Iso 17664 - Sterilisation (Re-Sterilisation)

FINAL INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 17664
ISO/TC 198
Secretariat: ANSI Sterilization of medical devices —

Information to be provided by the
Voting begins on:
2003-07-10 manufacturer for the processing of
resterilizable medical devices
Voting terminates on:
2003-09-10
Stérilisation des dispositifs médicaux — Informations devant être
fournies par le fabricant pour le processus de restérilisation des
dispositifs médicaux
Please see the administrative notes on page iii
RECIPIENTS OF THIS DRAFT ARE INVITED TO

SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPORT-
ING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
LOGICAL, COMMERCIAL AND USER PURPOSES, ISO/FDIS 17664:2003(E)
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2003
ISO/FDIS 17664:2003(E)
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ii © ISO 2003 – All rights reserved

ISO/FDIS 17664:2003(E)
ISO/CEN PARALLEL PROCESSING

This final draft International Standard is a draft European Standard developed within the European
Committee for Standardization (CEN) and processed under the CEN-lead mode of collaboration as defined
in the Vienna Agreement. Following parallel ISO member body voting and CEN enquiry on the DIS, this
final draft, established on the basis of comments received, has been transmitted by CEN to ISO for
circulation for a parallel two-month FDIS vote in ISO and formal vote in CEN.
Positive votes shall not be accompanied by comments.

Negative votes shall be accompanied by the relevant technical reasons.
© ISO 2003 – All rights reserved iii

ISO/FDIS 17664:2003(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 17664 was prepared by the European Committee for Standardization (CEN) in collaboration with
Technical Committee ISO/TC 198, Sterilization of health care products, in accordance with the Agreement on
technical cooperation between ISO and CEN (Vienna Agreement).
Throughout the text of this document, read “...this European Standard...” to mean “...this International
Standard...”.
iv © ISO 2003 – All rights reserved

prEN ISO 17664:2003 (E) FINAL DRAFT / PROJET FINAL
Contents Page
Foreword ............................................................................................................................................................. 3
Introduction ........................................................................................................................................................ 4
1 Scope...................................................................................................................................................... 5
2 Terms and definitions ........................................................................................................................... 5
3 Information to be provided by the medical device manufacturer .................................................... 7
3.1 Reprocessing instructions................................................................................................................... 7
3.2 Limitations and restrictions on reprocessing.................................................................................... 7
3.3 Preparation at the point of use prior to processing .......................................................................... 7
3.4 Preparation before cleaning................................................................................................................. 8
3.5 Cleaning ................................................................................................................................................. 8
3.6 Disinfection............................................................................................................................................ 8
3.7 Drying ..................................................................................................................................................... 9
3.8 Inspection, maintenance and testing .................................................................................................. 9
3.9 Packaging ............................................................................................................................................ 10
3.10 Sterilization .......................................................................................................................................... 10
3.11 Storage ................................................................................................................................................. 10
4 Presentation of the information......................................................................................................... 10
5 Validation of the reprocessing information provided ..................................................................... 11
6 Risk analysis........................................................................................................................................ 11
Annex A (informative) Commonly utilized reprocessing methods.............................................................. 12
Annex B (informative) An example of reprocessing instructions for reusable medical
devices ................................................................................................................................................. 17
Annex ZA (informative) Clauses of this European Standard addressing essential
requirements or other provisions of EU Directives......................................................................... 22
Bibliography ..................................................................................................................................................... 23
2
FINAL DRAFT / PROJET FINAL prEN ISO 17664:2003 (E)
Foreword
This document (prEN ISO 17644:2003) has been prepared by Technical Committee CEN/TC 204
"Sterilization of medical devices", the secretariat of which is held by BSI, in collaboration with
Technical Committee ISO/TC 198 "Sterilization of health care products".
This document is currently submitted to the parallel Formal Vote.
This Standard has been prepared under a mandate given to CEN by the European Commission and
the European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
Informative Annexes A and B are attached to this document.
3
Introduction
This Standard applies to those medical devices which are intended for multiple use and require
processing to take them from their state at the end of one use to the state of being sterile and ready
for their subsequent use. Some medical devices supplied non-sterile but intended to be used in a
sterile state, will also require similar treatment.
4
1 Scope
This Standard specifies the information to be provided by the medical device manufacturer on the
processing of medical devices claimed to be re-sterilizable and medical devices intended to be
sterilized by the processor
This Standard specifies requirements for the information to be provided by the medical device
manufacturer, so that the medical device can be processed safely and will continue to meet its
performance specification.
Requirements are specified for processing that consists of all or some of the following activities:
preparation at the point of use;
preparation, cleaning, disinfection;
drying;
inspection, maintenance and testing;
packaging;
sterilization;
storage.
When providing instructions for these activities, medical device manufacturers are expected to be
aware of the training and knowledge of procedures. and of the processing equipment available to the
persons likely to be responsible for processing. It is likely that some processing procedures will be
generic and well known and will use equipment and consumables conforming to recognized
standards. In this case, a reference in the instructions is all that is required. For those medical devices
where instructions for use are not required to accompany the medical device, other means of
communicating the information can be used, e.g. user manuals, symbols or wall charts supplied
separately.
This Standard excludes textile devices used in-patient draping systems or surgical clothing.
NOTE The principles of this Standard may be applied when considering the information to be supplied with
medical devices which only require disinfection prior to re-use.
2 Terms and definitions

