IEC 60601-1-8:2006/FDAmd 2

FINAL
IEC
AMENDMENT
DRAFT
60601-1-8:2006
FDAM 2
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Voting begins on:
Part 1-8:
2020-04-24
General requirements for basic safety
Voting terminates on:
and essential performance — Collateral
2020-06-19
standard: General requirements,
tests and guidance for alarm systems
in medical electrical equipment and
medical electrical systems
AMENDMENT 2
Appareils électromédicaux —
Partie 1-8: Exigences générales pour la sécurité de base et les
performances essentielles — Norme collatérale: Exigences générales,
essais et guides pour les systèmes d'alarme des appareils et des
systèmes électromédicaux
AMENDEMENT 2
This draft is submitted to a parallel vote in ISO and in IEC.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
IEC 60601-1-8:2006/FDAM 2:2020(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. IEC 2020
---------------------- Page: 1 ----------------------
– 2 – IEC FDIS 60601-1-8:2006/AMD2
© IEC 2020
FOREWORD

This amendment has been prepared by subcommittee 62A: Common aspects of electrical

equipment used in medical practice, of IEC technical committee 62: Electrical equipment in

medical practice, and ISO subcommittee 3: Respiratory devices and related equipment used for

patient care, of ISO technical committee 121: Anaesthetic and respiratory equipment.

Full information on the voting for the approval of this amendment can be found in the report on

voting indicated in the above table. In ISO, the amendment has been approved by XXX P

The committee has decided that the contents of this amendment and the base publication will

"http://webstore.iec.ch" in the data related to the specific publication. At this date, the

NOTE The attention of users of this document is drawn to the fact that equipment manufacturers and testing

organizations may need a transitional period following publication of a new, amended or revised IEC or

ISO publication in which to make products in accordance with the new requirements and to equip themselves for

conducting new or revised tests. It is the recommendation of the committee that the content of this publication be

adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.

IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates

that it contains colours which are considered to be useful for the correct understanding

of its contents. Users should therefore print this document using a colour printer.

The second edition of IEC 60601-1-8 was published in 2006 and amended in 2012. Since the

publication of IEC 60601-1-8:2006+A1:2012, the IEC Subcommittee (SC) 62A Secretariat has

been collecting issues from a variety of sources including comments from National Committees.

At the November 2015 meeting of IEC/SC 62A in Kobe, Japan, the subcommittee initiated a

process to identify high-priority issues that need to be considered in an amendment and should

not wait until the third edition of IEC 60601-1-8, which is presently targeted for publication

Those issues selected for inclusion on the final "short list" to be addressed in Amendment 2

were those approved by a 2/3 majority of the National Committees present and voting at the

Frankfurt meeting of SC 62A. At the meeting held on 10 October 2016, 20 items were presented

to the National Committees present. All 20 items received the required 2/3 majority of the

National Committees present and voting and have been included in the "short list" for

consideration in preparing Amendment 2. All remaining issues have been placed on a "long list"

The "short list" of issues was documented in the design specification for Amendment 2. As

IEC 60601-1-8 was jointly developed with ISO/TC 121/SC 3, the work was assigned to

IEC/SC 62A-ISO/TC 121/SC 3 Joint Working Group (JWG) 2. JWG 2 was directed to consider

each issue described in Clause 6 of the design specification and develop an appropriate

solution for the identified problem. That final solution in this amendment can encompass any

technical solution proposed by the author of the issue or it can involve a different solution

developed by the expert group. The expert group can also have recommended that no change

Because this is an amendment to IEC 60601-1-8:2006, the style in force at the time of

publication of IEC 60601-1-8 has been applied to this amendment. The style specified in

ISO/IEC Directives Part 2:2018 has only been applied when implementing the new style

guidance would not result in additional editorial changes. For example, notes to definitions are

Users of this document should note that when constructing the dated references to specific

elements in a standard, such as definitions, amendments are only referenced if they modified

the text being cited. For example, if a reference is made to a definition that has not been

modified by an amendment, then the reference to the amendment is not included in the dated

Replace, in the second sentence of the existing second paragraph, "source" with "origin".

– "this collateral standard" designates IEC 60601-1-8 alone, including any amendments;

Replace the existing references to IEC 60601-1, IEC 61672-1 and IEC 62366-1 by the following

IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety

IEC 62366-1:2015, Medical devices – Part 1: Application of usability engineering to medical

ALARM SYSTEM that involves more than one item of equipment in a ME SYSTEM intended for delivery

NOTE 1 The parts of a DISTRIBUTED ALARM SYSTEM can be widely separated in distance.

