{"id":279284,"date":"2024-10-19T18:50:26","date_gmt":"2024-10-19T18:50:26","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-60601-1-62007\/"},"modified":"2024-10-25T15:24:24","modified_gmt":"2024-10-25T15:24:24","slug":"bs-en-60601-1-62007","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-60601-1-62007\/","title":{"rendered":"BS EN 60601-1-6:2007"},"content":{"rendered":"

Specifies requirements for a process to analyse, design, verify and validate the usability, as it relates to basic safety and essential performance of medical electrical equipment. This collateral standard addresses normal use and use errors but excludes abnormal use. The object of this collateral standard is to specify general requirements that are in addition to those of the general standard IEC 60601-1 and to serve as the basis for particular standards.<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
9<\/td>\n1 Scope, object and related standards
1.1 Scope
1.2 Object
1.3 Related standards
1.3.1 IEC\u00a060601-1
1.3.2 Particular standards
2 Normative references <\/td>\n<\/tr>\n
10<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
12<\/td>\n4 General requirements
4.1 *\u00a0Conditions for application to me\u00a0equipment
4.2 *\u00a0Risk management process for me\u00a0equipment
5 Me\u00a0equipment identification, marking and documents
5.1 *\u00a0Accompanying documents <\/td>\n<\/tr>\n
13<\/td>\n5.2 *\u00a0Training and materials for training
6 *\u00a0Use error and usability
6.1 *\u00a0Safety for the patient, operator and other persons
6.2 *\u00a0Usability engineering process
6.2.1 General <\/td>\n<\/tr>\n
14<\/td>\n6.2.2 Input for the usability engineering process
6.2.2.1 *\u00a0Me\u00a0equipment application specification
6.2.2.2 Primary operating functions
6.2.2.3 *\u00a0Information for safety as a risk control <\/td>\n<\/tr>\n
15<\/td>\n6.2.3 *\u00a0Usability specification
6.2.4 *\u00a0Usability verification <\/td>\n<\/tr>\n
16<\/td>\n6.2.5 Usability validation plan
6.2.6 *\u00a0Usability validation <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Medical electrical equipment – General requirements for basic safety and essential performance. Collateral Standard. Usability<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2010<\/td>\n78<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":279287,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[136,2641],"product_tag":[],"class_list":{"0":"post-279284","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-01","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\/279284","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\/279287"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=279284"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=279284"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=279284"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}