IQOQPQ

IQ Documentation
OQ Documentation
PQ Documentation
For products from the company Memmert GmbH + Co. KG
Version: 2012-05/1
Memmert GmbH + Co. KG

uere Rittersbacher Str. 38
91126 Schwabach, Germany
Phone 09122/925-0
E-Mail:sales@memmert.com
www.memmert.com
www.atmosafe.com
www.facebook.com/memmert.family
Overview
Table of Contents
Version: Version: 2012-05/1
Applicable chapter based on appliances

Appliances
Chapter
U/I/SNB/E
1. Introduction / General
1.1
x
1.2
x
1.3
x
1.4
1.4.1
x
1.4.2
x
1.4.3
1.4.4
1.4.5
x
1.4.6
2. IQ
2.1
x
2.2
x
2.3
x
2.4
x
2.5
2.5.1
x
2.5.2
x
2.6
x
3. OQ
3.1
x
3.2
3.2.1
x
3.2.2
3.2.3
3.2.4
3.2.5
3.2.6
3.2.7
3.3
3.3.1
3.3.2
x
3.3.3
3.3.4
3.3.5
3.3.6
3.3.7
3.3.8
3.3.9
3.4
3.4.1
x
3.4.2
x
3.5
3.6
3.7
3.8
3.8.1
3.8.2
3.9
3.10
3.11
x
4. PQ
4.1
4.1.1
x
4.1.2
x
4.2
4.3
4.4
4.5
4.5.1
4.5.2
4.6
4.7
4.8
x
5.
x
Attachment
U/I/SNP
U/I/SFB/E
U/I/SFP
HPP
INCO2
HCP
ICP
ICH
IPP
IPS
CTC/TTC
VO
x
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Testing personnel ........................................................................................... 6
Overview
Table of Contents
Revision history .............................................................................................. 6

Distributor...................................................................................................... 6
1
Introduction / General ............................................................................ 7

Purpose of qualifications .......................................................................... 7
Measuring equipment............................................................................... 7
Test object ................................................................................................ 8
Test data of initial test .............................................................................. 8
Electrical test ............................................................................................ 8
Function test and calibration oven, incubator, climate chamber........... 10
Function test and calibration vacuum oven .......................................... 11
Calibration light intensity ........................................................................ 12
Test of the overtemperature protection device oven, incubator, climate
chamber ................................................................................................. 14
Test of overtemperature protection device vacuum oven ..................... 14
IQ ......................................................................................................... 16
Packaging/ appliance .............................................................................. 16
Documentation / accessories ................................................................... 16
Installation of the appliance.................................................................... 16
Installation of software ........................................................................... 17
Assessment of the qualification .............................................................. 17
Damaged or missing parts ...................................................................... 17
Preparing for operation / instruction of operating personnel .................. 19
Release for next qualification level .......................................................... 19
OQ ........................................................................................................ 20
Testing the display elements ................................................................... 20
Test of the alarm- /overtemperature protection function ........................ 22
Universal oven, incubator, steriliser (Uxx/ Ixx /Sxx) ................................... 22
Constant climate chamber (HPP) ............................................................. 24
CO2 incubator / humidity chamber (INC / HCP) ....................................... 26
Cooled incubator (ICP / ICH / IPP) ............................................................ 26
IPS Temperature control storage chamber (IPS)....................................... 29
Overview
Table of Contents
Climatic / Temperature test chamber (CTC / TTC) ..................................... 31

Vacuum oven (VO) .................................................................................. 33
Functional tests....................................................................................... 34
Internal card reader ................................................................................ 34
Air vent controls, mechanical .................................................................. 35
Air vent controls, electrical ...................................................................... 36
Active humidity control or humidity limit control .................................... 37
Control air circulation motor................................................................... 39
Solenoid valves VO: OUT, IN1 and / or IN2 .................................... 40
VO leak test ............................................................................................ 41
Solenoid valves INCO2: IN1 and IN2 ................................................. 42
Functional testing option: Light module ................................................. 43
Testing temperature distribution
in compliance with DIN 12880: 2007-05 ................................................. 44
Measurement results for
temperature distribution / humidity measurement .................................. 45
Measurement results on the temperature fluctuation ............................. 50
Measurement result for calibrating humidity .......................................... 51
Measurement result for calibrating CO2 ................................................. 51
Measurement result for calibrating O2 ................................................... 51
Testing the thermoshelves ...................................................................... 52
Measurement results for area temperature distribution (VO) .................. 53
Measurement results on the temperature fluctuation (VO) ..................... 55
Calibration of the vacuum controller....................................................... 56
Measurement of light intensity ............................................................... 58
Release of the tested appliance for use ................................................... 59
PQ ........................................................................................................ 60
in compliance with DIN 12880: 2007-05 ................................................. 60
Measurement results for
temperature distribution / humidity measurement .................................. 61
Measurement results on the temperature fluctuation ............................. 65
Measurement result for calibrating humidity .......................................... 66
Overview
Table of Contents
Measurement result for calibrating CO2 ................................................. 66

Measurement result for calibrating O2 ................................................... 66
Testing the thermoshelves ...................................................................... 67
Measurement results for area temperature distribution (VO) .................. 68
Measurement results on the temperature fluctuation (VO) ..................... 69
Calibration of the vacuum controller....................................................... 70
Measurement of light intensity ............................................................... 72
Release of the tested appliance for use ................................................... 73
Attachment .......................................................................................... 74
Notes 75
Appliance Qualification
Date: 30.08.2012
Testing personnel
Company-internal qualification
Created by:
Memmert
GmbH + Co. KG
Reviewed by:
Memmert
GmbH + Co. KG
Name
Position
Signature
Date
---
---
---
---
---
---
Name
Position
On site qualification
Signature
Date
Performed by:
Performed by:
Performed by:
Revision history
Version
01
Date
Reason for revision

New facility / first installation
02
Installation after successful repair
03
New application field for appliance
Signature
Distributor
Department
Function
Number/ copies
Original
1. copy
2. copy
Test performed by
Date
Signature
Reviewed by
Date
Signature
by MEMMERT GmbH + Co. KG
Ref.: D24374_IQ_OQ_PQ_eng
Page 6 of 76
Introduction / General
Date: 24.05.2012
Chapter not applicable must be marked NA
Purpose of qualifications
IQ: This qualification is used to review the appliance listed under test object for
the completeness of the delivery and for its fundamental readiness for operation.
It also documents all important specifications and parameters stipulated by the
manufacturer, whether the safety regulations are fulfilled and which persons have
been instructed in the basic functions of the appliance and its operation.
OQ: This qualification is used for the verification / testing of the function and
production readiness of the appliance listed under test object.
The following is tested on site:
- All quality or process relevant alarm and switching functions
- All quality or process-relevant control functions
- Temperature distribution as well as measurement of humidity,
/CO2/O2/pressure and light
The settings for the setpoints (parameters) necessary for the test must be made as
described in the respective operating manuals
PQ: This documentation is used as a support for the testing of the function and
production readiness under process-dependent conditions of the appliance listed
under test object.
The following is recorded on site with the test specimens:
- All quality or process relevant alarm and switching functions
- All quality or process relevant control functions
- Temperature distribution as well as measurement of humidity, /CO2
O2/pressure and light
Measuring equipment
The calibration certificates for the measuring instruments used for temperature,
humidity, pressure, CO2, O2 and lux and W/m can be found in the attachment.
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 7 of 76
Date: 24.05.2012
Test object
Manufacturer:
MEMMERT GmbH + Co. KG, 91107 Schwabach, Germany
Designation:
Type:
Voltage:
Nominal
temperature:
Serial No.
----- ----- V, 50 / 60 Hz
--- C
yes
yes
yes
no
no
no
yes
no
VO Shelves
Shelf 1
Shelf 2
Shelf 3
Shelf 4
Serial number
# --# --# --# ---
Variant
---------
N/A
yes
yes
yes
yes
no
no
no
no
Test data of initial test
Electrical test
PE conductor resistance
High voltage test
Power input
Limit values
Measured values
max. 200 m with a minimum 10 A

