EN ISO 11138-8:2021
(Main)Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021)
Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021)
1.1 This document specifies the requirements for a test method to be utilized to establish or confirm a reduced incubation time (RIT) that is shorter than the 7-day reference incubation time specified in 7.3.2 of ISO 11138-1:2017 for biological indicators used to monitor moist heat sterilization processes or ethylene oxide (EO) sterilization processes.
NOTE: For biological indicators used for EO sterilization, the stated RIT is applicable to 100 % EO processes or processes that use EO blends, regardless of the product load.
1.2 This document is applicable to manufacturers of biological indicators (BIs) and to end users of BIs who intend to, if required by their quality system, establish, validate or confirm a RIT.
1.3 This document does not apply to biological indicators used to monitor dry heat, low temperature steam formaldehyde (LTSF) or vaporized hydrogen peroxide (VH2O2) sterilization processes.
NOTE The method described in this document to establish a RIT for biological indicators used to monitor moist heat or EO sterilization processes has been used extensively for many years. However, there is limited experience in use of this method to establish a RIT for biological indicators used to monitor dry heat, low temperature steam formaldehyde or vaporized hydrogen peroxide sterilization processes. This document, therefore, does not include these sterilization processes.
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 8: Methode zur Validierung einer reduzierten Inkubationszeit eines biologischen Indikators (ISO 11138-8:2021)
1.1 Dieses Dokument legt die Anforderungen an ein Prüfverfahren fest, das zur Bestimmung oder Bestätigung einer reduzierten Inkubationszeit (en: reduced incubation time, RIT) zu verwenden ist, die kürzer ist als die in ISO 11138 1:2017, 7.3.2, festgelegte 7 tägige Referenz-Inkubationszeit für biologische Indikatoren, welche zur Überwachung von Sterilisationsverfahren mit feuchter Hitze oder mit Ethylenoxid (EO) eingesetzt werden.
ANMERKUNG Für biologische Indikatoren, die für die EO-Sterilisation verwendet werden, gilt die angegebene reduzierte Inkubationszeit für jedes 100 % EO Verfahren oder für jedes Verfahren, das EO-Gemische nutzt, unabhängig von der Produktbelastung.
1.2 Dieses Dokument ist anzuwenden für Hersteller biologischer Indikatoren (en: biological indicators, BIs) sowie für Endbenutzer von BIs, die beabsichtigen, eine reduzierte Inkubationszeit zu bestimmen, zu validieren oder zu bestätigen, wenn dies von ihrem Qualitätsmanagmentsystem gefordert wird.
1.3 Dieses Dokument ist nicht anzuwenden für biologische Indikatoren, die zur Überwachung von Sterilisations¬verfahren mit trockener Hitze, der Niedertemperatur-Dampf-Formaldehyd-Sterilisation (en: low temperature steam formaldehyde, LTSF) oder Sterilisationsverfahren mit verdampftem Wasserstoffperoxid (en: vaporized hydrogen peroxide , VH2O2) eingesetzt werden.
ANMERKUNG Die in diesem Dokument beschriebene Methode zur Bestimmung einer reduzierten Inkubationszeit für biologische Indikatoren, die zur Überwachung von Sterilisationsverfahren mit feuchter Hitze oder EO eingesetzt werden, wird seit vielen Jahren weitverbreitet verwendet. Es liegen allerdings nur in begrenztem Umfang Erfahrungen in der Anwendung dieser Methode zur Bestimmung einer verkürzten Inkubationszeit für biologische Indikatoren vor, die zur Überwachung von Sterilisationsverfahren mit trockener Hitze, der Niedertemperatur-Dampf-Formaldehyd-Sterilisation oder Sterilisationsverfahren mit verdampftem Wasserstoffperoxid eingesetzt werden. Diese Sterilisationsverfahren werden daher nicht in diesem Dokument behandelt.
Stérilisation des produits de santé - Indicateurs biologiques - Partie 8 : Méthode pour la validation d'un temps d'incubation réduit pour un indicateur biologique (ISO 11138-8:2021)
1.1 Le présent document spécifie les exigences relatives à une méthode d’essai à utiliser pour établir ou confirmer un temps d’incubation réduit (TIR) inférieur au temps d’incubation de référence de 7 jours spécifié en 7.3.2 de l’ISO 11138-1:2017 pour les indicateurs biologiques utilisés dans la surveillance des procédés de stérilisation à la chaleur humide ou à l’oxyde d’éthylène (OE).
