EN 285:2015
(Main)Sterilization - Steam sterilizers - Large sterilizers
Sterilization - Steam sterilizers - Large sterilizers
This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizers for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads.
This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l.
Large steam sterilizers can also be used during the commercial production of medical devices.
This European Standard does not specify requirements for equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process biological waste or human tissues.
This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer.
NOTE 1 Attention is drawn to the standards for quality management systems e.g. EN ISO 13485.
NOTE 2 Environmental aspects are addressed in Annex A.
Sterilisation - Dampf-Sterilisatoren - Groß-Sterilisatoren
Diese Europäische Norm legt Anforderungen an und die entsprechenden Prüfungen für Dampf Groß-Sterilisatoren fest, die überwiegend im Gesundheitswesen zur Sterilisation von Medizinprodukten und deren Zubehörs in einer oder mehreren Sterilisiereinheiten verwendet werden. Die in dieser Europäischen Norm beschriebenen Prüfbeladungen wurden gewählt, um bei der Beurteilung der für allgemeine Zwecke dienenden Dampf Sterilisatoren für Medizinprodukte für die Mehrzahl der Beladungen repräsentativ zu sein (d. h. verpackte Güter aus Metall, Gummi und porösen Materialien). Besondere Beladungen (z. B. schwere Metall¬gegenstände oder lange und/oder enge Lumen) erfordern jedoch die Verwendung anderer Prüfbeladungen.
Diese Europäische Norm gilt für Dampf-Sterilisatoren, die dafür ausgelegt sind, mindestens eine Sterilisier¬einheit aufzunehmen oder ein Kammervolumen von mindestens 60 l haben.
Dampf-Groß-Sterilisatoren können auch bei der gewerblichen Herstellung von Medizinprodukten verwendet werden.
Diese Europäische Norm legt keine Anforderungen an Ausrüstung fest, die für den Gebrauch, die Aufnahme von entflammbaren Substanzen oder brandfördernden Substanzen vorgesehen oder diesen ausgesetzt ist. Diese Europäische Norm legt keine Anforderungen an Ausrüstung fest, die für die Bearbeitung von biologischen Abfall oder menschlichem Gewebe vorgesehen ist.
Diese Europäische Norm beschreibt kein Qualitätsmanagementsystem für die Überwachung aller Phasen der Herstellung von Sterilisatoren.
ANMERKUNG 1 Es wird auf die Normen für Qualitätsmanagementsysteme verwiesen, z. B. EN ISO 13485.
ANMERKUNG 2 Umweltgesichtspunkte werden in Anhang A behandelt.
Stérilisation - Stérilisateurs à la vapeur d'eau - Grands stérilisateurs
La présente Norme européenne spécifie les exigences et les essais relatifs aux grands stérilisateurs à la vapeur d'eau utilisés essentiellement dans le domaine de la santé pour la stérilisation de dispositifs médicaux et de leurs accessoires, dans une ou plusieurs unités de stérilisation. Les charges d’essai décrites dans la présente Norme européenne ont été sélectionnées afin de représenter la majorité des charges (par exemple, les produits emballés en métal, en caoutchouc ou en matériaux poreux) pour l'évaluation des stérilisateurs à la vapeur d'eau à usage général utilisés pour les dispositifs médicaux. Cependant, pour certaines charges spécifiques (par exemple, objets métalliques lourds ou cavités longues et/ou étroites), l’usage d’autres charges d’essai sera requis.
La présente Norme européenne s'applique aux stérilisateurs à la vapeur d'eau conçus pour contenir au moins une unité de stérilisation ou ayant un volume de chambre d’au moins 60 litres.
Les grands stérilisateurs à la vapeur d'eau peuvent être également utilisés pour la production commerciale de dispositifs médicaux.
La présente Norme européenne ne spécifie pas les exigences applicables aux grands stérilisateurs à la vapeur d’eau destinés à utiliser ou à contenir des substances inflammables ou pouvant engendrer une combustion, ou à y être exposé. La présente Norme européenne ne spécifie pas les exigences applicables à un équipement destiné à traiter des déchets biologiques ou des tissus humains.
La présente Norme européenne ne décrit pas un système de management de la qualité pour le contrôle de toutes les étapes de fabrication des stérilisateurs.
NOTE 1 L'attention doit être portée sur les normes relatives aux systèmes de management de la qualité, par exemple l'EN ISO 13485.
NOTE 2 Les aspects environnementaux sont traités dans l'Annexe A.
