SIST-TS CEN/TS 16244:2018

SLOVENSKI STANDARD
SIST-TS CEN/TS 16244:2018
01-julij-2018
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Ventilation for hospitals - Coherent hierarchic structure and common terms and
definitions for a standard related to ventilation in hospitals
Krankenhauslüftung - Coherent hierarchische Struktur und gemeinsame Begriffe für die
Normung in Bezug auf Lüftung in Krankenhäusern
Ventilation des hôpitaux - Structure hiérarchique cohérente et termes et définitions
usuels pour une norme relatives à la ventilation dans les hôpitaux
Ta slovenski standard je istoveten z: CEN/TS 16244:2018
ICS:
11.140 Oprema bolnišnic Hospital equipment
91.140.30 3UH]UDþHYDOQLLQNOLPDWVNL Ventilation and air-
VLVWHPL conditioning systems
SIST-TS CEN/TS 16244:2018 en,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TS CEN/TS 16244:2018


CEN/TS 16244
TECHNICAL SPECIFICATION

SPÉCIFICATION TECHNIQUE

April 2018
TECHNISCHE SPEZIFIKATION
ICS 91.040.10; 91.140.30
English Version

Ventilation in hospitals - Coherent hierarchic structure and
common terms and definitions for a standard related to
ventilation in hospitals
Ventilation des hôpitaux - Structure hiérarchique Krankenhauslüftung - Coherent hierarchische Struktur
cohérente et termes et définitions usuels pour une und gemeinsame Begriffe für die Normung in Bezug auf
norme relatives à la ventilation dans les hôpitaux Lüftung in Krankenhäusern
This Technical Specification (CEN/TS) was approved by CEN on 10 December 2017 for provisional application.

The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.

CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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
© 2018 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN/TS 16244:2018 E
worldwide for CEN national Members.

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Contents Page
European foreword . 3
Introduction . 4
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Abbreviated terms for ventilation in hospitals . 13
5 Structure of the standard for Ventilation in Hospitals . 14
6 Design phase . 19
7 Construction phase. 22
8 Verification phase . 23
9 Operation and maintenance phase. 24
10 Test method . 25
Annex A (informative) Background information on the V-model . 26
Bibliography . 28

