{"id":278143,"date":"2024-10-19T18:44:31","date_gmt":"2024-10-19T18:44:31","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-111972016\/"},"modified":"2024-10-25T15:16:36","modified_gmt":"2024-10-25T15:16:36","slug":"bs-en-iso-111972016","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-111972016\/","title":{"rendered":"BS EN ISO 11197:2016"},"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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nNational foreword <\/td>\n<\/tr>\n
4<\/td>\nEuropean foreword <\/td>\n<\/tr>\n
5<\/td>\nAnnex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93\/42\/EEC <\/td>\n<\/tr>\n
10<\/td>\nForeword <\/td>\n<\/tr>\n
11<\/td>\nIntroduction <\/td>\n<\/tr>\n
13<\/td>\n201.1 Scope, object and related standards
201.1.1 Scope
201.1.2 Object
201.1.3 Related standards
201.1.3.1 Collateral standards
201.1.3.2 Particular standards <\/td>\n<\/tr>\n
14<\/td>\n201.2 Normative references <\/td>\n<\/tr>\n
15<\/td>\n201.3 Terms and definitions <\/td>\n<\/tr>\n
16<\/td>\n201.4 General requirements
201.5 General requirements for testing me equipment
201.5.101 Medical supply unit test results <\/td>\n<\/tr>\n
17<\/td>\n201.6 Classification of me equipment and me systems
201.6.1 Protection against electric shock
201.7.2.1 Minimum requirements for marking on me equipment and on interchangeable parts
201.7.2.6 Connection to the supply mains
201.7 Me equipment identification, marking and documents <\/td>\n<\/tr>\n
18<\/td>\n201.7.2.8 Output connectors
201.7.2.19 Functional earth terminals
201.7.3 Marking on the outside of me equipment or me equipment parts
201.7.9 Accompanying documents
201.7.9.1 General
201.7.9.2 Instructions for use and maintenance <\/td>\n<\/tr>\n
19<\/td>\n201.7.9.3 Technical description <\/td>\n<\/tr>\n
20<\/td>\n201.8 Protection against electrical hazards from me equipment
201.8.1 Fundamental rule of protection against electric shock
201.8.6 Protection earthing, functional earthing and potential equalization of me equipment
201.8.6.2 Protective earth terminal <\/td>\n<\/tr>\n
21<\/td>\n201.8.6.101 Conductors
201.8.6.102 Bus bar <\/td>\n<\/tr>\n
22<\/td>\n201.8.10 Components and wiring
201.8.10.7 Insulation of internal wiring <\/td>\n<\/tr>\n
25<\/td>\n201.8.11 Main parts, components and layout
201.8.11.1 Isolation from the supply mains <\/td>\n<\/tr>\n
26<\/td>\n201.9.1.101 Dynamic forces
201.9.1.102 Impact resistance test
201.9.1.103 Static forces
201.9.1.104 Static load test
201.9.1.105 Mechanical damage
201.9 Protection against mechanical hazards of me equipment and me systems <\/td>\n<\/tr>\n
27<\/td>\n201.9.6 Acoustic energy (including infra- and ultrasound) and vibration <\/td>\n<\/tr>\n
28<\/td>\n201.9.8 Mechanical hazards associated with support systems
201.10 Protection against unwanted and excessive radiation hazards
201.11 Protection against excessive temperatures and other hazards
201.11.1 Excessive temperatures in me equipment
201.11.2 Fire prevention
201.12 Accuracy of controls and instruments and protection against hazardous outputs
201.13 Hazardous situations and fault conditions
201.13.2 Single fault conditions <\/td>\n<\/tr>\n
29<\/td>\n201.14 Programmable electrical medical systems (pems)
201.15 Construction of me equipment
201.15.1 Arrangements of controls and indicators of me equipment
201.15.4 me equipment components and general assembly <\/td>\n<\/tr>\n
33<\/td>\n201.15.101 Venting
201.16 Me systems
201.17 Electromagnetic compatibility of me equipment and me systems
202 Medical electrical equipment – part 1-2 General requirements for basic safety and essential performance \u2013 Collateral standard: Electromagnetic disturbances \u2013 Requirements and tests
206 Medical electrical equipment – part 1-6 General requirements for basic safety and essential performance \u2013 Collateral standard: Usability <\/td>\n<\/tr>\n
34<\/td>\nAnnex AA (informative) Rationale <\/td>\n<\/tr>\n
35<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Medical supply units<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2018<\/td>\n36<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":278147,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[137,2641],"product_tag":[],"class_list":{"0":"post-278143","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-10","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\/278143","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\/278147"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=278143"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=278143"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=278143"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}