What is ISO 13926-3 - Seals for pen-injectors about?
ISO 13926 discusses Pen systems. ISO 13926-3 is an international standard that provides seals for pen-injectors for medical use.
ISO 13926-3 is the third part of a multi-part series that outlines the shape, dimensions, material, performance requirements, and labeling of seals for pen-injectors for medical use.
Note: The potency, purity, stability, and safety of a medicinal product during its manufacture and storage can be significantly affected by the nature and performance of the primary packaging.
Who is ISO 13926-3 - Seals for pen-injectors for?
ISO 13926-3 for seals for pen-injectors for medical use is relevant to:
- Pen-injectors manufacturers
- Medical laboratories
- Hospitals
- Regulatory authorities
Why should you use ISO 13926-3 - Seals for pen-injectors?
A pen-injector (Also called a medication pen) is a device used for injecting medications under the skin. Pen-injectors are designed to make injectable medication easier and more convenient to use.
ISO 13926-3 guideline assists you with shape, dimensions, designation, material, physical requirements, chemical requirements, biological requirements, and labeling for seals for pen-injectors for medical use.
This helps in maintaining the acceptable quality of seals for pen-injectors and prevents getting in contact with any infectious substance.
By adopting ISO 13926-3 the user can enhance the efficiency and quality of pen-injectors to make them more convenient and effective to use.
What’s changed since the last update?
BS ISO 13926-3:2019 supersedes ISO 13926-3:2012, which has been withdrawn. BS ISO 13926-3:2019 has made some technical changes with respect to ISO 13926-3:2012. These includes:
- Extension of the nature of cap in 7.1
- Change of the reference in 8.2.2 to a needle for medical use
- Complete editorial revision