| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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041
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Date of Entry 04/04/2016
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FR Recognition Number
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14-333
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| Standard | |
ISO 17665-1 First edition 2006-08-15
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
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Identical AdoptionANSI AAMI ISO 17665-1:2006/(R)2013
Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices |
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Scope/AbstractISO 17665-1:2006 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices.
Moist heat sterilization processes covered by ISO 17665-1:2006 include but are not limited to:
-saturated steam venting systems;
-saturated steam active air removal systems;
-air steam mixtures;
-water spray;
-water immersion. |
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| Extent of Recognition
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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. |
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Transition Period
| FDA recognition of ISO TS 17665-2 First edition 2009-01-15 [Rec# 14-277], and ISO 17665-1 First edition 2006-08-15 [Rec# 14-333] will be superseded by recognition of ISO 17665 First edition 2024-03 [Rec# 14-601]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-277] and [Rec# 14-333] until July 04, 2027. After this transition period, declarations of conformity to [Rec# 14-277] and [Rec# 14-333] will not be accepted. |
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Relevant FDA Guidance and/or Supportive Publications*
Parenteral Drug Association Technical Report No. 1 (Revised 2007), Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control.
ISO/TS 17665-2:2009 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1.
AAMI TIR 17:2008 Compatibility of materials subject to sterilization.
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. |