at least 1.25 kV at max. 3000 A
--- m at --- A
--- kV at --- A
--- Watt
(for VO-thermoshelves position 1 and 2 for models 400 and 500, position 1 for model 200)
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 8 of 76
Date: 24.05.2012
Only VO:
N/A
High voltage test
Limit values
Measured values
--- m at Fehler!
Verweisquelle konnte
nicht gefunden werden.
A
--- kV at Fehler!
Verweisquelle konnte
nicht gefunden werden.
A
--- Watt
Power consumption
(for VO-thermoshelves position 3 and 4 for models 400 and 500, position 2 for model 200)
Only VO:
N/A
High voltage test
Limit values
Measured values
--- m at Fehler! Es
wurde kein
Textmarkenname
vergeben. A
--- kV at Fehler! Es
wurde kein
Textmarkenname
vergeben. A
--- Watt
Power consumption
(for VO-thermoshelves position 3 for model 200)
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 9 of 76
Date: 24.05.2012
Func
Function test and calibration oven,
oven, incubator, climate chamber
N/A
Function test
Tested at a room temperature of 22C +/-2K
Warm-up time up to 40 C
cool down time from 40 C to 5 C
Maximum working temperature reaches 50 C
--- C
--- Minutes
--- minutes
yes
no
Calibration setpoint 1
Setpoint temperature 1
Actual value on the controller
Reference value measured in the working chamber (acc. to
DIN 12880 and 50011), permissible: actual value +/-0,5 K
Calibration setpoint 2
N/A
Setpoint temperature
Calibration set value 3
N/A
Setpoint temperature
Humidity calibration at 30 C
Humidity setpoint
Reference value measured in the working chamber,
permissible: actual value +/-3% rh
Test performed by
Date
Signature
Reviewed by
Date
Signature
--- C
--- C
--- C
--- C
--- C
--- C
--- C
--- C
--- C
N/A
--- %rh
--- %rh
--- %rh
Page 10 of 76
Date: 24.05.2012
CO2 calibration
Setpoint value CO2
permissible: actual value +/-0.3 % CO2
Setpoint value CO2
permissible: actual value +/-0.5 % CO2
Setpoint value CO2
permissible: actual value +/0.7 % CO2
N/A
O2 calibration
N/A
Setpoint value O2
permissible: actual value +/-0.5 % O2
5 % CO2
--- % CO2
--- % CO2
10 % CO2
--- % CO2
--- % CO2
15 % CO2
--- % CO2
--- % CO2
5 % O2
--- % O2
--- % O2
Function test and calibration vacuum oven

N/A
Function test
Tested at a room temperature of 22C +/- 2K
Heating up to 200 C at 50 mbar
(on 1st shelf from bottom)
--- C
yes
no
Calibration
Setpoint on shelf at 50 mbar
--- C
--- C
Thermoshelf 1 = reference value measured on 1st shelf
--- C
from bottom,
permissible: stainless steel shelf actual value +/-5 K
aluminium shelf shelf actual value +/2 K
The other thermoshelves can be ignored since controlling for all thermoshelves
is from the same controller.
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 11 of 76
Date: 24.05.2012
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 12 of 76
Date: 24.05.2012
N/A
ICP
(measurement is made vertically, in parallel with and at a distance of 10 cm from the
light module, on the middle level, see measurement arrangement Nxxx in the
attachment)
Calibration pressure
Setpoint pressure
measured reference value, permissible: actual value +/- 3
mbar
--- mbar
--- mbar
--- mbar
Calibration light intensity

intensity
N/A
To record the light intensity, the light modules must be switched on for at least 30
minutes
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 13 of 76
Date: 24.05.2012
Measured reference value

--- Lux
(at least ICP500 1,000 Lux, ICP600 2,500 Lux, ICP700 1,000 Lux, ICP800 2,000 Lux)
HPP108L
N/A
(measurement is made vertically, in parallel with and at a distance of 10 cm from the
light module,
3. bead from below, see measurement arrangement Nxxx in the attachment)
cold white (light performance set to 100%) N/A
Measured reference value (at least 8,000 Lux)
--- Lux
cold white /warm white (light performance set to 100%)
N/A
--- Lux
ICH256L
N/A
ICH256L (Standard light cartridge)
(measurement is made on the 4th bead from the bottom, centrally, beneath the light
cartridge,
see measurement arrangement Nxxx in the attachment)
cold white
--- Lux
UV light
Measured reference value (at least 4 W/m)
--- W/m
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 14 of 76
Date: 24.05.2012
Test of the overtemperature protection device oven, incubator, climate

chamber
N/A
For appliances of the P-class a selection of the temperature protection class (SK 3.x
/SK 2) is necessary (see operating instructions basic appliance settings chapter).
The acoustic alarm (for P class only) must also be activated (see operating
instructions basic appliance settings chapter.)
Over/ undertemperature protection class
(delete if not applicable)
Setpoint set to
Switch off point overtemperature protection (display
temperature controller) 3.1 /3.3 TWW and TWB 2
Limit value 5K above set setpoint
Switch off point overtemperature protection (display
temperature controller) 3.1 /3.3 TWW
Limit value 5K below set setpoint
Class 3.1/3.3 TWW

Class 2 TWB
--- C
--- C
--- C
Test of overtemperature protection device vacuum oven

N/A
A selection of the temperature protection class SK 3.1/SK 2 is necessary (see
operating instructions basic appliance settings chapter). The acoustic alarm
must also be activated (see operating instructions basic appliance settings
chapter.)
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 15 of 76
Date: 24.05.2012
Setpoint set to 70C.

Thermoshelf 1 = 1st shelf from bottom
Switch off point < 73 C
--Switch on point > 68 C
--The other thermoshelves can be ignored since the overtemperature control is the same
for all thermoshelves.
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 16 of 76
IQ
Date: 30.08.2012
IQ
Packaging/ appliance
Packaging undamaged?
yes
no
Are all appliance parts undamaged as far as can be seen on outside?
yes
no
Completeness of the scope of delivery, according to the order and

order confirmation (e.g. steel grids/ thermoshelves)
yes
no
yes
no
yes
no
yes
no
yes
no
yes
no
yes
no
yes
no
yes
no
Documentation / accessories
Operating manual available?

