EN 13060:2004+A1:2009

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Mali parni sterilizatorjiDampf-Klein-SterilisatorenPetits stérilisateurs à la vapeur d'eauSmall steam sterilizers11.080.10Sterilizacijska opremaSterilizing equipmentICS:Ta slovenski standard je istoveten z:EN 13060:2004+A1:2009SIST EN 13060:2005+A1:2009en,fr,de01-oktober-2009SIST EN 13060:2005+A1:2009SLOVENSKI
STANDARD
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 13060:2004+A1
May 2009 ICS 11.080.10 Supersedes EN 13060:2004English Version
Small steam sterilizers
Petits stérilisateurs à la vapeur d'eau
Dampf-Klein-Sterilisatoren This European Standard was approved by CEN on 16 April 2004 and includes Amendment 1 approved by CEN on 12 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 13060:2004+A1:2009: ESIST EN 13060:2005+A1:2009

Clarification of the definition of hollow space A and hollow space B (see 3.19 and 3.20) . 57Annex B (informative)
Process evaluation system . 59Annex C (informative)
Suggested maximum limits of contaminants in and specification for water for steam sterilization. 60Annex D (informative)
Example of a table to be supplied with pre-purchase documentation and with the instructions for use . 61Annex E (informative)
Load support systems . 62Annex F (informative)
Rationale for the tests . 63Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42 EEC on medical devices . 65Bibliography . 68
EN 867-1:1997, Non-biological systems for use in sterilizers — Part 1: General requirements2 EN 867-5:2001, 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 (all parts), Packaging materials and systems for medical devices which are to be sterilized3 EN 10088-1, Stainless steels — Part 1: List of stainless steels EN 60529, Degrees of protection provided by enclosures (IP code) (IEC 60529:1989) EN 61010-1, Safety requirements for electrical equipment for measurement, control and laboratory use — Part 1: General requirements (IEC 61010-1:2001)
Currently under revision by CEN/TC 102. 2
EN 867-1 is currently under revision by ISO/TC 198 and CEN/TC 102 (Vienna Agreement). 3
EN 868-1 is currently under revision by ISO/TC 198 and CEN/TC 102 (Vienna Agreement). SIST EN 13060:2005+A1:2009

EN 61326, Electrical equipment for measurement, control and laboratory use — EMC requirements (IEC 61326:1997) EN ISO 228-1, Pipe threads where pressure-tight joints are not made on the threads — Part 1: Dimensions, tolerances and designation (ISO 228-1:2000) EN ISO 3746, Acoustics — Determination of sound power levels of noise sources using sound pressure — Survey method using and enveloping measurement surface over a reflecting plane (ISO 3746:1995) EN ISO 4017, Hexagon head screws — Product grades A and B (ISO 4017:1999) EN ISO 4126-1, Safety devices for protection against excessive pressure — Part 1: Safety valves (ISO 4126-1:2004) EN ISO 13485:2003, Medical devices — Quality management systems — Requirements for regulatory purposes (ISO 13485:2003) EN ISO 14937, Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices (ISO 14937:2000) 3 Terms and definitions !For the purposes of this document, the following terms and definitions apply." NOTE Other definitions relevant to steam sterilization and its validation are given in EN 285 and EN 554. 3.1 absolute pressure pressure for which the zero value is associated with absolute vacuum [EN 764-1:2004, definition 4.5] 3.2 active drain of small steam sterilizers drain through which fluids present in the chamber are discharged during the process 3.3 air removal removal of air from the sterilizer chamber and sterilizer load sufficient to facilitate steam penetration [EN 285:1996, definition 3.2] 3.4 automatic controller device that, in response to pre-determined cycle variables, operates the sterilizer sequentially through the required stages of the cycle(s) [EN 285:1996, definition 3.3] 3.5 biological indicator inoculated carrier contained within its primary pack ready for use
Currently under revision by IEC/TC 66/WG 7. SIST EN 13060:2005+A1:2009

(L ≤ 1 500 mm) or double ended open space where the ratio of length to diameter of the cavity is greater than/or equal to 2 and less than or equal to 1 500 (2 ≤ L/D
≤1 500) and where the length of the cavity is not greater than 3 000 mm (L ≤ 3 000 mm) and which is not hollow load B NOTE See annex A. 3.20 hollow load B single ended open space where the ratio of length to diameter of the cavity is greater than or equal to 1 and less than/or equal to 5 (1 ≤ L/D
≤ 5) and where the diameter is greater than or equal to 5 mm (D ≥ 5 mm) or double ended open space where the ratio of length to diameter of the cavity is greater than/or equal to 2 and less than/or equal to 10 (2 ≤ L/D ≤ 10) and where the diameter is greater than or equal to 5 mm (D ≥ 5 mm) NOTE See annex A. 3.21 inoculated carrier carrier on which a defined number of test organisms has been deposited [EN 866-1:1997, definition 3.8] 3.22 installation test
series of checks and tests performed after installation of the sterilizer in the place of use [EN 554:1994, definition 3.9] 3.23 locked door door with the locking device(s) fully engaged and where separate actions are required to unlock and open the door 3.24 maximum allowable pressure maximum pressure for which the equipment is designed [EN 764-1:2004, definition 4.9] SIST EN 13060:2005+A1:2009

