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)

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
• 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: 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
• Directive: 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
• Directive: 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
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 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
• Mandate: 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
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Mandate: M/575 AMD 2 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medicial devices in support of Regulation (EU) 2017746
• Mandate: M/BC/CEN/89/9 - Joint Standardization request to CEN/CENELEC concerning harmonized standards relating to horizontal aspects in the field of medical devices
• Mandate: 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

Overview

EN ISO 11737-1:2018/A1:2021 is Amendment 1 to ISO 11737‑1:2018, adopted by CEN to support harmonized microbiological methods for the sterilization of health care products. The standard specifies procedures for the determination of a population of microorganisms on products (commonly referred to as bioburden). This amendment updates the European adoption of the ISO document and clarifies its relationship to EU regulatory requirements (MDR 2017/745 and IVDR 2017/746).

Keywords: EN ISO 11737-1:2018/A1:2021, ISO 11737-1, bioburden, sterilization validation, microbiological methods, medical devices, MDR, IVDR.

Key topics and requirements

• Scope: Methods for determining the microbial population present on health-care products prior to sterilization (bioburden assessment).
• Purpose: Support validation and maintenance of sterilization processes and, where applicable, development/validation of processes to achieve specific microbial states other than sterility.
• Normative references: Cited standards include ISO 10012, ISO 13485, ISO 15189 and ISO/IEC 17025 (as referenced in the European foreword). Undated references imply the latest editions apply.
• Regulatory linkage: Annex ZA and ZB map the standard’s clauses to the General Safety and Performance Requirements of EU Regulations (MDR 2017/745 and IVDR 2017/746), providing a presumption of conformity for relevant requirements when the standard is cited in the Official Journal of the EU.
• Limitations: The standard addresses bioburden determination but does not cover packaging design for maintenance of sterility during transport/storage or manufacturing aspects unrelated to bioburden testing. Risk management references must be consistent with the applicable EU regulation wording.

Applications

• Sterilization validation and routine control: Establishing baseline bioburden for validation protocols and ongoing process monitoring.
• Product development: Assessing microbial load during design iterations when planning sterilization strategies.
• Quality and regulatory compliance: Demonstrating conformity with regulatory expectations for microbiological characterization of medical devices and in‑vitro diagnostic products.
• Laboratory implementation: Guidance for microbiology and testing laboratories performing product bioburden assays and for accreditation alignment (e.g., ISO/IEC 17025).

Who should use this standard

• Medical device and IVD manufacturers (quality, sterilization, R&D teams)
• Contract sterilization and microbiological testing laboratories
• Regulatory affairs professionals preparing conformity documentation for MDR/IVDR
• Accreditation bodies and notified bodies assessing sterilization validation evidence

Related standards

• ISO 11737‑2 (sterility testing methods) - complementary to Part 1
• ISO 13485 (quality management for medical devices)
• ISO/IEC 17025, ISO 15189 (laboratory competence)

Use EN ISO 11737‑1:2018/A1:2021 when establishing robust, regulatory‑aware bioburden testing programs that feed sterilization validation and ongoing process control.

Standards Content (Sample)

SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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.

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

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 by BSI.
This Amendment to the European Standard EN ISO 11737-1:2018 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by December 2021,
and conflicting national standards shall be withdrawn at the latest by December 2021.
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 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) and Regulations, see informative Annex ZA and ZB, which are an
integral part of this document.
The following referenced documents are indispensable for the application of this document. For
undated references, the edition of the referenced document (including any amendments) listed below
applies. For dated references, only the edition cited applies. However, for any use of this standard
within the meaning of Annex ZA or ZB, the user should always check that any referenced document has
not been superseded and that its relevant contents can still be considered the generally acknowledged
state-of-art.
When an IEC or ISO standard is referred to in the ISO standard text, this should be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table – Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO
standard
ISO 10012 EN ISO 10012:2003 ISO 10012:2003
ISO 13485 EN ISO 13485:2016 ISO 13485:2016
ISO 15189 EN ISO 15189:2012 ISO 15189:2012
ISO/IEC 17025 EN ISO/IEC 17025:2017 ISO/IEC 17025:2017
NOTE The standards normatively referred to by ISO 11737-1:2018/Amd 1:2021 are undated. These referred
standards also include normative references to other dated and undated standards. For undated normative
references, it should always be assumed that the latest edition applies.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: 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 the
United Kingdom.
Endorsement notice
The text of ISO 11737-1:2018/Amd1:2021 has been approved by CEN as EN ISO 11737-
1:2018/A1:2021 without any modification.

Annex ZA
(informative)
Relationship between this European standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered
This European standard has been prepared under a Commission’s standardisation request to provide
one voluntary means of conforming to the General Safety and Performance Requirements of Regulation
(EU) 2017/745 of 5 April 2017 concerning medical devices [OJ L 117].
This document is an adoption of an International Standard. As the scope of the applicable regulatory
requirements differ from nation to nation and region to region, the scope of this document can differ
from the scope of the European Regulations that it supports. This document supports European
regulatory requirements only to the extent of the scope of the European regulations for medical devices
((EU) 2017/745).
Once this standard is cited in the Official Journal of the European Union under that Regulation,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding General Safety and
Performance Requirements of that Regulation, and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Regulation (EU) 2017/745. This means that risks have to be
‘reduced as far as possible’, ‘reduced to the lowest possible level’, ‘reduced as far as possible and appropriate’,
‘removed or reduced as far as possible’, ‘eliminated or reduced as far as possible’, ’removed or minimized as far as
possible’, or ‘minimized’, according to the wording of the corresponding General Safety and Performance
Requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with General Safety
and Performance Requirements 1, 2, 3, 4, 5, 8, 9, 10, 11, 14, 16, 17, 18, 19, 20, 21 and 22 of the Regulation.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
Foreword, replacing the references in the core text.
NOTE 4 When a General Safety and Performance Requirement does not appear in Table ZA.1, it means that it is
not addressed by this European Standard.
Table ZA.1 – Correspondence between this European standard and Annex I of Regulation (EU)
2017/745 [OJ L 117]
General Safety and Performance
Clause(s) / sub-clause(s)
Requirements of Regulation Remarks / Notes
of this EN
(EU) 2017/745
11.3 4,5,6,7,8,9 This standard addresses the
determination of bioburden in the
validation and maintenance of a
sterilization process for medical
devices. It could also be applied in the
development, validation and routine
control of a process for attainment of a
specific microbial state other than
sterility.
This relevant General Safety and
Performance Requirement is only
partly addressed in this European
Standard. Design and packaging for
maintenance of a specific microbial
state during transportation and storage
are not covered. Aspects of
manufacture other than those related
to determination of bioburden in
attainment of a specific microbial state
are not covered.
11.4 first sentence only 4,5,6,7,8,9 This standard addresses the
determination of bioburden in the
validation and maintenance of a
sterilization process for medical
devices.
This relevant General Safety and
Performance Requirement is only
partly addressed in this European
Standard. Design and packaging for
maintenance of sterility during
transportation and storage are not
covered. Aspects of manufacture other
than those related determination of
bioburden in definition, validation and
maintenance of a sterilization process
are not covered.
...