EN 14180:2014
(Main)Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only.
These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities.
This European Standard specifies minimum requirements:
- for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices;
- for the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.
Sterilisatoren für medizinische Zwecke - Niedertemperatur-Dampf-Formaldehyd-Sterilisatoren - Anforderungen und Prüfung
Diese Europäische Norm legt Anforderungen und Prüfverfahren für NTDF-Sterilisatoren fest, in denen als Sterilisiermittel ein Gemisch von Niedertemperatur-Dampf und Formaldehyd angewendet wird und die nur unterhalb des Umgebungsdruckes arbeiten.
Diese Sterilisatoren werden in erster Linie in medizinischen Einrichtungen zur Sterilisation hitzeempfindlicher Medizinprodukte verwendet.
Diese Europäische Norm legt Mindest-Anforderungen zu folgenden Punkten fest,
für die Leistung und Konstruktion von Sterilisatoren zur Sicherstellung, dass das Verfahren in der Lage ist, Medizinprodukte zu sterilisieren;
an die Ausrüstung und Steuerung dieser Sterilisatoren, die für die Validierung und Routineüberwachung des Sterilisationsverfahrens erforderlich sind.
Stérilisateurs à usage médical - Stérilisateurs à la vapeur et au formaldéhyde à basse température - Exigences et essais
La présente Norme européenne spécifie les exigences et les essais relatifs aux stérilisateurs à la vapeur et au formaldéhyde à basse température, utilisant comme agent stérilisant un mélange à basse température de vapeur d'eau et de formaldéhyde et fonctionnant uniquement à une pression inférieure à la pression atmosphérique.
Ces stérilisateurs sont utilisés en priorité pour stériliser les dispositifs médicaux thermolabiles dans les centres de soins.
La présente Norme européenne spécifie les exigences minimales :
- de performances et de conception des stérilisateurs afin de garantir que le procédé permet de stériliser des dispositifs médicaux ;
- pour le matériel et les systèmes nécessaires aux opérations de validation et de contrôle de routine du procédé de stérilisation.
Sterilizatorji za uporabo v medicini - Sterilizatorji s paro z nizko temperaturo in s formaldehidom - Zahteve in preskušanje
Standard EN 14180 določa zahteve in preskuse za sterilizatorje s paro z nizko temperaturo in s formaldehidom kot sterilizacijskim sredstvom, ki delujejo samo pri nizkem zračnem tlaku. Ti sterilizatorji se primarno uporabljajo v zdravstvenih ustanovah za sterilizacijo medicinskih pripomočkov, občutljivih na vročino. Ta evropski standard določa minimalne zahteve: – za delovanje in načrtovanje sterilizatorjev za sterilizacijo medicinskih pripomočkov; – za opremo in kontrolnike teh sterilizatorjev, potrebnih za preverjanje in rutinski nadzor med postopkom sterilizacije.
General Information
- Status
- Withdrawn
- Publication Date
- 20-May-2014
- Withdrawal Date
- 13-Apr-2025
- Technical Committee
- CEN/TC 102 - Sterilizers for medical purposes
- Drafting Committee
- CEN/TC 102/WG 6 - Gas sterilizers
- Current Stage
- 9960 - Withdrawal effective - Withdrawal
- Start Date
- 02-Apr-2025
- Completion Date
- 14-Apr-2025
Relations
- Effective Date
- 08-Jun-2022
- Effective Date
- 19-Jan-2023
Frequently Asked Questions
EN 14180:2014 is a standard published by the European Committee for Standardization (CEN). Its full title is "Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing". This standard covers: This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only. These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities. This European Standard specifies minimum requirements: - for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices; - for the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.
This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient pressure only. These sterilizers are primarily used for the sterilization of heat labile medical devices in health care facilities. This European Standard specifies minimum requirements: - for the performance and design of sterilizers to ensure that the process is capable of sterilizing medical devices; - for the equipment and controls of these sterilizers necessary for the validation and routine control of the sterilization processes.
EN 14180:2014 is classified under the following ICS (International Classification for Standards) categories: 11.080.10 - Sterilizing equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
EN 14180:2014 has the following relationships with other standards: It is inter standard links to EN 14180:2003+A2:2009, EN 14180:2025. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 14180:2014 is associated with the following European legislation: EU Directives/Regulations: 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.
