SIST EN ISO 11138-3:2017
(Main)Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017)
Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017)
ISO 11138-3:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent.
NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by the ISO 17665 series.
NOTE 2 National or regional regulations can provide requirements for work place safety.
Stérilisation des produits de santé - Indicateurs biologiques - Partie 3: Indicateurs biologiques pour la stérilisation à la chaleur humide (ISO 11138-3:2017)
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 feuchte Hitze als sterilisierendes Agens anwenden.
ANMERKUNG 1 Anforderungen an die Validierung und Überwachung von Sterilisationsverfahren mit feuchter Hitze sind in ISO 17665 angegeben.
ANMERKUNG 2 Anforderungen an die Sicherheit am Arbeitsplatz können in nationalen oder regionalen Bestimmungen angegeben sein.
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 3: Biologische Indikatoren für Sterilisationsverfahren mit feuchter Hitze (ISO 11138-3:2017)
ISO 11138-3:2017 spécifie des exigences pour les organismes d'essai, les suspensions, les porte-germes inoculés, les indicateurs biologiques et les méthodes d'essai utilisés dans l'évaluation des performances des procédés de stérilisation qui emploient la chaleur humide comme agent stérilisant.
NOTE 1 Les exigences de validation et de contrôle des procédés de stérilisation par chaleur humide sont fournies par l'ISO 17665.
NOTE 2 Des réglementations nationales ou régionales peuvent fournir des exigences relatives à la sécurité du lieu de travail.
Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 3. del: Biološki indikatorji za sterilizacijske postopke z vlažno toploto (ISO 11138-3:2017)
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 vlažno toploto.
OPOMBA 1: zahteve za potrjevanje in nadzor sterilizacijskih postopkov z vlažno toploto zagotavlja skupina standardov ISO 17665.
OPOMBA 2: zahteve za varnost na delovnem mestu lahko zagotavljajo nacionalni ali regionalni predpisi.
General Information
Relations
Overview
EN ISO 11138-3:2017 (ISO 11138-3:2017) specifies requirements for biological indicators, inoculated carriers, suspensions, test organisms and test methods used to assess the performance of moist heat (steam) sterilization processes. Published by CEN and aligned with ISO, this part of the ISO 11138 series focuses on biological indicators intended for use with dry saturated steam (moist heat) and is intended for production, labelling, testing and performance declaration of those indicators.
Key topics and technical requirements
- Test organism: Spores of Geobacillus stearothermophilus are specified as the primary test organism; other strains with demonstrated equivalent performance are permitted. (The standard notes reclassification of Bacillus stearothermophilus to Geobacillus stearothermophilus and cites example strains.)
- Suspensions, inoculated carriers and biological indicators: Requirements cover production, packaging, labelling and the form in which spores are supplied for validation and monitoring.
- Carrier and primary packaging: Suitability must be demonstrated; defined exposure conditions are used to test carriers (e.g., exposure to dry saturated steam, minimum/maximum temperature criteria and a representative exposure time).
- Population and resistance:
- Manufacturers must state viable counts and resistance characteristics.
- Resistance is expressed as the D value at 121 °C (minutes) and reported to one decimal place.
- The standard requires determination of z value across at least three temperatures in the 110–138 °C range.
- The document sets minimum resistance criteria (e.g., a specified minimum D value at 121 °C) and defines test methods (Annex A) for resistance determination.
- Test methods and calculations: Normative annexes provide the method to determine moist-heat resistance and calculation of z value and statistical parameters.
Applications
- Validation and routine monitoring of steam autoclaves and other moist heat sterilization equipment.
- Supplier specification and quality control for manufacturers of biological indicators.
- Performance testing during sterilizer qualification, requalification and process change control.
- Reference guidance for test laboratories performing biological indicator characterization.
Who uses this standard
- Manufacturers of biological indicators and inoculated carriers
- Sterilizer and medical device manufacturers
- Sterilization validation and quality assurance engineers in healthcare and industry
- Test laboratories and regulatory bodies involved in sterilization conformity assessment
Related standards
- ISO 11138‑1:2017 - General requirements for biological indicators
- ISO 17665 series - Validation and routine control of moist heat sterilization processes
- ISO 14161 - Guidance on selection, use and interpretation of biological indicators
Keywords: EN ISO 11138-3:2017, ISO 11138-3:2017, biological indicators, moist heat sterilization, Geobacillus stearothermophilus, D value, z value, inoculated carriers, sterilization validation, dry saturated steam.
