Cleaning and sterilization

Guidelines for Nobel Biocare products

including MRI information
Note: In order to improve readability, Nobel Biocare does
not use ™ or ® in the running text. By doing so, however,
Nobel Biocare does not waive any right to the trademark
or registered mark and nothing herein shall be construed
to the contrary.

Disclaimer: Some products may not be regulatory

cleared / released for sale in your market. Please contact
your local Nobel Biocare office for current product
assortment and availability.
 Cleaning and sterilization guidelines 3

Contents

Introduction Purpose of this document and general information 4

Abbreviations5
Explanation of symbols on labels and instruction leaflets 6
Magnetic Resonance Imaging (MRI) information 7
Terms and definitions 9
Workflow 10

1 Point of use  12

2 Transport  13

3 Preparation and disassembly  14

4 Cleaning 4a Manual cleaning, disinfection and drying 15

4b Automated cleaning, disinfection and drying 20

5 Inspection  23

6 Assembly and packaging 6a Assembly and packaging of single devices 24

6b Assembly and packaging of kit boxes 25

7 Sterilization 7a Sterilization of single devices 26

7b Sterilization of kit boxes 28

8 Storage  30

Handpiece Zygoma 20:1 – specific cleaning  31

and sterilization guidelines

Appendices References 36
Cleaning agents and disinfectants 37
Examples for end of shelf life  38
Frequently asked questions 52
Customer service worldwide 55
4 Cleaning and sterilization guidelines // Introduction

Purpose of this document

and general information

Purpose of this document

This document gives general guidance on how medical devices
supplied by Nobel Biocare that are suitable for cleaning and
sterilization may be processed to prepare them for use. It also
gives guidelines for inspection to determine when an instru-
ment has reached the end of its serviceable life and must be
replaced.

General information Alternative methods of processing may be equally suitable.

The applicability of these guidelines for Nobel Biocare devices In the event of conflicting national cleaning and sterilization
is indicated on the respective labels and in the Instructions requirements, these shall prevail over Nobel Biocare
for Use (IFU), where applicable. For detailed explanations of recommendations.
the symbols, see page 6.
Equipment, operators, cleaning agents and procedures all
Where required, disassembly and assembly shall be performed contribute to the efficacy of the processing. The healthcare
in accordance with this document or applicable IFUs. facility should ensure that the combination actually in use
results in medical devices that are safe for use.
Nobel Biocare has demonstrated that the processes described
in these cleaning, disinfection and sterilization guidelines are The information on Nobel Biocare passive implants in MR
effective and that the devices are compatible with the environments is intended to provide the necessary data for
described methods. The guidelines are based on validated radiologists to perform safe diagnostic imaging.
processes. It is recommended to follow these instructions to
avoid affecting the performance of the products negatively. Note: According to EN ISO 17664 it remains the responsibility
Procedure manuals with an earlier publishing date will be of the processor to ensure that the reprocessing as actually
superseded by this document with regards to cleaning, performed using equipment, materials and personnel in the
disinfection and sterilization. Wherever the Instructions for reprocessing facility achieves the desired result. Likewise any
Use for a specific product show other procedure conditions, deviation by the processor from the instructions provided
these will supersede the recommendations given in these should be properly evaluated for effectiveness and potential
general guidelines. adverse consequences.
 Cleaning and sterilization guidelines // Introduction 5

Abbreviations

°C Degree Celsius
°F Degree Fahrenheit
AAMI Association for the Advancement of Medical Instrumentation
ANSI American Nation Standards Institute
ASTM American Society for Testing and Materials
CFR Code of Federal Regulations
CFU Colony Forming Unit
CSA Canadian Standards Association
DIN Deutsches Institut für Normung (German Institute for Standardization)
EN European Norms
EU Endotoxin Units
FDA US Food and Drug Administration
IFU Instructions for Use
ISO International Standards Organisation
MR Magnetic Resonance
MRI Magnetic Resonance Imaging
PEEK Polyether Ether Ketone
PMMA Polymethyl Methacrylate
PPSU Polyphenylsulfone
RKI Robert Koch Institute
SAR Specific Absorption Rate
6 Cleaning and sterilization guidelines // Introduction

Explanation of symbols on
labels and instruction leaflets

Batch code Legal manufacturer

Sterilized using irradiation Catalog number

Non-sterile Caution
Medical device has not been subjected to a Consult the Instructions for Use for important
sterilization process cautionary information

Do not resterilize Consult Instructions for Use

Devices are not designed to perform as in-
tended after the first usage or an additional
sterilization process. Changes in mechanical,
physical or chemical characteristics introduced
under conditions of repeated use, cleaning
and/or resterilization may compromise the in- Open the package like this
tegrity of the design and/or material, leading
to diminished safety, performance and/or
compliance with relevant specifications.
MR Safe
Device poses no known hazards in all
MR environments

Do not reuse
When "Do not reuse" devices are supplied MR Conditional
non-sterile and require sterilization prior to Device poses no known hazards in a
usage, the appropriate sections in these specified MR environment with specified
guidelines may be applied. conditions of use

Do not use if package is damaged CE-mark and Notified Body number

Use by Rx only
Indicates the date after which the medical Federal Law (US) restricts this product
device is not to be used to sale by or on the order of a dentist
or physician
 Cleaning and sterilization guidelines // Introduction 7

Magnetic Resonance Imaging (MRI) information

The following definitions of Magnetic Resonance (MR) Safe and MR Conditional have been developed by
the American Society for Testing and Materials (ASTM) International.1
This section is intended to provide MR symbol information and is not intended to make any MR claims. It is meant to
provide additional information regarding the MR symbol and other MR related information and is not intended to be
device specific. Please review the device labeling for specific MRI information.

MR Safe
Items that pose no known hazards in all MRI environments
are labeled MR Safe. This includes all Nobel Biocare products
that are non-conducting, non-metallic and non-magnetic.
Examples are abutments, crowns and bridges made of
ceramic, temporary abutments made of PEEK and healing
caps made of nylon.

Items marked with the MR Safe icon may be taken into, used
or placed anywhere within any MRI environment without
causing any additional risk to the patient or any other individual.

MR Conditional
Items that have been demonstrated to pose no known hazards
in a specified MRI environment with specified conditions of
use are labeled MR Conditional.

A patient with such a device may be scanned safely after

placement under the following conditions:
– Static magnetic field of 1.5–3.0 Tesla
– Maximum spatial gradient magnetic field of 4000 Gauss/cm
(40 T/m)
– Maximum MR system reported, whole body averaged
specific absorption rate (SAR) of 4 W/kg (First Level
Controlled Mode)
– Normal operating mode of the MR system

1 American Society for Testing and Materials (ASTM) International, Designation: F2503. Standard Practice for Marking Medical Devices and Other Items for
Safety in the Magnetic Resonance Environment. ASTM International, West Conshohocken, PA, 2005
8 Cleaning and sterilization guidelines // Introduction

MRI-related heating
In non-clinical worst-case testing, some metallic Nobel Biocare
products caused the following maximum temperature rises dur-
ing 15 minutes of MRI scanning with 1.5 and 3.0 Tesla.
The raised temperature does not pose any known hazard to the
patient.

