{"id":282604,"date":"2024-10-19T19:06:20","date_gmt":"2024-10-19T19:06:20","guid":{"rendered":"https:\/\/pdfstandards.shop\/product\/uncategorized\/bsi-20-30382352-dc-2020\/"},"modified":"2024-10-25T15:49:31","modified_gmt":"2024-10-25T15:49:31","slug":"bsi-20-30382352-dc-2020","status":"publish","type":"product","link":"https:\/\/pdfstandards.shop\/product\/publishers\/bsi\/bsi-20-30382352-dc-2020\/","title":{"rendered":"BSI 20\/30382352 DC 2020"},"content":{"rendered":"

This document specifies requirements and test methods for design verification of containers and integrated fluid paths to be used with Needle-Based Injection Systems (NIS) that fulfil the requirements of ISO 11608-1<\/span><\/span> (and other subparts as appropriate). It is applicable to single and multi-dose containers (either filled by the manufacturer [primary container closure] or by the end-user [reservoir]) and fluid paths that are integrated with the NIS at the point of manufacture.<\/p>\n

\n
\n NOTE\n <\/div>\n

Prefilled syringes (ISO 11040-8<\/span><\/span>) are included in the scope when used with a NIS; see also scope of ISO 11608-1:20xx<\/span><\/span>.<\/p>\n<\/div>\n

Products excluded from scope are:<\/p>\n