IEC 60601 1 4th Ed FINAL Design Specification Outline 1701413653
IEC 60601 1 4th Ed FINAL Design Specification Outline 1701413653
IEC 60601 1 4th Ed FINAL Design Specification Outline 1701413653
This Design Specification supplements the Architectural Specification for Safety Standards of Medical
Electrical Equipment, Medical Electrical Systems, and Software used in Healthcare (62/348/Q) that was
drafted by the representatives of IEC TC 62 and its subcommittees and finalized in 2020. It outlines the
concepts and goals for the IEC 60601 series of standards. This includes the IEC 80601 and ISO 80601 series
of standards.
Once the Architectural Specification was finalized and approved by the National Committees of IEC/TC 62
and subcommittees, IEC/SC 62A was tasked with developing this Design Specification. The aim of this
Design Specification is to provide clear, concise basis for developing the next edition of IEC 60601-1. It is
intended to provide information to develop a user-friendly, distinct and easily readable edition of IEC
60601-1.
The new structure of the requirements is mirrored by a new structure of the Working Groups, each
working on a separate cluster. A table is provided which maps the clauses of Ed.3.2 and other documents
into each cluster. The numbering (A … L) of the clusters does not reflect the final numbering of the Clauses
of Ed.4.
This document provides the philosophy, principles in drafting the fourth edition as well as how the
proposed grouping of the work will be performed.
The Design Specification and the 4th edition are intended to support the UN sustainable Development
Goal 3: Good health and well-being—ensure healthy lives and promote well-being for all.
2. Clustering of requirements
The IEC 60601 series contains requirements for medical electrical equipment, medical electrical systems
and its software. Those requirements can apply to all equipment/systems (as in the general standard), to
specific groups of equipment or to specific properties/aspects of equipment (as in the collateral standards
and in some particular standards that address general issues (i.e., 60601-2-22, 80601-2-49, 60601-2-57,
60601-2-75).
It is the intention of the 4th edition to include the requirements of the general standard and collateral
standards (as well as some “general” particular standards) into one document. To better manage the
number of requirements in the development phase of the standard, corresponding requirements are
grouped into clusters. All technical requirements related to specific hazards (e.g., electrical, mechanical,
electromagnetic, radiation) are grouped into separate clusters.
The clusters are indicated with capital letters (A, B, C, …) to distinguish them from clauses. It is the
intention that each cluster be managed by one Working Group (WG). The responsible WG can decide on
grouping the requirements into one clause or into more clauses where necessary or appropriate.
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4. The first three clauses are determined per ISO/IEC Directives, Part 2 (and will
be handled by the editing team):
1. Scope
2. Normative references
3. Terms and definitions
5. Clusters of requirements
The content and specific requirements are grouped into general requirements and a set of clusters
according to kind or source of harm/hazardous situation: [62/348/Q-Goal 3]
A. General requirements
B. Physical environment hazards
C. User interface related hazards (including all labelling and information to be provided)
D. Materials hazards
E. PEMS (e.g., SaMD (Software as a medical device), SiMD (Software in a medical device), firmware,
software, apps, OS, drivers) related hazards
F. Electrical hazards
G. Mechanical hazards
H. Thermal and fire hazards
I. Optical radiation (visible, UV and IR) hazards
J. Ionizing radiation hazards
K. Electromagnetic exposure (not optical or ionizing but including SAR) hazards
L. Electromagnetic disturbances (including coexistence) hazards
A separate cluster for medical electrical systems is not included in this list, because system aspects are
covered in the hazard-specific clusters. Where applicable, the system-specific requirements need to be
indicated clearly in those clusters.
A separate cluster for ‘Hazardous situations and fault conditions for ME Equipment’, former Clause 13, is
not included because hazardous situations and single fault conditions are distributed into the hazard-
specific clusters.
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7. The following topics were considered but are not to be included in the 4th
edition.
Following topics have been moved to the scope of IEC/SC 62A/WG 20 and IEC/TC 62 – ISO/TC 210/JAG 5
to be considered in a separate standard in the future.
