ISO 17664:2004
(Main)Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices
Sterilization of medical devices — Information to be provided by the manufacturer for the processing of resterilizable medical devices
ISO 17664:2004 specifies the information to be provided by the medical device manufacturer on the processing of medical devices claimed to be resterilizable, and medical devices intended to be sterilized by the processor. ISO 17664:2004 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: a) preparation at the point of use; b) preparation, cleaning, disinfection; c) drying; d) inspection, maintenance and testing; e) packaging; f) sterilization; g) 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. The principles of ISO 17664:2004 may be applied when considering the information to be supplied with medical devices which only require disinfection prior to re-use. ISO 17664:2004 is not applicable to textile devices used in patient-draping systems or surgical clothing.
Stérilisation des dispositifs médicaux - Informations devant être fournies par le fabricant pour le processus de restérilisation des dispositifs médicaux
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Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 17664
First edition
2004-03-01
Sterilization of medical devices —
Information to be provided by the
manufacturer for the processing of
resterilizable medical devices
Stérilisation des dispositifs médicaux — Informations devant être
fournies par le fabricant pour le processus de restérilisation des
dispositifs médicaux
Reference number
ISO 17664:2004(E)
©
ISO 2004
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ISO 17664:2004(E)
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ISO 17664:2004(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.”.
For the purposes of this International Standard, the CEN annex regarding fulfilment of European Council
Directives has been removed.
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ISO 17664:2004(E)
Contents Page
Foreword .v
Introduction.vi
1 Scope.1
2 Terms and definitions .1
3 Information to be provided by the medical device manufacturer .3
3.1 Reprocessing instructions .3
3.2 Limitations and restrictions on reprocessing .3
3.3 Preparation at the point of use prior to processing .3
3.4 Preparation before cleaning.4
3.5 Cleaning .4
3.6 Disinfection .4
3.7 Drying .5
3.8 Inspection, maintenance and testing .5
3.9 Packaging.6
3.10 Sterilization .6
3.11 Storage .6
4 Presentation of the information.6
5 Validation of the reprocessing information provided.7
6 Risk analysis.7
Annex A (informative) Commonly utilized reprocessing methods.8
A.1 General .8
A.2 Matrix for identifying methods of processing .9
Annex B (informative) An example of reprocessing instructions for reusable medical devices .13
Bibliography.18
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ISO 17664:2004(E)
Foreword
This document (EN ISO 17644:2004) 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 European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by September 2004, and conflicting national standards
shall be withdrawn at the latest by September 2004.
This document 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).
Informative annexes A and B are attached to this document.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg,
Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and the United
Kingdom.
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ISO 17664:2004(E)
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.
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ISO 17664:2004(E)
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 European 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
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ISO 17664:2004(E)
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 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).
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
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ISO 17664:2004(E)
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 being 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.
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ISO 17664:2004(E)
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.
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.
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.
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;
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ISO 17664:2004(E)
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
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