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BSI PD ISO/TS 5111:2022:2023 Edition

BSI PD ISO/TS 5111:2022:2023 Edition

$189.07

Guidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care products

Published By Publication Date Number of Pages
BSI 2023 50
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PDF Catalog

PDF Pages PDF Title
2 undefined
7 Foreword
8 Introduction
9 1 Scope
1.1 Inclusions
1.2 Exclusions
2 Normative references
3 Terms and definitions
16 4 Potable water quality
4.1 General
4.2 Water analysis
17 5 Water quality requirements for different applications/processes
18 6 Water in direct contact with the product being treated
6.1 Washer-disinfectors (WDs)
6.1.1 General
6.1.2 Water quality
19 6.1.3 Final rinse water quality
6.1.4 Water quality used during operational qualification (OQ) and performance qualification (PQ) of WDs
6.2 Moist heat sterilization using water spray or immersion
7 Water to generate steam that contacts the product
7.1 Moist heat sterilization
20 7.2 Ethylene oxide (EO) sterilization
21 7.3 Low temperature steam and formaldehyde (LTSF) sterilization
7.4 Vaporized hydrogen peroxide (VH202) sterilization
22 8 Water for the equipment without direct contact to the product
8.1 Washer-disinfectors (WDs)
8.2 Sterilizers
8.2.1 General
8.2.2 Ethylene oxide (EO) sterilizers
23 8.2.3 Vaporized hydrogen peroxide (VH202) sterilizers
9 Water treatment systems
9.1 General
9.2 Considerations for water treatment
24 9.3 Prefiltration
9.4 Carbon filter
9.5 Water softeners
9.6 Deionization (DI) or demineralization
9.7 Reverse osmosis (RO)
25 9.8 Electrodeionization (EDI)
9.9 Ultrafiltration
9.10 Distillation
10 Water distribution and storage
10.1 General
26 10.2 Storage vessels
10.3 Distribution pipework
10.4 Storage and distribution system disinfection
10.5 Distribution pumps
10.6 Inline ultraviolet (UV) lamps
27 11 Monitoring, maintenance and control
11.1 General
11.2 Water sampling technique
11.2.1 Sampling consistency
11.2.2 Sampling containers
28 11.2.3 Flushing
11.2.4 Sampling technique
11.3 Sterilizers — Water sampling and tests
11.4 Washer-disinfector (WD) — Water sampling and tests
11.4.1 Supply and final rinse water
29 11.4.2 Chemical quality
11.4.3 Microbial quality
30 11.4.4 Bacterial endotoxins
12 Investigation of out-of-specification results
12.1 General
12.2 Elements of out-of-specification investigation
12.2.1 Interpretation of results
31 12.2.2 Investigation
13 Maintaining water quality
13.1 Sterilizers
32 13.2 Washer-disinfectors (WDs)
14 Cleaning and disinfection of water treatment systems
14.1 General
14.2 Access to the water treatment system
33 14.3 Cleaning and disinfection methods
34 Annex A (informative) Water quality treatment methods and processes
36 Annex B (informative) Water quality for use in sterilizers and washer-disinfectors (WDs)
41 Annex C (informative) Examples of presentation of water quality issues during the processing of medical devices
44 Bibliography

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BSI PD ISO/TS 5111:2022
$189.07