NOTE Pour les indicateurs biologiques utilisés pour la stérilisation à l’OE, le TIR déclaré s’applique à tous les procédés avec 100 % d’OE ou à ceux qui utilisent des mélanges d’OE, indépendamment de la charge du produit.
1.2 Le présent document est applicable aux fabricants d’indicateurs biologiques (IB) et aux utilisateurs finaux d'indicateurs biologiques qui ont l'intention, si leur système qualité l'exige, d'établir, de valider ou de confirmer un TIR.
1.3 Le présent document ne s’applique pas aux indicateurs biologiques utilisés dans la surveillance des procédés de stérilisation à la chaleur sèche, à la vapeur et au formaldéhyde à basse température (LTSF) ou au peroxyde d'hydrogène vaporisé (VH2O2).
NOTE La méthode décrite dans le présent document pour établir un TIR pour les indicateurs biologiques utilisés dans la surveillance des procédés de stérilisation à la chaleur humide ou à l’oxyde d’éthylène est largement utilisée depuis de nombreuses années. L’expérience est en revanche limitée concernant l’utilisation de cette méthode pour établir un TIR pour les indicateurs biologiques utilisés dans la surveillance des procédés de stérilisation à la chaleur sèche, à la vapeur et au formaldéhyde à basse température ou au peroxyde d'hydrogène vaporisé. Par conséquent, le présent document ne traite pas de ces procédés de stérilisation.
Sterilizacija izdelkov za zdravstveno oskrbo - Biološki indikatorji - 8. del: Metoda za validacijo skrajšanega časa inkubacije biološkega indikatorja (ISO 11138-8:2021)
General Information
Overview
EN ISO 11138-8:2021 - "Sterilization of health care products - Biological indicators - Part 8" specifies a standardized method to establish, validate or confirm a reduced incubation time (RIT) for biological indicators (BIs). The RIT is an incubation period shorter than the 7‑day reference incubation time defined in ISO 11138-1:2017. This part applies to BIs used to monitor moist heat and ethylene oxide (EO) sterilization processes and is intended for BI manufacturers and end users who need to shorten the time-to-result as part of their quality systems.
Key topics and requirements
- Scope: Validates RIT for moist heat and EO processes only; explicitly excludes dry heat, low‑temperature steam formaldehyde (LTSF) and vaporized hydrogen peroxide (VH2O2).
- Reference incubation: RIT must be shorter than the 7‑day reference incubation time specified in ISO 11138‑1:2017.
- Applicability for EO: RIT established per this standard applies to 100% EO processes and EO blend processes, independent of product load.
- Test exposure design: Exposure must produce a fractional response using either:
- a resistometer meeting ISO 18472 requirements, or
- a sterilizer with fully specified, controlled and repeatable parameters.
- Sample types: Method applies to BI designs whose primary components include a spore carrier plus a recovery medium (e.g., spore strips with kit recovery medium or self-contained BIs).
- End‑user reuse: End users need not repeat manufacturer RIT validation provided they use the BI with the same sterilant and incubation temperature used in the validation.
- Quality control: Manufacturers may perform ongoing lot‑to‑lot assessment of RIT using statistically valid sampling plans per their quality systems.
Practical applications
- Rapid verification of sterilization cycles where faster BI results are needed for product release or clinical workflows (e.g., hospitals, dental clinics, outpatient facilities).
- Enabling manufacturers to provide BIs with validated shorter incubation times for improved operational efficiency.
- Supporting quality assurance teams and sterilization technicians in implementing validated RITs within regulatory and accreditation frameworks.
- Useful for laboratories performing BI performance testing and for organizations needing documented, standardized RIT validation methods.
Who should use this standard
- BI manufacturers developing and validating reduced incubation BI products.
- End users (healthcare facilities, sterilization departments) that require validated RITs for process monitoring and product release.
- Regulatory and QA personnel responsible for sterilization validation, acceptance criteria, and documentation.
Related standards
- ISO 11138-1:2017 - General requirements for biological indicators.
- Other parts of ISO 11138 series (Parts 2–7) - specific indicator types and guidance.
- ISO 18472 - Test equipment (resistometer) requirements referenced for exposure control.