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Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Sterilizatorji za uporabo v medicini - Sterilizatorji s paro z nizko temperaturo in s formaldehidom - Zahteve in preskušanjeSterilisatoren für medizinische Zwecke - Niedertemperatur-Dampf-Formaldehyd-Sterilisatoren - Anforderungen und PrüfungStérilisateurs à usage médical - Stérilisateurs à la vapeur et au formaldéhyde à basse température - Exigences et essaisSterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing11.080.10Sterilizacijska opremaSterilizing equipmentICS:Ta slovenski standard je istoveten z:EN 14180:2014SIST EN 14180:2014en,fr,de01-oktober-2014SIST EN 14180:2014SLOVENSKI
STANDARDSIST EN 14180:2003+A2:20091DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 14180
May 2014 ICS 11.080.10 Supersedes EN 14180:2003+A2:2009English Version
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
Stérilisateurs à usage médical - Stérilisateurs à la vapeur et au formaldéhyde à basse température - Exigences et essais
Sterilisatoren für medizinische Zwecke - Niedertemperatur-Dampf-Formaldehyd-Sterilisatoren - Anforderungen und Prüfung This European Standard was approved by CEN on 10 April 2014.
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, 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 © 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 14180:2014 ESIST EN 14180:2014
Foreword . 3 Introduction . 4 1 Scope . 5 2 Normative references . 5 3 Terms and definitions . 6 4 Technical requirements . 11 4.1 Sterilizer chamber . 11 4.2 Design and construction . 14 4.3 Indicating, measuring, operating and recording devices . 16 5 Process control . 22 5.1 General . 22 5.2 Software verification and validation . 22 5.3 Operating cycle and automatic control . 23 5.4 Override of automatic control . 24 5.5 Fault . 24 6 Performance requirements . 25 6.1 Sterilizing performance . 25 6.2 Desorption efficacy . 27 6.3 Drying . 27 7 Sound power and vibration . 27 8 Packaging, marking and labelling . 28 9 Information to be supplied by the manufacturer . 29 10 Service and local environment . 31 10.1 General . 31 10.2 Electricity . 31 10.3 Sterilant . 31 10.4 Steam . 32 10.5 Water . 32 10.6 Compressed air . 32 10.7 Drainage and discharges . 32 10.8 Ventilation and environment . 33 10.9 Lighting . 33 Annex A (normative) Test methids . 34 Annex B (normative) Sterilizer classification and testing . 40 Annex C (normative) Test equipment . 43 Annex D (normative) Determination of formaldehyde residuals in a filter indicator . 46 Annex E (informative) Formaldehyde residues on medical devices . 49 Annex F (informative) Environmental aspects . 51 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices . 54 Bibliography . 60
3.45 sterilizing agent physical or chemical entity, or combination of entities having sufficient microbicidal activity to achieve sterility under defined conditions [SOURCE: ISO/TS 11139:2006, 2.50] Note 1 to entry: The sterilizing agent is the condensate film, generated by condensation of the sterilant on the surface of the medical devices to be sterilized. 3.46 theoretical sterilant temperature temperature of the sterilant, calculated from the temperature versus vapour pressure relationship of the sterilant Note 1 to entry: This value is calculated from the beginning of the exposure time until the beginning of aeration. 3.47 unloading door door in a double-ended sterilizer through which the sterilization load is removed from the sterilizer chamber after a sterilization cycle Note 1 to entry: See also 3.18 loading door. 3.48 usable space specified space inside the sterilizer chamber, which is not restricted by fixed parts and which is available to accept the sterilization load 3.49 validation documented procedure for obtaining recording and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications [SOURCE: EN ISO 11139:2006, 3.35] 3.50 verification confirmation through provision of objective evidence that specified requirements have been fulfilled [SOURCE: EN 62304:2006, 2.55] 3.51 works test series of tests performed prior to delivery to demonstrate compliance of each piece of equipment with its specification 4 Technical requirements 4.1 Sterilizer chamber 4.1.1 Materials 4.1.1.1 The surfaces of the materials for the pressure vessel (including, for example, welds) that can come into contact with process chemicals shall be of materials which, under the designed operating conditions, are not impaired by these chemicals. They shall not release any substances known to be toxic in such quantities that can create a health or environmental hazard. SIST EN 14180:2014
Key a
pipe thread ISO 228-G1/2A Figure 1 — Example of the connection for test instruments 4.1.5.2 The sterilizer chamber shall be provided with a straight thermometry entry connection. An example is given in Figure 2. This connection shall be at a point of easy access. The connection shall be provided with a cap marked TT (Temperature Test) and sealed with a sterilant proof and mechanically resistant O-ring seal or flat seal. SIST EN 14180:2014
Key a
