{"id":291475,"date":"2024-10-19T19:47:28","date_gmt":"2024-10-19T19:47:28","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-22442-12015-tc\/"},"modified":"2024-10-25T16:49:50","modified_gmt":"2024-10-25T16:49:50","slug":"bs-en-iso-22442-12015-tc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-22442-12015-tc\/","title":{"rendered":"BS EN ISO 22442-1:2015 – TC"},"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
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\ncompares BS EN ISO 22442-1:2015 <\/td>\n<\/tr>\n
2<\/td>\nTRACKED CHANGES
Text example 1 \u2014 indicates added text (in green) <\/td>\n<\/tr>\n
47<\/td>\nEuropean foreword <\/td>\n<\/tr>\n
49<\/td>\nRelationship between this European Standard and the Essential Requirements of EU Directive 93\/42\/EEC <\/td>\n<\/tr>\n
52<\/td>\nForeword <\/td>\n<\/tr>\n
53<\/td>\nIntroduction <\/td>\n<\/tr>\n
55<\/td>\n1\tScope
2\tNormative references <\/td>\n<\/tr>\n
56<\/td>\n3\tTerms and definitions <\/td>\n<\/tr>\n
57<\/td>\n4\tRisk management process
4.1\tGeneral
4.2\tRisk analysis
4.2.1\tIdentification of qualitative and quantitative characteristics related to the safety of medical devices <\/td>\n<\/tr>\n
58<\/td>\n4.2.2\tIdentification of hazards and hazardous situations <\/td>\n<\/tr>\n
59<\/td>\n4.3\tRisk evaluation
4.4\tRisk control
4.4.1\tGeneral
4.4.2\tRisk control for viruses and TSE agents
4.4.3\tRisk control of other hazards <\/td>\n<\/tr>\n
60<\/td>\n4.4.4\tResidual risk evaluation
4.5\tEvaluation of overall residual risk acceptability
4.5.1\tGeneral
4.5.2\tDocumentation <\/td>\n<\/tr>\n
61<\/td>\n4.6\tProduction and post-production information system <\/td>\n<\/tr>\n
62<\/td>\nAnnex\u00a0A (informative) Guidance on the application of this part of ISO\u00a022442 <\/td>\n<\/tr>\n
63<\/td>\nAnnex\u00a0B (informative) Graphical representation of part of the risk management process for medical devices utilizing animal material <\/td>\n<\/tr>\n
65<\/td>\nAnnex\u00a0C (normative) Special requirements for some animal materials considering the risk management for TSE agents <\/td>\n<\/tr>\n
70<\/td>\nAnnex\u00a0D (informative) Information relevant to the management of TSE risk <\/td>\n<\/tr>\n
79<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Tracked Changes. Medical devices utilizing animal tissues and their derivatives – Application of risk management<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2020<\/td>\n83<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":291480,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[164,2641],"product_tag":[],"class_list":{"0":"post-291475","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-100-99","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\/291475","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\/291480"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=291475"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=291475"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=291475"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}