The Directive 93/42/EEC on medical devices (MDD 93/42), is a document that sets out the general criteria to be used in the design and construction of certain categories of medical devices.
Standard EN 455 – part 1
The legislation specifies the requirements and provides methods for the testing of medical disposable gloves to determine the absence of holes
- Sampling, control level and AQL:
Reflexx brand examination gloves meet the ISO 2859-1 general inspection level 1 and the level of compliance to the absence of holes, which must be an AQL (Acceptable Quality Level) equal to or less than the world standard for surgical gloves, i.e. 1, 5.
Standard EN 455 – part 2
The EN 455 specifies the requirements and test methods for the physical properties of medical disposable gloves, to ensure an adequate level of protection from mutual contamination of the patient and the user.
- Dimensions:The disposable glove must have a minimum dimension of 240 mm.
- Resistance:Resistance tests are determined “before and after” the aging of the glove, as described in Sections 5.2 and 5.3, in order to ensure the resistance of the glove under various conditions of use.
Standard EN 455 – Part 3
The regulation specifies the requirements relating to the evaluation of biological safety for the medical disposable gloves and clarifies the indications on the labeling and packaging of gloves, and disclosure of information relating to the test methods used.
Standard EN 455 – Part 4
The regulation EN 455-4 indicates the requirements and test methods for establishing the validity period of the product ( “shelf life determination”) and indicate the deadline.