Medical vehicles and their equipment - Air ambulances - Part 2: Operational and technical requirements for air ambulances

This part of EN 13718 specifies the requirements for performance and equipping for air ambulances, including requirements for interfaces to medical devices used for the transport and treatment of sick or injured persons. This part of EN 13718 is applicable to air ambulances capable of transporting at least one person on a stretcher.
NOTE   Requirements are specified for categories of air ambulances based on the different intended use. These are the helicopter emergency medical service (HEMS) the helicopter intensive care medical service (HICAMS) and the fixed wing air ambulance (FWAA).

Medizinische Fahrzeuge und ihre Ausrüstung - Luftfahrzeuge zum Patiententransport - Teil 2: Operationelle und technische Anforderungen an Luftfahrzeuge zum Patiententransport

Dieser Teil von EN 13718 legt die Anforderungen an die Leistung und Ausrüstung von Luftfahrzeugen zum Patiententransport fest, die für den Transport und die Behandlung kranker oder verletzter Personen eingesetzt werden; dies schließt Anforderungen an die Schnittstellen mit den Medizinprodukten (Geräten) ein. Dieser Teil von EN 13718 ist für Luftfahrzeuge zum Patiententransport anwendbar, die in der Lage sind, mindestens eine Person auf einer Krankentrage zu transportieren.
ANMERKUNG Die Anforderungen für Kategorien von Luftfahrzeugen zum Patiententransport werden auf der Grundlage der verschiedenen vorgesehenen Verwendungszwecke festgelegt. Bei diesen Kategorien handelt es sich um Rettungstransporthubschrauber (RTH) (en: helicopter emergency medical service (HEMS)), intensivmedizinische Hubschrauber (ITH) (en: helicopter intensive care medical service (HICAMS)) und Flächenflugzeuge zum Patiententransport (en: fixed wing air ambulance (FWAA)).

Véhicules sanitaires et leurs équipements - Ambulances aériennes - Partie 2 : Exigences opérationnelles et techniques pour les ambulances aérienness

N/A

Ambulantna vozila in njihova oprema - Ambulantna zračna vozila - 2. del: Operativne in tehnične zahteve za ambulantna zračna vozila

General Information

Status
Published
Publication Date
24-Mar-2020
Technical Committee
Drafting Committee
Current Stage
9020 - Submission to 2 Year Review Enquiry - Review Enquiry
Due Date
15-Jul-2021
Completion Date
15-Jul-2021

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SLOVENSKI STANDARD
SIST EN 13718-2:2015+A1:2020
01-maj-2020
Nadomešča:
SIST EN 13718-2:2015
Ambulantna vozila in njihova oprema - Ambulantna zračna vozila - 2. del:
Operativne in tehnične zahteve za ambulantna zračna vozila
Medical vehicles and their equipment - Air ambulances - Part 2: Operational and
technical requirements for air ambulances

Medizinische Fahrzeuge und ihre Ausrüstung - Luftfahrzeuge zum Patiententransport -

Teil 2: Operationelle und technische Anforderungen an Luftfahrzeuge zum
Patiententransport

Véhicules sanitaires et leurs équipements - Ambulances aériennes - Partie 2 : Exigences

opérationnelles et techniques pour les ambulances aérienness
Ta slovenski standard je istoveten z: EN 13718-2:2015+A1:2020
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
11.160 Prva pomoč First aid
49.020 Letala in vesoljska vozila na Aircraft and space vehicles in
splošno general
SIST EN 13718-2:2015+A1:2020 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN 13718-2:2015+A1:2020
---------------------- Page: 2 ----------------------
SIST EN 13718-2:2015+A1:2020
EN 13718-2:2015+A1
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2020
EUROPÄISCHE NORM
ICS 11.040.01; 11.160; 49.020
English Version
Medical vehicles and their equipment - Air ambulances -
Part 2: Operational and technical requirements for air
ambulances

Véhicules sanitaires et leur équipement - Ambulances Medizinische Fahrzeuge und ihre Ausrüstung -

aériennes - Partie 2 : Exigences opérationnelles et Luftfahrzeuge zum Patiententransport - Teil 2:

techniques pour les ambulances aériennes Operationelle und technische Anforderungen an

Luftfahrzeuge zum Patiententransport

This European Standard was approved by CEN on 26 December 2014 and includes Amendment 1 approved by CEN on 16

December 2019.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this

European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references

concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN

member.