Control software CELSIUS on CD-ROM is at hand?
(only with PERFECT appliances and INC with communication
module)
Operating manual for CELSIUS at hand?
(only with PERFECT appliances and INC with communication
module)
STERI-card at hand? (INP / IFP / INC / HCP)
MEMory-card at hand?
(only with PERFECT appliances, not with INC)
Calibration certificate available?(VO: one for each thermoshelf)
Installation of the appliance
Uxx / Ixx / Sxx / VO appliances

N/A
Compliance with the following environmental conditions?
- Ambient temperature +5 C to +40 C
- rel. humidity max. 80 %, not condensing
INC / HCP appliances
N/A
- Ambient temperature +5 C to +35
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 17 of 76
IQ
Date: 30.08.2012
IPP / ICP / IPS / ICHICH- appliances

N/A
- Ambient temperature
+12 C to +28 C (IPP / IPS-models)
+16 C to +28 C (ICP-models)
+ 5 C to +28 C (ICH-models)
- rel. humidity max. 80%, not condensing
yes
no
yes
no
Does the local mains voltage match with the nameplate?
yes
no
Mains voltage connected according to manufacturer specifications?
yes
no
yes
yes
yes
no
no
no
yes
yes
no
no
HPP / CTC / TTC appliances

N/A
- Ambient temperature +16 to +28
Mains voltage
Installation of software
Installation der CD: Celsius (falls Vorhanden)

Has the software been successfully installed?
Does the software start without an error message?
Can the chamber connection (online) be established?
N/A
Assessment of the qualification
Damaged or missing parts
The appliance is operational

Corrective action necessary
The necessary corrective action must be performed by:
Test performed by
Date
Signature
Reviewed by
Date
Signature
________________
Page 18 of 76
IQ
Date: 30.08.2012
The action itself must be documented and confirmed in the document:

_______________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 19 of 76
IQ
Date: 30.08.2012
Preparing for operation / instruction of operating personnel

Appliance was correctly installed and is operational:
Instruction of operating personnel:
yes
yes
Name of operator instructed

Signature
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Instruction of operating personnel on the appliance was performed by:
Name
Company
Date
no
no
Date
Signature
Release for next qualification

qualification level
The release of the appliance for the next qualification level (OQ) is done by:
Name
Company / Department
Test performed by
Date
Signature
Reviewed by
Date
Signature
Date
Signature
Page 20 of 76
OQ
Date: 24.05.2012
OQ
Testing the display elements
Setting the normal operation mode (see operating manual)

Does display light up?
yes
no
Setpoint energy controller 10 C above displayed actual temperature
Is the yellow heating icon flashing?
yes
no
Setpoint energy controller on maximum
Is the yellow heating icon lit permanently?
yes
no
Setpoint of the overtemperature controller to minimum (low actual temperature)
Is the red alarm icon lit up and the heating icon is off?
yes
no
Setpoint of the overtemperature controller to maximum (high actual temperature)
Is the yellow heating icon lit up and the alarm icon is off? (Nur bei
yes
no
Schutzklasse 3.1 TWW)
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 21 of 76
OQ
Date: 24.05.2012
In addition for HPP / IPP / ICP / ICH / CTC / TTC appliances

N/A
Setpoint energy controller minimum
Is the cooling icon permanently lit up?
yes
no
Setpoint of the overtemperature controller to minimum (low actual temperature)
Is the red alarm icon lit up and the heating icon and cooling icon are
yes
no
off?
Setpoint of the overtemperature controller to maximum (high actual temperature)
Is the cooling icon lit up (flashing) and the alarm icon is off? (Only
for protection class 3.3 TWW)
yes
no
Comments: _________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 22 of 76
OQ
Date: 24.05.2012
Test of the alarmalarm- /overtemperature protection function

The functional readiness of the overtemperature protection function must be tested according to
predefined fixed limit values.
First, the specified test temperature must be set. 30 minutes after the setpoint is stable the
temperature protection must be adjusted in 1 C steps downwards or upwards until the alarm is
triggered or switched off.
For appliances of the P-class, a selection of the temperature protection class is necessary (see
operating instructions basic appliance settings chapter). The acoustic alarm (for P class
appliances/INC/IPS/VO/ICH only) must also be activated (see operating instructions basic appliance
settings chapter.)
Universal oven, incubator, steriliser (Uxx/ Ixx /Sxx)

N/A
Electronic overtemperature protection class
Class 3.1 TWW
(delete where not applicable)
Class 2 TWB
Test temperature Uxx/Sxx 70 C; Ixx 40 C, working temperature settled
Switch off temperature (TWW/TWB) > 68 C (39C)
Alarm icon on
yes
no
Acoustic alarm on (P-class only)
yes
no
Switch on temperature (TWW) < 72 C (41C)
Alarm icon off
yes
no
Acoustic alarm off (P-class only)
yes
no
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 23 of 76
OQ
Date: 24.05.2012
Test temperature Uxx/Sxx 250 C, Ixx 70 C

(working temperature settled)
Abschalttemperatur (TWW/TWB) > 248 C (69 C)
Alarm icon on
Acoustic alarm on (P-class only)
Switch on temperature (TWW) < 252 (71 )
Alarm icon off
Acoustic alarm off (P-class only)
yes
yes
no
no
yes
yes
no
no
Comments: _________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 24 of 76
OQ
Date: 24.05.2012
Additionally for protection class 2 TWB

N/A
Is the alarm icon flashing?
(even if setpoint / actual value is changed)?
Is the activated alarm icon, switched off when appliance is switched
off and on again (TWB reset)?
yes
no
yes
no
Constant climate chamber (HPP)

N/A
Electronic over - /undertemperature protection class
Test temperature10.0 C (working temperature settled)
Switch off temperature (TWW/TWB) > 9.7
Alarm icon on
Acoustic alarm on
Switch on temperature (TWW) < 10.3
Alarm icon off
Acoustic alarm off
Test temperature 37.0 C (working temperature settled)
Alarm icon on
Acoustic alarm on
Alarm icon off
Acoustic alarm off
N/A
Is the alarm icon flashing (even if setpoint / actual value is
changed)?
Class 3.3 TWW

Class 2 TWB
yes
yes
no
no
yes
yes
no
no
yes
yes
no
no
yes
yes
no
no
yes
no
Comments: _________________________________________________________________
yes
no
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 25 of 76
OQ
Date: 24.05.2012
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 26 of 76
OQ
Date: 24.05.2012
CO2 incubator
incubator / humidity chamber (INC / HCP)
N/A
Class 3.1 TWW
INC / HCP - test temperature 37 HCP (working temperature stabilised)
Switch-off temperature (TWW) < 36.7
Alarm icon on
yes
no
Acoustic alarm on
yes
no
Alarm icon off
yes
no
Acoustic alarm off
yes
no
HCP - test temperature 160 (working temperature stabilised)
Switch-off temperature (TWW) < 158
Alarm icon on
Acoustic alarm on
Switch on temperature (TWW) < 162
Alarm icon off
Acoustic alarm off
yes
yes
no
no
yes
yes
no
no
Cooled incubator (ICP / ICH / IPP)

N/A
Test temperature10.0 C (working temperature settled)
Alarm icon on
Acoustic alarm on
Class 3.3 TWW