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European foreword
This document (CEN/TS 16244:2018) has been prepared by Technical Committee CEN/TC 156/WG 18
“Ventilation in Hospitals”, the secretariat of which is held by NEN.
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.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to announce this Technical Specification: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
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Introduction
The aim of CEN/TC 156 working group 18 is to establish a standard for all aspects of ventilation in
hospitals. This Technical Specification (TS) is work item 00156231 of CEN/TC 156 and gives a
framework and structure for the parts of the standard “Ventilation in Hospitals”. Based on this
framework the standard will be developed. The TS also provides preliminary definitions to be used in
the standard and gives an overview of the scope.
The standard “Ventilation in hospitals” could be applied to all healthcare premises whether located in a
hospital, clinic or other premises where healthcare services are delivered. It will include the specific
high risk areas and covers the aspects of construction and ventilation that provide defined levels of air
quality/cleanliness for classification of these areas. The standard will deal with the design,
classification, operation and maintenance phase of a project. The standard will not consider the general
ventilation aspects covered by other standards or the medical implications.
The resulting standard is intended for healthcare managers, design, construction and commissioning
engineers, estates managers and operations managers.
When drafting the parts of the standard for ventilation in hospitals, at least the following standards will
be taken into account for normative references:
EN 308, Heat exchangers ― Test procedures for establishing the performance of air to air and flue gases
heat recovery devices
EN 1506, Ventilation for buildings ― Sheet metal air ducts and fittings with circular cross-section ―
Dimensions
EN 1507, Ventilation for buildings ― Sheet metal air ducts with rectangular section ― Requirements for
strength and leakage
EN 1751, Ventilation for buildings ― Air terminal devices ― Aerodynamic testing of dampers and valves
EN 1822 series, High efficiency air filters (EPA, HEPA and ULPA)
EN 1886, Ventilation for buildings ― Air handling units ― Mechanical performance
EN 10088-1, Stainless steels ― Part 1: List of stainless steels
EN 12097, Ventilation for buildings ― Ductwork ― Requirements for ductwork components to facilitate
maintenance of ductwork systems
EN 12792, Ventilation for buildings ― Symbols, terminology and graphical symbols
EN 12237, Ventilation for buildings ― Ductwork ― Strength and leakage of circular sheet metal ducts
EN 12599, Ventilation for buildings ― Test procedures and measuring methods for handing over installed
ventilation and air conditioning systems
EN 13030, Ventilation for buildings - Terminals. Performance testing of louvres subjected to simulated
rain
EN 13053, Ventilation for buildings ― Air handling units ― Rating and performance for units, components
and sections
EN 13779, Ventilation for non-residential buildings ― Performance requirements for ventilation and
room-conditioning systems
EN 15780, Ventilation for buildings ― Ductwork ― Cleanliness of ventilation systems
EN 16032, Acoustics ― Measurement of sound pressure level from service equipment in buildings
EN 60068-2-11, Environmental testing ― Part 2: Tests ― Test Ka: Salt mist (IEC 60068-2-11)
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EN ISO 9000, Quality management systems ― Fundamentals and vocabulary (ISO 9000)
EN ISO 14644-1, Cleanrooms and associated controlled environments ― Part 1: Classification of air
cleanliness by particle concentration (ISO 14644-1)
EN ISO 14644-3, Cleanrooms and associated controlled environments ― Part 3: Test methods
(ISO 14644-3)
EN ISO 16890 series, Air filters for general ventilation ― Part 1: Technical specifications, requirements
and classification system based upon particulate matter efficiency (ePM)
For the consistency in the standard on ventilation in hospitals, the preliminary terms, definitions and
abbreviated terms defined in Clauses 3 and 4 will be used. Part 1, the general part, will repeat (possibly
with improvement) the terms that are necessary for all parts of the standard. If additional definitions or
adaption of the given definitions are necessary they will be defined in the specific part of the standard.
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1 Scope
This Technical Specification sets out the framework and structure for the standard related to
ventilation in hospitals. It gives the requirements for the drafting of the parts of the standard, including
preliminary terms and definitions.
The standard for ventilation in hospitals is intended for all healthcare premises where healthcare
services are delivered. It is applicable for healthcare services located in a hospital, clinic or other
premises. This includes general and specific risk areas, within healthcare and provides defined levels of
air quality/cleanliness for classification of these areas. The standard addresses the minimum
requirements for ventilation systems. It specifies the design, installation, operation, qualification
process and maintenance of the ventilation systems.
The standard describes the following hygienic issues related to the ventilation system:
a) air quality (e.g. cleanliness levels, temperature, humidity, air quantity);
b) the protection of patients, staff and visitors against harmful agents;
