SIST EN ISO 11073-10101:2021/A1:2026

• Status: Published
• Public Enquiry End Date: 09-May-2026
• Publication Date: 13-Sep-2026
• ICS: 01.040.35 - Information technology (Vocabularies)
• ICS: 35.240.80 - IT applications in health care technology
• Technical Committee: ITC - Information technology
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 13-Aug-2026
• Due Date: 18-Oct-2026
• Completion Date: 14-Sep-2026
• Ref Project: EN ISO/IEEE 11073-10101:2020/A1:2026 - Health informatics - Device interoperability - Part 10101: Point-of-care medical device communication - Nomenclature - Amendment 1: Additional definitions (ISO/IEEE 11073-10101:2020/Amd 1:2026)

• Amends: SIST EN ISO 11073-10101:2021 - Health informatics - Device interoperability - Part 10101:Point-of-care medical device communication - Nomenclature (ISO/IEEE 11073-10101:2020)
• Effective Date: 01-Oct-2026

Overview

SIST EN ISO 11073-10101:2021/A1:2026 addresses device interoperability in health informatics, focusing on point-of-care (POC) medical device communication. This amendment, aligned with ISO/IEEE 11073-10101:2020/Amd 1:2026, introduces additional definitions and updates to the nomenclature used in acute care medical device communication. Developed by the Slovenian Institute for Standardization (SIST), this document represents a significant step forward in the consistent exchange of clinical and operational data between medical devices and external systems in healthcare environments.

The amendment strengthens the semantic framework for interoperability by enhancing definitions and expanding terminologies relevant to critical devices such as infusion pumps, ventilators, dialysis machines, and event and alert systems. This harmonized nomenclature underpins robust integration and real-time data capture that can be leveraged across multiple healthcare IT systems.

Key Topics

• Expanded Medical Device Nomenclature:

  • Additional terms covering acute care devices, including those for infusion therapy, ventilation modes, dialysis, and patient monitoring.
  • Enhanced event and alert identifiers for better clinical workflow integration and safety.

• Object-Oriented Information Model Support:

  • The nomenclature is designed with object-oriented modeling principles, supporting scalable and modular device communication.

• Alarm and Alert Management:

  • New definitions for alarm inactivation and added attributes to improve alert communication, ensuring timely and accurate response to patient needs.

• Units of Measure and Enumerations:

  • Extension of standard units, observation codes, and enumeration sets, supporting accurate data representation and exchange.

• Collaboration and Alignment with International Standards:

  • Integrates ongoing work from organizations such as IHE (Integrating the Healthcare Enterprise), ISO/TC 121, and aligns ventilation nomenclature with ISO 19223.

Applications

Implementing SIST EN ISO 11073-10101:2021/A1:2026 delivers substantial benefits in acute, chronic, and non-acute care settings:

• Medical Device Integration:

  • Enables plug-and-play interoperability for infusion pumps, ventilators, dialysis machines, and monitoring equipment at the point-of-care.
  • Facilitates automated data capture of patient vitals and device metrics, streamlining clinical documentation and reducing manual entry errors.

• Clinical Decision Support:

  • Supports advanced alarm and alert mechanisms, providing real-time, actionable information for clinical teams.

• Vendor-Neutral Data Exchange:

  • Standardized codes and terminology reduce system integration complexity, making multi-vendor device environments manageable and future-proof.

• Regulatory and Quality Compliance:

  • Lays a foundation for meeting interoperability requirements in national healthcare regulations and international directives.

• Support for Service-Oriented Device Connectivity:

  • Enables integration with IT infrastructures using modern, service-oriented approaches for healthcare device data.

Related Standards

Organizations adopting this amendment should be aware of the following closely related standards to ensure comprehensive and interoperable medical device communication architectures:

• ISO/IEEE 11073-10101:2020 – Health informatics – Device interoperability – Nomenclature (the foundational document).
• ISO 19223 – Lung ventilators and related equipment – Vocabulary, for ventilation mode definitions.
• IHE Patient Care Devices Technical Framework – For harmonized profiling in hospital environments.
• SIST EN ISO 11073 series – For broader point-of-care device interoperability requirements.

Practical Value

Adoption of SIST EN ISO 11073-10101:2021/A1:2026 enables healthcare organizations and device manufacturers to:

• Achieve seamless integration of diverse medical devices into health IT platforms.
• Improve patient safety and care quality through standardized alarm and alert handling.
• Foster innovation and compliance with rapidly evolving health informatics requirements.

