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.
Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 3: Biologische Indikatoren für Sterilisationsverfahren mit feuchter Hitze (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.
Stérilisation des produits de santé - Indicateurs biologiques - Partie 3: Indicateurs biologiques pour la stérilisation à la chaleur humide (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
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
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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
...
Frequently Asked Questions
EN ISO 11138-3:2017 is a standard published by the European Committee for Standardization (CEN). 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.
EN ISO 11138-3:2017 is classified under the following ICS (International Classification for Standards) categories: 11.080.01 - Sterilization and disinfection in general; 11.080.20 - Disinfectants and antiseptics. The ICS classification helps identify the subject area and facilitates finding related standards.
EN ISO 11138-3:2017 has the following relationships with other standards: It is inter standard links to EN ISO 11138-3:2009. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
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 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 CEN standards.
The EN ISO 11138-3:2017 standard provides comprehensive guidelines for the effective sterilization of healthcare products using moist heat sterilization processes. Its scope focuses on specifying the requirements for test organisms, suspensions, inoculated carriers, biological indicators, and the associated test methods. This clarity ensures that healthcare facilities can accurately assess the performance of their sterilization processes, thus enhancing patient safety. One of the strengths of this standard is its detailed specification of biological indicators for moist heat sterilization, which are crucial for monitoring the efficacy of these sterilization methods. The standard also emphasizes the importance of using validated test organisms and methods, ensuring consistent and reliable results when testing sterilization processes. By adhering to these specifications, healthcare providers can maintain high standards of infection control and assurance in their sterile processing departments. Additionally, the EN ISO 11138-3:2017 aligns well with additional guidelines from the ISO 17665 series, which provides requirements for the validation and control of moist heat sterilization processes. This interconnectivity reinforces the relevance of the standard in practical applications, as users can easily integrate it with related standards to achieve comprehensive sterilization monitoring. The standard's attention to details-such as the characteristics of biological indicators and protocols for using inoculated carriers-establishes a robust framework for ensuring the effectiveness of sterilization methods. This specificity is advantageous for healthcare organizations striving to comply with stringent regulations and maintain optimal safety standards for medical products. Overall, the EN ISO 11138-3:2017 standard is a pivotal document for professionals involved in sterilization practices, providing essential guidance for ensuring the reliable and effective sterilization of healthcare products through moist heat processes. Its structured approach not only supports compliance with national or regional regulations concerning workplace safety but also underscores the standard’s relevance in the healthcare sector.
SIST EN ISO 11138-3:2017 표준은 의료 제품의 멸균 과정에서의 생물학적 지표에 대한 요구 사항을 명확히 규정하고 있습니다. 본 표준의 범위는 습열 멸균 과정을 평가하기 위해 사용되는 시험 생물, 서스펜션, 접종된 운반체, 생물학적 지표 및 시험 방법을 포함합니다. 즉, 이 표준은 멸균 과정의 성능을 평가하고 보증하기 위한 강력한 기준을 제공합니다. 이 표준의 주요 강점 중 하나는 멸균 과정을 구성하는 다양한 혁신적인 요소들에 대한 철저한 규정을 제공한다는 점입니다. 이를 통해 의료 제품의 안전성과 효율성을 높일 수 있으며, 특히 멸균 과정에서의 생물학적 지표의 신뢰도를 강화하는 데 기여합니다. 또한, EST EN ISO 11138-3:2017은 ISO 17665 시리즈와 연관되어, 습열 멸균 과정의 검증 및 통제에 대한 보완 정보를 제공합니다. 표준이 제시하는 모듈화된 접근 방식은 실험실과 의료 시설 모두에서 적용 가능하여, 일관된 결과를 도출할 수 있는 기반을 마련합니다. 덕분에 이 표준은 멸균의 품질 보증 체계 내에서 필수적인 지침으로 자리 잡고 있습니다. SIST EN ISO 11138-3:2017은 생물학적 지표를 통해 멸균 과정의 정확성을 확인하고, 연구 및 개발 단계에서도 유용하게 사용될 수 있는 정보와 절차를 제공합니다. 그러므로 의료 분야에서의 적용 뿐만 아니라, 생물학적 안전성을 보장하기 위한 일반적인 규정으로서도 매우 중요한 역할을 수행합니다. 이러한 점에서 본 표준은 오늘날 의료 제품의 안전성을 확보하는 데 있어 필수적인 기준이 됩니다.
