SIST 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
SIST EN 285:2006+A1:2008
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
SIST EN 285:2006+A1:2008 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
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.
---------------------- Page: 2 ----------------------
EN 285:2006+A1:2008 (E)
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
2
---------------------- Page: 3 ----------------------
EN 285:2006+A1:2008 (E)
Annex ZA (informative) Relationship between this European Standard and the Essential Requirements
of EU Directive 93/42/EEC on medical devices .80
Bibliography.81
3
---------------------- Page: 4 ----------------------
EN 285:2006+A1:2008 (E)
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.
4
---------------------- Page: 5 ----------------------
EN 285:2006+A1:2008 (E)
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)
5
---------------------- Page: 6 ----------------------
EN 285:2006+A1:2008 (E)
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 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(s)
3.4
biological indicator
microbiological test system providing a defined resistance to a specified sterilization process
[ISO/TS 11139:2001, definition 2.4]
6
---------------------- Page: 7 ----------------------
EN 285:2006+A1:2008 (E)
3.5
calibration
set of operations that establish, under specified conditions, the relationship between values of a quantity indicated
by a measuring instrument or measuring system, or values represented by a material measure or a reference
material, and the corresponding values realized by standards
[IVM:1994, definition 6.11]
3.6
chamber depth
depth of the sterilizer chamber which is available for the sterilizer load
3.7
chamber height
height of the sterilizer chamber which is available for the sterilizer load
3.8
chamber width
width of the sterilizer chamber which is available for the sterilizer load
3.9
cycle complete
indication that the sterilization cycle has been completed according to programme and that the sterilized load is
ready for removal from the sterilizer chamber
3.10
door
lid or similar device provided as a means of closing and sealing the sterilizer chamber
3.11
double ended sterilizer
sterilizer in which there is a door at each end of the sterilizer chamber
!3.12
endpoint
point of the observed change as defined by the manufacturer occurring after the indicator has been exposed to
specified stated values
[EN ISO 11140-1:2005]"
3.13
equilibration time
period which elapses between the attainment of the sterilization temperature at the reference measurement point
and the attainment of the sterilization temperature at all points within the load
3.14
holding time
period for which the temperatures at the reference measurement point and at all points within the load are
continuously within the sterilization temperature band
NOTE The holding time follows immediately after the equilibration time. The extent of the holding time is related to the
sterilization temperature.
3.15
inoculated carrier
carrier on which a defined number of test organisms has been deposited
[EN 866-1:1997, definition 3.8]
7
---------------------- Page: 8 ----------------------
EN 285:2006+A1:2008 (E)
3.16
installation qualification
IQ
process of obtaining and documenting evidence that equipment has been provided and installed in accordance
with its specification
[ISO/TS 11139:2001, definition 2.20]
3.17
loading door
door in a double ended sterilizer through which the sterilizer load is put into the sterilizer chamber prior to
sterilization
3.18
medical device
instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or
other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings
for one or more of the specific purpose(s) of
diagnosis, prevention, monitoring, treatment or alleviation of disease,
diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
investigation, replacement, modification or support of the anatomy or of a physiological process,
supporting or sustaining life,
control of conception
disinfection of medical devices,
providing information for medical purposes by means of in vitro examination of specimens derived from the
human body,
and which does not achieve its primary intended action in or on the human body by pharmacological,
immunological or metabolic means, but which may be assisted in its function by such means
[EN ISO 13485:2003, definition 3.7]
3.19
non-condensable gas
air and other gas which will not condense under the conditions of steam sterilization
3.20
operating cycle
sequence of operating stages which is performed automatically by a sterilizer
3.21
operational qualification
OQ
process of obtaining and documenting evidence that installed equipment operates within predetermined limits when
used in accordance with its operational procedures
[ISO/TS 11139:2001, definition 2.24]
3.22
operator
person operating equipment for its intended purpose
8
---------------------- Page: 9 ----------------------
EN 285:2006+A1:2008 (E)
3.23
plateau period
equilibration time plus the holding time
3.24
pressure vessel
vessel comprising the sterilizer chamber, jacket (if fitted), door(s) and components that are in permanent
connection with the sterilizer chamber
!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"
3.26
reference measurement point
point where the temperature sensor for the sterilization cycle control is located
3.27
reference standard
standard, generally having the highest metrological quality available at a given location or in a given organization,
from which measurements made there are derived
[IVM:1994, definition 6.6]
3.28
saturated steam
water vapour in a state of equilibrium between condensation and evaporation
[ISO 13683:1997, definition 3.18]
3.29
sterile
condition of a medical device that is free from viable microorganisms
[EN 556-1:2001, definition 3.4]
3.30
sterilization
validated process used to render a product free from viable microorganisms
[ISO/TS 11139:2001, definition 2.42]
NOTE In a sterilization process, the nature of microbial inactivation is described by an exponential function. Therefore the
presence of a viable microorganism on any individual item can be expressed in terms of probability. This probability can be
reduced to a very low number, it can never be reduced to zero.
