Foreword

ISO (the International Organization for Standardization)

and IEC (the International Electrotechnical
Commission) form the specialized system for worldwide
standardization. National bodies that are members of
ISO or IEC participate in the development of
International Standards through technical committees
established by the respective organization to deal with
particular fields of technical activity. ISO and IEC
technical committees collaborate in fields of mutual
interest. Other international organizations,
governmental and non-governmental, in liaison with ISO
and IEC, also take part in the work. In the field of
information technology, ISO and IEC have established a
joint technical committee, ISO/IEC JTC 1.

The procedures used to develop this document and

those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular
the different approval criteria needed for the different
types of document should be noted. This document was
drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2
(see www.iso.org/directives).

Attention is drawn to the possibility that some of the

elements of this document may be the subject of patent
rights. ISO and IEC shall not be held responsible for
identifying any or all such patent rights. Details of any
patent rights identified during the development of the
document will be in the Introduction and/or on the ISO
list of patent declarations received
(see www.iso.org/patents).

Any trade name used in this document is information

given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific
terms and expressions related to conformity
assessment, as well as information about ISO's
adherence to the WTO principles in the Technical
Barriers to Trade (TBT), see the following
URL: Foreword — Supplementary information.

The committee responsible for this document is

ISO/TC 121, Anaesthetic and respiratory equipment,
Subcommittee SC 1, Breathing attachments and
anaesthetic machines and Technical Committee
IEC/TC 62, Electrical equipment in medical
practice, Subcommittee SC D, Electromedical
equipment.

Introduction

The first edition of IEC 80601-2-13 was published in

2011. This amendment is intended to update the
references to IEC 60601-1:2005 to include Amendment
1:2012, to update the references to IEC 60601-1-6:2010
to include Amendment 1:2013, to update the references
toIEC 60601-1-8:2006 to include Amendment 1:2012
and to update the references to IEC 60601-1-10 to
include Amendment 1:2012. This amendment also
introduces technical modifications to clarify the
relationship between this standard and IEC 60601-2-49
and to further specify ACCESSORIES. It amends
requirements on the following aspects, in part due to
the publication of the before-mentioned amendments:

 — addition of a definition on INTERCHANGEABLE

ANAESTHETIC VAPOUR DELIVERY SYSTEM;

 — marking the mass of MOBILE ME EQUIPMENT;

 — movement over a threshold;

 — rough handling test;

  — MULTIPLE SOCKET-OUTLETS;

 — specific requirements on ANAESTHETIC GAS

DELIVERY SYSTEMS and ANAESTHETIC BREATHING
SYSTEMS including instructions for use;

 — vapour concentration during and after oxygen

flush;

 — inspiratory pause.

Where appropriate, this amendment also includes

modifications of specific informative annexes related to
the amended requirements as listed above. Finally,
minor editorial updates were made.

201.1 Scope, object and related standards

Replace IEC 60601-1:2005 by IEC 60601-

1:2005+A1:2012.

201.1.4 * Particular standards

Replace IEC 60601-1:2005 by IEC 60601-

1:2005+A1:2012.

Add the following paragraph at the end of this

subclause:

If an ANAESTHETIC WORKSTATION is supplied with

physiological monitoring, having more than one APPLIED
PART on the PATIENT, then IEC 60601-2-49 applies.
Measured parameters related to the inherent function
of an ANAESTHETIC WORKSTATION (i.e. airway pressure,
ventilation volume, oxygen concentration, volatile
anaesthetic agent concentration, CO2/N2O), including
derived and related parameters such as spontaneous
ventilation volume or CO2 production, are not
considered to be a PHYSIOLOGICAL MONITORING UNIT as
per IEC 60601-2-49.

201.2 Normative references

In the existing introductory paragraph, replace the first
sentence with:

The following documents, in whole or in part, are

normatively referenced in this document and are
indispensable for its application.

