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QUALITY ASSURANCE

Process monitoring and documentation have grown in importance in the fi eld of medical device reprocessing over the past years which, in turn, has led to a signifi cant increase in quality. The use of batch controls and random tests is commonplace today and ensures proper processing. Routine controls in between annual maintenance and validation cycles ensure consistent procedures and help to guarantee compliance with the applicable guidelines and standards. Interlock’s product portfolio in this segment is growing continuously to enable you to maintain high quality standards.

• Indicators for standard washer-disinfectors, EWDs and ultrasonic cuvettes for checking cleaning effi cacy/ultrasonic energy

• Protein tests for detecting non-visible residues in hollow instruments such as MIS instruments, on instrument and workplace surfaces and in endoscopes

• Ink-based seam seal integrity tests or colour analysis with indicator strips

• Various tests to ensure uniform water quality

• Hollow load process challenge tests for routine monitoring – multiple and single use versions

• Interlock routine and batch control systems for long-term use

• Batch controls for all widely used sterilisation methods such as steam, low temperature (EO, FO, H2O2) or hot air, various models

• Bio-indicators for routine checks and microbiological validation of most sterilisation/disinfection procedures

• Other quality controls such as disinfection indicators, indicator dots, counting strips, control/insertion cards, sterilisation protocols and sieve documentation pads

• Test materials for quality control of medical instruments (functional capacity, cleaning outcome, information on diameter, length and weight) and for workplace optimisation

Cleaning indicators

Protein tests

Routine checks for sealing machines

Monitoring water quality

Bowie and Dick tests

Interlock routine monitoring systems

Sterilisation batch control

Bio-Indicators

Miscellaneous for quality assurance

Quality monitoring

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Quality assurance – Cleaning indicators

Since cleaning is the first and one of the most important steps in the reprocessing cycle, appropriate

care must be taken when verifying it. To ensure high cleaning efficacy is maintained, cleaning indicators

and monitoring systems are essential:

• For simulation of the surface structure, joints, cavities and complex lumina

• Human blood-like or synthetic soiling for visual assessment of the cleaning result

• Special solutions for EWDs

• Systems for checking ultrasonic energy

Other cleaning indicators and accessories (for testing the cleaning efficacy of standard washer-disinfectors)

REF Description Specification SU

a 08554 Cleaning indicator “Wash-Check”to simulate human blood and tissue residues

for single use, compatible with REF 08555 10 units

b 08555 Holder for “Wash-Check” made of stainless steel, compatible with REF 08554

1 unit

c 50052 Josafe CCI easyfor routine checks of washer-disinfectors in ac-cordance with ISO 15883

for single use, simulates 4 different narrow gaps 12 units

d 50039 Adapter for Wassenburg EWD - 1 unit

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Miele quick protein test

It is becoming increasingly difficult to test the quality of cleaning of the complex and delicate instruments required in ever more widely used minimally invasive surgery. In order to measure protein residues from blood or tissue, a quick protein test has been developed which allows the quality of machine cleaning of instruments to be assessed in less than seven minutes. The quick protein test comprises 48 sealed containers containing a reaction solution, thus allowing 48 tests to be conducted.

For single use

Pro-Check indicators

To check the cleaning performance of washer-disinfectors. Testing of instrument surfaces for protein residues. Of course, hygiene tests on work surfaces can also be performed.

For single use

Hygiena MediCheck

Ready-to-use, highly sensitive quick protein test for detecting protein residues on surfaces

For single use

REF Description SU

b 08005 50 swabs with 2 indicators / box 1 box

REF Description SU

a 01420 For surgical instruments - set for 48 tests 1 set

Quality assurance – Protein tests

Detecting residues that are not visually recognisable, such as protein and blood, presents a major

challenge in the CSSD. Interlock provides special tests to detect whether residues are present as part of

quality assurance after cleaning and disinfection.