NOTE 2 A DISTRIBUTED ALARM SYSTEM is intended to notify OPERATORS of the existence of an ALARM CONDITION.

NOTE 3 For the purposes of this document, technical confirmation means that each element of a DISTRIBUTED ALARM

SYSTEM confirms or guarantees the successful delivery of the ALARM CONDITION to the next element or appropriate

Replace, in the existing note, "the equipment itself" with "the ALARM SYSTEM itself".

NOTE 1 The priority is assigned through RISK ANALYSIS. See 6.1.2 for the assignment of priority.

NOTE 2 Immediate implies the interruption of current workflow is expected [59], [60].

Replace, in the existing parenthetical, "Figure 1" with "Figure 1 and Figure G.1".

NOTE For the purposes of this document, when an AUDITORY ICON is used, the INTERBURST INTERVAL begins at the

NOTE 1 The priority is assigned through RISK ANALYSIS. See 6.1.2 for the assignment of priority.

NOTE 1 The priority is assigned through RISK ANALYSIS. See 6.1.2 for the assignment of priority.

NOTE 2 Prompt implies the re-planning of current workflow is expected [59], [60].

Replace the existing term, definition and notes, added by Amendment 1, with the following new

state of an ALARM SYSTEM initiated by OPERATOR action, where the auditory ALARM SIGNAL

associated with a currently active ALARM CONDITION is inactivated until the ALARM CONDITION no

NOTE ACKNOWLEDGED only affects ALARM SIGNALS that are active at the time of the OPERATOR action.

INFORMATION SIGNAL notifying the OPERATOR of a condition of the PATIENT or ME EQUIPMENT

providing contextual awareness that is intended to improve the clinical workflow or

NOTE 1 A notification that lab result is available, where the lab result requires immediate clinical action is not an

NOTE 2 A signal associated with an ADVISORY, which is an INFORMATION SIGNAL, is required by this document to be

designed so that an OPERATOR does not confuse it with an ALARM SIGNAL. See 6.3.2.2.2 and 6.3.3.2.

EXAMPLE 2 A battery status notification that replacement will be needed in a day.

EXAMPLE 4 A notification that lab result is available, where the lab results are normal.

situation wherein the presence of frequent ALARM SIGNALS desensitizes an OPERATOR to an

NOTE 1 A desensitized OPERATOR can fail to perceive, recognize or act on an ALARM SIGNAL.

NOTE 2 The response of a desensitized OPERATOR can be inadequate, delayed or non-existent.

situation wherein OPERATORS receive more ALARM SIGNALS in a time period than they can

synonym for the combination of PHYSIOLOGICAL ALARM CONDITIONS, TECHNICAL ALARM CONDITIONS

[SOURCE: ISO/IEEE 11073-10201:2020 [76], 3.3, modified – Replaced "alarms" with "ALARM

CONDITIONS", "equipment-user advisory signals" with "ADVISORIES" and deleted "patient

NOTE 1 An AUDITORY ICON is typically a real-world sound or mimics a real-world sound.

NOTE 2 An AUDITORY ICON can aid in locating the COMMUNICATOR and the SOURCE type.

sound that attracts attention, denotes the priority and aids in localization of the COMMUNICATOR

type of ALARM CONDITION for which a panel of experts would agree that OPERATOR action is

necessary to prevent HARM within the timeframe implied by the priority communicated by the

NOTE 1 An OPERATOR action can include assessment of a PATIENT or the changing of ALARM LIMITS when they are

NOTE 2 A LOW PRIORITY ALARM CONDITION, which requires action within the timeframe of a MEDIUM PRIORITY or HIGH

PRIORITY timeframe, is considered CLINICALLY ACTIONABLE. A HIGH PRIORITY ALARM CONDITION, which requires action

within the timeframe of a LOW PRIORITY or MEDIUM PRIORITY timeframe, is considered CLINICALLY NONACTIONABLE. In

NOTE 3 A FALSE POSITIVE ALARM CONDITION is never considered CLINICALLY ACTIONABLE even though an unrelated

OPERATOR action might be required to prevent a future FALSE POSITIVE ALARM CONDITION.

