{"id":279401,"date":"2024-10-19T18:51:13","date_gmt":"2024-10-19T18:51:13","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-2852015\/"},"modified":"2024-10-25T15:25:14","modified_gmt":"2024-10-25T15:25:14","slug":"bs-en-2852015","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-2852015\/","title":{"rendered":"BS EN 285:2015"},"content":{"rendered":"

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.<\/p>\n

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PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
8<\/td>\nEuropean foreword <\/td>\n<\/tr>\n
10<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
14<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
20<\/td>\n4 Mechanical components
4.1 Dimensions
4.2 Materials
4.3 Pressure vessel
4.3.1 General
4.3.2 Double ended sterilizers <\/td>\n<\/tr>\n
21<\/td>\n4.3.3 Test connections <\/td>\n<\/tr>\n
22<\/td>\nFigure 1 \u2014 Connection for test
Figure 2 \u2014 Connection sleeve for thermo elements
4.3.4 Insulation <\/td>\n<\/tr>\n
23<\/td>\n4.4 Framework and panelling <\/td>\n<\/tr>\n
24<\/td>\nTable 1 \u2014Tolerances for the aperture into which the sterilizer is installed
Table 2 \u2014 Deviation from vertical and horizontal flatness and alignment <\/td>\n<\/tr>\n
25<\/td>\n4.5 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 <\/td>\n<\/tr>\n
26<\/td>\n5.2.2 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 <\/td>\n<\/tr>\n
28<\/td>\nFigure 3 \u2014 Illustration of the measuring systems <\/td>\n<\/tr>\n
29<\/td>\n6.3 Status indicators
6.4 Measuring chains and time equipment
6.4.1 Temperature probes <\/td>\n<\/tr>\n
30<\/td>\n6.4.2 Temperature measuring chains for control, recording and indication
6.4.3 Pressure transducers
6.4.4 Pressure measuring chains for control, recording and indication <\/td>\n<\/tr>\n
31<\/td>\n6.4.5 Time control and indicating equipment
6.5 Recording systems
6.5.1 General
6.5.2 Records <\/td>\n<\/tr>\n
32<\/td>\nFigure 4 \u2014 Diagram of specimen operation cycle given as an example only <\/td>\n<\/tr>\n
33<\/td>\nTable 3 \u2014 Examples of data to be recorded
6.5.3 Data processing
6.5.3.1 General <\/td>\n<\/tr>\n
34<\/td>\n6.5.3.2 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 <\/td>\n<\/tr>\n
35<\/td>\n7.2 Fault indication system <\/td>\n<\/tr>\n
36<\/td>\n7.3 Software verification and validation
8 Performance requirements
8.1 Steam penetration <\/td>\n<\/tr>\n
37<\/td>\n8.2 Physical parameters
8.2.1 Temperature characteristics
8.2.1.1 Sterilization temperature band
8.2.1.2 Small load, thermometric <\/td>\n<\/tr>\n
38<\/td>\n8.2.1.3 Full load, thermometric <\/td>\n<\/tr>\n
39<\/td>\n8.2.2 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 <\/td>\n<\/tr>\n
40<\/td>\n8.3.2 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 <\/td>\n<\/tr>\n
41<\/td>\n11 Safety, risk control and usability
11.1 Protective measures <\/td>\n<\/tr>\n
42<\/td>\n11.2 Risk control, usability
12 Packaging and marking <\/td>\n<\/tr>\n
43<\/td>\n13 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 <\/td>\n<\/tr>\n
44<\/td>\nTable 4 \u2014 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 <\/td>\n<\/tr>\n
45<\/td>\n13.6 Compressed air
13.7 Electromagnetic interference
13.8 Drains
13.9 Working Environment
13.10 Service connections
14 Testing
14.1 General <\/td>\n<\/tr>\n
47<\/td>\nTable 5 \u2014 Recommended test programme
14.2 Calibration
14.3 Environment <\/td>\n<\/tr>\n
48<\/td>\n15 Hollow load test
15.1 General
15.2 Apparatus
15.3 Procedure <\/td>\n<\/tr>\n
49<\/td>\n16 Thermometric tests
16.1 Small load, thermometric
16.1.1 General
16.1.2 Apparatus <\/td>\n<\/tr>\n
50<\/td>\nFigure 5 \u2014 Example of a method used to introduce temperature probes into a sterilizer chamber
16.1.3 Procedure <\/td>\n<\/tr>\n
51<\/td>\nFigure 6 \u2014 Location of temperature probes <\/td>\n<\/tr>\n
52<\/td>\n16.2 Full load, thermometric
16.2.1 General
16.2.2 Apparatus
16.2.3 Procedure <\/td>\n<\/tr>\n
53<\/td>\n17 Bowie and Dick test
17.1 General <\/td>\n<\/tr>\n
54<\/td>\n17.2 Apparatus
17.3 Procedure
18 Air leakage test
18.1 General
18.2 Apparatus <\/td>\n<\/tr>\n
55<\/td>\n18.3 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 <\/td>\n<\/tr>\n
56<\/td>\n19.2.1.7 Connected services complying with Clause 13.
19.2.2 Procedure <\/td>\n<\/tr>\n
57<\/td>\n19.3 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 <\/td>\n<\/tr>\n
58<\/td>\n19.3.2.13 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 \u00b1 0,1) kPa\/min.
