ISO 11040-8:2016
Prefilled syringes - Part 8: Requirements and test methods for finished prefilled syringes

Standard No.

ISO 11040-8:2016

Release Date

2016

Published By

International Organization for Standardization (ISO)

Latest

ISO 11040-8:2016

ISO 11040-8:2016 Referenced Document

• IEC 62366:2007 Medical devices - Application of usability engineering to medical devices
• IEC 80369-5:2016 Small-bore connectors for liquids and gases in healthcare applications — Part 5: Connectors for limb cuff inflation applications
• ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
• ISO 11040-4:2015 Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
• ISO 11040-5:2012 Prefilled syringes - Part 5: Plunger stoppers for injectables
• ISO 11040-6:2012 Prefilled syringes - Part 6: Plastic barrels for injectables
• ISO 11608-1:2014 Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
• ISO 11608-2:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles
• ISO 11608-3:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 3: Finished containers
• ISO 11608-4:2006 Pen-injectors for medical use - Part 4: Requirements and test methods for electronic and electromechanical pen-injectors
• ISO 11608-5:2012 Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions
• ISO 13408-1:2008 Aseptic processing of health care products - Part 1: General requirements
• ISO 14971:2007 Medical devices - Application of risk management to medical devices
• ISO 17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
• ISO 23908:2011 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
• ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods
• ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
• ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
• ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
• ISO 80369-6:2016 Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
• ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
• ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods

ISO 11040-8:2016 history

• 2016 ISO 11040-8:2016 Prefilled syringes - Part 8: Requirements and test methods for finished prefilled syringes