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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Entry 01/14/2019 
FR Recognition Number 11-348
Standard
ISO  19227 First edition 2018-03
Implants for surgery - Cleanliness of orthopedic implants - General requirements
Scope/Abstract
This document specifies requirements for the cleanliness of orthopaedic implants, hereafter referred to as implants, and test methods for the cleaning process validation and controls, which are based on a risk management process.

This document does not specify requirements for packaging or sterilization which are covered by other International Standards.

This document applies to in-process cleaning and final cleaning.

This document does not apply to liquid or gaseous implants.

This document does not apply to cleaning processes performed by the user or under the responsibility of the user.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Clause 5.6 Note 5 first sentence.
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 5.6 Note 5 first sentence refers to ISO 10993-17, see clause 6.1 of ISO 10993-1 listed below.
Relevant FDA Guidance and/or Supportive Publications*
ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices--Part 1: Evaluation and testing within a risk management process", Issued September 2023.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Aprajita Garg
  FDA/OC/CDRH/OPEQ/OHTVI/DHTVIC/
  240-402-7667
  Aprajita.Garg@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Groups (STG)
Orthopedic (primary)
Biocompatibility
*These are provided as examples and others may be applicable.
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