{"id":279255,"date":"2024-10-19T18:50:16","date_gmt":"2024-10-19T18:50:16","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-151972013\/"},"modified":"2024-10-25T15:24:12","modified_gmt":"2024-10-25T15:24:12","slug":"bs-en-iso-151972013","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-151972013\/","title":{"rendered":"BS EN ISO 15197:2013"},"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\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
5<\/td>\nAnnex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 98\/79\/EC in vitro diagnostic medical devices
Table ZA.1 \u2014 Correspondence between this European Standard and Directive 98\/79\/EC in vitro diagnostic medical devices <\/td>\n<\/tr>\n
8<\/td>\nForeword <\/td>\n<\/tr>\n
9<\/td>\nIntroduction <\/td>\n<\/tr>\n
11<\/td>\nSection sec_1
Section sec_2
1\tScope
2\tNormative references <\/td>\n<\/tr>\n
12<\/td>\nSection sec_3
Section sec_3.1
Section sec_3.2
Section sec_3.3
Section sec_3.4
3\tTerms and definitions <\/td>\n<\/tr>\n
13<\/td>\nSection sec_3.5
Section sec_3.6
Section sec_3.7
Section sec_3.8 <\/td>\n<\/tr>\n
14<\/td>\nSection sec_3.9
Section sec_3.10
Section sec_3.11
Section sec_3.12
Section sec_3.13 <\/td>\n<\/tr>\n
15<\/td>\nSection sec_3.14
Section sec_3.15
Section sec_3.16 <\/td>\n<\/tr>\n
16<\/td>\nSection sec_3.17
Section sec_3.18
Section sec_3.19 <\/td>\n<\/tr>\n
17<\/td>\nSection sec_3.20
Section sec_3.21
Section sec_3.22
Section sec_3.23
Section sec_3.24 <\/td>\n<\/tr>\n
18<\/td>\nSection sec_3.25
Section sec_3.26
Section sec_3.27
Section sec_3.28
Section sec_4
Section sec_4.1
Section sec_4.2
4\tDesign and development
4.1\tGeneral requirements
4.2\tMetrological traceability <\/td>\n<\/tr>\n
19<\/td>\nSection sec_4.3
Section sec_4.3.1
Section sec_4.3.2
Section sec_4.3.3
4.3\tSafety and risk management <\/td>\n<\/tr>\n
20<\/td>\nSection sec_4.4
Section sec_4.5
Section sec_5
Section sec_5.1
Section sec_5.1.1
4.4\tErgonomics and human factors
4.5\tUser verification requirements
5\tSafety and reliability testing
5.1\tGeneral requirements <\/td>\n<\/tr>\n
21<\/td>\nSection sec_5.1.2
Section sec_5.1.3
Section sec_5.2
Section sec_5.3
Section sec_5.4
Section sec_5.5
Section sec_5.6
5.2\tProtection against electric shock
5.3\tProtection against mechanical hazards
5.4\tElectromagnetic compatibility
5.5\tResistance to heat
5.6\tResistance to moisture and liquids <\/td>\n<\/tr>\n
22<\/td>\nSection sec_5.7
Section sec_5.8
Section sec_5.9
Section sec_5.10
Section sec_5.10.1
Section sec_5.10.2
5.7\tProtection against liberated gases, explosion and implosion
5.8\tMeter components
5.9\tPerformance test
5.10\tMechanical resistance to vibration and shock <\/td>\n<\/tr>\n
23<\/td>\nSection sec_5.11
Section sec_5.11.1
Section sec_5.11.2
Section sec_5.12
5.11\tEquipment temperature exposure limits for storage
5.12\tEquipment humidity exposure limits for storage <\/td>\n<\/tr>\n
24<\/td>\nSection sec_6
Section sec_6.1
Section sec_6.1.1
Section sec_6.1.2
6\tAnalytical performance evaluation
6.1\tGeneral requirements <\/td>\n<\/tr>\n
25<\/td>\nSection sec_6.1.3
Section sec_6.1.4 <\/td>\n<\/tr>\n
26<\/td>\nSection sec_6.2
Section sec_6.2.1
Section sec_6.2.2
Section sec_6.2.3
Section sec_6.2.3.1
Section sec_6.2.3.2
6.2\tMeasurement precision <\/td>\n<\/tr>\n
27<\/td>\nTable tab_1
Section sec_6.2.3.3
Section sec_6.2.3.4 <\/td>\n<\/tr>\n
28<\/td>\nSection sec_6.2.4
Section sec_6.2.4.1
Section sec_6.2.4.2
Table tab_2
Section sec_6.2.4.3 <\/td>\n<\/tr>\n
29<\/td>\nSection sec_6.2.4.4
Section sec_6.3
Section sec_6.3.1
Section sec_6.3.2
6.3\tSystem accuracy <\/td>\n<\/tr>\n
30<\/td>\nSection sec_6.3.3
Section sec_6.3.4
Section sec_6.3.5 <\/td>\n<\/tr>\n
31<\/td>\nTable tab_3
Section sec_6.3.6 <\/td>\n<\/tr>\n
32<\/td>\nSection sec_6.3.7
Section sec_6.3.7.1
Section sec_6.3.7.2 <\/td>\n<\/tr>\n
33<\/td>\nTable tab_a
Figure fig_1 <\/td>\n<\/tr>\n
34<\/td>\nTable tab_b
Figure fig_2
Section sec_6.3.7.3 <\/td>\n<\/tr>\n
35<\/td>\nSection sec_6.3.7.4
Table tab_4
Table tab_5
Table tab_6
Section sec_6.4
Section sec_6.4.1
6.4\tInfluence quantities <\/td>\n<\/tr>\n
36<\/td>\nSection sec_6.4.2
Section sec_6.4.3
Section sec_6.4.3.1
Section sec_6.4.3.2
Section sec_6.4.3.3 <\/td>\n<\/tr>\n
37<\/td>\nSection sec_6.4.3.4
Section sec_6.4.3.5 <\/td>\n<\/tr>\n
38<\/td>\nSection sec_6.4.4
Section sec_6.4.4.1
Section sec_6.4.4.2
Section sec_6.4.4.3 <\/td>\n<\/tr>\n
39<\/td>\nSection sec_6.4.4.4
Section sec_6.4.4.5 <\/td>\n<\/tr>\n
40<\/td>\nSection sec_6.5
Section sec_6.5.1
Section sec_6.5.2
Section sec_7
Section sec_7.1
6.5\tStability of reagents and materials
7\tInformation supplied by the manufacturer
7.1\tGeneral requirements <\/td>\n<\/tr>\n
41<\/td>\nSection sec_7.2
Section sec_7.3
Section sec_8
Section sec_8.1
7.2\tPerformance characteristics
7.3\tOptions for supplying instructions for use
8\tUser performance evaluation
8.1\tGeneral requirements <\/td>\n<\/tr>\n
42<\/td>\nSection sec_8.2
Section sec_8.3
Section sec_8.4
8.2\tAcceptance criteria and evaluation of results
8.3\tSelection and preparation of subjects
8.4\tExecution of study protocol <\/td>\n<\/tr>\n
43<\/td>\nSection sec_8.5
Section sec_8.6
Section sec_8.7
Section sec_8.7.1
8.5\tGlucose reference values
8.6\tHuman factors
8.7\tData analysis and presentation of results <\/td>\n<\/tr>\n
44<\/td>\nSection sec_8.7.2
Section sec_8.8
Section sec_8.8.1
Section sec_8.8.2
Section sec_8.8.3
8.8\tEvaluation of instructions for use <\/td>\n<\/tr>\n
45<\/td>\nAnnex sec_A
Annex sec_A.1
Annex sec_A.2
Annex\u00a0A
\n(informative)<\/p>\n