Add the following reference:

IEC 60601-2-49:2011, Medical electrical equipment —

Part 2-49: Particular requirements for the basic safety
and essential performance of multifunction patient
monitoring equipment

Amend the following existing references:

IEC 60601-1:2005, Medical electrical equipment —

Part 1: General requirements for basic safety and
essential performance

+Amendment 1:2012

IEC 60601-1-6:2010, Medical electrical equipment —

Part 1-6: General requirements for basic safety and
essential performance — Collateral standard: Usability

+Amendment 1:2013

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

+Amendment 1:2012

IEC 60601-1-10:2007, Medical electrical equipment —

Part 1-10: General requirements for basic safety and
essential performance — Collateral standard:
Requirements for the development of physiologic
closed-loop controllers
+Amendment 1:2012

201.3 Terms and definitions

Replace the introductory sentence by the following

sentence:

For the purposes of this document, the terms and

definitions given in ISO 4135:2001, IEC 60601-
1:2005+A1:2012, IEC 60601-1-2:2007, IEC 60601-1-
6:2010+A1:2013, IEC 60601-1-8:2006+A1:2012 and the
following apply.

Add the following new term and definition:

201.3.240

* INTERCHANGEABLE ANAESTHETIC VAPOUR DELIVERY SYSTEM

ANAESTHETIC VAPOUR DELIVERY SYSTEM that

 — by design is intended to be used with

different ANAESTHETIC WORKSTATIONS, and

 — can be exchanged by the clinical user without

the use of tools and without the need for specific
tests

201.4 General requirements

Replace IEC 60601-1:2005 by IEC 60601-

1:2005+A1:2012.

Table 201.101 — Distributed ESSENTIAL

PERFORMANCE requirements

In the second column, fourth line, replace "reserve

flow" by "reverse flow".

201.5 General requirements for testing ME EQUIPMENT

Replace IEC 60601-1:2005 by IEC 60601-

1:2005+A1:2012.
201.7 ME EQUIPMENT identification, marking and
documents

Replace IEC 60601-1:2005 by IEC 60601-

1:2005+A1:2012.

Add the following subclause:

201.7.2.21 * Mass of MOBILE EQUIPMENT

Replacement:

The ANAESTHETIC WORKSTATION shall be legibly marked

with its maximum mass in kilograms [see also
201.101.1.1 k)].

201.7.2.106 * Marking with mass

Delete this subclause completely.

201.7.9.3.101 Components

Replace IEC 60601-1:2005 by IEC 60601-

1:2005+A1:2012.

201.8 Protection against electrical HAZARDS from ME

EQUIPMENT

Replace IEC 60601-1:2005 by IEC 60601-

1:2005+A1:2012.

201.9 Protection against mechanical HAZARDS of ME

EQUIPMENT and ME SYSTEMS

Replace IEC 60601-1:2005 by IEC 60601-

1:2005+A1:2012.

201.9.4 Instability HAZARDS

Replace IEC 60601-1:2005 by IEC 60601-

1:2005+A1:2012.

201.9.4.2.4.3 Movement over a threshold

Replace the text by the following text:

Amendment:

ANAESTHETIC WORKSTATIONS that are intended only to be

used when mounted to a wall or pendant, but may need
to be removed from the wall or pendant for service or at
initial installation, are not considered MOBILE
EQUIPMENT and the threshold test specified in
IEC 60601-1:2005+A1:2012, 9.4.2.4.3 does not apply.
Such non-MOBILE machines can use small casters to aid
service and installation of the device. See also
201.7.9.3.102.

The first paragraph

("In the requirement replace the height of the threshold

by 10 mm (instead of 20 mm) and in the test method
replace the height of the solid vertical plane
obstruction by 10 mm (instead of 20 mm.")

is deleted.

201.10 Protection against unwanted and excessive

radiation HAZARDS

Replace IEC 60601-1:2005 by IEC 60601-

1:2005+A1:2012.

201.11 Protection against excessive temperatures and

other HAZARDS

Replace IEC 60601-1:2005 by IEC 60601-

1:2005+A1:2012.

201.12 Accuracy of controls and instruments and

protection against hazardous outputs

Replace IEC 60601-1:2005 by IEC 60601-

1:2005+A1:2012.