This European Standard exists in three official versions (English, French, German). A version in any other language made by

translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management

Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,

Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,

Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and

United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels

© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13718-2:2015+A1:2020 E

worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN 13718-2:2015+A1:2020
EN 13718-2:2015+A1:2020 (E)
Contents Page

European foreword ....................................................................................................................................................... 4

Introduction .................................................................................................................................................................... 5

1 Scope .................................................................................................................................................................... 6

2 Normative references .................................................................................................................................... 6

3 Terms and definitions ................................................................................................................................ 10

4 General requirements for air ambulances .......................................................................................... 11

4.1 General ............................................................................................................................................................. 11

4.2 Environmental conditions in the patient compartment ................................................................ 12

4.2.1 Temperature and humidity ...................................................................................................................... 12

4.2.2 Air conditioning system (ACS) ................................................................................................................. 12

4.2.3 Variable atmospheric pressure .............................................................................................................. 12

4.2.4 Interior light................................................................................................................................................... 12

4.2.5 Ventilation ...................................................................................................................................................... 12

4.2.6 Noise exposure .............................................................................................................................................. 13

4.3 Requirements for electrical power supply for medical devices in the patient

compartment ................................................................................................................................................. 13

4.4 Electromagnetic interference .................................................................................................................. 14

4.5 Rail systems .................................................................................................................................................... 14

4.6 Mechanical vibration .................................................................................................................................. 14

4.7 Requirements for fixation of medical devices ................................................................................... 14

4.8 Restraint systems in the patient compartment ................................................................................. 14

4.9 Patient compartment .................................................................................................................................. 15

4.9.1 General ............................................................................................................................................................. 15

4.9.2 Hygienic ........................................................................................................................................................... 15

4.9.3 Patient loading and unloading ................................................................................................................ 15

4.9.4 Communication systems ............................................................................................................................ 16

4.9.5 Fire safety requirements ........................................................................................................................... 16

4.9.6 Emergency exit .............................................................................................................................................. 16

4.10 Patient treatment area ............................................................................................................................... 16

4.10.1 General ............................................................................................................................................................. 16

4.10.2 Dimensions ..................................................................................................................................................... 16

4.11 Lists of equipment........................................................................................................................................ 18

5 Air ambulances, operation and performance requirements ....................................................... 19

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SIST EN 13718-2:2015+A1:2020
EN 13718-2:2015+A1:2020 (E)

5.1 Personnel ......................................................................................................................................................... 19

5.1.1 Flight crew ....................................................................................................................................................... 19

5.1.2 Medical crew ................................................................................................................................................... 19

5.2 Specific requirements for helicopters operated in Helicopter Emergency Medical

Service (HEMS) .............................................................................................................................................. 19

5.3 Specific requirements for Helicopter Intensive Care Medical Service (HICAMS) ................. 19

5.4 Specific requirements for Fixed Wing Air Ambulances (FWAA) ................................................. 20

6 Gas installations in air ambulances ....................................................................................................... 20

6.1 System components ..................................................................................................................................... 20

6.2 General requirements ................................................................................................................................. 20

6.2.1 Capacity and pressure operating range................................................................................................ 20

6.2.2 Continuity of supply ..................................................................................................................................... 21

6.3 Supply systems with gas cylinders ......................................................................................................... 21

6.4 Supply systems for compressed medical air ....................................................................................... 21

6.5 Supply systems with air compressor ..................................................................................................... 22

6.6 Pipeline distribution system .................................................................................................................... 22

6.7 Marking and colour coding ....................................................................................................................... 23

6.8 Alarms ............................................................................................................................................................... 23

6.9 Testing .............................................................................................................................................................. 23

6.9.1 General ............................................................................................................................................................. 23

6.9.2 Test for mechanical integrity for compressed medical gas systems .......................................... 23

6.9.3 Test for leakage on all pipeline systems and for mechanical integrity of vacuum

pipeline systems ........................................................................................................................................... 24

6.9.4 Leakage from the compressed medical gas pipelines ..................................................................... 24

6.9.5 Test for cross connection ........................................................................................................................... 24

6.10 Maintenance ................................................................................................................................................... 24

Annex A (normative) Medical devices in air ambulances ........................................................................... 25

A.1 Introduction.................................................................................................................................................... 25

A.2 Additional equipment ............................................................................... Error! Bookmark not defined.

Annex B (normative) Medicinal products and equipment additional to medical devices in

air ambulances .............................................................................................................................................. 31

B.1 Introduction.................................................................................................................................................... 31

Annex C (informative) A–deviations ................................................................................................................... 34

C.1 Deviation in Germany ................................................................................................................................. 34

C.1.1 Additional specifications for the medical crew ................................................................................. 34

Annex ZA (informative) !Relationship between this European standard and the essential

requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered .................................... 35

Bibliography ................................................................................................................................................................. 37

---------------------- Page: 5 ----------------------
SIST EN 13718-2:2015+A1:2020
EN 13718-2:2015+A1:2020 (E)
European foreword

This document (EN 13718-2:2015+A1:2020) has been prepared by Technical Committee CEN/TC 239

“Rescue systems”, the secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of an

identical text or by endorsement, at the latest by September 2020, and conflicting national standards

shall be withdrawn at the latest by September 2020.

