{"id":459910,"date":"2024-10-20T10:06:39","date_gmt":"2024-10-20T10:06:39","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bs-iso-11040-42024-2\/"},"modified":"2024-10-26T18:40:43","modified_gmt":"2024-10-26T18:40:43","slug":"bs-iso-11040-42024-2","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bs-iso-11040-42024-2\/","title":{"rendered":"BS ISO 11040-4:2024"},"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\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\n<\/tr>\n
2<\/td>\nundefined <\/td>\n<\/tr>\n
7<\/td>\nForeword <\/td>\n<\/tr>\n
9<\/td>\nIntroduction <\/td>\n<\/tr>\n
11<\/td>\n1 Scope
2 Normative references <\/td>\n<\/tr>\n
12<\/td>\n3 Terms and definitions <\/td>\n<\/tr>\n
14<\/td>\n4 General requirements
4.1 Quality systems
4.2 Testing
4.3 Documentation
5 Syringe barrel
5.1 Design including dimensions
5.1.1 Dimensions for 6 % Luer slip and 6 % Luer slip for Luer lock adapter front end syringes <\/td>\n<\/tr>\n
16<\/td>\n5.1.2 Specific dimensions for front end design for 6 % Luer slip and 6 % Luer slip for Luer lock adapter <\/td>\n<\/tr>\n
17<\/td>\n5.1.3 Dimensions for staked needle (SN) syringes <\/td>\n<\/tr>\n
19<\/td>\n5.1.4 Front end design for staked needle syringe <\/td>\n<\/tr>\n
20<\/td>\n5.2 Functional testing of Luer connection
5.3 Material
5.4 Performance requirements
5.4.1 Hydrolytic resistance glass barrel
5.4.2 Annealing quality
5.4.3 Lubrication of the inner surface
5.4.4 Flange breakage resistance <\/td>\n<\/tr>\n
21<\/td>\n5.4.5 Front end breakage resistance
6 Sterilized subassembled syringes ready for filling
6.1 General
6.1.1 Design
6.1.2 Raw materials properties
6.1.3 Documentation
6.2 Sterility <\/td>\n<\/tr>\n
22<\/td>\n6.3 Pyrogenicity\/endotoxins
6.4 Particulate matter
6.5 Additional requirements to specific components of sterilized subassembled syringes ready for filling
6.5.1 Syringe barrel <\/td>\n<\/tr>\n
23<\/td>\n6.5.2 Needle <\/td>\n<\/tr>\n
24<\/td>\n6.5.3 Syringe closure system <\/td>\n<\/tr>\n
25<\/td>\n6.6 Syringe closure system tightness
7 Packaging <\/td>\n<\/tr>\n
26<\/td>\n8 Labelling <\/td>\n<\/tr>\n
27<\/td>\nAnnex A (informative) Examples of types of sterilized subassembled syringes ready for filling <\/td>\n<\/tr>\n
29<\/td>\nAnnex B (informative) Additional components for a subassembled syringe ready for filling <\/td>\n<\/tr>\n
30<\/td>\nAnnex C (normative) Test methods for syringe barrels <\/td>\n<\/tr>\n
36<\/td>\nAnnex D (informative) Sample preparation for endotoxin and particulate determination <\/td>\n<\/tr>\n
39<\/td>\nAnnex E (informative) Glide force test method <\/td>\n<\/tr>\n
42<\/td>\nAnnex F (informative) Needle penetration test <\/td>\n<\/tr>\n
45<\/td>\nAnnex G (normative) Test methods for front end components <\/td>\n<\/tr>\n
60<\/td>\nAnnex H (informative) Tightness test <\/td>\n<\/tr>\n
62<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

Prefilled syringes – Glass barrels for injectables and sterilized subassembled syringes ready for filling<\/b><\/p>\n\n\n\n\n
Published By<\/td>\nPublication Date<\/td>\nNumber of Pages<\/td>\n<\/tr>\n
BSI<\/b><\/a><\/td>\n2024<\/td>\n64<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":459916,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[139,2641],"product_tag":[],"class_list":{"0":"post-459910","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\/459910","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\/459916"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=459910"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=459910"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=459910"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}