1.5 Tesla 3.0 Tesla

64 MHz 128 MHz

Maximum MR system, whole body averaged SAR 4 W/kg 4 W/kg

Calorimetry measured values, whole body 2.1 W/kg 2.7 W/kg

averaged SAR

Highest temperature change (all tests) +4.1˚C +2.9˚C

Maximum spatial gradient magnetic field 4000 W/kg 4000 W/kg

Test system Magnetom (active-shielded, horizontal field scanner) Excite, HDx

Software Numaris/4, Version Syngo MR 2002B DHHS Software 14X.M5
Siemens Medical Solutions, Malvern, PA, USA General Electric Healthcare, Milwaukee, WI, USA

Artifact information
The quality of the MR image may be compromised, if the
area of interest is in the same area or relatively close to the
position of the MR-conditional device. It may therefore be
necessary to optimize the MR imaging parameters to com-
pensate for the presence of the device. The maximum artifact
size (as seen on the gradient echo pulse sequence) extends
up to approximately 30 mm relative to the size and shape of
the device.

Pulse sequence T1-SE* T1-SE GRE** GRE

Plane orientation Parallel Perpendicular Parallel Perpendicular

Signal void size*** 2754 mm2 2229 mm2 4458 mm2 5463 mm2

* T1-SE: Longitudinal relaxation, spin-echo sequence

** GRE (low flip angle): Gradient-echo MRI sequence
*** Maximum void size found in all tests

Notes:
– Removable restorations should be taken out prior to scan-
ning, as is done with watches, jewelry etc.
– Polymeric (e.g., PEEK, PMMA, PPSU) and ceramic devices
are considered to be MR Safe. However, if the restoration
consists of multiple parts, it must be classified according to
the component with the lowest safety level.
 Cleaning and sterilization guidelines // Introduction 9

Terms and definitions

To avoid misunderstandings of the most frequently used terms, the meaning

of each of these terms inside this document is listed:

Pre-cleaning
Wiping or rinsing the device to remove gross soil, blood and
tissue before the initial cleaning process starts.

Cleaning
Removal of visible soil (e.g., organic and inorganic material).
This is normally accomplished manually or mechanically us-
ing water with detergents or enzymatic products. Thorough
cleaning is essential prior to disinfection and sterilization, as
inorganic and organic materials that remain on the surfaces of
instruments interfere with the effectiveness of the described
processes.

After cleaning no visible contamination shall be found by

inspection with the naked eye under good light conditions.
Special attention must be given to edges, lumina, hollows
and other soil traps.

Decontamination
Removal of pathogenic microorganisms from objects so that
the devices are safe to handle, use or discard.

Disinfection
A process that kills most disease-producing microorganisms,
but not necessarily all microbial forms (e.g., bacterial spores).

Sterilization
A validated process used to render a product free from viable
microorganisms.

Note: In a sterilization process, the nature of microbial death

is described by a mathematical function. Therefore, the
presence of microorganisms on any specific device can be
expressed in terms of probability. While this probability can be
reduced to a very low number, it can never be reduced to zero.
10 Cleaning and sterilization guidelines // Introduction

Workflow

The preparation for reuse of medical devices or for initial use of new devices requires a
sequence of processing steps shown in this workflow. More detailed instructions for each step are given
on the following pages. The circled numbers refer to the corresponding section in these guidelines.

– Handle devices with tweezers

1 Point of use – Remove gross soil
– Dispose devices if needed

– Avoid mechanical damage

2 Transport – Minimize time before cleaning
– Immerse devices in cleaning solution if needed

Preparation and – Disassemble devices if applicable

3 – Disassemble kit boxes completely
disassembly

– Remove debris in lukewarm water and – Remove debris in lukewarm water and
immerse devices in cleaning solution immerse devices in cleaning solution
– Scrub with soft bristled nylon brush – Scrub with soft bristled nylon brush
– Flush reusable devices with channels/ Automated cleaning, – Flush reusable devices with channels/
Manual cleaning, lumina using cleaning solution lumina using cleaning solution
4a – Immerse in ultrasonic bath 4b disinfection and drying – Rinse with tap water
disinfection and drying – Rinse & flush with purified or sterile water
(incl. pre-cleaning)
– Immerse in disinfection solution – Load devices into thermodisinfector
– Flush internal channels/lumina with disinfection solution – Run cleaning and disinfection cycle
– Rinse and flush with purified or sterile water – Run drying cycle
– Dry with compressed air or wipes – Dry with compressed air or wipes if needed

Inspection, – Inspect devices visually

5 assembly of devices – Perform functional check

– Assemble devices and seal them – Assemble devices and kit box
Packaging of Assembly and
6a in pouches 6b – Place kit box into pouch
single devices – Label pouches packaging of kit boxes – Label pouch

Pre-vacuum Pre-vacuum
3 pre-vacuum cycles <60 mbar 3 pre-vacuum cycles <60 mbar
USA: sterilization at 270 °F (132 °C) for USA: sterilization at 270 °F (132 °C) for
4 mins; drying time 20 – 30 mins 4 mins; drying time 30 mins
Outside USA: sterilization at 132 °C / Outside USA: sterilization at 132 °C /
max. 137 °C (270 °F / max. 279 °F) for max. 137 °C (270 °F / max. 279 °F) for
3 mins*; drying time 10 mins in chamber 4 mins*; drying time 30 mins in chamber
UK: sterilization at 134 °C / max. 137 °C UK: sterilization at 134 °C / max. 137 °C
(273 °F / max. 279 °F) for 3 mins*; (273 °F / max. 279 °F) for 3 mins*;
drying time 10 mins in chamber drying time 10 mins in chamber
7a Sterilization 7b Sterilization
Gravity Gravity
USA: sterilization at 270 °F (132 °C) for USA: sterilization at 270 °F (132 °C) for
15 mins; drying time 15 – 30 mins 15 mins; drying time 30 mins
Outside USA: sterilization at 132 °C / Outside USA: sterilization at 132 °C /
max. 137 °C (270 °F / max. 279 °F) for max. 137 °C (270 °F / max. 279 °F) for
3 mins*; drying time 10 mins in chamber 15 mins*; drying time 30 mins in chamber
UK: sterilization at 134 °C / max. 137 °C UK: sterilization at 134 °C / max. 137 °C
(273 °F / max. 279 °F) for 3 mins*; (273 °F / max. 279 °F) for 15 mins*;
drying time 10 mins in chamber drying time 30 mins in chamber

– Control storage conditions

8 Storage – Control shelf life

  Following the recommendations of the Robert Koch Institute (RKI), the exposure time can be extended up to 20 minutes.
*
 Cleaning and sterilization guidelines // Introduction 11

The preparation for reuse of medical devices or for initial use of new devices requires a
sequence of processing steps shown in this workflow. More detailed instructions for each step are given
on the following pages. The circled numbers refer to the corresponding section in these guidelines.