For the purposes of this Standard the following terms and definitions apply.
2.1
chemical
formulation of compounds intended for use in reprocessing
NOTE This includes, for example, detergents, surfactants, rinse aids, disinfectants, enzymatic cleaners,
sterilants.
2.2
cleaning
removal of contamination from an item to the extent necessary for further processing or for intended
use
5
2.3
disinfection
process used to reduce the number of viable microorganisms on a product to a level previously
specified as appropriate for its further handling or use
2.4
manual cleaning
cleaning without the use of a washer-disinfector
2.5
manufacturer
organization with responsibility for the design, manufacture, packaging and labelling of a device
before it is placed on the market under its own name, regardless of whether these operations are
carried out by that person himself or on its behalf by a third party
2.6
processing
activity including cleaning, disinfection and sterilization, necessary to prepare a new or used medical
device in order to prepare it for its intended use
2.7
processor
organization with the responsibility for carrying out the actions necessary to prepare a new or used
device for its intended use
2.8
sterilant
chemical which has properties to destroy micro-organisms including viruses, when used at correct
dilution/dose and applied for recommended exposure time
2.9
sterile
free from all viable microorganisms
2.10
sterilization
process used to render a device free from all forms of viable microorganisms
NOTE In a sterilization process, the nature of microbiological death is described by an exponential function.
Therefore, the presence of microorganisms on any individual item may be expressed in terms of probability.
Whist this probability may be reduced to a very low number, it can never be reduced to zero.
(See ISO 11134:1994). This probability can only be assured for validated processes.
2.11
validation
documented procedure for obtaining, recording and interpreting the results required to establish that a
process will consistently yield product complying with predetermined specifications
2.12
verification
confirmation by examination and provision of objective evidence that specified requirements have
been fulfilled
6
2.13
washer-disinfectors
machine intended to clean and disinfect medical devices and other articles used in the context of
medical, dental, pharmaceutical and veterinary practice
NOTE 1 This type of machine does not include those designed specifically to wash linen or clothing. Machines
intended to sterilize, or designated as sterilizers, are specified in other standards e.g. EN 285.
NOTE 2 Preliminary standards for washer-disinfectors (prEN 15883) are prepared in an ISO-CEN project.
3 Information to be provided by the medical device manufacturer
3.1 Reprocessing instructions
At least one validated method for reprocessing the medical device shall be specified.
The following information shall be stated where it is critical to the maintenance of the intended
function of the medical device and the safety of the user(s) and the patient:
details of process steps;
A description of special equipment and/or accessories;
specification of process parameters and their tolerances.
NOTE Further information is provided in Annex A.
3.2 Limitations and restrictions on reprocessing
The manufacturer shall determine if processing in accordance with the provided instructions leads to a
degree of degradation that will limit the useful life of the medical device. Where such degradation is
established, the manufacturer shall provide an indication of the number of reprocessing cycles that
can normally be tolerated, or some other indication of the end of the medical device’s ability to safely
fulfil its intended use.
3.3 Preparation at the point of use prior to processing
Requirements for preparation at the point of use to ensure satisfactory reprocessing of the medical
device, shall be specified, if applicable.
Where appropriate, at least the following information shall be included:
the containers for transportation
a description of the support systems
the maximum period of time that may elapse between use and cleaning
a description of the pre-cleaning techniques critical to further processing
the requirements for transportation
7
3.4 Preparation before cleaning
Requirements for the preparation of the medical device prior to cleaning shall be specified if
applicable. Where appropriate, instructions for at least the following procedures shall be given:
the requirements for capping/opening of ports
disassembly of the device
leak testing the device
