{"id":425445,"date":"2024-10-20T06:56:53","date_gmt":"2024-10-20T06:56:53","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-pd-iso-ts-51112022-3\/"},"modified":"2024-10-26T13:06:04","modified_gmt":"2024-10-26T13:06:04","slug":"bsi-pd-iso-ts-51112022-3","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-pd-iso-ts-51112022-3\/","title":{"rendered":"BSI PD ISO\/TS 5111:2022"},"content":{"rendered":"
PDF Pages<\/th>\n | PDF Title<\/th>\n<\/tr>\n | ||||||
---|---|---|---|---|---|---|---|
2<\/td>\n | undefined <\/td>\n<\/tr>\n | ||||||
7<\/td>\n | Foreword <\/td>\n<\/tr>\n | ||||||
8<\/td>\n | Introduction <\/td>\n<\/tr>\n | ||||||
9<\/td>\n | 1 Scope 1.1 Inclusions 1.2 Exclusions 2 Normative references 3 Terms and definitions <\/td>\n<\/tr>\n | ||||||
16<\/td>\n | 4 Potable water quality 4.1 General 4.2 Water analysis <\/td>\n<\/tr>\n | ||||||
17<\/td>\n | 5 Water quality requirements for different applications\/processes <\/td>\n<\/tr>\n | ||||||
18<\/td>\n | 6 Water in direct contact with the product being treated 6.1 Washer-disinfectors (WDs) 6.1.1 General 6.1.2 Water quality <\/td>\n<\/tr>\n | ||||||
19<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
20<\/td>\n | 7.2 Ethylene oxide (EO) sterilization <\/td>\n<\/tr>\n | ||||||
21<\/td>\n | 7.3 Low temperature steam and formaldehyde (LTSF) sterilization 7.4 Vaporized hydrogen peroxide (VH202) sterilization <\/td>\n<\/tr>\n | ||||||
22<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
23<\/td>\n | 8.2.3 Vaporized hydrogen peroxide (VH202) sterilizers 9 Water treatment systems 9.1 General 9.2 Considerations for water treatment <\/td>\n<\/tr>\n | ||||||
24<\/td>\n | 9.3 Prefiltration 9.4 Carbon filter 9.5 Water softeners 9.6 Deionization (DI) or demineralization 9.7 Reverse osmosis (RO) <\/td>\n<\/tr>\n | ||||||
25<\/td>\n | 9.8 Electrodeionization (EDI) 9.9 Ultrafiltration 9.10 Distillation 10 Water distribution and storage 10.1 General <\/td>\n<\/tr>\n | ||||||
26<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
27<\/td>\n | 11 Monitoring, maintenance and control 11.1 General 11.2 Water sampling technique 11.2.1 Sampling consistency 11.2.2 Sampling containers <\/td>\n<\/tr>\n | ||||||
28<\/td>\n | 11.2.3 Flushing 11.2.4 Sampling technique 11.3 Sterilizers \u2014 Water sampling and tests 11.4 Washer-disinfector (WD) \u2014 Water sampling and tests 11.4.1 Supply and final rinse water <\/td>\n<\/tr>\n | ||||||
29<\/td>\n | 11.4.2 Chemical quality 11.4.3 Microbial quality <\/td>\n<\/tr>\n | ||||||
30<\/td>\n | 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 <\/td>\n<\/tr>\n | ||||||
31<\/td>\n | 12.2.2 Investigation 13 Maintaining water quality 13.1 Sterilizers <\/td>\n<\/tr>\n | ||||||
32<\/td>\n | 13.2 Washer-disinfectors (WDs) 14 Cleaning and disinfection of water treatment systems 14.1 General 14.2 Access to the water treatment system <\/td>\n<\/tr>\n | ||||||
33<\/td>\n | 14.3 Cleaning and disinfection methods <\/td>\n<\/tr>\n | ||||||
34<\/td>\n | Annex A (informative) Water quality treatment methods and processes <\/td>\n<\/tr>\n | ||||||
36<\/td>\n | Annex B (informative) Water quality for use in sterilizers and washer-disinfectors (WDs) <\/td>\n<\/tr>\n | ||||||
41<\/td>\n | Annex C (informative) Examples of presentation of water quality issues during the processing of medical devices <\/td>\n<\/tr>\n | ||||||
44<\/td>\n | Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":" Guidance on quality of water for sterilizers, sterilization and washer-disinfectors for health care products<\/b><\/p>\n |