201.12.4.102 * Additional requirements for ANAESTHETIC

WORKSTATIONS
Correct the reference in the 9th list item and correct
the corresponding text in Table 201.C.103
(ACCOMPANYING DOCUMENTS, general) to read:

 — ANAESTHETIC BREATHING SYSTEM continuing-

positive-pressure ALARM CONDITION complying with
201.12.4.106;

201.13 HAZARDOUS SITUATIONS and fault conditions

Replace IEC 60601-1:2005 by IEC 60601-

1:2005+A1:2012.

201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS

(PEMS)

Replace IEC 60601-1:2005 by IEC 60601-

1:2005+A1:2012.

201.15 Construction of ME EQUIPMENT

Replace IEC 60601-1:2005 by IEC 60601-

1:2005+A1:2012.

Add the following subclause:

201.15.3.5 Rough handling test

Amend as follows:

For an ANAESTHETIC WORKSTATION with a weight

exceeding 125 kg in its NOMINAL configuration and
only movable manually, the speed in a) ascending step
shock and b) descending step shock shall be reduced
from 0,8 m/s to 0,4 m/s.

201.16 ME SYSTEMS

Replace IEC 60601-1:2005 by IEC 60601-

1:2005+A1:2012.

201.16.9.2.1 MULTIPLE SOCKET-OUTLET

Replace the existing text by the following:

Delete the second dash of 16.9.2.1 a) and add the
following text under the last list item in 16.9.2.1 a):

An ANAESTHETIC WORKSTATION may provide MULTIPLE

SOCKET-OUTLETS that can accept standard MAINS
PLUGS of the kind specified in IEC/TR 60083.

Addition:

Add the following list item:

 ee) The ANAESTHETIC WORKSTATION and

each MULTIPLE SOCKET-OUTLET which can accept a
standard MAINS PLUG shall be provided with
separate fuses or over-current releases as
required for a single piece of ME EQUIPMENT in
IEC 60601-1:2005+A1:2012, 8.11.5.

These fuses or over-current releases shall be designed

such that the ANAESTHETIC WORKSTATION including
the MULTIPLE SOCKET-OUTLET maintain normal function
with each MULTIPLE SOCKET-OUTLET loaded to the
maximum rating.

If any MULTIPLE SOCKET-OUTLET is overloaded by a factor

of 7,5 ± 2,5, all remaining MULTIPLE SOCKET-
OUTLETS and the ANAESTHETIC WORKSTATIONshall
maintain normal function.

Check compliance by visual inspection and functional

testing.

Replace the 3rd dash of 16.9.2.1 c) by:

 — PROTECTIVE EARTH TERMINALS and PROTECTIVE

EARTH CONNECTIONS shall comply with 8.6, except
that the total impedance of the protective earth
path for an ANAESTHETIC WORKSTATION may be up to
400 mΩ, or higher if the conditions of 8.6.4 b) are
satisfied.
201.101 Additional requirements for ANAESTHETIC GAS
DELIVERY SYSTEMS

201.101.1.1 Instructions for use

Amend this subclause and the corresponding text in

Table 201 C.103 (ACCOMPANYING DOCUMENTS, general) as
follows:

Amend item g) as follows:

 g) if the ANAESTHETIC GAS DELIVERY SYSTEM is

designed to be equipped with an INTERCHANGEABLE
ANAESTHETIC VAPOUR DELIVERY SYSTEM, a statement to
the effect that the INTERCHANGEABLE ANAESTHETIC
VAPOUR DELIVERY SYSTEM used with the ANAESTHETIC
GAS DELIVERY SYSTEMshall comply with this
International Standard;

Add a new list item k):

 k) the mass in kilograms (kg) in

the NOMINAL configuration and a definition of
the NOMINAL configuration. The mass in kilograms
(kg) shall be disclosed for each ACCESSORY with a
mass exceeding 1,5 kg.

201.101.4.1.4 * Reserve oxygen supply

Amend this subclause as follows:

In addition to a connection for the main oxygen supply,

the ANAESTHETIC GAS DELIVERY SYSTEM shall be equipped
with means of connection to a reserve (back-up)
oxygen supply.