Class 2 TWB
yes
yes
no
no
Comments: _________________________________________________________________
Alarm icon off
yes
no
Acoustic alarm off
yes
no
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 27 of 76
OQ
Date: 24.05.2012
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 28 of 76
OQ
Date: 24.05.2012
Test temperature 37.0 (working temperature stabilised)

Alarm icon on
Acoustic alarm on
Alarm icon off
Acoustic alarm off
Zustzlich bei Schutzklasse 2 TWB
N/A
Blinkt das Alarm-Symbol (auch bei nderung des Sollwertes /
Istwertes)?
Wird das aktivierte Alarm-Symbol durch Aus Einschalten des
Gertes wieder abgeschaltet (TWB zurckgesetzt)?
Test performed by
Date
Signature
Reviewed by
Date
Signature
yes
yes
no
no
yes
yes
no
no
yes
no
yes
no
Page 29 of 76
OQ
Date: 24.05.2012
IPS Temperature control storage chamber (IPS)

N/A
Test temperature 20.0 C (working temperature settled)
Alarm icon on
Acoustic alarm on
Alarm icon off
Acoustic alarm off
Class 3.3 TWW

Class 2 TWB
yes
yes
no
no
yes
yes
no
no
Comments: _________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 30 of 76
OQ
Date: 24.05.2012
Test temperature 37.0 (working temperature settled)

Alarm icon on
Acoustic alarm on
Alarm icon off
Acoustic alarm off
N/A
changed)?
Test performed by
Date
Signature
Reviewed by
Date
Signature
yes
yes
no
no
yes
yes
no
no
yes
no
yes
no
Page 31 of 76
OQ
Date: 24.05.2012
Climatic / Temperature test chamber (CTC / TTC)

N/A
Test temperature -20 (working temperature settled)
Alarm icon on
Acoustic alarm on
Alarm icon off
Acoustic alarm off
Test temperature 30 (working temperature settled)
Alarm icon on
Acoustic alarm on
Alarm icon off
Acoustic alarm off
Class 3.3 TWW

Class 2 TWB
yes
yes
no
no
yes
yes
no
no
yes
yes
no
no
yes
yes
no
no
Comments: __________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 32 of 76
OQ
Date: 24.05.2012
Test temperature 160 (working temperature settled)

Alarm icon on
Acoustic alarm on
Alarm icon off
Acoustic alarm off
N/A
changed)?
yes
yes
no
no
yes
yes
no
no
yes
no
yes
no
Comments: _________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 33 of 76
OQ
Date: 24.05.2012
Vacuum oven (VO)

N/A
Class 3.1 TWW

Class 2 TWB
Test temperature 70 , working temperature settled

Settings setpoint: Overtemperature controller 72C / working chamber 70C
Switch off point < 73
yes
no
Switch on point > 69
yes
no
Alarm icon on
yes
no
Acoustic alarm on
yes
no
The other thermoshelves can be ignored since the controls for all thermoshelves
are the same.
Test temperature 160 , working temperature settled
Settings setpoint: Overtemperature controller 162 / working chamber 160
Switch off point < 163
yes
no
Switch on point > 159
yes
no
Alarm icon on
yes
no
Acoustic alarm on
yes
no
The other thermoshelves can be ignored since the controls for all thermoshelves
are the same.
Comments: _________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 34 of 76
OQ
Date: 24.05.2012
Functional tests
Internal card reader

N/A
MEMory Card
N/A
Switch appliance to normal operation mode (see operating manual Selecting
operating modes UIS PERFECT/HPP/IPP/ICP/ICH/HCP/CTC/TTC), insert MEMory card into
internal card reader
Display of temperature controller shows 32KB MEMCARD OK?
yes
no
Automatic switching to ramp timer?
yes
no
SteriCard
N/A
Insert SteriCard into the card reader (see operating manual Sterilisation chip card)
(only for INC / INP / IFP /HCP appliances)
Display of temperature controller shows STERI CARD OK?
yes
no
USER ID
N/A
Set appliance to Normal operation mode (see operating manual selecting operating
mode), insert USER ID Card into the internal card reader
(only PERFECT appliances)
Display of temperature controller shows ID OK?
Test performed by
Date
Signature
Reviewed by
Date
Signature
yes
no
Page 35 of 76
OQ
Date: 24.05.2012
Air vent controls, mechanical

N/A
(only for UxB/E IxB/E SxB/E appliances)
Switch appliance to Normal operation mode (see operating
manual selecting operating mode chapter)
Set slider to air vent position MAX (right), is air vent (rear of
appliance) fully open?
Set slider to air vent position MIN (left), is air vent (rear of
appliance) fully closed?
N/A
yes
no
yes
no
Comments: _________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 36 of 76
OQ
Date: 24.05.2012
Air vent controls, electrical

N/A
(only for UxP/ IxP/ SxP appliance)
Select FLAP display icon and set air vent position to MAX (right),
is air vent (rear of appliance) fully open?
Select FLAP display icon and set air vent position to MIN (right),
is air vent (rear of appliance) fully closed?
Test performed by
Date
Signature
Reviewed by
Date
Signature
N/A
yes
no
yes
no
Page 37 of 76
OQ
Date: 24.05.2012
Active humidity control or humidity limit control

N/A
Fill container as described in the operating manual under Initial operation
(for the limit control, a water tray, for active humidity control, a can).
N/A
(bei HPP / ICH / HCP / CTC-Gert)
Set working temperature to 40.0 C
(working temperature settled)
Active humidity control
Humidifying: Humidity setpoint to 60 % rh
After a few minutes the steam process icon lights up (display for
steam supply)
After a maximum of 30 minutes the setpoint is reached
(60 % rh +/- 3%rh)
Dehumidifying: Humidity setpoint to 40 % rh
After a few minutes the dehumidifying icon lights up (display for
steam supply)
After a maximum of 30 minutes the setpoint is reached
(40 % rh +/- 3%rh)
yes
no
yes
no
yes
no
yes
no
Comments: _________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 38 of 76
OQ
Date: 24.05.2012
Set working temperature to 37.0 -working temperature settled

Active humidity control:
N/A
Does the steam process icon light up after a few minutes?
Is the set relative humidity of 95 % rh +/- 3% rh reached after max.
30 minutes?
Dehumidifying: Humidity setpoint to 60% rh
After max. 30 minutes the setpoint of 60 % rh +/- 3% rh is reached
Humidity limit control:
N/A
Is the set relative humidity of 95 % rh +/- 3% rh reached after max.
90 minutes?
Dehumidifying: Humidity setpoint to 88 % rh
Nach max. 30 Minuten ist der Sollwert von 88 % rh +/- 3% rh
erreicht
N/A
(for INC appliance)
Test performed by
Date
Signature
Reviewed by
Date
Signature
yes
yes
no
no
yes
no
yes
no
yes
no
Page 39 of 76
OQ
Date: 24.05.2012
Control air circulation motor

N/A
(for UFx/ IFx/ SFx/ ICP / ICH / CTC / TTC appliance)
Select FAN display icon and set air speed to MAX, does fan run
at maximum speed?
Select FAN display icon and set air speed to MIN, does fan run
at minimum speed?
Select FAN display icon and set air speed to Off, does fan stop
running? (test does not apply for ICP / ICH / CTC / TTC!)
yes
no
yes
no
yes
no
Comments: _________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 40 of 76
OQ
Date: 24.05.2012
Solenoid valves VO: OUT, IN1 and / or IN2