Possible interfering substances <\/td>\n<\/tr>\n

46<\/td>\nAnnex sec_B
Figure fig_B.1
Annex\u00a0B
\n(informative)<\/p>\n

Traceability chain <\/td>\n<\/tr>\n

48<\/td>\nAnnex sec_C
Annex sec_C.1
Annex sec_C.2
Annex sec_C.3
Annex\u00a0C
\n(informative)<\/p>\n

Rationale for the analytical performance requirements
Annex\u00a0C
\n(informative)<\/p>\n

Rationale for the analytical performance requirements <\/td>\n<\/tr>\n

49<\/td>\nAnnex sec_C.4 <\/td>\n<\/tr>\n
50<\/td>\nTable tab_C.1 <\/td>\n<\/tr>\n
52<\/td>\nTable tab_e
Figure fig_C.1 <\/td>\n<\/tr>\n
53<\/td>\nTable tab_f
Figure fig_C.2
Table tab_C.2 <\/td>\n<\/tr>\n
54<\/td>\nAnnex sec_C.5 <\/td>\n<\/tr>\n
55<\/td>\nReference ref_1
Reference ref_2
Reference ref_3
Reference ref_4
Reference ref_5
Reference ref_6
Reference ref_7
Reference ref_8
Reference ref_9
Reference ref_10
Reference ref_11
Reference ref_12
Reference ref_13
Reference ref_14
Reference ref_15
Reference ref_16
Reference ref_17
Reference ref_18
Bibliography
Bibliography <\/td>\n<\/tr>\n
56<\/td>\nReference ref_19
Reference ref_20 <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

In vitro diagnostic test systems. Requirements for blood-glucosemonitoring systems for self-testing in managing diabetes mellitus<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2013<\/td>\n60<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":279260,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[161,2641],"product_tag":[],"class_list":{"0":"post-279255","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-100-10","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\/279255","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\/279260"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=279255"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=279255"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=279255"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}