UNE-EN ISO 17664-2-2024 PDF

Full title and description

STB UNE-EN ISO 17664-2:2024 — Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 2: Non‑critical medical devices. This document is the Spanish (UNE) adoption of the EN/ISO text that specifies the information manufacturers must supply to enable safe and effective processing (cleaning, disinfection and related activities) of non‑critical medical devices that are not intended to be sterilized.

Abstract

This part of ISO 17664 defines the requirements for the information that manufacturers shall provide for the reprocessing (preparation, cleaning, disinfection, drying, inspection/maintenance, packaging, storage and transport) of non‑critical medical devices — i.e., devices intended to contact intact skin only or not intended for direct patient contact. It does not prescribe processing methods but sets the information content and format to support safe reprocessing and use. The document excludes critical and semi‑critical devices, devices intended for sterilization, certain textiles and devices specified as single‑use only.

General information

• Status: Active / National adoption (UNE - Spanish adoption of EN ISO).
• Publication date: UNE edition published 11 June 2024 (national adoption date). (EN/ISO base document published as ISO 17664‑2:2021 / EN ISO 17664‑2:2023).
• Publisher: AENOR (UNE national body) — adoption of the EN/ISO text.
• ICS / categories: 11.080.01 — Sterilization and disinfection in general; also relevant to medical equipment standards.
• Edition / version: UNE‑EN ISO 17664‑2:2024 — adoption of ISO 17664‑2:2021 (EN ISO 17664‑2:2023).
• Number of pages: 41 pages (UNE PDF edition).

Scope

The standard specifies the content and presentation of manufacturer‑supplied processing information for non‑critical medical devices that are not intended to be sterilized. It covers information needed for processing before first use or for re‑use, including preparation, cleaning, disinfection, drying, inspection and maintenance, packaging, storage and transportation. It explicitly excludes critical/semi‑critical devices, devices intended for sterilization, certain textile medical devices used in draping or surgical clothing, and devices declared single‑use by the manufacturer.

Key topics and requirements

• Required elements of manufacturer processing information: identification, intended use, processing steps, safety warnings and rationale.
• Detailed content areas to be addressed where applicable: preparation before processing, cleaning, chemical/thermal disinfection, drying, inspection and maintenance, packaging, storage and transport.
• Exclusions and limitations: devices for sterilization, critical/semi‑critical devices and single‑use devices are outside scope.
• Format and clarity: information should be unambiguous, verifiable and usable by healthcare reprocessing personnel and comply with applicable regulatory requirements.
• Alignment with regulatory frameworks (e.g., EU Medical Device Regulation expectations for reprocessing information).

Typical use and users

Primary users are medical device manufacturers (for creating compliant processing instructions), hospital sterile services/reprocessing departments, infection prevention teams, regulatory/compliance personnel and notified bodies reviewing device documentation. The standard is also used by procurement and clinical engineering to verify that supplied reprocessing information is adequate for safe device use.

Related standards

ISO 17664 is a multi‑part series; Part 1 (ISO 17664‑1:2021) addresses information for processing critical and semi‑critical devices (including sterilization) and is the companion document to Part 2. The original ISO 17664 family (previous editions) and the EN adoption texts (EN ISO 17664‑2:2023) are directly related and frequently referenced together in regulatory and conformity assessments.

Keywords

processing information, reprocessing, cleaning, disinfection, non‑critical medical devices, manufacturer instructions, UNE, EN ISO 17664‑2, AENOR, sterilization exclusions, reprocessing validation.

FAQ

Q: What is this standard?

A: A national (UNE) adoption of EN/ISO 17664‑2 that sets out the information manufacturers must provide for the processing (cleaning, disinfection and related steps) of non‑critical medical devices not intended for sterilization.

Q: What does it cover?

A: The content and presentation of processing instructions (preparation, cleaning, disinfection, drying, inspection/maintenance, packaging, storage, transport) and the exclusions for device types not covered by this part. It does not prescribe specific processing technologies but requires manufacturers to provide sufficient, verifiable information.

Q: Who typically uses it?

A: Medical device manufacturers, hospital reprocessing/sterile services departments, infection prevention teams, conformity assessment and regulatory reviewers, and clinical engineering/procurement staff.

Q: Is it current or superseded?

A: The UNE adoption (UNE‑EN ISO 17664‑2:2024) is current as a national publication (June 11, 2024) and is based on ISO 17664‑2:2021 / EN ISO 17664‑2:2023. The ISO 17664 family was revised in 2021 (parts 1 and 2).

Q: Is it part of a series?

A: Yes — ISO 17664 is a series. Part 1 (ISO 17664‑1:2021) covers critical and semi‑critical devices (including sterilization) and Part 2 covers non‑critical devices; both parts are intended to be used together to cover the spectrum of device processing needs.

Q: What are the key keywords?

A: processing information, reprocessing, cleaning, disinfection, non‑critical medical devices, manufacturer instructions, EN ISO 17664, UNE adoption.