What is BS EN 455-3 - Medical gloves for single-use about?
BS EN 455-3 is an international standard that focuses on testings and requirements for biological evaluation of medical gloves for single-use. BS EN 455-3 specifies requirements for the evaluation of biological safety for medical gloves for single use. BS EN 455-3 gives requirements for labelling and the disclosure of information relevant to the test methods used.
Note:
BS EN 455-3 does not specifically address adverse reactions that can result from the use of medical gloves (e.g, immediate-type allergies).
Who is BS EN 455-3 - Medical gloves for single-use?
BS EN 455-3 on testings and requirements for biological evaluation for medical gloves for single-use is useful for:
- Healthcare departments
- Medical gloves manufacturers
- Laboratory scientists and workers
- Local public health officials
Why should you use BS EN 455-3 - Medical gloves for single-use?
Adverse reactions to proteins in latex products have been reported over several years in variable rates of prevalence. Additionally, adverse reactions due to chemicals, lubricants, sterilization residues, pyrogens or other residues are described in the scientific literature.
BS EN 455-3 specifies requirements and test methods for the biological evaluation of medical devices. These adverse reactions occur to specific allergens that can be present in gloves.
Several factors contribute to the risk of reaction:
- The duration and frequency of skin contact with gloves
- The exposure to the allergens through direct contact to mucosa and skin (especially when not intact)
- The occlusive nature of the glove/skin interaction during glove use
BS EN 455-3 gives requirements and test methods for evaluation of the biological safety of medical gloves as part of a risk management process.
What’s changed since the last update?
BS EN 455-3:2015 supersedes BS EN 455-3:2006. BS EN 455-3:2015 includes some technical changes concerning BS EN 455-3:2006. These include:
- Normative references revised
- Subclause 4.2 "chemicals" was specified
- Subclause 4.4 specified as "powder-free gloves"
- Level "As Low As Reasonably Practicable" (ALARP) removed in the whole standard
