EN 285:2006+A2:2009

Sterilization - Steam sterilizers - Large sterilizers

1.1   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 sterilizer 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.
Large steam sterilizers can also be used during the commercial production of medical devices.
1.2   This European Standard is not applicable to steam sterilizers designed to process a size of load less than one sterilization module or having a chamber volume less than 60 l.
1.3   This European Standard does not describe a quality assurance system for the control of all stages of the manufacture of the sterilizer.
NOTE   Attention is drawn to the standards for quality management systems e.g. EN ISO 13485.
1.4   Planning and design of products applying to this European Standard should consider the environmental impact from the product during its life cycle. Environmental aspects are addressed in Annex A.
NOTE   Additional aspects of environmental impact are addressed in EN ISO 14971.

Sterilisation - Dampf-Sterilisatoren - Groß-Sterilisatoren

1.1 Diese Europäische Norm legt Anforderungen und die entsprechenden Prüfungen für Dampf-Groß-
Sterilisatoren fest, die überwiegend im Gesundheitswesen zur Sterilisation von Medizinprodukten und ihres
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
Metallgegenstände oder Hohlkörper mit langem und/oder engem Lumen) erfordern jedoch die Verwendung
anderer Prüfbeladungen.
Dampf-Groß-Sterilisatoren können auch bei der gewerblichen Herstellung von Medizinprodukten verwendet
werden.
1.2 Diese Europäische Norm ist nicht für Dampf-Sterilisatoren anwendbar, die für die Behandlung einer
Beladung ausgelegt sind, die kleiner als eine Sterilisiereinheit ist, oder die ein Kammervolumen von weniger
als 60 l aufweisen.
1.3 Diese Europäische Norm beschreibt nicht ein Qualitätssicherungssystem für die Überwachung aller
Phasen der Herstellung von Sterilisatoren.
ANMERKUNG Es wird auf die Normen für Qualitätsmanagementsysteme verwiesen, z. B. EN ISO 13485.
1.4 Bei der dem Lebenszyklus entsprechenden Planung und Gestaltung von Produkten, für die diese
Europäische Norm gilt, sollten die vom Produkt ausgehenden Umweltauswirkungen berücksichtigt werden.
Umweltgesichtspunkte werden in Anhang A behandelt.
ANMERKUNG Zusätzliche Gesichtspunkte der Auswirkungen auf die Umwelt werden in EN ISO 14971 behandelt.

Stérilisation - Stérilisateurs à la vapeur d'eau - Grands stérilisateurs

1.1 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) en vue de 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 objets à cavités extrêmement longues (corps creux)), des charges d’essai différentes
seront nécessaires.
Les grands stérilisateurs à la vapeur d'eau peuvent être également utilisés pour la production commerciale de
dispositifs médicaux.
1.2 La présente Norme européenne n’est pas applicable aux stérilisateurs à la vapeur d'eau conçus pour stériliser
une charge de taille inférieure à une unité de stérilisation ou de volume inférieur à 60 l.
1.3 La présente Norme européenne ne décrit pas un système d'assurance qualité pour le contrôle de toutes les
étapes de la fabrication du stérilisateur.
NOTE L'attention est attirée sur les normes pour les systèmes de management de la qualité, par exemple l’EN ISO 13485.
1.4 Il convient que la planification et la conception des produits traités dans la présente Norme européenne
tiennent compte de l’impact environnemental du produit durant son cycle de vie. Les aspects environnementaux sont
traités à l’Annexe A.
NOTE D’autres aspects environnementaux sont abordés dans l’EN ISO 14971.

