{"id":402926,"date":"2024-10-20T05:03:42","date_gmt":"2024-10-20T05:03:42","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-22-30445135-dc\/"},"modified":"2024-10-26T09:00:35","modified_gmt":"2024-10-26T09:00:35","slug":"bsi-22-30445135-dc","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-22-30445135-dc\/","title":{"rendered":"BSI 22\/30445135 DC"},"content":{"rendered":"

PDF Catalog<\/h4>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n
PDF Pages<\/th>\nPDF Title<\/th>\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
13<\/td>\n4 Considerations for design inputs
4.1 General
4.2 Risk assessment and usability engineering
4.2.1 Risk assessment
4.2.2 Usability engineering
4.3 Determination of the intended demographic population <\/td>\n<\/tr>\n
14<\/td>\n4.4 Considerations for the determination of requirements for the design of medical devices specific to paediatric users
4.4.1 Considerations in relation to risk (risk-based approach to design)
4.4.2 Considerations in relation to human factors <\/td>\n<\/tr>\n
15<\/td>\n4.4.3 Considerations in relation to design attributes <\/td>\n<\/tr>\n
19<\/td>\n4.4.4 Considerations for accompanying documentation
5 Development of the design specification <\/td>\n<\/tr>\n
20<\/td>\n6 Design verification and validation
6.1 General
6.2 Design verification
6.3 Design validation
6.3.1 General
6.3.2 Usability evaluations (also known as usability tests or user studies) <\/td>\n<\/tr>\n
21<\/td>\n6.3.3 Clinical evaluation <\/td>\n<\/tr>\n
23<\/td>\nAnnex\u20acA (informative) Additional considerations for the “paediatric population” <\/td>\n<\/tr>\n
44<\/td>\nBibliography <\/td>\n<\/tr>\n<\/table>\n","protected":false},"excerpt":{"rendered":"

BS ISO 23217. Injection systems intended for self-administration by paediatric patients. Guidance for design<\/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>\n46<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n","protected":false},"featured_media":402934,"template":"","meta":{"rank_math_lock_modified_date":false,"ep_exclude_from_search":false},"product_cat":[2641],"product_tag":[],"class_list":{"0":"post-402926","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\/402926","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\/402934"}],"wp:attachment":[{"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/media?parent=402926"}],"wp:term":[{"taxonomy":"product_cat","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_cat?post=402926"},{"taxonomy":"product_tag","embeddable":true,"href":"https:\/\/pdfstandards.shop\/wp-json\/wp\/v2\/product_tag?post=402926"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}