{"id":277889,"date":"2024-10-19T18:43:12","date_gmt":"2024-10-19T18:43:12","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-235002015\/"},"modified":"2024-10-25T15:14:42","modified_gmt":"2024-10-25T15:14:42","slug":"bs-en-iso-235002015","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-235002015\/","title":{"rendered":"BS EN ISO 23500:2015"},"content":{"rendered":"

ISO 23500:2014 provides dialysis practitioners with guidance on the preparation of dialysis fluid for haemodialysis and related therapies and substitution fluid for use in online therapies, such as haemodiafiltration and haemofiltration. As such, ISO 23500:2014 functions as a recommended practice. ISO 23500:2014 addresses the user’s responsibility for the dialysis fluid once the equipment used in its preparation has been delivered and installed. For the purposes of ISO 23500:2014, the dialysis fluid includes dialysis water used for the preparation of dialysis fluid and substitution fluid, dialysis water used for the preparation of concentrates at the user’s facility, as well as concentrates and the final dialysis fluid and substitution fluid.<\/p>\n

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\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\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
6<\/td>\nForeword <\/td>\n<\/tr>\n
7<\/td>\nIntroduction <\/td>\n<\/tr>\n
9<\/td>\nSection sec_1
Section sec_1.1
Section sec_1.2
Section sec_1.3
Section sec_2
1\tScope
1.1\tGeneral
1.2\tInclusions
1.3\tExclusions
2\tNormative references <\/td>\n<\/tr>\n
10<\/td>\nSection sec_3
Section sec_3.1
Section sec_3.2
Section sec_3.3
Section sec_3.4
Section sec_3.5
3\tTerms and definitions <\/td>\n<\/tr>\n
11<\/td>\nSection sec_3.6
Section sec_3.7
Section sec_3.8
Section sec_3.9
Section sec_3.10
Section sec_3.11
Section sec_3.12 <\/td>\n<\/tr>\n
12<\/td>\nSection sec_3.13
Section sec_3.14
Section sec_3.15
Section sec_3.16
Section sec_3.17 <\/td>\n<\/tr>\n
13<\/td>\nSection sec_3.18
Section sec_3.19
Section sec_3.20
Section sec_3.21
Section sec_3.22
Section sec_3.23 <\/td>\n<\/tr>\n
14<\/td>\nSection sec_3.24
Section sec_3.25
Section sec_3.26
Section sec_3.27
Section sec_3.28
Section sec_3.29
Section sec_3.30 <\/td>\n<\/tr>\n
15<\/td>\nSection sec_3.31
Section sec_3.32
Section sec_3.33
Section sec_3.34
Section sec_3.35
Section sec_3.36
Section sec_3.37
Section sec_3.38 <\/td>\n<\/tr>\n
16<\/td>\nSection sec_3.39
Section sec_3.40
Section sec_3.41
Section sec_3.42
Section sec_3.43
Section sec_3.44
Section sec_3.45 <\/td>\n<\/tr>\n
17<\/td>\nSection sec_3.46
Section sec_4
Section sec_4.1
Section sec_4.1.1
Section sec_4.1.2
Table tab_1
4\tSummary of quality requirements of ISO\u00a013958, ISO\u00a013959 and ISO\u00a011663
4.1\tDialysis water <\/td>\n<\/tr>\n
18<\/td>\nTable tab_2
Section sec_4.1.3 <\/td>\n<\/tr>\n
19<\/td>\nTable tab_3
Section sec_4.2
Section sec_4.2.1
Section sec_4.2.2
Section sec_4.3
Section sec_4.3.1
Section sec_4.3.2
4.2\tRequirements for concentrate
4.3\tRequirements for dialysis fluid <\/td>\n<\/tr>\n
20<\/td>\nTable tab_4
Section sec_4.3.3
Section sec_4.3.4
Section sec_4.4
Section sec_5
4.4\tRecord retention
5\tCritical aspects of system design <\/td>\n<\/tr>\n
21<\/td>\nSection sec_5.1
Section sec_5.2
5.1\tTechnical aspects
5.2\tMicrobiological aspects <\/td>\n<\/tr>\n
22<\/td>\nSection sec_6
Section sec_6.1
6\tValidation of system performance
6.1\tValidation plan <\/td>\n<\/tr>\n
23<\/td>\nTable tab_b
Figure fig_1
Section sec_6.2
6.2\tInstallation and operational qualification <\/td>\n<\/tr>\n
24<\/td>\nSection sec_6.3
Section sec_6.4
6.3\tPerformance qualification
6.4\tRoutine monitoring and revalidation <\/td>\n<\/tr>\n
25<\/td>\nSection sec_7
Section sec_7.1
Section sec_7.2
Section sec_7.2.1
Section sec_7.2.2
7\tQuality management
7.1\tGeneral
7.2\tMonitoring of fluid quality <\/td>\n<\/tr>\n
26<\/td>\nSection sec_7.2.3
Section sec_7.3
Section sec_7.3.1
Section sec_7.3.2
Section sec_7.3.3
Section sec_7.3.4
7.3\tMonitoring of water treatment equipment <\/td>\n<\/tr>\n
27<\/td>\nSection sec_7.3.5
Section sec_7.3.6 <\/td>\n<\/tr>\n
28<\/td>\nSection sec_7.3.7 <\/td>\n<\/tr>\n
29<\/td>\nSection sec_7.3.8
Section sec_7.3.9
Section sec_7.4
Section sec_7.4.1
7.4\tMonitoring of dialysis water storage and distribution <\/td>\n<\/tr>\n
30<\/td>\nSection sec_7.4.2
Section sec_7.4.3
Section sec_7.4.3.1
Section sec_7.4.3.2
Section sec_7.4.3.3 <\/td>\n<\/tr>\n
31<\/td>\nSection sec_7.5
Section sec_7.5.1
Section sec_7.5.2
Section sec_7.6
Section sec_7.7
7.5\tMonitoring of concentrate preparation
7.6\tMonitoring of concentrate distribution
7.7\tMonitoring of dialysis fluid proportioning <\/td>\n<\/tr>\n
32<\/td>\nSection sec_8
Section sec_8.1
Section sec_8.2
Section sec_8.2.1
8\tStrategies for microbiological control
8.1\tGeneral
8.2\tDisinfection <\/td>\n<\/tr>\n
33<\/td>\nSection sec_8.2.2
Section sec_8.2.2.1
Section sec_8.2.2.2
Section sec_8.2.2.3 <\/td>\n<\/tr>\n
34<\/td>\nSection sec_8.2.2.4
Section sec_8.3
Section sec_8.3.1
Section sec_8.3.2
Section sec_8.3.2.1
8.3\tMicrobiological monitoring methods <\/td>\n<\/tr>\n
35<\/td>\nSection sec_8.3.2.2
Section sec_8.3.3
Section sec_8.3.3.1
Section sec_8.3.3.2
Section sec_8.3.3.2.1
Section sec_8.3.3.2.2
Section sec_8.3.3.2.3 <\/td>\n<\/tr>\n
36<\/td>\nSection sec_8.3.3.2.4
Section sec_8.3.3.3
Table tab_5
Section sec_8.3.4
Section sec_9
9\tEnvironment <\/td>\n<\/tr>\n
37<\/td>\nSection sec_10
10\tPersonnel <\/td>\n<\/tr>\n
38<\/td>\nAnnex sec_A
Annex sec_A.1
Annex sec_A.2
Annex sec_A.3
Annex sec_A.4
Annex\u00a0A
\n(informative)<\/p>\n