• Solutions in a set or a single test e.g. in pen format

• Handy quick tests with response times from 10 seconds

• Special solutions for detecting residues in endoscope biopsy channels

REF Description SU

c 50070 Sensitivity: 20 μg after 10 minutes at room temperature3 μg after 30 minutes at 37°C colour change from green to grey to pink to lilac

100 units

c 50071 See REF 50070 50 units

c 50072 See REF 50070 25 units

Interlock Medizintechnik GmbHZum Windpark 1 23738 Lensahn • GermanyTel.: +49 4363 905900Internet: www.interlockmed.com

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REF Description SU

a 08101 InkCheck®, for single use 50 vials of 2 ml

REF Description Ink colour SU

b 08116 Interlock InkCheck® Plus seal seam integrity test blue 30 cartridges

b 08124 Interlock InkCheck® Plus Tyvek seal seam integrity test red 30 cartridgesNEW

Interlock InkCheck® seal seam integrity test For the routine testing of seal seams, seal seam integrity test as per DIN EN ISO 11607-1, Annex B, for the routine testing of sealers.• Compliant with DIN EN ISO 11607-1, Annex B (ASTM F1929)• Ready-to-use vial with 2 ml of indicator solution• No complicated removal and measurement of test liquid• Simple handling thanks to the twist-off closure• No spills or drips• Suitable for all standard paper and Tyvek® packaging• Quick evaluation (5 seconds per seal seam)

Set comprising:• 50 vials of 2 ml• Magnifying card (REF 08529)

The integrity of seal seams is extremely important for maintaining the germ barrier during transportation

and storage. For this reason, they must be checked on a daily basis. Whether with a simple seal check or

an ink test, with our products you are on the safe side.

• Colour ink tests, three versions

• Indicator strip with colour change

• Versions for various materials - paper/foil and Tyvek

Quality assurance – Routine checks for sealing machines

Interlock InkCheck® Plus seal seam integrity test For the routine testing of seal seams, seal seam integrity test as per DIN EN ISO 11607-1, Annex B, for the routine testing of your sealer

The latest generation of seal seam integrity tests

• Simple, clean handling• All seal seals can be checked in one procedure

for single use

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REF Formatin mm

Description SU

a 08011 173 x 91 For transparent pouches (paper/film) 250 units

a 08022 173 x 91 For transparent pouches (paper/film) 50 units

a 08017 172 x 90 For Tyvek pouches 100 units

REF Formatin mm

Description SU

b 08021 205 x 150 For single use 250 units

Interlock Seal ProofFor checking Redary sealers. Deviations in the sealing temperature and sealing pressure are visible on the indicator strip.1. Put the Seal Proof in a transparent pouch without a side gusset2. Pass it through the sealer once3. Assess the colour changeFor single use

Steriking Seal ControlSterilisation packaging must be sealed in such a way that it cannot be penetrated by microorganisms, and the sealing process must be validated accordingly. In accordance with ISO standard 11607-2: 2006, users and processors are responsible for implementing a process validation programme to demonstrate the efficacy and reproducibility of all sterilisation and packaging processes. With the Steriking® Seal Control sheet SC250, Wipak offers users reliable and quick validation of sealers and seal quality.

Quality assurance – Routine checks for sealing machines

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a 08018 pH test, for testing solutions pH 1 - 14 50 units

b 08505 pH tester 0.2 pH Range: 0.00 - 14.00 pH Resolution: 0.1 pH Accuracy +/- 0.1 pH

1 unit

c 08525 Storage solution for electrodes Compatible with REF 08505 230 ml

d 08526 Storage solution for electrodes Compatible with REF 08505 500 ml

* 08528 Buffer solution pH 4 and pH 7For calibrating pH testers

5 bags of 20 mlCompatible with REF 08505

1 pack

e 08507 Buffer solution pH 7 and pH 10For calibrating pH testers

5 bags pH 7 / 20 ml, 5 bags pH 10 / 20 mlCompatible with REF 08505

1 pack

f 08506 Conductivity tester 10-19 DiST3 Range 0 - 1999 μS/cm Resolution 1 μS/cm Accuracy (20°C) +/- 2% of the range EMC deviation +/- 1% of the range Manual calibration 1 point Automatic temperature compensation 0 - 50°C

1 unit

g 08508 Calibration solution 1413 μS/cm For calibrating pH testers

Compatible with REF 08506 230 ml

Images to follow soon on our website*

Quality assurance – Monitoring water quality

Water quality is of central importance when reprocessing medical devices. We recommend using fully

desalinated water (SU water) and check and document the quality of the water for interim and final rinsing

in washer-disinfectors and EWDs. Poor water quality poses potential hazards and risks such as calcium

deposits or pitting. High water quality ensures material integrity of instruments and washer-disinfectors/

EWDs is maintained over the long term.