Keywords: EN ISO 11138-8:2021, reduced incubation time, RIT, biological indicators, sterilization validation, moist heat, ethylene oxide, BI manufacturers, ISO 11138.
Frequently Asked Questions
EN ISO 11138-8:2021 is a standard published by the European Committee for Standardization (CEN). Its full title is "Sterilization of health care products - Biological indicators - Part 8: Method for validation of a reduced incubation time for a biological indicator (ISO 11138-8:2021)". This standard covers: 1.1 This document specifies the requirements for a test method to be utilized to establish or confirm a reduced incubation time (RIT) that is shorter than the 7-day reference incubation time specified in 7.3.2 of ISO 11138-1:2017 for biological indicators used to monitor moist heat sterilization processes or ethylene oxide (EO) sterilization processes. NOTE: For biological indicators used for EO sterilization, the stated RIT is applicable to 100 % EO processes or processes that use EO blends, regardless of the product load. 1.2 This document is applicable to manufacturers of biological indicators (BIs) and to end users of BIs who intend to, if required by their quality system, establish, validate or confirm a RIT. 1.3 This document does not apply to biological indicators used to monitor dry heat, low temperature steam formaldehyde (LTSF) or vaporized hydrogen peroxide (VH2O2) sterilization processes. NOTE The method described in this document to establish a RIT for biological indicators used to monitor moist heat or EO sterilization processes has been used extensively for many years. However, there is limited experience in use of this method to establish a RIT for biological indicators used to monitor dry heat, low temperature steam formaldehyde or vaporized hydrogen peroxide sterilization processes. This document, therefore, does not include these sterilization processes.
1.1 This document specifies the requirements for a test method to be utilized to establish or confirm a reduced incubation time (RIT) that is shorter than the 7-day reference incubation time specified in 7.3.2 of ISO 11138-1:2017 for biological indicators used to monitor moist heat sterilization processes or ethylene oxide (EO) sterilization processes. NOTE: For biological indicators used for EO sterilization, the stated RIT is applicable to 100 % EO processes or processes that use EO blends, regardless of the product load. 1.2 This document is applicable to manufacturers of biological indicators (BIs) and to end users of BIs who intend to, if required by their quality system, establish, validate or confirm a RIT. 1.3 This document does not apply to biological indicators used to monitor dry heat, low temperature steam formaldehyde (LTSF) or vaporized hydrogen peroxide (VH2O2) sterilization processes. NOTE The method described in this document to establish a RIT for biological indicators used to monitor moist heat or EO sterilization processes has been used extensively for many years. However, there is limited experience in use of this method to establish a RIT for biological indicators used to monitor dry heat, low temperature steam formaldehyde or vaporized hydrogen peroxide sterilization processes. This document, therefore, does not include these sterilization processes.
EN ISO 11138-8:2021 is classified under the following ICS (International Classification for Standards) categories: 11.080.01 - Sterilization and disinfection in general. The ICS classification helps identify the subject area and facilitates finding related standards.
You can purchase EN ISO 11138-8:2021 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-oktober-2021
Sterilizacija izdelkov za zdravstveno oskrbo - Biološki indikatorji - 8. del: Metoda
za validacijo skrajšanega časa inkubacije biološkega indikatorja (ISO 11138-
8:2021)
Sterilization of health care products - Biological indicators - Part 8: Method for validation
of a reduced incubation time for a biological indicator (ISO 11138-8:2021)
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 8:
Methode zur Validierung einer reduzierten Inkubationszeit eines biologischen Indikators
(ISO 11138-8:2021)
Stérilisation des produits de santé - Indicateurs biologiques - Partie 8: Méthode pour la
validation d'un temps d'incubation réduit pour un indicateur biologique (ISO 11138-
8:2021)
Ta slovenski standard je istoveten z: EN ISO 11138-8:2021
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 11138-8
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2021
EUROPÄISCHE NORM
ICS 11.080.01
English Version
Sterilization of health care products - Biological indicators
- Part 8: Method for validation of a reduced incubation
time for a biological indicator (ISO 11138-8:2021)
Stérilisation des produits de santé - Indicateurs Sterilisation von Produkten für die
biologiques - Partie 8: Méthode pour la validation d'un Gesundheitsfürsorge - Biologische Indikatoren - Teil 8:
temps d'incubation réduit pour un indicateur Methode zur Validierung einer reduzierten
biologique (ISO 11138-8:2021) Inkubationszeit eines biologischen Indikators (ISO
11138-8:2021)
This European Standard was approved by CEN on 24 June 2021.
