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Dosing Tests

Our pen passes rigorous dosing accuracy tests. According to certified results, our dosing accuracy falls well within the ISO-11608 standard range. Moreover, our pens pass dosing accuracy tests after exposure to stress tests:

  • Storage at -20 oC or 70 oC,
  • Within an environment of 0 oC or 40 oC,
  • After mechanical vibration from 3Hz to 300Hz,
  • After 1m free fall on a hard surface.

Functional Tests

  • Torque required for dose selection: <0.01 Nm
  • Force required for injection: <20 N
  • Force required to attach holder to dosing: <80 N
  • Force required to remove holder from dosing: >150 N
  • Torque required to attach needle: < 0.01 Nm
  • Torque required to strip needle screw: > 0.5 Nm
  • Torque required to break pen after end of use: >2.5 Nm
  • Force required to remove injection button: >100 N
  • Force required to remove cap: 3.5 N
  • Force required to attach cap: 3.5 N
SG04_Logo ISO 13485 (1)

ISO 13485 Medical Devices

Pooyesh Injection has implemented ISO 13485:2016 including the risk management approaches for quality management. The important objectives of ISO 13485 include the following aspects:

  • Establish quality management requirements for medical device manufacturers and involved suppliers.
  • Demonstrate the company’s ability to provide compliant medical devices and related services
  • Meet appropriate regulatory requirements through compliance with standards
  • Harmonize regulatory requirements for quality management systems applicable to medical devices in different countries.
  • Define special requirements for medical devices

Quality Management System

SO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.


National Medical Device Directorate is responsible for monitoring and evaluating the authenticity, quality, and safety of medical, dental, and laboratory devices and licensing the applicants for various actions and processes in production, import, export, distribution, supply, and after-sales services.

Pooyesh Injection is in the process of audition by IMED for manufacturing injection systems for insulin pens

ISO 11608-1:2022

Needle-based injection systems for medical use — Requirements and test methods — Part 1: Needle-based injection systems

The injector pens manufactured by Pooyesh Injection comply with all requirments described in ISO 11608-1:2014​