EN ISO 17664:2004

SLOVENSKI STANDARD
01-oktober-2004
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Sterilization of medical devices - Information to be provided by the manufacturer for the
processing of resterilizable medical devices (ISO 17664:2004)
Sterilisation von Medizinprodukten - Vom Hersteller bereitzustellende Informationen für
die Aufbereitung von resterilisierbaren Medizinprodukten (ISO 17664:2004)
Stérilisation des dispositifs médicaux - Informations devant etre fournies par le fabricant
pour le processus de re-stérilisation des dispositifs médicaux (ISO 17664:2004)
Ta slovenski standard je istoveten z: EN ISO 17664:2004
ICS:
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 17664
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2004
ICS 11.080.01
English version
Sterilization of medical devices - Information to be provided by
the manufacturer for the processing of resterilizable medical
devices
Stérilisation des dispositifs médicaux - Informations devant Sterilisation von Medizinprodukten - Vom Hersteller
être fournies par le fabricant pour le processus de re- bereitzustellende Informationen für die Aufbereitung von
stérilisation des dispositifs médicaux (ISO 17664:2004) resterilisierbaren Medizinprodukten (ISO 17664:2004)
This European Standard was approved by CEN on 3 November 2003.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Central Secretariat or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Slovakia,
Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2004 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17664:2004: E
worldwide for CEN national Members.

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
(informative)
Annex A Commonly utilized reprocessing methods.12
A.1 General .12
A.2 Matrix for identifying methods of processing .13
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
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).
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.
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.
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.
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
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
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.
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;
 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 descriptio
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