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, 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 11138-8:2021 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 11138-8:2021) 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 January 2022, and conflicting national standards shall
be withdrawn at the latest by January 2022.
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.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN websites.
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
─ Part 6: Biological indicators for hydrogen peroxide sterilization processes
─ Part 7: Guidance for the selection, use and interpretation of results
─ Part 8: Method for validation of a reduced incubation time for a biological indicator
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 11138-8:2021 has been approved by CEN as EN ISO 11138-8:2021 without any
modification.
INTERNATIONAL ISO
STANDARD 11138-8
First edition
2021-07
Sterilization of health care products —
Biological indicators —
Part 8:
Method for validation of a reduced
incubation time for a biological
indicator
Stérilisation des produits de santé — Indicateurs biologiques —
Partie 8: Méthode pour la validation d'un temps d'incubation réduit
pour un indicateur biologique
Reference number
ISO 11138-8:2021(E)
©
ISO 2021
ISO 11138-8:2021(E)
© ISO 2021
All rights reserved. Unless otherwise specified, or required in the context of its implementation, 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 the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2021 – All rights reserved
ISO 11138-8:2021(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General . 2
5 Selection and preparation of samples . 3
6 Exposure and culturing . 3
7 Determination of reduced incubation time . 4
Bibliography . 7
ISO 11138-8:2021(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
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
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 of 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 www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
A list of all parts in the ISO 11138 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved
ISO 11138-8:2021(E)
Introduction
A biological indicator incubation time is the minimum period of cultivation required before making a
final determination that a biological indicator is negative (shows no growth). The reference incubation
time for biological indicators for established sterilization processes such as moist heat and ethylene
oxide is 7 d (see ISO 11138-1:2017). In some instances where biological indicator results are needed as
part of the product release process, a 7-day incubation time might not be practical. This is especially
the case where biological indicators are used to monitor sterilization processes in hospitals or other
health care facilities such as dental or general practitioner offices.
The purpose of a reduced incubation time procedure is to demonstrate recovery of the surviving test
organisms within the specified reduced incubation time period. The reduced incubation time is a
function of the test method and conditions used to establish the incubation time and is independent of
the process parameters for the sterilization method used to deliver the lethality.
Biological indicators with an incubation time of less than 7 d (a Reduced Incubation Time, or RIT)
have been in use since the 1970s. The methodology to determine the RIT was originally created by the
biological indicator manufacturers. Later, the United States Food and Drug Administration published
guidance for manufacturers seeking regulatory clearance to market biological indicators to health
care facilities in the United States (see Reference [1]). This guidance contained a protocol for validating
an incubation time that was less than 7 d. This document was specific to regulations for commercial
practices in a single country and did not address requirements for RIT methodology outside of that
application. The purpose of this document is to describe an internationally agreed approach to the
validation of the reduced incubation time of a biological indicator.
...