N/A
Set appliance to Normal operation mode (see operating manual
selecting operating mode chapter), connect vacuum supply
Set the vacuum setpoint smaller than the actual value (e.g. 500
mbar), does OUT output icon light up and is OUT solenoid valve
opened? (pressure value is reduced)
yes
no
Activate ventilation input IN1 (see operating manual chapter

Basic device settings)
Set the vacuum setpoint to maximum, does IN1 input icon light
yes
no
up and is IN1 solenoid valve opened? (pressure value increases)
Only if equipped with switch to inert gas
N/A
Activate ventilation input IN2 (see operating manual chapter basic device settings),
set vacuum setpoint to 500 mbar and wait for conditions to settle
Set the vacuum setpoint to maximum (larger than actual value),
yes
no
does IN2 input icon light up and is IN2 solenoid valve opened?
Is ventilation via IN1 quicker than ventilation via IN2?
yes
no
Comments: _________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 41 of 76
OQ
Date: 24.05.2012
VO leak test
N/A
Switch appliance to Normal operation mode (see operating manual selecting
operating mode chapter)
Set vacuum setpoint to 50 mbar, wait for conditions to settle (max. 20 minutes)
Is actual value, the same as setpoint and fluctuation less than +/- 3
yes
no
mbar
Switch of vacuum source (pump module external vacuum supply),
disconnect solenoid valve (as described in Service instructions) and seal off OUT
Pressure display after one hour < 60 mbar
yes
no
(Vacuum loss < 10 mbar)
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 42 of 76
OQ
Date: 24.05.2012
Solenoid valves INCO2: IN1 and IN2

N/A
INCO2 (only for corresponding model)
Activate CO2 connection IN1 (see operating manual chapter basic device settings),
the CO2 supply must be connected
Set the CO2 setpoint to maximum (larger than actual value), does
IN1 input icon light up and is IN1 solenoid valve opened? (CO2
yes
no
actual value increases)
Interrupt CO2 connection IN1, activate gas input IN2 (see operating manual
chapter basic device settings), the CO2 supply must be connected
Set the CO2 setpoint to maximum (larger than actual value), is IN1
input icon off, does IN2 input icon light up and is IN2 solenoid
yes
no
valve opened? (CO2 actual value increases)
Interrupt CO2 gas supply IN1 and IN2
Set CO2 setpoint to maximum (larger than actual value), alarm icon
yes
no
flashes and display shows CO2 EMPTY after max. 15 min.
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 43 of 76
OQ
Date: 24.05.2012
Functional testing option:

option: Light module
N/A
(only for ICP/ICH256L)
Can the light module be switched on and off (depending on device
model)
N/A
Daylight
UV light (only for ICH256L with UV lighting)
yes
yes
no
no
(only for HPP108L)

Can the light module be dimmed?
Light module can be dimmed in stages (stages: Off to 10)
10
yes
no
N/A
Comments: _________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 44 of 76
OQ
Date: 24.05.2012
Testing temperature distribution in compliance with DIN 12880: 20072007-05
N/A
The distribution of the temperature in the working chamber is recorded via 9
measurement points for an interior volume below 50 litres, above 50 litres is tested
with 27 measurement points.
Apart from determining the lowest and highest temperature inside the chamber
(distribution of temperature), the maximum fluctuations in temperature must be
recorded.
To do this, the lowest and chronologically following highest temperature at same
measurement point (middle of chamber) is recorded and documented after a state
of inertia has been reached.
Measurements performed by the company MEMMERT are documented in the
attachment. (see Attachment No. III)
OQ measurements performed at the customer must be entered in the table below.
The temperature sensors for testing temperature distribution and temperature
fluctuation, must be placed in accordance with DIN 12880: 2007-05 (see
Attachment No. II).
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 45 of 76
OQ
Date: 24.05.2012
Measurement results for temperature distribution / humidity measurement

Measurement 1
N/A
Set setpoint temperature
Displayed actual temperature (wait for state of inertia - at least
120 min. after setpoint temperature has been reached
Set humidity setpoint N/A
Displayed humidity actual value (a humidity setpoint +/- 3% rh)
N/A
Level 0
Sensor # 1 --- C
Sensor # 2 --- C
Sensor # 3 --- C
Sensor # 4 --- C
Sensor # 5 --- C
Sensor # 6 --- C
Sensor # 7 --- C
Sensor # 8 --- C
Sensor # 9 --- C
Level 1
Sensor # 11 --- C
Sensor # 12 --- C
Sensor # 13 --- C
Sensor # 14 --- C
Sensor # 15 --- C
Sensor # 16 --- C
Sensor # 17 --- C
Sensor # 18 --- C
Sensor # 19 --- C
--- C
--- C
--- %rh
--- %rh
Level 2
Sensor # 21 --- C
Sensor # 22 --- C
Sensor # 23 --- C
Sensor # 24 --- C
Sensor # 25 --- C
Sensor # 26 --- C
Sensor # 27 --- C
Sensor # 28 --- C
Sensor # 29 --- C
Maximum temperature difference (spatially)

permissible: <70 = +/- 0.5K; 70 - 180 = +/- 1.5K; >180 = +/3K
Humidity sensor middle of chamber (permissible: actual value +/3% rh)
N/A
--- K
--- %rh
Comments: _________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 46 of 76
OQ
Date: 24.05.2012
Measurement 2
N/A
N/A
Level 0
Sensor # 1 --- C
Sensor # 2 --- C
Sensor # 3 --- C
Sensor # 4 --- C
Sensor # 5 --- C
Sensor # 6 --- C
Sensor # 7 --- C
Sensor # 8 --- C
Sensor # 9 --- C
Level 1
Sensor # 11 --- C
Sensor # 12 --- C
Sensor # 13 --- C
Sensor # 14 --- C
Sensor # 15 --- C
Sensor # 16 --- C
Sensor # 17 --- C
Sensor # 18 --- C
Sensor # 19 --- C
--- C
--- C
--- %rh
--- %rh
Level 2
Sensor # 21 --- C
Sensor # 22 --- C
Sensor # 23 --- C
Sensor # 24 --- C
Sensor # 25 --- C
Sensor # 26 --- C
Sensor # 27 --- C
Sensor # 28 --- C
Sensor # 29 --- C

permissible: <70 = +/- 0.5K; 70 - 180 = +/- 1.5K; >180 = +/3K
N/A
Test performed by
Date
Signature
Reviewed by
Date
Signature
--- K
--- %rh
Page 47 of 76
OQ
Date: 24.05.2012
Comments: _________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 48 of 76
OQ
Date: 24.05.2012
Measurement 3
N/A
N/A
Level 0
Sensor # 1 --- C
Sensor # 2 --- C
Sensor # 3 --- C
Sensor # 4 --- C
Sensor # 5 --- C
Sensor # 6 --- C
Sensor # 7 --- C
Sensor # 8 --- C
Sensor # 9 --- C
Level 1
Sensor # 11 --- C
Sensor # 12 --- C
Sensor # 13 --- C
Sensor # 14 --- C
Sensor # 15 --- C
Sensor # 16 --- C
Sensor # 17 --- C
Sensor # 18 --- C
Sensor # 19 --- C
--- C
--- C
--- %rh
--- %rh
Level 2
Sensor # 21 --- C
Sensor # 22 --- C
Sensor # 23 --- C
Sensor # 24 --- C
Sensor # 25 --- C
Sensor # 26 --- C
Sensor # 27 --- C
Sensor # 28 --- C
Sensor # 29 --- C