Two evaluated methods for cleaning Whenever possible the automated method should be used.
Nobel Biocare has evaluated two methods for cleaning The automated cleaning process is more reproducible and
medical devices, and appropriate instructions are provided therefore more reliable. In addition, staff is less exposed to
in these guidelines: contaminated devices and cleaning agents.
– Manual method
– Method using an automated thermodisinfector

Protective clothing and equipment

Whichever method is used, staff should use suitable protec-
tive clothing and equipment at all times.

In particular, take note of the instructions provided by the

cleaning agent manufacturer for correct handling and use of
the product.

Cleaning agents and disinfectants The guidelines for concentrations and times for device im-
For cleaning or disinfecting medical devices only specifically mersion in the cleaning solutions and/or disinfectants given
formulated cleaning agents and/or disinfectants (detergents) by the detergent manufacturers must be observed. If these
should be used. concentrations and times are significantly exceeded, discolor-
ation or corrosion could occur with some materials. This
Since not all cleaning agents and disinfectants may be available could also happen if rinsing after cleaning and/or disinfecting
worldwide, criteria for the selection of appropriate detergents is insufficient.
are provided in the appendix. A list of cleaning agents and
disinfectants that Nobel Biocare used in the validation of
these cleaning and sterilization guidelines is also provided
(see page 37). Nobel Biocare does not recommend any specific
cleaning and/or disinfection agents.

Water quality
The quality of the water used for diluting cleaning agents Mineral residues from hard water as well as higher contamina-
and/or disinfectants and for rinsing medical devices should tion with microorganisms and endotoxins can result in staining
be carefully considered. Application of freshly prepared of the device or prevent effective cleaning and disinfection.
purified water / highly purified water or sterile water for
rinsing purposes (according to the pharmacopeias) with
less than 10 cfu/ml and 0.25 EU/ml is highly recommended.
12 Cleaning and sterilization guidelines // Point of use

1 Point of use

1 Handle devices with tweezers

To avoid contamination of the kit box (mainly the instrument
plate) and damage of the sterile gloves by the sharp drills,
it is recommended to pick up the devices using a pair of
tweezers.

2 Remove gross soil

Directly after use of reuseable tools (within a maximum of
1 hour postoperatively), remove gross soil using absorbent
paper wipes. Additionally, intensive rinsing of the medical
devices with running water is recommended.

3 Dispose devices if needed

Sharp and cutting single-use products, dull multi-use drills,
worn out tools, etc., must be properly disposed of in the sur-
gery room, in containers specially designed for this purpose.
 Cleaning and sterilization guidelines // Transport 13

2 Transport

1 Avoid mechanical damage

Avoid mechanical damage, e.g., do not mix heavy devices
with delicate ones. Pay particular attention to cutting
edges, both to avoid injury and to avoid damage to the
medical devices.

2 Minimize time before cleaning

Get the medical devices to the point where cleaning is to be
performed as soon as practical. If transfer to the processing
area is likely to be delayed, consider covering the medical
devices with a damp cloth or store the medical devices in
closed boxes to avoid drying of soil and/or debris.

3 Immerse devices in cleaning solution if needed

When longer delays are expected, immerse the devices in
a bath of a lukewarm cleaning solution to avoid drying of soil
and/or debris.
14 Cleaning and sterilization guidelines // Preparation and disassembly

3 Preparation and disassembly

1 Disassemble devices
Demountable devices must be disassembled prior to cleaning:
– Abutment Retrieval Instrument Zirconia
(see IFU for instructions)
– Manual Torque Wrench Surgical and Prosthetic
(see IFU for instructions)
– Impression Coping Open Tray
– Impression Coping Closed Tray
– Handle for Guided Drill Guide
– Guided Template Abutment
– Guided Implant Mount
– Drill Stop

2 Disassemble kit boxes completely

Kit boxes must be disassembled completely before cleaning
and disinfection.

Note: It is recommended that the grommets are disassem-

bled.
 Cleaning and sterilization guidelines // Cleaning 15

4a Manual cleaning, disinfection and drying

Cleaning procedure

Required equipment
–U  ltrasonic bath large enough to allow complete immersion of
the devices; frequency 25–50 kHz, temperature according to
detergent manufacturer’s instructions.
– Cleaning agent intended for manual cleaning and suitable
for ultrasonic treatment, meeting the criteria given on page
37; concentration as specified in detergent manufacturer’s
instructions.
– Soft nylon brushes, syringes (20 ml), irrigation needles,
absorbent paper, etc.
– Freshly prepared purified water / highly purified water or
sterile water for rinsing purposes.
– Personal protective equipment as recommended by the
cleaning agent supplier (minimum water impermeable
protection gown, gloves, face/eye shield).

1 Remove debris in lukewarm water and immerse

devices in cleaning solution
Remove residual tissue or bone debris by immersing the
used instruments in lukewarm water (<40°C/104°F). Do not
use fixation agents or hot water (>40°C/104°F) as this could
influence subsequent cleaning results. Instruments should be
kept in a wet environment until the next step is initiated.

Immerse the instruments in an enzymatic cleaning solution

(e.g., enzymatic detergent with a pH level between 7–10)
prepared with lukewarm tap water. Follow the detergent
manufacturer’s instructions.

Cleaning agents are commercially available. For a general

description of suitable agents see page 37.
16 Cleaning and sterilization guidelines // Cleaning

2 Scrub devices with soft bristled nylon brush

Scrub the outer and, if applicable, the inner side of the
instruments with a soft bristled nylon brush under cold tap
water until all visible soil and debris is removed. Pay particular
attention to features that may be shielded from the brushing
action.

3 Flush reusable devices with channels/lumina using

cleaning solution
Flush the internal channels/lumina with 20 ml cleaning solution
using the irrigation needle (provided either with the surgical
kit or purchased separately) connected to a 20 ml syringe.
Check the channels/lumina for residual soil and/or debris.

Note: The irrigation needle must pass the silicone barrier in

the middle of the drills with irrigation holes.

4 Immerse in ultrasonic bath

Prepare an ultrasonic bath with a cleaning solution at the
concentration and temperature specified in the detergent
manufacturer’s instructions.

Immerse the device completely and activate the bath for

at least the time specified in the detergent manufacturer’s
instructions.

Notes:
– Avoid direct contact of the instruments with sharp cutting
edges during ultrasonic treatment so as not to damage
devices or reduce shelf life (e.g., drills).
– Detergent used in Nobel Biocare validation see page 37.
 Cleaning and sterilization guidelines // Cleaning 17

5 Rinse with purified or sterile water

Rinse for at least 1 minute with freshly prepared purified
­water / highly purified water or sterile water until all traces of
cleaning solution are removed.

6 Flush internal channels/lumina

with purified or sterile water
Flush the internal channels/lumina with 20 ml freshly pre-
pared purified water / highly purified water or sterile water
­using the irrigation needle (provided with the surgical kit or
purchased separately) connected to a 20 ml syringe.

