EN
ZHEN 455 Parts 1 to 4: 2000 to 2009
Medical gloves for single use
This includes tests to assess the freedom from holes which is based on a penetration resistance test similar to that of EN 374 Part 2, plus tests to assess the dimensions of the gloves and the mechanical strength of its materials, both before and after an ageing process.
EN 455 was originally written to support the Medical Devices Directive, but since the various amendments enabling CE marking of products as both Medical devices and PPE, the annex ZAs of more recent versions of EN 455 also make reference to the PPE Directive.
Part 1
EN 455-1 covers requirements and testing of gloves for freedom from holes. For this the standard uses a water leak test that is carried out using AQL statistical sampling techniques based on production batch sizes.
Part 2
EN 455-2 covers requirements and tests for physical properties such as dimensions (length & width) and force at break both before and after heat ageing.
Part 3
EN 455-3 covers requirements and tests for biological evaluation.
This part of the standard includes test procedures for measuring endotoxin contamination of sterile gloves, powder residue for powder free gloves and leachable proteins in natural rubber latex gloves.
Part 4
Covers requirements and testing for shelf life determination.
This part of the standard covers protocol to be followed to evaluate the gloves shelf life by using real time studies or a suitably validated alternative.