What is BS EN 13975 - Sampling procedures for acceptance testing of in vitro diagnostic medical devices about?
BS EN 13975 is a European standard that discusses the acceptance testing of in vitro diagnostic medical devices. BS EN 13975 outlines the sampling procedure requirements for acceptance testing of finished in vitro diagnostic medical devices, which require EC verification by a notified body to ensure safety in the operation of in vitro diagnostic medical devices.
Under BS EN 13975 two different provisions are addressed:
- Verification by testing attributes and/or variables on a statistical basis
- Verification by testing a homogeneous batch that has been defined by appropriate means of process validation and in-process control
BS EN 13975 layouts the requirements and criteria for testing procedures to establish and verify the homogeneity of processes and products. BS EN 13975 applies for drawing up sampling plans for finished products according to the requirements laid down for manufacturers' product certification and production quality systems.
Who is BS EN 13975 - Sampling procedures for acceptance testing of in vitro diagnostic medical devices for?
BS EN 13975 on the sampling procedures for acceptance testing of in vitro diagnostic medical devices:
- In vitro diagnostic medical devices manufacturers and developers
- Medical laboratories
- Regulatory authorities
Why should you use BS EN 13975 - Sampling procedures for acceptance testing of in vitro diagnostic medical devices?
Inspection and verification of the finished in vitro devices are complementary to process control and final testing performed by the manufacturer. Valid conclusions can only be drawn from a limited number of units of the final product, if adequate in-process testing, monitoring and control procedures ensure the homogeneity of the final product batch and its components at the intermediate stage(s) of manufacture as well as the suitability of the process applied. Any sampling plan used for tfinal testing of in vitro diagnostic medical devices is based on statistical considerations.
BS EN 13975 guideline assists you with procedures, statistical verification, final testing based on process control, statistical process control (SPC), other types of process control, and final testing for acceptance testing of in vitro diagnostic medical devices.
With obedience and compliance to BS EN 13975, you can establish and verify the homogeneity of processes and products.
