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
- Status
- Published
- Publication Date
- 14-Nov-2021
- Technical Committee
- VAZ - Healthcare
- Current Stage
- 6060 - National Implementation/Publication (Adopted Project)
- Start Date
- 13-Oct-2021
- Due Date
- 18-Dec-2021
- Completion Date
- 15-Nov-2021
Relations
- Effective Date
- 01-Dec-2021
- Effective Date
- 01-Dec-2021
Overview
SIST EN 285:2016+A1:2021 - Sterilization: Steam sterilizers - Large sterilizers is the European standard that specifies requirements and test methods for large steam sterilizers used primarily in healthcare for sterilizing medical devices and their accessories. The standard applies to sterilizers that accommodate at least one sterilization module or have a chamber volume of at least 60 L. It covers mechanical construction, piping, measuring and control systems, performance tests (thermometric, hollow load, steam penetration), safety, and service conditions. The standard does not cover equipment intended for flammable substances, biological waste or human tissue processing, nor does it define a quality management system for manufacture (see EN ISO 13485 for QMS).
Key topics and technical requirements
- Scope and applicability: Large steam sterilizers for healthcare and commercial production of medical devices; minimum chamber volume or modular design requirement.
- Mechanical components: Pressure vessel construction, insulation, framework, loading equipment and transport considerations.
- Piping and steam supply: Requirements for steam source (dedicated generator or central supply), piping, air filters and vacuum systems.
- Measuring, indicating and recording systems: Specification of temperature, pressure and time measuring chains, probes, transducers, recording systems and status indicators.
- Control and safety systems: Control logic, fault indication, software verification/validation and usability/risk control requirements.
- Performance testing: Steam penetration, physical parameters (temperature characteristics, dryness), Bowie-Dick test, air leakage/air detectors, hollow load tests, thermometric tests for small and full loads.
- Operational limits and environment: Sound and vibration, rate of pressure change, steam quality (non‑condensable gases, dryness, contaminants), service connections and working environment.
- Documentation and testing program: Calibration, recommended test programme and record keeping for validation and routine testing.
- Environmental considerations: Addressed in Annex A.
Practical applications and users
SIST EN 285 is used to:
- Validate and type-test large steam sterilizers during design and manufacture.
- Define acceptance and routine test procedures for hospital central sterile services departments (CSSD).
- Guide procurement specifications for biomedical engineers, hospital purchasing and clinical engineering.
- Support regulatory compliance and conformity assessment for sterilizer manufacturers and test laboratories.
Typical users:
- Sterilizer manufacturers and designers
- Hospital CSSD managers and biomedical engineering teams
- Quality assurance and validation specialists
- Independent test laboratories and notified bodies
Related standards and notes
- The standard explicitly references quality management standards (for example, EN ISO 13485) for manufacture-related QMS.
- See Annex A of EN 285:2015+A1:2021 for environmental aspects.
Keywords: SIST EN 285, EN 285:2015+A1:2021, steam sterilizers, large sterilizers, medical device sterilization, sterilizer validation, Bowie-Dick test, hollow load test, thermometric tests.
Frequently Asked Questions
SIST EN 285:2016+A1:2021 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Sterilization - Steam sterilizers - Large sterilizers". This standard covers: 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.
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.
SIST EN 285:2016+A1:2021 is classified under the following ICS (International Classification for Standards) categories: 11.080.10 - Sterilizing equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
SIST EN 285:2016+A1:2021 has the following relationships with other standards: It is inter standard links to SIST EN 285:2016, SIST EN 285:2016/kprA1:2020. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
SIST EN 285:2016+A1:2021 is associated with the following European legislation: EU Directives/Regulations: 2017/745, EUR-PUB; Standardization Mandates: M/575, M/575 AMD 2. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase SIST EN 285:2016+A1:2021 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of SIST standards.
Standards Content (Sample)
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
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
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
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
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 . 68
21.4 Sampling of steam condensate . 69
21.4.1 General . 69
21.4.2 Apparatus . 69
21.4.3 Procedure . 69
Figure 12 — Apparatus for sampling steam condensate . 70
22 Rate of pressure change . 71
22.1 General . 71
22.2 Apparatus . 71
22.3 Procedure . 71
23 Test apparatus, equipment and material . 71
23.1 Standard test pack . 71
Figure 13 — Folding and assembling the test pack . 73
23.2 Reduced test pack . 74
23.3 Test instruments . 75
23.3.1 General . 75
23.3.2 Pressure instruments . 75
23.3.3 Temperature instruments . 76
23.3.4 Recording instruments . 77
23.4 Full load, textiles . 78
23.5 Test pack, metal . 78
Figure 14 — Details of test box for test load dryness, metal . 80
23.6 Metering device . 80
24 Documentation to be supplied with the sterilizer . 81
25 Information to be supplied with the sterilizer . 81
Annex A (informative) Environmental aspects . 85
Table A.1 — Environmental aspects addressing clauses of this European Standard . 86
Annex B (informative) Suggested maximum values of contaminants in feed water . 88
Table B.1 — Contaminants in feed water supplied to a dedicated steam generator . 88
Annex C (informative) Temperature and time tolerances during the small load
thermometric test . 89
Figure C.1 — Temperature and time tolerances during the small load thermometric test . 89
Annex D (informative) Guidance for installation and operational qualification tests which
can be included in the instructions for use supplied with a sterilizer. 90
Table D.1 — Suggested tests . 91
Annex E (informative) Criteria for identifying sterilizers as the same type . 92
Annex F (normative) Protective measures . 93
Annex ZA (informative) Relationship between this European Standard and the General
Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be
covered. 95
Table ZA.1 — Correspondence between this European Standard and Annex I of
Regulation 2017/745 [2017 OJ L 117] . 95
Table ZA.2 — Correspondence between this European Standard and Annex II of
Regulation 2017/745 [2017 OJ L 117] . 105
Table ZA.3 — Relevant Essential Health and Safety Requirements from Directive
2006/42/EC on machinery that are addressed by this European Standard
(according to article 1, item 12 of Regulation (EU) 2017/745) . 107
Bibliography . 116
European foreword
This document (EN 285:2015+A1:2021) has been prepared by Technical Committee CEN/TC 102
“Sterilizers for medical purposes”, the secretariat of which is held by DIN.