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. CEN shall not be held responsible for identifying any or all such patent rights.

This document includes Amendment 1 approved by CEN on 2019-12-16.
This document supersedes !EN 13718-2:2015."

The start and finish of text introduced or altered by amendment is indicated in the text by tags !".

This document has been prepared under a mandate given to CEN by the European Commission and the

European Free Trade Association, and supports essential requirements of EU Directive(s).

For relationship with EU Directive(s), see informative Annex ZA which is an integral part of this

document.

EN 13718-2:2008 has been technically revised. The following points represent the most important

changes in the revision:

a) clarified unclear issues in this part of the standard and between the two parts of the standard (for

example requirements for patient's compartment illumination);

b) changed text related to enhancing safety related to the risk from rotors on helicopters;

c) clarified the requirements for the patient compartment;

d) the standard has been modified/integrated to meet the Medical Devices Directive 93/42/EEC

requirements.

EN 13718 consists of the following parts, under the general title: Medical vehicles and their equipment –

Air ambulance:
— Part 1: Requirements for medical devices used in air ambulances;
— Part 2: Operational and technical requirements for air ambulances.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,

Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,

Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of

North Macedonia, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United

Kingdom.
---------------------- Page: 6 ----------------------
SIST EN 13718-2:2015+A1:2020
EN 13718-2:2015+A1:2020 (E)
Introduction

This part of EN 13718 provides requirements for air ambulances, and in particular covers requirements

for the ambulance role of the aircraft.

Air ambulances are equipped with medical devices as well as drugs and rescue equipment to be used by

medical personnel. Requirements for medical devices intended for use in air ambulances are provided

in EN 13718-1. This standard is supplementary to several European Standards as well as laws and

regulations providing the requirements for aircraft in order to provide continuous patient care and

monitoring during transport in and between various ambulance types and hospitals. The requirements

cover ambulance flights in general. Several national and regional rules and regulations apply to aircraft

being used as ambulances. This part of EN 13718 gives information on these in the annexes and in notes

throughout the text. Provisions for the safety and care both of the patient as well as of the crew and the

medical personnel are contained in existing national and international laws, regulations and guidelines.

This part of EN 13718 provides some general requirements for the safe operation of aircraft being used

as ambulances. These requirements are not covered by the scope of the Medical Devices Directive or by

international agreements for craft, transportation and traffic. They are provided in order to secure the

safe and secure handling of patients. In order to accommodate continuity of patient care between

different kinds of ambulances, some specific requirements are given. Requirements are set in order to

secure safe use and handling of medical devices.

Aircraft being used as ambulances are equipped with medical devices, medicinal products and rescue

equipment to enable the medical personnel to provide continuous patient care. The minima for the

medical devices are specified in Annex A. The requirements set out in this part of EN 13718 give the

minimum provisions for an ambulance service to provide satisfactory care and medical attention to

emergency patients as well as other patients during transportation. The requirements are based on the

state of the art of today and common practice in Europe.

This European Standard gives minimum requirements for interfaces and compatibility of medical

devices used in air ambulances. The standards work was called for by the EU Commission by a mandate

linked with the Medical Devices Directive (see Annex ZA and Bibliography [1]).

This European Standard is supplementary to several other European Standards and gives requirements

for medical devices when used in situations where the ambient conditions differ from the normal

indoor conditions prevailing within the health care system. Several specific requirements are related to

the conditions prevailing in air ambulances. The requirements set are carefully selected to ensure

interoperability and continuous patient care.

Medical devices need to conform to the applicable essential requirements in the Medical Devices

Directive, 93/42/EEC. The essential requirements are listed in Annex I of the Medical Devices Directive.

Annex ZA in this European Standard lists the essential requirements that are covered by the identified

clauses of this European Standard.

The environmental conditions for medical devices used in air ambulances are different from those

expected in a normal hospital environment. In particular, this implies environmental conditions such as

temperature and humidity, vibration and shock caused by movement of the air ambulances, variable

atmospheric pressures and electromagnetic disturbances between the air ambulances and the medical

device.
---------------------- Page: 7 ----------------------
SIST EN 13718-2:2015+A1:2020
EN 13718-2:2015+A1:2020 (E)
1 Scope

This part of EN 13718 specifies the requirements for performance and equipping for air ambulances,

including requirements for interfaces to medical devices used for the transport and treatment of sick or

injured persons. This part of EN 13718 is applicable to air ambulances capable of transporting at least

one person on a stretcher.

