What is BS EN 455-1 about?
BS EN 455 informs us about medical gloves for single use. BS EN 455-1 is the first part of multiple series that discusses requirements and gives test methods for medical gloves for single use to determine freedom from holes.
In accordance with Clause 5, Medical gloves for single use shall not leak when tested.
Note: Medical gloves labelled as single use are medical devices for single use according to the Medical Device Regulation (MDR). A single use medical device means a device that is intended to be used on one individual during a single procedure.
Who is BS EN 4551 for?
BS EN 455-1 on medical gloves for single use is useful for:
- Manufacturers of medical gloves
- Hospitals and medical facilities
- Test centres for medical gloves
- Quality control personnel
- Regulatory bodies
Why should you use BS EN 455-1?
Medical gloves for single use are gloves intended for use in the medical field to protect patients and users from cross-contamination. These medical gloves for single use are intended to be used on one individual during a single procedure.
BS EN 455-1 guideline help you with general requirements and test methods such as water tightness test for detection of holes- referee testing and routine testing, sampling, and inspection that assures the acceptance quality level for medical gloves for single use.
What’s changed since the last update?
BS EN 455-1:2020 supersedes EN 455-1:2000, which has been withdrawn. BS EN 455-1:2020 has some technical changes with respect to EN 4551:2000. These include:
- The term 3.1 “medical gloves for single-use” has been amended by a Note to entry
- The term 3.2 “hole” has been added
- In 5.1 the referee testing has been enhanced to cover the issue on the extension of the glove when it is filled with water
- In Clause 6 the first paragraph has been slightly changed to accommodate the EU commission rules for referencing ISO standards which are not available as EN standards
- Due to that there is currently no standardization request by the EU commission for this part of EN 455 the harmonization process to provide a presumption of conformity to the Medical Device Regulation (MDR) cannot be applied. However, to provide at least guidance on the relationship between this European Standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745 [OJ L 117] aimed to be covered, Annex A has been added