{"id":277230,"date":"2024-10-19T18:39:54","date_gmt":"2024-10-19T18:39:54","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-45502-2-12003\/"},"modified":"2024-10-25T15:09:11","modified_gmt":"2024-10-25T15:09:11","slug":"bs-en-45502-2-12003","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-45502-2-12003\/","title":{"rendered":"BS EN 45502-2-1:2003"},"content":{"rendered":"

This Part 2-1 specifies requirements that are applicable to those active implantable medical devices<\/small> intended to treat bradyarrhythmias.<\/p>\n

The tests that are specified in EN 45502 are type tests, and are to be carried out on samples of a device to show compliance.<\/p>\n

This Part 2-1 is also applicable to some non-implantable parts and accessories of the devices (see Note 1).<\/p>\n

The characteristics of the implantable pulse generator<\/small> or lead<\/small> shall be determined by either the appropriate method detailed in this Part 2-1 or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this Part 2-1 shall apply.<\/p>\n

Any features of an active implantable medical device<\/small> intended to treat tachyarrhythmias are covered by EN 45502-2-2.<\/p>\n

\n

NOTE 1 The device that is commonly referred to as an active implantable medical device may in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.<\/p>\n<\/blockquote>\n

\n

NOTE 2 The terminology used in this European Standard is intended to be consistent with the terminology of Directive 90\/385\/EEC.<\/p>\n<\/blockquote>\n

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NOTE 3 In this European Standard, terms printed in small capital letters are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.<\/p>\n<\/blockquote>\n","protected":false},"excerpt":{"rendered":"

Active implantable medical devices – Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2004<\/td>\n98<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":277236,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[141,2641],"product_tag":[],"class_list":{"0":"post-277230","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\/277230","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\/277236"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=277230"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=277230"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=277230"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}