Sterilizacija - Parni sterilizatorji - Veliki sterilizatorji
Ta evropski standard določa zahteve in zadevne preskuse za velike parne sterilizatorje, ki se uporabljajo predvsem v zdravstvu ter so namenjeni sterilizaciji medicinskih pripomočkov in opreme v enem ali več sterilizacijskih modulih. Preskusne obremenitve, opisane v tem evropskem standardu, predstavljajo večino obremenitev (npr. zavito blago iz kovine, gume in poroznih materialov) za oceno parnega sterilizatorja za splošne namene za medicinske pripomočke. Vendar pa nekatere obremenitve (npr. predmeti iz težkih kovin ali z dolgim in/ali ozkim lumnom) zahtevajo uporabo drugih preskusnih obremenitev.
Velike parne sterilizatorje je mogoče uporabljati pri komercialni proizvodnji medicinskih pripomočkov.
Ta evropski standard ne opredeljuje zahtev za opremo, ki je namenjena za uporabo z vnetljivimi snovmi, ali snovmi, ki lahko povzročijo vžig, ali take snovi vsebuje oziroma jim je izpostavljena. Ta evropski standard ne opredeljuje zahtev za opremo, ki je namenjena obdelavi patogenih snovi ali človeških tkiv.
Ta evropski standard velja za parne sterilizatorje, ki vsebujejo vsaj en sterilizacijski modul oziroma imajo prostornino komore vsaj 60 l.
Ta evropski standard ne opisuje sistema vodenja kakovosti za nadzor vseh faz proizvodnje sterilizatorja.
OPOMBA: Izpostavljeni so standardi za sisteme vodenja kakovosti, npr. EN ISO 13485.
Pri načrtovanju in oblikovanju sterilizatorjev, za katere se uporablja ta evropski standard, naj bi upoštevali vpliv izdelka na okolje v času njegove življenjske dobe. Okoljski vidiki so obravnavani v dodatku A.
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Sterilizacija - Parni sterilizatorji - Veliki sterilizatorjiSterilisation - Dampf-Sterilisatoren - Groß-SterilisatorenStérilisation - Stérilisateurs à la vapeur d'eau - Grands stérilisateursSterilization - Steam sterilizers - Large sterilizers11.080.10Sterilizacijska opremaSterilizing equipmentICS:Ta slovenski standard je istoveten z:EN 285:2015SIST EN 285:2016en,fr,de01-marec-2016SIST EN 285:2016SLOVENSKI
STANDARDSIST EN 285:2006+A2:20091DGRPHãþD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 285
December
t r s w ICS
s sä r z rä s r Supersedes EN
t z wã t r r x ªA tã t r r {English Version
Sterilization æ Steam sterilizers æ Large sterilizers Stßrilisation æ Stßrilisateurs à la vapeur d 5eau æ Grands stßrilisateurs
Sterilisation æ DampfæSterilisatoren æ GroßæSterilisatoren This European Standard was approved by CEN on
s w November
t r s wä
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 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:
Avenue Marnix 17,
B-1000 Brussels
t r s w CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Membersä Refä Noä EN
t z wã t r s w ESIST EN 285:2016
Environmental aspects . 85 Annex B (informative)
Suggested maximum values of contaminants
in feed water . 88 Annex C (informative)
Temperature and time tolerances during the
small load thermometric test. 89 Annex D (informative)
Guidance for installation and operational qualification tests
which can be included in the instructions for use supplied with a sterilizer . 90 Annex E (informative)
Criteria for identifying sterilizers as the same type . 92 Annex F (normative)
Protective measures . 93 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices . 95 Bibliography . 100
1) Working Party on Pressure-steam Sterilisers (JW Howie, Allison VD, JH Bowie, Darmady EM, Knox R, EJK Penikett, Shone JAV, Sykes G, Weir CD, Wells CA, Wyllie CAP, Kelsey JC): Sterilization by Steam Under Increased Pressure, The Lancet (1959), p. 425-435. SIST EN 285:2016
2) A. Steeves*, R.M. Steeves: Endotoxin and Reprocessing of Medical Devices, ZentrSteril 2006 (5), 364-368 and D. Goullet, V. Flocard & J. Freney: Evaluation of the endotoxin risk posed by use of contaminated water during sterilisation of surgical instruments, WFHSS Conference 2007. SIST EN 285:2016
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Frequently Asked Questions
EN 285:2015 is a standard published by the European Committee for Standardization (CEN). Its full title is "Sterilization - Steam sterilizers - Large sterilizers". This standard covers: This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizers for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads. This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l. Large steam sterilizers can also be used during the commercial production of medical devices. This European Standard does not specify requirements for equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process biological waste or human tissues. This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer. NOTE 1 Attention is drawn to the standards for quality management systems e.g. EN ISO 13485. NOTE 2 Environmental aspects are addressed in Annex A.
