{"id":379430,"date":"2024-10-20T03:02:23","date_gmt":"2024-10-20T03:02:23","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-pd-iso-tr-215822021\/"},"modified":"2024-10-26T05:27:13","modified_gmt":"2024-10-26T05:27:13","slug":"bsi-pd-iso-tr-215822021","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-pd-iso-tr-215822021\/","title":{"rendered":"BSI PD ISO\/TR 21582:2021"},"content":{"rendered":"

This document specifies the principles and methods for pyrogen testing of medical devices and their materials.<\/p>\n

PDF Catalog<\/h4>\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
6<\/td>\nForeword <\/td>\n<\/tr>\n
7<\/td>\nIntroduction <\/td>\n<\/tr>\n
9<\/td>\n1 Scope
2 Normative references
3 Terms and definitions <\/td>\n<\/tr>\n
10<\/td>\n4 Abbreviated terms <\/td>\n<\/tr>\n
11<\/td>\n5 Characterization of pyrogen
5.1 General
5.2 Bacterial endotoxin
5.3 Microbial components other than endotoxin <\/td>\n<\/tr>\n
12<\/td>\n5.4 Pro-inflammatory cytokines
5.5 Chemical agents and other pyrogens <\/td>\n<\/tr>\n
13<\/td>\n5.6 Principle of febrile reaction
6 \u200bAssessment of pyrogenicity
6.1 General
6.2 Bacterial endotoxin test (BET)
6.2.1 General <\/td>\n<\/tr>\n
14<\/td>\n6.2.2 Principle of LAL reaction
6.2.3 General procedure of BET
6.2.4 Properties of the BET <\/td>\n<\/tr>\n
15<\/td>\n6.3 Rabbit pyrogen test
6.3.1 General
6.3.2 Principle of the rabbit test
6.3.3 Procedure of the rabbit test
6.3.4 Characteristic of the rabbit test <\/td>\n<\/tr>\n
16<\/td>\n6.4 Human cell-based pyrogen test (HCPT)
6.4.1 General
6.4.2 Principle of the HCPT
6.4.3 Selection of human cells <\/td>\n<\/tr>\n
17<\/td>\n6.4.4 Selection of marker cytokine
6.4.5 Procedure of HCPT <\/td>\n<\/tr>\n
18<\/td>\n6.4.6 Characteristic of the HCPT <\/td>\n<\/tr>\n
19<\/td>\n6.4.7 Validation study
7 Conclusion <\/td>\n<\/tr>\n
20<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Pyrogenicity. Principles and methods for pyrogen testing of 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>\n2021<\/td>\n26<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":379438,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[162,2641],"product_tag":[],"class_list":{"0":"post-379430","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-100-20","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\/379430","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\/379438"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=379430"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=379430"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=379430"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}