AS 60601.2.23-2018 PDF

Full title and description

AS 60601.2.23:2018 — Medical electrical equipment — Part 2.23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment. This Australian adoption/modification is based on IEC 60601-2-23:2011 (Edition 3.0), and specifies requirements for the safety and essential performance of transcutaneous monitors used across adult, pediatric and neonatal care including fetal monitoring during birth.

Abstract

This particular standard supplements the general IEC 60601 series by giving product‑specific requirements for transcutaneous partial pressure monitoring equipment (tcpO2/tcpCO2). It addresses applied‑part temperature control, electrical protection, accuracy and performance tests, alarm and fault behaviour, mechanical design of applied parts and leads, and relevant test setups and informative annexes. The Australian publication is a national adoption (with modifications) of the IEC third edition.

General information

• Status: Published / National adoption (AS publication).
• Publication date: 29 June 2018.
• Publisher: Standards Australia.
• ICS / categories: 11.040.55 — Diagnostic equipment (transcutaneous monitoring).
• Edition / version: 1st edition (AS adoption of IEC 60601-2-23:2011, ED.3.0, MOD).
• Number of pages: 41 pages (AS publication).

Scope

AS 60601.2.23:2018 applies to transcutaneous partial pressure monitoring equipment — devices and associated transducers that monitor the partial pressures of oxygen and/or carbon dioxide at the skin surface. It applies to equipment used with adults, children and neonates and includes use in fetal monitoring during birth. The standard does not apply to haemoglobin saturation oximeters or to sensors applied to non‑skin surfaces (for example conjunctiva or mucosa). It is a particular standard that supplements and, where stated, modifies the general IEC 60601‑1 requirements.

Key topics and requirements

• Basic safety and essential performance requirements specific to transcutaneous partial pressure monitors (tcpO2 / tcpCO2).
• Applied‑part temperature management: set temperature, temperature limiter, limits and labelling to reduce risk of burns.
• Accuracy and performance tests for oxygen and carbon dioxide partial‑pressure measurement (test gases, calibration and accuracy limits).
• Alarm and indicator requirements (physiological vs technical alarms, audible/visual behaviour, silencing and fault handling).
• Electrical protection, leakage current limits and applied‑part classification consistent with IEC 60601‑1 requirements (with particular modifications where specified).
• Mechanical, constructional and durability requirements for transducers, cables and applied parts (strain relief, materials, connectors).
• Electromagnetic compatibility (EMC) and immunity considerations for safe operation near other medical equipment.
• Normative and informative test configurations, annexes and normative references to supporting documents (e.g., related IEC/ISO/ASTM performance references).

Typical use and users

Primary users include medical device manufacturers (design and verification teams), test laboratories, clinical engineers, regulatory and quality professionals, and procurement/biomed teams in hospitals that specify or validate transcutaneous monitoring equipment. The standard is used to demonstrate compliance with product‑specific safety and performance requirements when placing these devices on the Australian market.

Related standards

Key related standards frequently referenced alongside AS 60601.2.23:2018 include: IEC 60601‑1 (general requirements for basic safety and essential performance); IEC 60601‑1‑2 (EMC); IEC 60601‑3‑1 / IEC 80601‑2‑23 (performance requirements and the ongoing revision activity for transcutaneous monitors); ASTM and other test method documents referenced for specific performance verification (for example ASTM F984); and applicable national variants (CAN/CSA, ANSI/AAMI adoptions).

Keywords

transcutaneous monitoring, tcpO2, tcpCO2, partial pressure, applied part, temperature limiter, medical electrical equipment, IEC 60601‑2‑23, AS 60601.2.23, diagnostic equipment, essential performance.

FAQ

Q: What is this standard?

A: AS 60601.2.23:2018 is the Australian adoption (with national modifications) of IEC 60601‑2‑23, providing particular safety and essential performance requirements for transcutaneous partial pressure monitoring equipment (tcpO2 / tcpCO2).

Q: What does it cover?

A: It covers device‑specific requirements including applied‑part temperature control, measurement accuracy and calibration, alarm behaviour, electrical protection, mechanical construction of applied parts and leads, EMC considerations and associated test procedures and annexes for transcutaneous partial pressure monitors. It excludes haemoglobin saturation oximeters and sensors applied to non‑skin surfaces.

Q: Who typically uses it?

A: Device manufacturers, test laboratories, clinical/biomedical engineers, regulatory and quality teams, and healthcare procurement staff use the standard to design, test, certify and select transcutaneous partial pressure monitoring equipment.

Q: Is it current or superseded?

A: AS 60601.2.23:2018 is the Australian adoption published 29 June 2018 and remains the national published edition. At the international level IEC 60601‑2‑23 (ED3, 2011) has been the base document; work to revise/adopt an IEC/ISO edition (prEN/IEC 80601‑2‑23 / IEC DIS 80601‑2‑23) was active in 2024–2025, so manufacturers and testers should monitor ongoing international revisions that may lead to future national updates.

Q: Is it part of a series?

A: Yes — it is a "particular" standard in the IEC 60601 family (series) of medical electrical equipment standards. It supplements the general standard IEC 60601‑1 and related collateral standards (for example IEC 60601‑1‑2 for EMC). The particular‑standard approach means where this document modifies or replaces clauses of the general standard, its requirements take precedence for transcutaneous monitors.

Q: What are the key keywords?

A: Transcutaneous, partial pressure, tcpO2, tcpCO2, applied part, temperature limiter, alarm, IEC 60601‑2‑23, AS 60601.2.23, diagnostic equipment.