This part of EN 455 specifies requirements for shelf life for medical gloves for single use. It also specifies the requirements for labelling and the disclosure of information relevant to the test methods used.This European Standard 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 of time.This European Standard 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 500000.
EN 455-4:2009 Referenced Document
EN 1041 Information supplied by the manufacturer of medical devices*， 2013-09-01 Update
EN 455 Medical gloves for single use - Part 4: Requirements and testing for shelf life determination
EN ISO 11607 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1 (ISO 11607-2:2019/DAM 1:2022)
EN 455-4:2009 history
2009EN 455-4:2009 Medical gloves for single use - Part 4: Requirements and testing for shelf life determination