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ISO 7886-1

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ISO 7886-1

ISO 7886-1 is the norm published by the International Organization for Standardization (ISO). "Sterile single-use injection syringes - Part 1: Syringes for manual use", d. H "Sterile single use injection syringes - Part 1: Manual syringes". The current version ISO 7886-1:2017; Possible revisions and the state of national implementation should be checked using the relevant official sources before the work begins.

Association in the ISO 7886 series: The series divides sterile disposable syringes according to different areas of application:

  • ISO 7886-1: Syringes for manual application (theme of this page)
  • ISO 7886-2: Syringes for Motorized Syringe Pumps
  • ISO 7886-3: Fixed Dosage Syringes (Auto-Disable)
  • ISO 7886-4: Syringe with Reuse Protection (Re-Use Prevention)

Regulatory Status Notice: ISO 7886-1 is often used as a reference in evaluating safety and performance requirements for sterile disposable syringes under the EU Medical Devices Regulation (MDR 2017/745) and the FDA used. It is connected to ISO 10993-1 (biocompatibility), ISO 11607 (packaging), ISO 11135/11137/17665 (sterilization) and ISO 7864 (injection needles) applied.

Scope

The standard defines the requirements for Sterile Disposable and Manually operated injectors (with or without a needle). Scope:

  • Normal Use: Suction and Injection of Liquids
  • Syringes offered without a needle: cases where the needle is offered separately
  • Special purpose syringes: Low volume types, such as B. Insulin injections (with special requirements)

Not included in the scope: Dental injectors, motor-driven pump injectors (ISO 7886-2), fixed dosage injectors (ISO 7886-3) and injectors that prevent reuse (ISO 7886-4).

The key parameters reported in the study are as follows:

  • Description of syringe, type (2 or 3-piece), nominal capacity and condition of the needle
  • Information on the materials and lubricants used
  • Visual inspection and particle evaluation
  • Leak test results
  • Polon Motion Measurements (break-loose and glide force)
  • Assessment accuracy and tolerances
  • Dead volume measurement
  • Cone fitting and needle connection tests
  • Sterility and Endotoxin Results
  • Packaging and Durability Data
  • Conformity of the labeling
  • Applied version of ISO 7886-1 and related standards
  • Data on measurement uncertainty and repeatability

Why is this being done?

ISO 7886-1 is used for the following scientific, technical and regulatory purposes:

  • Patient and User Safety Warranty: Verification of the safe, correct and effective use of the syringe
  • Dose accuracy: Ensuring scaling accuracy and correct dosage taking into account dead volume
  • MDR conformity: Fulfillment of safety and performance requirements in accordance with the EU Medical Devices Regulation (2017/745)
  • FDA Compliance: Presentation of performance data according to ISO 7886-1 at 510(k) and other applications
  • Quality control in production: Monitoring of consistency between production batches and checking compliance with specifications
  • Design and Development: Rating of new syringe constructions, materials and lubricants
  • Sterility Assurance: Sterilization Validation and Verification of Sterility and Pyrogen Freedom by Checking Packaging Integrity
  • Approval Support: Provision of Performance, Biocompatibility and Sterility Data for Technical Documents
  • Approach of probative value: Contribution to the holistic evaluation of the product in accordance with ISO 10993-1, ISO 11607, ISO 11135/11137/17665, ISO 11737-2/-3 and ISO 7864

ISO 7886-1 does not guarantee the clinical performance of the syringe in all aspects; The results must be interpreted in connection with material, design, manufacturing process, sterilization, packaging and the clinical application scenario.

As a NanoTest, we carry out the assessments of injectors within the framework of ISO 7886-1 with scientific care based on our accredited laboratory infrastructure and quality management system.

For more information on testing strategies, performance tests, biocompatibility and sterility integration, packaging and shelf life studies, the test schedule, and the reporting processes as part of your syringe assessments in accordance with ISO 7886-1, please contact contact nanotest.

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