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ISO 4135, Fourth Edition: Two Decades of Progress in ISO/TC 121.

Debra R Milamed1

  • 1Debra R. Milamed, MS, is the committee manager for ISO/TC 121/SC 4 and associate in anaesthesia at Harvard Medical School in Boston, MA.

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Summary

The new ISO 4135 standard for anesthetic and respiratory equipment vocabulary expands the scope of ISO Technical Committee 121. This, along with ISO 19223, ensures consistent terminology in medical device standards.

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Area of Science:

  • Medical Device Standardization
  • Biomedical Engineering Terminology

Background:

  • The International Organization for Standardization (ISO) Technical Committee (TC) 121 has been active for two decades.
  • Standardization of terminology is crucial for clarity and safety in medical equipment.

Purpose of the Study:

  • To announce the publication of ISO 4135, fourth edition.
  • To highlight the expanded scope of ISO/TC 121.
  • To promote consistent and specific terminology across related standards.

Main Methods:

  • Publication of a new international standard (ISO 4135:2023).
  • Development of vocabulary and semantics for medical equipment.

Main Results:

  • ISO 4135, Anaesthetic and respiratory equipment-Vocabulary, fourth edition, is now published.
  • The scope of ISO/TC 121 has been expanded.
  • ISO 4135 complements ISO 19223:2019 for enhanced terminological consistency.

Conclusions:

  • The updated ISO 4135 standard supports the broader work of ISO/TC 121.
  • Consistent terminology across standards like ISO 4135 and ISO 19223 improves the development and use of respiratory and anesthetic equipment.