By ensuring consistent communication and interoperability, this amendment plays a critical role in advancing digital health transformation and supporting evidence-based clinical workflows in modern healthcare settings.

SLOVENSKI STANDARD
01-oktober-2026
Zdravstvena informatika - Interoperabilnost naprav - 10101. del: Komunikacija
medicinskih naprav na mestu oskrbe - Nomenklatura - Dopolnilo A1: Dodatne
opredelitve (ISO/IEEE 11073-10101:2020/Amd 1:2026)
Health informatics - Device interoperability - Part 10101: Point-of-care medical device
communication - Nomenclature - Amendment 1: Additional definitions (ISO/IEEE 11073-
10101:2020/Amd 1:2026)
Medizinische Informatik - Geräteinteroperabilität - Teil 10101: Kommunikation
patientennaher medizinischer Geräte - Nomenklatur - Änderung 1 (ISO/IEEE 11073-
10101:2020/Amd 1:2026)
Informatique de santé - Interopérabilité des dispositifs - Partie 10101: Communication
entre dispositifs médicaux sur le site des soins - Nomenclature - Amendement 1:
Définitions supplémentaires (ISO/IEEE 11073-10101:2020/Amd 1:2026)
Ta slovenski standard je istoveten z: EN ISO/IEEE 11073-10101:2020/A1:2026
ICS:
01.040.35 Informacijska tehnologija. Information technology
(Slovarji) (Vocabularies)
35.240.80 Uporabniške rešitve IT v IT applications in health care
zdravstveni tehniki technology
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO/IEEE 11073-
EUROPEAN STANDARD
10101:2020/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2026
ICS 35.240.80; 01.040.35
English Version
Health informatics - Device interoperability - Part 10101:
Point-of-care medical device communication -
Nomenclature - Amendment 1: Additional definitions
(ISO/IEEE 11073-10101:2020/Amd 1:2026)
Informatique de santé - Interopérabilité des dispositifs Medizinische Informatik - Geräteinteroperabilität - Teil
- Partie 10101: Communication entre dispositifs 10101: Kommunikation patientennaher medizinischer
médicaux sur le site des soins - Nomenclature - Geräte - Nomenklatur - Änderung 1 (ISO/IEEE 11073-
Amendement 1: Définitions supplémentaires 10101:2020/Amd 1:2026)
(ISO/IEEE 11073-10101:2020/Amd 1:2026)
This amendment A1 modifies the European Standard EN ISO 11073-10101:2020; it was approved by CEN on 4 August 2026.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of
this amendment into the relevant national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO/IEEE 11073-
worldwide for CEN national Members. 10101:2020/A1:2026 E

Contents Page
European foreword . 3

European foreword
This document (EN ISO/IEEE 11073-10101:2020/A1:2026) has been prepared by Technical Committee
ISO/TC 215 "Health informatics" in collaboration with Technical Committee CEN/TC 251 “Health
informatics” the secretariat of which is held by NEN.
This Amendment to the European Standard EN ISO 11073-10101:2020 shall be given the status of a
national standard, either by publication of an identical text or by endorsement, at the latest by February
2027, and conflicting national standards shall be withdrawn at the latest by February 2027.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO/IEEE 11073-10101:2020/Amd 1:2026 has been approved by CEN as EN ISO/IEEE
11073-10101:2020/A1:2026 without any modification.