This European Standard specifies requirements and the relevant tests for large steam sterilizers primarily used in health care for the sterilization of medical devices and their accessories contained in one or more sterilization modules. The test loads described in this European Standard are selected to represent the majority of loads (i.e. wrapped goods consisting of metal, rubber and porous materials) for the evaluation of general purpose steam sterilizers for medical devices. However, specific loads (e.g. heavy metal objects or long and/or narrow lumen) will require the use of other test loads. This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l. Large steam sterilizers can also be used during the commercial production of medical devices. This European Standard does not specify requirements for equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process biological waste or human tissues. This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer. NOTE 1 Attention is drawn to the standards for quality management systems e.g. EN ISO 13485. NOTE 2 Environmental aspects are addressed in Annex A.
EN 285:2015 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 285:2015 has the following relationships with other standards: It is inter standard links to EN 285:2006+A2:2009, EN 285:2015+A1:2021, EN 285:2015/FprA1. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN 285:2015 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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The article is about the European Standard EN 285:2015, which specifies requirements and tests for large steam sterilizers used in healthcare. These sterilizers are primarily used for sterilizing medical devices and their accessories. The tests described in the standard are designed to represent common sterilization loads, but specific loads may require different tests. The standard applies to sterilizers that can accommodate at least one sterilization module or have a chamber volume of at least 60 liters. Large steam sterilizers can also be used in commercial production of medical devices. The standard does not cover equipment intended for flammable or combustible substances, biological waste, or human tissues. It also does not include a quality management system, but refers to other standards for that purpose. Environmental aspects are addressed in Annex A of the standard.
기사 제목 : EN 285:2015 - 살균 - 증기 살균기 - 대형 살균기 기사 내용 : 이 유럽 표준은 의료 현장에서 주로 사용되는 대형 증기 살균기에 대한 요구 사항과 관련 테스트를 명시합니다. 이 테스트는 의료기기의 살균 모듈에 포함된 의료 기기 및 액세서리의 대부분의 적재물(금속, 고무 및 다공성 재료로 이루어진 포장된 상품)를 평가하기 위해 선택됩니다. 그러나 특정 적재물(예: 무거운 금속 물체 또는 길거나 좁은 유도관)은 다른 테스트 적재물을 사용해야 합니다. 이 유럽 표준은 적어도 하나의 살균 모듈을 수용하거나 적어도 60L의 내부 용적을 가진 증기 살균기에 적용됩니다. 대형 증기 살균기는 의료기기의 상업적 생산 중에도 사용될 수 있습니다. 이 유럽 표준은 인화성 물질이나 연소를 유발할 수 있는 물질을 사용하거나 담지거나 노출시키도록 설계된 장비에 대한 요구 사항을 명시하지 않습니다. 이 유럽 표준은 생물학적 폐기물이나 인체 조직을 처리하기 위해 설계된 장비에 대한 요구 사항을 명시하지 않습니다. 이 유럽 표준은 살균기 제조의 모든 단계를 제어하기 위한 품질 관리 시스템을 설명하지 않습니다. 노트 1: 품질 관리 시스템에 대한 표준(예: EN ISO 13485)에 주의를 기울이십시오. 노트 2: 환경적 측면은 부록 A에서 다루고 있습니다.
記事のタイトル：EN 285: 2015-滅菌-蒸気滅菌器-大型滅菌器 記事の内容：このヨーロッパ標準は、医療現場で主に使用される大型蒸気滅菌器に関する要件と関連するテストを規定しています。この規格で説明されているテスト負荷は、一般的な用途のための医療器具の蒸気滅菌器の評価を行うために選択されます（つまり、金属、ゴム、多孔質材料から成る包まれた商品）。ただし、特定の負荷（例：重い金属物体や長い/細いルーメン）には他のテスト負荷を使用する必要があります。 このヨーロッパ標準は、少なくとも1つの滅菌モジュールを収容するか、少なくとも60リットルの容量を持つ蒸気滅菌器に適用されます。大型蒸気滅菌器は医療機器の商業生産時にも使用することができます。 このヨーロッパ標準は、可燃性物質や燃焼を引き起こす可能性のある物質を使用、収容、または露出させる装置に対する要件を規定していません。また、生体廃棄物や人体組織を処理するための装置についても要件を規定していません。 このヨーロッパ標準では、滅菌器の製造のすべての段階を管理するための品質管理システムについては記述されていません。 注1：品質管理システムに関する標準（例：EN ISO 13485）に注意が必要です。 注2：環境の側面は付録Aで取り扱われています。
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