This document supersedes !EN 285:2015".
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 December 2021, and conflicting national standards
shall be withdrawn at the latest by June 2022.
This document has been prepared under a standardization request given to CEN by the European
Commission and the European Free Trade Association, and supports essential requirements of
EU Regulation(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
This document includes Amendment 1 approved by CEN on 23 May 2021.
The start and finish of text introduced or altered by amendment is indicated in the text by tags !".
The following amendments have been made in comparison EN 285:2015:
— normative references have been updated and corrected in the normative text;
— note to entry was added to 3.17 and 3.27;
— 6.2 was adopted;
— subclause 6.4.4.2 was added;
— note was added to 8.1.3 and 15.1;
— Annex ZA relationship with the General Safety and Performance Requirements of Regulation (EU)
2017/745 including Tables ZA.1, ZA.2 and ZA.3 was added.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
According to the CEN/CENELEC Internal Regulations, the national standards organisations of the
following countries are bound to implement this European Standard: 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United
Kingdom.
Introduction
This document specifies test procedures and acceptance criteria to confirm whether the sterilizer is safe
and can deliver an operating cycle for sterilizing the range of medical devices and loading
configurations used in healthcare. It can also be used in other manufacturing sectors and industries. In
addition, national regulations can necessitate consideration of the impact the sterilizer could have on
the environment.
A steam sterilization process uses water in its liquid and vaporous state to penetrate as steam into the
load and to condense on the surfaces of a device. The distribution of moisture and temperature
throughout the sterilization load and the process of sterilization itself cannot be measured directly for
each routine sterilization process. This is done by comparison of measurement results with cycle
parameters shown previously by validation to deliver an efficient sterilization process to the exposed
medical devices.
An instruction manual supplied with the sterilizer is required to have comprehensive information on
the sterilizer, programmed operating cycles and safe operation. Requirements for the validation and
routine control of sterilization are not addressed as they are specified EN ISO 17665-1.
Medical devices used in health care can differ in properties such as materials, mass, shape, volume and
packaging. Each sterilizer load can comprise a variable number of packages each containing different
types of variably distributed medical devices.
The reproducibility of the sterilization process can be affected by this variability and also by other
changes which can include:
— deviation of the defined cycle parameters,
— retention of air in the load, air leakage and non-condensable gases in the steam,
— excessive accumulation of non-condensable gases and/or condensate,
— overheating of the steam,
— selection of an inappropriate operating cycle, and
— orientation of the load.
The state “sterile” is specified in EN 556-1. For the steam sterilization in health care national
regulations and the European Pharmacopoeia require or recommend combinations of minimum
process parameters to produce a substantial overkill. This European Standard identifies combinations
of sterilization temperatures and holding times, with tolerances, recommended by the “Working Party
1)
on Pressure-steam Sterilisers” . The use of these values is justified when also considering the variable
characteristics of sterilizer loads in healthcare.
Process variables and process parameters as defined in EN ISO 17665-1 characterize the microbicidal
effectiveness of the sterilization process. Cycle parameters are associated with the control of the
operating cycle and have implications on the attainment of process parameters, the uniformity of steam
penetration, the removal of air, drying and deterioration of medical devices and their packaging.
1) Working Party on Pressure-steam Sterilisers (JW Howie, Allison VD, JH Bowie, Darmady EM, Knox R, EJK Penikett, Shone
JAV, Sykes G, Weir CD, Wells CA, Wyllie CAP, Kelsey JC): Sterilization by Steam Under Increased Pressure, The Lancet (1959), p.
425-435.
This European Standard specifies test loads and test pieces designed to present a specific challenge to
the operating cycle. The results from each test collectively contribute to a presumption that the
sterilizer and the operating cycles are suitable for use in health care facilities. A test load does not
necessarily mimic a configuration of medical devices. The suitability of an operating cycle for a
particular product will require validation (see EN ISO 17665-1). By specifying numeric pass and fail-
conditions the tests are used to confirm that the cycle parameters of the operating cycle are attained
and maintained.
