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BS EN 285:2015:2016 Edition

BS EN 285:2015:2016 Edition

$215.11

Sterilization. Steam sterilizers. Large sterilizers

Published By Publication Date Number of Pages
BSI 2016 106
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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.

PDF Catalog

PDF Pages PDF Title
8 European foreword
10 Introduction
13 1 Scope
2 Normative references
14 3 Terms and definitions
20 4 Mechanical components
4.1 Dimensions
4.2 Materials
4.3 Pressure vessel
4.3.1 General
4.3.2 Double ended sterilizers
21 4.3.3 Test connections
22 Figure 1 — Connection for test
Figure 2 — Connection sleeve for thermo elements
4.3.4 Insulation
23 4.4 Framework and panelling
24 Table 1 —Tolerances for the aperture into which the sterilizer is installed
Table 2 — Deviation from vertical and horizontal flatness and alignment
25 4.5 Loading equipment
4.6 Transport
5 Piping system and components
5.1 Pipework and fittings
5.2 Steam source
5.2.1 Steam supply from a dedicated steam generator
26 5.2.2 Steam supply from a central source
5.3 Air filter
5.4 Vacuum system
6 Measuring system, indicating and recording devices for temperature, pressure, time and status indicators
6.1 General
6.2 Measuring system
28 Figure 3 — Illustration of the measuring systems
29 6.3 Status indicators
6.4 Measuring chains and time equipment
6.4.1 Temperature probes
30 6.4.2 Temperature measuring chains for control, recording and indication
6.4.3 Pressure transducers
6.4.4 Pressure measuring chains for control, recording and indication
31 6.4.5 Time control and indicating equipment
6.5 Recording systems
6.5.1 General
6.5.2 Records
32 Figure 4 — Diagram of specimen operation cycle given as an example only
33 Table 3 — Examples of data to be recorded
6.5.3 Data processing
6.5.3.1 General
34 6.5.3.2 Resolution of graphic records of pressure and temperature
6.5.3.3 Resolution of tabular records of pressure and temperature
7 Control systems
7.1 General
35 7.2 Fault indication system
36 7.3 Software verification and validation
8 Performance requirements
8.1 Steam penetration
37 8.2 Physical parameters
8.2.1 Temperature characteristics
8.2.1.1 Sterilization temperature band
8.2.1.2 Small load, thermometric
38 8.2.1.3 Full load, thermometric
39 8.2.2 Bowie and Dick test
8.2.3 Air leakage
8.2.4 Air detector
8.2.4.1 General
8.2.4.2 Air detector, small load
8.2.4.3 Air detector, full load
8.2.4.4 Air detector function
8.2.5 Hollow load test
8.3 Load dryness
8.3.1 Load dryness, small load, textiles
40 8.3.2 Load dryness, full load, textiles
8.3.3 Load dryness, metal load
9 Sound power and vibration
9.1 Sound power
9.2 Vibration
10 Rate of pressure change
41 11 Safety, risk control and usability
11.1 Protective measures
42 11.2 Risk control, usability
12 Packaging and marking
43 13 Service and working environment
13.1 General
13.2 Electrical supply
13.3 Steam supply to the sterilizer chamber
13.3.1 Non-condensable gases
13.3.2 Dryness value
13.3.3 Superheat
13.3.4 Contaminants
44 Table 4 — Suggested maximum values of contaminants in condensate from steam supply to the sterilizer chamber
13.3.5 Pressure fluctuation
13.3.6 Feed water
13.4 Lighting
13.5 Water, except water specified in 13.3.6
45 13.6 Compressed air
13.7 Electromagnetic interference
13.8 Drains
13.9 Working Environment
13.10 Service connections
14 Testing
14.1 General
47 Table 5 — Recommended test programme
14.2 Calibration
14.3 Environment
48 15 Hollow load test
15.1 General
15.2 Apparatus
15.3 Procedure
49 16 Thermometric tests
16.1 Small load, thermometric
16.1.1 General
16.1.2 Apparatus
50 Figure 5 — Example of a method used to introduce temperature probes into a sterilizer chamber
16.1.3 Procedure
