Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 055 Date of Entry 12/21/2020 
FR Recognition Number 14-550
Standard
ANSI AAMI  ST67:2019
Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled "sterile"
Scope/Abstract
This standard specifies requirements and provides guidance on selecting approaches to establish assurance of sterility for a health care product labelled as "sterile"
Extent of Recognition
Complete standard
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.
Public Law, CFR Citation(s) and Procode(s)*
This standard is relevant for all medical devices where sterilization is a component of the development and manufacture of the product.
Relevant FDA Guidance and/or Supportive Publications*
ISO/TS 19930 First edition 2017-12 Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6.

ANSI/AAMI/ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices.

ANSI/AAMI/ISO 11137-1:2006/(R)2010, Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013)].

ANSI/AAMI/ISO 11137-2:2013, Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose.

ANSI/AAMI/ISO 11137-3:2017, Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control.

ANSI/AAMI/ISO 20857:2010/(R)2015, Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices

ANSI/AAMI/ISO 17665-1:2006/(R)2013, Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation, and control of a sterilization process for medical devices.

ANSI/AAMI/ISO TIR 17665-2:2009, Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ANSI/AAMI/ISO 17665-1:2006.

ANSI/AAMI/ISO TIR 17665-3:2014, Sterilization of health care products - Moist Heat - Guidance on the designation of a medical product to a product family and processing category for steam 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.
FDA Technical Contact
 Myra Smith
  FDA/OC/CDRH/OPEQ/OHTV/DHTVA/
  301-796-6507
  Myra.Smith@fda.hhs.gov
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
Sterility
*These are provided as examples and others may be applicable.
-
-