Test strips or electronic testers can be used to measure electrical conductance and water characteristics

such as pH value, hardness. Water parameters are specified in DIN EN ISO 15883 Part 1 Washer-

disinfectors and DIN EN 285 Steam sterilisers (for boiler water).*

Various different testing and measuring devices are listed below to help you with this:

• pH test strips with colour chart

• pH meters for immersion in water to be tested

• Conductivity testers to determine salt content of water (to prevent deposits or corrosion forming on medical devices and washer-disinfectors/EWDs)

• Calibration and storage solutions for the pH meter and conductivity tester

* See DGSV's Central Service 5/2014 and 6/2014: Recommendations by the Quality Task Group (87 + 88)

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6 7 8 9 10

11 12 13 14 15

16 17 18 19 20

Testpack20 x verwendbar

Besonders zu beachten: Dieses Deckblatt ist Teil des Testpacks und wird mitsterilisiert.Testpack nur in ausgelüftetem Zustand wiederverwenden. Eintragungen mit wasserfestem Stift vornehmen.

REF xxxxx LOT xxxxx

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Bowie and Dick tests

The Bowie and Dick test is a daily steam penetration test that is performed for steam sterilisers with

pulsed flow vacuum processes. It verifies a complete air removal and consequent steam penetration. The

BD test is an alternative to the very time and material consuming cloth package. Interlock Medizintechnik

offers different kinds of standard compliant (DIN EN ISO 11140-4) tests for the quality management of

our sterilisation processes.

• Useful and time-saving single-use packages

• Sustainable multi-use solutions to be used along with clamping frames of diverse brands

• Indicator sheets for the application in multi-use packs are sold separately

Quality assurance – Bowie and Dick tests


a 04012 Interlock Bowie & Dick single use test pack Sterilisation program: Steam (134°C/3.5 min) according to EN ISO 11140-4 class 2 for sterilisers with pulsed flow vacuum process, for single use

1 unit

b 04200 Bowie & Dick multiple test pack for sterilisers with pulsed flow vacuum process – for TOLZIN clamping frame Format: 220 x 295 mm

Routine monitoring for steam sterilisation

DIN A4 without indicator for 20 applications

1 pack

c 04202 Bowie & Dick multiple test pack for sterilisers with pulsed flow vacuum process – for HAWO clamping frame Format: 220 x 295 mm



1 pack

d 04201 Bowie & Dick multiple test pack for sterilisers with pulsed flow vacuum process for TOLZIN clamping frame Format: 106 x 148 mm



1 pack

e 1001013 Routine monitoring – hollow load process chal-lenge test according to DIN EN ISO 11140

DIN A6 Bowie & Dick-Simtest test sheet pack: 50 indicator sheets/50 laminated sheets, for single use

1 pack

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NEW

NEW

Quality assurance – Interlock Routine monitoring systems

Routine checks using a PCD are not only required in DIN EN ISO 17665-1 but are also recommended

by the Robert Koch Institute to allow statements on air removal, steam quality and hollow load process

challenges to be made.

Interlock’s BDpro air removal test can be used as an alternative to the conventional Bowie & Dick test.

Interlock’s LCpro is a load control test for process monitoring of steam sterilisers with air removal via

pulsed fl ow pre-vacuum stages.

• Specially developed indicator system type 2 according to DIN EN ISO 11140-1

• Detection over long periods due to high colour stability of indicator strips and self-adhesive properties

of sterilised indicator strips

• High quality, durable materials

• Self-test to check PCD working properly

• Simple handling

• Perfect simulation since design mirrors a nested MIS instrument

REF Description Contents SU

a 08122 Interlock BDpro set • 1 PCD• 250 x 6-level indicators (REF 08123)• 1 holder• 1 sealing ring• Screw with sealing ring for self-test

1 pack

b 08126 Interlock BDpro tube • 1 PCD• 1 holder• Screw with sealing ring for self-test

1 pack

c 08123 Indicator Refi ll pack for 134°C - 3.5 min.(Compatible with REF 08122 & 08126)

• 250 x 6-level indicators• 1 sealing ring

1 pack

Interlock BDpro

as air removal test

Interlock LCpro

for batch control

REF Description Specifi cation SU

d 08120 Interlock LCpro set(121 °C – 15 min / 134 °C – 5 min)

• 1 PCD• 500 x 4-level indicators (REF 08121)• 1 holder• 2 sealing rings• Screw with sealing ring for self-test

1 pack

d 08145 Interlock LCpro set(134 °C – 18 min)

• 1 PCD• 500 x 4-level indicators (REF 08130)• 1 holder• 2 sealing rings• Screw with sealing ring for self-test

1 pack

e 08125 Interlock LCpro tube • 1 PCD• 1 holder• Screw with sealing ring for self-test

1 pack

f 08121 Indicator Refi ll pack for 121°C – 15min/134°C – 5 min. (Compatible with REF 08120 & 08125)

• 500 strips of 4-level indicators• 2 sealing rings

1 pack

g 08130 Indicator Refi ll pack for 134°C - 18 min.(Compatible with REF 08120 & 08125)

• 200 strips of 4-level indicators• 1 sealing ring

1 pack

REF 08026

INTEGRATOR

FAIL

PASS

EXCEEDED

LOT: 12.2017ISO 11140-1

EXP.: 2022-12Type 5

STEAM

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Quality assurance – Sterilisation batch control

Interlock provides suitable PCDs and indicators for batch monitoring in the steriliser.

