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ISO 4135, Fourth Edition: Two Decades of Progress in ISO/TC 121
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.
The International Organization for Standardization (ISO) published ISO 4135, a new vocabulary standard for anesthetic and respiratory equipment. This standard promotes consistent terminology across all ISO/TC 121 documents.
Area of Science:
- Medical Device Standards
- Respiratory Care Terminology
Background:
- The International Organization for Standardization (ISO) Technical Committee (TC) 121 has been active for two decades.
- Standardization in medical equipment is crucial for safety and efficacy.
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 in respiratory and anesthetic equipment standards.
Main Methods:
- Publication of a new vocabulary standard (ISO 4135).
- Development of related standards, such as ISO 19223:2019.
- Collaboration within ISO/TC 121 and its subcommittees.
Main Results:
- ISO 4135:2023, Anaesthetic and respiratory equipment-Vocabulary, fourth edition, is now available.
- The scope of ISO/TC 121 has expanded significantly over 20 years.
- ISO 4135 complements ISO 19223:2019 for enhanced terminological consistency.
Conclusions:
- The new ISO 4135 standard enhances the terminological framework for anesthetic and respiratory devices.
- Consistent terminology across ISO/TC 121 standards improves clarity and reduces ambiguity.
- This publication reflects the ongoing work and expansion of ISO/TC 121.
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