IEC 80601-2-30-2018 PDF

Full title and description

IEC 80601-2-30:2018 — Medical electrical equipment — Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers. This particular IEC collateral standard specifies safety, performance and accuracy requirements for electrically powered automatic blood-pressure monitors (cuff-based sphygmomanometers), including devices intended for professional and home or public self-use.

Abstract

This standard applies to automated non‑continuous, cuff‑based sphygmomanometers used for indirect estimation of blood pressure without arterial puncture. It specifies requirements for basic safety and essential performance of the ME (medical electrical) equipment and accessories, including accuracy of measurement, and includes additional requirements for public self‑use devices. The 2018 edition cancels and replaces the 2009 edition and its 2013 amendment and aligns requirements with relevant IEC 60601 series documents and ISO connector standards.

General information

• Status: Published
• Publication date: 22 March 2018
• Publisher: International Electrotechnical Commission (IEC), TC 62/SC 62D
• ICS / categories: 11.040.01 (Medical equipment)
• Edition / version: Edition 2.0 (2018)
• Number of pages: 117

Scope

The standard covers automatic electrically powered, intermittent, cuff‑based devices for non‑continuous indirect estimation of arterial blood pressure (sphygmomanometers) and their accessories, for use in professional, home‑care and public self‑use environments. It does not replace standards for manual (non‑automated) sphygmomanometers, for which ISO 81060‑1 is referenced; it also excludes hazards inherent in the device’s intended physiological function except where specifically addressed. The document sets requirements both for individual ME equipment and for ME systems where stated.

Key topics and requirements

• Basic safety and essential performance requirements specific to automated non‑invasive sphygmomanometers.
• Accuracy requirements and performance testing for blood‑pressure determination.
• Requirements for accessories and for devices intended for public self‑use (e.g., kiosks).
• Alignment and normative references to IEC 60601‑1 family (general medical electrical safety), IEC 60601‑1‑2 (EMC), IEC 60601‑1‑11 (home healthcare), IEC 60601‑1‑8 and related collateral standards.
• Connector compatibility changes (operator‑accessible cuff connector compatibility with ISO 80369 series) and other interface requirements.
• Listing of primary operating functions and specific tests for performance under expected conditions of use.

Typical use and users

Manufacturers and designers of automated blood‑pressure monitors, regulatory and conformity assessment bodies, clinical engineers, device test laboratories, and procurement/specification writers for hospitals, clinics, home‑health suppliers and public health kiosks use this standard to demonstrate compliance with safety and performance expectations.

Related standards

Key related documents include the IEC 60601 series (general requirements for basic safety and essential performance of medical electrical equipment), IEC 60601‑1‑2 (EMC), IEC 60601‑1‑11 (home healthcare), IEC 60601‑1‑10 and IEC 60601‑1‑12 (as referenced where applicable), and ISO 81060‑1 (requirements for non‑automated sphygmomanometers). The ISO 80369 series is referenced for small‑bore connector compatibility where noted.

Keywords

sphygmomanometer; blood pressure monitor; automated non‑invasive; cuff; medical electrical equipment; safety; essential performance; accuracy; IEC 80601‑2‑30:2018; public self‑use; home healthcare.

FAQ

Q: What is this standard?

A: IEC 80601‑2‑30:2018 is a particular‑requirements (collateral) standard for the basic safety and essential performance of automated non‑invasive cuff‑based sphygmomanometers (automatic blood‑pressure monitors).

Q: What does it cover?

A: It covers safety, essential performance, accuracy and testing requirements for electrically powered automatic sphygmomanometers and their accessories, including additional provisions for devices intended for home and public self‑use.

Q: Who typically uses it?

A: Device manufacturers, test laboratories, regulatory authorities, clinical engineers, and procurement/specification teams—any stakeholder involved in the design, certification, testing or purchase of automated blood‑pressure monitoring equipment.

Q: Is it current or superseded?

A: The 2018 second edition is the current published edition (issued 22 March 2018). The IEC webstore lists the document as published with a stability/review date into 2026 and indicates periodic review; users should verify whether a newer revision or DIS has been published after 2018 when preparing compliance materials.

Q: Is it part of a series?

A: Yes. It is one of the IEC 80601‑2‑XX series of particular‑requirements documents that supplement IEC 60601‑1 (general medical electrical equipment safety). It also cross‑references and relies on other IEC collateral and particular standards in the IEC 60601 family and relevant ISO connector and non‑automated sphygmomanometer standards.

Q: What are the key keywords?

A: Sphygmomanometer, blood pressure, non‑invasive, automated, cuff, IEC 80601‑2‑30, accuracy, safety, essential performance, public self‑use, home healthcare.