EN 285:2006+A1:2008
(Main)Sterilization - Steam sterilizers - Large sterilizers
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
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-julij-2008
Sterilizacija - Parni sterilizatorji - Veliki sterilizatorji
Sterilization - Steam sterilizers - Large sterilizers
Sterilisation - Dampf-Sterilisatoren - Groß-Sterilisatoren
Stérilisation - Stérilisateurs à la vapeur d'eau - Grands stérilisateurs
Ta slovenski standard je istoveten z: EN 285:2006+A1:2008
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN 285:2006+A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2008
ICS 11.080.10 Supersedes EN 285:2006
English Version
Sterilization - Steam sterilizers - Large sterilizers
Stérilisation - Stérilisateurs à la vapeur d'eau - Grands Sterilisation - Dampf-Sterilisatoren - Groß-Sterilisatoren
stérilisateurs
This European Standard was approved by CEN on 27 April 2006 and includes Amendment 1 approved by CEN on 4 February 2008.
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: rue de Stassart, 36 B-1050 Brussels
© 2008 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 285:2006+A1:2008: E
worldwide for CEN national Members.
Contents
Page
Foreword.4
1 Scope .5
2 Normative references .5
3 Terms and definitions .6
4 Mechanical components .11
5 Process components .14
6 Instrumentation, indicating and recording devices .15
7 Control systems.22
8 Performance requirements .23
9 Sound power .26
10 Rate of pressure change.26
11 Safety .27
12 Marking .27
13 Service and local environment.27
14 Testing .29
15 !!!!Hollow load test.31
16 Thermometric tests.32
17 Bowie and Dick test.36
18 Air leakage test .37
19 Air detector tests .38
20 Load dryness tests .41
21 Sound power test.44
22 Steam quality tests .45
23 Dynamic sterilizer chamber pressure test .55
24 Test apparatus, equipment and material.56
25 Documentation to be supplied by the manufacturer .63
26 Information to be supplied by the manufacturer.64
Annex A (informative) Environmental aspects.67
Annex B (informative) Steam supply; suggested maximum values of contaminants in feed water and
condensate .72
Annex C (informative) Recommended materials .73
Annex D (informative) Temperature and time tolerances during the small load thermometric test .76
Annex E (informative) Guidance for installation and operational qualification tests to be included in
the instructions for use supplied with a sterilizer.77
Annex F (informative) Criteria for identifying sterilizers as the same type.79
Annex ZA (informative) Relationship between this European Standard and the Essential Requirements
of EU Directive 93/42/EEC on medical devices .80
Bibliography.81
Foreword
This document (EN 285:2006+A1:2008) has been prepared by Technical Committee CEN/TC 102 “Sterilizers for
medical purposes”, the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an identical text or
by endorsement, at the latest by September 2008 and conflicting national standards shall be withdrawn at the latest
by November 2008.
This document includes Amendment 1, approved by CEN on 2008-02-04.
This document supersedes !EN 285:2006".
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.
This document does not specify requirements for the validation and routine control of sterilization by moist heat. A
European Standard specifying requirements for the validation and routine control of sterilization by moist heat was
prepared by CEN/TC 204 "Sterilization of medical devices", see EN 554 (currently under revision, see
prEN ISO 17665).
The performance requirements specified in this document are not intended for the process to be effective in
inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform
encephalopathy and Creutzfeld-Jakob disease. However, some national regulations require the use of modified
steam processes as part of a general prion decontamination programme.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following
countries are bound to implement this European Standard: 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.
1 Scope
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.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated references,
only the edition cited applies. For undated references, the latest edition of the referenced document (including any
amendments) applies.
EN 764-1:2004, Pressure equipment — Part 1: Terminology — Pressure, temperature, volume, nominal size
!deleted text"
EN 867-3, Non-biological systems for use in sterilizers — Part 3: Specification for Class B indicators for use in the
Bowie and Dick test
!EN 867-5, Non-biological systems for use in sterilizers — Part 5: Specification for indicator systems and
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)
EN 60751:1995, Industrial platinum resistance thermometer sensors (IEC 60751:1983 + A1:1986)
EN 61010-1, Safety requirements for electrical equipment for measurement, control and laboratory use — Part 1:
General requirements (IEC 61010-1:2001)
EN 61010-2-040, Safety requirements for electrical equipment 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 part
...
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