soaking/brushing techniques required
ultrasonic treatment of the device
If special tools are required for disassembly/re-assembly, these shall be specified in the instructions.
3.5 Cleaning
A validated method of manual cleaning shall be specified. At least one validated automated method
using a washer-disinfector shall also be specified unless the medical device cannot withstand any
such process, in which case a warning should be issued.
A description of the accessories required for cleaning process
identification and concentration of chemicals required for cleaning
identification of water quality to be used for the process
limits and monitoring of chemical residues remaining on the device
limits on temperature, concentration of solution(s), exposure time to be used
the process temperature(s) to be used
the techniques to be used including rinsing
NOTE Cleaning and Disinfecting Processing Equipment should be qualified and validated to ensure
suitability for its intended purpose.
3.6 Disinfection
A validated non-automatic method of disinfection shall be specified. At least one validated automated
method using a washer-disinfector shall also be specified unless the medical device cannot withstand
any such process.
a description of the accessories required for the disinfection process
the contact time of the disinfectant
identification and concentration of chemicals required for the disinfection process;
identification of water quality required for the process
8
the limits and monitoring of chemical residues remaining on the device
the limits on temperature, concentration of solution(s), exposure time
the process temperature(s) to be used
the techniques to be used including rinsing
NOTE 1 In certain circumstances disinfection may be carried out concurrently with cleaning of the medical
device.
NOTE 2 Wherever practical a washer-disinfector using thermal disinfection is preferred.
NOTE 3 Certain clinical procedures lead to an enhanced probability of contamination with agents with high
resistances against certain disinfectants (e.g. mycobacteria). This should be considered in the risk analysis and
in the choice of recommended disinfectant.
3.7 Drying
Where drying is necessary, a validated method of drying shall be specified. Where appropriate at
least the following information shall be included:
the accessories required for the drying process
the maximum temperature and exposure time for the device
specifications of the drying agent to be used
the techniques to be used
NOTE In certain circumstances drying may be achieved as part of an automated cleaning and disinfection
process.
3.8 Inspection, maintenance and testing
When methods are required at any stage of processing to confirm the cleanliness or performance or
both, of the medical device, these shall be stated. Where particular maintenance actions are required
during processing to ensure the proper performance and safety of the medical device, these shall be
stated. Where appropriate, these shall include details such as any part or component that requires
routine replacement and/or calibration and where necessary, details for return to the manufacturer or
other qualified organization.
Where appropriate at least the following information shall be given:
the method to be used for adjustment/calibration of the device
a description of the lubrication to be used
the performance criteria for the device to ensure its safe use
the instructions for re-assembly of the device
the method to be used for the replacement of components
a description of special tools to be used to maintain the device
the requirements for visual inspection
9
NOTE If instruction to return the medical device to the manufacturer or other qualified organization is
specified, the manufacturer should give clear instructions as to the cleanliness and/or microbiological status
required.
3.9 Packaging
If a specific method for packaging or containing the medical device during and after sterilization is
required, it shall be stated and be compatible with the sterilization process and the medical device.
3.10 Sterilization
A validated method of sterilization shall be specified.
Where appropriate, at least the following information shall be given; this shall include set points and
the upper and lower limits of critical process parameters that are capable of achieving sterility of the
medical device:
the accessories required for sterilization of the medical device
the identification and concentration of the sterilant required for the sterilization process
the identification of maximum values of contaminants in condensate from steam, used in

