| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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054
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Date of Entry 07/06/2020
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FR Recognition Number
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14-515
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| Standard | |
ISO 17664 Second edition 2017-10
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices |
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U.S. Identical AdoptionANSI AAMI ISO 17664:2017
Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices |
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Scope/AbstractISO 17664:2017 specifies requirements for the information to be provided by the medical device manufacturer for the processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the device is safe and effective for its intended use.
This includes information for processing prior to use or reuse of the medical device. The provisions of ISO 17664:2017 are applicable to medical devices that are intended for invasive or other direct or indirect patient contact. |
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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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Transition Period
| FDA recognition of ISO 17664 Second edition 2017-10 [Rec# 14-515] will be superseded by recognition of ISO 17664-1 First edition 2021-07 [Rec# 14-578]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-515] until July 9, 2023. After this transition period, declarations of conformity to [Rec# 14-515] will not be accepted. |
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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 TIR12:2010 Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical 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. |