c) reducing the growth of microorganisms (e.g. clean-ability, accessibility, wet surfaces, accumulation
of particles);
d) control of the airflow direction (e.g. tightness of systems and constructions, pressure difference).
The standard describes a structured approaches for all phases from design up to and including
maintenance and requalification and gives minimum requirements for the ventilation systems:
a) minimum user requirement specification (URS);
b) functional design requirements (FD);
c) requirements for components in the detailed design (DD).
This standard is intended for healthcare ventilation system project managers, designers, construction
and commissioning engineers, estates managers and operations/facilities managers.
2 Normative references
There are no normative references in this document.
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
active sampling of air
sampling of air by a sampling tube or probe using a pump and collection of microbial particles on to an
3
agar surface or filter surface to determine the microbial load (CFU/m )
3.2
air lock
enclosed space having two doors, situated between two environments with different air conditions,
making it possible to pass from one environment to the other without significant disturbance to either
[SOURCE: ISO 6707-1]
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3.3
air handling unit
factory made encased assembly consisting of sections containing a fan or fans and other necessary
equipment to perform one or more of the following functions: circulating, filtrating, heating, cooling,
heat recovery, humidifying, dehumidifying and mixing air
[SOURCE: EN 13053]
3.4
air terminal
device through which the supply air is distributed into ventilated space or exhaust air is extracted from
the ventilated space
Note 1 to entry: Air terminals can also include other functions, such as air flow control, heating, cooling, filtration
or room air circulation and treatment.
3.5
alarm
signal of system malfunction or critical situation that can cause malfunction of the system resulting in a
situation that is not in accordance with the required (system) performances or break down of system
components
Note 1 to entry: As-built condition where the installation is complete with all services connected and functioning
but with no production equipment (e.g. operating lamps, operating table, anaesthesia equipment), materials or
personnel present [EN ISO 14644-1].
3.6
at-rest
condition where the installation is complete with equipment (e.g. operating lamps, operating table,
anaesthesia equipment) installed and operating in a manner agreed upon by the customer and supplier,
but with no personnel present
[SOURCE: EN ISO 14644-1]
3.7
certification body
organization that meets the requirements of EN ISO/IEC 17024 for third-party certification bodies and
issues a certificate of conformity
[SOURCE: ISO 18436-1]
3.8
colony forming unit
CFU
bacteria carrying particle which gives rise to a colony on a culture plate
3.9
controlled humidity
actively controlled humidity of the air by dehumidification and humidification to realize a certain dew
point
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3.10
corrosion-resistant
sustainable way of protection against corrosion by means of the materials used
[SOURCE: EN 60068-2-11]
3.11
critical zone
dedicated space in the operating room which covers the critical areas, including tables with the sterile
instruments in which the concentration of contamination (including microbiological, gaseous and
particulate) is controlled and that is constructed and used in a manner to minimize the introduction and
maximize recovery of contamination inside the area
Note 1 to entry: The size of the critical zone is usually marked permanently on the floor based on the worst-case
conditions (maximum space).
3.12
customer
organization, or the agent thereof, responsible for specifying the requirements of an operating
room/suite
[SOURCE: EN ISO 14644-1]
3.13
detail design
DD
drawings, data, calculations and specifications from which constructed works, components and
assemblies can be constructed
Note 1 to entry: By the end of the detailed design process, the design should be dimensionally correct and
coordinated, describing all the main components of the system and how they fit together. A detailed design will
provide sufficient information for applications for statutory approval to be made.
[SOURCE: ISO 15686-3]
3.14
design verification
DQ
documented evidence that the proposed design of the facilities, systems and equipment is suitable for
the intended use
[SOURCE: EN ISO 13408-6]
3.15
dilution mixing system
system that creates air cleanliness by dilution of the airborne contaminants by mixing and diluting with
supplied clean air and removing the diluted air
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3.16
functional design
FD
specification of the functions of the components of a system and of the working relationships among
them
Note 1 to entry: At the end of the functional design all the functional specifications of the ventilation system are
defined.
[SOURCE: ISO/IEC 2382]
3.17
installation
operating room one or more operating rooms, together with all associated structures, air-treatment
systems, services, and utilities
[SOURCE: EN ISO 14644-1]
3.18
installation verification
IQ
process of obtaining and documenting evidence that equipment has been provided and installed in
accordance with its specification
[SOURCE: ISO/TS 11139]
3.19
lay-up preparation room
lay-up preparation area
room or area where sterile packs are opened, checked and arranged on the trollies