NOTE 4 A CLINICALLY ACTIONABLE ALARM CONDITION is generally considered useful by the OPERATOR.

type of ALARM CONDITION for which a panel of experts would agree that OPERATOR action is not

expected within a timeframe equal to or shorter than the timeframe implied by its priority

NOTE 1 A LOW PRIORITY ALARM CONDITION, which requires action within the timeframe of a MEDIUM PRIORITY or HIGH

PRIORITY timeframe, is considered CLINICALLY ACTIONABLE. A HIGH PRIORITY ALARM CONDITION, which requires action

within the timeframe of a LOW PRIORITY or MEDIUM PRIORITY timeframe, is considered CLINICALLY NONACTIONABLE. In

NOTE 2 CLINICALLY NONACTIONABLE ALARM CONDITIONS are considered detrimental to OPERATOR performance and

NOTE 3 ALARM SIGNALS for an ALARM CONDITION of which the OPERATOR is already aware are considered CLINICALLY

function of the ALARM SYSTEM that generates ALARM SIGNALS to notify an OPERATOR (e.g. the

DISTRIBUTED ALARM SYSTEM that includes the capability to receive an OPERATOR response

system that involves more than one item of equipment in a ME SYSTEM intended to provide

information about ALARM CONDITIONS but does not guarantee delivery of that information

NOTE 1 A disTRIBUTED INFORMATION SYSTEM ABOUT ALARM CONDITIONS is not intended to notify OPERATORS of the

existence of an ALARM CONDITION as a RISK CONTROL measure. A DISTRIBUTED INFORMATION SYSTEM ABOUT ALARM

CONDITIONS is intended to provide information about an ALARM CONDITION while the OPERATOR is aware of the

NOTE 2 A DISTRIBUTED INFORMATION SYSTEM ABOUT ALARM CONDITIONS is not intended for confirmed delivery of

function of the ALARM SYSTEM that distributes ALARM CONDITIONS, combines ALARM CONDITIONS

NOTE 1 An INTEGRATOR can direct or redirect an ALARM CONDITION to another COMMUNICATOR and hence OPERATOR.

NOTE 2 An INTEGRATOR can send the acceptance of responsibility from a COMMUNICATOR to a SOURCE.

ALARM SIGNAL for which a panel of experts would agree that the HARM associated with the ALARM

SIGNAL is greater than the benefit associated with action resulting from the ALARM SIGNAL

NOTE 3 A NUISANCE ALARM SIGNAL can arise from a CLINICALLY NONACTIONABLE ALARM CONDITION.

NOTE 5 An ALARM SIGNAL that unnecessarily irritates or startles the PATIENT or OPERATOR can be a NUISANCE ALARM

means by which an INTEGRATOR provides a response hierarchy for directing an ALARM CONDITION

state created by an OPERATOR response accepting ownership for addressing an ALARM

NOTE 1 A RESPONSIBILITY ACCEPTED can be used to initiate an ALARM SIGNAL inactivation state.

state created by an OPERATOR response rejecting ownership for addressing an ALARM CONDITION

NOTE 1 A RESPONSIBILITY REJECTED can be used to initiate an ESCALATION or REDIRECTION.

state, automatically initiated when neither a RESPONSIBILITY ACCEPTED nor RESPONSIBILITY

REJECTED is received within a specified period, which indicates that an OPERATOR is not

NOTE 1 RESPONSIBILITY UNDEFINED is not used as an indication that the COMMUNICATOR and INTEGRATOR cannot

absence of an ALARM CONDITION when no valid triggering event has occurred in the PATIENT, the

presence of an ALARM CONDITION when a valid triggering event has occurred in the PATIENT, the

e) changes the characteristics of the generated ALARM SIGNALS (for example, volume, pitch,

Replace, in the first sentence of the existing first paragraph, "ALARM SIGNALS" with "ALARM

Replace, in the existing Note 3, modified by Amendment 1, "IEC 62366" with "IEC 62366-1".

NOTE 5 It is recognized that visual INFORMATION SIGNALS and visual ALARM SIGNALS can sometimes contain identical

or similar information. When they are intended to convey different meanings, care needs to be taken to ensure that

Replace, in the existing first paragraph, modified by Amendment 1, the first sentence with:

b) of HIGH PRIORITY, the HIGH PRIORITY auditory ALARM SIGNALS of that COMMUNICATOR shall

convey a higher level of urgency than the MEDIUM or LOW PRIORITY auditory ALARM SIGNALS of

that ALARM SIGNAL set as well as a higher level of urgency than any auditory INFORMATION

c) of MEDIUM PRIORITY, the MEDIUM PRIORITY auditory ALARM SIGNALS of that COMMUNICATOR shall

convey a higher level of urgency than the LOW PRIORITY auditory ALARM SIGNALS of that ALARM

SIGNAL set as well as a higher level of urgency than any auditory INFORMATION SIGNAL;

2) * is generated by means of different technology (e.g., voice synthesizing of verbal

SIGNALS) and is VALIDATED (e.g., by clinical or simulated clinical USABILITY testing); or

Replace, in the existing Note 2, modified by Amendment 1, "IEC 62366" with "IEC 62366-1".

