🔥🔥 Don’t Miss Out on Our End of Autumn Sale. If you have any questions, feel free to click the bottom right corner to contact our customer service..

Concat us[email protected]
Shopping Cart

No products in the cart.

🔍
BS EN 285:2015+A1:2021

BS EN 285:2015+A1:2021

$215.11

Sterilization. Steam sterilizers. Large sterilizers

Published By Publication Date Number of Pages
BSI 2021 144
PDF Format Searchable Printable Preview Now
Guaranteed Safe Checkout
Categories: ,

If you have any questions, feel free to reach out to our online customer service team by clicking on the bottom right corner. We’re here to assist you 24/7.
Email:[email protected]

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
2 undefined
15 1 Scope
2 Normative references
17 3 Terms and definitions
22 4 Mechanical components
4.1 Dimensions
4.2 Materials
4.3 Pressure vessel
4.3.1 General
23 4.3.2 Double ended sterilizers
4.3.3 Test connections
24 4.3.4 Insulation
25 4.4 Framework and panelling
27 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
28 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
31 6.3 Status indicators
6.4 Measuring chains and time equipment
6.4.1 Temperature probes
32 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
6.4.4.1 !Chamber pressure measuring chains”
33 6.4.4.2 !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
35 6.5.3 Data processing
6.5.3.1 General
36 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
37 7.2 Fault indication system
38 7.3 Software verification and validation
8 Performance requirements
8.1 Steam penetration
39 8.2 Physical parameters
8.2.1 Temperature characteristics
8.2.1.1 Sterilization temperature band
8.2.1.2 Small load, thermometric
40 8.2.1.3 Full load, thermometric
41 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
42 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
43 11 Safety, risk control and usability
11.1 Protective measures
44 11.2 Risk control, usability
12 Packaging and marking
45 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
46 13.3.5 Pressure fluctuation
13.3.6 Feed water
13.4 Lighting
13.5 Water, except water specified in 13.3.6
47 13.6 Compressed air
13.7 Electromagnetic interference
13.8 Drains
13.9 Working Environment
13.10 Service connections
14 Testing
14.1 General
49 14.2 Calibration
14.3 Environment
50 15 Hollow load test
15.1 General
15.2 Apparatus
15.3 Procedure
51 16 Thermometric tests
16.1 Small load, thermometric
16.1.1 General
16.1.2 Apparatus
52 16.1.3 Procedure
54 16.2 Full load, thermometric
16.2.1 General
16.2.2 Apparatus
16.2.3 Procedure
55 17 Bowie and Dick test
17.1 General
56 17.2 Apparatus
17.3 Procedure
18 Air leakage test
18.1 General
18.2 Apparatus
57 18.3 Procedure
19 Air detector tests
19.1 General
19.2 Air detector, small load
19.2.1 Apparatus
58 19.2.2 Procedure
59 19.3 Air detector, full load
19.3.1 Apparatus
19.3.2 Procedure
60 19.4 Air detector function
19.4.1 General
19.4.2 Apparatus
19.4.3 Procedure
61 20 Load dryness test
20.1 Load dryness, small load, textiles
20.1.1 General
20.1.2 Apparatus
20.1.3 Procedure
62 20.2 Load dryness, full load, textile
20.2.1 General
20.2.2 Apparatus
20.2.3 Procedure
63 20.3 Load dryness, metal
20.3.1 General
20.3.2 Apparatus
20.3.3 Procedure
64 21 Steam quality test
21.1 Non-condensable gases
21.1.1 General
21.1.2 Apparatus
65 21.1.3 Procedure
67 21.2 Dryness
21.2.1 General
21.2.2 Apparatus
68 21.2.3 Procedure
71 21.3 Superheat
21.3.1 General
21.3.2 Apparatus
21.3.3 Procedure
73 21.4 Sampling of steam condensate
21.4.1 General
21.4.2 Apparatus
21.4.3 Procedure
75 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
78 23.2 Reduced test pack
79 23.3 Test instruments
23.3.1 General
23.3.2 Pressure instruments
80 23.3.3 Temperature instruments
23.3.3.1 Probes for testing
23.3.3.2 Temperature measuring chains
81 23.3.4 Recording instruments
23.3.4.1 Thermometric recording instrument
23.3.4.2 Pressure recording instrument
82 23.4 Full load, textiles
23.5 Test pack, metal
84 23.6 Metering device
85 24 Documentation to be supplied with the sterilizer
25 Information to be supplied with the sterilizer
89 Annex A (informative)Environmental aspects
92 Annex B (informative)Suggested maximum values of contaminants in feed water
93 Annex C (informative)Temperature and time tolerances during the small load thermometric test
94 Annex D (informative)Guidance for installation and operational qualification tests which can be included in the instructions for use supplied with a sterilizer
96 Annex E (informative)Criteria for identifying sterilizers as the same type
97 Annex F (normative)Protective measures
99 Annex ZA (informative)Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered

Related products

BS EN 285:2015+A1:2021
$215.11