Die Norm EN ISO 11138-3:2017 ist ein wesentlicher Bestandteil der Sterilisation von Gesundheitsprodukten, die sich auf biologische Indikatoren konzentriert, insbesondere im Kontext der feuchtheißen Sterilisationsprozesse. Sie definiert umfassend die Anforderungen an Testorganismen, Suspensionen, inokulierte Träger, biologische Indikatoren und Prüfmethoden, die zur Bewertung der Leistung von Sterilisationsprozessen eingesetzt werden, die feuchte Wärme als Sterilisationsmittel verwenden. Ein herausragendes Merkmal dieser Norm ist ihre klare Struktur, die es Fachleuten im Gesundheitssektor ermöglicht, präzise und konsistente Maßnahmen zur Überwachung und Kontrolle von Sterilisationsprozessen zu implementieren. Die Anforderungen, die sie an die biologischen Indikatoren stellt, tragen entscheidend dazu bei, die Wirksamkeit der Sterilisationsverfahren sicherzustellen und potenzielle Risiken bei der Anwendung zu minimieren. Die Relevanz dieser Norm ist unbestreitbar, insbesondere in einem Gesundheitsumfeld, in dem die Sicherheit von Patienten an oberster Stelle steht. Sie bietet wertvolle Leitlinien, die in Kombination mit den Anforderungen der ISO 17665-Serie zur Validierung und Kontrolle von feuchtheißen Sterilisationsprozessen zu sehen sind. Hier wird deutlich, dass die Norm nicht nur eine technische Spezifikation bietet, sondern auch grundlegende Aspekte der Arbeitsplatzsicherheit berührt, was wiederum den rechtlichen und ethischen Standards entspricht, die in vielen Ländern oder Regionen geltend sind. Durch die Verankerung von Anforderungen, die die Integrität der biologischen Indikatoren gewährleisten, können Organisationen sicherstellen, dass ihre Sterilisationsprozesse höchsten Standards entsprechen. Die Implementierung dieser Norm stärkt somit die allgemeine Qualitätssicherung im Gesundheitswesen und bietet gleichzeitig einen Rahmen für die kontinuierliche Verbesserung von Sterilisationsmethoden. Insgesamt stellt die EN ISO 11138-3:2017 ein unverzichtbares Werkzeug für alle Einrichtungen dar, die im Bereich der Gesundheitsversorgung tätig sind und die Sicherheit und Wirksamkeit ihrer Sterilisationsprozesse garantieren möchten.
La norme EN ISO 11138-3:2017 est un document crucial dans le domaine de la stérilisation des produits de santé, en particulier pour les processus de stérilisation par chaleur humide. Son champ d'application précis et bien défini établit les exigences relatives aux organismes de test, aux suspensions, aux supports inoculés, aux indicateurs biologiques, ainsi qu'aux méthodes d'essai, offrant ainsi une base solide pour évaluer la performance des processus de stérilisation utilisant l'humidité comme agent stérilisant. L'une des forces majeures de cette norme est sa capacité à harmoniser les pratiques de contrôle et de validation dans le domaine de la stérilisation. En fournissant des critères clairs et des procédures standardisées, la norme facilite la conformité avec les exigences réglementaires nationales ou régionales relatives à la sécurité au travail, ce qui est un aspect essentiel dans la gestion des processus de stérilisation en milieu de santé. De plus, la norme EN ISO 11138-3:2017 contribue à une meilleure assurance qualité des produits de santé, en garantissant que les méthodes de stérilisation sont non seulement efficaces mais également fiables. En intégrant des indicateurs biologiques spécifiques à la stérilisation par chaleur humide, elle permet aux établissements de santé de suivre et de valider leurs processus stériles avec précision, renforçant ainsi la protection des patients et la réduction des risques d'infections nosocomiales. En somme, la norme EN ISO 11138-3:2017 se révèle être un document essentiel, en offrant des directives claires pour la mise en œuvre et le contrôle des processus de stérilisation, tout en répondant aux exigences réglementaires et en garantissant un niveau élevé de sécurité dans le domaine des soins de santé.
SIST EN ISO 11138-3:2017は、医療製品の滅菌に関連する重要な標準であり、主に湿熱滅菌プロセスにおける生物学的指標に関する要求事項を規定しています。この標準は、試験用生物、サスペンション、接種されたキャリア、生物学的指標、および湿熱を滅菌剤として使用する滅菌プロセスの性能を評価するために必要な試験方法を指定しています。 この標準の強みは、湿熱滅菌プロセスの評価に必要な明確な要件を提供することであり、これにより医療機関は安全で効果的な滅菌手続きを確保することができます。特に、ISO 11138-3:2017は、試験用生物の選定やそれに伴う試験方法の正確性を重視しており、これが実践的な滅菌プロセスの向上に寄与します。 さらに、ISO 17665シリーズによって提供される湿熱滅菌プロセスのバリデーションおよびコントロールに関する要件とも関連付けられているため、滅菌の一貫性と信頼性を高めるための効果的なガイドラインを提供しています。これにより、医療関連の方針や規制に準拠しつつ、製品の安全性を担保することが可能です。 加えて、国や地域の規制に基づく職場の安全に関する要件も考慮されているため、SIST EN ISO 11138-3:2017は、医療製品の製造および取り扱いにおいて非常に重要な役割を果たします。これにより、業界全体にわたって一貫した滅菌プロセスが促進され、結果的に患者の安全向上につながります。
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