International standards in comparison
-
Upload
satishkumar-durairajan -
Category
Health & Medicine
-
view
1.847 -
download
1
description
Transcript of International standards in comparison
Weiss Klimatechnik GmbHInternational Hygienic Standards
MEDICLEAN®
Christoph Löhner
Weiss Klimatechnik GmbHInternational Hygienic Standards
MEDICLEAN®
Christoph Löhner
Clean Enviroment in the Industry to prevent contamination of the product
Weiss Klimatechnik GmbHInternational Hygienic Standards
MEDICLEAN®
Christoph Löhner
Clean Enviroment in the Operating theatre to prevent an Infection of the patient
Weiss Klimatechnik GmbHLidwell-Study ( Correlation of CFU and Infection rate)
- 7500 surgeries - 19 Hospitals- 5 ½ years- Finished in 1980
Weiss Klimatechnik GmbH
100%
21%16%
21%
42%
0%
20%
40%
60%
80%
100%
Distribution hospital infection
total
others
infected wound
acute respiratorydisease
urinary tract infection
Frequency of Infections in Germany
Weiss Klimatechnik GmbH
95%
5%
0%
20%
40%
60%
80%
100%
operativ postoperativ
Surgical hospital infection
Frequency of Infections in Germany
Weiss Klimatechnik GmbH
15
10
1
02468
10121416
1
days
Extension of hospital treatment though infection
infected wound
acute respiratorydisease
urinary tract infection
Frequency of Infections in Germany
Weiss Klimatechnik GmbH
711
618
126
0
100
200
300
400
500
600
700
800
1
Cost through hospital infection in Mio. Euro
infected wound
acute respiratorydisease
urinary tract infection
Frequency of Infections in Germany
Weiss Klimatechnik GmbH
Tasks of Hygienic Air Conditioning:
• Prevention of Air Born Infections during Surgery
• Management of thermal loads
• Reduction of content of harmful narcotic gases
• Maintenance of a comfortable climate in the OT
6
Weiss Klimatechnik GmbHTable of Various Standards and Design Indices
Room Class I(a)German DIN
Dec. 2008Russian GOST RSince 21.04.2006
Size of Laminar Flow Ceiling
3,2 x 3,2 m Min. 9 m2
Recirculation ?Fresh Air Amount
Yes (1.200 m3/h Fresh Air)
Yes(min. 100 m³/h x person)
Supply air velocityTotal Air Volume
≥ 0,23 m/s, 8.800 m³/h
0,24 – 0,3 m/s9.000-11.000 m³/h
Overflow into adjoining rooms ?
Yes, no figure Yes, no figure
Air Curtain 2,0 m above floor level
2,1 m above floor level
Three stage supply air filtration
Min F5 + F9 + H13 F7 + F9 + H14
Sound pressure level ≤ 48 dB (A) Not specified
Acceptance Test Rate of Turbulence Or Measurements by protection degree
Clean Room Class ISO 5/6
English HTM 03-01Since 2007
2,8 m x 2,8 m Rec 3,2 m x 3,2 m
Yes(AC/hr 25, min.2700 m³/h fresh air)
0,38 m/s on 2 m height11.900 m³/h
Yes, no figure (close to ceiling recommended)
2 m above floor level
G3 + min. F9 + min. H 10
≤ 55 dB (A)
Velocity/Validation
Weiss Klimatechnik GmbHDesigning - Main Topics
Room Class I(a)German DIN
Dec. 2008ASHRAE
2007
Size of Air Diffusor 3,2 x 3,2 m2 No information(laminar airflow “interest”)
Recirculation ? Yes (1.200 m3/h)Fresh air
Yes(20 AC/hr)Fresh air 4 AC/hr
Supply air velocityTotal Air Volume
≥ 0,23 m/s, 8.800 m³/h
Not specified2.000-2.700 m³/h depending on size of OT
Overflow into adjoining rooms ?
Yes, no figure Yes, with pressure monitoring
Air Curtain 2,0 m above floor level
Not specified
Three stage supply air filtration
Min F5 + F9 + H13 2 Filters (8, 17)(2 could be HEPA filter)
Sound pressure level ≤ 48 dB (A) Not specified
Acceptance Test Rate of Turbulence Or Measurements by protection degree
Weiss Klimatechnik GmbHDIN 1946-4 (German Standard)
General Design Criteria for OR Class 1AOperating Rooms Class1 A are for Orthopaedic, Cardiac,Neurosurgery,Transplant Surgery RoomsMinimum Size of OR 45 m²Height requirements (Clear Height FFL) 3,5 m Minimum size of a Laminar Flow Ceiling 3.2 x 3.2 mPartial walls or Curtains around the LF down to 2,1 m Temperature 19 – 26°CHumidity 35 – 60% r.h.Noise Level in the OR 48 db(A)Exhaust Air should be extracted homogenously from the roomAir Volume is defined by Downflow velocity below the LF Velocity 0.24 m/s average = 8.800 m3/h
Weiss Klimatechnik GmbHDesign indices
air supply between difference etemperatur t Q
[kJ/kgK] 1,0 air ofheat specificc 8.850
Q
][kg/m 1,2 air of density 8.850Q
[kW] load cooling Q t cVQ
/h][mflow air V 3,2mm3V
3
3
Δ 3
3600
112,1
ς 112,1
Δς
3600/24,02,
kW
sm
Calculation of air flow for removal head load
∆ t Cooling load (kW)
0,5 1,5
1 3,0
1,5 4,5
2 6,0
Weiss Klimatechnik GmbH
Requirements of the DIN 1946-4; December 2008
Building elements “RLT units for OT departments” shall be preferably installed on the floor directly above or close by.