permissible: <70 = +/- 0.5K; 70 - 180 = +/- 1.5K; >180 = +/3K
N/A
--- K
--- %rh
Comments: _________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 49 of 76
OQ
Date: 24.05.2012
Measurement 4
N/A
N/A
Level 0
Sensor # 1 --- C
Sensor # 2 --- C
Sensor # 3 --- C
Sensor # 4 --- C
Sensor # 5 --- C
Sensor # 6 --- C
Sensor # 7 --- C
Sensor # 8 --- C
Sensor # 9 --- C
Level 1
Sensor # 11 --- C
Sensor # 12 --- C
Sensor # 13 --- C
Sensor # 14 --- C
Sensor # 15 --- C
Sensor # 16 --- C
Sensor # 17 --- C
Sensor # 18 --- C
Sensor # 19 --- C
--- C
--- C
--- %rh
--- %rh
Level 2
Sensor # 21 --- C
Sensor # 22 --- C
Sensor # 23 --- C
Sensor # 24 --- C
Sensor # 25 --- C
Sensor # 26 --- C
Sensor # 27 --- C
Sensor # 28 --- C
Sensor # 29 --- C

permissible: <70 = +/- 0.5K; 70 - 180 = +/- 1.5K; >180 = +/3K
N/A
--- K
--- %rh
Comments: _________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 50 of 76
OQ
Date: 24.05.2012
Measurement results on the temperature fluctuation

N/A
Recorded temperature at sensor position 11 / level 1 (middle of chamber)
N/A
Measuremen Measuremen Measuremen Measuremen
Measurement
t1
t2
t3
t4
Temperature minimum
--- C
--- C
--- C
--- C
Temperature maximum
--- C
--- C
--- C
--- C
Temperature fluctuation
max. +/- 0.5 K
--- K
--- K
Recorded humidity at sensor position (middle of chamber)

Humidity minimum
--- %rh
--- %rh
Humidity maximum
--- %rh
--- %rh
Humidity fluctuation
max. +/- 3% rh
--- % rh
--- % rh
--- K
--- K
--- %rh
--- %rh
N/A
--- %rh
--- %rh
--- % rh
--- % rh
Comments: _________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 51 of 76
OQ
Date: 24.05.2012
Measurement result for calibrating humidity
N/A
Humidity calibration
Humidity setpoint
Reference value measured in the working chamber (actual
value +/-3% rh)
--- % rh
--- % rh
--- % rh
Measurement result for calibrating CO2
N/A
CO2 calibration
Setpoint value CO2
value +/-0.7 % CO2)
--- % CO2
--- % CO2
--- % CO2
Measurement result for calibrating O2
N/A
O2 calibration
Setpoint value O2
value +/-0.5 % O2)
--- % O2
--- % O2
--- % O2
Comments: _________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 52 of 76
OQ
Date: 24.05.2012
Testing the thermoshelves
N/A
(only VO appliances)
The distribution of temperature for each installed thermoshelf via 5 measuring
points (see Attachment I for arrangement of measuring sensors on thermoshelves).
Apart from determining the lowest and highest temperature on the thermoshelves
recorded.
To do this, the lowest and chronologically following highest temperature at one
measurement point (middle of respective thermoshelf) is recorded and documented
after a state of inertia has been reached.
Comments: _________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 53 of 76
OQ
Date: 24.05.2012
Measurement results for area temperature distribution (VO)

N/A
Test conditions to record temperature distribution:
- for a precise description of positions of the sensors see Attachment
Attachment No. I:
- Close doors, switch on oven, set temperature to the desired calibration
setpoint
- Wait for state of inertia to be reached at least 120 min. after setpoint
temperature has been reached
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 54 of 76
OQ
Date: 24.05.2012
The temperature values determined must be entered in

in the table below.
Thermoshelf (serial No.)
Actual temperature displayed
---C
N
--- C
N ----- C
N ----- C
N
--- C
Measurement position
front left T1
rear left T2
rear right T3
front right T4
--- C
--- C
--- C
--- C
--- C
--- C
--- C
--- C
--- C
--- C
--- C
--- C
--- C
--- C
--- C
--- C
Thermoshelf, middle T5
--- C
--- C
--- C
--- C
Maximum temperature
difference
- Aluminium sheet max. +/- 2%
- stainless steel sheet max. +/5%
(the actual temperature
displayed)
--- K
--- K
--- K
--- K
Comments: _________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 55 of 76
OQ
Date: 24.05.2012
Measurement results on the temperature fluctuation (VO)

N/A
Test conditions to record temperature fluctuation:
- Positioning of thermoshelves in the vacuum oven
- Positioning of the reference sensor at position T5, middle
- Close doors, switch on oven, set temperature to the desired
calibration setpoint
- Documentation of the highest and lowest value
The temperature values determined must be entered in the table below.
below.
Thermoshelf
N
--- C
--- C
N
--- C
--- C
N
--- C
--- C
N
--- C
--- C
Temperature minimum
Recorded at sensor position
--- C
--- C
--- C
--- C
Temperature maximum
--- C
--- C
--- C
--- C
--- K
--- K
max. +/- 0.3 K
--- K
--- K
Comments: _________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 56 of 76
OQ
Date: 24.05.2012
Calibration of the vacuum controller
N/A
Test conditions:
- Positioning of the thermo shelves in the vacuum oven (see Chapter 0 Function
Function
test, calibration - vacuum oven)
- Connection of vacuum calibration system to the IN1 connection on the rear of
the appliance
- Close doors and switch on oven with pump, set vacuum to the desired
- Wait until the vacuum value has stabilised (at least 60 minutes)
- Set vacuum value to the maximum (1100 mbar) a notice to connect the
calibration system with the vacuum chamber (solenoid valve for IN1 inlet is
opened)
- Wait until the display of the vacuum controller and of the calibration system has
stabilised (at least 5 minutes)
The final steps must be repeated in each case if more than one vacuum value is to
be tested!
Setpoint for vacuum
Actual value vacuum controller
Measured reference value (permissible: actual value +/- 5
mbar)
N/A
Setpoint for vacuum
mbar)
N/A
Setpoint for vacuum
--- C
--- mbar
--- mbar
--- mbar
--- mbar
--- mbar
--- mbar
--- mbar
Comments: _________________________________________________________________
--- mbar
--- mbar
mbar)
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 57 of 76
OQ
Date: 24.05.2012
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 58 of 76
OQ
Date: 24.05.2012
Measurement of light intensity
N/A
To measure the light intensity, the light modules must be switched on for at least
30 minutes
ICP
N/A
HPP108L
Cold white N/A
N/A
--- Lux
--- Lux
Cold white / warm white N/A