Note: The irrigation needle must pass the silicone barrier

in the middle of the drills with irrigation holes.

7 Repeat cleaning steps if needed

If encrusted soil and/or debris remain on the device after
cleaning, repeat all cleaning steps from 1 to 6.
18 Cleaning and sterilization guidelines // Cleaning

Disinfection and drying procedure

Required equipment
– Bath large enough to allow complete immersion of the
devices; temperature according to detergent manufacturer’s
instructions.
– Disinfection agent intended for manual disinfection and
compatible with the applied cleaning detergent meeting the
criteria given on page 37; concentration as specified in
detergent manufacturer’s instructions.
– Syringe (20 ml) together with the irrigation needle (provided
with the surgical kit or purchased separately).
– Freshly prepared purified water / highly purified water or
sterile water for rinsing purposes.
– Filtered medical compressed air (if available) or clean and
lint-free single-use wipes.
– Personal protective equipment as recommended by the
cleaning agent supplier (minimum water impermeable
protection gown, gloves, face/eye shield).

Note: The use of an ultrasonic bath is recommended.

8 Immerse in disinfection solution

Prepare a bath with a disinfection solution at the concentra-
tion and temperature specified in the detergent manufac-
turer’s instructions.

Ensure all lumina are filled with the disinfection solution and
all surfaces are wetted with it.

Immerse the devices for at least the time specified in the

detergent manufacturer’s instructions.

Note: Detergent used in Nobel Biocare validation see

page 37.
 Cleaning and sterilization guidelines // Cleaning 19

9 Flush internal channels/lumina

with disinfection ­solution
Flush the internal channels/lumina a minimum of three times
with 20 ml disinfection solution using the irrigation needle
(provided with the surgical kit or purchased separately)
connected to a 20 ml syringe.

Note: The irrigation needle must pass the silicone barrier in

the middle of the drills with irrigation holes.

10 Rinse with purified or sterile water

Thoroughly rinse the device for a minimum of 1 minute with
freshly prepared purified water / highly purified water or
sterile water. Remove the device and discard the rinse water.
Repeat this stage another two times, for a total of three
rinses. Do not reuse the water. Always use fresh volumes
of water for each rinse.

11 Flush internal channels/lumina

with purified or sterile water
Flush the internal channels/lumina a minimum of three times
with 20 ml freshly prepared purified water / highly purified
water or sterile water using the irrigation needle (provided
with the surgical kit or purchased separately) connected to
a 20 ml syringe.

Note: The irrigation needle must pass the silicone barrier in

the middle of the drills with irrigation holes.

12 Dry with compressed air or wipes

Dry the medical devices using medical compressed air and
clean and lint-free single-use wipes.

13 Repeat complete cleaning and disinfection if needed

Visually inspect and repeat complete manual cleaning and
disinfection if necessary.
20 Cleaning and sterilization guidelines // Cleaning

4b Automated cleaning, disinfection

and drying (incl. pre-cleaning)

Pre-cleaning

Required equipment
– Ultrasonic bath large enough to allow complete immersion
of the devices; frequency 25–50 kHz, temperature
according to detergent manufacturer’s instructions.
– Cleaning agent intended for manual cleaning and suitable
for ultrasonic treatment, meeting the criteria given on page
37; concentration as specified in detergent manufacturer’s
instructions.
– Soft nylon brushes, syringes (20 ml), irrigation needles,
absorbent paper, etc.
–P  ersonal protective equipment as recommended by the
cleaning agent supplier (minimum water impermeable
protection gown, gloves, face/eye shield).

1 Remove debris in lukewarm water and immerse

devices in cleaning solution
Remove residual tissue or bone debris by immersing the used
instruments in lukewarm water (<40°C/104°F). Do not use
fixation agents or hot water (>40°C/104°F) as this could
influence subsequent cleaning results. Instruments should
be kept in a wet environment until the next step is initiated.

In case of highly contaminated medical devices to be subjected

to an automatic cleaning process, pre-cleaning in an ultrasonic
bath is recommended.

Immerse the instruments in an enzymatic cleaning solution

(e.g., enzymatic detergent with a pH level between 7–10)
prepared with lukewarm tap water. Immersion time not less
than specified in the detergent manufacturer’s instructions
(temperature not exceeding 40°C/104°F).

Cleaning agents are commercially available. For a general

description of suitable agents see page 37.

Note: Detergent used in Nobel Biocare validation see

page 37.
 Cleaning and sterilization guidelines // Cleaning 21

2 Scrub devices with soft bristled nylon brush

Scrub the outer and, if applicable, the inner side of the instru-
ments with a soft bristled nylon brush until all visible soil and
debris is removed. Pay particular attention to features that
may be shielded from the brushing action.

3 Flush reusable devices with channels/lumina using

cleaning solution
Flush the internal channels/lumina with 20 ml cleaning solution
using the irrigation needle (provided with the surgical kit or
purchased separately) connected to a 20 ml syringe. Check
the channels/lumina for residual soil and/or debris.

Note: The irrigation needle must pass the silicone barrier in

the middle of the drills with irrigation holes.

4 Rinse with tap water

To remove all cleaning solution:
– Rinse the outer surface with cold tap water.
– Flush the lumina with cold tap water using a 20 ml syringe
connected to an irrigation needle.

Note: The irrigation needle must pass the silicone barrier in

the middle of the drills with irrigation holes.
22 Cleaning and sterilization guidelines // Cleaning

Automated cleaning, disinfection and drying

5 Load devices into washer/disinfector

After pre-cleaning, place the instruments in an instrument
tray or on an instrument rack and load them into the
washer/disinfector.

Note: Kit boxes must be disassembled completely before

cleaning and disinfection. It is recommended that the grom-
mets are disassembled.

6 Run cleaning and disinfection cycle

Follow the instructions provided by the manufacturers of the
washing machines.

The following parameters were used in Nobel Biocare validation

(Miele G7735 CD / Miele G7836 CD; cleaning Program Vario TD):
– 2 minutes pre-cleaning with cold tap water
– Draining
– 5 minutes cleaning at 55°C/131°F tap water with a 0.5%
solution of alkaline cleaning agent (e.g., neodisher®
MediClean)
– Draining
– 3 minutes neutralization with tap water
– Draining
– 2 minutes intermediate rinsing with cold tap water
– Draining

Note: Detergents used in Nobel Biocare validation see page 37.

7 Run drying cycle

Dry the outer side of the instruments through drying cycle of
washer/disinfector.