Add a new Subclause 201.101.10:

201.101.10 Interface to INTERCHANGEABLE ANAESTHETIC

VAPOUR DELIVERY SYSTEMS
For ANAESTHETIC GAS DELIVERY SYSTEMS intended to be
used with INTERCHANGEABLE ANAESTHETIC VAPOUR
DELIVERY SYSTEMS the flow of gas from the oxygen flush
shall be delivered to the FRESH-GAS OUTLET without
passing through an anaesthetic vapour delivery module.

When the FRESH-GAS OUTLET is open to atmosphere, the

pressure at the outlet from the ANAESTHETIC VAPOUR
DELIVERY SYSTEM shall not increase by more than
10 kPa above its normal working pressure and not
decrease by more than 10 kPa below its normal
working pressure when the oxygen flush is operated
throughout the RATED range of inlet pressure.

Compliance is checked by functional testing. For test

procedures see 201.104.2.2.

201.102.1.2 Instructions for use

Amend this subclause and the corresponding text in

Table 201.C.103 (ACCOMPANYING DOCUMENTS, general) as
follows:

Amend item l) as follows:

 l) for breathing ACCESSORIES intended to be

assembled by the OPERATOR, the resistance at
2,5 l/min, 15 l/min and 30 l/min and the
compliance of those ACCESSORIES;

add a new item n) as follows:

 n) The instructions for use shall disclose the

inspiratory and expiratory pressure/flow rate
characteristics of the ANAESTHETIC BREATHING
SYSTEM, including the pressure at

o — 30 l/min if the ANAESTHETIC BREATHING

SYSTEM is intended for adult PATIENTS;

o — 15 l/min if the ANAESTHETIC BREATHING

SYSTEM is intended for paediatric PATIENTS;
 o — 2,5 l/min if the ANAESTHETIC BREATHING
SYSTEM is intended for neonatal PATIENTS;

at a FRESH GAS flow rate of 10 l/min ±1 l/min or the

maximum FRESH-GAS INLET flow rate specified in the
instructions for use, whichever is greater.

201.102.5.3 * Reservoir bag connection port

Amend this subclause as follows:

The reservoir bag connection port, if provided, shall be

 — compatible with a reservoir bag complying

with ISO 5362 and a BREATHING TUBE complying
with ISO 5367, or

 — a 22 mm socket complying with ISO 5356-1.

NOTE This amendment to ISO 80601-2-13 deliberately includes two

options for the reservoir bag connection port in order to allow for a
transition period. It is intended to revise this subclause during the next
revision of ISO 80601-2-13 by mandating that the reservoir bag be
(exclusively) a 22 mm socket complying with ISO 5356-1.

This connection shall be within 20 ° of the vertical

axis.

The reservoir connection port shall not be on

the PATIENT side of the inspiratory or expiratory
valve(s).

The reservoir bag connection port shall be marked with

the word “bag” or the equivalent in a language that is
acceptable to the intendedOPERATOR, or an appropriate
symbol.

Check compliance by inspection, functional testing and

application of the tests
of ISO 5362, ISO 5367 and ISO 5356-1.
201.102.7* Inspiratory and expiratory pressure/flow rate
characteristics

Amend the text as follows:

The pressure, either positive or subatmospheric,

generated at the PATIENT CONNECTION PORT, in any
combination of the ANAESTHETIC BREATHING
SYSTEM and ACCESSORIES such as breathing hoses,
water traps, microbial filters and Y-PIECES as
recommended by the MANUFACTURER, shall not exceed 6
hPa (6 cmH2O) at the peak flow rate of

 — 30 l/min if the ANAESTHETIC BREATHING

SYSTEM and the ACCESSORIES are intended for
adult PATIENTS;

 — 15 l/min, if the ANAESTHETIC BREATHING

SYSTEM and the ACCESSORIES are intended for
paediatric PATIENTS;

 — 2,5 l/min, if the ANAESTHETIC BREATHING

SYSTEM and the ACCESSORIES are intended for
neonatal PATIENTS;

at a FRESH GAS flow rate of 10 l/min ± 1 l/min or the

maximum FRESH-GAS INLET flow rate specified in the
instructions for use, whichever is greater.

Check compliance by functional testing of any

combination of the ANAESTHETIC BREATHING
SYSTEM and ACCESSORIES such as breathing hoses,
water traps, microbial filters and Y-PIECES as
recommended by the MANUFACTURER under the worst
case scenario and inspection of the instructions for
use.

