SIST EN 285:2016+A1:2021
(Main)Sterilization - Steam sterilizers - Large sterilizers
Sterilization - Steam sterilizers - Large sterilizers
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 sterilizers 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.
This European Standard applies to steam sterilizers designed to accommodate at least one sterilization module or having a chamber volume of at least 60 l.
Large steam sterilizers can also be used during the commercial production of medical devices.
This European Standard does not specify requirements for equipment intended to use, contain or be exposed to flammable substances or substances which could cause combustion. This European Standard does not specify requirements for equipment intended to process biological waste or human tissues.
This European Standard does not describe a quality management system for the control of all stages of the manufacture of the sterilizer.
NOTE 1 Attention is drawn to the standards for quality management systems e.g. EN ISO 13485.
NOTE 2 Environmental aspects are addressed in Annex A.
Sterilisation - Dampf-Sterilisatoren - Groß-Sterilisatoren
Diese Europäische Norm legt Anforderungen an und die entsprechenden Prüfungen für Dampf Groß-Sterilisatoren fest, die überwiegend im Gesundheitswesen zur Sterilisation von Medizinprodukten und deren 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 Metall¬gegenstände oder lange und/oder enge Lumen) erfordern jedoch die Verwendung anderer Prüfbeladungen.
Diese Europäische Norm gilt für Dampf-Sterilisatoren, die dafür ausgelegt sind, mindestens eine Sterilisier¬einheit aufzunehmen oder ein Kammervolumen von mindestens 60 l haben.
Dampf-Groß-Sterilisatoren können auch bei der gewerblichen Herstellung von Medizinprodukten verwendet werden.
Diese Europäische Norm legt keine Anforderungen an Ausrüstung fest, die für den Gebrauch, die Aufnahme von entflammbaren Substanzen oder brandfördernden Substanzen vorgesehen oder diesen ausgesetzt ist. Diese Europäische Norm legt keine Anforderungen an Ausrüstung fest, die für die Bearbeitung von biologischen Abfall oder menschlichem Gewebe vorgesehen ist.
Diese Europäische Norm beschreibt kein Qualitätsmanagementsystem für die Überwachung aller Phasen der Herstellung von Sterilisatoren.
ANMERKUNG 1 Es wird auf die Normen für Qualitätsmanagementsysteme verwiesen, z. B. EN ISO 13485.
ANMERKUNG 2 Umweltgesichtspunkte werden in Anhang A behandelt.
Stérilisation - Stérilisateurs à la vapeur d'eau - Grands stérilisateurs
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) pour 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 cavités longues et/ou étroites), l’usage d’autres charges d’essai sera requis.
La présente Norme européenne s'applique aux stérilisateurs à la vapeur d'eau conçus pour contenir au moins une unité de stérilisation ou ayant un volume de chambre d’au moins 60 litres.
Les grands stérilisateurs à la vapeur d'eau peuvent être également utilisés pour la production commerciale de dispositifs médicaux.
La présente Norme européenne ne spécifie pas les exigences applicables aux grands stérilisateurs à la vapeur d’eau destinés à utiliser ou à contenir des substances inflammables ou pouvant engendrer une combustion, ou à y être exposé. La présente Norme européenne ne spécifie pas les exigences applicables à un équipement destiné à traiter des déchets biologiques ou des tissus humains.
La présente Norme européenne ne décrit pas un système de management de la qualité pour le contrôle de toutes les étapes de fabrication des stérilisateurs.
NOTE 1 L'attention doit être portée sur les normes relatives aux systèmes de management de la qualité, par exemple l'EN ISO 13485.
NOTE 2 Les aspects environnementaux sont traités dans l'Annexe A.