8 Dry with compressed air or wipes if needed

If needed, additional manual drying can be performed with
clean and lint-free single-use wipes. Insufflate cavities, chan-
nels or lumina of the disinfected parts can be dried by using
sterile compressed air.
 Cleaning and sterilization guidelines // Inspection and assembly 23

5 Inspection

1 Inspect devices visually

Before preparing for sterilization, all medical devices should Particular attention should be paid to:
be inspected. Generally, unmagnified visual inspection ­under – Soil “traps” such as mating surfaces and shafts of reamers.
good light conditions is sufficient. All parts of the devices – Recessed features like channels/lumina and threads.
should be checked for visible soil and/or corrosion. – Features where soil may be pressed into contact with
the device, e.g., drill flutes adjacent to the cutting tip.
Following questions need to be answered (if applicable):
– Is the device visibly clean?
– Are the cutting edges dull or worn out?
– Are the fittings deformed?
– Are any parts broken?
– Have any parts fallen apart?
– Is there any rust or corrosion?

Check that the device has not reached the end of its shelf
life. Please find examples in the appendix on pages 38–51.

2 Perform functional check Notes:

– Check mating devices for proper assembly. – Nobel Biocare does usually not define the maximum num-
– Perform a functional check with devices with moving parts ber of uses appropriate for reusable medical devices. The
to ensure proper function (e.g., manual torque wrench). useful life of these devices depends on a number of factors
– Check drills for sharpness and damages (for examples see including the method and duration of each use and the
pages 42-44). handling between uses.
– Careful inspection and functional testing of the device
before use is the best method for determining the end of
serviceable life for the medical device.
– Single-use devices that must be cleaned, disinfected and
sterilized prior to use are not intended to be reused.
24 Cleaning and sterilization guidelines // Packaging

6a Assembly and packaging of single devices

1 Assemble devices and seal them in pouches

Where appropriate, the cleaned, disinfected and checked The packaging for thermal sterilized medical devices should
medical devices should be assembled. fulfill the following requirements:
– ISO 11607 and/or DIN 58953-7.
To sterilize abutments, screws, crowns, bridges and instruments – Suitable for steam sterilization (temperature resistance up
place them in sterilization pouches for further processing. to at least 137°C/279°F, sufficient steam permeability).
– Sufficient protection of the instruments and sterilization
Note: Instruments with sharp or cutting edges like drills must packaging from mechanical damage.
be packed separately in pouches if they are not placed in a kit – For USA: Use FDA-cleared sterilization accessories.
box.

2 Label pouches
It is common practice to label the pouches with the following:
– Expiration date
– Name of the person who packed the devices
– Lot (if applicable)
– “Sterile” and the sterilization method (if several methods
are available).

For packages without a clear window for identifying the

devices inside, it is recommended that the following be
added to the above-mentioned information:
– Product name with article number
– Number of devices
 Cleaning and sterilization guidelines // Packaging 25

6b Assembly and packaging of kit boxes

1 Assemble devices and kit box

Where appropriate, the cleaned, disinfected, and checked
medical devices should be assembled.

Reassemble the surgical and prosthetic kit boxes and mount

the instruments in the silicone grommets / brackets.

2 Place kit box into pouch

Place the kit box in a sterilization pouch.

The packaging for thermal sterilized medical devices should

fulfill the following requirements:
– ISO 11607 and/or DIN 58953-7.
– Suitable for steam sterilization (temperature resistance up
to at least 137°C/279°F, sufficient steam permeability).
– Sufficient protection of the instruments as well as of the
sterilization packaging to mechanical damage.
– For USA: Use FDA-cleared sterilization accessories.

3 Label pouch
It is common practice to label the pouches/packages with the
following:
– Expiration date
– Name of the person who packed the devices
– Lot (if applicable)
– “Sterile” and the sterilization method (if several methods
are available)

For packages without a clear window for identifying the

devices inside, it is recommended that the following be
added to the above-mentioned information:
– Product name with article number
– Number of devices
26 Cleaning and sterilization guidelines // Sterilization

7a Sterilization of single devices

Most heat sterilization methods have been validated by For USA: FDA-cleared sterilization accessories are to be used
Nobel Biocare including pre-vacuum, gravity, saturated steam for the recommended sterilization parameters.
and saturated steam with fractional forced air removal.
For devices made of zirconia, the presence of steam may
However, autoclave design and performance can affect the impair the long-term performance of the device, as it triggers
efficacy of the process. Healthcare facilities should validate the so-called low temperature degradation or aging of tetrag-
the processes that they use, employing the actual equipment onal zirconia. Therefore the number of sterilization cycles is to
and operators that routinely process the devices. be kept as low as necessary.

All autoclaves/sterilizers should comply with the requirements

of, and be validated, maintained and checked in
accordance with SN EN 13060, EN 285, EN ISO 17665-1,
AAMI ST79 or your national standard.

When loading the autoclave with several blister packages or

pouches, place them in an upright position, side by side, with
the clear foil surfaces facing each other.

The parameters recommended in this section in general are Note: With these cleaning and sterilization guidelines,
applicable to the Nobel Biocare portfolio. Always consult the Nobel Biocare provides a validated procedure to ensure clean
Instructions for Use in case of exceptions. and sterile products. According to EN ISO 17664, it remains
the responsibility of the processor to ensure that the reprocess-
If you are in doubt about the applicable sterilization para­meters ing as actually performed using equipment, materials and per-
for a particular product, consult the specific Instructions for sonnel in the reprocessing facility achieves the desired result.
Use or contact your local Nobel Biocare sales office. Likewise any deviation by the processor from the instructions
provided should be properly evaluated for effectiveness and
potential adverse consequences.
 Cleaning and sterilization guidelines // Sterilization 27

Recommended sterilization parameters for single devices sealed in pouches

USA
Method Moist heat sterilization
Cycle Pre-vacuum Gravity
Temperature 270°F (132°C)
Exposure time 4 minutes 15 minutes
Pre-vacuum 3 times < 60 mbar N/A
Drying time 20 – 30 minutes 15 – 30 minutes
Cooling time 10 minutes at room temperature

Outside USA
Method Moist heat sterilization according to ISO 17665
Cycle Saturated steam with Saturated steam
fractional forced air removal
Temperature 132°C (270°F)
Temperature max. 137°C (279°F)
Exposure time 3 minutes*
Pre-vacuum 3 times < 60 mbar N/A
Drying time 10 minutes in chamber

Alternative UK
Method Moist heat sterilization according to ISO 17665
Cycle Saturated steam with Saturated steam
fractional forced air removal
Temperature 134°C (273°F)
Temperature max. 137°C (279°F)
Exposure time 3 minutes*
Pre-vacuum 3 times < 60 mbar N/A
Drying time 10 minutes in chamber

Special instructions for Ratchet

Seal the Ratchet (art.no. 2080) in a pouch and sterilize at 135°C (275°F) for 20 minutes with gravity cycle.
Drying time minimum 5 minutes.

*Following the recommendations of the Robert Koch Institute (RKI), the exposure time can be extended up to 20 minutes.
28 Cleaning and sterilization guidelines // Sterilization

7b Sterilization of kit boxes

Most heat sterilization methods have been validated by All autoclaves/sterilizers should comply with the requirements
Nobel Biocare including pre-vacuum, gravity, saturated steam of, and be validated, maintained and checked in accordance
and saturated steam with fractional forced air removal. with, SN EN 13060, EN 285, EN ISO 17665-1, AAMI ST79 or
your national standard.
However, autoclave design and performance can affect the
efficacy of the process. Healthcare facilities should therefore For USA: FDA-cleared sterilization accessories are to be used
validate the processes that they use, employing the actual for the recommended sterilization parameters.
equipment and operators that routinely process the devices.