3.31
sterilization cycle
operating cycle performed by a sterilizer for the purpose of sterilization
3.32
sterilization module
rectangular parallelepiped of dimensions 300 mm (height) × 600 mm (length) x 300 mm (width)
3.33
sterilization temperature
minimum temperature on which the evaluation of the sterilization efficacy is based
9
---------------------- Page: 10 ----------------------
EN 285:2006+A1:2008 (E)
3.34
sterilization temperature band
temperature tolerance range for the load and the reference measurement point, the minimum of which is the
sterilization temperature
NOTE These temperatures are usually stated in whole degrees Celsius.
3.35
sterilizer
apparatus designed to achieve sterilization
3.36
sterilizer chamber
part of the sterilizer which receives the sterilizer load
[EN 554:1994, definition 3.27]
3.37
sterilizer load
items that are to be sterilized simultaneously in the same sterilizer chamber
3.38
superheated steam
water vapour whose temperature is higher than the boiling point of water at the corresponding pressure
3.39
test organism
microorganisms used for the manufacture of inoculated carriers
[EN 866-1:1997, definition 3.16]
3.40
type test
series of checks and tests for a particular design of sterilizer to demonstrate compliance with the requirements of
this European Standard
3.41
unloading door
door in a double ended sterilizer through which the sterilizer load is removed from the sterilizer chamber after a
sterilization cycle
3.42
usable space
space inside the sterilizer chamber which is not restricted by fixed parts and which is available to accept the
sterilizer load
3.43
works test
series of tests performed at the manufacturer´s works to demonstrate that each sterilizer will comply with its
specification
10
---------------------- Page: 11 ----------------------
EN 285:2006+A1:2008 (E)
4 Mechanical components
4.1 Dimensions
The usable space within the sterilizer chamber shall accommodate one or more sterilization modules.
4.2 Materials
Materials in contact with steam shall:
resist attack from steam and condensate;
not cause deterioration of the quality of the steam;
not release any substances known to be toxic in such quantities that could create a health or
environmental hazard.
NOTE 1 Guidance on steam contaminants is given in Table B.2.
NOTE 2 Because of the different types of sterilizers and the large number of uses, it is not possible to specify detailed
requirements for materials for specific applications. The purchaser should provide the manufacturer with information about the
goods to be sterilized.
NOTE 3 Advice on the various combinations of materials is given in Annex C. However, for some applications, a combination
of materials selected from more than one group may be appropriate.
4.3 Pressure vessel
4.3.1 General
4.3.1.1 The pressure vessel shall comply with EN 13445.
4.3.1.2 The door seal shall be a replaceable component.
It shall be possible to inspect and clean the surface of the door seal which comes into contact with the sealing
faces without the need to dismantle the door assembly.
4.3.1.3 After closing the sterilizer door, it shall be possible to open it before a cycle has been started.
4.3.1.4 It shall not be possible to open a sterilizer door(s) during a cycle.
4.3.2 Double ended sterilizers
4.3.2.1 Except for maintenance purposes it shall not be possible for more than one door to be open at one
time.
4.3.2.2 It shall not be possible to open the unloading door until a cycle complete indication is obtained.
4.3.2.3 It shall not be possible to open the unloading door if a Bowie and Dick cycle or an air leakage test has
been carried out (see 7.1.14 and 7.1.15).
4.3.2.4 The control used to start the sterilization cycle shall be located at the loading side of the sterilizer.
4.3.3 Test connections
4.3.3.1 The connections as required by 4.3.3.2 and 4.3.3.3 shall be provided.
11
---------------------- Page: 12 ----------------------
EN 285:2006+A1:2008 (E)
NOTE The test connection for pressure test and temperature test as shown in Figure 1 and Figure 2 may be provided as a
combined detachable adapter.