moist heat, eto and/or steam and formaldehyde sterilization
the humidity required for the sterilization process
the minimum holding or exposure time of sterilant
a description of post-sterilisation techniques/activities
pressure required for the sterilization process
a description of the techniques to be used
the required temperature of the sterilant
NOTE Wherever possible, moist heat sterilization is recommended.
3.11 Storage
Any specific limitations for the time or conditions of storage of the reprocessed medical device prior to
use shall be stated.
4 Presentation of the information

4.1 Where applicable, the information required by clause 3 shall accompany the medical device,
e.g. in the instructions for use supplied with the medical device, or on the medical device label or
packaging.
NOTE An example format for giving detailed information for a particular medical device is given in Annex B.
4.2 The information specified in clause 3 shall take into account the nature of the medical device, its
intended use and the knowledge and training of the persons involved in the processing.
NOTE: The information specified in clause 3 may make reference to:
10
standards available;
general processing information provided by the manufacturer;
general processing information provided by the manufacturer of the equipment of materials involved in
the specified process.
Such reference may be achieved by the use of symbols. (ref: ISO 15223 and ISO 7000).
4.3 The equipment or materials necessary in the specified processes shall be identified by its
generic names or specification. Only in those cases where this does not provide sufficient information,
trade names may be given in addition.
5 Validation of the reprocessing information provided

The manufacturer shall validate that any process identified in the information provided is capable of
reprocessing the medical device for its intended use.
NOTE Where the manufacturer supplies a number of different medical devices which share common
features and attributes, the validation specified may be performed with respect to these medical devices as a
group or family, provided that the manufacturer can demonstrate the commonality of the medical devices and that
the tests and assessments address the “worst case” feature or attribute of the group or family.
6 Risk analysis
In the risk analysis performed by the medical device manufacturer to determine the content and detail
of the information to be provided, the medical device manufacturer shall take into account:
The nature of the medical device.
The intended use of the medical device.
The likely training and knowledge of the processor.
The equipment likely to be available to the processor.
NOTE See EN ISO 14937 as guidance.
11
Annex A
(informative)
Commonly utilized reprocessing methods
A.1 General
The following example of a matrix is intended to assist the manufacturer of medical devices to identify
methods of processing that may be considered for inclusion in the processing instructions provided.
The general acceptability of each of the methods for various categories of medical devices is
indicated and may be used as a guide when considering the equipment, training and resources likely
to be available to processors of the various medical device categories and so allow selection of
processing methods most readily implemented by the processor.
Thorough cleaning prior to disinfection and sterilization is especially important for infection control.
This information also indicates what an experienced processor may assume to be appropriate
reprocessing methods for certain medical device categories. As such it may be used as an input to
the risk analysis required by this standard (clause 6) to determine the extent of warnings to avoid
damaging or unsafe processing methods for a particular medical device.
The information in the following matrix is for guidance only and cannot be universally applied to all
makes of medical devices within a category without reference to and compliance with the specific
instructions provided.
IT IS STILL THE RESPONSIBILTY OF THE MANUFACTURER TO IDENTIFY AND VALIDATE

SPECIFIC PROCEDURES FOR THE PARTICULAR MEDICAL DEVICE BEING CONSIDERED.
LIKEWISE PROCESSORS SHOULD REFER TO, AND COMPLY WITH, THE SPECIFIC
INSTRUCTIONS PROVIDED BY THE MANUFACTURER OF THE MEDICAL DEVICE,
PROCESSING EQUIPMENT AND/OR PROCESSING CHEMICAL.
12
prEN ISO 17664:2003 (E)
A.2 Matrix for identifying methods of processing
Table A.2.1 — Examples of processes that may be applied
Medical device
A B C D G H I J
Process Reusable Endoscopes Endoscopes Instruments reusable Elastic HF-cable Powertools
1)
surgical (thermostable) (thermolabile for use with containers products and
instruments endoscopes handpieces
Preparation at the Deposition Wet + + + + - + + +
point of use Dry + + + + + + + +
Decontamination Preparation Selection according to the Cleaning and Disinfection Procedures
3)
Cleaning Manual + + + + + + + +
3)
Machine + + + + + + + +
ultrasonic + - - + N.A. - + -
2)
Alkaline detergent + + + + - + + -
2)
Acidic detergent - - - - - + + -
Neutral detergent + + + + + + + +
3)
Rinsing
Disinfection chemical + + + + + + + +
thermal + + - + + + + +
FINAL DRAFT / PROJET FINAL
Drying Tmax
13
prEN ISO 17664:2003 (E)
Table A.2.1 (continued)
Maintenance
Sterilization Moist heat + + - + + + + +
(preferred method)
Low temperature + + + + - + + -
steam and
fomaldehyde
Ethylene oxide + + + + - + + -
Dry heat +
Liquid Steriliant + + + + + + +
Gas Plasma + + + + + + + +
1)
Rubber or latex (also combined), siliconelastomer, plastics, closed hollow bodies, thermolabile.
2)
Applies only for aluminium alloys.
3)
For final rinsing deionized water is recommended.
Key: + may be suitable

