ISO 21647-2004 PDF

Full title and description

ISO 21647:2004 — Medical electrical equipment — Particular requirements for the basic safety and essential performance of respiratory gas monitors. This International Standard defined safety and essential‑performance requirements for respiratory gas monitors (anaesthetic gas, carbon dioxide and oxygen monitoring) intended for continuous operation for use with humans; it supplemented IEC 60601‑1 and included environmental considerations in an annex.

Abstract

ISO 21647:2004 set out particular requirements for the basic safety and essential performance of respiratory gas monitors (RGMs). It specified requirements for anaesthetic gas monitoring, carbon dioxide (CO2) monitoring and oxygen (O2) monitoring, and stated that it did not apply to monitors intended for use with flammable anaesthetic agents. The standard was later corrected by a technical corrigendum (2005) and subsequently superseded by ISO 80601‑2‑55.

General information

• Status: Withdrawn / Superseded.
• Publication date: November 2004 (Edition 1).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.10 (Anaesthetic, respiratory and reanimation equipment).
• Edition / version: Edition 1 (2004); Technical Corrigendum ISO 21647:2004/Cor 1:2005 issued July 2005.
• Number of pages: 40 (original published document).

Scope

ISO 21647:2004 applied to respiratory gas monitors intended for continuous operation on humans. Its scope covered measurement and monitoring of anaesthetic gases, CO2 and O2, and provided particular requirements that supplemented and — where specified — took precedence over the general requirements of IEC 60601‑1 (and its relevant amendments). The standard explicitly excluded RGMs intended for use with flammable anaesthetic agents. Environmental aspects were addressed (see the standard’s annex).

Key topics and requirements

• Definitions and classification of respiratory gas monitors (RGM) and intended use.
• Performance and accuracy requirements for anaesthetic gas, CO2 and O2 measurement channels (including sampling, response time and calibration guidance).
• Alarm and indication requirements for out‑of‑range conditions and sensor failures.
• Specific electrical and mechanical safety requirements that supplement IEC 60601‑1.
• Requirements for information supplied by the manufacturer (labelling, instructions for use, maintenance and calibration procedures).
• Environmental and reliability considerations (annex material), and application of risk management principles per ISO 14971 (cross‑reference).

Typical use and users

Intended users and stakeholders included medical device manufacturers (design and compliance teams), clinical engineers and biomedical technicians, hospital procurement and risk managers, conformity assessment and testing laboratories, and regulatory authorities reviewing safety/performance documentation for anaesthesia and critical‑care monitoring equipment. Clinicians who rely on respiratory gas measurements would be indirect beneficiaries of the safety and performance requirements.

Related standards

Relevant and related standards include IEC 60601‑1 (general requirements for safety of medical electrical equipment), ISO 14971 (risk management for medical devices), and the series ISO/IEC standards that replace or succeed ISO 21647 — principally ISO 80601‑2‑55 (first published December 2011, revised edition published February 2018 and confirmed in review). National/adopted versions and regional variations (EN/ISO adoptions, national deviations) also exist.

Keywords

respiratory gas monitor; RGM; anaesthetic gas monitoring; carbon dioxide monitoring; oxygen monitoring; medical electrical equipment; IEC 60601‑1; safety and essential performance; ISO 21647; withdrawn; superseded.

FAQ

Q: What is this standard?

A: ISO 21647:2004 is an International Standard that specified particular requirements for the basic safety and essential performance of respiratory gas monitors (RGMs) used continuously on humans — covering anaesthetic gas, CO2 and O2 monitoring. It was published in November 2004.

Q: What does it cover?

A: It covered definitions, performance and accuracy requirements, alarm/indication behavior, safety requirements supplementing IEC 60601‑1, manufacturer information (labelling and instructions), and environmental considerations (annex material). It excluded RGMs intended for flammable anaesthetic agents.

Q: Who typically uses it?

A: Device manufacturers, design and compliance engineers, test laboratories, hospital biomedical engineering teams, procurement and regulatory reviewers. Clinicians rely on the outcomes (safe, accurate monitors) but typically do not use the standard text directly.

Q: Is it current or superseded?

A: ISO 21647:2004 has been withdrawn/superseded. It was corrected by a technical corrigendum in July 2005 and subsequently replaced by ISO 80601‑2‑55 (first published 15 December 2011); that part has itself been updated (ISO 80601‑2‑55:2018, with later amendment activity). For current compliance and certification requirements, refer to ISO 80601‑2‑55 (2018 edition and its amendments).

Q: Is it part of a series?

A: Yes — ISO 21647 was a particular‑requirements standard in the family of medical electrical equipment standards that work with IEC/ISO 60601 series documents. Its subject area was subsequently integrated into the ISO 80601‑2‑55 part (the “80601” series groups Part 2.x particular requirements for types of medical electrical equipment).

Q: What are the key keywords?

A: Respiratory gas monitor (RGM), anaesthetic gas, CO2 monitoring, oxygen monitoring, essential performance, IEC 60601‑1, medical electrical equipment, safety, withdrawn/superseded.