Limiting values for the properties and the purity of the services are related to the characteristics of the
medical devices, therefore this European Standard does not include specific requirements on services.
However, it does provide guidance and information on recommended properties, limit values and test
methods.
Condensate derived from the sterilizer chamber will include additional impurities from the load and as
a consequence is not representative of the quality of the supplied steam. Recommended limits for the
purity of feed water and condensate are different from the requirements of the European Pharmacopeia
for purified water. This difference is to compensate for increased corrosion to the sterilizer chamber
and instruments resulting from a higher condensate temperature. The level of bacterial endotoxins
2)
contained in the steam will depend on the quality of feed water and the steam generation equipment .
To minimize human errors during routine use this European Standard specifies automatic control of the
operating cycle and a fault detection system designed to automatically detect changes to both services
and operating cycle significant to affect sterility assurance. An air detector is an optional provision
which when set and tested according to this European Standard will routinely challenge the operating
cycle and register a pass/failure. Other methods for routinely assessing specific performance aspects
can be used, such as chemical or biological indicators, providing their performance is determined and
verified using validated test procedures.
Software can only be used in combination with hardware. The tests described in this standard can be
used for the verification and final validation of the repe
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記事タイトル：SIST EN 285:2016+A1:2021 - 殺菌 - 蒸気滅菌器 - 大型滅菌器 記事内容：この欧州規格は、主に医療分野で使用される大型蒸気滅菌器に関する要件と関連するテストを規定しています。この欧州規格に記載されたテスト負荷は、医療機器の蒸気滅菌器の一般的な評価のために選択されたものであり、金属、ゴム、多孔質材料からなる包装品を代表するものです。ただし、特定の負荷（例：重い金属のオブジェクトや長くて細い管など）には、異なるテスト負荷を使用する必要があります。 この欧州規格は、少なくとも1つの殺菌モジュールを収容するか、少なくとも60リットルのチャンバ容量を持つ蒸気滅菌器に適用されます。 大型蒸気滅菌器は、医療機器の商業生産中にも使用することができます。 この欧州規格は、可燃性物質や燃焼を引き起こす可能性のある物質を使用、含有、または露出するための機器についての要件を規定していません。また、生物廃棄物や人体組織を処理するための機器についても要件を記述していません。 また、この欧州規格は、滅菌器の製造のすべての段階を制御するための品質管理システムについて説明していません。 注1：品質管理システムの規格（たとえば、EN ISO 13485）に注意が必要です。 注2：環境の側面については、付属書Aで取り上げられています。
기사 제목: SIST EN 285:2016+A1:2021 - 살균 - 증기 살균기 - 대형 살균기 기사 내용: 이 유럽 표준은 주로 의료 분야에서 의료 기기와 그 액세서리를 살균하는 데 사용되는 대형 증기 살균기에 대한 요구 사항과 관련 테스트를 명시합니다. 이 유럽 표준에 설명된 테스트 부하는 일반 의료 기기용 증기 살균기의 평가를 위해 대표적인 부하(즉, 금속, 고무 및 다공성 물질로 이루어진 포장된 상품)를 대표하도록 선택되었습니다. 그러나 특정 부하(예: 무거운 금속 물체 또는 길고/협소한 유관)의 경우 다른 테스트 부하를 사용해야 합니다. 이 유럽 표준은 적어도 하나의 살균 모듈을 수용하거나 적어도 60 l의 챔버 용량을 갖춘 증기 살균기에 적용됩니다. 대형 증기 살균기는 의료 기기의 상용 생산 중에도 사용될 수 있습니다. 이 유럽 표준은 가연성 물질 또는 연소를 유발할 수 있는 물질을 사용, 포함 또는 노출시키기 위한 장비에 대한 요구 사항을 명시하지 않습니다. 이 유럽 표준은 생물학적 폐기물이나 인체 조직을 처리하기 위한 장비에 대한 요구 사항을 기술하지 않습니다. 이 유럽 표준은 살균기의 제조 과정의 모든 단계를 통제하기 위한 품질 관리 시스템에 대해 설명하지 않습니다. 참고 1: 품질 관리 시스템에 대한 표준(예: EN ISO 13485)에 유의가 필요합니다. 참고 2: 환경적 측면은 부록 A에서 다룹니다.
The article discusses the requirements and tests outlined in European Standard EN 285:2016+A1:2021 for large steam sterilizers. These sterilizers are primarily used in healthcare settings to sterilize medical devices and their accessories. The standard specifies the test loads to be used for evaluating the sterilizers, which include wrapped goods made of metal, rubber, and porous materials. However, specific loads such as heavy metal objects or long and narrow items require different test loads. The standard applies to steam sterilizers that can accommodate at least one sterilization module or have a chamber volume of at least 60 liters. Large steam sterilizers can also be used in the commercial production of medical devices. It is important to note that the standard does not cover sterilizers intended for flammable substances or biological waste. Additionally, it does not provide guidelines for a quality management system, but references EN ISO 13485 for that purpose. Annex A addresses environmental aspects.
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