NOTE Requirements are specified for categories of air ambulances based on the different intended use. These

are the helicopter emergency medical service (HEMS) the helicopter intensive care medical service (HICAMS) and

the fixed wing air ambulance (FWAA).
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

EN 3-7:2004+A1:2007, Portable fire extinguishers — Part 7: Characteristics, performance requirements

and test methods

EN 3-8:2006, Portable fire extinguishers — Part 8: Additional requirements to EN 3-7 for the construction,

resistance to pressure and mechanical tests for extinguishers with a maximum allowable pressure equal to

or lower than 30 bar

!EN 3-9:2006+AC:2007, Portable fire extinguishers — Part 9: Additional requirements to EN 3-7 for

pressure resistance of CO2 extinguishers"

EN 3-10:2009, Portable fire extinguishers — Part 10: Provisions for evaluating the conformity of a

portable fire extinguisher to EN 3-7

!EN 143:2000+A1:2017, Respiratory protective devices — Particle filters — Requirements, testing,

marking (Corrigendum AC:2002 and AC:2005 incorporated)"

!EN ISO 374-1:2016+A1:2018, Protective gloves against dangerous chemicals and micro-organisms —

Part 1: Terminology and performance requirements for chemical risks (ISO 374-1:2016+A1:2018)"

EN 455-1:2000, Medical gloves for single use — Part 1: Requirements and testing for freedom from holes

!EN 455-2:2015, Medical gloves for single use — Part 2: Requirements and testing for physical

properties"

!EN 455-3:2015, Medical gloves for single use — Part 3: Requirements and testing for biological

evaluation"

EN 794-3:1998+A2:2009, Lung ventilators — Part 3: Particular requirements for emergency and

transport ventilators

EN 1618:1997, Catheters other than intravascular catheters — Test methods for common properties

!Deleted tex"t"

!EN 1865-1:2010+A1:2015, Patient handling equipment used in road ambulances — Part 1: General

stretcher systems and patient handling equipment"
---------------------- Page: 8 ----------------------
SIST EN 13718-2:2015+A1:2020
EN 13718-2:2015+A1:2020 (E)

!EN 13718-1:2014+A1:2020, Medical vehicles and their equipment — Air ambulances — Part 1:

Requirements for medical devices used in air ambulances"

!EN 13976-1:2018, Rescue systems — Transportation of incubators — Part 1: Interface conditions"

!EN 13976-2:2018, Rescue systems — Transportation of incubators — Part 2: System requirements"

EN 14605:2005+A1:2009, Protective clothing against liquid chemicals — Performance requirements for

clothing with liquid-tight (Type 3) or spray-tight (Type 4) connections, including items providing

protection to parts of the body only (Types PB [3] and PB [4])
!Deleted text"

EN 60601-2-4:2011, Medical electrical equipment — Part 2-4: Particular requirements for the basic

safety and essential performance of cardiac defibrillators (IEC 60601-2-4:2010)
!Deleted text"

!EN 60601-2-24:2015, Medical electrical equipment — Part 2-24: Particular requirements for basic

safety and essential performance of infusion pumps and controllers (IEC 60601-2-24:2012)"

!EN 60601-2-34:2014, Medical electrical equipment — Part 2-34: Particular requirements for the basic

safety and essential performance of invasive blood pressure monitoring equipment
(IEC 60601-2-34:2011)"

!EN 80601-2-30:2010+A1:2015, Medical electrical equipment — Part 2-30: Particular requirements

for the basic safety and essential performance of automated non-invasive sphygmomanometers

(IEC 80601-2-30:2009 + Corrigendum Jan. 2010 + A1:2013)"

!EN ISO 5356-1:2015, Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones

and sockets (ISO 5356-1:2015)"

!EN ISO 5359:2014+A1:2017, Anaesthetic and respiratory equipment — Low-pressure hose assemblies

for use with medical gases (ISO 5359:2014+Amd1:2017)"

!EN ISO 5361:2016, Anaesthetic and respiratory equipment — Tracheal tubes and connectors

(ISO 5361:2016)"
!EN ISO 5364:2016, Anaesthetic and respiratory equipment — Oropharyngeal airways
(ISO 5364:2016)"

!EN ISO 5366:2016, Anaesthetic and respiratory equipment — Tracheostomy tubes and connectors

(ISO 5366:2016)"

EN ISO 5367:2014, Anaesthetic and respiratory equipment — Breathing sets and connectors