Sterilizacija - Parni sterilizatorji - Veliki sterilizatorji
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 285:2016+A1:2021
01-december-2021
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 285:2015+A1:2021
ICS:
11.080.10 Sterilizacijska oprema Sterilizing equipment
SIST EN 285:2016+A1:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN 285:2016+A1:2021
---------------------- Page: 2 ----------------------
SIST EN 285:2016+A1:2021
EN 285:2015+A1
EUROPEAN STANDARD
NORME EUROPÉENNE
October 2021
EUROPÄISCHE NORM
ICS 11.080.10 Supersedes EN 285:2015
English Version
Sterilization - Steam sterilizers - Large sterilizers
Stérilisation - Stérilisateurs à la vapeur d'eau - Grands Sterilisation - Dampf-Sterilisatoren - Groß-
stérilisateurs Sterilisatoren
This European Standard was approved by CEN on 15 November 2015 and includes Amendment 1 approved by CEN on 23 May
2021.
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-CENELEC 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-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 285:2015+A1:2021 E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN 285:2016+A1:2021
EN 285:2015+A1:2021 (E)
Contents Page
European foreword . 7
Introduction . 8
1 Scope . 11
2 Normative references . 11
3 Terms and definitions . 13
4 Mechanical components . 18
4.1 Dimensions . 18
4.2 Materials . 18
4.3 Pressure vessel . 18
4.3.1 General . 18
4.3.2 Double ended sterilizers . 19
4.3.3 Test connections . 19
Figure 1 — Connection for test . 20
Figure 2 — Connection sleeve for thermo elements . 20
4.3.4 Insulation . 20
4.4 Framework and panelling . 21
Table 1 —Tolerances for the aperture into which the sterilizer is installed . 22
Table 2 — Deviation from vertical and horizontal flatness and alignment . 22
4.5 Loading equipment . 23
4.6 Transport . 23
5 Piping system and components . 23
5.1 Pipework and fittings . 23
5.2 Steam source . 23
5.2.1 Steam supply from a dedicated steam generator . 23
5.2.2 Steam supply from a central source . 24
5.3 Air filter . 24
5.4 Vacuum system . 24
6 Measuring system, indicating and recording devices for temperature, pressure, time
and status indicators. 24
6.1 General . 24
6.2 Measuring system . 24
Figure 3 — Illustration of the measuring systems . 26
6.3 Status indicators . 27
6.4 Measuring chains and time equipment . 27
6.4.1 Temperature probes . 27
6.4.2 Temperature measuring chains for control, recording and indication . 28
6.4.3 Pressure transducers. 28
6.4.4 Pressure measuring chains for control, recording and indication . 28
6.4.5 Time control and indicating equipment . 29
6.5 Recording systems . 29
6.5.1 General . 29
6.5.2 Records . 29
2
---------------------- Page: 4 ----------------------
SIST EN 285:2016+A1:2021
EN 285:2015+A1:2021 (E)
Figure 4 — Diagram of specimen operation cycle given as an example only. 30
Table 3 — Examples of data to be recorded . 31
6.5.3 Data processing . 31
7 Control systems . 32
7.1 General . 32
7.2 Fault indication system . 33
7.3 Software verification and validation . 34
8 Performance requirements . 34
8.1 Steam penetration . 34
8.2 Physical parameters . 35
8.2.1 Temperature characteristics . 35
8.2.2 Bowie and Dick test . 37
8.2.3 Air leakage . 37
8.2.4 Air detector . 37
8.2.5 Hollow load test . 37
8.3 Load dryness . 37
8.3.1 Load dryness, small load, textiles . 37
8.3.2 Load dryness, full load, textiles . 38
8.3.3 Load dryness, metal load . 38
9 Sound power and vibration. 38
9.1 Sound power . 38
9.2 Vibration . 38
