SIST EN 13060:2015+A1:2019
(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
- Status
- Withdrawn
- Publication Date
- 05-Dec-2018
- Withdrawal Date
- 08-Sep-2025
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 9900 - Withdrawal (Adopted Project)
- Start Date
- 04-Sep-2025
- Due Date
- 27-Sep-2025
- Completion Date
- 09-Sep-2025
Relations
- Effective Date
- 01-Jan-2019
- Effective Date
- 01-Oct-2025
- Consolidates
SIST EN 13060:2015 - Small steam sterilizers - Effective Date
- 18-Jan-2023
- Effective Date
- 18-Jan-2023
Frequently Asked Questions
SIST EN 13060:2015+A1:2019 is a standard published by the Slovenian Institute for Standardization (SIST). 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).
SIST EN 13060:2015+A1:2019 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.
SIST EN 13060:2015+A1:2019 has the following relationships with other standards: It is inter standard links to SIST EN 13060:2015, SIST EN 13060:2025, SIST EN 13060:2015, SIST EN 13060:2015/oprA1:2018. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 13060:2015+A1:2019 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 SIST EN 13060:2015+A1:2019 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)
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標準として、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の滅菌に使用される機器の性能要件と試験方法を詳述しています。この欧州標準の適用範囲は、主に、電気ヒーターを使用して蒸気を生成する自動制御の小型蒸気滅菌器に限られ、滅菌モジュールを収容できない60リットル未満のチャンバー容積を持つ医療機器の滅菌に焦点を当てています。 この標準の強みは、滅菌プロセスの具体的な要求事項を示すことにありますが、特に医療機器の滅菌に特化しているため、実際の使用を前提としたガイドラインを提供しています。また、品質管理やリスク管理については他の標準（例：EN ISO 13485、EN ISO 14971）に委ねている点も、専門的なアプローチを体現しています。これは、様々な分野での滅菌器の利用を考慮しつつ、特定のニーズに応じた柔軟性を提供しています。 しかし、注意が必要なのは、この標準が液体や医薬品の滅菌に使用される小型蒸気滅菌器には適用されないことです。また、発火性ガスなど特定のリスクに関連する安全要件も指定しておらず、蒸気による湿熱滅菌の検証や定期的な管理に関する要求はEN ISO 17665-1に記載されているため、使用する際には関連する標準を併せて考慮する必要があります。 全体的に、SIST EN 13060:2015+A1:2019は、小型蒸気滅菌器に関する明確で実用的な基準を提供しているため、医療分野における滅菌作業の安全性と効率性を向上させるための重要なリソースと言えます。
SIST EN 13060:2015+A1:2019 표준은 소형 스팀 멸균기와 멸균 주기에 대한 성능 요구 사항과 시험 방법을 규정하고 있으며, 주로 의료 목적이나 혈액 또는 체액과 접촉할 가능성이 있는 재료를 위해 사용됩니다. 이 표준은 전기 히터를 사용해 증기를 생성하거나 멸균기 외부 시스템에서 생성된 증기를 사용하는 자동 제어 소형 스팀 멸균기에 적용됩니다. 이 표준의 주요 강점은 의료 기기의 멸균을 위한 소형 스팀 멸균기의 명확한 사용 범위를 제공한다는 것입니다. 특히 챔버 용적이 60리터 미만인 장치와 멸균 모듈을 수용할 수 없는 기기들에 대해 필요한 성능 기준을 제시합니다. 이를 통해 의료 시설에서의 안전하고 효과적인 멸균 과정을 보장하는 데 기여합니다. 또한, SIST EN 13060은 품질 관리 및 위험 관리에 관한 요구 사항을 다른 관련 표준, 예를 들어 EN ISO 13485 및 EN ISO 14971와 연결지어 관리합니다. 이는 사용자가 멸균 장비의 품질과 안전성을 폭넓게 관리할 수 있는 기반을 마련합니다. 다만, 이 표준은 액체나 제약 제품의 멸균을 위한 소형 스팀 멸균기에 적용되지 않으며, 멸균기 사용 지역과 관련된 안전 요구 사항이나 습열에 의한 멸균의 검증 및 일상 관리에 대한 요구 사항도 포함하고 있지 않습니다. 습열 멸균의 검증 및 일상 관리는 EN ISO 17665-1에서 별도로 다루어지고 있습니다. 결론적으로, SIST EN 13060:2015+A1:2019 표준은 소형 스팀 멸균기를 위한 명확한 기준을 제공하여 의료 기기의 멸균 과정에서의 일관성과 안전성을 높이고 있으며, 이러한 점에서 매우 중요한 역할을 하고 있습니다.
The SIST EN 13060:2015+A1:2019 standard provides critical specifications for small steam sterilizers utilized in medical settings, particularly for devices that may come into contact with blood or body fluids. The scope of this European Standard is precisely defined, catering specifically to automatically controlled small steam sterilizers, either electrically heated or connected to an external steam source, with a chamber volume less than 60 liters. One of the strengths of this standard is its clarity regarding performance requirements and test methods, which are essential for ensuring the effective sterilization of medical devices. By focusing on small steam sterilizers, the standard effectively addresses the unique needs of medical facilities that must comply with stringent sterilization protocols, thereby enhancing patient safety. Moreover, the exclusion of small steam sterilizers meant for the sterilization of liquids or pharmaceutical products further sharpens the standard's focus. This delineation ensures that manufacturers and users can align their practices specifically with the type of sterilization processes relevant to their equipment, without confusion arising from broader applications. The standard’s integration with quality management and risk management requirements from other established standards, such as EN ISO 13485 and EN ISO 14971, strengthens its framework. It recognizes the interconnectedness of various aspects of medical device safety and sterilization, leading to more holistic compliance within the medical industry. However, it is crucial to note what the standard does not cover; it does not address safety requirements specific to the working environment or validate routine control of sterilization using moist heat, which are provided in EN ISO 17665-1. This acknowledgment of its limitations allows users to seek complementary guidelines as needed, facilitating a comprehensive understanding of sterilization practices. In summary, the SIST EN 13060:2015+A1:2019 standard is fundamental in establishing robust guidelines for small steam sterilizers, ensuring that they meet necessary performance criteria while aligning with broader quality and risk management standards. Its focus on specific applications and clear exclusions emphasizes relevance in the medical field, promoting enhanced safety and efficacy in sterilization processes.
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