Sterilizacija - Parni sterilizatorji - Veliki sterilizatorji

General Information

• Status: Withdrawn
• Publication Date: 05-May-2009
• Withdrawal Date: 22-Dec-2015
• ICS: 11.080.10 - Sterilizing equipment
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102/WG 3 - Requirements
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 23-Dec-2015
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 285:2006+A2:2009 - Sterilization - Steam sterilizers - Large sterilizers

Relations

• Merged From: EN 285:2006/prA2 - Sterilization - Steam sterilizers - Large sterilizers
• Effective Date: 19-Jan-2023
• Merged From: EN 285:2006+A1:2008 - Sterilization - Steam sterilizers - Large sterilizers
• Effective Date: 18-Jan-2023
• Replaced By: EN 285:2015 - Sterilization - Steam sterilizers - Large sterilizers
• Effective Date: 30-Dec-2015
• Consolidates: EN 285:2006 - Sterilization - Steam sterilizers - Large sterilizers
• Effective Date: 23-Mar-2009

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 285:2006+A2:2009SIST EN 285:2006+A2:2009en,fr,de01-julij-2009SIST EN 285:2006+A2:2009SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 285:2006+A2
May 2009 ICS 11.080.10 Supersedes EN 285:2006+A1:2008English Version
Sterilization - Steam sterilizers - Large sterilizers
Stérilisation - Stérilisateurs à la vapeur d'eau - Grands stérilisateurs
Sterilisation - Dampf-Sterilisatoren - Groß-Sterilisatoren This European Standard was approved by CEN on 27 April 2006 and includes Amendment 1 approved by CEN on 4 February 2008 and Amendment 2 approved by CEN on 5 April 2009.
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 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 Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2009 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 285:2006+A2:2009: ESIST EN 285:2006+A2:2009

Environmental aspects . 67Annex B (informative)
Steam supply; suggested maximum values of contaminants in feed water and condensate . 72Annex C (informative)
Recommended materials . 73Annex D (informative)
Temperature and time tolerances during the small load thermometric test. 76Annex E (informative)
Guidance for installation and operational qualification tests to be included in the instructions for use supplied with a sterilizer . 77Annex F (informative)
Criteria for identifying sterilizers as the same type . 79Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices . 80SIST EN 285:2006+A2:2009

process challenge devices for use in performance testing for small sterilizers Type B and Type S" EN 868-5, Packaging materials and systems for medical devices which are to be sterilized — Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction — Requirements and test methods EN 1822 (all parts), High efficiency air filters (HEPA and ULPA) EN 10088-1, Stainless steels — Part 1: List of stainless steels EN 10088-3, Stainless steels — Part 3: Technical delivery conditions for semi-finished products, bars, rods, wire, sections and bright products of corrosion resistant steels for general purposes EN 12953 (all parts), Shell boilers EN 13445 (all parts), Unfired pressure vessels EN 14222, Stainless steel shell boilers EN 60584-2:1993, Thermocouples — Part 2: tolerances (IEC 60584-2:1982 + A1:1989) SIST EN 285:2006+A2:2009

for measurement, control and laboratory use —
Part 2-040: Particular requirements for
sterilizers and washer-disinfectors used to
treat medical materials (IEC 61010-2- 040:2005) EN 61326:1997, Electrical equipment for measurement, control and laboratory use — EMC requirements (IEC 61326:1997) EN 61672-1:2003, Electroacoustics — Sound level meters — Part 1: Specifications (IEC 61672-1:2002) EN 61672-2:2003, Electroacoustics — Sound level meters — Part 2: Pattern evaluation tests (IEC 61672-2:2003) EN ISO 3746:1995, Acoustics — Determination of sound power levels of noise sources using sound pressure — Survey method using an enveloping measurement surface over a reflecting plane (ISO 3746:1995) EN ISO 4017, Hexagon head screws — Product grades A and B (ISO 4017:1999) 3 Terms and definitions For the purposes of this document, the terms and definitions given in EN 764-1:2004 and the following apply. NOTE Other definitions relevant to validation are given in EN 554. 3.1 access device means used to permit access to restricted parts of the equipment NOTE This may be by dedicated key, code or tool. 3.2 air removal removal of air from the sterilizer chamber and sterilizer load to facilitate steam penetration 3.3 automatic controller device that, in response to pre-determined cycle variables, operates the sterilizer sequentially through the required stages of the cycle
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