pipe thread ISO 228-G1A Figure 2 — Example of thermometry entry connection NOTE The test connections can be provided as accessories to be attached to a single entry port of the chamber. 4.2 Design and construction 4.2.1 Risk control and usability 4.2.1.1 Risk assessment and risk control for sterilizer design and software should be performed following the procedures and requirements given in EN ISO 14971:2012, Clauses 4, 5 and 6. Specific requirements and results should be established and documented. For products designed and placed on the market prior to publication of this edition of EN 14180 other standards may have been applied instead of EN ISO 14971. 4.2.1.2 Risk analysis shall address the specific sterilizer design and features. Measures taken for risk reduction shall consider aspects as user knowledge, experience, training, ergonomics and usability. NOTE EN ISO 12100 or EN 61508–1 can provide further helpful information. 4.2.2 Safety 4.2.2.1 Safety of the design shall be based on risk assessment. Technical solutions shall consider applicable standards. NOTE 1 For general design related to safety see EN 61010–1 and EN 61010–2–040. NOTE 2 Additional guidance is given in EN ISO 12100. NOTE 3 For guidance regarding specific design aspects, EN 60204–1 can apply. The guidance in EN 60204–1 can reduce testing. 4.2.2.2 If a powered chamber door is fitted, systems shall be provided to permit the removal of persons or objects entrapped by the moving door before the pressure, force and temperature specified in EN 61010-1:2010, 7.3.4, and 10.1 are exceeded. NOTE Reversing the direction of the door movement is a way to achieve this. 4.2.2.3 Sterilizers shall comply with EN 61326-1 regarding electromagnetic compatibility (EMC). SIST EN 14180:2014
bar and at maximum airflow. Means shall be provided between the filter and the sterilisation chamber to prevent fluid flow from the sterilizer chamber into the filter. SIST EN 14180:2014
1500 mm high, and the access shall not be obstructed. Fixings for these panels shall remain attached to either the panels or to the body of the sterilizer when panels are removed. The access for maintenance shall be positioned so that it will not compromise the safety of either the product or persons. NOTE Requirements for access are also specified in EN 61010–1:2010, 7.3.2 and 7.3.5. 4.2.8 Accessories If required for ergonomic reasons, loading equipment shall be available as a separate accessory to the sterilizer. If the equipment is intended to be connected to dedicated accessories, these combinations shall not cause any hazard or detrimental effect to the performance of the sterilizer. The mutual compatibility of both systems shall be verified (see 4.2.1 and 5.2). 4.2.9 Transport Where the weight, size or shape of the sterilizer or its various component parts prevents them from being moved by hand, the sterilizer, or each component part shall either be fitted with attachments for lifting gear, or be designed so that it can be fitted with such attachments, or be shaped in such a way that standard lifting gear can easily be attached. The sterilizer, it’s components and dedicated consumables (if applicable) shall be packed for transportation and storage in a way that their performance characteristics are maintained. When handled or transported, all parts of the sterilizer shall remain in their position and orientation so that the sterilizer remains stable and no moving part can cause a hazard. 4.3 Indicating, measuring, operating and recording devices 4.3.1 General 4.3.1.1 Indicating and operating devices shall be identified as to their function. They shall be readily accessible, clearly and durably marked with their function and designed to be easy to operate and read. 4.3.1.2 The devices shall be positioned and/or protected such that their performance is within the specified tolerances during the operation of the sterilizer. SIST EN 14180:2014
2 0,9 < 5 s when tested in flowing water according EN 60751:2008, 6.5.2. 4.3.2.6 Temperature control systems shall have a function which causes a fault to be indicated if a sensor fails. 4.3.3 Temperature indicating devices In addition to the requirements in 4.3.2.1, the temperature indicating devices shall: — be graduated in degrees Celsius; — have a scale, which includes 0 °C to 100 °C; — for analogue instruments be graduated in divisions not greater than 2 °C; — for digital instruments have a resolution of at least 0,1 °C. SIST EN 14180:2014
Key 1 chamber
Temperature indicating instrument Temperature recorder Temperature controller