• Helix test PCD and testing tubes for multiple use

• Ready-to-use test system for single use

• Multi-phase indicators for monitoring different parameters such as time, temperature or condensate

• Indicators for steam sterilisation, low temperature processes (FO, EO, H2O2) and hot air

• Special indicator for steam sterilisation in the Prion Program (CJD)


a 08003 Steam control indicator – type 2 Steam indicator for performing self checks. Sterilisation with saturated steam and at temperatures between 121°C and 134°C. Colour change from ochre-brown through grey to black. Size of individual indicator: 6 x 74 mm, self-adhesive. Test strips supplied make it easier to evaluate the indicator after sterilisation. Self-adhesive, 200 strips/box, with test specimen

1 box

b 08000 Unit load batch control – type 2 Steam: SMU-LC 121°C/134°C Sterilisation Monitoring Unit Load Control ready-to-use test system to monitor the steam sterilisation process of hollow medical instruments, for single use

50 units

c 08016 Steam indicator – type 6 Steam: 134°C / 3.5 mins | 121°C / 15 mins The emulating indicator reacts to all critical parameters. Parameters for steam sterilisation are: time, temperature and condensate (from saturated steam). For single use 250 units/box

1 box

d 08026 Three-phase indicator (steam) – type 5 Steam: 134°C/3.5 min. | 121°C/15 min. The blue indicator changes to black when exposed to steam. This change is not sufficient on its own and is des-ignated as UNSAFE. The pink indicator changes to black once the stated values for the critical variables for type 5 indicators are obtained. This is the case when the steam steriliser is able to ster-ilise at 134ºC for 3.5 minutes or at 121ºC for 15 minutes. This change is designated as OK. With longer sterilisation times or higher temperatures, the green indicator changes to dark brown or black. This situation is designated as OPTIMUM.For single use 250 pcs./box

1 box

e 08006 Formaldehyde indicator – type 2 Indicator for steam-formaldehyde sterilisation; colour change depends on formaldehyde concentration, expo-sure time and operating temperature. Format of individual indicator: 6 x 74 mm, self-adhesive. Colour strips includ-ed make it easier to evaluate the indicator after sterilisa-tion. Colour change from beige to violet. 200 strips/box, with PCD

1 box

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Quality assurance – Sterilisation batch control


a 08001 Hot air indicator – type 4 / thermotest H Indicator for hot air sterilisation. The strips undergo a complete change of colour from white to brown depending on time and temperature. A colour sample for an exposure time of 30 mins at 180°C is enclosed with each package. Format: 10 x 60 mm, for single use 200 strips/box

1 box

b 08002 Hot air indicator – type 4 / thermocontrol Indicator for hot air sterilisation, self-adhesive, with punch holes and perforation. To facilitate documentation, after sterilisation the individual strips can be stuck onto the five documentation sheets supplied. A test strip for an exposure time of 30 mins at 180°C makes it easier to evaluate the indicator. For single use Format: 9 x 48 mm 120 strips/box

1 box

c 08102 H2O2 indicator (plasma) – type 2 Indicator for plasma sterilisation (colour change from pink to yellow), self-adhesive 100 strips/box, with PCD

1 box

d 08051 Steam control indicator – type 5 Sterilisation program: Steam 134°C /18 minutes, self-adhesive, with PCD and colour strip, Format: 6 x 74 mmPack: 200 strips + 1 PCD

1 box

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Indicator dots and strips - type 1For single use

REF Format in mm

Indicator Self-adhesive

Description SU

a 01159 Ø 15 Steam Single Colour change: pink to brown 5000/reel

b 01165 Ø 15 Steam Single Colour change: blue to black, core Ø 40 mm 5000/reel

c 01401 Ø 10 Steam Single Colour change: pink to brown 10,000/reel

d 01195 Ø 9 Steam Single Colour change: pink to brown 10,000/reel

e 01410 20 x 170 Steam No Colour change: pink to brown, without slit, imprint: documentation field and indication of applicable standard and colour change

1000 units

f 01408 Ø 16 EO Single Colour change: white to yellow, 20 sheets each with 54 labels

1080 units

g 01414 Ø 15 EO Single Colour change: white to yellow 5000/reel

h 01415 100 x 50 FO Single Colour change: violet to green, 20 sheets each with 42 labels

840 units

i 01413 10 x 10 VH2O2 Single Colour change: yellow to blue, made of Tyvek, 20 sheets each with 25 labels

500 units

Interlock offers indicators in different designs for an additional quality control.

