EN 13060:2014+A1:2018
(Main)Small steam sterilizers
Small steam sterilizers
This European Standard specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids.
This European Standard applies to automatically controlled small steam sterilizers that generate steam using electrical heaters or use steam that is generated by a system external to the sterilizer.
This European Standard applies to small steam sterilizers used primarily for the sterilization of medical devices with a chamber volume of less than 60 l and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm).
The requirements concerning the quality management and risk management are addressed by other standards (e.g. EN ISO 13485, EN ISO 14971).
This European Standard does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products.
This European Standard does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases).
This European Standard does not specify requirements for the validation and routine control of sterilization by moist heat.
NOTE Requirements for the validation and routine control of sterilization by moist heat are given in EN ISO 17665-1.
This European Standard does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).
Dampf-Klein-Sterilisatoren
Petits stérilisateurs à la vapeur d'eau
La présente Norme européenne spécifie les exigences de performance et les méthodes d’essai relatives
aux petits stérilisateurs à la vapeur d’eau et aux cycles de stérilisation utilisés à des fins médicales ou
pour des matériels susceptibles d’entrer en contact avec du sang ou des fluides corporels.
La présente Norme européenne s’applique aux petits stérilisateurs à la vapeur d’eau à commande
automatique qui produisent de la vapeur d’eau à l’aide d’éléments chauffants électriques, ou qui
utilisent la vapeur d’eau produite par un système externe au stérilisateur.
La présente Norme européenne s’applique aux petits stérilisateurs à la vapeur d’eau employés
essentiellement pour la stérilisation de dispositifs médicaux, dont le volume de la chambre est inférieur
à 60 l et qui ne peuvent pas loger une unité de stérilisation (300 mm 300 mm 600 mm).
Les exigences relatives au management de la qualité et à la gestion des risques sont traitées dans
d’autres normes (par exemple, EN ISO 13485, EN ISO 14971).
La présente Norme européenne ne s’applique pas aux petits stérilisateurs à la vapeur d’eau qui sont
utilisés pour stériliser des liquides ou des produits pharmaceutiques.
La présente Norme européenne ne précise pas les exigences de sécurité en rapport avec les risques
associés à la zone dans laquelle le stérilisateur est utilisé (par exemple, gaz inflammables).
La présente Norme européenne ne spécifie pas les exigences relatives à la validation et au contrôle de
routine de la stérilisation à la chaleur humide.
NOTE Les exigences relatives à la validation et au contrôle de routine d’un procédé de stérilisation à la
chaleur humide sont indiquées dans l’EN ISO 17665-1.
La présente Norme européenne ne définit pas d’exigences relatives à d’autres procédés de stérilisation
qui utilisent également de la chaleur humide (à savoir : stérilisation au formaldéhyde, à l’oxyde
d’éthylène).
Mali parni sterilizatorji
Ta evropski standard določa zahteve za delovanje in preskusne metode za male parne sterilizatorje in sterilizacijske cikle, ki se uporabljajo za medicinske namene ali za materiale, ki lahko pridejo v stik s krvjo ali telesnimi tekočinami.
Ta evropski standard se uporablja za avtomatsko nadzorovane male parne sterilizatorje, ki paro proizvajajo z uporabo električnih grelcev ali uporabljajo paro, ki jo proizvaja sistem zunaj sterilizatorja.
Ta evropski standard s uporablja za male parne sterilizatorje, ki se uporabljajo predvsem za sterilizacijo medicinskih pripomočkov in se vanje ne more namestiti sterilizacijski modul (300 mm × 300 mm × 600 mm), s prostornino komore pod 60 l.
Zahteve glede vodenja kakovosti in obvladovanja tveganj so obravnavane v drugih standardih (npr. EN ISO 13485, EN ISO 14971).
Ta evropski standard se ne uporablja za male parne sterilizatorje, ki se uporabljajo za sterilizacijo tekočin ali farmacevtskih izdelkov.
Ta evropski standard ne določa varnostnih zahtev v zvezi s tveganji, povezanimi z območjem, na katerem se uporablja sterilizator (npr. vnetljivi plini).
Ta evropski standard ne določa zahtev za validacijo in rutinsko kontrolo sterilizacije z vlažno toploto.
OPOMBA: Zahteve za validacijo in rutinsko kontrolo sterilizacije z vlažno toploto so določene v standardu EN ISO 17665-1.