This document specifies the general requirements for the basic safety and essential performance of MEE and MES,
intended for use by the specific users and in the specific environments of use as specified in the instructions for use.
This document applies to software integrated into an MEE (SiMD). This document applies to software as a medical
device (SaMD) in an MES when the SaMD contributes to basic safety or essential performance.
Hazards related to the intended physiological effect of MEE or MES are not covered by the specific requirements of
this document except in xxx (formerly 7.2.13) and xxx (formerly 8.4.1).
– in vitro diagnostic equipment that does not fall within the definition of MEE, which is covered by the IEC 61010
series;
– implantable parts of active implantable medical devices covered by the ISO 14708 series; or
NOTE 2 ISO 7396-1 applies the requirements of IEC 60601-1-8 to certain monitoring and ALARM SIGNALS.
Definitions in this document are only informative for better understanding of this document; definitions will be
specified in IEC 60050-880.
Once they are published in IEC 60050-880, they will be used in IEC 60601-1 Ed.4.
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Note 1 to entry: Products which can be considered to be medical devices in some jurisdictions but not in
others include:
— disinfection substances,
— aids for persons with disabilities,
— devices incorporating animal or human tissues,
— devices for in-vitro fertilization or assisted reproductive technologies .
[SOURCE: ISO/IEC Guide 63:2019, 3.7, modified — replaced “and/or” with “or” and “human being”
and “human body” with “patient”.]
9.6 patient
subject of care
living being (person or animal) receiving healthcare services
Note 1 to entry: Healthcare services include diagnostic, therapeutic, monitoring, surgical or dental
procedures and can be delivered in the home healthcare environment, professional healthcare environment
and emergency medical services environment.
Note 2 to entry: A patient can be a user.
Note 3 to entry: Safety limit values can be different for different patients, especially for non-human patients.
[SOURCE: IEC 60601-1:2005, 3.76, modified — replaced “undergoing a medical, surgical or dental
procedure” with “receiving healthcare services” and "operator" with "user" and added notes 1 and 3.]
part of MEE (IEV 880-09-25) that in normal use (IEV 880-21-07) necessarily comes into physical
contact with the patient (IEV 880-14-16) for an MEE to perform its function
[SOURCE: IEC 60601-1:2005, 3.8, modified — deleted “or an MES” and notes.]
9.8 user
DEPRECATED: operator
person interacting with (i.e., operating or handling) the medical device (IEV 880-09-23), accessory
(IEV 880-09-04) and associated items
Note 1 to entry: There can be more than one user of a medical device.
Note 2 to entry: Common users include, among others, healthcare professional providers, patients, lay
persons, processors, maintenance and service personnel.
[SOURCE: IEC 62366-1:2015, 3.24, modified — added “, accessory and associated items” and
"lay persons", replaced “cleaners” with “processors”.]
Additionally, IEC/SC 62A will utilize an editing team to ensure consistency of content and writing style
authored by the different WGs as well as making the document consistent with the current ISO/IEC
Directives, Part 2.
Also, to assist in developing the 4th edition, there will be two phases of training provided. First set will be
for the groups drafting the texts for IEC 60601-1. Second set will be for those who will need to reference
IEC 60601-1 in their publication, most notably the writers of part 2 standards and other documents in the
IEC 60601 series.
A mapping between the relevant goals of the Architecture Document 62/348/Q and how each goal will
be implemented for the 4th edition project is detailed in Annex A.
a) Regarding normative references, the following text will be added to the general Clause (WG A):
[62/348/Q-Goal 3]
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Where this document specifies a specific edition of a normatively referenced document, the
manufacturer may substitute a more current version provided the manufacturer can demonstrate
that the residual risk that results from the substitution remains acceptable and is comparable to the
residual risk that results from applying the normatively referenced document.
