What is BS EN 556-2 – Aseptically processed medical devices about?
BS EN 556-2 is an international standard that focuses on requirements for aseptically processed medical devices. BS EN 556-2 specifies the requirements for an aseptically processed medical device to be designated 'STERILE'.
Who is BS EN 556-2 - Aseptically processed medical devices for?
BS EN 556-2 on requirements for aseptically processed medical devices is useful for:
- Doctors
- Testing laboratories/test personnel of medical devices
- Healthcare facilities
- Medical laboratories
Why should you use BS EN 556-2 - Aseptically processed medical devices?
Medical devices designated 'STERILE' are prepared using appropriate and validated methods. Whenever possible, sterile medical devices are terminally sterilized using a properly validated and controlled sterilization process. When a medical device is intended to be sterile but cannot be terminally sterilized, aseptic processing is the method of manufacture. BS EN 556-2 covers instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used.
BS EN 556-2 assist you:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease
- Diagnosis, monitoring, treatment, alleviation of or compensation for an injury
- Investigation, replacement, modification or support of the anatomy or a physiological process
- Supporting or sustaining life
- Control of conception
- Providing information for medical purposes using in vitro examination of specimens derived from the human body
What’s changed since the last update?
BS EN 556-2:2015 supersedes BS EN 556-2:2003. BS EN 556-2:2015 includes some technical changes concerning BS EN 556-2:2003. These include:
- Normative references have been updated
- Terms and definitions have been aligned with ISO/TS 11139 and EN ISO 13408-1
- Requirements on validation and routine control have been revised
- Table 1 and Table 2 on acceptance limits and actions for the occurrence of non-sterile units in process simulations in initial performance qualification and periodic requalification, respectively, have been added
- Editorial revision according to the CEN Internal Regulations