4.3.3.2 A test connection in accordance with Figure 1 shall be fitted to the sterilizer chamber or in a pipe which
is in direct connection with the sterilizer chamber providing it causes no adverse effect on the measurement of the
pressure in the sterilizer chamber. The test connection which is used for the connection of a test instrument shall
be provided with a cap, marked PT (pressure test) and sealed with either an O-ring-seal or a flat seal.
Dimensions in millimetres
Key
a
Pipe thread EN ISO 228-G 1/2 A
Figure 1 — Connection for test instrument
4.3.3.3 A straight connecting sleeve, in accordance with Figure 2, shall be provided at a point of easy access
in order to pass flexible cords to the temperature sensors.
Dimensions in millimetres
Key
a
Pipe thread EN ISO 228-G 1 A
Figure 2 — Connection sleeve for thermoelements
The connecting sleeve with its O-ring-seal or flat seal shall be closed with a cap, and a temperature proof and
mechanically resistant soft packing. The cap shall be marked with the letters TT (temperature test).
4.3.3.4 Test tee(s) and valve cock(s) with sealing plug(s) shall be fitted to permit connection of reference
instruments for the calibration of all pressure instruments, connected to the sterilizer chamber and jacket (see 6.1.2
and 6.1.4).
12
---------------------- Page: 13 ----------------------
EN 285:2006+A1:2008 (E)
4.3.4 Insulating material
Except where insulation would interfere with the function and operation of the sterilizer, external surfaces of the
pressure vessel shall be insulated to reduce heat transmission to the environment [see also 26.2 g) and h)].
4.4 Framework and panelling
4.4.1 Where the sides of the sterilizer are visible from the operator area, they shall be enclosed with panelling.
The manufacturer shall provide instructions for the cleaning of the panelling.
NOTE The panelling should have a corrosion-resistant finish to the cleaning agents specified by the manufacturer.
4.4.2 The panelling of the sterilizer shall allow access for maintenance work. Such panelling shall be
demountable or the dimensions of any personal access shall be not less than 500 mm wide and not less than
1 500 mm high, and the access shall not be obstructed.
NOTE 1 If the pressure equipment is housed in a frame, this frame should not promote corrosion of the equipment.
NOTE 2 The access for maintenance should be positioned so that it will not compromise the safety of either the product or
persons.
NOTE 3 Requirements for access are specified in EN 61010-2-040.
4.4.3 The panelling shall be designed to provide a continuous contact with the surfaces of the building in which it
is installed when these surfaces are within the tolerances given in Tables 1 and 2.
Sterilizers designed for incorporation into existing buildings, or purpose built rooms shall provide a continuous joint
with adjacent surfaces when these are within the limits given in Tables 1 and 2.
Table 1 — Tolerances for the aperture into which the sterilizer is installed
Dimension Tolerance
m mm
Horizontal plane Vertical plane
up to 3 ± 12 ± 16
above 3 to 6 ± 16 ± 16
above 6 to 15 ± 24 ± 20
above 15 to 30 ± 24 ± 20
above 30 ± 30 ± 30
13
---------------------- Page: 14 ----------------------
EN 285:2006+A1:2008 (E)
Table 2 — Deviation from vertical and horizontal flatness and alignment
Distance between Deviation
checkpoints
m mm
Finished surfaces of walls Finished floor
and ceilings (bearing surface)
0,1 3 2
1 5 4
4 10 10
10 20 12
15 25 15
5 Process components
5.1 Pipework and fittings
5.1.1 Pipe joints and fittings shall be both pressure-tight and vacuum-tight.
5.1.2 Except where this will interfere with the function of the sterilizer the pipework for steam or water at a
temperature greater than 60 °C shall be thermally insulated to reduce heat transmission to the environment [see
also 26.2 g) and h)].
NOTE To reduce the formation of condensation cold water pipework should be insulated.
5.1.3 Means shall be provided to prevent the ingress of particulates of a size and quantity which could affect the
performance of a sterilizer.
NOTE Strainers of a relevant pore size may be used.
5.1.4 All control valves in the pipework shall be marked with permanent identification in relation to their functions
(see 12.2).
NOTE Reference numbers or written descriptions can be used.
5.2 Steam source
5.2.1 General
A sterilizer can be operated with steam from an external supply, or generated solely for the sterilizer or a group of
sterilizers, or generated from within the sterilizer chamber.
5.2.2 Steam supply from a dedicated steam generator
5.2.2.1 Shell boilers shall comply with EN 14222 or EN 12953 as applica
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.