Pressure indicating instrument Pressure recorder Pressure controller Figure 3 — Arrangements for temperature and pressure sensors 4.3.4 Pressure measuring and indicating devices 4.3.4.1 When used for control, monitoring or registration purposes, pressure measuring and indicating systems shall be protected against unauthorised operation by the use of an access device. 4.3.4.2 When used for process control, monitoring or registration purposes, absolute pressure measuring systems shall be used. 4.3.4.3 At least two independent sensors shall be used for the measurement of the chamber pressure, being dedicated to indication, control and registration. 4.3.4.4 The registration and monitoring/controlling devices shall be mutually independent as given by any of the arrangements shown in Figure 3. 4.3.4.5 When used for process control, monitoring or registration purposes, pressure measuring and indicating chain shall have maximum permissible errors of 1 % or less over the scale range, and be adjusted to ± 0,8 kPa (±0,008 bar) or less over the range from 0 kPa (0 bar) up to the sterilization pressure. 4.3.4.6 When used for process control, monitoring or registration purposes, pressure measuring systems shall have a function which causes a fault to be indicated if a sensor fails. 4.3.4.7 Pressure indicating devices shall: — be graduated in kilopascals or bars; — have a scale which includes the range 0 kPa (0 bar) to at least 10 % above the maximum process operating pressure when used for process control or monitoring purposes; SIST EN 14180:2014
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Die Norm EN 14180:2014 bietet eine umfassende Regelung für Sterilisatoren im medizinischen Bereich, insbesondere für Niedertemperatur-Dampf- und Formaldehydsterilisatoren, die einen entscheidenden Beitrag zur Sicherheit in der Gesundheitsversorgung leisten. Der Geltungsbereich dieser Europäischen Norm ist klar definiert und richtet sich auf Sterilisatoren, die eine Mischung aus niedrigtemperaturigem Dampf und Formaldehyd als Sterilisationsmittel nutzen und unterhalb des Umgebungsdrucks arbeiten. Eine der größten Stärken der EN 14180:2014 ist die Festlegung von Mindestanforderungen sowohl für die Leistung als auch für das Design der Sterilisatoren. Dies gewährleistet, dass der Sterilisationsprozess zuverlässig medizinische Geräte, die temperaturempfindlich sind, sterilisiert und somit den hohen Anforderungen im Gesundheitswesen gerecht wird. Die Norm bietet eine solide Grundlage, die sicherstellt, dass nur Geräte von höchster Qualität und Sicherheit in der Patientenversorgung eingesetzt werden. Zusätzlich zu den Anforderungen an die Sterilisatoren selbst spezifiziert die EN 14180:2014 auch die notwendigen Ausstattungen und Kontrollen, die für die Validierung und die routinemäßige Überwachung der Sterilisationsprozesse erforderlich sind. Diese elementaren Vorgaben sind entscheidend, um konsistente und reproduzierbare Ergebnisse in der Sterilisation zu erzielen, was wiederum das Risiko von Infektionen in Krankenhäusern und anderen Gesundheitseinrichtungen erheblich reduziert. Die Relevanz dieser Norm kann nicht genug betont werden, da sie nicht nur gesetzliche Anforderungen erfüllt, sondern auch das Vertrauen in die sterilen Produkte und deren Anwendung erheblich stärkt. In einer Zeit, in der die Sicherheit und Wirksamkeit von medizinischen Geräten von größter Bedeutung sind, bietet die EN 14180:2014 eine wertvolle Richtlinie für alle Einrichtungen, die mit der Sterilisation von hitzeempfindlichen medizinischen Geräten befasst sind. Durch die Berücksichtigung dieser Norm können Hersteller und Gesundheitsdienstleister sicherstellen, dass ihre Betriebsmethoden den neuesten Standards entsprechen und somit die Patientensicherheit an oberster Stelle bleibt. Die EN 14180:2014 stellt somit einen unverzichtbaren Bestandteil im Bereich der medizinischen Sterilisation dar.
The EN 14180:2014 standard serves a crucial role within the healthcare sector, addressing the specific requirements and testing protocols for low temperature steam and formaldehyde (LTSF) sterilizers. Its primary scope encompasses the sterilization of heat-labile medical devices, which are especially sensitive to high temperatures, thus ensuring the safe and effective processing of these critical items in healthcare facilities. One of the key strengths of this standard is its clear delineation of minimum design and performance requirements for LTSF sterilizers. By specifying these essential criteria, the standard facilitates consistent results in sterilization efficacy, ensuring that medical devices are properly sterilized before use. This is vital for infection control and patient safety, reinforcing the importance of reliable sterilization methods. Furthermore, EN 14180:2014 emphasizes the necessary equipment and control mechanisms that must be in place to validate and routinely monitor the sterilization processes. This focus on process control is significant as it helps healthcare providers maintain compliance with hygiene standards and supports the continuous improvement of sterilization practices. The relevance of this standard extends beyond mere compliance; it embodies a commitment to quality in healthcare by providing the frameworks necessary to ensure that sterilization practices are both scientifically sound and practically applicable. It addresses the unique challenges posed by the use of low temperature steam and formaldehyde, making it particularly relevant for facilities aiming to optimize their sterilization protocols for heat-sensitive devices. Overall, EN 14180:2014 stands as an indispensable resource for healthcare organizations that prioritize the safety and effectiveness of their sterilization processes, thereby helping to enhance patient care outcomes.