Rationale for the development and provisions of this International\u00a0Standard <\/td>\n<\/tr>\n

39<\/td>\nAnnex sec_A.5
Annex sec_A.6
Annex sec_A.7 <\/td>\n<\/tr>\n
40<\/td>\nAnnex sec_A.8 <\/td>\n<\/tr>\n
41<\/td>\nAnnex sec_A.9
Annex sec_A.10 <\/td>\n<\/tr>\n
42<\/td>\nAnnex sec_B
Annex sec_B.1
Annex sec_B.2
Annex sec_B.2.1
Annex\u00a0B
\n(informative)<\/p>\n

Equipment <\/td>\n<\/tr>\n

43<\/td>\nAnnex sec_B.2.2
Annex sec_B.2.3
Annex sec_B.2.4 <\/td>\n<\/tr>\n
44<\/td>\nAnnex sec_B.2.5 <\/td>\n<\/tr>\n
45<\/td>\nAnnex sec_B.2.6 <\/td>\n<\/tr>\n
46<\/td>\nAnnex sec_B.2.7 <\/td>\n<\/tr>\n
47<\/td>\nAnnex sec_B.2.8 <\/td>\n<\/tr>\n
48<\/td>\nAnnex sec_B.2.9
Annex sec_B.3
Annex sec_B.3.1 <\/td>\n<\/tr>\n
49<\/td>\nAnnex sec_B.3.2
Annex sec_B.3.3 <\/td>\n<\/tr>\n
50<\/td>\nTable tab_B.1
Annex sec_B.3.4
Annex sec_B.3.4.1
Annex sec_B.3.4.2 <\/td>\n<\/tr>\n
51<\/td>\nAnnex sec_B.3.4.3
Annex sec_B.3.4.4 <\/td>\n<\/tr>\n
52<\/td>\nAnnex sec_B.4
Annex sec_B.4.1
Annex sec_B.4.2 <\/td>\n<\/tr>\n
53<\/td>\nAnnex sec_B.4.3
Annex sec_B.4.3.1
Annex sec_B.4.3.2
Annex sec_B.4.3.3
Annex sec_B.4.3.4
Annex sec_B.4.4
Annex sec_B.4.4.1 <\/td>\n<\/tr>\n
54<\/td>\nAnnex sec_B.4.4.2
Annex sec_B.4.4.3
Annex sec_B.4.5 <\/td>\n<\/tr>\n
55<\/td>\nAnnex sec_B.5
Annex sec_B.5.1
Annex sec_B.5.2
Annex sec_B.5.3
Annex sec_B.5.3.1
Annex sec_B.5.3.2 <\/td>\n<\/tr>\n
56<\/td>\nAnnex sec_B.5.3.3 <\/td>\n<\/tr>\n
57<\/td>\nAnnex sec_B.6
Table tab_B.2 <\/td>\n<\/tr>\n
58<\/td>\nAnnex sec_B.7
Annex sec_B.7.1
Annex sec_B.7.2 <\/td>\n<\/tr>\n
59<\/td>\nAnnex sec_B.7.3
Annex sec_B.7.4 <\/td>\n<\/tr>\n
60<\/td>\nAnnex sec_C
Annex sec_C.1
Table tab_C.1
Annex\u00a0C
\n(informative)<\/p>\n

