ISO 11040-7:2015
Prefilled syringes - Part 7: Packaging systems for sterilized subassembled syringes ready for filling

Standard No.

ISO 11040-7:2015

Release Date

2015

Published By

International Organization for Standardization (ISO)

Latest

ISO 11040-7:2015

Scope

This part of ISO 11040 specifies the packaging system that is used to deliver sterilized subassembled syringes ready for filling in tubs and nests. Downstream processes (processes after filling such as in house/outside transport, reprocessing) can result in specific requirements on the packaging system used to deliver sterilized subassembled syringes ready for filling. However, these requirements are not within the scope of this part of ISO 11040. NOTE 1 Glass barrels and sterilized subassembled syringes ready for filling, plungers, and plastic barrels for injectables are specified in ISO 11040-4, ISO 11040-5, and ISO 11040-6. NOTE 2

ISO 11040-7:2015 Referenced Document

• ISO 11135-1:2007 Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• ISO 11137-1:2006 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
• ISO 11137-2:2013 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
• ISO 11137-3:2006 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
• ISO 11138-1:2006 Sterilization of health care products - Biological indicators - Part 1: General requirements
• ISO 11138-2:2006 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
• ISO 11138-3:2006 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes
• ISO 11138-4:2006 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes
• ISO 11138-5:2006 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes
• ISO 11140-1:2014 Sterilization of health care products - Chemical indicators - Part 1: General requirements
• ISO 11140-3:2007 Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test
• ISO 7000:2014 Graphical symbols for use on equipment - Registered symbols
• ISO/TS 11139:2006 Sterilization of health care products - Vocabulary

ISO 11040-7:2015 history

• 2015 ISO 11040-7:2015 Prefilled syringes - Part 7: Packaging systems for sterilized subassembled syringes ready for filling