EN ISO 11138-5:2017

Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017)

ISO 11138-5:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing low-temperature steam and formaldehyde as the sterilizing agent.
NOTE 1       Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 14937.
NOTE 2       Requirements for work place safety can be provided by national or regional regulations.

Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 5: Biologische Indikatoren für Sterilisationsverfahren mit Niedertemperatur-Dampf-Formaldehyd (ISO 11138-5:2017)

Dieses Dokument legt spezifische Anforderungen an Prüfkeime, Suspensionen, beimpfte Keimträger, biologische Indikatoren und Prüfverfahren fest, die für die Anwendung bei der Beurteilung der Leistung von Sterilisationsverfahren vorgesehen sind, die Niedertemperatur–Dampf–Formaldehyd als sterilisierendes Agens anwenden.
ANMERKUNG 1   Anforderungen an die Validierung und Überwachung von Sterilisationsverfahren mit Niedertemperatur Dampf Formaldehyd sind in ISO 14937 angegeben.
ANMERKUNG 2   Anforderungen an die Sicherheit am Arbeitsplatz können in nationalen oder regionalen Bestimmungen festgelegt sein.

Stérilisation des produits de santé - Indicateurs biologiques - Partie 5: Indicateurs biologiques pour la stérilisation à la vapeur d'eau et au formaldéhyde à basse température (ISO 11138-5:2017)

ISO 11138-5:2017 spécifie des exigences spécifiques pour les organismes d'essai, les suspensions, les porte-germes inoculés, les indicateurs biologiques et les méthodes d'essai prévus pour être utilisés dans l'évaluation des performances des procédés de stérilisation qui emploient la vapeur d'eau et le formaldéhyde à basse température comme agent stérilisant.
NOTE 1       Les exigences de validation et de contrôle des procédés de stérilisation à la vapeur d'eau et au formaldéhyde à basse température sont fournies par l'ISO 14937.
NOTE 2       Des exigences relatives à la sécurité sur le lieu de travail peuvent être fournies par des réglementations nationales ou régionales.

Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 5. del: Biološki indikatorji za sterilizacijske postopke s paro nizke temperature in formaldehidom (ISO 11138-5:2017)

Ta dokument določa zahteve za preskusne organizme, suspenzije, vcepljene prenašalce in biološke indikatorje ter preskusne metode za uporabo pri vrednotenju učinkovitosti sterilizacijskih postopkov, ki kot sterilizacijsko sredstvo uporabljajo paro nizke temperature in formaldehid.
OPOMBA 1: zahteve za potrjevanje in nadzor sterilizacijskih postopkov s paro nizke temperature in formaldehidom zagotavlja standard ISO 14937.
OPOMBA 2: zahteve za varnost na delovnem mestu lahko zagotavljajo nacionalni ali regionalni predpisi.

General Information

• Status: Published
• Publication Date: 28-Mar-2017
• Withdrawal Date: 29-Sep-2017
• ICS: 11.080.01 - Sterilization and disinfection in general
• ICS: 11.080.20 - Disinfectants and antiseptics
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102 - Sterilizers for medical purposes
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 29-Mar-2017
• Completion Date: 29-Mar-2017
• 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 11138-5:2017 - Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017)

Relations

• Replaces: EN ISO 11138-5:2006 - Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2006)
• Effective Date: 13-May-2014

Overview

EN ISO 11138-5:2017 - "Sterilization of health care products - Biological indicators - Part 5" defines requirements for biological indicators (BIs) and associated materials used to assess low‑temperature steam and formaldehyde sterilization processes. The standard specifies test organisms, suspensions, inoculated carriers, BI construction and test methods intended for use in performance assessment, routine monitoring and production control of these low‑temperature sterilization cycles.

Key topics and technical requirements

• Test organisms: Spores of Geobacillus stearothermophilus are the primary test organism; other strains may be used if demonstrated equivalent performance. Several commercially used strains are cited as suitable examples.
• Population and resistance:
  • Resistance is expressed as the D value at 60 °C, stated in minutes to one decimal place for each batch/lot.
  • For BIs containing G. stearothermophilus, the standard requires a D value ≥ 6 min when tested per Annex A.
  • Viable counts and resistance characteristics must be declared in accordance with ISO 11138‑1.
• Carrier and packaging:
  • Suitability of carrier materials and primary packaging must be demonstrated (ISO 11138‑1 and Annex B).
  • Note: filter‑paper‑based carriers can be unsuitable because formaldehyde chemisorption on cellulose may alter performance.
• Exposure challenge for carrier testing:
  • Minimum exposure temperature: ≥ 5 °C above the manufacturer’s stated maximum exposure temperature.
  • Maximum exposure temperature: manufacturer’s stated maximum or, if not stated, ≥ 100 °C.
  • Exposure time: ≥ 160 minutes - chosen to realistically challenge carrier materials while remaining within practical process limits.
• Test methods and annexes:
  • Annex A provides the liquid‑phase method for determination of resistance to low‑temperature steam and formaldehyde.
  • Annex B explains the rationale for the chosen test methodology.

