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EN ISO 11737-1:2018/A1:2021

(Amendment)

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)

Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)

Sterilisation von Produkten für die Gesundheitsfürsorge - Mikrobiologische Verfahren - Teil 1: Bestimmung der Population von Mikroorganismen auf Produkten - Änderung 1 (ISO 11737-1:2018/Amd 1:2021)

No scope available

Stérilisation des produits de santé - Méthodes microbiologiques - Partie 1: Détermination d'une population de microorganismes sur des produits - Amendement 1 (ISO 11737-1:2018/Amd 1:2021)

Sterilizacija izdelkov za zdravstveno nego - Mikrobiološke metode - 1. del: Določevanje populacije mikroorganizmov na izdelku - Dopolnilo A1 (ISO 11737-1:2018/Amd 1:2021)

General Information

Status
Published
Publication Date
15-Jun-2021
Withdrawal Date
30-Dec-2021
ICS
07.100.10 - Medical microbiology
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
6060 - Definitive text made available (DAV) - Publishing
Start Date
16-Jun-2021
Completion Date
16-Jun-2021
Directive
2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
Mandate
M/252 - Standardization Mandate to CEN/CENELEC concerning the development of European standards relating to in vitro diagnostic medical devices
M/565 - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
M/MDR - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
Ref Project
SIST EN ISO 11737-1:2018/A1:2021 - Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd 1:2021)

Relations

Amends
EN ISO 11737-1:2018 - Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018)
Effective Date
19-Sep-2018

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11737-1:2018/A1:2021
01-september-2021
Sterilizacija izdelkov za zdravstveno nego - Mikrobiološke metode - 1. del:
Določevanje populacije mikroorganizmov na izdelku - Dopolnilo A1 (ISO 11737-
1:2018/Amd 1:2021)
Sterilization of health care products - Microbiological methods - Part 1: Determination of
a population of microorganisms on products - Amendment 1 (ISO 11737-1:2018/Amd
1:2021)
Sterilisation von Produkten für die Gesundheitsfürsorge - Mikrobiologische Verfahren -
Teil 1: Bestimmung der Population von Mikroorganismen auf Produkten - Änderung 1
(ISO 11737-1:2018/Amd 1:2021)
Stérilisation des produits de santé - Méthodes microbiologiques - Partie 1: Détermination
d'une population de microorganismes sur des produits - Amendement 1 (ISO 11737-
1:2018/Amd 1:2021)
Ta slovenski standard je istoveten z: EN ISO 11737-1:2018/A1:2021
ICS:
07.100.10 Medicinska mikrobiologija Medical microbiology
11.080.01 Sterilizacija in dezinfekcija na Sterilization and disinfection
splošno in general
SIST EN ISO 11737-1:2018/A1:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11737-1:2018/A1:2021

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SIST EN ISO 11737-1:2018/A1:2021


EN ISO 11737-1:2018/A1
EUROPEAN STANDARD

NORME EUROPÉENNE

June 2021
EUROPÄISCHE NORM
ICS 07.100.10; 11.080.01
English Version

Sterilization of health care products - Microbiological
methods - Part 1: Determination of a population of
microorganisms on products - Amendment 1 (ISO 11737-
1:2018/Amd 1:2021)
Stérilisation des produits de santé - Méthodes Sterilisation von Produkten für die
microbiologiques - Partie 1: Détermination d'une Gesundheitsfürsorge - Mikrobiologische Verfahren -
population de microorganismes sur des produits - Teil 1: Bestimmung der Population von
Amendement 1 (ISO 11737-1:2018/Amd 1:2021) Mikroorganismen auf Produkten - Änderung 1 (ISO
11737-1:2018/Amd 1:2021)
This amendment A1 modifies the European Standard EN ISO 11737-1:2018; it was approved by CEN on 28 September 2020.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant 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 amendment 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, 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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11737-1:2018/A1:2021 E
worldwide for CEN national Members.

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SIST EN ISO 11737-1:2018/A1:2021
EN ISO 11737-1:2018/A1:2021 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 5
Annex ZB (informative)  Relationship between this European standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/746 aimed to be
covered. 7

2

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SIST EN ISO 11737-1:2018/A1:2021
EN ISO 11737-1:2018/A1:2021 (E)
European foreword
This document (EN ISO 11737-1:2018/A1:2021) 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 b
...

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