EN ISO 11138-8:2021は、医療製品の滅菌に関する標準規格であり、特に生物指標の検証における低い培養時間の手法について規定しています。この文書は、湿熱滅菌プロセスやエチレンオキシド（EO）滅菌プロセスを監視するために使用される生物指標に関して、従来の7日間の培養時間よりも短い培養時間（RIT）を確立または確認するための試験方法の要件を明示しています。 この標準の強みは、湿熱およびエチレンオキシド滅菌プロセスの監視に特化しており、医療製品の滅菌効果を迅速に評価できる点です。特に、100％エチレンオキシドプロセスやエチレンオキシド混合物を使用するプロセスにおいて、RITの適用が明記されているため、製造業者や最終ユーザーがそれぞれの品質システムに従って迅速な検証を行うことが可能です。 文書は、RITを確立するために古くから使用されている方法を基にしており、長年の実績があります。これにより、信頼性のある手法として、特に湿熱滅菌およびエチレンオキシド滅菌が求められる分野での必要性が強調されています。ただし、この文書は、乾燥熱、低温スチームホルマリン（LTSF）や蒸気水素過酸化物（VH2O2）滅菌プロセスに関連する生物指標には適用されないことも明記されており、対象範囲が非常に明確です。これにより、使用者は自身のニーズに合った指標を選択する際に、余分な混乱を避けることができます。 EN ISO 11138-8:2021は、医療機器の安全性と有効性を保障するための重要な文書であり、医療分野での滅菌プロセスの品質管理に対する信頼性と迅速さを提供します。標準化された方法により、業界全体での一貫したアプローチが促進され、製品の信頼性向上に寄与しています。
The EN ISO 11138-8:2021 standard plays a crucial role in the field of health care product sterilization, particularly in the validation of reduced incubation times (RIT) for biological indicators (BIs). The document delineates specific requirements for a test method designed to establish or confirm an RIT shorter than the typical seven-day incubation period mandated in ISO 11138-1:2017. This methodology is particularly pertinent for biological indicators employed in moist heat and ethylene oxide (EO) sterilization processes. One of the main strengths of this standard is its applicability to manufacturers and end users of biological indicators who are looking to validate or confirm a reduced incubation time as part of their quality systems. By providing clear guidelines, it aids manufacturers in streamlining their quality assurance processes and supports end users in ensuring that their sterilization processes are both effective and compliant. The standard's focus on the validation of RIT for 100% EO processes and EO blends, without being contingent on product load, further enhances its relevance in the practical applications of sterilization. This flexibility allows for wider adoption in various health care settings, making it an essential resource for organizations looking to optimize their sterilization protocols. Another significant aspect of the EN ISO 11138-8:2021 is its historical context; the method for establishing a reduced incubation time has been in use for many years, which lends credence to its reliability and effectiveness. However, it rightly notes the limited experience regarding the application of this method to other sterilization processes such as dry heat, low temperature steam formaldehyde (LTSF), or vaporized hydrogen peroxide (VH2O2). By explicitly stating these limitations, the standard ensures that users maintain a clear understanding of the contexts in which the RIT can be validated, thereby preventing potential misuse or misapplication. In conclusion, the EN ISO 11138-8:2021 standard stands out for its specificity and practical applicability within the sterilization sector. Its structured approach to validating reduced incubation times for biological indicators makes it an invaluable resource for manufacturers and users alike, reinforcing its significance in maintaining high standards of health care product safety and efficiency.
ISO 11138-8:2021 표준은 생물학적 지표(BIs)의 검증 절차를 명확히 하며, 특히 의료 제품의 살균 과정에서의 중요성을 강조합니다. 이 표준의 범위는 생물학적 지표를 모니터링하는 데 필요한 단축 배양 시간(RIT)을 설정하거나 확인하는 테스트 방법의 요구 사항을 규정하는 것입니다. 특히, 이 표준은 습열 살균 및 에틸렌 옥사이드 살균 과정에 사용되는 생물학적 지표에 적용됩니다. 이를 통해 제조사 및 최종 사용자가 품질 시스템 요구에 따라 RIT를 설정, 검증 또는 확인할 수 있는 체계를 제공합니다. 이 문서의 강점 중 하나는 단축 배양 시간을 설정하기 위한 구체적인 요구 사항을 포함하여, 기존의 표준(ISO 11138-1:2017)에서 규정한 7일의 기준 배양 시간보다 짧은 배양 시간을 효과적으로 검증할 수 있도록 돕는다는 점입니다. 아울러, 이 표준은 100% 에틸렌 옥사이드 프로세스와 에틸렌 옥사이드 혼합물을 사용하는 과정에서도 적용 가능하므로, 다양한 살균 조건에서의 유연성을 제공합니다. 그러나 이 표준은 건열, 저온 증기 포름알데히드(LTSF) 또는 기화된 과산화수소(VH2O2) 살균 과정에 사용되는 생물학적 지표에는 적용되지 않으므로, 이러한 특정 환경에서의 검증 필요성은 분석과 고려가 필요합니다. 이로 인해 특정한 제한이 존재하지만, 습열 및 에틸렌 옥사이드 살균 모니터링에서의 폭넓은 경험이 이 표준의 신뢰성을 높입니다. 결론적으로, EN ISO 11138-8:2021 표준은 생물학적 지표의 검증 및 탈의 배양 시간 설정을 위한 명료한 가이드라인을 제공하며, 의료 제품의 살균 품질을 확보하는 데 필수적인 도구로 자리잡고 있습니다.
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