IEC 60601-1-8:2006/AMD1:2012

Amendment 1 - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Amendement 1 - Appareils électromédicaux - Partie 1-8: Exigences générales pour la sécurité de base et les performances essentielles - Norme collatérale: Exigences générales, essais et guide pour les systèmes d'alarme des appareils et des systèmes électromédicaux

General Information

• Status: Published
• Publication Date: 27-Nov-2012
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Drafting Committee: JWG 2 - TC 62/SC 62A/JWG 2
• Current Stage: PPUB - Publication issued
• Start Date: 15-Nov-2012
• Completion Date: 28-Nov-2012

Relations

• Amends: IEC 60601-1-8:2006 - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-1-8
Edition 2.0 2012-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
Medical electrical equipment –
Part 1-8: General requirements for basic safety and essential performance –
Collateral standard: General requirements, tests and guidance for alarm systems
in medical electrical equipment and medical electrical systems

Appareils électromédicaux –
Partie 1-8: Exigences générales pour la sécurité de base et les performances
essentielles – Norme collatérale: Exigences générales, essais et guide pour
les systèmes d’alarme des appareils et des systèmes électromédicaux

IEC 60601-1-8:2006/A1:2012
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IEC 60601-1-8
Edition 2.0 2012-11
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
Medical electrical equipment –

Part 1-8: General requirements for basic safety and essential performance –

Collateral standard: General requirements, tests and guidance for alarm systems

in medical electrical equipment and medical electrical systems

Appareils électromédicaux –
Partie 1-8: Exigences générales pour la sécurité de base et les performances

essentielles – Norme collatérale: Exigences générales, essais et guide pour

les systèmes d’alarme des appareils et des systèmes électromédicaux

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX U
ICS 11.040.01 ISBN 978-2-83220-442-9

– 2 – 60601-1-8 Amend. 1 © IEC:2012
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 SC 3: Lung ventilators and related devices of
ISO technical committee 121: Anaesthetic and respiratory equipment.
The text of this amendment is based on the following documents:
FDIS Report on voting
62A/824/FDIS 62A/837/RVD
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 standard has been approved by 19 P-
members out of 21 having cast a vote.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the stability date indicated on the IEC web site under
"http://webstore.iec.ch" in the data related to the specific publication. At this date, the
publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
_____________
INTRODUCTION TO THE AMENDMENT
The second edition of IEC 60601-1-8 was published in 2006. Since its publication, an issue
has been identified with respect to pulse and burst testing. In addition, issues have been
raised by IEC/62D/MT 22, Electromedical diagnostic and patient monitoring equipment, during
implementation of alarm system requirements in particular standards within their scope of
work.
At the Brussels meeting, IEC/SC 62A accepted a proposal, based on ISO/TC 121/SC 3
st
Resolution Orebro 6, to develop the 1 amendment to IEC 60601-1-8:2006 to address the
issues identified above. IEC/SC 62A – ISO/TC 121/SC 3 Joint Working Group 2, Alarms, was
reactivated as a maintenance team to develop this amendment.
Foreword
Add the following note at the end of the Foreword:
NOTE The attention of National Committees 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.