3.20
lint (fluff) separator
fine-mesh net or perforated plate installed in the exhaust channel to protect the exhaust ducts from
fibres
[SIS/TS 39]
3.21
maintenance
servicing any periodic or unplanned support and verification operations designed to keep premises and
equipment in proper working condition
[SOURCE: EN ISO 22716]
3.22
medical location
premises where any examination, treatment, or other act having preventive, diagnostic therapeutic or
rehabilitative aims and which is carried out by a health care provider
3.23
microbiological testing
active or passive microbiological tests are carried out to determine and evaluate the extent of the
airborne microbial load
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3.24
occupancy state
state for which prescribed requirements and according tests refer to, as one or more of four of them,
viz. “as-built”, “at-rest”, setback or “operational”
Note 1 to entry: It should be recognized that the “as-built” state is applicable to newly completed or newly
modified operating rooms. Once testing in the “as-built” state is completed, further testing for compliance will be
performed in the “at-rest” or the “operational” state, or both.
[SOURCE: EN ISO 14644-1]
3.25
operating suite
collection of rooms e.a. lay-up room, operating room, corridors, staff rest room, air locks
3.26
operating room
room especially equipped for the performance of surgical operations, and is constructed and used in a
manner to minimize the introduction, generation, and retention of contamination and where
temperature, humidity, and pressure are controlled as necessary
3.27
operational
condition where the installation is functioning in the specified manner, with the specified number of
personnel present and working in the manner agreed upon
[SOURCE: EN ISO 14644-1]
3.28
operational verification
OQ
process of obtaining and documenting evidence that installed equipment operates within
predetermined limits when used in accordance with its operational procedures
[SOURCE: ISO/TS 11139]
3.29
passive sampling
2
sedimentation of microbial particles on to an agar surface to determine the microbial load (CFU/cm ,
2 2
CFU/dm or CFU/m )
3.30
particle
solid, liquid or microbial object which, for purposes of classification of air cleanliness, falls within a
cumulative distribution that is based upon a threshold (lower limit) size
[SOURCE: EN ISO 14644-1]
3.31
particle concentration
3
number of individual particles per unit volume of air (particles/m )
[SOURCE: EN ISO 14644-1]
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3.32
performance verification
PQ
process of obtaining and documenting evidence that the equipment, as installed and operated in
accordance with operational procedures, consistently performs in accordance with predetermined
criteria and thereby yields product meeting its specification
[SOURCE: ISO/TS 11139]
3.33
periphery area
area in the operating room around the critical zone which allows supporting the operating team to
circulate and may include the anaesthetist, the anaesthetic and other equipment
Note 1 to entry: For proper air circulation it has been found that for vertical down-flow systems there is need for
a distance between protected zone and the walls of minimum 1,5 m.
3.34
plenum
compartment or chamber to which one or more air ducts are connected and that forms part of the air
distribution system
Note 1 to entry: A plenum can also be used as a pressure chamber for evenly distributing air through a filter to a
supply air inlet to the room or exhaust air outlet from the room to the ducting system.
[SOURCE: ISO/IEC 18010]
3.35
pressure difference
difference between the pressure inside an enclosure and outside the enclosure at a specified elevation
[SOURCE: ISO 16737]
3.36
protective isolation
sterile care
technical mean for taking care of patients with an elevated risk of infection
3.37
protected zone
critical zone protected by a protected zone system
3.38
protected zone system
system that segregates a protected zone from the periphery area by the sweeping action of the air and
prevents entrainment of ambient room air
3.39
qualification
process of demonstrating whether an entity is capable of fulfilling specified requirements
[SOURCE: ISO/IEC 12207]
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3.40
recovery test
test performed to determine the ability of the installation to reduce the concentration of airborne
particles after a particle generation event, evaluated by using the 100:1 recovery time for ≥ 0,5 µm
particles
Note 1 to entry: Recovery test is evaluated by using the 100:1 recovery time of ≥ 0,5 µm particles or the
cleanliness recovery rate. The 100:1 recovery time is defined as the time required for decreasing a challenge
concentration of ≥ 0,5 µm particles by a factor of 0,01 times and the cleanliness recovery rate is defined as the rate
of change of particle concentration of ≥ 0,5 µm particles by time. It is possible to estimate both of them from the
same particles concentration decay curve. The measurements should be made inside the time range where the
decay of particle concentration is described by a single exponential, indicated by a straight line on a semi-log chart
(concentrations on the ordinate by the logarithmic scale, and the time values on the abscissa by the linear scale).
Moreover the test concentration should not be so high that the coincident loss should occur or so low that the
counting uncertainty should occur.
[SOURCE: EN ISO 14644-3]
3.41
repair
activities performed to preserve or to restore the function of a structure that fall outside the definition