201.102.9.2 *Absorbent bypass mechanism

In the last sentence, replace IEC 60601-

1:2005 by IEC 60601-1:2005+A1:2012.
201.104 Additional requirements for an ANAESTHETIC
VAPOUR DELIVERY SYSTEM

Add the following

The following requirements for an ANAESTHETIC VAPOUR

DELIVERY SYSTEM apply whether the ANAESTHETIC VAPOUR
DELIVERY SYSTEMS are interchangeable systems or not.

201.104.3 * Vapour outlet during and after oxygen flush

Amend the headline and the text of this subclause as

follows:

201.104.3 * Vapour concentration during and after

oxygen flush

During and after oxygen flush, the anaesthetic vapour

concentration delivered by the ANAESTHETIC VAPOUR
DELIVERY SYSTEM shall not increase by more than 20 %.

For INTERCHANGEABLE ANAESTHETIC VAPOUR DELIVERY

SYSTEMS, check compliance with the following test:

 a) Set up the INTERCHANGEABLE ANAESTHETIC

VAPOUR DELIVERY SYSTEM according to 201.104.2.2
a) through e).

Set the fresh gas flow rate through

the INTERCHANGEABLE ANAESTHETIC VAPOUR DELIVERY
SYSTEM to (8 ± 0,8) l/min.

To simulate activation of the O2 flush, apply a steady

pressure at the ANAESTHETIC VAPOUR DELIVERY
SYSTEM outlet of (100 ± 5) hPa [(100 ± 5) cmH2O] for
10 s.

Measure the concentration at the outlet for 1 min

before, during the application of the pressure and for
30 s after relief of the pressure.
Repeat this for each of the settings given in Table
201.104.

 b) Set up the INTERCHANGEABLE ANAESTHETIC

VAPOUR DELIVERY SYSTEM according to
201.104.2.2 a) through e).

To simulate activation of the O2 flush, apply a steady

subatmospheric pressure of 100 hPa (100 cmH2O) for
10 s.

Measure the concentration at the outlet for 1 min

before, during the application of the pressure and for
30 s after relief of the pressure.

Repeat this for each of the settings given in Table

201.104.

For non- INTERCHANGEABLE ANAESTHETIC VAPOUR DELIVERY

SYSTEMS, check compliance with the following test:

Set up the ANAESTHETIC WORKSTATION according to the

instructions for use.

Set the FRESH GAS flow rate to (8 ± 0,8) l/min.

Activate the O2 flush for 10 s.

Measure the concentration at the FRESH GAS OUTLET for

1 min before, during activation of the O2 flush and for
30 s after releasing the O2flush.

NOTE Concentration values can be filtered with a 5 s moving average for

evaluation.

Repeat this for each of the settings given in Table

201.104.

201.105.7.1 Expiratory pause

In list item d) replace IEC 60601-1-

8:2006 by IEC 60601-1-8:2006+A1:2012.
201.105.7.2 Inspiratory pause

Correct the reference in item b):

 b) The high-pressure ALARM CONDITION of

201.12.4.109 and the PROTECTION DEVICE of
201.105.2 shall remain active during an inspiratory
pause.

In list item e) replace IEC 60601-1-

8:2006 by IEC 60601-1-8:2006+A1:2012.

201.106.2 Flow-volume loops

Delete this subclause completely.

208 General requirements, tests and guidance

for ALARM SYSTEMS in MEDICAL ELECTRICAL
EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS

Replace IEC 60601-1-8:2006 by IEC 60601-1-

8:2006+A1:2012.

208.6.12 *ALARM CONDITION logging

Replace the headline of this subclause by:

208.6.12 *ALARM SYSTEM logging

210 PROCESS requirements for the development of

physiologic closed-loop controllers

Replace IEC 60601-1-10:2007 by IEC 60601-1-

10:2007+A1:2012.

