{"id":385274,"date":"2024-10-20T03:29:56","date_gmt":"2024-10-20T03:29:56","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-2852015a12021\/"},"modified":"2024-10-26T06:20:36","modified_gmt":"2024-10-26T06:20:36","slug":"bs-en-2852015a12021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-2852015a12021\/","title":{"rendered":"BS EN 285:2015+A1:2021"},"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
2<\/td>\nundefined <\/td>\n<\/tr>\n
15<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
17<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
22<\/td>\n4 Mechanical components
4.1 Dimensions
4.2 Materials
4.3 Pressure vessel
4.3.1 General <\/td>\n<\/tr>\n
23<\/td>\n4.3.2 Double ended sterilizers
4.3.3 Test connections <\/td>\n<\/tr>\n
24<\/td>\n4.3.4 Insulation <\/td>\n<\/tr>\n
25<\/td>\n4.4 Framework and panelling <\/td>\n<\/tr>\n
27<\/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
28<\/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
31<\/td>\n6.3 Status indicators
6.4 Measuring chains and time equipment
6.4.1 Temperature probes <\/td>\n<\/tr>\n
32<\/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
6.4.4.1 !Chamber pressure measuring chains” <\/td>\n<\/tr>\n
33<\/td>\n6.4.4.2 !Jacket and steam supply measuring chains
6.4.5 Time control and indicating equipment
6.5 Recording systems
6.5.1 General
6.5.2 Records <\/td>\n<\/tr>\n
35<\/td>\n6.5.3 Data processing
6.5.3.1 General <\/td>\n<\/tr>\n
36<\/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
37<\/td>\n7.2 Fault indication system <\/td>\n<\/tr>\n
38<\/td>\n7.3 Software verification and validation
8 Performance requirements
8.1 Steam penetration <\/td>\n<\/tr>\n
39<\/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
40<\/td>\n8.2.1.3 Full load, thermometric <\/td>\n<\/tr>\n
41<\/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
42<\/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
43<\/td>\n11 Safety, risk control and usability
11.1 Protective measures <\/td>\n<\/tr>\n
44<\/td>\n11.2 Risk control, usability
12 Packaging and marking <\/td>\n<\/tr>\n
45<\/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
46<\/td>\n13.3.5 Pressure fluctuation
13.3.6 Feed water
13.4 Lighting
13.5 Water, except water specified in 13.3.6 <\/td>\n<\/tr>\n
47<\/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
49<\/td>\n14.2 Calibration
14.3 Environment <\/td>\n<\/tr>\n
50<\/td>\n15 Hollow load test
15.1 General
15.2 Apparatus
15.3 Procedure <\/td>\n<\/tr>\n
51<\/td>\n16 Thermometric tests
16.1 Small load, thermometric
16.1.1 General
16.1.2 Apparatus <\/td>\n<\/tr>\n
52<\/td>\n16.1.3 Procedure <\/td>\n<\/tr>\n
54<\/td>\n16.2 Full load, thermometric
16.2.1 General
16.2.2 Apparatus
16.2.3 Procedure <\/td>\n<\/tr>\n
55<\/td>\n17 Bowie and Dick test
17.1 General <\/td>\n<\/tr>\n
56<\/td>\n17.2 Apparatus
17.3 Procedure
18 Air leakage test
18.1 General
18.2 Apparatus <\/td>\n<\/tr>\n
57<\/td>\n18.3 Procedure
19 Air detector tests
19.1 General
19.2 Air detector, small load
19.2.1 Apparatus <\/td>\n<\/tr>\n
58<\/td>\n19.2.2 Procedure <\/td>\n<\/tr>\n
59<\/td>\n19.3 Air detector, full load
19.3.1 Apparatus
19.3.2 Procedure <\/td>\n<\/tr>\n
60<\/td>\n19.4 Air detector function
19.4.1 General
19.4.2 Apparatus
19.4.3 Procedure <\/td>\n<\/tr>\n
61<\/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
62<\/td>\n20.2 Load dryness, full load, textile
20.2.1 General
20.2.2 Apparatus
20.2.3 Procedure <\/td>\n<\/tr>\n
63<\/td>\n20.3 Load dryness, metal
20.3.1 General
20.3.2 Apparatus
20.3.3 Procedure <\/td>\n<\/tr>\n
64<\/td>\n21 Steam quality test
21.1 Non-condensable gases
21.1.1 General
21.1.2 Apparatus <\/td>\n<\/tr>\n
65<\/td>\n21.1.3 Procedure <\/td>\n<\/tr>\n
67<\/td>\n21.2 Dryness
21.2.1 General
21.2.2 Apparatus <\/td>\n<\/tr>\n
68<\/td>\n21.2.3 Procedure <\/td>\n<\/tr>\n
71<\/td>\n21.3 Superheat
21.3.1 General
21.3.2 Apparatus
21.3.3 Procedure <\/td>\n<\/tr>\n
73<\/td>\n21.4 Sampling of steam condensate
21.4.1 General
21.4.2 Apparatus
21.4.3 Procedure <\/td>\n<\/tr>\n
75<\/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
78<\/td>\n23.2 Reduced test pack <\/td>\n<\/tr>\n
79<\/td>\n23.3 Test instruments
23.3.1 General
23.3.2 Pressure instruments <\/td>\n<\/tr>\n
80<\/td>\n23.3.3 Temperature instruments
23.3.3.1 Probes for testing
23.3.3.2 Temperature measuring chains <\/td>\n<\/tr>\n
81<\/td>\n23.3.4 Recording instruments
23.3.4.1 Thermometric recording instrument
23.3.4.2 Pressure recording instrument <\/td>\n<\/tr>\n
82<\/td>\n23.4 Full load, textiles
23.5 Test pack, metal <\/td>\n<\/tr>\n
84<\/td>\n23.6 Metering device <\/td>\n<\/tr>\n
85<\/td>\n24 Documentation to be supplied with the sterilizer
25 Information to be supplied with the sterilizer <\/td>\n<\/tr>\n
89<\/td>\nAnnex A (informative)Environmental aspects <\/td>\n<\/tr>\n
92<\/td>\nAnnex B (informative)Suggested maximum values of contaminants in feed water <\/td>\n<\/tr>\n
93<\/td>\nAnnex C (informative)Temperature and time tolerances during the small load thermometric test <\/td>\n<\/tr>\n
94<\/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
96<\/td>\nAnnex E (informative)Criteria for identifying sterilizers as the same type <\/td>\n<\/tr>\n
97<\/td>\nAnnex F (normative)Protective measures <\/td>\n<\/tr>\n
99<\/td>\nAnnex ZA (informative)Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017\/745 aimed to be covered <\/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>\n2021<\/td>\n144<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":385280,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[155,2641],"product_tag":[],"class_list":{"0":"post-385274","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\/385274","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\/385280"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=385274"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=385274"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=385274"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}