19.4 Air detector function
19.4.1 General
19.4.2 Apparatus
19.4.3 Procedure <\/td>\n<\/tr>\n
59<\/td>\n20 Load dryness test
20.1 Load dryness, small load, textiles
20.1.1 General
20.1.2 Apparatus
20.1.3 Procedure <\/td>\n<\/tr>\n
60<\/td>\n20.2 Load dryness, full load, textile
20.2.1 General
20.2.2 Apparatus
20.2.3 Procedure <\/td>\n<\/tr>\n
61<\/td>\n20.3 Load dryness, metal
20.3.1 General
20.3.2 Apparatus
20.3.3 Procedure <\/td>\n<\/tr>\n
62<\/td>\n21 Steam quality test
21.1 Non-condensable gases
21.1.1 General
21.1.2 Apparatus <\/td>\n<\/tr>\n
63<\/td>\n21.1.3 Procedure <\/td>\n<\/tr>\n
64<\/td>\nFigure 7 \u2014 Diagrammatic representation of the apparatus for the measurement of non-condensable gases <\/td>\n<\/tr>\n
65<\/td>\n21.2 Dryness
21.2.1 General
21.2.2 Apparatus
Figure 8 \u2014 Pitot tube <\/td>\n<\/tr>\n
66<\/td>\n21.2.3 Procedure <\/td>\n<\/tr>\n
67<\/td>\nFigure 9 \u2014 Diagrammatic representation of the apparatus for the measurement of steam dryness value <\/td>\n<\/tr>\n
69<\/td>\n21.3 Superheat
21.3.1 General
21.3.2 Apparatus
Figure 10 \u2014 Expansion tube
21.3.3 Procedure <\/td>\n<\/tr>\n
70<\/td>\nFigure 11 \u2014 Diagrammatic representation of the apparatus for the measurement of superheat <\/td>\n<\/tr>\n
71<\/td>\n21.4 Sampling of steam condensate
21.4.1 General
21.4.2 Apparatus
21.4.3 Procedure <\/td>\n<\/tr>\n
72<\/td>\nFigure 12 \u2014 Apparatus for sampling steam condensate <\/td>\n<\/tr>\n
73<\/td>\n22 Rate of pressure change
22.1 General
22.2 Apparatus
22.3 Procedure
23 Test apparatus, equipment and material
23.1 Standard test pack <\/td>\n<\/tr>\n
75<\/td>\nFigure 13 \u2014 Folding and assembling the test pack <\/td>\n<\/tr>\n
76<\/td>\n23.2 Reduced test pack <\/td>\n<\/tr>\n
77<\/td>\n23.3 Test instruments
23.3.1 General
23.3.2 Pressure instruments <\/td>\n<\/tr>\n
78<\/td>\n23.3.3 Temperature instruments
23.3.3.1 Probes for testing
23.3.3.2 Temperature measuring chains <\/td>\n<\/tr>\n
79<\/td>\n23.3.4 Recording instruments
23.3.4.1 Thermometric recording instrument
23.3.4.2 Pressure recording instrument <\/td>\n<\/tr>\n
80<\/td>\n23.4 Full load, textiles
23.5 Test pack, metal <\/td>\n<\/tr>\n
82<\/td>\nFigure 14 \u2014 Details of test box for test load dryness, metal
23.6 Metering device <\/td>\n<\/tr>\n
83<\/td>\n24 Documentation to be supplied with the sterilizer
25 Information to be supplied with the sterilizer <\/td>\n<\/tr>\n
87<\/td>\nAnnex A (informative) Environmental aspects <\/td>\n<\/tr>\n
88<\/td>\nTable A.1 \u2014 Environmental aspects addressing clauses of this European Standard <\/td>\n<\/tr>\n
90<\/td>\nAnnex B (informative) Suggested maximum values of contaminants in feed water
Table B.1 \u2014 Contaminants in feed water supplied to a dedicated steam generator <\/td>\n<\/tr>\n
91<\/td>\nAnnex C (informative) Temperature and time tolerances during the small load thermometric test
Figure C.1 \u2014 Temperature and time tolerances during the small load thermometric test <\/td>\n<\/tr>\n
92<\/td>\nAnnex D (informative) Guidance for installation and operational qualification tests which can be included in the instructions for use supplied with a sterilizer <\/td>\n<\/tr>\n
93<\/td>\nTable D.1 \u2014 Suggested tests <\/td>\n<\/tr>\n
94<\/td>\nAnnex E (informative) Criteria for identifying sterilizers as the same type <\/td>\n<\/tr>\n
95<\/td>\nAnnex F (normative) Protective measures <\/td>\n<\/tr>\n
97<\/td>\nAnnex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93\/42\/EEC on medical devices
Table ZA.1 \u2014 Correspondence between this European Standard and Directive 93\/42\/EEC on medical devices <\/td>\n<\/tr>\n
99<\/td>\nTable ZA.2 \u2014 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) <\/td>\n<\/tr>\n
102<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Sterilization. Steam sterilizers. Large sterilizers<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2016<\/td>\n106<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":279404,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[155,2641],"product_tag":[],"class_list":{"0":"post-279401","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-080-10","7":"product_cat-bsi","9":"first","10":"instock","11":"sold-individually","12":"shipping-taxable","13":"purchasable","14":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/279401","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product"}],"about":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/types\/product"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media\/279404"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=279401"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=279401"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=279401"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}