EN 285:2006

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Sterilization - Steam sterilizers - Large sterilizersSterilizacija - Parni sterilizatorji - Veliki sterilizatorjiStérilisation - Stérilisateurs a la vapeur d'eau - Grands stérilisateursSterilisation - Dampf-Sterilisatoren - Groß-SterilisatorenTa slovenski standard je istoveten z:EN 285:2006SIST EN 285:2006en11.080.10ICS:SIST EN 285:2000/AC:2000SIST EN 285:20001DGRPHãþDSLOVENSKI
STANDARDSIST EN 285:200601-julij-2006

EUROPEAN STANDARDNORME EUROPÉENNEEUROPÄISCHE NORMEN 285May 2006ICS 11.080.10Supersedes EN 285:1996
English VersionSterilization - Steam sterilizers - Large sterilizersStérilisation - Stérilisateurs à la vapeur d'eau - GrandsstérilisateursSterilisation - Dampf-Sterilisatoren - Groß-SterilisatorenThis European Standard was approved by CEN on 27 April 2006.CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this EuropeanStandard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such nationalstandards may be obtained on application to the Central Secretariat or to any CEN member.This European Standard exists in three official versions (English, French, German). A version in any other language made by translationunder the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the officialversions.CEN members are the national standards bodies of Austria, Belgium, 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 STANDARDIZATIONCOMITÉ EUROPÉEN DE NORMALISATIONEUROPÄISCHES KOMITEE FÜR NORMUNGManagement Centre: rue de Stassart, 36
B-1050 Brussels© 2006 CENAll rights of exploitation in any form and by any means reservedworldwide for CEN national Members.Ref. No. EN 285:2006: E

Environmental aspects.68 Annex B (informative)
Steam supply; suggested maximum values of contaminants in feed water and condensate.73 Annex C (informative)
Recommended materials.74 Annex D (informative)
Temperature and time tolerances during the small load thermometric test.77 Annex E (informative)
Guidance for installation and operational qualification tests to be included in the instructions for use supplied with a sterilizer.78

Criteria for identifying sterilizers as the same type.80 Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices.81 Bibliography.82

1) Currently under revision.
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]

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.

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). 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.

mm Dimension
m 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
Table 2 — Deviation from vertical and horizontal flatness and alignment Deviation
mm Distance between checkpoints
m Finished surfaces of walls and ceilings Finished floor (bearing surface)
0,1
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.

Sterilizer chamber temperature
indicating instrument Temperature recorder Control and/or monitoring of
plateau period by temperature Key 1 sterilizer chamber Figure 3 — Possible arrangement of temperature sensors The sensor used for the control of the sterilization cycle and for the indication and also the sensor used to record the sterilization cycle shall be located at the point identified by the manufacturer as the reference measurement point (see 7.1.4). 6.2.1.2 Moveable temperature sensors inside sterilizers Where a moveable temperature sensor and its wiring is located inside the sterilizer chamber, it shall be manufactured in such a way as to be temperature resistant as well as pressure-tight, vacuum-tight and steam-tight.

Pressure Sterilization a
Programme step Time (measured value) Cycle identification Counter No Date a and sterilizer identification ON X
X START X
X X X t1 X
X b
t2 X
X b
t3 X X X
t4 X X X
t5 X
X
t6 X
X
END X
OFF X
a Optional for analogue records b For each change: t1 time at the start of the first steam injection; t2 time at the start of the second vacuum pulse; t3 time at the start of the plateau period; t4 time at the end of the holding time; t5 time at the start of the drying period; t6 time at the end of the drying period
Key 1
start 2
end Figure 4 — Diagram of a specimen sterilization cycle given as an example only
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