SIST EN 14180:2014は、医療用の低温蒸気とホルムアルデヒドを使用する滅菌器に関する欧州標準であり、その範囲は非常に重要です。この標準は、低温蒸気とホルムアルデヒドの混合物を滅菌剤として使用し、常圧以下で動作するLTSF（Low Temperature Steam and Formaldehyde）滅菌器に適用されます。これらの滅菌器は、熱に敏感な医療機器を健康管理施設で滅菌するための主要な手段として使用されています。 この標準の強みは、医療機器が確実に滅菌されるプロセスを確保するための性能と設計に関する最低要件が規定されている点です。具体的には、滅菌器の性能、設計、並びに滅菌プロセスのバリデーションおよび定期的な管理に必要な機器と制御に関する基準が含まれています。これにより、医療施設での使用において信頼性の高い滅菌が保証されるため、患者の安全が向上します。 さらに、SIST EN 14180:2014は、滅菌プロセスの一貫性を確保するための試験方法についても言及しており、これにより製造業者は製品の品質を維持しやすくなります。このような点から、この標準は医療業界において非常に relevancy を持つものです。また、低温蒸気とホルムアルデヒドを使用することで、熱に敏感な材料でも効果的に滅菌できるため、特に重要性が増していると言えるでしょう。 全体として、SIST EN 14180:2014は、医療機器の安全で効果的な滅菌を確保するために欠かせない標準であり、その適用範囲の広さと明確な要件は、医療業界にとって大変な価値があります。
표준 EN 14180:2014에 대한 리뷰는 다음과 같습니다. 이 유럽 표준은 저온 증기 및 포름알데히드 혼합물을 멸균제로 사용하는 저온 증기 포름알데히드(LTSF) 멸균기의 요구사항 및 테스트를 규정하고 있습니다. 표준의 범위는 주로 의료 시설에서 열에 민감한 의료 기기의 멸균에 적용됩니다. 이러한 멸균기는 주변 압력 이하에서 작동하며, 이는 특정 환경에서의 안전성과 효율성을 보장합니다. EN 14180:2014의 강점 중 하나는 멸균기의 성능 및 설계에 대한 최소 요구 사항을 명확히 하고 있다는 점입니다. 이 표준은 의료 기기가 효과적으로 멸균될 수 있도록 하는 과정의 가능성을 확보하는 데 필요한 요소들을 정의하고 있습니다. 또한 멸균 과정의 검증 및 일상적인 제어를 위한 장비 및 제어 시스템에 대해서도 명확한 가이드를 제공하여 실질적인 현장 적용성을 높이고 있습니다. 이 표준이 의료 기기 멸균 분야에서 가지는 중요성은 멸균 프로세스의 일관성과 신뢰성을 보장하는 데 있습니다. 의료 시설에서 사용하는 저온 증기 및 포름알데히드 멸균기는 환자의 안전과 직결되므로 이 BSI EN 14180:2014 표준은 의료 기기를 다루는 모든 기관에 필수적이라 할 수 있습니다. 이를 통해 의료 기기의 생명을 보호하고, 병원 감염을 감소시키는 효과를 증대시킬 것으로 기대됩니다.
La norme SIST EN 14180:2014 se distingue par son approche systématique et rigoureuse des stérilisateurs à basse température, spécifiquement ceux utilisant un mélange de vapeur d'eau à basse température et de formaldéhyde. Cette norme européenne établit des exigences clés et des méthodes d'essai pour ces dispositifs, garantissant ainsi que leur performance soit conforme aux besoins stricts de l'asepsie dans les établissements de santé. L'un des principaux atouts de la norme réside dans sa capacité à définir des exigences minimales tant au niveau de la conception que des performances des stérilisateurs. Cela assure non seulement l'efficacité du processus de stérilisation des dispositifs médicaux sensibles à la chaleur, mais garantit aussi la sécurité des patients et du personnel médical. En stipulant des critères précis pour la validation et le contrôle routinier des processus de stérilisation, cette norme favorise une pratique standardisée et fiable dans le domaine de la santé. La norme est particulièrement pertinente dans le contexte actuel, où les dispositifs médicaux à faible tolérance thermique sont de plus en plus utilisés. La spécification des exigences pour l'équipement et les contrôles nécessaires aux stérilisateurs renforce la fiabilité des résultats de stérilisation et aide les établissements de santé à maintenir des standards de qualité élevée. En résumé, la SIST EN 14180:2014 joue un rôle crucial dans l’harmonisation des pratiques de stérilisation dans le secteur de la santé, en apportant des directives claires et des exigences rigoureuses qui répondent aux défis contemporains de la stérilisation des dispositifs médicaux.
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