{"id":277780,"date":"2024-10-19T18:42:34","date_gmt":"2024-10-19T18:42:34","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-53612012\/"},"modified":"2024-10-25T15:13:53","modified_gmt":"2024-10-25T15:13:53","slug":"bs-en-iso-53612012","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-53612012\/","title":{"rendered":"BS EN ISO 5361:2012"},"content":{"rendered":"

This International Standard provides essential performance and safety requirements for oro-tracheal and naso-tracheal tubes and tracheal tube connectors. Tracheal tubes with walls reinforced with metal or nylon, tracheal tubes with shoulders, tapered tracheal tubes, tracheal tubes with means for suctioning or monitoring or delivery of drugs or other gases, and the many other types of tracheal tubes devised for specialized applications are included in this International Standard, as many specialized tracheal tubes are now commonly used, and all share similar essential requirements as defined in this International Standard.<\/p>\n

Tracheobronchial (endobronchial) tubes, tracheostomy tubes and supralaryngeal airways are excluded from the scope of this International Standard.<\/p>\n

Tracheal tubes intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are outside the scope of this International Standard.<\/p>\n

\n

NOTE ISO\/TR 11991, ISO 11990-1, ISO 11990-2, and ISO 14408 cover this[1][2][3][4].<\/p>\n<\/blockquote>\n

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\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
9<\/td>\nForeword <\/td>\n<\/tr>\n
10<\/td>\nIntroduction <\/td>\n<\/tr>\n
12<\/td>\n1\t*Scope
2\tNormative references <\/td>\n<\/tr>\n
13<\/td>\n3\tTerms and definitions <\/td>\n<\/tr>\n
16<\/td>\n4\t*General requirements for tracheal tubes and tracheal tube connectors
4.1\tRisk assessment <\/td>\n<\/tr>\n
17<\/td>\n4.2\tSafety
5\tSpecific requirements for tracheal tubes and tracheal tube connectors
5.1\tSize designation
5.2\tDimensions <\/td>\n<\/tr>\n
25<\/td>\n5.3\t*Materials <\/td>\n<\/tr>\n
26<\/td>\n5.4\tTracheal tube bevel
5.5\t*Tracheal tube cuffs <\/td>\n<\/tr>\n
27<\/td>\n5.6\tInflating system for cuffs
5.7\tCurvature of the tube <\/td>\n<\/tr>\n
29<\/td>\n5.8\t*Radiopaque marker
5.9\t*Kink resistance <\/td>\n<\/tr>\n
30<\/td>\n6\tAdditional requirement for tracheal tubes with a Murphy eye
6.1\tSize of the Murphy eye
6.2\tLocation of the Murphy eye
6.3\tResistance to kinking or collapse of the Murphy eye
6.4\tSurface characteristics of the Murphy eye <\/td>\n<\/tr>\n
31<\/td>\n7\tRequirements for tracheal tubes with tracheal tube connectors supplied sterile
7.1\tSterility assurance
7.2\tPackaging for tracheal tubes and tracheal tube connectors supplied sterile
8\tMarking
8.1\tUse of symbols
8.2\tTracheal tubes <\/td>\n<\/tr>\n
32<\/td>\n8.3\tMarking on the tracheal tube individual pack or any insert <\/td>\n<\/tr>\n
34<\/td>\n8.4\tMarking on tracheal tube connectors <\/td>\n<\/tr>\n
35<\/td>\nAnnex\u00a0A
\n(informative)<\/p>\n

Rationale <\/td>\n<\/tr>\n

39<\/td>\nAnnex\u00a0B
\n(normative)<\/p>\n

Determination of cuff diameter <\/td>\n<\/tr>\n

40<\/td>\nAnnex\u00a0C
\n(normative)<\/p>\n

Test method for cuffed tube collapse <\/td>\n<\/tr>\n

43<\/td>\nAnnex\u00a0D
\n(normative)<\/p>\n

*Test method for cuff herniation <\/td>\n<\/tr>\n

45<\/td>\nAnnex\u00a0E
\n(informative)<\/p>\n

Guidance on design of tracheal tube connectors <\/td>\n<\/tr>\n

46<\/td>\nAnnex\u00a0F
\n(informative)<\/p>\n

Hazard identification for risk assessment
Annex\u00a0F
\n(informative)<\/p>\n

Hazard identification for risk assessment <\/td>\n<\/tr>\n

49<\/td>\nAnnex\u00a0G
\n(normative)<\/p>\n

*Test method for tracheal seal
Annex\u00a0G
\n(normative)<\/p>\n

*Test method for tracheal seal <\/td>\n<\/tr>\n

52<\/td>\nAnnex\u00a0H
\n(normative)<\/p>\n

Test method to determine kink resistance
Annex\u00a0H
\n(normative)<\/p>\n

Test method to determine kink resistance <\/td>\n<\/tr>\n

54<\/td>\nBibliography
Bibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Anaesthetic and respiratory equipment. Tracheal tubes and connectors<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2014<\/td>\n56<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":277784,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[137,2641],"product_tag":[],"class_list":{"0":"post-277780","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-10","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\/277780","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\/277784"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=277780"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=277780"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=277780"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}