Related Packages
Frequently Asked Questions
SIST EN ISO 11138-3:2017 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes (ISO 11138-3:2017)". This standard covers: ISO 11138-3:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent. NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by the ISO 17665 series. NOTE 2 National or regional regulations can provide requirements for work place safety.
ISO 11138-3:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing moist heat as the sterilizing agent. NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by the ISO 17665 series. NOTE 2 National or regional regulations can provide requirements for work place safety.
SIST EN ISO 11138-3:2017 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.
SIST EN ISO 11138-3:2017 has the following relationships with other standards: It is inter standard links to SIST EN ISO 11138-3:2009. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN ISO 11138-3:2017 is associated with the following European legislation: EU Directives/Regulations: 2007/47/EC, 90/385/EEC, 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase SIST EN ISO 11138-3:2017 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 SIST standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2017
1DGRPHãþD
SIST EN ISO 11138-3:2009
Sterilizacija izdelkov za zdravstveno nego - Biološki indikatorji - 3. del: Biološki
indikatorji za sterilizacijske postopke z vlažno toploto (ISO 11138-3:2017)
Sterilization of health care products - Biological indicators - Part 3: Biological indicators
for moist heat sterilization processes (ISO 11138-3:2017)
Stérilisation des produits de santé - Indicateurs biologiques - Partie 3: Indicateurs
biologiques pour la stérilisation à la chaleur humide (ISO 11138-3:2017)
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 3:
Biologische Indikatoren für Sterilisationsverfahren mit feuchter Hitze (ISO 11138-3:2017)
Ta slovenski standard je istoveten z: EN ISO 11138-3:2017
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 11138-3
EUROPEAN STANDARD
NORME EUROPÉENNE
March 2017
EUROPÄISCHE NORM
ICS 11.080.20 Supersedes EN ISO 11138-3:2009
English Version
Sterilization of health care products - Biological indicators
- Part 3: Biological indicators for moist heat sterilization
processes (ISO 11138-3:2017)
Stérilisation des produits de santé - Indicateurs Sterilisation von Produkten für die
biologiques - Partie 3: Indicateurs biologiques pour la Gesundheitsfürsorge - Biologische Indikatoren - Teil 3:
stérilisation à la chaleur humide (ISO 11138-3:2017) Biologische Indikatoren für Sterilisationsverfahren mit
feuchter Hitze (ISO 11138-3:2017)
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 11138-3:2017 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 11138-3:2017) 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 11138-3:2009.
The standard is a full technical revision of the previous version. The following amendments have been
made in comparison with EN ISO 11138-3:2009:
— requirements on population and resistance (clause 9) revised;
— Annex A, in particular A.2.4 step 4 revised;
— informative Annex ZA respective relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered was deleted.
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 11138-3:2017 has been approved by CEN as EN ISO 11138-3:2017 without any
modification.
INTERNATIONAL ISO
STANDARD 11138-3
Third edition
2017-03
Sterilization of health care products —
Biological indicators —
Part 3:
Biological indicators for moist heat
sterilization processes
Stérilisation des produits de santé — Indicateurs biologiques —
Partie 3: Indicateurs biologiques pour la stérilisation à la chaleur
humide
Reference number
ISO 11138-3:2017(E)
©
ISO 2017
ISO 11138-3:2017(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
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2017 – All rights reserved
ISO 11138-3:2017(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 . 1
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 moist heat sterilization .4
Annex B (normative) Calculation of z value and coefficient of determination, r .5
Bibliography . 8
ISO 11138-3:2017(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
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 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 third edition cancels and replaces the second edition (ISO 11138-3:2006), 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 11138-3:2017(E)
Introduction
This document specifies production, labelling, test methods and performance requirements for the
manufacture of biological indicators including inoculated carriers and suspensions intended for use
in validation and monitoring of sterilization processes. This document gives specific requirements for
those biological indicators intended for use in moist heat sterilization processes.
Moist heat as the sterilizing agent is defined in this document as dry saturated steam. While air-steam
mixtures can be used in moist heat sterilization processes, the methods and performance requirements
of this document might not be applicable for biological indicators used in such processes.
