{"id":424044,"date":"2024-10-20T06:49:47","date_gmt":"2024-10-20T06:49:47","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-23-30457240-dc-2023\/"},"modified":"2024-10-26T12:49:29","modified_gmt":"2024-10-26T12:49:29","slug":"bsi-23-30457240-dc-2023","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-23-30457240-dc-2023\/","title":{"rendered":"BSI 23\/30457240 DC 2023"},"content":{"rendered":"

This document specifies the requirements for an aseptically processed medical device to be designated ‘STERILE’. NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is ‘STERILE’ is permissible when a validated manufacturing and sterilization process has been applied. Requirements for validation and routine control of aseptic processes are specified in EN ISO 13408-1. Specific requirements for the aseptic processing of solid medical devices and combination products are specified in ISO 13408-7.<\/p>\n

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
7<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
8<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
10<\/td>\n4 Requirements
4.1 Validation and routine control <\/td>\n<\/tr>\n
13<\/td>\n4.2 Compliance
4.3 Documentation and records <\/td>\n<\/tr>\n
14<\/td>\nAnnex\u00a0ZA (informative)Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017\/745 aimed to be covered <\/td>\n<\/tr>\n
17<\/td>\nAnnex\u00a0ZB (informative)Relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017\/746 aimed to be covered <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

BS EN 556-2. Sterilization of medical devices. Requirements for medical devices to be designated ”STERILE” – Part 2. requirements for aseptically processed medical devices<\/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>\n20<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":424053,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[154,2641],"product_tag":[],"class_list":{"0":"post-424044","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-080-01","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\/424044","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\/424053"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=424044"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=424044"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=424044"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}