{"id":416090,"date":"2024-10-20T06:08:51","date_gmt":"2024-10-20T06:08:51","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-22-30437369-dc-2022\/"},"modified":"2024-10-26T11:25:18","modified_gmt":"2024-10-26T11:25:18","slug":"bsi-22-30437369-dc-2022","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-22-30437369-dc-2022\/","title":{"rendered":"BSI 22\/30437369 DC 2022"},"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\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
1<\/td>\n30437369-NC.pdf <\/td>\n<\/tr>\n
3<\/td>\nISO_DIS 18562-4 ed.2 – id.82898 Enquiry PDF (en).pdf <\/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 <\/td>\n<\/tr>\n
10<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
11<\/td>\n4 General principles
4.1 Type tests
4.2 General
5 Leachables in condensate
5.1 Identifying applicable gas pathway surfaces
5.2 Determining if testing is required <\/td>\n<\/tr>\n
12<\/td>\n5.3 Test methods
5.3.1 General <\/td>\n<\/tr>\n
13<\/td>\n5.3.2 Sample collection <\/td>\n<\/tr>\n
14<\/td>\n5.3.3 Chemical characterization of leachables in condensate <\/td>\n<\/tr>\n
15<\/td>\n5.3.4 Calculation of tolerable exposure
5.3.5 Calculation of exposure dose estimate
5.3.6 Risk assessment <\/td>\n<\/tr>\n
16<\/td>\n5.3.7 Biological evaluation according to ISO 10993 standards <\/td>\n<\/tr>\n
17<\/td>\n6 Reporting <\/td>\n<\/tr>\n
18<\/td>\nAnnex\u20acA (informative) Rationale and guidance <\/td>\n<\/tr>\n
20<\/td>\nAnnex\u20acB (informative) Reference to the IMDRF essential principles and labelling guidances <\/td>\n<\/tr>\n
21<\/td>\nAnnex\u20acC (informative) Reference to the essential principles <\/td>\n<\/tr>\n
22<\/td>\nAnnex\u20acZA (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
25<\/td>\nBibliography <\/td>\n<\/tr>\n
27<\/td>\nTerminology \u2014 Alphabetized index of defined terms <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

BS EN ISO 18562-4. Biocompatibility evaluation of breathing gas pathways in healthcare applications – Part 4. Tests for leachables in condensate<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2022<\/td>\n27<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":416095,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2641],"product_tag":[],"class_list":{"0":"post-416090","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-bsi","8":"first","9":"instock","10":"sold-individually","11":"shipping-taxable","12":"purchasable","13":"product-type-simple"},"_links":{"self":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product\/416090","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\/416095"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=416090"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=416090"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=416090"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}