60601-1-8 Amend. 1 © IEC:2012 – 3 –
1.2 Object
In the first paragraph, change the print type of the defined terms "basic safety" and "essential
performance" to small caps.
1.3.1 IEC 60601-1
Replace the existing first dash with:
– "the general standard" designates IEC 60601-1 alone (latest edition including any
amendments);
2 Normative references
Replace the introductory paragraph with:
The following documents, in whole or in part, are normatively referenced in this document and
are indispensable for its application. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any
amendments) applies.
Replace the normative references for IEC 60417 and IEC 60601-1 with the following:
IEC 60417, Graphical symbols for use on equipment. Available from: symbols.info/equipment>
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
Amendment 1:2012
Delete the normative references for IEC 60601-1-2, and IEC 60601-1-6.
Replace the normative reference to IEC 60651:1979 and its Amendment 1 (1993) and
Amendment 2 (2000) with the following:
IEC 61672-1:2002, Electroacoustics – Sound level meters – Part 1: Specifications
Add the following normative reference:
IEC 62366:2007, Medical devices – Application of usability engineering to medical devices
Replace the normative references for ISO 3744:1994 and ISO 7000:1989 with the following:
ISO 3744:2010, Acoustics – Determination of sound power levels and sound energy levels of
noise sources using sound pressure – Engineering methods for an essentially free field over a
reflecting plane
ISO 7000, Graphical symbols for use on equipment. Available from: symbols.info/equipment>
– 4 – 60601-1-8 Amend. 1 © IEC:2012
3 Terms and definitions
Replace the existing first paragraph with the following:
For the purposes of this document, the terms and definitions given in
IEC 60601-1:2005+A1:2012 and IEC 62366:2007, and the following terms and definitions
apply.
3.1
* ALARM CONDITION
Replace the existing definition with the following:
state of the ALARM SYSTEM when it has determined that a potential or actual HAZARDOUS
SITUATION exists for which OPERATOR awareness or response is required
NOTE 1 An ALARM CONDITION can be invalid, i.e. a FALSE POSITIVE ALARM CONDITION.
NOTE 2 An ALARM CONDITION can be missed, i.e. a FALSE NEGATIVE ALARM CONDITION.
Add the following new definition:
3.37
* ACKNOWLEDGED
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
longer exists
NOTE 1 ACKNOWLEDGED only affects ALARM SIGNALS that are active at the time of the OPERATOR action.
NOTE 2 ACKNOWLEDGED can terminate after a predetermined time interval has elapsed.
6 Alarm systems
6.1 ALARM CONDITION
6.1.2 * ALARM CONDITION priority
Replace the existing title and text of this subclause including Table 1 with the following:
6.1.2 * Determination of ALARM CONDITIONS and assignment of priority
For each HAZARDOUS SITUATION where the MANUFACTURER has chosen to use an ALARM SYSTEM
as a means of RISK CONTROL, the MANUFACTURER shall assign an ALARM CONDITION and its
priority using Table 1.
For HAZARDOUS SITUATIONS where the onset of potential HARM is delayed and the potential
result of a failure to respond is discomfort or minor reversible injury, the MANUFACTURER may
determine that no ALARM CONDITION is required. In such cases, the MANUFACTURER may
implement an INFORMATION SIGNAL.
NOTE Not all LOW PRIORITY ALARM CONDITIONS require prompt notification of the OPERATOR. On this basis an
auditory ALARM SIGNAL or repeating auditory ALARM SIGNAL can be omitted, when appropriate, since the OPERATOR is
expected to check the ME EQUIPMENT at intervals. In the event that the OPERATOR does not check the ME EQUIPMENT
in a timely fashion, the ALARM CONDITION should escalate from LOW PRIORITY to MEDIUM PRIORITY or HIGH PRIORITY,
and can additionally increase the sound pressure level of the related auditory ALARM SIGNALS, as appropriate.
The priority of each ALARM CONDITION shall be disclosed in the instructions for use. Priorities
may be identified in groups.
Compliance is checked by inspection of the instructions for use and RISK MANAGEMENT FILE.

60601-1-8 Amend. 1 © IEC:2012 – 5 –
Table 1 – Determination of ALARM CONDITIONS and assignment of priorities
a
Potential result of failure Onset of potential HARM
to respond to the cause
b c d
Immediate Prompt Delayed
of ALARM CONDITION
Death or irreversible injury HIGH PRIORITY ALARM HIGH PRIORITY ALARM MEDIUM PRIORITY ALARM
e
CONDITION  CONDITION CONDITION
Reversible injury HIGH PRIORITY ALARM MEDIUM PRIORITY ALARM LOW PRIORITY ALARM
CONDITION CONDITION CONDITION
Discomfort or reversible MEDIUM PRIORITY ALARM LOW PRIORITY ALARM LOW PRIORITY ALARM
minor injury CONDITION CONDITION CONDITION, no ALARM
CONDITION or
INFORMATION SIGNAL
a
Onset of potential HARM refers to when an injury occurs and not to when it is manifested.
b
Having the potential for the event to develop within a period of time not usually sufficient for manual corrective
action.
c
Having the potential for the event to develop within a period of time usually sufficient for manual corrective
action.
d
Having the potential for the event to develop within an unspecified time greater than that given under “prompt”.
e
Where practicable, ME EQUIPMENT with a therapeutic function incorporates automatic safety mechanisms to
prevent immediate death or irreversible injury caused by the ME EQUIPMENT. See also appropriate particular
standards.
6.3.2 * Visual ALARM SIGNALS
6.3.2.2 Characteristics of visual ALARM SIGNALS
Restructure the content of this subclause by creating two new subclauses as follows:
6.3.2.2.1 * 4 m (distant) visual ALARM SIGNALS
Under this subclause place the existing text of 6.3.2.2 through Table 2.
In the second paragraph delete the last sentence reading "A
...