Annex C (informative) — Guide to marking and labelling

requirements for ME EQUIPMENT and ME SYSTEMS or their
parts

Table 201.C.101 — Marking on the outside of

the ANAESTHETIC WORKSTATION and its individual
components
Delete row for subclause 201.7.2.106 * Marking with
mass and add corresponding row for 201.7.2.21 *
Mass of MOBILE ME EQUIPMENT:

The ANAESTHETIC WORKSTATION shall be legibly marked

with its maximum mass in kilograms [see also
201.101.1.1 k)].

Table 201.C.103 – ACCOMPANYING DOCUMENTS, general

Amend Table 201 C.103 as follows:

Subclause 201.101.1.1

Replace g) by:

 g) if the ANAESTHETIC GAS DELIVERY SYSTEM is

designed to be equipped with an INTERCHANGEABLE
ANAESTHETIC VAPOUR DELIVERY SYSTEM, a statement to
the effect that the INTERCHANGEABLE ANAESTHETIC
VAPOUR DELIVERY SYSTEM used with the ANAESTHETIC
GAS DELIVERY SYSTEMshall comply with this
International Standard;

Add a new list item k):

 k) the mass in kilograms (kg) in

the NOMINAL configuration and a definition of
the NOMINAL configuration. The mass in kilograms
(kg) shall be disclosed for each ACCESSORY with a
mass exceeding 1,5 kg.

Subclause 201.102.1.2

Replace item l) by the following text:

 l) for breathing ACCESSORIES intended to be

assembled by the OPERATOR, the resistance at
2,5 l/min, 15 l/min and 30 l/min and the
compliance of those ACCESSORIES;

Add a new item n) as follows:

  n) The instructions for use shall disclose the
inspiratory and expiratory pressure/flow rate
characteristics of the ANAESTHETIC BREATHING
SYSTEM, including the pressure at

o — 30 l/min if the ANAESTHETIC BREATHING

SYSTEM is intended for adult PATIENTS;

o — 15 l/min if the ANAESTHETIC BREATHING

SYSTEM is intended for paediatric PATIENTS;

o — 2,5 l/min if the ANAESTHETIC BREATHING

SYSTEM is intended for neonatal PATIENTS;

at a FRESH GAS flow rate of 10 l/min ± 1 l/min or the

maximum FRESH-GAS INLET flow rate specified in the
instructions for use, whichever is greater.

Delete the row for 201.102.7 because this is covered by

the additional entry 201.102.1.2 n).

Table 201.C.104 – Technical description

In the 2nd line, first row of Table 201 C.104,

replace IEC 60601-1:2005 by IEC 60601-
1:2005+A1:2012.

Annex D (informative) — Symbols on marking

In the introductory sentence, replace IEC 60601-

1:2005 by IEC 60601-1:2005+A1:2012.

Annex AA (informative) — Particular guidance and

rationale

Add the following new text:

Subclause 201.1.4 Particular standards

IEC 60601-2-49 specifies requirements for

multiparameter monitors, i.e. devices that monitor more
than one parameter with more than oneAPPLIED PART (=
sensor) on one PATIENT. In detail these are
  b) electrical safety of devices with more than
one APPLIED PART in contact with the PATIENT;

 c) multi-parameter ALARM SYSTEMS;

 d) ingress protection (IP class) requirements;

 e) electromagnetic compatibility.

Even if this basic definition seems to apply

to ANAESTHETIC WORKSTATIONS, all of these aspects are
covered by the General Standard.ANAESTHETIC
WORKSTATIONS are exempt from the requirements of
IEC 60601-2-49 to allow MANUFACTURERS to fully
integrate any component considered useful into
the ANAESTHETIC WORKSTATION. They are encouraged to
develop a consistent user interface for all integrated
functions, especially regarding the ALARM SYSTEM.
However, the required RISK MANAGEMENT PROCESS has to
fully address any RISKS arising from integration of
additional components.

Add the following new text:

Subclause 201.3.240 INTERCHANGEABLE ANAESTHETIC

VAPOUR DELIVERY SYSTEM

Currently, two designs of anaesthetic vapour delivery

devices are known. They are either an integral part of
the ANAESTHETIC WORKSTATION and cannot be exchanged
by users at all or only between ANAESTHETIC
WORKSTATIONS of the same type.

The other, allows the use of a non-integral vaporizer

that may be exchanged by the clinician not requiring
tools.

