ISO 10985:2009 specifies general requirements and test methods for caps made of aluminium-plastics combinations in accordance with ISO 8536-7 or ISO 8362-6 intended for use respectively on infusion bottles as specified in ISO 8536-1 and/or injection bottles as specified in ISO 8362-1 and ISO 8362-4.
The purpose of ISO 10985:2009 is to specify caps that provide:
- guarantee of originality of the closure up to the point of administration;
- compression of the sealing element (rubber closure) on to the sealing surfaces of the infusion and/or injection bottles;
- protection of the sealing element against soiling and mechanical damage;
- simple and injury-free opening of the closure in order to expose the penetration area of the rubber closure and/or to permit total removal of the cap.
Status: WithdrawnPublication date: 2009-02
Edition: 3Number of pages: 4
Technical Committee: ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use