Ta evropski standard ne določa zahtev za druge sterilizacijske postopke, ki prav tako uporabljajo vlažno toploto (tj. formaldehid, etilenoksid).
General Information
Relations
Frequently Asked Questions
EN 13060:2014+A1:2018 is a standard published by the European Committee for Standardization (CEN). Its full title is "Small steam sterilizers". This standard covers: This European Standard specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids. This European Standard applies to automatically controlled small steam sterilizers that generate steam using electrical heaters or use steam that is generated by a system external to the sterilizer. This European Standard applies to small steam sterilizers used primarily for the sterilization of medical devices with a chamber volume of less than 60 l and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm). The requirements concerning the quality management and risk management are addressed by other standards (e.g. EN ISO 13485, EN ISO 14971). This European Standard does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products. This European Standard does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases). This European Standard does not specify requirements for the validation and routine control of sterilization by moist heat. NOTE Requirements for the validation and routine control of sterilization by moist heat are given in EN ISO 17665-1. This European Standard does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).
This European Standard specifies the performance requirements and test methods for small steam sterilizers and sterilization cycles which are used for medical purposes or for materials that are likely to come into contact with blood or body fluids. This European Standard applies to automatically controlled small steam sterilizers that generate steam using electrical heaters or use steam that is generated by a system external to the sterilizer. This European Standard applies to small steam sterilizers used primarily for the sterilization of medical devices with a chamber volume of less than 60 l and unable to accommodate a sterilization module (300 mm × 300 mm × 600 mm). The requirements concerning the quality management and risk management are addressed by other standards (e.g. EN ISO 13485, EN ISO 14971). This European Standard does not apply to small steam sterilizers that are used to sterilize liquids or pharmaceutical products. This European Standard does not specify safety requirements related to risks associated with the zone in which the sterilizer is used (e.g. flammable gases). This European Standard does not specify requirements for the validation and routine control of sterilization by moist heat. NOTE Requirements for the validation and routine control of sterilization by moist heat are given in EN ISO 17665-1. This European Standard does not specify requirements for other sterilization processes that also employ moist heat as part of the process (i.e. formaldehyde, ethylene oxide).
EN 13060:2014+A1:2018 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 13060:2014+A1:2018 has the following relationships with other standards: It is inter standard links to EN 13060:2014, EN 13060:2014/prA1:2017, EN 13060:2025. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 13060:2014+A1:2018 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.
You can purchase EN 13060:2014+A1:2018 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)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Mali parni sterilizatorjiDampf-Klein-SterilisatorenPetits stérilisateurs à la vapeur d'eauSmall steam sterilizers11.080.10Sterilizacijska opremaSterilizing equipmentICS:Ta slovenski standard je istoveten z:EN 13060:2014+A1:2018SIST EN 13060:2015+A1:2019en,fr,de01-januar-2019SIST EN 13060:2015+A1:2019SLOVENSKI
STANDARDSIST EN 13060:20151DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 13060:2014+A1
November
t r s z ICS
s sä r z rä s r Supersedes EN
s u r x rã t r s vEnglish Version
Small steam sterilizers Petits stérilisateurs à la vapeur d 5eau
DampfæKleinæSterilisatoren This European Standard was approved by CEN on
s w November
t r s v and includes Amendment
s approved by CEN on
t v June
t r s zä
egulations which stipulate the conditions for giving this European Standard the status of a national standard without any alterationä Upætoædate lists and bibliographical references concerning such national standards may be obtained on application to the CENæCENELEC Management Centre or to any CEN memberä
translation under the responsibility of a CEN member into its own language and notified to the CENæCENELEC Management Centre has the same status as the official versionsä
CEN members are the national standards bodies of Austriaá Belgiumá Bulgariaá Croatiaá Cyprusá Czech Republicá Denmarká Estoniaá Finlandá Former Yugoslav Republic of Macedoniaá Franceá Germanyá Greeceá Hungaryá Icelandá Irelandá Italyá Latviaá Lithuaniaá Luxembourgá Maltaá Netherlandsá Norwayá Polandá Portugalá Romaniaá Serbiaá Slovakiaá Sloveniaá Spainá Swedená Switzerlandá Turkey and United Kingdomä
EUROPEAN COMMITTEE FOR STANDARDIZATION COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre:
Rue de la Science 23,
B-1040 Brussels
t r s z CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN
s u r x rã t r s v ªA sã t r s z ESIST EN 13060:2015+A1:2019
Clarification of the definition of narrow lumens and simple hollow items (see 3.18 and 3.30) . 67 Annex B (informative)
Process evaluation system . 69 Annex C (informative)
Suggested maximum limits of contaminants in and specification for water for steam sterilization . 70 Annex D (informative)
Example of a table to be supplied with pre-purchase documentation and with the instructions for use . 71 Annex E (informative)
Load support systems . 72 Annex F (informative)
Rationale for the tests . 73 Annex G (informative)
Example of a process challenge device for narrow lumen . 76 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42 EEC on medical devices . 77 Bibliography . 82
This document supersedes EN 13060:2014. The start and finish of text introduced or altered by amendment is indicated in the text by tags !".
