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BSI - 23/30462494 DC

Draft BS EN 455-5 Medical gloves for single use Part 5: Extractable chemical residues

pending, Most Current
Organization: BSI
Publication Date: 17 April 2023
Status: pending
Page Count: 31
ICS Code (Hospital equipment): 11.140

Document History

23/30462494 DC
April 17, 2023
Draft BS EN 455-5 Medical gloves for single use Part 5: Extractable chemical residues
A description is not available for this item.

References

This document references:
EN ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Published by CEN on December 1, 2020
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the...
This document references:
EN ISO 10993-10 - Biological evaluation of medical devices - Part 10: Tests for skin sensitization
Published by CEN on February 1, 2023
This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to induce skin sensitization. This document includes: —...
This document references:
EN ISO 10993-12 - Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
Published by CEN on June 1, 2021
This document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological...
This document references:
EN ISO 20417 - Medical devices - Information to be supplied by the manufacturer
Published by CEN on May 1, 2021
NOTE 1 There is guidance or rationale for this Clause contained in Clause A.2. This document specifies the requirements for information supplied by the manufacturer for a medical device or by the...
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