ISO 22077-1-2022 PDF

Full title and description

Health informatics — Medical waveform format — Part 1: Encoding rules. This International Standard specifies encoding rules for representing medical waveforms (for example ECG, EEG, spirometry) to support interoperability between healthcare information systems and device/software implementations.

Abstract

Part 1 of ISO 22077 (MFER — Medical Waveform Format Encoding Rules) defines a general, implementation‑independent encoding model and rules for describing medical waveform signals and associated metadata so they can be exchanged, stored and interpreted by electronic health record systems, device interfaces and other health‑IT components. The document is intended to be used in conjunction with application‑specific parts and with other health data standards (for example HL7, DICOM, ISO/IEEE 11073), while excluding lower‑layer transport protocols and real‑time monitoring specifics.

General information

• Status: Published (International Standard)
• Publication date: 4 January 2022
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 35.240.80 (IT applications in health care technology)
• Edition / version: Edition 2 (ed. 2.0)
• Number of pages: 41.

Scope

ISO 22077-1:2022 specifies the encoding rules and general structure for medical waveform data (the Medical Waveform Format — MFER). It covers representation of sampled biological signals, channel and lead descriptions, timing and sampling information, annotations/markers, and metadata necessary for correct interpretation. The standard is explicitly a general encoding specification and does not define lower‑layer message transport or real‑time streaming requirements; application‑specific waveform descriptions and harmonization with other formats (for example DICOM or SCP‑ECG) are addressed in other parts or companion documents.

Key topics and requirements

• Definition of the MFER encoding rules and overall file/record structure for medical waveforms.
• Representation of channels/leads, sampling frequency, signal scaling and time stamping.
• Metadata model for patient/study/context information linked to waveform data.
• Annotation and marker mechanisms for events, measurements and diagnostic notes.
• Guidance for interoperability with other health IT standards and legacy waveform formats.
• Conformance requirements for implementing encoders/decoders to ensure consistent interpretation.
• Explicit exclusion of lower‑layer transport and continuous real‑time monitoring protocols (left to implementation-specific specifications).

Typical use and users

Implementers and users include medical device manufacturers (ECG/EEG/respiratory monitors, Holter recorders), health‑IT and EHR system vendors, PACS/DICOM integrators, clinical data managers, biomedical engineers, hospital IT teams and standards bodies developing harmonized profiles for waveform exchange. The standard is used where waveform data needs to be stored, exchanged or processed reliably across systems and vendors.

Related standards

ISO 22077 is a multipart series; notable related documents are ISO 22077‑2 (application for electrocardiography), ISO 22077‑3 (long‑term electrocardiography) and earlier related technical specifications such as ISO/TS 22077‑4 (stress test ECG). Implementers frequently map or interoperate with DICOM waveform objects, HL7 messaging, and ISO/IEEE 11073 device communication profiles for end‑to‑end integration.

Keywords

Medical waveform format; MFER; waveform encoding; ECG; EEG; spirometry; health informatics; interoperability; metadata; annotations; ISO 22077.

FAQ

Q: What is this standard?

A: ISO 22077‑1:2022 is the part of the ISO 22077 series that defines encoding rules for medical waveform data (Medical Waveform Format — MFER), providing a generalized model for representing sampled physiological signals and associated metadata.

Q: What does it cover?

A: It specifies the encoding structure, channel/lead descriptions, timing and sampling conventions, annotations, and required metadata to enable consistent storage and exchange of medical waveform data. It does not specify transport protocols or real‑time monitoring interfaces; those are left to implementations or other standards.

Q: Who typically uses it?

A: Medical device manufacturers, EHR and clinical software vendors, biomedical engineers, hospital IT/PACS teams, and integrators who need a vendor‑neutral, interoperable format for waveform storage and exchange.

Q: Is it current or superseded?

A: ISO 22077‑1:2022 is published and current (Edition 2, published January 2022). There is no indication on the ISO publication record that this part has been superseded as of 28 February 2026.

Q: Is it part of a series?

A: Yes — ISO 22077 is a multipart standard addressing medical waveform encoding and specific applications; subsequent parts provide application‑specific rules such as electrocardiography and long‑term ECG. See parts 2 and 3 (published after Part 1) and related technical specifications for other waveform use cases.

Q: What are the key keywords?

A: MFER, waveform encoding, ECG, EEG, spirometry, annotations, metadata, interoperability, medical waveform format, health informatics, ISO 22077.