51 Figure 6 — Location of temperature probes
52 16.2 Full load, thermometric
16.2.1 General
16.2.2 Apparatus
16.2.3 Procedure
53 17 Bowie and Dick test
17.1 General
54 17.2 Apparatus
17.3 Procedure
18 Air leakage test
18.1 General
18.2 Apparatus
55 18.3 Procedure
18.3.2 Stabilize the temperature of the sterilizer chamber by carrying out one of the following:
19 Air detector tests
19.1 General
19.2 Air detector, small load
19.2.1 Apparatus
56 19.2.1.7 Connected services complying with Clause 13.
19.2.2 Procedure
57 19.3 Air detector, full load
19.3.1 Apparatus
19.3.1.2 Thermometric recording instrument as described in 23.3.4.1.
19.3.2 Procedure
58 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.
19.4 Air detector function
19.4.1 General
19.4.2 Apparatus
19.4.3 Procedure
59 20 Load dryness test
20.1 Load dryness, small load, textiles
20.1.1 General
20.1.2 Apparatus
20.1.3 Procedure
60 20.2 Load dryness, full load, textile
20.2.1 General
20.2.2 Apparatus
20.2.3 Procedure
61 20.3 Load dryness, metal
20.3.1 General
20.3.2 Apparatus
20.3.3 Procedure
62 21 Steam quality test
21.1 Non-condensable gases
21.1.1 General
21.1.2 Apparatus
63 21.1.3 Procedure
64 Figure 7 — Diagrammatic representation of the apparatus for the measurement of non-condensable gases
65 21.2 Dryness
21.2.1 General
21.2.2 Apparatus
Figure 8 — Pitot tube
66 21.2.3 Procedure
67 Figure 9 — Diagrammatic representation of the apparatus for the measurement of steam dryness value
69 21.3 Superheat
21.3.1 General
21.3.2 Apparatus
Figure 10 — Expansion tube
21.3.3 Procedure
70 Figure 11 — Diagrammatic representation of the apparatus for the measurement of superheat
71 21.4 Sampling of steam condensate
21.4.1 General
21.4.2 Apparatus
21.4.3 Procedure
72 Figure 12 — Apparatus for sampling steam condensate
73 22 Rate of pressure change
22.1 General
22.2 Apparatus
22.3 Procedure
23 Test apparatus, equipment and material
23.1 Standard test pack
75 Figure 13 — Folding and assembling the test pack
76 23.2 Reduced test pack
77 23.3 Test instruments
23.3.1 General
23.3.2 Pressure instruments
78 23.3.3 Temperature instruments
23.3.3.1 Probes for testing
23.3.3.2 Temperature measuring chains
79 23.3.4 Recording instruments
23.3.4.1 Thermometric recording instrument
23.3.4.2 Pressure recording instrument
80 23.4 Full load, textiles
23.5 Test pack, metal
82 Figure 14 — Details of test box for test load dryness, metal
23.6 Metering device
83 24 Documentation to be supplied with the sterilizer
25 Information to be supplied with the sterilizer
87 Annex A (informative) Environmental aspects
88 Table A.1 — Environmental aspects addressing clauses of this European Standard
90 Annex B (informative) Suggested maximum values of contaminants in feed water
Table B.1 — Contaminants in feed water supplied to a dedicated steam generator
91 Annex C (informative) Temperature and time tolerances during the small load thermometric test
Figure C.1 — Temperature and time tolerances during the small load thermometric test
92 Annex D (informative) Guidance for installation and operational qualification tests which can be included in the instructions for use supplied with a sterilizer
93 Table D.1 — Suggested tests
94 Annex E (informative) Criteria for identifying sterilizers as the same type
95 Annex F (normative) Protective measures
97 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on medical devices
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC on medical devices
99 Table ZA.2 — Relevant Essential Health and Safety Requirements from Directive 2006/42/EC on machinery that are addressed by this European Standard (according to Article 3 of amended Directive 93/42/EEC)
102 Bibliography

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