Add the following new text:

Subclause 201.7.2.21 Mass of MOBILE ME EQUIPMENT

Modern ANAESTHETIC WORKSTATIONS are quite heavy,
especially if fully equipped with various components
required in this International Standard and other
devices needed for routine clinical use. ANAESTHETIC
WORKSTATIONS are usually MOBILE devices that are
intended to be moved between operating rooms and
taken to maintenance locations by the clinical user or
hospital technicians. Marking the device with its mass
allows users to select a route more convenient for
heavy equipment or to call for assistance to help with
the transport.

Subclause 201.7.2.106 Marking with mass

Delete the rationale to this subclause

(201.7.2.106) completely.

Subclause 201.102.6 Leakage

Replace the existing text by the following:

The limit of 150 ml/min for an entire ANAESTHETIC

BREATHING SYSTEM was established for two reasons:

 — to restrict the loss of gas volume intended to be

delivered to the PATIENT, and

 — to limit ANAESTHETIC GAS pollution in the area of

the ANAESTHETIC WORKSTATION.

This limit was considered to be the maximum

acceptable in view of all the other potential sources of
gas leaks. Today the MANUFACTURER of an ANAESTHETIC
WORKSTATION usually provides an
integrated ANAESTHETIC BREATHING SYSTEM with
the ANAESTHETIC WORKSTATION. Users frequently
assemble breathing attachments, such as hoses, water
traps, filters, and Y-PIECES, as they need from
different MANUFACTURERS. The split of the leakage into
75 ml/min for each the ANAESTHETIC BREATHING
SYSTEM and the external ACCESSORIES was introduced
to encourage the use of specified combinations that
meet at least minimum requirements.

Subclause 201.102.7 Inspiratory and expiratory

pressure/flow rate characteristics

Delete the last sentence so that the complete rationale

to this subclause reads:

Total expiratory and total inspiratory resistance are

established at a maximum of 6 hPa (6 cmH2O) each in
order to limit the work of breathing for the
spontaneously breathing PATIENT and to restrict
positive end-expiratory pressure. In setting the
maximum, the Committee considered the resistances of
commercially available components and selected a
value between those considered and the ideal of zero
resistance. This limit is considered to be the generally
acceptable maximum physiological value by clinicians.

Annex DD (informative) — Reference to the essential

principles

In Table DD.1, replace all references to IEC 60601-

1:2005 by IEC 60601-1:2005+A1:2012.

Alphabetized index of defined terms used in this

particular standard

Add the new term

INTERCHANGEABLE ANAESTHETIC DELIVERY 201.3.240
SYSTEM
Amend the references to the following terms:
ALARM CONDITION IEC 60601-1-
8:2006+A1:2012, 3.1
CLEARLY LEGIBLE IEC 60601-1:2005+A1:2012,
3.15
ESSENTIAL PERFORMANCE IEC 60601-1:2005+A1:2012,
3.27
HAZARD IEC 60601-1:2005+A1:2012,
3.39
HAZARDOUS SITUATION IEC 60601-1:2005+A1:2012,
3.40
MANUFACTURER IEC 60601-1:2005+A1:2012,
3.55
MULTIPLE SOCKET-OUTLET IEC 60601-1:2005+A1:2012,
3.67
NORMAL USE IEC 60601-1:2005+A1:2012,
3.71
PATIENT IEC 60601-1:2005+A1:2012,
3.76
PROCEDURE IEC 60601-1:2005+A1:2012
3.88
PROCESS IEC 60601-1:2005+A1:2012,
3.89
RISK IEC 60601-1:2005+A1:2012,
3.102
RISK CONTROL IEC 60601-1:2005+A1:2012,
3.105
RISK MANAGEMENT IEC 60601-1:2005+A1:2012,
3.107
RISK MANAGEMENT FILE IEC 60601-1:2005+A1:2012,
3.108
SINGLE FAULT CONDITION IEC 60601-1:2005+A1:2012,
3.116
TRANSPORTABLE IEC 60601-1:2005+A1:2012,
3.130
USABILITY ENGINEERING IEC 60601-1:2005+A1:2012,
3.137

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