fluid pressure occurring during specified operating conditions [EN 764:2004, definition 4.8] NOTE For the purposes of steam sterilization operating pressure is specified for the plateau period of a sterilization cycle. 3.28 plateau period equilibration time plus the holding time [EN 285:1996, definition 3.24] 3.29 porous ability of a material or configuration of material(s) to absorb fluids 3.30 pressure vessel vessel describing the sterilizer chamber, jacket (if fitted), door(s) and components that are in permanent open connection with the sterilizer chamber [EN 285:1996, definition 3.25] SIST EN 13060:2005+A1:2009

(1) where T is the theoretical steam temperature in Kelvin; P is the measured pressure in megapascals, time averaged to result in a time constant between 1 s and 2,5 s; A is 42,677 6 K;
5 IRVINE TH.F., LILEY, P.E., Steam and Gas tables with computer equations. Academic Press, 1984. SIST EN 13060:2005+A1:2009

EN ISO 228-1. 4.3.2.3 The test connection(s) shall be at a point of easy access to the chamber. The test connection(s) shall be clearly marked. 4.3.2.4 The steam inlet or vacuum ports and pipelines shall not be used for test connections. 4.3.3 Air filter 4.3.3.1 The air admitted to return the sterilizer chamber to atmospheric pressure after a vacuum assisted drying stage shall be admitted through a filter. SIST EN 13060:2005+A1:2009

When digital pressure indicators are used, an additional mechanically actuated indicator can be required for compliance with national pressure vessel regulations. NOTE 3 Standards supporting the Pressure Equipment Directive 97/23/EC may contain different requirements for the scale range. 4.4.2.4 Jacket pressure indicating instrument (if the sterilizer is fitted with a pressurised jacket); The jacket pressure indicating instrument shall: a) be either digital or analogue; b) be graduated in kilopascals or bars; c) have a scale which includes the range 100 kPa and 1,3 times the maximum allowable pressure, or 0 bar and 1,3 times the maximum allowable pressure, given as absolute pressure value; d) have an accuracy of better than or equal to ± 10 kPa (0,10 bar) over the scale range; e) for analogue instruments, be graduated in divisions not greater than 20 kPa (0,2 bar); f) for digital instruments, have a resolution of better than or equal to 10 kPa (0,10 bar); g) when used for a control function, have a broken sensor protection that fails to safety ; h) have an ambient temperature error compensation not exceeding 0,04 %/K over the scale range; SIST EN 13060:2005+A1:2009

x x x t1, 3, 5 x
xb
t2, 4 x
xb
t6 x X x
ts xa xd xd
t7 x x x
t8 x
x
t9 x
x
END x
t1, 3, 5
time for vacuum pulse t2, 4
time for pressure pulse t6
sterilization start time ts
holding time t7
sterilization end time t8
drying start time t9
drying end time a optional b maximum or minimum achieved c if the sterilizer is provided with different cycles d the highest and the lowest values of both, the pressure and the temperature prevailing during the holding time shall be printed unless
these values are not evaluated by a process evaluation system according to 4.4.5 SIST EN 13060:2005+A1:2009

Key 1 Start 2 End Figure 1 — Diagram of a specimen sterilization cycle (given as an example only) 4.4.5 Process evaluation system If fitted the process evaluation system shall: a) compare with a validated cycle any change in pressure and temperature and the period of the cycle during which the change occurs; any change beyond programmed limits shall cause a fault to be indicated; b) compare two independent temperature sensors, which may be those associated with the sterilizer chamber temperature indicating instrument and the temperature recorder; or c) be capable of comparing the theoretical steam temperature with the chamber temperature during the holding time; d) have a temperature measuring system accuracy better than or equal to that specified for the chamber temperature indicating instrument; e) have a pressure measuring system accuracy better than or equal to that specified for the chamber pressure indicating instrument; f) have a time measuring system with an accuracy of ± 1 % or better; g) operate to limits as specified by the manufacturer taking into account the process evaluation system accuracy; h) have been verified for its intended reaction upon specified process failures. NOTE 1
See annex B for additional information on process evaluation systems. NOTE 2 If a registration unit is fitted in addition to the process evaluation system, the following data should be registered: sterilizer identification, date, program, cycle number, process satisfactory or not satisfactory. SIST EN 13060:2005+A1:2009
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