{"id":440403,"date":"2024-10-20T08:14:43","date_gmt":"2024-10-20T08:14:43","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-23-30468236-dc-2023\/"},"modified":"2024-10-26T15:25:06","modified_gmt":"2024-10-26T15:25:06","slug":"bsi-23-30468236-dc-2023","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-23-30468236-dc-2023\/","title":{"rendered":"BSI 23\/30468236 DC 2023"},"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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\n30468236-NC.pdf <\/td>\n<\/tr>\n
3<\/td>\n65A_1102e_CDV.pdf <\/td>\n<\/tr>\n
7<\/td>\nFOREWORD <\/td>\n<\/tr>\n
9<\/td>\n1. Scope
2. Normative references
3. Terms and definitions <\/td>\n<\/tr>\n
10<\/td>\n3.1 Terms and definitions <\/td>\n<\/tr>\n
11<\/td>\n3.2 Abbreviations <\/td>\n<\/tr>\n
12<\/td>\n4. General
4.101 Essential Performance
4.102 Basic Safety <\/td>\n<\/tr>\n
13<\/td>\n5. EMC test plan
5.1 General
5.2 Configuration of EUT during testing <\/td>\n<\/tr>\n
14<\/td>\n5.2.101 Subsystems
5.3 Operation conditions of EUT during testing
5.3.101 Operation conditions
5.4 Specification of functional performance
5.5 Test description <\/td>\n<\/tr>\n
15<\/td>\n6. Immunity requirements
6.1 Conditions during the tests
6.101 Conditions during the tests
6.2 Immunity test requirements
6.201 Risk assessment and consideration of EMC immunity requirements <\/td>\n<\/tr>\n
21<\/td>\n6.3 Random aspects
6.4 Performance criteria
6.401 Pass\/fail criteria <\/td>\n<\/tr>\n
22<\/td>\n7. Emission requirements
8. Test results and test report <\/td>\n<\/tr>\n
23<\/td>\n9. Instructions for use
9.101 General requirements for the ivd mee instructions for use <\/td>\n<\/tr>\n
24<\/td>\n9.102 Additional requirements for the instructions for use for equipment to be used in a home healthcare environment
9.103 Additional requirements for the instructions for use for equipment to be used in a professional healthcare facility environment <\/td>\n<\/tr>\n
25<\/td>\nAnnex A (normative) Immunity test requirements for portable test and measurement equipment powered by battery or from the circuit being measured <\/td>\n<\/tr>\n
26<\/td>\nAnnex B (informative) General guidance and rationale
B.1 Background for maintenance leading to edition 4 of this standard <\/td>\n<\/tr>\n
28<\/td>\nAnnex C (informative) How to apply this standard and its environments <\/td>\n<\/tr>\n
29<\/td>\nAnnex D (informative) (leveraged from IEC 60601-1-2:2020 Annex G) Guidance: Test plan
D.1 Test plan contents <\/td>\n<\/tr>\n
31<\/td>\nAnnex E (informative) (leveraged from IEC 60601-1-2:2020 Table 1)
Table E.1 \u2013 Power input voltages and frequencies during the tests (1 of 2) <\/td>\n<\/tr>\n
32<\/td>\nAnnex F (informative) Guidance on the application of risk management with regard to Electromagnetic Disturbances and the Identification of Immunity pass\/fail criteria risks of EUT to identify critical immunity testing
F.1 Immunity pass\/fail criteria principles
F.1.1 General
F.1.2 Immunity pass\/fail criteria for non-ivd mee used in an ivd mee
F.1.3 Immunity pass\/fail criteria determination
F.2 Basic safety <\/td>\n<\/tr>\n
33<\/td>\nF.3 ESSENTIAL PERFORMANCE <\/td>\n<\/tr>\n
34<\/td>\nF.4 Immunity pass\/fail criteria examples
F.4.1 General examples <\/td>\n<\/tr>\n
35<\/td>\nF.4.2 essential performance Immunity pass criteria examples for IVD Immunoassay Analyzer <\/td>\n<\/tr>\n
37<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

BS EN IEC 61326-2-6. Electrical equipment for measurement, control and laboratory use. EMC requirements – Part 2-6. Particular requirements. In vitro diagnostic (IVD) medical equipment<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2023<\/td>\n37<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":440410,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[285,2641],"product_tag":[],"class_list":{"0":"post-440403","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-17-220-20","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\/440403","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\/440410"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=440403"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=440403"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=440403"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}