{"id":279562,"date":"2024-10-19T18:52:21","date_gmt":"2024-10-19T18:52:21","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-en-iso-10555-62017\/"},"modified":"2024-10-25T15:26:15","modified_gmt":"2024-10-25T15:26:15","slug":"bs-en-iso-10555-62017","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-en-iso-10555-62017\/","title":{"rendered":"BS EN ISO 10555-6:2017"},"content":{"rendered":"

ISO 10555-6:2015 specifies requirements, performance, and user safety issues related to subcutaneous implanted ports and catheters for intravascular long-term use supplied in sterile condition and intended for single use. ISO 10555-6:2015 does not specify requirements, performance, and user safety issues related to non-coring needles.<\/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>\nundefined <\/td>\n<\/tr>\n
6<\/td>\nAnnex ZA (informative)Relationship between this European Standard and the Essential Requirements of Directive 93\/42\/EEC [OJ L 169] aimed to be covered <\/td>\n<\/tr>\n
10<\/td>\nForeword <\/td>\n<\/tr>\n
11<\/td>\n1\tScope
2\tNormative references
3\tTerms and definitions <\/td>\n<\/tr>\n
13<\/td>\n4\tRequirements of the implantable subcutaneous implanted port and catheter
4.1\tGeneral <\/td>\n<\/tr>\n
14<\/td>\n4.2\tBiocompatibility
4.3\tDistance markings
4.4\tNominal dimensions of the subcutaneous implanted port
4.5\tPhysical requirements
4.5.1\tRadio-detectability
4.5.2\tSurface finish
4.5.3\tFreedom from leakage
4.5.4\tFlushing volume <\/td>\n<\/tr>\n
15<\/td>\n4.5.5\tCharacteristics of the septum
4.5.6\tCharacteristics of the connection or the catheter
4.6\tFlow rate
4.6.1\tSubcutaneous implanted ports not indicated for power injection
4.6.2\tSubcutaneous implanted ports indicated for power injection <\/td>\n<\/tr>\n
16<\/td>\n4.7\tBurst pressure of the subcutaneous implanted port and catheter
4.7.1\tSubcutaneous implanted ports not indicated for power injection
4.7.2\tSubcutaneous implanted ports indicated for power injection
5\tMagnetic Resonance Imaging (MRI) compatibility
6\tInformation to be supplied by the manufacturer
6.1\tMarking on the device
6.2\tPrimary packaging <\/td>\n<\/tr>\n
17<\/td>\n6.3\tLabels for traceability
6.4\tInstruction for use <\/td>\n<\/tr>\n
18<\/td>\nAnnex A (normative) Test method for freedom from air leakage <\/td>\n<\/tr>\n
20<\/td>\nAnnex B (informative) Determination of flushing volume <\/td>\n<\/tr>\n
22<\/td>\nAnnex C (informative) Guidance on further characterization testing: Needle penetration and withdrawal <\/td>\n<\/tr>\n
24<\/td>\nAnnex D (normative) Test method for freedom from leakage after multiple punctures <\/td>\n<\/tr>\n
25<\/td>\nAnnex E (normative) Peak tensile force <\/td>\n<\/tr>\n
26<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Intravascular catheters. Sterile and single-use catheters – Subcutaneous implanted ports<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2017<\/td>\n28<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":279566,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[139,2641],"product_tag":[],"class_list":{"0":"post-279562","1":"product","2":"type-product","3":"status-publish","4":"has-post-thumbnail","6":"product_cat-11-040-25","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\/279562","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\/279566"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=279562"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=279562"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=279562"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}