10 Rate of pressure change . 38
11 Safety, risk control and usability . 39
11.1 Protective measures . 39
11.2 Risk control, usability . 40
12 Packaging and marking . 40
13 Service and working environment . 41
13.1 General . 41
13.2 Electrical supply . 41
13.3 Steam supply to the sterilizer chamber . 41
13.3.1 Non-condensable gases . 41
13.3.2 Dryness value . 41
13.3.3 Superheat. 41
13.3.4 Contaminants . 41
Table 4 — Suggested maximum values of contaminants in condensate from steam supply to
the sterilizer chamber . 42
13.3.5 Pressure fluctuation . 42
13.3.6 Feed water . 42
13.4 Lighting . 42
13.5 Water, except water specified in 13.3.6. 42
13.6 Compressed air . 43
13.7 Electromagnetic interference . 43
13.8 Drains . 43
13.9 Working Environment . 43
13.10 Service connections . 43
14 Testing . 43
14.1 General . 43
3
---------------------- Page: 5 ----------------------
SIST EN 285:2016+A1:2021
EN 285:2015+A1:2021 (E)
Table 5 — Recommended test programme . 45
14.2 Calibration . 45
14.3 Environment . 45
15 Hollow load test . 46
15.1 General . 46
15.2 Apparatus . 46
15.3 Procedure. 46
16 Thermometric tests . 47
16.1 Small load, thermometric . 47
16.1.1 General . 47
16.1.2 Apparatus . 47
Figure 5 — Example of a method used to introduce temperature probes into a sterilizer
chamber . 48
16.1.3 Procedure. 48
Figure 6 — Location of temperature probes . 49
16.2 Full load, thermometric . 50
16.2.1 General . 50
16.2.2 Apparatus . 50
16.2.3 Procedure. 50
17 Bowie and Dick test . 51
17.1 General . 51
17.2 Apparatus . 52
17.3 Procedure. 52
18 Air leakage test . 52
18.1 General . 52
18.2 Apparatus . 52
18.3 Procedure. 53
18.3.2 Stabilize the temperature of the sterilizer chamber by carrying out one of the
following: . 53
19 Air detector tests . 53
19.1 General . 53
19.2 Air detector, small load . 53
19.2.1 Apparatus . 53
19.2.1.7 Connected services complying with Clause 13. . 54
19.2.2 Procedure. 54
19.3 Air detector, full load . 55
19.3.1 Apparatus . 55
19.3.1.2 Thermometric recording instrument as described in 23.3.4.1. . 55
19.3.2 Procedure. 55
19.3.2.13 If the air leakage causes the sterilizer chamber pressure to rise more than
1,1 kPa/min re-adjust the metering device to cause a pressure rise of
(1,0 ± 0,1) kPa/min. 56
19.4 Air detector function . 56
19.4.1 General . 56
19.4.2 Apparatus . 56
19.4.3 Procedure. 56
20 Load dryness test . 57
20.1 Load dryness, small load, textiles . 57
20.1.1 General . 57
4
---------------------- Page: 6 ----------------------
SIST EN 285:2016+A1:2021
EN 285:2015+A1:2021 (E)
20.1.2 Apparatus . 57
20.1.3 Procedure . 57
20.2 Load dryness, full load, textile . 58
20.2.1 General . 58
20.2.2 Apparatus . 58
20.2.3 Procedure . 58
20.3 Load dryness, metal . 59
20.3.1 General . 59
20.3.2 Apparatus . 59
20.3.3 Procedure . 59
21 Steam quality test . 60
21.1 Non-condensable gases . 60
21.1.1 General . 60
21.1.2 Apparatus . 60
21.1.3 Procedure . 61
Figure 7 — Diagrammatic representation of the apparatus for the measurement of non-
condensable gases . 62
21.2 Dryness . 63
21.2.1 General . 63
21.2.2 Apparatus . 63
Figure 8 — Pitot tube . 63
21.2.3 Procedure . 64
Figure 9 — Diagrammatic representation of the apparatus for the measurement of steam
dryness value . 65
21.3 Superheat. 67
21.3.1 General . 67
21.3.2 Apparatus . 67
Figure 10 — Expansion tube . 67
21.3.3 Procedure . 67
Figure 11 — Diagrammatic representation of the apparatus for the measurement of
superheat .
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.