Replace, in the third sentence of the existing compliance check, modified by Amendment 1,

Replace the existing last sentence of the compliance check, modified by Amendment 1, with

When the sound files of Annex G are utilized, only testing of t is required and testing of the

Replace the existing last paragraph, added by Amendment 1, with the following new paragraph:

Amongst the required frequency components with the largest sound pressure levels,

acoustically confirm the presence of at least one frequency component in range of 150 Hz to

1 000 Hz and at least the required components in the range of 150 Hz to 4 000 Hz in the auditory

ALARM SIGNAL at 1 m or the intended OPERATOR's POSITION. Only the AUDITORY POINTERS need

Replace, in the paragraph at the bottom of the table starting with "Where", modified by

Replace the existing Table 4, modified by Amendment 1, with the following new table:

Frequency component in the range of 150 Hz to At least one that is among the four frequency

Within the frequency range of 150 Hz to 4 000 Hz, the relative sound pressure levels of the four frequency

components with the largest sound pressure levels should be within 15 dB of each other.

NOTE Care is needed to ensure that the MEDIUM PRIORITY ALARM SIGNAL cannot be confused with the audible

6.3.3.2 * Volume and characteristics of auditory ALARM SIGNALS and INFORMATION SIGNALS

Replace the existing first paragraph, modified by Amendment 1, with the following new

The auditory HIGH PRIORITY and MEDIUM PRIORITY ALARM SIGNAL sound pressure level range and

measurement radius, measured in accordance with the method of this subclause, shall be

Replace the existing list items c) to k), added by Amendment 1, with the following new items:

the sound level meter complying with the requirements of type 1 instruments specified in

IEC 61672-1:2013, measure the sound pressure levels at least at positions 1, 2, 3, 4, 5, 6,

7, 8, 9 and 10, as specified in Figure B.1 and Table B.1 of ISO 3744:2010, in a hemisphere

COMMUNICATOR, where d , as calculated in Figure 1 a) of ISO 3744:2010, is greater than

0,5 m, utilize a radius such that the distance from the surface of the COMMUNICATOR to the

hemisphere is at least 0,5 m everywhere, extended to the next higher value in the series

d) Measure the maximum time-weighted sound pressure level using frequency weighting A and

e) For ALARM SIGNALS utilizing AUDITORY POINTERS complying with Annex G, confirm that the

drive signal of the audio transducer utilizing an oscilloscope or other suitable instrument is

f) Calculate the A-weighted sound pressure level averaged over the measurement surface

g) If the ALARM SYSTEM is provided with a MEDIUM PRIORITY ALARM CONDITION, simulate a MEDIUM

h) If the ALARM SYSTEM is provided with a LOW PRIORITY ALARM CONDITION, simulate a LOW

i) Set the ALARM SIGNAL sound pressure level (volume level) to its minimum setting.

k) Confirm that the criteria for background noise, including any INFORMATION SIGNALS, specified

l) Confirm that the measured sound pressure level range is in compliance with the values

Replace the existing title and entire subclause 6.4.2, modified by Amendment 1, with the

6.4.2 * Delays to or from a DISTRIBUTED INFORMATION SYSTEM ABOUT ALARM CONDITIONS (DIS)

If an ALARM SYSTEM is provided with a means to send or receive ALARM CONDITIONS in a DIS or

the ALARM CONDITION leaves the SIGNAL INPUT/OUTPUT PART shall be disclosed in the

b) the maximum ALARM SIGNAL GENERATION DELAY of the COMMUNICATOR, including the method

the generation of the TECHNICAL ALARM CONDITION (see 6.11.2.2.1 b)) shall be disclosed in

3) the point that the presentation of the ALARM CONDITION leaves the SIGNAL INPUT/OUTPUT

4) the point that the presentation of the ALARM CONDITION arrives at the SIGNAL INPUT/OUTPUT

1) the point that the presentation of the ALARM CONDITION leaves the SIGNAL INPUT/OUTPUT

2) the point that the presentation of the ALARM CONDITION arrives at the SIGNAL INPUT/OUTPUT

Compliance is checked by functional testing under maximum load conditions of NORMAL USE and

NOTE Care is needed to ensure that the OPERATOR is aware of which previously retained ALARM SETTINGS are

Replace, in the existing first paragraph, modified by Amendment 1, ''6.10 and 6.11.2.2.1" with

During the ALARM OFF or ALARM PAUSED ALARM SIGNAL inactivation states, the ALARM SYSTEM may

discontinue the processing of signals used to generate the inactivated ALARM CONDITIONS.

NOTE 3 If the ALARM SYSTEM discontinues the processing of a signal used to generate an ALARM CONDITION, the

Replace the existing fifth and sixth rows of Table 5, modified by Amendment 1, with the