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

Standard No.

BS ISO 11040-8:2016

Release Date

2016

Published By

British Standards Institution (BSI)

Latest

BS ISO 11040-8:2016

BS ISO 11040-8:2016 Referenced Document

• ANSI/AAMI HE75 
• IEC 62366 Medical devices - Application of usability engineering to medical devices
• IEC 80369-5 Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications; Corrigendum 2*， 2021-05-01 Update
• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
• ISO 11040-4:2015 Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling
• ISO 11040-5 Prefilled syringes - Part 5: Plunger stoppers for injectables
• ISO 11040-6 Prefilled syringes — Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling*， 2019-01-10 Update
• ISO 11608-1 Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems*， 2022-04-07 Update
• ISO 11608-2 Needle-based injection systems for medical use — Requirements and test methods — Part 2: Double-ended pen needles*， 2022-04-07 Update
• ISO 11608-3 Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths*， 2022-04-07 Update
• ISO 11608-4 Needle-based injection systems for medical use — Requirements and test methods — Part 4: Needle-based injection systems containing electronics*， 2022-04-07 Update
• ISO 11608-5 Needle-based injection systems for medical use — Requirements and test methods — Part 5: Automated functions*， 2022-04-07 Update
• ISO 13408-1 Aseptic processing of health care products — Part 1: General requirements*， 2023-06-01 Update
• ISO 14971 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements*， 2019-12-10 Update
• ISO 17665-1 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 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 Sterile hypodermic needles for single use - Requirements and test methods
• ISO 80369-1 Small-bore connectors for liquids and gases in healthcare applications — Part 1: General requirements*， 2018-11-05 Update
• ISO 80369-3 Amendment 1 — Small-bore connectors for liquids and gases in healthcare applications — Part 3: Connectors for enteral applications*， 2019-02-12 Update
• ISO 80369-6 Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
• ISO 80369-7 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications*， 2021-04-30 Update
• ISO 9626 Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods

BS ISO 11040-8:2016 history

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