Applications and who uses this standard

• Validation engineers and sterilization specialists - for designing and validating low‑temperature steam/formaldehyde sterilization processes.
• Manufacturers of biological indicators and test kits - to produce BIs that meet defined population and resistance criteria.
• Hospital central sterile departments and medical device manufacturers - for routine process monitoring and quality control.
• Regulatory and conformity assessors - to evaluate BI performance claims and compliance documentation.

Related standards

• ISO 11138‑1 - General requirements for biological indicators (production, labelling, test methods).
• Other parts of the ISO 11138 series (Parts 1–4) for different sterilization modalities.
• ISO 14937 / ISO 25424 and ISO 14161 - standards referenced for process validation, control and interpretation guidance.

Keywords: EN ISO 11138-5:2017, biological indicators, low-temperature steam and formaldehyde, Geobacillus stearothermophilus, D value, sterilization validation, carrier suitability.

Standards Content (Sample)

SLOVENSKI STANDARD
01-junij-2017
1DGRPHãþD
SIST EN ISO 11138-5:2006
Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 5. del: Biološki
indikatorji za sterilizacijske postopke s paro nizke temperature in formaldehidom
(ISO 11138-5:2017)
Sterilization of health care products - Biological indicators - Part 5: Biological indicators
for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017)
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 5:
Biologische Indikatoren für Sterilisationsverfahren mit Niedertemperatur-Dampf-
Formaldehyd (ISO 11138-5:2017)
Stérilisation des produits de santé - Indicateurs biologiques - Partie 5: Indicateurs
biologiques pour la stérilisation à la vapeur d'eau et au formaldéhyde à basse
température (ISO 11138-5:2017)
Ta slovenski standard je istoveten z: EN ISO 11138-5:2017
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.

EN ISO 11138-5
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2017
EUROPÄISCHE NORM
ICS 11.080.20 Supersedes EN ISO 11138-5:2006
English Version
Sterilization of health care products - Biological indicators
- Part 5: Biological indicators for low-temperature steam
and formaldehyde sterilization processes (ISO 11138-
5:2017)
Stérilisation des produits de santé - Indicateurs Sterilisation von Produkten für die
biologiques - Partie 5: Indicateurs biologiques pour la Gesundheitsfürsorge - Biologische Indikatoren - Teil 5:
stérilisation à la vapeur d'eau et au formaldéhyde à Biologische Indikatoren für Sterilisationsverfahren mit
basse température (ISO 11138-5:2017) Niedertemperatur-Dampf-Formaldehyd (ISO 11138-
5:2017)
This European Standard was approved by CEN on 19 January 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: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11138-5:2017 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11138-5:2017) has been prepared by Technical Committee ISO/TC 198
“Sterilization of health care products in collaboration with Technical Committee CEN/TC 102
“Sterilizers and associated equipment for processing of medical devices”, the secretariat of which is held
by DIN.
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 2017 and conflicting national standards
shall be withdrawn at the latest by September 2017.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 11138-5:2006.
The standard is a full technical revision of the previous version. The following amendments have been
made in comparison with EN ISO 11138-5:2006:
— requirements on determination of resistance characteristics (9.6) revised.
EN ISO 11138 consists of the following parts, under the general title Sterilization of health care
products — Biological indicators:
— Part 1: General requirements
— Part 2: Biological indicators for ethylene oxide sterilization processes
— Part 3: Biological indicators for moist heat sterilization processes
— Part 4: Biological indicators for dry heat sterilization processes
— Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
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, 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 the United Kingdom.
Endorsement notice
The text of ISO 11138-5:2017 has been approved by CEN as EN ISO 11138-5:2017 without any
modification.
INTERNATIONAL ISO
STANDARD 11138-5
Second edition
2017-03
Sterilization of health care products —
Biological indicators —
Part 5:
Biological indicators for low-
temperature steam and formaldehyde
sterilization processes
Stérilisation des produits de santé — Indicateurs biologiques —
Partie 5: Indicateurs biologiques pour la stérilisation à la vapeur
d’eau et au formaldéhyde à basse température
Reference number
ISO 11138-5:2017(E)
©
ISO 2017
ISO 11138-5:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
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ii © ISO 2017 – All rights reserved

ISO 11138-5:2017(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 1
5 Test organism . 2
6 Suspension . 2
7 Carrier and primary packaging . 2
8 Inoculated carriers and biological indicators . 2
9 Population and resistance . 2
Annex A (normative) Method for determination of resistance to low-temperature steam
and formaldehyde . 4
Annex B (informative) Rationale for the liquid-phase test method for low-temperature
steam and formaldehyde biological indicators . 6
Bibliography . 7
ISO 11138-5:2017(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
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ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO’s adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: w w w . i s o .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This second edition cancels and replaces the first edition (ISO 11138-5:2006), which has been
technically revised.
A list of all parts of ISO 11138 can be found on the ISO website.
iv © ISO 2017 – All rights reserved

ISO 11138-5:2017(E)
Introduction
ISO 11138-1 specifies production, labelling, test methods and performance requirements for the
manufacture of biological indicators including inoculated carriers and suspensions inte
...