Complete kit boxes with tools and assembled instruments

must be sterilized in their “ready for use” state. There is
no need to disassemble these instruments for sterilization.
The process parameters shown are validated and recom-
mended by Nobel Biocare for sterilization.

The parameters recommended in this section in general are

applicable to the Nobel Biocare portfolio. Always consult the
Instructions for Use in case of exceptions.

If you are in doubt about the applicable sterilization para­meters

for a particular product, consult the specific Instructions for
Use or contact your local Nobel Biocare sales office.

With these cleaning and sterilization guidelines, Nobel Biocare

provides a validated procedure to ensure clean and sterile prod-
ucts. According to EN ISO 17664, it remains the responsibility
of the processor to ensure that the reprocessing as actually
performed using equipment, materials and personnel in the
reprocessing facility achieves the desired result. Likewise any
deviation by the processor from the instructions provided
should be properly evaluated for effectiveness and potential
adverse consequences.
 Cleaning and sterilization guidelines // Sterilization 29

Recommended sterilization parameters for devices mounted in kit boxes and sealed in pouches

USA
Method Moist heat sterilization
Cycle Pre-vacuum Gravity
Temperature 270°F (132°C)
Exposure time 4 minutes 15 minutes
Pre-vacuum 3 times < 60 mbar N/A
Drying time 30 minutes
Cooling time 10 minutes at room temperature

Outside USA
Method Moist heat sterilization according to ISO 17665
Cycle Saturated steam with Saturated steam
fractional forced air removal
Temperature 132°C (270°F)
Temperature max. 137°C (279°F)
Exposure time 4 minutes* 15 minutes*
Pre-vacuum 3 times < 60 mbar N/A
Drying time 30 minutes in chamber

Alternative UK
Method Moist heat sterilization according to ISO 17665
Cycle Saturated steam with Saturated steam
fractional forced air removal
Temperature 134°C (273°F)
Temperature max. 137°C (279°F)
Exposure time 3 minutes* 15 minutes*
Pre-vacuum 3 times < 60 mbar N/A
Drying time 10 minutes in chamber 30 minutes in chamber

*Following the recommendations of the Robert Koch Institute (RKI), the exposure time can be extended up to 20 minutes.
30 Cleaning and sterilization guidelines // Storage

8 Storage

After sterilization, place the devices in a dry and dark place

such as a closed cupboard or drawer.

Follow the instructions of the manufacturer of the pouches

regarding storage conditions and expiration date of sterilized
goods.
 Cleaning and sterilization guidelines // Handpiece Zygoma 20:1 31

Handpiece Zygoma 20:1 – specific cleaning

and sterilization guidelines

1 Pre-cleaning

Required equipment
– Piece of cloth.
– Soft bristled brush.
– Ultrasonic bath.
– Cleaning agent suitable for ultrasonic treatment, meeting
the criteria given on page 37; concentrations as specified in
detergent manufacturer's instructions.
– Personal protective equipment as recommended by the
cleaning agent supplier (minimum water impermeable pro-
tection gown, gloves, face/eye shield).

1 Wipe with a cloth

Remove gross contamination by wiping the Handpiece
Zygoma with a wetted piece of cloth.

2 Brush under lukewarm water

Brush the Handpiece Zygoma under running lukewarm tap
water with a soft bristled brush until all visible contamination
(blood, residual tissue or bone debris) is removed.

3 Immerse in cleaning solution

Prepare an ultrasonic bath with a cleaning solution at the
concentration and temperature specified in the detergent
manufacturer’s instructions. Place the device so that three
quarters of the Handpiece Zygoma are immersed in the
cleaning solution.

Activate the bath for at least the time specified in the deter-
gent manufacturer’s instructions.

Notes:
− Place the Handpiece Zygoma vertically into the solution.
Do not place it horizontally to avoid contact of fluid with the
inner components.
− Detergent used in Nobel Biocare validation see page 37.
32 Cleaning and sterilization guidelines // Handpiece Zygoma 20:1

2a – Manual cleaning

Required equipment
– Water jet gun.
– Adapter, e.g., piece of a flexible plastic tube (see picture).
– Compressed air supply.

1 Rinse outer surface with water jet gun

Rinse the outer surface of the Handpiece Zygoma with
a water jet gun. Pay special attention to the gaps near
the locking mechanism. Repeat this step three times for
5 seconds each (static pressure 3–4 bar).

2 Flush lumen
Connect the lumen of the Handpiece Zygoma via an adapter
from behind to a water jet gun and flush three times for
5 seconds (static pressure 3–4 bar).

3 Dry handpiece
Dry the outer surface and the lumen of the Zygoma Hand-
piece with compressed air.
 Cleaning and sterilization guidelines // Handpiece Zygoma 20:1 33

2b – Automated cleaning

Required equipment
– Washer/disinfector

1 Place handpiece in washer/disinfector

Place the Handpiece Zygoma on an ophthalmologic rack in
the washer/disinfector (e.g., Miele G 7836 CD).

Make sure that the Handpiece Zygoma is connected via

adapters to the flushing ports of the rack.

Note: Detergent used in Nobel Biocare validation see page 37.

2 Run cleaning program

Use a general purpose cleaning program (e.g., Vario TD).

Nobel Biocare validation was performed with the following

steps:
– 2 minutes pre-washing with cold water
– Draining
– 5 minutes washing at 55°C/131°F with a 0.5% solution of
alkaline cleaning agent (e.g., neodisher® MediClean)
– Draining
– 3 minutes neutralizing with cold water
– Draining
– 2 minutes rinsing with cold water
– Draining
34 Cleaning and sterilization guidelines // Handpiece Zygoma 20:1

3 Disinfection

Required equipment
– Washer/disinfector
– Cleaning agent

1 Disinfect in washer/disinfector
Disinfect the Handpiece Zygoma by means of washer/
disinfector. Follow the detergent manufacturer's instructions.

Nobel Biocare recommends thermodisinfectors in accordance

with EN ISO 15883-1, which are operated with alkaline clean-
ing agents with a pH value of max. 10 (e.g., Miele G 7836 CD
– validation was carried out with program “Vario TD” using
cleaning agent neodisher® MediClean).

Note: Do not place the Handpiece Zygoma in disinfectant

baths, as this may result in malfunction. Only disinfect in the
thermodisinfector.
 Cleaning and sterilization guidelines // Handpiece Zygoma 20:1 35

4 Sterilization

1 Ensure that the handpiece is dry

In order to prevent negative effects on the Handpiece Zygoma,
make sure that interior and exterior are dry after completion
of the cleaning.