International
Standard
ISO/IEEE
11073-10101
Second edition
Health informatics — Device
2020-08
interoperability —
AMENDMENT 1
Part 10101:
2026-07
Point-of-care medical device
communication — Nomenclature
AMENDMENT 1: Additional definitions
Informatique de santé — Interopérabilité des dispositifs —
Partie 10101: Communication entre dispositifs médicaux sur le
site des soins — Nomenclature
AMENDEMENT 1: Définitions supplémentaires
Reference number
ISO/IEEE 11073-10101:2020/Amd 1:2026(en)
© IEEE 2024
ISO/IEEE 11073-10101:2020/Amd 1:2026(en)
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All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
© IEEE 2024 – All rights reserved
ii
ISO/IEEE 11073-10101:2020/Amd 1:2026(en)
Foreword
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© IEEE 2024 – All rights reserved
iii
IEEE Std 11073-10101b™-2023
(Amendment to IEEE Std 11073-10101-2019)
Health informatics—Device Interoperability
Part 10101: Foundational—Nomenclature
Amendment 1: Additional definitions
Developed by the
IEEE 11073™ Standards Committee
of the
IEEE Engineering in Medicine and Biology Society
Approved 8 November 2023
IEEE SA Standards Board
ISO/IEEE 11073-10101:2020/Amd 1:2026(en)
Abstract: The scope of this standard is to define a nomenclature for communication of information from point-of-
care medical devices. Primary emphasis is placed on acute care medical devices and patient vital signs
information. The nomenclature also supports concepts in an object oriented information model that is for medical
device communications. This amendment extends IEEE Std 11073-10101-2019 to include additional terms
primarily related to infusion pumps, ventilators, dialysis and other key medical devices as well as event and alert
identifiers for devices and systems used in acute care.
Keywords: alarm, alarm inactivation, alarms, alert communication, anesthesia, device containment model, device
model, dialysis, diaphragm, ECG, EDI, electrocardiography, events, fluid chemistry, hemodialysis, hemodynamic
monitoring, HFV, high flow therapy, high frequency ventilation, IEEE 11073-10101b™, IHE PCD, information
model, infusion pump, ISO 19223, ISO/IEEE 11073-10101, medical device alarms, medical device alerts, medical
device communication, medical device types, NAVA, network communication controller, neurally adjusted
ventilatory assist, neuromuscular blockade, neuromuscular stimulation, neuromuscular transmission, NMT,
nomenclature, observation set identifier, ontology, patient, patient controlled analgesia, PCA, POC, point-of-care,
pulse oximetry, pump library, query identifier, regional cerebral oximetry, rSO2, semantics, service-oriented device
connectivity, signal quality index, SQI, target controlled infusion, TCI, terminology, UCUM, units of measure,
ventilation, ventilation mode
•
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ISO/IEEE 11073-10101:2020/Amd 1:2026(en)

Participants
At the time this standard was completed, the Point-of-Care Devices Working Group had the following membership:
Stefan Schlichting, Working Group Chair
Paul Schluter, Working Subgroup Chair
Björn Andersen Martin Hurrell Roland Persson
Piyush Bhageriya Anders Häggström Mikael Petrini
Manfred Bier Per Johansson Jan-Alrik Philipsen
Kimberly Brauer Norman Jones Dalibor Pokrajac
Malcolm Clarke Martin Kasparick John Rhoads
Todd Cooper Tobias Klotz Jeff Rinda
Steven Dain Tom Kowalczyk Mathieu Roullet
Lisa Diggett Mike Krajnak Daniel Rubery
Kurt Elliason Thomas Kreuger Neil Seidl
Al Engelbert Konstantinos Makrodimitris Naveen Sharma
Javier Espina Duane Martz Michael Tietz
Michael Faughn Eldon Metz Peter Verständig
Kenneth Fuchs Steve Myers John Walsh
John Garguilo Teri Neal Rob Wilder
David Gregorczyk Steven Nichols Brian Witkowski
Bill Haralson Monroe Pattillo Daidi Zhong

The following members of the individual Standards Association balloting group voted on this standard. Balloters may have
voted for approval, disapproval, or abstention.
Björn Andersen David Gregorczyk Stefan Schlichting
Pradeep Balachandran Charles Gropper Paul Schluter
Malcolm Clarke Werner Hoelzl Harry Solomon
Kurt Elliason Piotr Karocki Walter Struppler
Javier Espina Martin Kasparick Lisa Ward
Michael Faughn Raymond Krasinski Yu Yuan
Kenneth Fuchs H. Moll Oren Yuen
John Garguilo Rajesh Murthy Janusz Zalewski
Frank Golatowski John Rhoads Daidi Zhong
Scott Robertson
When the IEEE SA Standards Board approved this standard on 8 November 2023, it had the following membership:
David J. Law, Chair
Ted Burse, Vice Chair
Gary Hoffman, Past Chair
Konstantinos Karachalios, Secretary
Sara R. Biyabani Joseph S. Levy Paul Nikolich
Doug Edwards Howard Li Annette D. Reilly
Ramy Ahmed Fathy Johnny Daozhuang Lin Robby Robson
Guido R. Hiertz Gui Lin Lei Wang
Yousef Kimiagar Xiaohui Liu F. Keith Waters
Joseph L. Koepfinger* Kevin W. Lu Karl Weber
Thomas Koshy Daleep C. Mohla Philip B. Winston
John D. Kulick Andrew Myles Don Wright

*Member Emeritus
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ISO/IEEE 11073-10101:2020/Amd 1:2026(en)

