EN ISO 10993-10:2023
Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)

Standard No.
EN ISO 10993-10:2023
Release Date
2023
Published By
European Committee for Standardization (CEN)
Status
 2023-08
Latest
EN ISO 10993-10:2023
 
Scope
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: — details of in vivo skin sensitization test procedures; — key factors for the interpretation of the results. NOTE Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.

EN ISO 10993-10:2023 history

  • 2023 EN ISO 10993-10:2023 Biological evaluation of medical devices - Part 10: Tests for skin sensitization (ISO 10993-10:2021)
  • 2013 EN ISO 10993-10:2013 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
  • 2010 EN ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
  • 2009 EN ISO 10993-10:2009 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
  • 2002 EN ISO 10993-10:2002 Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity
  • 1995 EN ISO 10993-10:1995 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Sensitization (ISO 10993-10 : 1995)

Topics on standards and specifications

Delayed type hypersensitivity reaction iso 10993-10 Stimulus and delayed hypersensitivity tests Type IV Hypersensitivity

Standard and Specification

EN 62304:2006 Medical device software - Software life-cycle processes (Incorporating corrigendum November 2008) EN ISO 10993-11:2018 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process ISO 9000:2015 Quality management systems - Fundamentals and vocabulary ISO 780:2015 Packaging - Distribution packaging - Graphical symbols for handling and storage of packages ISO 8600-3:2019 Endoscopes — Medical endoscopes and endotherapy devices — Part 3: Determination of field of view and direction of view of endoscopes with optics ISO 11137-2:2013/Amd 1:2022 Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose — Amendment 1 EN ISO 10993-7:2008/A1:2022 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019) ISO 8600-1:2025 Endoscopes — Medical endoscopes and endotherapy devices — Part 1: General requirements ISO 10993-7:2008/Amd 1:2019 Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals — Amendment 1: Applicability of allowable limits for neonates and infants ISO 8600-4:2023 Endoscopes — Medical endoscopes and endotherapy devices — Part 4: Determination of maximum width of insertion portion EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009) ISO 11737-1:2018/Amd 1:2021 Sterilization of health care products — Microbiological methods — Part 1: Determination of a population of microorganisms on products — Amendment 1 EN ISO 15223-1:2021 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021) ISO 11135:2014/Amd 1:2018 Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices — Amendment 1: Revision of Anne EN ISO 13485:2016/A11:2021 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) ISO 7376:2020 Anaesthetic and respiratory equipment — Laryngoscopes for tracheal intubation ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods ISO 9001:2015/Amd 1:2024 Quality management systems — Requirements AMENDMENT 1: Climate action changes


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