This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s). For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. The following amendments have been made in comparison with EN 13060:2004+A2:2010: a) The scope of the standard has been revised with the aim to define small and large sterilizers on the chamber volume; b) Normative references, terms and definitions have been updated, e.g.
— term “hollow load A” has been changed to become “narrow lumen” ( 3.18) — term “hollow load B” has been changed to become “simple hollow items” ( 3.30) c) In Clause 4 various sub-clauses and relevant requirements have been added, such as: — General requirements for design and construction (4.3.1), — Vibrations (4.3.5) — Noise (4.3.6) — Steam penetration test (4.5.1.6) — Software (4.5.4); d) Sub-clause 4.8 has been divided into two subsections: — 4.8 Information to be provided — 4.9 Marking SIST EN 13060:2015+A1:2019
1) Under revision. 2) EN 868-1 has been replaced by EN ISO 11607-1. SIST EN 13060:2015+A1:2019
[SOURCE: prEN 285:2014, definition 3.25] 3.25 process challenge device PCD item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process [SOURCE: ISO/TS 11139:2006, definition 2.33] 3.26 reference measurement point point where the temperature sensor used for the operating cycle control is located [SOURCE: prEN 285:2014, definition 3.26, modified: "probes" replaced by "sensor"] 3.27 risk assessment overall process comprising a risk analysis and a risk evaluation [SOURCE: EN ISO 14971:2012, definition 2.18] 3.28 risk control process through which decisions are reached and protective measures are implemented for reducing risks to, or maintaining risks within, specified levels [SOURCE: EN ISO 14971:2012, definition 2.19, modified; “in” replaced by “through” and “made and measures” replaced by “reached and protective measures are] 3.29 saturated steam water vapour in a state of equilibrium between its liquid phase and its gas phase [SOURCE: EN ISO 17665-1:2006, definition 3.44, modified – “condensation and evaporation” replaced by “its liquid phase and its gas phase”] 3.30 simple hollow item single-ended open-space items where the ratio of length to diameter of the cavity is greater than or 5 -ended open-space items where the ratio of length to diameter of the cavity greater than or equal to 5 mm (D
· 5 mm) Note 1 to entry: See Annex A. SIST EN 13060:2015+A1:2019
k) have a response time 90τ= ¶ 5 s when t
...