Introduction
This introduction is not part of IEEE Std 11073-10101b-2023, Health informatics—Device interoperability—
Part 10101: Foundational—Nomenclature—Amendment 1: Additional definitions.
ISO/IEEE 11073 standards enable communication between medical devices and external computer systems. They provide
automatic and detailed electronic data capture of patient vital signs information and device operational data. The primary goals are
to:
 Provide real-time plug-and-play interoperability for patient-connected medical devices
 Facilitate the efficient exchange of vital signs and medical device data, acquired at the point-of-care, in all health care
environments
This amendment extends the nomenclature defined in IEEE Std 11073-10101-2019. It reflects the continued innovation in
medical device and is based on a highly successful collaboration with the following organizations:
 Integrating the Healthcare Enterprise Devices (IHE DEV) domain, which includes the Patient Care Devices (PCD),
Personal Connected Health (PCH) and Device Point-of-Care Interoperability (DPi) Programs
 ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee 4, Terminology and semantics
In addition, other vendors and standards development and profiling organizations have contributed to and have recognized the
value of this work and the benefit it provides to the user and provider communities and to the patients that we ultimately serve.
This nomenclature amendment includes significant extensions to support:
 Haemodynamic monitoring, pulse oximetry and regional cerebral oxygen monitoring
 Respiratory, ventilation and anesthesia: high-frequency ventilation, high-flow therapy, neurally adjusted ventilatory
assist (NAVA) and ventilation mode based on ISO 19223
 Infusion pumps, target-controlled infusion (TCI), patient-controlled analgesia (PCA) and other capabilities based on
the work of the IHE DEV PCD domain program
 Hemodialysis for chronic and acute care, including fluid chemistry and other fluid related metrics
 Neuromuscular transmission monitoring (NMT) and stimulation modes
 Signal quality index (SQI) and mapping to a unified vendor- and device-independent representation
 Major extension of medical device event and alert nomenclature and grouping with existing terms
 Alarm inactivation and additional attributes related to alert management and communication
 New units of measurement
 New medical device types and monitoring parameters

This amendment also includes:
 Units of measure associated with individual numeric observations and attributes
 Enumerated values with descriptions associated with individual observations and attributes

NOTES as used in this amendment (preceding editorial instructions) are not meant to be included in the rollup or part of the
editorial instructions. They are used solely to provide informative guidance and background to the reader as to why certain
changes were made.
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Acknowledgments
Permissions have been granted as follows:
Hemodialysis Overview reprinted with permission from the Dialysis Interoperability Consortium © 2022.

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Contents
1. Overview . 1
1.1 Scope . 1
1.2 Word usage . 1

2. Normative references . 2

3. Terms, definitions, acronyms, and abbreviations . 2
3.1 Terms and definitions . 2
3.2 Symbols and abbreviated terms . 2

Annex A (normative) Nomenclature semantics . 4
A.1 Overview of nomenclature for vital signs—Semantics . 4
A.3 Data dictionary and codes for object-oriented modeling elements (Partition 1) . 5
A.3.2 Object-oriented modeling elements: inventory tables . 5
A.5 Nomenclature, data dictionary, and codes for vital signs, diagnostic and therapeutic devices (Partition 1) . 16
A.6 Terminology and codes for units of measurement (Partition 4) . 23
A.6.4 Units of measurement . 23
A.7 Nomenclature, data dictionary, and codes for metrics (measurements and enumerations)
(Partition 2) . 25
A.7.1 Nomenclature for ECG measurements . 25
A.7.3 Nomenclature, data dictionary, and codes for haemodynamic monitoring measurements . 26
A.7.4 Nomenclature and codes for respiratory, ventilator, and anesthesia measurements . 28
A.7.5 Nomenclature, data dictionary, and codes for common blood-gas, blood, urine, and
other fluid chemistry measurements . 38
A.7.7 Nomenclature, data dictionary, and codes for pumps . 40
A.7.10 Nomenclature, data dictionary, and codes for stimulation modes . 53
A.7.11 Nomenclature, data dictionary, and codes for miscellaneous measurements . 58
A.7.15 Nomenclature and codes for hemodialysis measurements . 63
A.8 Nomenclature, data dictionary, and codes for body sites and enumerated values (Partition 7) . 87
A.8.11 Nomenclature and codes for ventilator mode based on ISO 19223 . 87
A.9 Nomenclature, data dictionary, and codes for events and alerts (Partition 3) . 99
A.9.1 Introduction . 99
A.9.2 Diagnostic pattern events . 100
A.9.3 Device-related and environment-related events and alerts . 109
A.9.4 Alarm Inactivation State (AIS) events . 179
A.16 Information attributes to support IHE PCD DEC and PCHA/Continua Services Interface
(Partition 1 and Partition 8) . 185
A.17 Nomenclature to support the Service-oriented Device Connectivity (SDC) series of standards (Partition 8) . 187
A.17.1 IEEE P11073-10700 Ensemble nomenclature . 187
A.17.2 IEEE P11073-10700 Context validator nomenclature . 187
A.17.3 IEEE P11073-10700 Enumerated value set for medical device operational mode . 188