- not suitable
N.A. not applicable
NOTE: The matrix provides typical results. Results may vary significantly depending on variations in device construction, device materials, device design and variations in
reprocessing method
14
prEN ISO 17664:2003 (E)
Table A.2.2 — Table: blank table to define suitable reprocessing procedures
Medical device
A B C D G H I J
Process Reusable Endoscopes Endoscopes Instruments reusable Elastic HF-cable Powertools
1)
surgical (thermostable) (thermolabile for use with containers products and
instruments endoscopes handpieces
Preparation at the Deposition Wet
point of use Dry
Decontamination Preparation Selection according to the Cleaning and Disinfection Procedures
3)
Cleaning Manual
3)
Machine
ultrasonic
Alkaline detergent
Acidic detergent
Neutral detergent
3)
Rinsing
Disinfection chemical
thermal
Drying Tmax
15
prEN ISO 17664:2003 (E)
Table A.2.2 (continued)
Maintenance
Sterilization Moist heat
(preferred method)
Low temperature
steam and
fomaldehyde
Ethylene oxide
Dry heat
Liquid Steriliant
Gas Plasma
1)
Rubber or latex (also combined), siliconelastomer, plastics, closed hollow bodies, thermolabile.
2)
Applies only for aluminium alloys.
3)
For final rinsing deionized water is recommended.
Key: + may be suitable

- not suitable
N.A. not applicable
16
Annex B
(informative)
An example of reprocessing instructions for reusable medical

devices
Processors may process medical devices from various device manufacturers, so for the sake of clarity
manufacturers should adopt a consistent presentation of instructions for processing.
Processing instructions may be presented in accordance with Figure B.1 to aid manufacturers in
achieving a consistent presentation.
The manufacturer should ensure that all required information is included, that it will be readily
understood and the prominence of the various elements of the information is appropriate to their
importance.
The following template Figure B.1 and example Figure B2 provide formats that may be used by
manufacturers to achieve such consistency and may be applicable for the majority of medical devices.
Note: This template represents one suggested format. There may be a number of different formats for the
information that may be more appropriate.
17
Manufacturer: <Manufacturer name> Method : <ref.> Symbol: <sym>
Device(s): <list by catalogue number and device description, or generic type>
WARNINGS <warnings re inappropriate chemicals, parameters, points of particular

attention>
Limitations on <the number of reprocessing cycles permitted or other indications of end

reprocessing of life
INSTRUCTIONS
Point of use: <instructions/cautions>
Preparation for <instructions/cautions>

decontamination:
Cleaning: Automated <instructions/cautions. Include equipment/materials/parameters>
Cleaning: Manual <instructions/cautions. Include equipment/materials/parameters>
Disinfection: <instructions/cautions. Include equipment/materials/parameters>
Drying <instructions/cautions, include equipment/materials/parameters>

Maintenance, <instructions/cautions. Include equipment/materials/parameters>
Inspection and Testing:
Packaging: <instructions/cautions. Include materials/methods>
Sterilization: <instructions/cautions. Include equipment/materials/parameters>
Storage: <instructions/cautions>
Additional Information: <Any other information considered helpful>
Manufacturer contact: <Contact information for further information>
The instructions provided above have been validated by the manufacturer of the medical device as being CAPABLE of
preparing a medical device for re-use. It remains the responsibility of the processor to ensure that the reprocessing as actually
performed using equipment, materials and personnel in the reprocessing facility achieve the desired result. This normally
requires validation and routine monitoring of the process.
Date issued: <date>
Figure B.1 — Template: Processing instructions (reusable medical devices)
18
Notes for use:
1) Instructions should be clear and concise.
2) Reference to materials and equipment should be generic where possible.
3) Instructions for disassembly/assembly, maintenance and inspection/test may be documented