2 Lubricate with suitable spray

Lubricate the Handpiece Zygoma before autoclaving by using
a suitable lubricant spray that meets the local regulatory re-
quirements.

Insert the Handpiece Zygoma in the nozzle and spray for about
one second. Hold the handpiece firmly against the nozzle
during spraying.

3 Pack handpiece
Single pack the Handpiece Zygoma in a sterilization pouch.
Depending on the clinical procedure, use either a single or
double pouch.

Sterilize the Handpiece Zygoma in a pre-vacuum steam steril-

ization process with the following parameters:
– 3 pre-vacuum phases
– Sterilization temperature: 132°C
– Holding time: 3 minutes (full cycle)
– Drying time: 1 minute

Note: Remove the Handpiece Zygoma from the autoclave

immediately after each cycle to prevent the risk of contact
corrosion.

5 Storage

Store the Handpiece Zygoma in a dry place at room tempera-

ture away from direct sunlight.
36 Cleaning and sterilization guidelines // Appendices

References

21CFR58 Good Laboratory Practice for ASTM F 2503-08 Standard Practice for ISO 14937 Sterilization of Health Care
Non-clinical Studies Marking Medical Devices and Other Products – General Requirements for
Items for Safety in the Magnetic characterization of a sterilizing agent
AAMI TIR12 Designing, testing, and Resonance Environment and the development, validation and
labeling reusable medical devices for routine control of a sterilization process
reprocessing in health care facilities: A Bundesgesundheitsblatt 2006: Infek- for medical devices
guide for medical device manufacturers tionsprävention in der Zahnheilkunde
– Anforderungen an die Hygiene ISO 15223-1 Medical devices – Symbols
AAMI TIR39 Guidance on selecting to be used with medical device labels,
a microbial challenge and inoculation Bundesgesundheitsblatt 2012: labeling and information to be supplied
sites sterilization validation of health Anforderungen an die Hygiene bei der
care products Aufbereitung von Medizinprodukten ISO 17664 Sterilization of medical
(Recommendations of the Robert Koch devices – Information to be provided by
ANSI/AAMI ST8 Hospital Steam Institute, RKI) the manufacturer for the processing of
Sterilizers re-sterilizable medical devices
CSA Standard Z314.8-08 Decontamina-
ANSI/AAMI ST79 Comprehensive guide tion of reusable medical devices ISO 17665-1 Sterilization of health care
to steam sterilization and sterility assur- products Part 1: Development, validation
ance in health care facilities CSA Standard Z314.3-09 Effective and routine control of a sterilization pro-
Sterilization in Health Care Facilities by cess for medical devices
ANSI/AAMI ST81 Sterilization of medical the Steam Process
devices – Information to be provided by
the manufacturer for the processing of DIN 58953-7 Anwendungs­technik
resterilizable medical devices von Sterilisationspapier, Vliesstoffen,
gewebten textilen Materialien, Papier-
ASTM E 1054-02 Standard Test Methods beuteln und siegelfähigen Klarsichtbeu-
for Evaluation of Inactivators of Antimi- teln und -schläuchen
crobial Agents
FDA Guidance Document 1748
ASTM E 1837-96 Standard Test Method Processing/Reprocessing Medical
to Determine Efficiency of Disinfection Devices in Health Care Settings:
Processes for Reusable Medical Devices Validation Methods and Labeling
(Simulated Use Test)
ISO 11607 Packaging for terminally
ASTM E 2314-03 Standard Test Method sterilized medical devices – Part 1:
for Determination of Effectiveness of Requirements for materials, sterile
Cleaning Processes for Reusable Medical barrier systems and packaging systems
Instruments Using a Microbiologic
Method (Simulated Use Test) ISO 14161 Sterilization of Health Care
Products – Biological Indicators –
Guidance for the selection, use and
interpretation of results
 Cleaning and sterilization guidelines // Appendices 37

Cleaning agents and disinfectants

Cleaning and sterilization step Detergents used in Nobel Biocare validation

If cleaning is delayed, place the devices in a bath of lukewarm Commercially available mild pre-cleaning solution with
cleaning solution to avoid the drying of soil and debris. a pH value of 7–10 and a temperature of approx. 35°C/95°F

Ultrasonic bath
A mild agent is recommended for removing all visible soil Cidecyme / Enzol
and/or debris, blood and other contaminations from the General devices: 0.5% cleaning solution in an ultrasonic bath
devices. for 5 minutes at 40°C/104°F
Handpiece Zygoma: 0.5% cleaning solution in an ultrasonic
bath for 10 minutes at 40°C/104°F

Manual disinfection
The solution was prepared according to the detergent manu- Cidex Opa
facturer's Instructions for Use. Devices were immersed in Minimum effective concentration 0.3%
the bath. Minimum temperature 20°C/68°F
Immersion time at least 12 minutes (do not exceed 14 days)
(specifications according to manufacturer’s Instructions for Use)

Automated cleaning, disinfection and drying

For this step, a washer/thermodisinfector was used. 0.5% solution of neodisher® MediClean

If the used detergents are not commercially available in your

market, use an equivalent one and follow the instructions of
the manufacturer.

Notes:
– Nobel Biocare does not recommend these detergents in – Suitability of alternative detergents should be checked by
preference to others that are available. Other detergents referencing the detergent manufacturer’s Instructions for
may perform equally well or better in conjunction with the Use and/or physical testing.
equipment being used. – Personal protection for operators should be provided in
– The detergent manufacturer’s Instructions for Use should accordance with the detergent manufacturer’s Instructions
be followed. for Use and safety data sheets.
38 Cleaning and sterilization guidelines // Appendices

Examples for end of shelf life

The following pages show examples that help determine

whether a device has reached the end of its shelf life or not.

Examples are shown for specific devices, features and corrosion:

– Torque wrench (without adapter)
– Torque wrench adapter
– Screwdriver
– Tapered multiple-use drill
– Implant driver
– Bone mill
– Latch of various instruments
– Drill extension
– Guided implant mount
– Depth probe
– Rust/corrosion

Torque wrench (without adapter)

ü
New torque wrench:
1 The torque spring is parallel to the tube.
2 The torque spring is properly guided and the laser marking
is clear.
3 The direction indicator moves properly back into the tube
after changing the working direction.
 Cleaning and sterilization guidelines // Appendices 39

 
Direction indicator does not move back completely into tube Direction indicator broken

 
Spring no longer fixed Head of tool broken

Spring out of guidance pillar

 Spring bent due to overload

40 Cleaning and sterilization guidelines // Appendices

Torque wrench adapter

ü 
New adapter Adapter structure worn out

ü 
New adapter O-ring broken
 Cleaning and sterilization guidelines // Appendices 41