The ISO 11138 series represents the current “state-of-the-art” according to the experts
...
Die Norm SIST EN ISO 11138-3:2017 befasst sich mit der Sterilisation von Gesundheitsprodukten und legt spezifische Anforderungen an biologische Indikatoren für Prozesse mit feuchter Wärme fest. Diese Norm stellt sicher, dass die verwendeten Testorganismen, Suspensions und inokulierten Träger den geforderten Standards entsprechen, um die Leistung von Sterilisationsprozessen zu bewerten, bei denen feuchte Wärme als Sterilisationsmittel eingesetzt wird. Ein herausragender Punkt der Norm ist die präzise Definition der Testmethoden, die dazu beitragen, die Effizienz solcher Sterilisationsverfahren zu gewährleisten. Durch die standardisierten biologischen Indikatoren wird sichergestellt, dass die Geräte und Produkte, die sich in einem gesundheitlichen Umfeld befinden, entsprechend den geforderten Sicherheitsstandards sterilisiert werden. Dies ist besonders relevant für die Einhaltung von Gesundheitsvorschriften und den Schutz von Patienten. Ein weiterer Vorteil dieser Norm liegt in der Klarheit, die sie hinsichtlich der Anwendungsbereiche und der Anforderungen an biologische Indikatoren schafft. Die Möglichkeit, verschiedene Testorganismen zu verwenden, erhöht die Flexibilität und Anwendbarkeit der Norm in unterschiedlichen klinischen und industriellen Umgebungen. Dies fördert nicht nur die Sicherheit, sondern auch die Effizienz im Sterilisationsprozess. Die Norm SIST EN ISO 11138-3:2017 spielt eine entscheidende Rolle in der Qualitätssicherung in der Gesundheitsbranche. Sie unterstützt die Validierung und Überwachung von Prozessen, um sicherzustellen, dass die Sterilisationsmethoden effektiv sind und die notwendigen Hygiene- und Sicherheitsstandards erfüllen. Durch die Integration dieser Norm in die bestehenden Richtlinien, wie der ISO 17665-Serie, wird eine umfassende Basis für die Bewertung und Kontrolle von Sterilisationsverfahren geschaffen. Insgesamt ist die SIST EN ISO 11138-3:2017 ein unverzichtbares Dokument für alle, die in der Medizin und Gesundheitsbranche tätig sind, und bietet eine wichtige Grundlage für die Gewährleistung der Sicherheit und Qualität von sterilisierten Produkten.
La norme SIST EN ISO 11138-3:2017 traite de la stérilisation des produits de santé, en se concentrant spécifiquement sur les indicateurs biologiques pour les processus de stérilisation par chaleur humide. Cette norme est d'une grande portée et importance, car elle précise les exigences relatives aux organismes de test, aux suspensions, aux supports inoculés, aux indicateurs biologiques et aux méthodes d'essai utilisés pour évaluer la performance des processus de stérilisation utilisant la chaleur humide comme agent stérilisant. Parmi les points forts de cette norme, on note la clarté des exigences permettant d'assurer une évaluation précise et fiable des protocoles de stérilisation. En régulant les organismes de test et les méthodes d'essai, la norme garantit que les produits stérilisés répondent aux critères nécessaires de sécurité et d'efficacité. De plus, le lien avec la série ISO 17665 pour la validation et le contrôle des processus de stérilisation par chaleur humide assure une cohérence et une intégration des pratiques de stérilisation dans divers contextes réglementaires. La pertinence de la norme SIST EN ISO 11138-3:2017 est également renforcée par le fait qu'elle contribue à la conformité avec d'éventuelles réglementations nationales ou régionales concernant la sécurité au travail. En établissant des lignes directrices claires et précises, cette norme encourage non seulement la sécurité des procédés de stérilisation, mais également le respect des normes de qualité exigées dans les environnements de soins de santé. Dans l'ensemble, la norme SIST EN ISO 11138-3:2017 est essentielle pour toute entité impliquée dans la stérilisation de produits de santé, car elle fournit un cadre robuste pour l'évaluation, validant ainsi l'efficacité des méthodes de stérilisation par chaleur humide.
