Ventilation in hospitals - Coherent hierarchic structure and common terms and definitions for a standard related to ventilation in hospitals

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.

Krankenhauslüftung — Kohärente hierarchische Struktur und gemeinsame Begriffe für die Normung in Bezug auf Lüftung in Krankenhäusern

Die vorliegende Technische Spezifikation legt den Rahmen und die Struktur für die Norm hinsichtlich der Lüftung in Krankenhäusern fest. Sie spezifiziert die Anforderungen für die Ausarbeitung der Teile der Norm, einschließlich vorläufiger Begriffe.
Die Norm für Lüftung in Krankenhäusern ist für alle Einrichtungen für das Gesundheitswesen vorgesehen, in denen Gesundheitsleistungen erbracht werden. Sie gilt für alle medizinischen Dienste, die sich in Krankenhäusern, klinischen oder sonstigen Einrichtungen befinden. Sie umfasst allgemeine und spezielle Risikobereiche innerhalb des Gesundheitswesens und bietet festgelegte Maße für die Luftqualität/-reinheit für die Klassifikation dieser Bereiche. Die Norm behandelt die Mindestanforderungen für Lüftungsanlagen. Sie legt den Design-, Installations-, Betriebs- und Qualifizierungsprozess sowie die Instandhaltung der Lüftungsanlagen fest.
Die Norm beschreibt die folgenden hygienischen Aspekte in Bezug auf die Lüftungsanlage:
a)   Luftqualität (z. B. Reinheitsgrade, Temperatur, Feuchte, Luftmenge);
b)   Schutz von Patienten, Personal und Besuchern vor Schadstoffen;
c)   Reduzierung des Wachstums von Mikroorganismen (z. B. Reinigungsfähigkeit, Zugänglichkeit, nasse Oberflächen, Ansammlung von Partikeln);
d)   Steuerung der Richtung des Luftstroms (z. B. Dichtheit von Systemen und Konstruktionen, Druckdifferenz).
Die Norm beschreibt einen strukturierten Ansatz für alle Phasen von Design bis einschließlich Instandhaltung und Requalifizierung und legt die Mindestanforderungen für die Lüftungsanlagen dar:
a)   Mindest-Kundenspezifikation (en: user requirement specification; URS);
b)   Anforderungen an das funktionelle Design (en: functional design; FD);
c)   Anforderungen an Komponenten im detaillierten Design (en: detailed design; DD).
Die vorliegende Norm ist für Projektmanager für Lüftungssysteme im Gesundheitswesen sowie für Design-, Bau- und Inbetriebnahme-Ingenieure, Gebäude-Manager und Betriebsleiter/Facility-Manager vorgesehen.

Ventilation des hôpitaux - Structure hiérarchique cohérente et termes et définitions usuels pour une norme relatives à la ventilation dans les hôpitaux

Prezračevanje bolnišnic - Usklajena nivojska struktura, skupni pojmi in definicije za standard za prezračevanje v bolnišnicah

Ta tehnična specifikacija določa strukturo standarda, ki se nanaša na prezračevanje bolnišnic. Podaja zahteve za izdelavo delov standarda, vključno s splošnimi izrazi in opredelitvami. Standard za prezračevanje bolnišnic je namenjen vsem zdravstvenim objektom, ki zagotavljajo zdravstvene storitve. Uporablja se tudi za zdravstvene storitve v bolnišnicah, klinikah in drugih objektih. Vključuje splošna in posebna območja tveganja ter podaja opredelitve stopenj kakovosti/čistosti zraka za razvrščanje teh območij. Standard določa minimalne zahteve za prezračevalne sisteme. Določa postopke za načrtovanje, namestitev, upravljanje, izvedbo kvalifikacijskega postopka in vzdrževanje prezračevalnih sistemov.

General Information

Status
Published
Publication Date
24-Apr-2018
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
25-Apr-2018
Completion Date
25-Apr-2018

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SLOVENSKI STANDARD
SIST-TS CEN/TS 16244:2018
01-julij-2018

3UH]UDþHYDQMHEROQLãQLF8VNODMHQDQLYRMVNDVWUXNWXUDVNXSQLSRMPLLQGHILQLFLMH

]DVWDQGDUG]DSUH]UDþHYDQMHYEROQLãQLFDK
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
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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

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

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

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

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

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

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

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
number of individual particles per unit volume of air (particles/m )
[SOURCE: EN ISO 14644-1]
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3.32
performance verification

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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SIST-TS CEN/TS 16244:2018
CEN/TS 16244:2018 (E)
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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SIST-TS CEN/TS 16244:2018
CEN/TS 16244:2018 (E)
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
...

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