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General information about a standard, not medical advice and not a processing procedure. Follow the instructions for use supplied with each device.
Short answer
ISO 17664 is the standard that tells a medical device manufacturer what reprocessing information to supply with a reusable device. It does not itself define the cleaning or sterilization steps. The current edition, ISO 17664-1:2021, covers critical and semi-critical devices and replaced the 2017 edition. Your facility follows the device’s instructions for use (IFU), not the standard.
Definition and scope
The 2021 edition is titled 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. It was published in July 2021 and runs 23 pages, according to the AFNOR listing of the standard. The scope statement says the document specifies requirements for the information to be provided by the medical device manufacturer
, and adds that processing instructions are not defined in this document
.
It applies to processing before first use and before reuse. The standard names exclusions: non-critical devices (unless they are intended to be sterilized), textile devices for patient draping or surgical clothing, and single-use devices supplied ready for use. For what critical and semi-critical mean, see the Spaulding classification guide.
How it is used in practice: standard, IFU, facility
Three parties each hold a different piece:
- The standard sets which information categories a manufacturer must provide.
- The manufacturer writes device-specific instructions. Health Canada’s guidance says reusable-device manufacturers must include appropriate reprocessing information, that disassembly instructions should carry photos or schematics, and that sterilization instructions should specify the reprocessing method, process temperatures and times, plus drying or aeration times. It also says instructions should account for equipment usually available in a health care facility.
- The facility (lab, clinic, sterile processing) reads and follows that IFU. The standard is the reason the IFU has a predictable structure; it is not the document staff work from at the bench.
Separately, the US FDA guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (issued March 2015, docket FDA-2011-D-0293) addresses how reprocessing instructions are validated and how reprocessing labeling is reviewed in premarket submissions. The FDA guidance page does not mention ISO 17664, so the two should not be treated as the same requirement.
Checklist: ten information areas to look for in an IFU
The 2021 edition says the manufacturer’s information must cover these activities. Use them as questions when you review a reusable device’s IFU before buying or onboarding it. If an area is silent, ask the manufacturer.
| Area | Question to ask of the IFU |
|---|---|
| Point-of-use treatment | Does it say what to do immediately after use? |
| Pre-cleaning | Is there preparation before the main cleaning? |
| Cleaning | Is a cleaning method given for this device? |
| Disinfection | Is disinfection addressed, or stated as not applicable? |
| Drying | Is drying addressed? |
| Inspection and maintenance | Does it say how to check the device and maintain it? |
| Packaging | Is packaging before sterilization addressed? |
| Sterilization | Is a sterilization method given, with parameters? |
| Storage | Is storage addressed? |
| Transport | Is transport addressed? |
Parts and editions
| Edition | Details | Source |
|---|---|---|
| ISO 17664:2004 | Specified information a manufacturer provides on reprocessing devices claimed to be resterilizable. Health Canada’s 2011 guidance says reprocessing information should meet it. | Health Canada |
| ISO 17664:2017 | Cancelled and replaced by the 2021 edition. | AFNOR listing |
| ISO 17664-1:2021 | Current Part 1 for critical and semi-critical devices; published July 2021. | AFNOR listing |
The Health Canada guidance (final June 1, 2011) cites the 2004 edition. That reflects its date; this page does not claim Health Canada has since adopted the 2021 text.
Where it matters for labs, clinics and supply decisions
- Reading a device listing. A reusable device should ship with reprocessing information. Single-use devices supplied ready for use fall outside Part 1. The trade-offs are covered in autoclavable vs single-use surgical instruments.
- Matching equipment to the IFU. Because the IFU states the method, temperatures and times, check that your equipment is one the IFU names; see the washer-disinfector guide for one such machine.
- Program context. Facility-side practice is covered in medical device reprocessing and in the ANSI/AAMI ST79 entry, which is a different standard.
Common misunderstandings
- It is not a cleaning protocol. The scope statement says processing instructions are not defined in it.
- It does not certify a device. It sets requirements for the information supplied, not for the device’s performance.
- It does not cover everything. Part 1 excludes non-critical devices unless intended to be sterilized, and the listed single-use and textile exclusions.
- It is not FDA’s rule. The FDA guidance addresses validation and labeling of reprocessing instructions and does not mention ISO 17664.
FAQ
What is ISO 17664?
A standard on the information a medical device manufacturer must provide for processing a device. The current edition is ISO 17664-1:2021.
Does ISO 17664 tell me how to sterilize instruments?
No. It states that processing instructions are not defined in it; the device IFU supplies them.
Does ISO 17664-1 cover non-critical devices?
No, unless they are intended to be sterilized. Single-use devices supplied ready for use and textile devices for patient draping or surgical clothing are also excluded.
Which edition is current?
ISO 17664-1:2021, published July 2021, replacing ISO 17664:2017 (per the AFNOR listing).
Sources
- AFNOR Boutique, ISO 17664-1:2021 listing, checked 2026-10-30: boutique.afnor.org
- Health Canada, guidance on information to be provided by manufacturers for sterilization of reusable medical devices (2011), checked 2026-10-30: canada.ca
- US FDA, Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (March 2015; page current as of 2018-06-13), checked 2026-10-30: fda.gov