--- Lux

Cold white N/A
N/A
--- Lux
UV light N/A
--- W/m
Comments: ______________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 59 of 76
OQ
Date: 24.05.2012
Release of the tested appliance for use
The original copies of the recorded temperature values entered in the qualification
documents (recording strips, PC printouts, etc.) must be enclosed with the
qualification documents.
The measurement of temperature distribution/temperature fluctuation was made
by
Name
Company
Date
Signature
The release of the appliance for the intended use was done by:
Name
Company
Date
Signature
Comments: ______________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 60 of 76
PQ
Date: 30.08.2012
PQ
distribution in compliance with DIN 12880: 20072007-05
N/A
The distribution of the temperature in the working chamber is recorded via 9
measurement points for an interior volume below 50 litres, above 50 litres is tested
with 27 measurement points.
Apart from determining the lowest and highest temperature inside the chamber
recorded.
To do this, the lowest and chronologically following highest temperature at same
measurement point (middle of chamber) is recorded and documented after a state
of inertia has been reached.
Measurements performed by the company MEMMERT are documented in the
attachment. (see Attachment No. III)
OQ measurements performed at the customer must be entered in the table below.
The temperature sensors for testing temperature distribution and temperature
fluctuation, must be placed in accordance with DIN 12880: 2007-05 (see
Attachment No. II).
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 61 of 76
PQ
Date: 30.08.2012
measurement
ement
Measurement results for temperature distribution / humidity measur
Measurement 1
N/A
N/A
Level 0
Sensor # 1 --- C
Sensor # 2 --- C
Sensor # 3 --- C
Sensor # 4 --- C
Sensor # 5 --- C
Sensor # 6 --- C
Sensor # 7 --- C
Sensor # 8 --- C
Sensor # 9 --- C
Level 1
Sensor # 11 --- C
Sensor # 12 --- C
Sensor # 13 --- C
Sensor # 14 --- C
Sensor # 15 --- C
Sensor # 16 --- C
Sensor # 17 --- C
Sensor # 18 --- C
Sensor # 19 --- C
--- C
--- C
--- % rh
--- % rh
Level 2
Sensor # 21 --- C
Sensor # 22 --- C
Sensor # 23 --- C
Sensor # 24 --- C
Sensor # 25 --- C
Sensor # 26 --- C
Sensor # 27 --- C
Sensor # 28 --- C
Sensor # 29 --- C

permissible: <70 = +/- 0.5K; 70 - 180 = +/- 1.5K; >180 = +/3K
N/A
--- K
--- % rh
Comments: _________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 62 of 76
PQ
Date: 30.08.2012
Measurement 2
N/A
N/A
Level 0
Sensor # 1 --- C
Sensor # 2 --- C
Sensor # 3 --- C
Sensor # 4 --- C
Sensor # 5 --- C
Sensor # 6 --- C
Sensor # 7 --- C
Sensor # 8 --- C
Sensor # 9 --- C
Level 1
Sensor # 11 --- C
Sensor # 12 --- C
Sensor # 13 --- C
Sensor # 14 --- C
Sensor # 15 --- C
Sensor # 16 --- C
Sensor # 17 --- C
Sensor # 18 --- C
Sensor # 19 --- C
--- C
--- C
--- % rh
--- % rh
Level 2
Sensor # 21 --- C
Sensor # 22 --- C
Sensor # 23 --- C
Sensor # 24 --- C
Sensor # 25 --- C
Sensor # 26 --- C
Sensor # 27 --- C
Sensor # 28 --- C
Sensor # 29 --- C

permissible: <70 = +/- 0.5K; 70 - 180 = +/- 1.5K; >180 = +/3K
N/A
--- K
--- % rh
Comments: ______________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 63 of 76
PQ
Date: 30.08.2012
Measurement 3
N/A
N/A
Level 0
Sensor # 1 --- C
Sensor # 2 --- C
Sensor # 3 --- C
Sensor # 4 --- C
Sensor # 5 --- C
Sensor # 6 --- C
Sensor # 7 --- C
Sensor # 8 --- C
Sensor # 9 --- C
Level 1
Sensor # 11 --- C
Sensor # 12 --- C
Sensor # 13 --- C
Sensor # 14 --- C
Sensor # 15 --- C
Sensor # 16 --- C
Sensor # 17 --- C
Sensor # 18 --- C
Sensor # 19 --- C
--- C
--- C
--- % rh
--- % rh
Level 2
Sensor # 21 --- C
Sensor # 22 --- C
Sensor # 23 --- C
Sensor # 24 --- C
Sensor # 25 --- C
Sensor # 26 --- C
Sensor # 27 --- C
Sensor # 28 --- C
Sensor # 29 --- C

permissible: <70 = +/- 0.5K; 70 - 180 = +/- 1.5K; >180 = +/3K
N/A
--- K
--- % rh
Comments: ______________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 64 of 76
PQ
Date: 30.08.2012
Measurement 4
N/A
N/A
Level 0
Sensor # 1 --- C
Sensor # 2 --- C
Sensor # 3 --- C
Sensor # 4 --- C
Sensor # 5 --- C
Sensor # 6 --- C
Sensor # 7 --- C
Sensor # 8 --- C
Sensor # 9 --- C
Level 1
Sensor # 11 --- C
Sensor # 12 --- C
Sensor # 13 --- C
Sensor # 14 --- C
Sensor # 15 --- C
Sensor # 16 --- C
Sensor # 17 --- C
Sensor # 18 --- C
Sensor # 19 --- C
--- C
--- C
--- % rh
--- % rh
Level 2
Sensor # 21 --- C
Sensor # 22 --- C
Sensor # 23 --- C
Sensor # 24 --- C
Sensor # 25 --- C
Sensor # 26 --- C
Sensor # 27 --- C
Sensor # 28 --- C
Sensor # 29 --- C

permissible: <70 = +/- 0.5K; 70 - 180 = +/- 1.5K; >180 = +/3K
N/A
--- K
--- % rh
Comments: _________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 65 of 76
PQ
Date: 30.08.2012
Measurement results on the temperature fluctuation

N/A
Recorded temperature at sensor position 11 / level 1 (middle of chamber)
N/A
Measuremen Measuremen Measuremen Measuremen
Measurement
t1
t2
t3
t4
Temperature minimum
--- C
--- C
--- C
--- C
Temperature maximum
--- C
--- C
--- C
--- C
max. +/- 0.5 K
--- K
--- K
Recorded humidity at sensor position (middle of chamber)

Humidity minimum
--- % rh
--- % rh
Humidity maximum
--- % rh
--- % rh
Humidity fluctuation
max. +/- 3% rh
--- % rh
--- % rh
--- K
--- K
--- % rh
--- % rh
N/A
--- % rh
--- % rh
--- % rh
--- % rh
Comments: _________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 66 of 76
PQ
Date: 30.08.2012
Measurement result for calibrating humidity
N/A
Humidity calibration
Humidity setpoint
value +/-3% rh)
--- % rh
--- % rh
--- % rh
Measurement result for calibrating CO2
N/A
CO2 calibration
Setpoint value CO2
value +/-0.7 % CO2)
--- % CO2
--- % CO2
--- % CO2
Measurement result for calibrating O2
N/A
O2 calibration
Setpoint value O2
value +/-0.5 % O2)
--- % O2
--- % O2
--- % O2
Comments: _________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 67 of 76
PQ
Date: 30.08.2012
Testing the thermoshelves
N/A
(only VO appliances)
The distribution of temperature for each installed thermoshelf via 5 measuring
points (see Attachment I for arrangement of measuring sensors on thermoshelves).
Apart from determining the lowest and highest temperature on the thermoshelves
recorded.
To do this, the lowest and chronologically following highest temperature at one
measurement point (middle of respective thermoshelf) is recorded and documented
after a state of inertia has been reached.
Comments: ______________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 68 of 76
PQ
Date: 30.08.2012
Measurement results for area temperature distribution (VO)