Annex C (normative) Terms, discriminators, and numeric codes . 189
C.3.18 Alarm Inactivation State [AIS] discriminator set . 189

Annex I (informative) Mapping vendor ventilation modes to ISO 19223 and IEEE 11073 . 235
I.1 Recommended process . 235
I.2 XSLT for converting ISO 19223 ventilator mode to IEEE 11073 Reference IDs . 252

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Annex J (normative) Units of measure and _UOM_GROUPS . 257
J.1 Specifying individual UOM_MDC and UOM_UCUM units of measure in Annex A . 257
J.2 Specifying _UOM_GROUPS . 258
J.3 Mapping UOM_MDC to UOM_UCUM units of measure . 259
J.4 List of UOM_MDC to UOM_UCUM units of measure . 259

Annex K (normative) MDC_ENUMGV enumeration groups and values. 284
K.3 Enum_Groups . 284
K.4 Enum_Values . 284
K.5 Creating Reference ID(s) from Enum_Group and Enum_Value . 285
K.6 Referencing enumerated value sets and/or PEGjs validation expressions . 285
K.7 Referencing enumerated value sets and/or PEGjs validation expressions . 286

Annex L (informative) Bibliography . 287

Annex M (informative) Revision history . 288

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Tables
Table A.3.2.2.2—Object-oriented modeling elements—Medical Package—attributes . 5
Table A.3.2.2.2.1—Enumerated values for [_MDC_ATTR_PT_BODY_POSN] (multipage table) . 5
Table A.3.2.2.2.1—Enumerated values for [_MDC_ATTR_PT_BODY_POSN] (multipage table) . 6
Table A.3.2.4.1—Object-oriented modeling elements—System Package—object class items . 7
Table A.3.2.4.2—Object-oriented modeling elements—System Package—attributes . 8
Table A.3.2.4.2.1—Enumerated values for [_MDC_ATTR_BATT_CONFIG] . 8
Table A.3.2.4.2.2—Enumerated values for [_MDC_ATTR_PILLAR_ASSEMBLY] . 9
Table A.3.2.4.2.3—PEGjs for [_MDC_ATTR_PILLAR_ASSEMBLY] . 9
Table A.3.2.4.2.4—PEGjs for [_MDC_ATTR_PUMP_PILLAR_DETAILS] . 9
Table A.3.2.4.6—Object-oriented modeling elements—System Package—additional object class items . 10
Table A.3.2.13.1—Object-oriented modeling elements—MEM-DMC NCC-Wired—attributes . 11
Table A.3.2.13.1.1—Enumerated values for [_BOOL] . 11
Table A.3.2.13.1.2—Enumerated values for [_MDC_NCC_WIRED_STATE] . 12
Table A.3.2.13.2—Object-oriented modeling elements—MEM-DMC NCC-Wireless—attributes (multipage table). 12
Table A.3.2.13.2.1—Enumerated values for [_MDC_NCC_WIRELESS_STATE] . 13
Table A.3.2.13.2.2—Enumerated values for [_MDC_NCC_WIRELESS_AUTH] . 13
Table A.3.2.13.2.3—Enumerated values for [_MDC_NCC_WIRELESS_ENCRYPT] . 14
Table A.3.2.13.2.4—Enumerated values for [_MDC_NCC_WIRELESS_BAND] . 14
Table A.3.2.14.2—Object-oriented modeling elements—USI—attributes . 15
Table A.3.2.15.1—Object-oriented modeling elements—QPD—message query name identifiers . 15
Table A.5.1—Nomenclature and codes for vital signs, diagnostic and therapeutic devices (multipage table) . 16
Table A.5.1—Nomenclature and codes for vital signs, diagnostic and therapeutic devices (multipage table) . 17
Table A.5.1—Nomenclature and codes for vital signs, diagnostic and therapeutic devices (multipage table) . 18
Table A.5.1—Nomenclature and codes for vital signs, diagnostic and therapeutic devices (multipage table) . 19
Table A.5.1—Nomenclature and codes for vital signs, diagnostic and therapeutic
...