Monitoring guidelines for water treatment equipment, distribution\u00a0systems, and dialysis fluid <\/td>\n<\/tr>\n

63<\/td>\nAnnex sec_C.2 <\/td>\n<\/tr>\n
64<\/td>\nTable tab_C.2 <\/td>\n<\/tr>\n
65<\/td>\nAnnex sec_D
Annex sec_D.1
Annex\u00a0D
\n(informative)<\/p>\n

Strategies for microbiological control
Annex\u00a0D
\n(informative)<\/p>\n

Strategies for microbiological control <\/td>\n<\/tr>\n

67<\/td>\nAnnex sec_D.2
Annex sec_D.2.1
Annex sec_D.2.2 <\/td>\n<\/tr>\n
68<\/td>\nAnnex sec_D.2.3
Annex sec_D.2.4 <\/td>\n<\/tr>\n
69<\/td>\nAnnex sec_D.3 <\/td>\n<\/tr>\n
70<\/td>\nAnnex sec_E
Annex sec_E.1
Annex sec_E.2
Annex sec_E.2.1
Annex sec_E.2.2
Annex\u00a0E
\n(informative)<\/p>\n

Validation
Annex\u00a0E
\n(informative)<\/p>\n

Validation <\/td>\n<\/tr>\n

71<\/td>\nAnnex sec_E.2.3
Annex sec_E.2.4 <\/td>\n<\/tr>\n
72<\/td>\nAnnex sec_E.3 <\/td>\n<\/tr>\n
73<\/td>\nAnnex sec_F
Annex sec_F.1
Annex sec_F.2
Annex sec_F.3
Annex sec_F.3.1
Annex\u00a0F
\n(informative)<\/p>\n

Special considerations for home haemodialysis
Annex\u00a0F
\n(informative)<\/p>\n

Special considerations for home haemodialysis <\/td>\n<\/tr>\n

74<\/td>\nAnnex sec_F.3.2
Annex sec_F.3.3 <\/td>\n<\/tr>\n
75<\/td>\nAnnex sec_F.4
Annex sec_F.5
Annex sec_F.5.1
Annex sec_F.5.2
Annex sec_F.5.3 <\/td>\n<\/tr>\n
76<\/td>\nAnnex sec_F.5.4
Annex sec_F.5.5
Annex sec_F.5.6
Annex sec_F.6
Annex sec_F.6.1
Annex sec_F.6.2 <\/td>\n<\/tr>\n
77<\/td>\nAnnex sec_F.7
Annex sec_F.7.1
Annex sec_F.7.2
Annex sec_F.7.2.1
Annex sec_F.7.2.2
Annex sec_F.7.2.3 <\/td>\n<\/tr>\n
78<\/td>\nAnnex sec_F.7.2.4
Annex sec_F.7.2.5 <\/td>\n<\/tr>\n
79<\/td>\nAnnex sec_G
Annex sec_G.1
Annex sec_G.2
Annex sec_G.3
Annex sec_G.3.1
Annex\u00a0G
\n(informative)<\/p>\n

Special considerations for acute haemodialysis
Annex\u00a0G
\n(informative)<\/p>\n

Special considerations for acute haemodialysis <\/td>\n<\/tr>\n

80<\/td>\nAnnex sec_G.3.2
Annex sec_G.3.3
Annex sec_G.3.4 <\/td>\n<\/tr>\n
81<\/td>\nAnnex sec_G.3.5
Annex sec_G.3.5.1
Annex sec_G.3.5.2 <\/td>\n<\/tr>\n
82<\/td>\nAnnex sec_G.3.6
Annex sec_G.3.7
Annex sec_G.4 <\/td>\n<\/tr>\n
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Reference ref_186 <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Guidance for the preparation and quality management of fluids for haemodialysis and related therapies<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2015<\/td>\n96<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":277894,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[141,2641],"product_tag":[],"class_list":{"0":"post-277889","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-40","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\/277889","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\/277894"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=277889"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=277889"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=277889"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}