{"id":416279,"date":"2024-10-20T06:09:54","date_gmt":"2024-10-20T06:09:54","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-22-30449644-dc-2022\/"},"modified":"2024-10-26T11:27:04","modified_gmt":"2024-10-26T11:27:04","slug":"bsi-22-30449644-dc-2022","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-22-30449644-dc-2022\/","title":{"rendered":"BSI 22\/30449644 DC 2022"},"content":{"rendered":"

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
7<\/td>\nForeword <\/td>\n<\/tr>\n
8<\/td>\nIntroduction <\/td>\n<\/tr>\n
9<\/td>\n1 Scope
1.1 General
1.2 Inclusions <\/td>\n<\/tr>\n
10<\/td>\n1.3 Exclusions
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
18<\/td>\n4 Quality requirements
4.1 General
4.2 Dialysis water
4.2.1 General
4.2.2 Chemical contaminants in dialysis water <\/td>\n<\/tr>\n
20<\/td>\n4.2.3 Organic Carbon, pesticides and other chemicals <\/td>\n<\/tr>\n
21<\/td>\n4.2.4 Microbiological contaminants in dialysis water
4.3 Requirements for concentrate
4.3.1 Chemical and microbiological contaminants in concentrate
4.3.2 Water used to prepare concentrate <\/td>\n<\/tr>\n
22<\/td>\n4.4 Requirements for dialysis fluid
4.4.1 General
4.4.2 Microbiological requirements for standard dialysis fluid
4.4.3 Microbiological requirements for ultrapure dialysis fluid <\/td>\n<\/tr>\n
23<\/td>\n4.4.4 Microbiological requirements for online-prepared substitution fluid
4.5 Record retention
5 System design and technical considerations
5.1 General <\/td>\n<\/tr>\n
24<\/td>\n5.2 Technical aspects <\/td>\n<\/tr>\n
25<\/td>\n5.3 Microbiological aspects
5.4 Environmental impact <\/td>\n<\/tr>\n
26<\/td>\n6 Validation of system performance
6.1 General <\/td>\n<\/tr>\n
27<\/td>\n6.2 Validation plan
6.3 Installation and operational qualification <\/td>\n<\/tr>\n
28<\/td>\n6.4 Performance qualification <\/td>\n<\/tr>\n
29<\/td>\n6.5 Validation
6.5.1 Initial Validation.
6.5.2 Retrospective [Annual] Validation
6.5.3 Revalidation
6.6 Surveillance <\/td>\n<\/tr>\n
30<\/td>\n7 Quality management
7.1 General
7.2 Surveillance of fluid quality
7.2.1 Surveillance of dialysis water quality <\/td>\n<\/tr>\n
31<\/td>\n7.2.2 Surveillance of concentrate quality
7.2.3 Surveillance of dialysis fluid quality
7.3 Surveillance of water treatment equipment
7.3.1 General
7.3.2 Surveillance of sediment filters
7.3.3 Surveillance of cartridge filters <\/td>\n<\/tr>\n
32<\/td>\n7.3.4 Surveillance of softeners
7.3.5 Surveillance of carbon media <\/td>\n<\/tr>\n
33<\/td>\n7.3.6 Surveillance of chemical injection systems
7.3.7 Surveillance of reverse osmosis <\/td>\n<\/tr>\n
34<\/td>\n7.3.8 Surveillance of deionization <\/td>\n<\/tr>\n
35<\/td>\n7.3.9 Surveillance of endotoxin-retentive filters
7.3.10 Surveillance of water storage tanks
7.3.11 Surveillance of the water distribution systems
7.3.12 Surveillance of bacterial control devices <\/td>\n<\/tr>\n
36<\/td>\n7.4 Surveillance of concentrate preparation
7.4.1 Surveillance of mixing systems
7.4.2 Surveillance of additives <\/td>\n<\/tr>\n
37<\/td>\n7.5 Surveillance of concentrate distribution
7.6 Surveillance of dialysis fluid proportioning
8 Strategies for microbiological control
8.1 General <\/td>\n<\/tr>\n
38<\/td>\n8.2 Disinfection
8.2.1 General
8.2.2 Microbiological aspects of fluid system design <\/td>\n<\/tr>\n
39<\/td>\n8.2.3 Disinfection frequency <\/td>\n<\/tr>\n
40<\/td>\n8.3 Microbiological surveillance methods
8.3.1 General
8.3.2 Sample collection <\/td>\n<\/tr>\n
41<\/td>\n8.3.3 Heterotrophic plate count <\/td>\n<\/tr>\n
43<\/td>\n8.3.4 Bacterial endotoxin test
8.3.5 Determination of yeast and mould <\/td>\n<\/tr>\n
44<\/td>\n9 Location of and access to the water treatment system
10 Personnel <\/td>\n<\/tr>\n
45<\/td>\nAnnex\u20acA (informative) Rationale for the development and provisions of this document <\/td>\n<\/tr>\n
51<\/td>\nAnnex\u20acB (informative) Equipment <\/td>\n<\/tr>\n
71<\/td>\nAnnex\u20acC (informative) Surveillance guidelines for water treatment equipment, distribution\u20acsystems, and dialysis fluid <\/td>\n<\/tr>\n
76<\/td>\nAnnex\u20acD (informative) Strategies for microbiological control <\/td>\n<\/tr>\n
83<\/td>\nAnnex\u20acE (informative) Validation <\/td>\n<\/tr>\n
90<\/td>\nAnnex\u20acF (informative) Special considerations for home haemodialysis <\/td>\n<\/tr>\n
97<\/td>\nAnnex\u20acG (informative) Special considerations for acute haemodialysis <\/td>\n<\/tr>\n
102<\/td>\nAnnex\u20acH (informative) Further considerations for the different water quality monitoring approaches <\/td>\n<\/tr>\n
104<\/td>\nAnnex\u20acI (informative) Further considerations for risk assessment <\/td>\n<\/tr>\n
107<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

BS EN ISO 23500-1. Preparation and quality management of fluids for haemodialysis and related therapies – Part 1. General requirements<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2022<\/td>\n113<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":416289,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2641],"product_tag":[],"class_list":{"0":"post-416279","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-bsi","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/416279","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\/416289"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=416279"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=416279"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=416279"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}