EN ISO 17664:2017

Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017)

ISO 17664:2017 specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective for its intended use.
This includes information for processing prior to use or reuse of the medical device. The provisions of ISO 17664:2017 are applicable to medical devices that are intended for invasive or other direct or indirect patient contact.

Aufbereitung von Produkten für die Gesundheitsfürsorge - Vom Medizinprodukt-Hersteller bereitzustellende Informationen für die Aufbereitung von Medizinprodukten (ISO 17664:2017)

Traitement de produits de soins de santé - Informations relatives au traitement des dispositifs médicaux à fournir par le fabricant du dispositif (ISO 17664:2017)

L'ISO 17664 :2017 spécifie les exigences relatives aux informations devant être fournies par un fabricant de dispositifs médicaux concernant le traitement d'un dispositif médical qui nécessite un nettoyage, puis une désinfection et/ou une stérilisation afin de s'assurer qu'il est sûr et efficace pour son utilisation prévue.
Elles incluent les informations de traitement avant l'utilisation ou la réutilisation du dispositif médical. Les dispositions du présent document s'appliquent aux dispositifs médicaux invasifs ou destinés à tout autre contact direct ou indirect avec le patient.

Procesiranje izdelkov za zdravstveno nego - Informacija, ki jo zagotovi proizvajalec medicinskih pripomočkov za postopek obdelave medicinskih pripomočkov (ISO 17664:2017)

Ta dokument določa zahteve za informacije, ki jih zagotovi proizvajalec medicinskih pripomočkov za postopek obdelave medicinskih pripomočkov, ki zahteva čiščenje, ki mu sledi razkuževanje in/ali sterilizacija, da se zagotovi, da je pripomoček varen in učinkovit za svojo predvideno uporabo.
To vključuje informacije za obdelavo pred uporabo ali ponovno uporabo medicinskega pripomočka. Določbe tega dokumenta se uporabljajo za medicinske pripomočke, ki so namenjeni invazivnim ali drugačnim neposrednim ali posrednim stikom z bolnikom.
Ta dokument ne določa navodil za obdelavo. Namesto tega ta dokument določa zahteve za pomoč proizvajalcem medicinskih pripomočkov pri zagotavljanju podrobnih navodil za obdelavo, ki po potrebi vsebujejo naslednje dejavnosti:
a) začetna obdelava na mestu uporabe;
b) priprava pred čiščenjem;
c) čiščenje;
d) razkuževanje;
e) sušenje;
f) pregledovanje in vzdrževanje;
g) pakiranje;
h) sterilizacija;
i) shranjevanje;
j) transport.
Ta dokument ne vključuje obdelave naslednjih proizvodov:
– nenujni medicinski pripomočki, ki niso namenjeni neposrednemu stiku z bolnikom;
– tekstilni pripomočki, ki se uporabljajo v sistemih za pokrivanje bolnikov ali operacijskih oblačilih;
– medicinski pripomočki, ki jih je proizvajalec določil za enkratno uporabo in so dobavljeni pripravljeni za takojšnjo uporabo.

General Information

• Status: Withdrawn
• Publication Date: 05-Dec-2017
• Withdrawal Date: 31-Aug-2021
• ICS: 11.080.01 - Sterilization and disinfection in general
• Technical Committee: CEN/TC 204 - Sterilization of medical devices
• Drafting Committee: CEN/TC 204 - Sterilization of medical devices
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 01-Sep-2021
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 17664:2018 - Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices (ISO 17664:2017)

Relations

• Replaces: EN ISO 17664:2004 - Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices (ISO 17664:2004)
• Effective Date: 13-Dec-2017
• Replaced By: EN ISO 17664-1:2021 - Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021)
• Effective Date: 08-Sep-2021

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 17664:2018
01-februar-2018
1DGRPHãþD
SIST EN ISO 17664:2004
3URFHVLUDQMHL]GHONRY]D]GUDYVWYHQRQHJR,QIRUPDFLMDNLMR]DJRWRYL
SURL]YDMDOHFPHGLFLQVNLKSULSRPRþNRY]DSRVWRSHNREGHODYHPHGLFLQVNLK
SULSRPRþNRY,62
Processing of health care products - Information to be provided by the medical device
manufacturer for the processing of medical devices (ISO 17664:2017)
Aufbereitung von Produkten für die Gesundheitsfürsorge - Vom Medizinprodukt-
Hersteller bereitzustellende Informationen für die Aufbereitung von Medizinprodukten
(ISO 17664:2017)
Traitement de produits de soins de santé - Informations devant être fournies par le
fabricant de l'appareil pour le traitement des dispositifs médicaux (ISO 17664:2017)
Ta slovenski standard je istoveten z: EN ISO 17664:2017
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 17664:2018 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 17664:2018

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SIST EN ISO 17664:2018


EN ISO 17664
EUROPEAN STANDARD

NORME EUROPÉENNE

December 2017
EUROPÄISCHE NORM
ICS 11.080.01 Supersedes EN ISO 17664:2004
English Version

Processing of health care products - Information to be
provided by the medical device manufacturer for the
processing of medical devices (ISO 17664:2017)
Traitement de produits de soins de santé - Aufbereitung von Produkten für die
Informations relatives au traitement des dispositifs Gesundheitsfürsorge - Vom Medizinprodukt-Hersteller
médicaux à fournir par le fabricant du dispositif (ISO bereitzustellende Informationen für die Aufbereitung
17664:2017) von Medizinprodukten (ISO 17664:2017)
This European Standard was approved by CEN on 3 August 2017.

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 CEN-CENELEC Management Centre 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 CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and United Kingdom.





EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 17664:2017 E
worldwide for CEN national Members.

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SIST EN ISO 17664:2018
EN ISO 17664:2017 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices . 4

2

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SIST EN ISO 17664:2018
EN ISO 17664:2017 (E)
European foreword
This document (EN ISO 17664:2017) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" in collaboration with Technical Committee CEN/TC 204
“Sterilization of medical devices” the secretariat of which is held by BSI.
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 June 2018, and conflicting national standards shall be
withdrawn at the latest by June 2018.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 17664:2004.
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)
...