ISO 17664-2-2021 PDF

Full title and description

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 International Standard specifies the information manufacturers must provide to support safe processing (cleaning, disinfection, drying, inspection, packaging, storage and transport) of non‑critical medical devices that are not intended to be sterilized.

Abstract

This document defines requirements for the content and format of processing information supplied by medical‑device manufacturers for non‑critical devices (devices that contact intact skin only or are not intended for direct patient contact). It addresses preparation before processing, cleaning, disinfection, drying, inspection/maintenance, packaging, storage and transportation, and it excludes critical/semi‑critical devices and devices intended to be sterilized.

General information

• Status: Published.
• Publication date: 25 February 2021 (published February 2021).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.080.01 (Sterilization and disinfection in general).
• Edition / version: Edition 1 (ISO 17664‑2:2021).
• Number of pages: 24 pages.

Scope

The standard applies to non‑critical medical devices for which sterilization is not intended. It specifies requirements for the information the manufacturer shall provide to enable proper cleaning, disinfection (where applicable), drying, inspection/maintenance, packaging, storage and transportation prior to use or reuse. It explicitly excludes critical and semi‑critical devices, devices intended to be sterilized, textile draping/surgical clothing and single‑use disposable devices supplied ready for use.

Key topics and requirements

• Mandatory content elements for processing instructions (e.g., intended use, limitations, materials, cleaning/disinfection methods and parameters).
• Recommended structure and level of detail to enable reprocessing by healthcare providers and reprocessing organizations.
• Activities covered where applicable: preparation before processing, cleaning, disinfection, drying, inspection and maintenance, packaging, storage and transportation.
• Exclusions and clarifications on device categories not covered (critical/semi‑critical, sterilizable devices, certain textiles and single‑use ready‑to‑use devices).
• Guidance note referencing the broader ISO 17664 series for device categorization and additional application guidance.

Typical use and users

Primary users are medical‑device manufacturers (for preparing compliant processing instructions), clinical reprocessing teams, central sterile services departments (CSSDs), health‑care facility quality and compliance staff, regulatory reviewers and notified bodies assessing device labelling and reprocessing claims. The standard is used to harmonize manufacturer information so that reprocessing personnel can follow validated and safe procedures.

Related standards

ISO 17664‑1:2021 — Part 1 covering critical and semi‑critical devices and devices intended for sterilization; ISO 17664:2017 (previous consolidated version, withdrawn and replaced by the 2021 series); regional/adopted versions include EN ISO 17664‑2 (adoptions published subsequently).

Keywords

processing instructions, reprocessing, cleaning, disinfection, medical device labelling, non‑critical medical devices, ISO 17664, CSSD, manufacturer information, packaging, storage, transportation.

FAQ

Q: What is this standard?

A: ISO 17664‑2:2021 is an International Standard that specifies the information manufacturers must provide to support processing (cleaning, disinfection, inspection, packaging, storage and transport) of non‑critical medical devices not intended to be sterilized.

Q: What does it cover?

A: It covers the required content and structure of manufacturer processing information for non‑critical devices, including preparation before processing, cleaning, disinfection (if applicable), drying, inspection/maintenance, packaging, storage and transportation — but does not define specific process protocols or validation methods.

Q: Who typically uses it?

A: Medical‑device manufacturers, hospital reprocessing teams (CSSD), regulatory and compliance personnel, notified bodies, and others involved in device reprocessing and labeling. Manufacturers use it to produce clear, auditable processing instructions; healthcare providers use those instructions to safely reprocess devices.

Q: Is it current or superseded?

A: ISO 17664‑2:2021 is the published, current Part 2 document for non‑critical devices (published February 2021). The earlier consolidated ISO 17664 (2017) has been revised by the 2021 two‑part series (Parts 1 and 2).

Q: Is it part of a series?

A: Yes — it is part of the ISO 17664 series. Part 1 (ISO 17664‑1:2021) addresses critical and semi‑critical devices and devices intended to be sterilized; Part 2 addresses non‑critical devices. Users should consult both parts and the relevant annexes for guidance on categorization and application.

Q: What are the key keywords?

A: Processing instructions, reprocessing, cleaning, disinfection, non‑critical medical devices, manufacturer information, ISO 17664‑2.