ISO 10985:2009

Caps made of aluminium-plastics combinations for infusion bottles and injection vials — Requirements and test methods ISO 10985:2009

Publication date:   Feb 3, 2009

95.99   Withdrawal of Standard   Nov 15, 2022

General information

95.99   Withdrawal of Standard   Nov 15, 2022

ISO

ISO/TC 76 Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use

International Standard

11.040.20   Transfusion, infusion and injection equipment

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Scope

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.


Life cycle

PREVIOUSLY

WITHDRAWN
ISO 10985:1999

NOW

WITHDRAWN
ISO 10985:2009
95.99 Withdrawal of Standard
Nov 15, 2022

REVISED BY

PUBLISHED
ISO 8872:2022




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