• Indicator spots for rapid confirmation of a performed sterilisation process

• Various counting strips as an easy to use tool for medical devices that can be reprocessed a certain

number of times only

• Quality control cards for your documentation and simple communication with the in-house interfaces

Quality assurance – Miscellaneous for quality assurance

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Quality documentation

REF Format in mm

Description Specification SU

a 01150 20 x 20 Insertion card for instrument trays

with steam indicator, colour change: pink to brown, imprint on both sides, for single use

1000 units

b 01154 45 x 45 Insertion card for instrument trays

with steam indicator, colour change: pink to brown, imprint on both sides, for single use

1000 units

c 01162 148 x 105 Sterilisation control card • Imprint: Sterilisation control, Datum / Date, Ladungs-Nr. / Load-No., Steri-No., Lot-No., Unterschrift / Signature, Etikett / Label, Menge / Quantity, Inhalt / Contents, Indicator accepted / not accepted • With steam indicator, colour change: light yellow to black • For single use

1000 units

d 09243 - Counting strips • Imprint: 1-10 (for 10 cycles)Made of plastic, washable, heat-resistant up to 134°C

200 units

e 09245 - Counting strips • Imprint: 11-20 (for 10 cycles)Made of plastic, washable, heat-resistant up to 134°C

200 units

f 09247 - Counting strips • Imprint: 1-10 (for 10 cycles)Made of silicone, washable, heat-resistant up to 134°C

100 units

Quality assurance – Miscellaneous for quality assurance

Interlock Medizintechnik GmbHZum Windpark 1 23738 Lensahn • GermanyTel.: +49 4363 905900Internet: www.interlockmed.com

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Other test equipment accessories

Quality assurance – Quality monitoring

REF Description Lens .5eter in mm

Magnifi-cation factor

Description SU

a 09973 LED magnifying glass (white) 9 W

150 2.25 x - Tabletop lamp with articulated arm (80 cm)- Attachment: Tabletop clamp with screw fitting- Clamping area 6.5 cm- On/Off switch on lamp- Hinged cover to protect the glass lens- Easy to clean- With internal springs- Light colour: Daylight (6500K)- Operating voltage 230 V- Dioptres: 5- 90 LEDs- Lamp included- Made of metal and plastic

1 unit

b 09978 Magnifying glass fluo-rescent ring

90 0.75 x and 4 x zoom

- Tabletop lamp with articulated arm - Attachment: Base - On/off switch integrated in base - Hinged cover to protect the glass lens - Easy to clean - With internal springs - Light colour: cold white - Operating voltage: 230 V - Dioptres: 3 and 12 - Lamp included- Made of sturdy plastic

1 unit

c 08529 Interlock magnifier card - - Non-sterile 50 units

c 08533 Interlock magnifier card - - Sterile packaging, for single use 50 units

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Other test equipment accessories

Quality assurance – Quality monitoring

REF Description Magnification factor

Description SU

a 09988 Replacement fluorescent ring

- compatible with REF 09978 1 unit

b 08514 Magnifying glass 2.5 x zoom - with 2-stage LED light - incl. 2 x 1.5 V AA batteries - case for safekeeping - can be wet-cleaned (e.g. with disinfection wipes)- made of aluminium

1 unit

c 08509 Monocular magnifying glass

10 x zoom for inspecting rigid endoscope lenses 1 unit

d 09987 Spring force scale 0-25N reading 1 unit

e 09800 Caliper gauge, digital - 6-digit jumbo LCD display - measuring range 0 - 150 mm - resolution 0.1 mm - metric/inch change-over - reset button - auto power-off function to conserve batteries - supplied with two 1.55 V button cells - in one stable box

1 unit

f 26045 Digital timer - with memory, countdown and stopwatch function- time range: 1s - 99 m 59s- battery not included

1 unit

REF Description SU

g 07500 Gauge with wire diameters: 0.7 - 3.0 mm 1 unit

Accessories for K-wires

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