b) Terminology shall be consistent and shall utilize the terminology of IEC 60050-880, International
Electrotechnical Vocabulary (IEV) - Part 880: Electrical equipment, electrical systems and software
used in healthcare, where appropriate. [62/348/Q-Goal 3]
c) Each Clause shall cover the needed requirements for MEE, MES and, as appropriate, should cover the
needed requirements for subassemblies or components. [62/348/Q-Goal 5]
d) Requirements shall clearly indicate whether they are applicable to MEE, MES, subassemblies or
components, as appropriate. [62/348/Q-Goals 5.5.3 and 5.5.6]
e) Each Clause shall consider whether requirements need to vary based on e.g., intended use
environment, intended patient or intended user. [62/348/Q-Goal 5]
f) Each requirement shall be reconciled into a single statement (i.e., each requirement is distinct and
has a unique identifier). [62/348/Q-Goal 2]
g) Each requirement should include rationale for the safety goal in the rationale annex. [62/348/Q-Goal
1],
h) Each requirement should include the correlation with IMDRF N47 and N52 in an Annex. [62/348/Q-
Goal 6]
i) Each requirement will be reviewed to ensure that it still reflects the generally acknowledged state of
the art. [62/348/Q-Goal 1]
j) Each requirement will be reviewed to ensure that the acceptance criteria are verifiable (quantitative
where possible). [62/348/Q-Goal 4]
k) Test methods should be described in sufficient detail, or referenced to an existing accepted standard,
to ensure that the test can be successfully reproducibly conducted and have consistent results.
[IMDRF N51]
l) Cross references within the document shall be avoided where practicable and, if necessary, be as
short as possible. [62/348/Q-Goal 3]
m) Normative reference to external standards should be as precise as practicable to avoid referencing
more of a standard than is necessary. Such references should be as specific as practicable. [62/348/Q-
Goals 3 and 4]
n) Small parts of external standards should be copied into the document (if possible verbatim) to avoid
the normative reference (e.g., a single requirement from an external standard). In such a case, a note
or the rationale should indicate the source of the requirement. [62/348/Q-Goal 3]
o) Informative references should be limited to notes or the rationale. [62/348/Q-Goal 3]
p) References to the outputs of processes (e.g., usability engineering, software development, risk
management) in conformance statements should be minimized, where practicable. However, the
conformance statement for each process document shall be clear and specific. [62/348/Q-Goal 4]
EXAMPLE Following a mechanical stress test:
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2. Confirm that the enclosure integrity is maintained and access to live parts is prevented.
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c. a subset of the hazard-related use scenarios based on the severity of the potential harm and
based on other circumstances specific to the MEE and the manufacturer;
7. to confirm that the manufacturer has established and maintained:
a. a user interface specification which includes whether accompanying documentation is required
and whether training is required, and
b. a user interface evaluation plan for the user interface;
8. If training on the medical device is required for the safe use by the intended user, to confirm that the
manufacturer has designed and implemented a training capability for the expected service life of the
medical device by doing at least one of the following:
a. provided the materials necessary for training, and
b. ensured the materials necessary for training are available,
c. make the training available, or
d. make training available to the responsible organization that enables it to train its users;
9. to confirm that the manufacturer has performed a summative evaluation of each selected hazard-
related use scenario;
10. to confirm that all use errors and use difficulties that occurred are to be identified;
a. Identify if new use errors, hazards, hazardous situations or hazard-related use scenarios
occurred.
11. to confirm whether further improvement of the user interface design as it relates to safety is
necessary and practicable:
a. if not, confirm that the manufacturer has documented why improvement is not necessary or not
practicable,
b. if not, confirm that the data from the usability engineering process needed to determine the
residual risk related to use is documented, and
c. confirm that the residual risk has been evaluated according to ISO 14971:2019, 7.3 (see
IEC 62366-1:2015 + A1:2020, Figure A.5); and
12. if user interface of unknown provenance (UOUP) is present, confirm that it was evaluated to
Annex C.
a. The instructions for use shall contain a summary of the use specification as specified in IEC
62366-1:2015 + A1:2020, 5.1;
b. The same information is also included in the technical description, if this is provided as a
separate document from instructions for use.
Where an entry indicates new, the existing 3rd edition does not address the issue and the WG will need
to identify or develop appropriate requirements. When a question mark is indicated in the “3rd edition
or other standard’s clauses/subclauses (specified numbering)” column, it represents work that the
cluster will need to do determine the specifics to be incorporated.
