FprCEN/TR 16244
(Main)Ventilation for hospitals
Ventilation for hospitals
This Technical Report applies to health service buildings and rooms used for medical examinations, treatments and interventions to be carried out on people as well as to rooms directly connected to those rooms by doors, corridors/hallways, etc.
It establishes rules for planning, construction, qualification, and operation of ventilation and air-conditioning (VAC) systems and components intended to be used in:
- hospitals buildings;
- day hospitals;
- physician’s practices with intervention rooms;
- outpatient surgery centres / facilities / ambulatories;
- dialysis centres;
- convalescent homes, rehabilitation facilities, sanatoria;
- long-term care facilities, senior retirement and nursing homes;
- facilities for internal and external (service) units for the processing of medical devices / sterilization areas.
In addition to that, air hygienically relevant guidance is given regarding building services / heating installations.
Lüftung für Krankenhäuser
Ventilation des hôpitaux
Prezračevanje za bolnišnice
General Information
Standards Content (Sample)
SLOVENSKI STANDARD
01-maj-2011
3UH]UDþHYDQMH]DEROQLãQLFH
Ventilation for hospitals
Lüftung für Krankenhäuser
Ventilation des hôpitaux
Ta slovenski standard je istoveten z: FprCEN/TR 16244
ICS:
91.040.10 Javne stavbe Public buildings
91.140.30 3UH]UDþHYDOQLLQNOLPDWVNL Ventilation and air-
VLVWHPL conditioning
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
TECHNICAL REPORT
FINAL DRAFT
RAPPORT TECHNIQUE
TECHNISCHER BERICHT
March 2011
ICS 91.140.30; 91.040.10
English Version
Ventilation for hospitals
Ventilation des hôpitaux Lüftung für Krankenhäuser
This draft Technical Report is submitted to CEN members for Technical Committee Approval. It has been drawn up by the Technical
Committee CEN/TC 156.
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, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.
Warning : This document is not a Technical Report. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a Technical Report.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2011 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprCEN/TR 16244:2011: E
worldwide for CEN national Members.
Contents Page
Foreword .3
1 Scope .4
2 Normative references .4
3 Terms, definitions, and abbreviations .4
4 Abbreviated terms .7
5 General requirements .7
6 Classification of rooms used for medical purposes (room classes) and ventilation
concepts .8
7 Requirements for ventilation and air-conditioning components . 14
8 System qualification . 40
9 Acceptance tests . 42
10 Periodic tests . 46
11 Requirement for the technical documentation . 48
Annex A (informative) Planning, construction, and operation . 50
A.1 General . 50
A.2 Project phases and objectives . 50
A.3 Analysis . 51
A.4 Project aims . 51
A.5 Planning . 53
A.6 Implementation . 54
A.7 Operation . 55
Annex B (informative) Examples of air flow distribution concepts (specifically for operating and
isolation rooms) . 58
B.1 Example of the symmetric arrangement of circulating air and extract air terminal devices
in operating rooms . 58
Annex C (normative) Qualification of rooms of room class H1. 60
C.1 Flow visualisation for room class H1a – General . 60
C.2 System test / Pre-qualification for room class H1a – Pre-qualification of LTF systems
(room with air duct and lighting system) in operating rooms of room class H1a . 61
C.3 Acceptance test following the procedure for measuring the turbulence intensity in room
class H1a . 67
C.4 Acceptance test by determining the protective effect for room class H1a . 70
C.5 Acceptance test of class H1a rooms in accordance with EN ISO 14644 . 76
Annex D (normative) Microbiological tests . 80
D.1 General . 80
D.2 Procedure . 80
D.3 Requirements . 80
D.4 Evaluation . 81
Annex E (informative) Maintenance plan for the VAC system . 82
Bibliography . 86
Foreword
This document (FprCEN/TR 16244:2011) has been prepared by Technical Committee CEN/TC 156
“Ventilation for buildings”, the secretariat of which is held by BSI.
This document is currently submitted to the Technical Committee Approval.
1 Scope
This Technical Report applies to health service buildings and rooms used for medical examinations,
treatments and interventions to be carried out on people as well as to rooms directly connected to those
rooms by doors, corridors/hallways, etc.
It establishes rules for planning, construction, qualification, and operation of ventilation and air-conditioning
(VAC) systems and components intended to be used in:
hospitals buildings;
day hospitals;
physician’s practices with intervention rooms;
outpatient surgery centres / facilities / ambulatories;
dialysis centres;
convalescent homes, rehabilitation facilities, sanatoria;
long-term care facilities, senior retirement and nursing homes;
facilities for internal and external (service) units for the processing of medical devices / sterilization areas.