separately (these instructions are more likely to be specific to a particular medical device,
whereas other instructions are more likely to apply to a group or family of medical devices)
4) All sections of the table require an entry. Phrases such as “no particular requirements”, “not
applicable” etc. can be used where appropriate.
5) The symbol field is optional, it may be used to refer to the instructions from markings on the
medical device or its packaging.
19
Manufacturer: l Method: Symbol:
Device(s): All reuseable surgical instruments supplied by _____Medical comprising fixed assemblies
(no moving parts) and simple hinged assemblies, excluding those containing aluminium alloy.
NOTE Aluminium alloy may be recognized by bright coloured (red, blue, green, yellow) coatings on metallic
components.
WARNINGS Aluminium based instruments are damaged by alkaline (pH>7)

detergents and solutions
Long narrow cannulations and blind holes require particular attention

during cleaning
Do not exceed yyC
Limitations on Repeated processing has minimal effect on these instruments. End of

reprocessing life is normally determined by wear and damage due to use.
INSTRUCTIONS
Point of use: Remove excess soil with disposable cloth/paper wipe.
Containment and No particular requirements.
transportation: It is recommended that instruments are reprocessed as soon as is
reasonably practical following use.
Preparation for cleaning: No particular requirements.
Disassembly not required.
Cleaning: Automated Equipment: Washer/disinfector, detergent (name)
1 Load instruments such that hinges are open and cannulations and
holes can drain.
2 Run cycle, minimum xx minutes wash and xx minutes rinse.
3 When unloading check cannulations, holes etc for complete removal
of visible soil. If necessary repeat cycle or use manual cleaning.
Cleaning: Manual Equipment: Detergent (example), brush, running water
Method:
1. Rinse excess soil from instrument
2. Using brush, apply detergent solution to all surfaces ensuring that
hinged instruments are cleaned in both open and closed positions
NOTE Clean cannulations and holes using an appropriate brush ensuring that
full depth of the feature is reached.
3 Rinse under clean running water for xx minutes. Ensure that
running water passes through cannulations, and that blind holes are
repeatedly filled and emptied.
Disinfection: Disinfectant solution (name) may be used in accordance with label
instructions.
If automated cleaning is employed, a final rinse at yy °C for xx
minutes may be used to effect thermal disinfection.
20
Drying: When drying is achieved as part of a washer disinfector cycle do not

exceed 120C
Maintenance: Apply a small quantity of surgical grade lubrication oil to hinges.
Discard blunt or damaged instruments.
Inspection and Function Hinged instruments: Check for smooth movement of hinge without
Testing: excessive “play”. Locking (ratchet) mechanisms should be checked for
action.
All instruments: Visually inspect for damage and wear. Cutting edges
should be free of nicks and present a continuous edge.
Check instruments with long slender features (particularly rotating
instruments) for distortion. Where instruments form part of a larger
assembly, check assembly with mating components.
Singly: A standard packaging material may be used. Ensure that the
pack is large enough to contain the instrument without stressing the
seals.
Packaging: In sets: Instruments may be loaded into dedicated instrument trays, or
general-purpose sterilisation trays. Ensure that cutting edges are
protected, and do not exceed z Kg per tray. Wrap the trays using
appropriate method
Sterilization: Vacuum autoclave, minimum of x minutes at y °C.
Do not exceed y °C
Storage: No particular requirements
Additional Information: When sterilising multiple instruments in one autoclave cycle ensure
that the sterilizer’s maximum load is not exceeded.
Manufacturer contact: See brochure for telephone and address of local representative or
telephone (44) 123 456 789.
The instructions provided above have been validated by the medical device manufacturer as being CAPABLE of
preparing a medical device for re-use. It remains the responsibility of the processor to ensure that the processing
as actually performed using equipment, materials and personnel in the processing facility achieve the desired
result. This requires validation and routine monitoring of the process. Likewise any deviation by the processor
from the instructions provided should be properly evaluated for effectiveness and potential adverse
consequences.
Figure B.2 — Example
21
Annex ZA
(informative)
Clauses of this European Standard addressing essential

requirements or other provisions of EU Directives
This European Standard has been prepared under a mandate given to CEN by the European
Commission and the European Free Trade Association and supports essential requirements of EU
Directive 93/42/EEC.
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling
within the scope of this standard.
The following clauses of this standard are likely to support requirements of Directive 93/42/EEC.
Compliance with these clauses of this standard provides one means of conforming with the specific
essential requirements of the Directive concerned and associated EFTA regulations.
Table ZA.1 — Correspondence between this European standard and EU Directives