(ISO 5367:2014)

!EN ISO 6009:2016, Hypodermic needles for single use — Colour coding for identification

(ISO 6009:2016)"

EN ISO 7376:2009, Anaesthetic and respiratory equipment — Laryngoscopes for tracheal intubation

(ISO 7376:2009)
---------------------- Page: 9 ----------------------
SIST EN 13718-2:2015+A1:2020
EN 13718-2:2015+A1:2020 (E)

!EN ISO 7396-1:2016, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical

gases and vacuum (ISO 7396-1:2016)"

EN ISO 7396-2:2007, Medical gas pipeline systems — Part 2: Anaesthetic gas scavenging disposal systems

(ISO 7396-2:2007)

!EN ISO 7864:2016, Sterile hypodermic needles for single use — Requirements and test methods

(ISO 7864:2016)"

!EN ISO 7886-1:2018, Sterile hypodermic syringes for single use — Part 1: Syringes for manual use

(ISO 7886 1:2017)"

EN ISO 7886-2:1997, Sterile hypodermic syringes for single use — Part 2: Syringes for use with power-

driven syringe pumps (ISO 7886-2:1996)

!EN ISO 8537:2016, Sterile single-use syringes, with or without needle, for insulin (ISO 8537:2016)"

EN ISO 9170-1:2008, Terminal units for medical gas pipeline systems — Part 1: Terminal units for use

with compressed medical gases and vacuum (ISO 9170-1:2008)

EN ISO 9360-1:2009, Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for

humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml

(ISO 9360-1:2000)

!EN ISO 10079-1:2015, Medical suction equipment — Part 1: Electrically powered suction equipment

(ISO 10079 1:2015)"

EN ISO 10079-2:2014, Medical suction equipment — Part 2: Manually powered suction equipment

(ISO 10079-2:2014)

EN ISO 10079-3:2014, Medical suction equipment — Part 3: Suction equipment powered from a vacuum

or positive pressure gas source (ISO 10079-3:2014)

EN ISO 10524-1:2006, Pressure regulators for use with medical gases — Part 1: Pressure regulators and

pressure regulators with flow-metering devices (ISO 10524-1:2006)

EN ISO 10524-2:2006, Pressure regulators for use with medical gases — Part 2: Manifold and line

pressure regulators (ISO 10524-2:2005)

!EN ISO 10524-3:2006+A1:2013, Pressure regulators for use with medical gases — Part 3: Pressure

regulators integrated with cylinder valves (ISO 10524-3:2005+Amd1:2013)"

EN ISO 10524-4:2008, Pressure regulators for use with medical gases — Part 4: Low-pressure regulators

(ISO 10524-4:2008)

!EN ISO 10555-1:2013+A1:2017, Intravascular catheters — Sterile and single-use catheters — Part 1:

General requirements (ISO 10555-1:2013+Amd1:2017)"

EN ISO 10555-3:2013, Intravascular catheters — Sterile and single-use catheters — Part 3: Central

venous catheters (ISO 10555-3:2013)

EN ISO 10555-5:2013, Intravascular catheters — Sterile and single-use catheters — Part 5: Over-needle

peripheral catheters (ISO 10555-5:2013)
---------------------- Page: 10 ----------------------
SIST EN 13718-2:2015+A1:2020
EN 13718-2:2015+A1:2020 (E)

!EN ISO 11070:2014+A1:2018, Sterile single-use intravascular introducers, dilators and guidewires

(ISO 11070:2014+Amd1:2018)"
EN ISO 13688:2013, Protective clothing — General requirements (ISO 13688:2013)

EN ISO 15002:2008, Flow-metering devices for connection to terminal units of medical gas pipeline

systems (ISO 15002:2008)

EN ISO 18777:2009, Transportable liquid oxygen systems for medical use — Particular requirements

(ISO 18777:2005)
!EN ISO 19054:2006+A1:2016, Rail systems for supporting medical equipment
(ISO 19054:2005+Amd1:2016)"

EN ISO 23328-1:2008, Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test

method to assess filtration performance (ISO 23328-1:2003)

EN ISO 23328-2:2009, Breathing system filters for anaesthetic and respiratory use — Part 2: Non-

filtration aspects (ISO 23328-2:2002)

!EN ISO 80601-2-55:2018, Medical electrical equipment — Part 2-55: Particular requirements for the

basic safety and essential performance of respiratory gas monitors (ISO 80601-2-55:2018)"

!EN ISO 80601-2-56:2017, Medical electrical equipment — Part 2-56: Particular requirements for

basic safety and essential performance of clinical thermometers for body temperature measurement

(IS
...

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