In addition to that, air hygienically relevant guidance is given regarding building services / heating installations.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated referen-
ces, only the edition cited applies. For undated references, the latest edition of the referenced document
(including any amendments) applies.
EN 12792:2003, Ventilation for buildings ― Symbols, terminology and graphical symbols
3 Terms, definitions, and abbreviations
For the purposes of this document, the terms and definitions given in EN 12792:2003 and the following (in
alphabetical order) apply.
3.1
air lock
room located between two rooms of different room classes
NOTE It is used to reduce transmission of aerobic infectious agents between rooms of different classes. The air lock
is supplied with air as well as vented by mechanical means and can be operated with overpressure or underpressure.
Alternatively, air locks that should be passed before entering a class H1b operating room can also be supplied with air by
over-flow from the operating room.
3.2
hygienist
according to this Technical Report, a medical specialist for hygiene pursuant to the advanced training
regulations of the federal states with special expertise in the fields of ventilation technology or an expert
working in an agency for the fulfilment of hygiene-related tasks, each with special knowledge and experience
in the field of ventilation and hospital hygiene (also called hygiene expert / specialist for hygiene / hospital
hygienist in different countries, function needs to be described)
3.3
interventions
as distinct from operations
NOTE This differentiation is made in correspondence with the annex to the attachment accompanying numbers 5.1
and 4.3.3 of the requirements for hygiene in ambulant surgery (Anforderungen der Hygiene beim ambulanten Operieren in
Krankenhaus und Praxis) published by the Robert Koch Institute, Berlin.
3.4
servicing
includes measures for determining and assessing the actual state of a system’s technical means (inspection)
as well as for maintaining the nominal condition of a system’s technical means (maintenance)
3.5
resistant to disinfectants
according to this TR, ventilation and air-conditioning components and products are considered to be resistant
to disinfectants if they are able to withstand a long-term application of disinfectants and disinfecting methods
NOTE The only disinfectants used are those included in the list published by the Robert Koch Institute (RKI) or the
Association for Applied Hygiene (Verbund für angewandte Hygiene e.V., VAH), respectively.
3.6
repair
measures for restoring the nominal condition of a system’s technical means
3.7
room classes
classes assigned to rooms used for medical purposes
3.8
protective isolation / sterile care
patients with a risk of infection
3.9
source isolation / infectious patients
patients with infection
3.10
VAC-central-plant
ventilation and air-conditioning system containing all components (sound attenuators, dampers, heat
exchangers etc.) installed inside a central plant in order to facilitate cleaning and maintenance
3.11 Qualifications
3.11.1
system qualification
qualification of systems that includes the partial steps installation qualification, function qualification, and per-
formance qualification
NOTE Each subsequent partial step should be started only after completing the improvements required and
successfully passing the re-checks for the previous partial step.
3.11.2
installation qualification
systematic sequence of inspections, measurements, and tests (as well as adjustments, if necessary) carried
out in order to ensure the compliance of all system parts with the planning requirements
3.11.3
function qualification
series of tests and measurements carried out in order to ensure the correct functioning of all system parts
3.11.4
performance qualification
tests and measurements proving that the entire system achieves the operating state agreed
3.11.5
planning qualification
planning ends with a qualification intended to demonstrate the compliance of the execution planning with the
requirements defined in the task formulation (performance specifications)
3.12 Operating-rooms
3.12.1
low turbulence flow (LTF) plenum
supply air plenum with a vertical air outlet used to obtain a low-turbulence displacement flow (Tu ≤ 20 %) in
the entire protected area
3.12.2
turbulence level Tu
measure for the fluctuations of the air velocity in relation to its mean value (relative standard deviation), in %
NOTE A flow with a turbulence level of less than 5 % is designated as “laminar” and “low-turbulence” between 5 %
and 20 %, respectively, whereas a flow with a turbulence level of more than 20 % is called “turbulent”.
3.13
overpressure / underpressure
positive or negative air balance
3.14
positioning analysis
Identification of floor space required specific for clinic of the protected area for which itself approximately 9 m²
(e.g. 3 m × 3 m) have proved themselves as a standard size in the international operation practise
NOTE The standard construction situations are to be shown for the operating field, the tables for exposed sterile
instruments and materials and the operating room staff wearing sterile clothing. The aforementioned potential disturbing
factors should be considered very carefully in cooperation with the hygienist and the VAC-consultant taking into acco
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