What is BS EN 455-4 - Shelf-life determination of medical gloves for single use about?
BS EN 455 is a European standard that discusses medical gloves for single use. BS EN 455-4 is the fourth part of the multi-part series that outlines the requirements for shelf life for medical gloves for single use to ensure their durability for a long period.
BS EN 455-4 also specifies the requirements for labelling and the disclosure of information relevant to the test methods used.
BS EN 455-4 applies to existing, new, and significantly changed designs. Existing designs that do not currently have ageing data available should generate that data within a reasonable period.
Note: BS EN 455-4 does not specify the size of a lot. Attention is drawn to the difficulties that can be associated with the distribution and control of very large lots. The recommended maximum individual lot size for production is 500 000.
Who is BS EN 455-4 - Shelf-life determination of medical gloves for single use for?
BS EN 455-4 on the shelf-life determination of medical gloves for single use is useful for:
- Manufacturers of medical gloves for a single use
- Medical laboratories
- Regulatory authorities
Why should you use BS EN 455-4 - Shelf-life determination of medical gloves for single use?
Medical Gloves are intended to be a barrier to agents responsible for the transmission of infections. To help ensure effectiveness, gloves must fit the hand properly, are free from holes and have adequate physical strength so as not to fail during use.
BS EN 455-4 assists you with requirements on shelf life and resistance to degradation, product changes, labelling, sterile barrier integrity, and storage conditions to improve the durability of medical gloves for single use.
BS EN 455-4 also provides test methods for real-time shelf-life determination and accelerated shelf-life determination for properly assessing the shelf-life of medical gloves for single-use.
With obedience and compliance to BS EN 455-4, you can improve the efficacy and prolong the shelf-life of medical gloves for single use.
