended purpose says that the device is to be used by an untrained nurse in the operating room on patients with inflammation of the pancreas, then it must be checked under precisely these conditions whether the device achieves its intended use. And not if a trained doctor uses it for an appendix operation.
Question 2: Validation of the design
The standard also writes:
"52.210.6 No member of a development team may be responsible for the VALIDATION of his own design."
The design is not validated at all, so this requirement makes little sense, does it? Is the design not verified, but are the requirements validated? Or how can I envision a design validation?
I think, without being able to prove it, that this is a somewhat impure formulation. In my opinion, what is meant is "Design and Implementation". So it's not about validating an architecture, but about validating the product. And here no members should be responsible for checking the results of the constructive phases (design & implementation).
In the 3rd edition, the guys formulated this a little more clearly, which may confirm my thesis:
“The person who has overall responsibility for PEMS VALIDATION must be independent of the development group. The MANUFACTURER must document a justification for the degree of independence. "
Writing standards neatly is not that trivial ...
The EN 60601-1 was supplemented by 10 additional standards. We announce all the sub-parts here in a very shortened form - they are therefore not a complete overview:
EN 60601-1-1: System standard
The supplement "Medical electrical equipment - Part 1-1: General requirements for safety - Supplementary standard: Requirements for the safety of medical electrical systems". Safety, tests and guidelines for electrical, medical systems are listed here. Above all, there are rules for the safety of patients and users.
Attention: Deharmonisation of the norm
The content of this standard was taken over as Chapter 16 in the third edition of EN 60601-1: 2006. The supplementary standard has been withdrawn by the standardization bodies, but according to VDE / DKE Frankfurt, it has not yet been officially disarmed by the EU Commission. It still appears in the last list of harmonized standards, so it has not yet been officially de-harmonized.
The expert Armin Gärtner writes about this:
I am not satisfied with this adoption of the earlier supplementary standard. In the old supplementary standard, the requirements for system developers were clearly described on the normative level. This standard was also known in hospitals as a small, thin and therefore manageable standard. By including the standard as Chapter 16 in the basic standard, the knowledge of these requirements has also been lost for operators. From my point of view, it also makes no sense to include these requirements in the basic standard. This also coincides with other voices in standardization committees, according to which it is thought time and again to pack the topic of normative requirements on systems into a separate supplementary standard.
EN 60601-1-2: EMC
In the section “Medical electrical equipment - Part 1-2: General requirements for safety including the essential performance characteristics - Supplementary standard: Electromagnetic compatibility - Requirements and tests”, the tests and requirements for electromagnetic compatibility are defined. Read a detailed article on IEC 60601-1-2 and the changes with the 4th edition here.
EN 60601-1-3: General radiation protection, diagnostics
The supplement "Medical electrical equipment - Part 1-3: General requirements for safety including the essential performance characteristics - Supplementary standard: Radiation protection of diagnostic X-ray equipment" regulates diagnostic X-ray equipment with regard to equipment safety and equipment tests. This also includes all devices that take radiological images of people. In summary, the elements radiation protection, construction of the radiator and radiation limitation are dealt with.
EN 60601-1-4: software
In the title "Medical electrical devices - Part 1-4: General requirements for the safety supplementary standard: Programmable electrical medical systems" all rules for the safety of medical electrical devices and systems with programmable electrical subsystems (PESS) are dealt with. The items risk management process, verification and validation of the software development process are included.
This standard has now been replaced by IEC 62304.
EN 60601-1-6: fitness for purpose
The heading "Medical electrical equipment - Part 1-6: General requirements for safety including the essential performance characteristics - Supplementary standard: Usability" hides regulations on safety and tests for usability. While abnormal use is not taken into account, the standard covers normal use and normal usage errors. This is intended to ensure a basic level of safety in terms of usability.
Although this standard continues to exist, it has essentially been replaced by IEC 62366.
EN 60601-1-8: Alarm systems
In the title “Medical electrical equipment; General specifications for safety, including the essential performance characteristics - Supplementary standard: Alarm systems - General specifications, tests and guidelines for alarm systems in medical electrical devices and in medical systems ”, the objective of creating and guaranteeing basic security for alarm systems in medical devices is hidden. Different alarm categories are defined for different levels of urgency.
EN 60601-1-9: Reduction of environmental impact
The supplement "Medical electrical equipment - Part 1-9: General requirements for safety including the essential performance characteristics - Supplementary standard: Requirements for reducing environmental impacts" refers explicitly to equipment and not systems. The requirement of the life cycle analysis is made here.
EN 60601-1-10: Closed control loops
The supplement to the standard "Medical electrical equipment - Part 1-10: General requirements for safety including the essential performance characteristics - Supplementary standard: Requirements for the development of physiological closed-loop control loops" (PCLC) can relate to physical properties such as the temperature of the patient, to chemistry of the body (blood sugar) or on the drug concentration. The requirements of accuracy and protection against dangerous initial values are assigned to these areas.
EN 60601-1-11: Medical technology in a domestic environment
Behind the title "Medical electrical equipment - Part 1-11: Special requirements for safety including the essential performance characteristics - Supplementary standard: Requirements for medical electrical equipment and medical electrical systems for medical care in a domestic environment" hides the challenges even in unusual locations to ensure the safe functioning of medical technology. In a domestic environment, there may be irregular voltages in the power grid or an inconvenient environment. Therefore, harsh environment, treatment and dielectric strength are treated as requirements.
EN 60601-1-12 medical technology for emergency use (in draft)
This section is still in draft mode and will probably show similar content as in EN 60601-1-11. The requirements outside of the hospital for emergency use are just as complicated as in the home environment.
Further training on IEC 60601-1
During a two-day intensive seminar on IEC 60601-1 you will learn
- know their requirements, also 4th edition and new IEC 60601-1-2,
- Terminology (normal state, first failure security, essential performance characteristic, basic security, MOOP, MOPP, PEMS, PESS),
- systematically evaluate functional safety and risks of architecture concepts,
- To meet MDD requirements for integrated security,
- Allocate protection concepts and measures to the hazard types and evaluate them,
- describe the interaction with risk management,
- Create isolation diagrams and
- To be documented in accordance with IEC 60601-1.
The seminar is aimed primarily at developers and architects as well as project managers and risk managers. You can find out more about the seminar here.
b) video training
The video training in the Auditgarant will introduce you to terms and give you a quick, compact and entertaining introduction to the world of this standard.
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