Screwdriver


Deformed tip

ü
New screwdriver


Deformed and worn-out tip
42 Cleaning and sterilization guidelines // Appendices

Tapered multiple-use dense bone drill

Sharp edge

Cutting area

Intact black coating

on the cutting edge

New dense bone drill with sharp blades

ü
 Cleaning and sterilization guidelines // Appendices 43

Edge starts to lose sharpness

Worn coating

Blades with lost sharpness


Edge is round

Coating is gone on the blade and

the steel shines silver

Dull blades

44 Cleaning and sterilization guidelines // Appendices

Tapered multiple-use drill

ü 
New drill with sharp cutting edges Cutting edges are dull / worn out


Starting corrosion
 Cleaning and sterilization guidelines // Appendices 45

Implant driver

Missing sliding ring

Worn-out edges
Corrosion

ü 
New implant driver Worn-out implant driver

ü 
New implant driver Worn-out edges
46 Cleaning and sterilization guidelines // Appendices

Latch

Intact connection to the handpiece

ü

 
Broken connection Incomplete connection
 Cleaning and sterilization guidelines // Appendices 47

Bone mill

New bone mill with sharp cutting edge

ü

 
Bone mill with round cutting edge Broken bone mill
48 Cleaning and sterilization guidelines // Appendices

Drill extension

New drill extension

ü


Drill extension fallen apart
 Cleaning and sterilization guidelines // Appendices 49

Guided implant mount


Broken guided implant mount
50 Cleaning and sterilization guidelines // Appendices

Depth probe

ü
New depth probe

 
Bent depth probe Broken depth probe
 Cleaning and sterilization guidelines // Appendices 51

Rust/corrosion

 


Instruments with rusty surface need to be discarded. Pictures
are examples only and do not show acceptance limits. Already
slightly corroded instruments can be non-biocompatible.
52 Cleaning and sterilization guidelines // Appendices

Frequently asked questions

How do you reprocess implants made of titanium? Implants must not be cleaned and sterilized. Any doubt
regarding the sterility of the implant must result in direct
disposal of the device or send it back to the manufacturer for
further investigation.

Can we use other sterilization parameters? Conditions other than those recommended by Nobel Biocare
can be used and may also lead to safe and sterile medical de-
vices. It is the responsibility of the processor to validate and
maintain their processes and equipment according to the ap-
plicable standards.

Can I deviate from these cleaning and sterilization With these cleaning and sterilization guidelines, Nobel Biocare
guidelines? provides a validated procedure to ensure clean and sterile
products. According to EN ISO 17664 it remains the respon-
sibility of the processor to ensure that the reprocessing as ac-
tually performed using equipment, materials and personnel in
the reprocessing facility achieves the desired result. Likewise
any deviation by the processor from the instructions provided
should be properly evaluated for effectiveness and potential
adverse consequences.

Are guidance documents from health authorities No, these are only recommendations. However, they are
(FDA, RKI, etc.) legally binding? sophisticated information and represent the thinking of health
authorities.

How often can a multiple-use drill be used? A direct value for reusable instruments cannot be given. The
shelf life of an instrument depends on a number of factors
during use as well as cleaning and sterilization. Chapter 5
gives recommendations and advice for your decision.

Is it possible to rework drills for further use? Drills are not designed for rework or resharpening due to their
special coating, which provides a smooth surface for better
transport of tissue and bone fragments.

What are the specific requirements for thermal The required final A0 value for thermal disinfection according
disinfection according to the A0 concept? to the A0 concept (ISO 15883-1) is country-specific. However,
it can be stated that any required final A0 value will be
reached safely if the temperature in and on the instrument
follows the water temperature in the washer / disinfector (in
compliance with ISO 15883) without delay.

Can I produce pure water applying the reverse osmosis Yes. Reverse osmosis is one of the accepted and widely used
technology? methods to produce pure water for the final flushing (by ap-
plying high pressure, the salts are being removed). An alter-
native method would be distillation, for example.

For questions that are not answered in these cleaning and sterilization guidelines, contact [email protected]
 Cleaning and sterilization guidelines // Appendices 53

Notes
54 Cleaning and sterilization guidelines // Appendices
 Cleaning and sterilization guidelines // Appendices 55

Customer service worldwide

Americas Europe, Middle East and Africa Russia

Brazil Austria Nobel Biocare Russia

Nobel Biocare Brazil Nobel Biocare Austria Phone: +7 495 974 77 55

Phone: 0800 16 999 6 Phone: +43 1 892 89 90 South Africa

Canada Belgium Nobel Biocare South Africa

Nobel Biocare Canada Nobel Biocare Belgium Phone: +27 11 802 0112

Phone: +1 800 939 9394 Phone: +32 2 467 41 70 Spain

Chile Denmark Nobel Biocare Spain

Dental Biocare Nobel Biocare Denmark Phone: +34 900 850 008

Phone: +56 220 19282 Phone: +45 39 40 48 46 Sweden

Colombia Finland Nobel Biocare Sweden

Hospimedics S.A. Nobel Biocare Finland Phone: +46 31 335 49 00

Phone: +57 1 640 0608 Phone: +358 20 740 61 00 Switzerland

Mexico France Nobel Biocare Switzerland

Nobel Biocare Mexico Nobel Biocare France Phone: 0800 211 424

Phone: +52 55 524 974 60 Phone: +33 1 49 20 00 30 United Kingdom

USA Germany Nobel Biocare UK

Nobel Biocare USA Nobel Biocare Germany Phone: +44 208 756 3300

Phone: +1 800 322 5001 Phone: +49 221 500 850

Hungary
Distributor markets
Nobel Biocare Hungary
Asia Pacific Phone: +36 1 279 33 79 Algeria, Bulgaria, Croatia, Cyprus,

Australia Czech Republic, Greece, Jordan, Kuwait,

Ireland
Nobel Biocare Australia Lebanon, Malta, Romania, Saudi Arabia,
Nobel Biocare Ireland
Phone: 1800 804 597 Serbia, Slovenia, Tunisia, Turkey,
Phone: 1800 677 306
United Arab Emirates
China Italy Phone: +34 933 560 562
Nobel Biocare China Nobel Biocare Italy
Phone: +86 21 6015 8245 Phone: +39 800 53 93 28
Hong Kong Lithuania
Nobel Biocare Hong Kong Nobel Biocare Lithuania
Phone: +852 2845 1266 Phone: +370 5 268 3448
India Netherlands
Nobel Biocare India Nobel Biocare Netherlands
Phone: 1800 266 9998 Phone: +31 30 635 49 49
Japan Norway
Nobel Biocare Japan Nobel Biocare Norway
Phone: +81 3 6717 6191 Phone: +47 64 95 75 55
New Zealand Poland
Nobel Biocare New Zealand Nobel Biocare Poland
Phone: 0800 441 657 Phone: +48 22 549 93 52
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Nobel Biocare Singapore Nobel Biocare Portugal
Phone: +65 6737 7967 Phone: +351 800 300 100
Taiwan
Nobel Biocare Taiwan
Phone: +886 080 00 779

nobelbiocare.com/contact

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trademarks of Nobel Biocare. Please refer to nobelbiocare.com/trademarks for more information. Product images are not necessarily to scale. For prescription use only. Caution: Federal (United States) law restricts this device to sale by or on the
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