Design Advice according DIN 1946-4
Weiss Klimatechnik GmbH
Advantage:
- Service and Maintenance outside OT
- Better Control of the Sound level
- Better mixing possibilities of fresh air and return air
Disadvantage:
-Required space for duct system
-Requires a large technical room
Air Conditioning Concept acc. DIN 1946-4(Remote plant system acc. HTM 03-01)
„Ideal solution – from technical-hygienic view“
Weiss Klimatechnik GmbH
Circulating Air Modules for Suspended Ceilings , Type ULA
Alternative System acc. DIN 1946-4(Modular System acc. HTM 03-01)
Weiss Klimatechnik GmbH
Advantages:- No requirement for large technical room for AHU`s- low space and room requirements for ducts- low operating costs
Disadvantages:- Reduced possibilities of mixing of circulating air with supply air- Reduced possibilities of sound absorption by very short air distances
Ceiling-suspended circulating air modulesAlternative System acc. DIN 1946-4
Weiss Klimatechnik GmbHAlternative Solution with Wall reciruclating modulesinstead of ceiling suspended modules
Weiss Klimatechnik GmbH
Circulating air wall module
Possibilities of installation:- Inside the OT- Directly outside the OT- Integral component in a wall
Alternative Solution with Wall reciruclating modulesinstead of ceiling suspended modules
Weiss Klimatechnik GmbH
Plant scheme Mediclean 120.3 DXU
FFA 32/32
Weiss Klimatechnik GmbHOperating Room Class 1 A
Weiss Klimatechnik GmbH
Operating Room Class 1 AMedia Supply Bridges (MVB)
Weiss Klimatechnik GmbHAlternative- Solution to normal Pendents:
Weiss Klimatechnik GmbH
Advantages with an example:
- Inspection possible from adjoining room
- Integral component of a wall
Circulating air wall module
Operating Room 1 A with Wall Recirculating Module
Weiss Klimatechnik GmbHNew HTM 03-01 (British Standard)
General Design Criteria for UCVUCV (Ultra clean ventilation) Theatres for Orthopaedic, CardiacTransplant, NeurosurgeryMinimum Size of OR 55 m²Minimum Clear Room Height 3,5 m ( better 3,8 m)Minimum size of a UCV Canopy 2.8 x 2.8 mor 3.2 x 3.2 m in case of bigger OR`s(Distance between UCVCeiling and perimeterial wall minimum 1 m)Partial walls around the UCV down to 2 m Temperature 19 – 23°CHumidity 35 – 60% r.h.Noise Level in the OR 55 db(A)Exhaust Air via Pressure Relief Dampers to the adjoining Rooms (normally no exhaust air in the OR)Air Volume is defined by Downflow velocity over the UCV At 2 metres 0.38 m/s average = 11.900 m3/h
Weiss Klimatechnik GmbH
Typical HTM03-01 Layout
Weiss Klimatechnik GmbHTypical Plant design acc.HTM03-01for Modular Plant System
Weiss Klimatechnik GmbH
Typical UCV Operating Room
Partial Walls
Recirculation Module
Weiss Klimatechnik GmbH
Typical UCV Operating Room
Pressure Relief Damper
Weiss Klimatechnik GmbH
Typical UCV Operating Room
Weiss Klimatechnik GmbH
Main Design Mistakes
1. The design of the Air Flow is done according Ashrae and does not match the requirements for a Laminar Flow Ceiling
Example: Operating room with the dimensions 5 x 6 meters and an internal room height of 3 meters would require according American ASHRAE 20 Air changes per hour which would result in a total Air Volume of 1.800 m³/h
A Laminar flow Ceiling with the dimensions 3 x 3 meters would require a minimum Air Flow Volume of 7.776 m3/h
Size of ceiling x 0,24 Velocity (m/s) x 3.600 seconds = m³/h
Ceiling (3 x 3 m) =9 m² x 0,24 m/s x 3.600= 7.776 m³/h
Weiss Klimatechnik GmbH
Main Design Mistakes
2. The design of the Room temperature and the Supply Air temperature is not matching because the Air Flow is not sufficient to provide a drought free enviroment when you have internal heat loads (light, monitors,staff)
Example: Operating room with an Internal heat load of 3,0 KW and a total Air Volume of 1.800 m³/h would mean keeping a room temperature of 20°C the supply air temperature has to be 15°C (∆ t = 5 K)
Consequences: In a combination with a Laminar Flow Ceiling this will lead to droughts and turbulences as well as to a reduction of the clean area at the height of the Operating table
Weiss Klimatechnik GmbH
MEDICLEAN®
Summary
1. Detailed knowledge of standards is important.
2. It will be profitable to include hygienists in due time.
3. Increasing requirements at operating theatres shall be considered duly.
4. Integrated strategy of architecture, room air technology, medicine technology and lighting
5. Highest possible safety for the hygiene acceptance