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
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