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There are classifications in Cluster A that will be used to determine which subclauses of the standard are
applicable to a given product and which test levels are applicable.
A. General requirements: general issues with respect to underlying concepts (e.g., basic
safety/essential performance, single fault safety, type testing), correlation with processes
relevant for the IEC 60601-1 defined by other process standards (e.g., risk management).
B. Physical environment hazards: safety issues due to specific environmental conditions, including
power supply.
C. User interface (means by which user and medical device interact) aspects (including all labelling
and information to be provided) hazards: safety issues related to user interfaces including
marking, indications, accompanying information, alarm systems and usability.
D. Materials hazards: safety issues related to interferences of materials of MEE/MES with users,
patients, used substances, including cleaning, disinfection, sterilization.
E. PEMS related hazards (e.g., Software as a medical device, Software in a medical device, firmware,
software, apps, operating system, drivers): safety issues related to software driven functionality.
F. Electrical hazards: safety issues related to electricity.
G. Mechanical hazards: safety issues related to mechanics, including acoustic and pneumatic energy
and vibration energy.
H. Thermal and fire hazards: safety issues related to thermal effects caused by MEE/MES and to fire
in MEE or MES.
I. Optical radiation (visible, UV and IR) hazards: safety issues related to (visible radiation, UV and or
IR).
J. Ionizing radiation hazards: safety issues related to ionizing radiation.
K. Electromagnetic exposure (not optical or ionizing but including SAR) hazards: safety issues related
to radiation not (not optical or ionizing radiation hazards but including SAR).
L. Electromagnetic disturbances (including wireless coexistence) hazards: safety issues related to
electromagnetic emissions or electromagnetic immunity, (including wireless coexistence).
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13. Proposed groupings for the IEC 60601 4th Edition development [62/348/Q-Goal 3]
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Annex A
Mapping of the goals of the Architecture Document to the implementation plan
for the 4th edition
No. Goal Goal in 62/348/Q Implementation in 60601-1 Ed. 4 project
No.
1 1 Sharpen the focus on basic safety and essential Cluster A and WG training
performance
2 1.1 Clarify the basic safety and essential performance Cluster A and Handbook for WG convenors covering
concept (specifications for design & type testing for these aspects
a "product standard", Basic safety & Essential
Performance in NC and SFC, not safety related
aspects outside of the scope)
3 1.2 Streamline the approach for safe use of new Handbook for WG convenors covering these aspects
technologies (for non-patient related safety use of
external IEC/ISO standards / collaboration with other “New” text needed in multiple clusters
TCs, for patient safety input from
clinicians/manufacturers, process elements to be
kept outside added to existing process standards)
4 1.3 Include protection goals (rationale) for each of the Protection goals and where appropriate rationales
safety requirements (goals for each subclause at the why the normative requirements support that goals
beginning of the subclause entry in the informative shall be written in Annex A for at least each "first-
annex with rationales where necessary for level" sub-clause (i.e., subclause x.y) in the beginning
compliance criteria and selected test methods) of the text (see examples in 5.1.3.4 of 62/348/Q for an
appropriate level of detail). The 62A review team that
assists the consistent implementation of architecture
and design spec will review this aspect before each
document stage and can propose solutions to the
corresponding WG, if necessary.
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20 3.7 Clarify the IEC/TC 62 policy for the use of dated and
undated references (all normative references dated,
amendments only if they modify the affected
contents, state in each document that subsequent
revisions of dated references standards can be
accepted provided it is demonstrated that the
affected hazard/ hazardous situation is also resolved
adequately in the subsequent revision, acceptance
of dated or undated informative references)
21 4 Increase separation of type testing and process See example process standard reference
requirements
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26 5 Clarification of scope of the IEC 60601 series See new scope and supporting definitions
27 5.1 Patients (especially particular standards need to
identify in their scope coverage with respect to
different patient groups and types of animals, with
specific considerations in the main part for allowable
values, IEC 60601-1 can also be used for some
animals)
28 5.2 Intended operators (consider the intended
operator/user who can be a lay, a professional, a
patient)
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