Clauses/sub-clauses of Corresponding Remarks
this European Standard annex/paragraph of
Directive 93/42/EEC
2 / The definitions provided complement

those in Directive 93/42/EEC
3, 4 13.6h /
Annexes / Guidance is given in Annexes A and B
22
Bibliography
[1] ISO 11134:1994, Sterilization of health care products — Requirements for validation and routine
control — Industrial moist heat sterilization
[2] EN 285:1996, Sterilization — Steam sterilizers — Large sterilizers
[3] ISO 11135:1994, Medical Devices — Validation and routine control of ethylene oxide sterilization
[4] ISO 11607: 1997, Packaging for terminally sterilized medical devices
[5] ISO 14937:2000, Sterilization of health care products — General requirements for
characterization of a sterilizing agent and development, validation and routine control of a sterilization
process for medical devices
[6] ISO 15223:2000, Medical devices – Symbols to be used with medical device labels, labelling and
information to be supplied
[7] ISO 7000:1989, Graphical symbols for use on equipment – index and synopsis
[8] Medical Devices Agency: Sterilization, Disinfection and Cleaning of Medical Equipment:
Guidance on Decontamination from Microbiology Advisory Committee to the Department of Health,
Medical Devices Agency; Part 1 Principles, Part 2 Protocols, Part 3 Procedures 1993-2000 London
23

Iso 17664 - Sterilisation (Re-Sterilisation)

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FINAL INTERNATIONAL ISO/FDIS

Secretariat: ANSI Sterilization of medical devices —

Please see the administrative notes on page iii

RECIPIENTS OF THIS DRAFT ARE INVITED TO

Reproduction may be subject to royalty payments or a licensing agreement.

Violators may be prosecuted.

ii © ISO 2003 – All rights reserved

ISO/CEN PARALLEL PROCESSING

Positive votes shall not be accompanied by comments.

© ISO 2003 – All rights reserved iii

iv © ISO 2003 – All rights reserved

This document is currently submitted to the parallel Formal Vote.

Informative Annexes A and B are attached to this document.

preparation at the point of use;

preparation, cleaning, disinfection;

inspection, maintenance and testing;

2 Terms and definitions

3 Information to be provided by the medical device manufacturer

3.1 Reprocessing instructions

details of process steps;

A description of special equipment and/or accessories;

specification of process parameters and their tolerances.

NOTE Further information is provided in Annex A.

3.2 Limitations and restrictions on reprocessing

3.3 Preparation at the point of use prior to processing

Where appropriate, at least the following information shall be included:

the containers for transportation

a description of the support systems

a description of the pre-cleaning techniques critical to further processing

the requirements for transportation

3.4 Preparation before cleaning

the requirements for capping/opening of ports

disassembly of the device

leak testing the device

soaking/brushing techniques required

ultrasonic treatment of the device

Where appropriate, at least the following information shall be included:

A description of the accessories required for cleaning process

identification and concentration of chemicals required for cleaning

identification of water quality to be used for the process

limits and monitoring of chemical residues remaining on the device

limits on temperature, concentration of solution(s), exposure time to be used

the process temperature(s) to be used

the techniques to be used including rinsing

Where appropriate, at least the following information shall be included:

a description of the accessories required for the disinfection process

the contact time of the disinfectant

identification and concentration of chemicals required for the disinfection process;

identification of water quality required for the process

the limits and monitoring of chemical residues remaining on the device

the limits on temperature, concentration of solution(s), exposure time

the process temperature(s) to be used

the techniques to be used including rinsing

NOTE 2 Wherever practical a washer-disinfector using thermal disinfection is preferred.

the accessories required for the drying process

the maximum temperature and exposure time for the device

specifications of the drying agent to be used

the techniques to be used

3.8 Inspection, maintenance and testing