N/A
Test conditions to record temperature distribution:
- for a precise description of positions of the sensors see Attachment No. I:
- Close doors, switch on oven, set temperature to the desired calibration
setpoint
reached
Thermoshelf (serial No.)
---C
N ----- C
N ----- C
N ----- C
N
--- C
Measurement position
front left T1
rear left T2
rear right T3
front right T4
--- C
--- C
--- C
--- C
--- C
--- C
--- C
--- C
--- C
--- C
--- C
--- C
--- C
--- C
--- C
--- C
--- C
--- C
--- C
--- C
Maximum temperature
difference
- Aluminium sheet max. +/- 2%
- stainless steel sheet max. +/5%
(the actual temperature
displayed)
--- K
--- K
--- K
--- K
Comments: _________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 69 of 76
PQ
Date: 30.08.2012
Measurement results on the temperature fluctuation (VO)

N/A
Test conditions to record temperature fluctuation:
- Positioning of thermoshelves in the vacuum oven
- Positioning of
of the reference sensor at position T5, middle
- Close doors, switch on oven, set temperature to the desired
- Documentation of the highest and lowest value
Thermoshelf
N
--- C
--- C
N
--- C
--- C
N
--- C
--- C
N
--- C
--- C
Temperature minimum
--- C
--- C
--- C
--- C
Temperature maximum
--- C
--- C
--- C
--- C
--- K
--- K
max. +/- 0.3 K
--- K
--- K
Comments: __________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 70 of 76
PQ
Date: 30.08.2012
Calibration of the vacuum controller
N/A
Test conditions:
- Positioning of the thermo shelves in the vacuum oven (see Chapter 0 Function
Function
test, calibration - vacuum
vacuum oven)
- Connection of vacuum calibration system to the IN1 connection on the rear of
the appliance
- Close doors and switch on oven with pump, set vacuum to the desired
- Wait until the vacuum value has stabilised (at least 60 minutes)
- Set vacuum value to the maximum (1100 mbar) a notice to connect the
calibration system with the vacuum chamber (solenoid valve for IN1 inlet is
opened)
- Wait until the display of the vacuum controller and of the calibration system has
stabilised (at least 5 minutes)
The final steps must be repeated in each case if more than one vacuum value is to
be tested!
Setpoint for vacuum
mbar)
N/A
Setpoint for vacuum
mbar)
--- C
--- mbar
--- mbar
--- mbar
--- mbar
--- mbar
--- mbar
N/A
Comments: _________________________________________________________________
Setpoint for vacuum
--- mbar
--- mbar
--- mbar
mbar)
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 71 of 76
PQ
Date: 30.08.2012
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 72 of 76
PQ
Date: 30.08.2012
Measurement of light intensity
N/A
To measure the light intensity, the light modules must be switched on for at least
30 minutes
ICP
N/A
HPP108L
Cold white N/A
N/A
--- Lux
--- Lux
Cold white / warm white N/A

--- Lux

Cold white N/A
N/A
--- Lux
UV light N/A
--- W/m
Comments: ______________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 73 of 76
PQ
Date: 30.08.2012
Release of the tested appliance for use
The original copies of the recorded temperature values entered in the qualification
documents (recording strips, PC printouts, etc.) must be enclosed with the
qualification documents.
The measurement of temperature distribution/temperature fluctuation was made
by
Name
Company
Date
Signature
The release of the appliance for the intended use was done by:
Name
Company
Date
Signature
Comments: _________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 74 of 76
Attachment
Date: 30.08.2012
Attachment
Exists:
I. VO cable allocation 5 points distribution measurement
- Document N D09032VO 200

D09032-A.pdf
D09033-B.pdf
D09034-A.pdf
II. 9/27 points distribution measurement acc. to DIN 12880: 2007-05
-Document N D30540.pdf
27 point measurement
-Document N D30541.pdf
9 point measurement
III. Test records
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 75 of 76
Attachment
Date: 30.08.2012
Notes
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 76 of 76
Notes
Date: 24.05.2012
Test performed by
Date
Signature
Reviewed by
Date
Signature
Page 77 of 77

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IQ Documentation

For products from the company Memmert GmbH + Co. KG

Memmert GmbH + Co. KG

Applicable chapter based on appliances

Testing personnel ........................................................................................... 6

Revision history .............................................................................................. 6

Introduction / General ............................................................................ 7

Climatic / Temperature test chamber (CTC / TTC) ..................................... 31

Measurement result for calibrating CO2 ................................................. 66

Reason for revision

Installation after successful repair

New application field for appliance

by MEMMERT GmbH + Co. KG

Version: Version: 2012-05/1

Chapter not applicable must be marked NA

by MEMMERT GmbH + Co. KG

MEMMERT GmbH + Co. KG, 91107 Schwabach, Germany

Test data of initial test

max. 200 m with a minimum 10 A

by MEMMERT GmbH + Co. KG

High voltage test

Version: Version: 2012-05/1

max. 200 m with a minimum 10 A

at least 1.25 kV at max. 3000 A

High voltage test

max. 200 m with a minimum 10 A

at least 1.25 kV at max. 3000 A

by MEMMERT GmbH + Co. KG

Version: Version: 2012-05/1

by MEMMERT GmbH + Co. KG

Version: Version: 2012-05/1

Function test and calibration vacuum oven

by MEMMERT GmbH + Co. KG

Version: Version: 2012-05/1

by MEMMERT GmbH + Co. KG

Version: Version: 2012-05/1

Calibration light intensity

by MEMMERT GmbH + Co. KG

Version: Version: 2012-05/1

Measured reference value

by MEMMERT GmbH + Co. KG

Version: Version: 2012-05/1

Test of the overtemperature protection device oven, incubator, climate

Class 3.1/3.3 TWW

Test of overtemperature protection device vacuum oven

by MEMMERT GmbH + Co. KG

Version: Version: 2012-05/1

Setpoint set to 70C.

by MEMMERT GmbH + Co. KG

Version: Version: 2012-05/1

Are all appliance parts undamaged as far as can be seen on outside?

Completeness of the scope of delivery, according to the order and

Operating manual available?

Uxx / Ixx / Sxx / VO appliances

by MEMMERT GmbH + Co. KG

Version: Version: 2012-05/1

IPP / ICP / IPS / ICHICH- appliances

Does the local mains voltage match with the nameplate?

Mains voltage connected according to manufacturer specifications?

HPP / CTC / TTC appliances

Installation der CD: Celsius (falls Vorhanden)

Assessment of the qualification

Damaged or missing parts

The appliance is operational