| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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058
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Date of Entry 05/30/2022
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FR Recognition Number
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14-578
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| Standard | |
ISO 17664-1 First edition 2021-07
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 |
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Scope/AbstractThis document specifies requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that enters normally sterile parts of the human body or a medical device that comes into contact with mucous membranes or non-intact skin) or medical devices that are intended to be sterilized.
This includes information for processing prior to use or reuse of the medical device.
Processing instructions are not defined in this document. Rather, this document specifies requirements to assist manufacturers of medical devices in providing detailed processing instructions that consist of the following activities, where applicable:
a) initial treatment at the point of use;
b) preparation before cleaning;
c) cleaning;
d) disinfection;
e) drying;
f) inspection and maintenance;
g) packaging;
h) sterilization;
i) storage;
j) transportation.
This document excludes processing of the following:
- non-critical medical devices unless they are intended to be sterilized;
- textile devices used in patient draping systems or surgical clothing;
- medical devices specified by the manufacturer for single use only and supplied ready for use.
NOTE See ISO 17664-2:2021, Annex E, for further guidance on the application of the ISO 17664 series to a medical device. |
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Extent of Recognition
| Partial recognition. The following part(s) of the standard is (are) not recognized: |
Clause 6.6.1.1 At least one validated automated cleaning method (which may include a validated manual cleaning method as part of the automated cleaning validation) shall be specified unless the medical device cannot withstand any such process, in which case a statement shall be provided which alerts the user to this issue.
Clause 6.7.1.1 If the medical device is intended to be disinfected, at least one validated automated disinfection method shall be specified unless the medical device cannot withstand any such process, in which case a statement shall be provided which alerts the user to this issue.
Clause 6.8 Drying: Where drying is necessary, at least one verified drying method shall be specified. If a drying method is specified, the following information shall be included, where applicable:
Clause 6.11.3 i) the pressure required for the sterilization process; |
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
This standard is recognized in part because:
Clause 6.6.1.1 is in conflict with an existing published final guidance, see section VI.5.D of the guidance #1 listed below.
Clause 6.7.1.1 is in conflict with an existing published final guidance, see section VI.5.I of the guidance #1 listed below.
Clause 6.8 is in conflict with an existing published final guidance, see section VI.5.K of the guidance #1 listed below.
Clause 6.11.3.i is in conflict with an existing published final guidance, see section VI.4, "Extended Cycles" of the guidance #1 listed below. |
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Relevant FDA Guidance and/or Supportive Publications*
1. Guidance for Industry and Food and Drug Administration Staff: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, Issued March 2015.
2. AAMI TIR12:2020 Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers.
3. ANSI/AAMI ST98:2022 Cleaning validation of health care products-Requirements for development and validation of a cleaning process for medical devices.
4. ANSI/AAMI ST41:2008/(R)2018 Ethylene oxide sterilization in health care facilities: Safety and effectiveness.
5. ANSI/AAMI ST79:2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018. |
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| FDA Technical Contacts
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| Standards Development Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