of maintenance
[SOURCE: ISO 16204]
3.42
resistant to disinfectants
made of materials able to withstand a long-term
application of disinfectants and disinfecting methods
3.43
room classification
classes assigned to rooms used for medical purposes
3.44
setback mode
condition where the installation is functioning outside the operational mode where no medical activity
is practised
3.45
servicing
servicing any periodic or unplanned support and verification operations designed to keep premises and
equipment in proper working condition
[SOURCE: EN ISO 22716]
3.46
source isolation/infectious patients
technical means for taking care of patients with infection
3.47
supplier
organization engaged to satisfy the specified requirements of an operating room
[SOURCE: EN ISO 14644-1]
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3.48
terminal
device through which the supply air is distributed into ventilated space or extract air is extracted from
the ventilated space
Note 1 to entry: A terminal may also include other functions, such as air flow control, heating, cooling, filtration or
room air circulation and treatment.
3.49
uncontrolled humidity
cooling down the air or heating up the air to a certain temperature creating the amount of
dehumidification and dew point to follow uncontrollably
3.50
user requirement specification
URS
approved document that states the specifications of the system as well as functional, operational and/or
technical aspects of the system required to realise the desired air quality
3.51
weather louvre
device intended to allow the passage of supply or exhaust air while minimising the ingress of rain,
which can have either fixed or adjustable blades
[SOURCE: EN 13030]
4 Abbreviated terms for ventilation in hospitals
For the purposes of this document, the following abbreviated terms apply.
Abbreviated term Unabbreviated term
ALARA As low as reasonable achievable
BA Building automation
BIU Building instrumentation and control
BMS Building Management System
CCU Cardio Care Unit
CFU Colony forming unit
CPP Critical process parameter
DD Detailed Design
DQ Design qualification
EHA Exhaust air
ETA Extract air
FD Functional Design
HEPA High Efficiency Particulate Air filter, air filter group in accordance with
EN 1822–1
ICU Intensive Care Unit
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Abbreviated term Unabbreviated term
IQ Installation qualification
LEV Local Exhaust Ventilation
MIS Minimally invasive surgery
NICU Neonatal intensive-care unit
OQ Operational qualification
OR Operating room
PQ Performance qualification
QM Quality management
REC Recirculation air
SEC Secondary air
UDF Uni Directional Flow
UEPF Upper edge of prefabricated floor
URS User requirement specification
VAC Ventilation and air-conditioning
5 Structure of the standard for Ventilation in Hospitals
5.1 General
This Technical Specification will be the base for the structure in the standard. All the basic requirements
for ventilation systems in hospitals will be defined in part 1 “General requirements”. Requirements for
ventilation systems servicing specific rooms shall be defined in other parts in the standard. Part 1
“General” and 2 “Operating suits” will be developed first and shall be seen as a package of inter-related
European Standards.
If needed, the standard will define different performance levels and concepts on how to reach the
defined performance levels. The standard will give the opportunity to select one or more of these
concepts. If there are specific regulations in a country, information on the preferred or perhaps
obligatory concept could be given in a national annex or national foreword. Also for the test methods to
prove compliance with the required performance the main principles will be normative. Some detailed
elaboration will be given in informative annexes, making it possible to select one and assign it to the
project. National regulation or guidelines could make use of these annexes as well.
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Figure 1 — Structure for the set of standard for ventilation in hospitals
5.2 Structure of the specific parts design, construction and qualification
In order to make sure the ventilation system for healthcare indoor environment and patient safety are
specified, designed, detailed, constructed, commissioned, verified, validated and maintained, a
structured approach shall be followed in all parts of the standard (Figure 1). This approach shall be
used in all parts of the standard and shall be based upon the following project phases and steps:
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Table 1 — Detailed design, construction and operation process
Project phase Project Step Objective
0. Analysis
Design phase (I) Determination of actual condition and
establishing the basis for the project
1. User requirements
Definition of project targets in terms of
specification (URS)
specifications of the system as well as
functional, operational and/or technical
aspects of the system required to realize the
desired air quality
2. Functional design
Translation of user requirements specification
(FD)
into specification of the functions of the
components of a system and of the working
relationships among them
3. Detailed design (DD)
Translation of the user requirements
specification and functional design into
drawings, data, calculations and specifications
from which constructed works, components
and assemblies can be constructed
4. Design verification
To verify that the proposed design of the
(DQ)
facilities, systems and equipment is suitable
for the intended use based on the URS
5. Realiza
...