SIST EN 13060:2015+A1:2019は、小型蒸気滅菌器に関するヨーロッパ標準であり、その範囲は非常に明確で、医療目的または血液や体液と接触する可能性のある材料に使用される小型蒸気滅菌器の性能要件および試験方法を定めています。この標準は、自動制御された小型蒸気滅菌器に適用され、電気加熱器を使用して蒸気を発生させるか、滅菌器外のシステムから生成された蒸気を使用するものに焦点を当てています。 特に、60リットル未満のチャンバー容積を持ち、滅菌モジュール（300 mm × 300 mm × 600 mm）を収容できない医療機器の滅菌に使用される小型蒸気滅菌器に限定されているため、関連性が高いと言えます。医療機器の安全性と効果的な滅菌プロセスを確保する上で、この標準は重要な役割を果たします。 強みとしては、特に性能要件や試験方法に関する詳細な指針を提供している点が挙げられます。これにより、製造業者が適切な蒸気滅菌器を設計し、実装するための基準となり、結果として病院などの医療環境における感染防止が促進されます。 さらに、管理品質およびリスク管理に関しては、他の標準（例えば、EN ISO 13485やEN ISO 14971）に委ねられているため、フォーカスが明確で、他の関連する品質管理のフレームワークと統合することが容易です。しかし、液体や医薬品の滅菌には適用されず、安全要件や湿熱による滅菌の検証および定期的な管理に関する要件については、別の基準で定められています（EN ISO 17665-1）。 全体として、EN 13060:2014+A1:2018は、小型蒸気滅菌器の設計と運用に関わる専門家にとって、不可欠な参考資料であり、特に医療分野において高い技術的基準を確保するための重要な基準です。
SIST EN 13060:2015+A1:2019 문서는 소형 증기 멸균기와 관련된 유럽 표준으로, 의료 목적으로 사용되는 소형 증기 멸균기의 성능 요구사항 및 시험 방법을 상세히 규명하고 있다. 이 표준은 혈액이나 체액과 접촉할 가능성이 있는 재료의 멸균 사이클에 적용된다. 주요 범위로는, 자동으로 제어되는 소형 증기 멸균기가 포함되며, 이 장치는 전기 히터를 사용하여 증기를 생성하거나 멸균기 외부의 시스템에서 생성된 증기를 사용할 수 있다. 특히, 이 표준은 60리터 미만의 챔버 용량을 가진 멸균기의 요구사항에 적용되며, 300mm × 300mm × 600mm 크기의 멸균 모듈을 수용할 수 없는 장치에 해당한다. 강점 중 하나는 품질 관리 및 위험 관리와 관련된 요구사항이 다른 표준(e.g. EN ISO 13485, EN ISO 14971)에 의해 다루어진다는 점이다. 이를 통해 사용자는 소형 증기 멸균기의 품질 보증 및 위험 분석에 있어 보다 전반적인 기준을 준수할 수 있다. 또한 이 표준은 액체나 제약 제품의 멸균에 사용되는 소형 증기 멸균기에는 적용되지 않는다는 점에서, 특정 용도에 맞는 명확한 경계를 설정하고 있다. 안전 요구사항에 대한 명시가 부족한 점은 다소 아쉬운 부분이나, 이는 사용 환경에서의 리스크를 고려하여 별도의 규정을 마련할 필요성을 반영하고 있다. 습기에 의한 멸균의 검증 및 일상적인 관리 요구사항은 EN ISO 17665-1에서 제공되며, 이 표준이 다루지 않는 영역이다. 이처럼 SIST EN 13060:2015+A1:2019은 의료 기기의 멸균 효율성을 높이는 데 필수적인 표준으로, 소형 증기 멸균기의 정확한 성능 기준을 마련하여 안전하고 효과적인 멸균 과정을 보장하는 데 중요한 역할을 한다.
The EN 13060:2014+A1:2018 standard, titled "Small steam sterilizers," offers a comprehensive framework that addresses the performance requirements and testing methodologies for small steam sterilizers used in medical environments. Its primary scope encompasses automatically controlled sterilizers that either produce steam via electrical heaters or utilize steam generated externally. This specificity effectively narrows down the application to sterilizers designed for medical devices, with a chamber volume of less than 60 liters, thus catering to the needs of smaller-scale medical practices. One of the significant strengths of this standard is its clear delineation of what types of sterilizers it applies to, thereby preventing confusion in compliance and operational practices. By excluding small steam sterilizers intended for sterilizing liquids or pharmaceutical products, the standard maintains a focused approach, ensuring that users can confidently apply its guidelines in relevant contexts without concerns of ambiguity. Furthermore, while the standard outlines essential performance requirements, it strategically references other established standards such as EN ISO 13485 and EN ISO 14971 for quality and risk management. This interconnectedness enhances its relevance by promoting a comprehensive approach to quality assurance in sterilization processes, ensuring that entities using small steam sterilizers adhere to high standards of safety and efficacy. Another notable aspect is the exclusion of requirements that pertain to safety risks within the sterilizer's operational zone, such as flammable gases, which ensures that the standard remains concentrated on performance criteria rather than peripheral safety assessments. Additionally, by not covering validation and routine control of sterilization through moist heat, as specified in EN ISO 17665-1, the standard enables organizations to refer to existing resources for those particular processes, further streamlining compliance. In conclusion, EN 13060:2014+A1:2018 stands out as a significant and highly relevant standard for small steam sterilizers for medical use. Its precise scope, strong performance guidelines, and integration with other quality management specifications collectively ensure that medical environments can efficiently implement effective sterilization practices while safeguarding public health.
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