SIST EN ISO 11138-3:2017 표준은 의료 제품의 멸균 과정에서 습기 열 멸균을 위한 생물학적 지표에 대한 요구 사항을 규정하고 있습니다. 이 표준의 범위는 테스트 유기체, 현탁액, 접종된 캐리어, 생물학적 지표 및 습기 열 멸균 과정의 성능을 평가하기 위한 테스트 방법을 포함하여 매우 포괄적입니다. 이 표준의 강점 중 하나는 습기 열 멸균 과정에서 요구되는 생물학적 지표의 정확성과 일관성을 보장하는 것입니다. 이러한 표준화는 의료 기기 및 제품의 안전성을 높이는 데 필수적이며, 전 세계적으로 통일된 기준을 제공함으로써 신뢰성을 강화합니다. 또한, SIST EN ISO 11138-3:2017은 멸균 과정의 성능 평가를 위한 명확한 지침을 제공하여 산업 전반에서 멸균 품질을 일관되게 유지할 수 있도록 합니다. 이는 의료 분야에서의 안전성을 향상시키는 데 기여하며, 특히 습기 열 멸균이 필수적인 환경에서 중요성이 더욱 강조됩니다. 마지막으로, 이 표준은 ISO 17665 시리즈와 연계된 멸균 과정의 검증 및 제어 요구 사항도 언급하고 있어, 보다 포괄적인 멸균 프로세스의 안전성을 확보할 수 있는 기초를 마련합니다. 이러한 점에서 SIST EN ISO 11138-3:2017은 의료 제품의 멸균 분야에서 매우 중요한 표준으로 간주됩니다.
SIST EN ISO 11138-3:2017は、医療製品の滅菌における生物学的指標に関する標準規格であり、湿熱滅菌プロセスの性能評価に使用されるテスト生物、懸濁液、接種キャリア、生物学的指標、および試験方法に関する要求事項を明確に定義しています。この標準は、湿熱滅菌を行う際に必要な基準を提供するものであり、滅菌プロセスの信頼性向上に寄与します。 この標準の強みの一つは、湿熱滅菌プロセスに特化した生物学的指標の使用方法を詳細に規定している点です。そのため、医療機関や製造者は、実効的なリスク管理を行い、国際的な水準に則った安全な滅菌を確保することが可能です。また、ISO 17665シリーズが湿熱滅菌プロセスのバリデーションと制御に関する追加的な要求を提供しているため、この標準を利用することで、より包括的なアプローチを取ることができます。 さらに、SIST EN ISO 11138-3:2017の関連性は、企業や施設が国または地域の規制に従いながら、適切な職場の安全基準を守ることを促進する点にもあります。生物学的指標を使用することで、湿熱滅菌プロセスの効果を評価するための信頼性の高い手段を提供し、患者の安全を確保するための重要なツールとなります。 このように、SIST EN ISO 11138-3:2017は、湿熱滅菌プロセスの性能を評価するための基盤を提供し、医療製品の安全性向上に寄与する重要な標準です。
SIST EN ISO 11138-3:2017 represents a crucial development in the field of sterilization of health care products, particularly addressing biological indicators for moist heat sterilization processes. The scope of this standard is comprehensive, as it specifies the requirements for test organisms, suspensions, inoculated carriers, biological indicators, and the test methods essential for evaluating the efficacy of sterilization processes utilizing moist heat as a sterilizing agent. One of the strengths of the SIST EN ISO 11138-3:2017 is its emphasis on uniformity and reliability in the testing mechanisms for biological indicators. By providing detailed specifications for inoculated carriers and test methods, the standard ensures that health care facilities can assess the performance of their sterilization processes in a consistent and reproducible manner. This reliability is paramount in the medical sector, where the efficacy of sterilization is critical to patient safety. Furthermore, the relevance of this standard cannot be overstated, as it not only supports the validation and control of moist heat sterilization processes, as outlined in the ISO 17665 series, but it also aligns with regulatory demands. The mention of the need for adherence to national or regional regulations regarding workplace safety underscores the standard’s commitment to a holistic approach to sterilization processes, which integrates effectiveness with safety considerations. Overall, SIST EN ISO 11138-3:2017 is a pivotal standard that enhances the assurance of sterilization methods through clearly defined procedures and requirements for biological indicators. Its robust framework promotes both safety and efficiency in health care settings, thereby playing a vital role in maintaining high sterilization standards.
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