ISO 17664-1-2021 PDF

Full title and description

ISO 17664-1:2021 — Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices. This International Standard specifies the required information and content that manufacturers must provide to support safe and effective processing (cleaning, disinfection, sterilization, inspection, packaging, storage and transport) of critical and semi-critical medical devices, including devices intended to be sterilized.

Abstract

This document defines the structure and essential content of manufacturer-supplied processing information for medical devices that enter sterile body sites or contact mucous membranes or non-intact skin (critical and semi‑critical devices). It sets out the types of processing activities to be addressed (initial treatment at point of use, preparation before cleaning, cleaning, disinfection, drying, inspection and maintenance, packaging, sterilization, storage and transportation) and clarifies exclusions (non‑critical devices unless intended to be sterilized, textile drapes/surgical clothing, and single‑use devices supplied ready for use).

General information

• Status: Published.
• Publication date: July 2021 (published 6 July 2021).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.080.01 (Sterilization and disinfection in general); ISO/TC 198 responsible technical committee.
• Edition / version: Edition 1, ISO 17664-1:2021.
• Number of pages: 23 pages.

Key bibliographic and lifecycle details (status, edition and page count) are recorded on the ISO catalogue entry for ISO 17664-1:2021.

Scope

Specifies requirements for the information to be provided by the medical device manufacturer to enable processing (initial treatment, cleaning, disinfection, drying, inspection, maintenance, packaging, sterilization where applicable, storage and transport) of critical and semi‑critical medical devices and devices intended to be sterilized. The document is intended to help manufacturers prepare detailed, unambiguous processor instructions but does not itself define specific processing procedures or performance validation methods. Exclusions are non‑critical devices unless intended for sterilization, textile drapes and surgical clothing, and single‑use devices supplied ready for use.

Key topics and requirements

• Manufacturer information requirements: what processing information must be supplied (format, content and clarity for end users).
• Processing stages to be addressed: initial point‑of‑use treatment, pre‑cleaning preparation, cleaning, disinfection, drying, inspection and maintenance, packaging, sterilization (where applicable), storage and transport.
• Identification of limitations: single‑use designation, maximum reprocessing cycles (where applicable), material‑specific constraints and incompatibilities.
• Labelling and instructions: mandatory elements for labels and IFU (symbols, warnings, traceability and storage/sterilization marking).
• Validation and performance expectations: requirements to reference appropriate validation conditions or methods (where relevant) and to communicate performance limits to processors.
• Risk and safety information: cross‑reference to risk management and device‑specific hazards that affect processing and reuse decisions.
• Traceability and sterilization method guidance: identification of intended sterilization methods or statements when sterilization is not intended or validated.
• Interoperability with related standards and normative references used to inform processing requirements and validation.

Typical use and users

This standard is used by medical device manufacturers preparing processing instructions and labelling for devices that are critical or semi‑critical or intended to be sterilized. Secondary users include sterilization/central sterile services departments (CSSD), infection prevention teams, regulatory reviewers, healthcare facility procurement specialists, and conformity assessment bodies who evaluate whether manufacturer information is adequate for safe processing and reuse. It is also used by contract sterilization and reprocessing service providers to interpret manufacturer instructions.

Related standards

ISO 17664-1:2021 is part of the ISO 17664 series and replaces/revises material from ISO 17664:2017. Relevant related and normative standards commonly referenced when developing processing and validation instructions include ISO 17664-2:2021 (guidance for application of the series), ISO 14971 (risk management for medical devices), and sterilization and washer/disinfector standards such as ISO 11135, ISO 11137 and ISO 15883. Manufacturers commonly cross‑reference these documents when specifying validated methods and risk‑based limits.

Keywords

processing instructions, medical device reprocessing, sterilization, cleaning, disinfection, manufacturer information, central sterile services, ISO 17664, critical medical devices, semi‑critical devices, labelling, IFU, validation

FAQ

Q: What is this standard?

A: ISO 17664-1:2021 specifies the information that medical device manufacturers must provide to support processing (cleaning, disinfection, sterilization, inspection, packaging, storage and transport) of critical and semi‑critical medical devices.

Q: What does it cover?

A: It covers the content, format and essential elements of manufacturer‑supplied processing instructions and labelling for devices that enter sterile body sites or contact mucous membranes/non‑intact skin, and devices intended to be sterilized. It defines which processing stages should be addressed and what limitations or warnings must be declared; it does not itself prescribe specific cleaning or sterilization procedures.

Q: Who typically uses it?

A: Primary users are medical device manufacturers and their regulatory/compliance teams. Secondary users include hospital CSSD staff, infection prevention professionals, contract processors and auditors/regulators who assess the adequacy of manufacturer instructions for safe processing and reuse.

Q: Is it current or superseded?

A: ISO 17664-1:2021 is the current published Part 1 of the ISO 17664 series and supersedes aspects of the earlier ISO 17664:2017 document; the 2021 Part 1 edition is the active international standard for critical and semi‑critical devices.

Q: Is it part of a series?

A: Yes. ISO 17664-1:2021 is part of the ISO 17664 series; ISO 17664-2:2021 provides additional guidance on applying the series to particular devices and situations. Manufacturers often use both parts together when preparing processing information.

Q: What are the key keywords?

A: processing instructions, cleaning, disinfection, sterilization, manufacturer information, central sterile services, IFU, reprocessing, critical devices, semi‑critical devices.