Approved American National Standards

681 Pages·2015·1.94 MB·English

The data in this document is reported as of Monday, September 28, 2015
Approved American National Standards
User Guide for American National Standards (ANS) related Data
Listed below are approved American National Standards (ANS) as of 9/28/2015. Additional information about these ANS has been published in ANSI’s Standards
Action during the standards development cycle as indicated by the PINS Date and/or Public Review Start Date and Approval Date. To review this additional
information, archived issues of ANSI's Standards Action in (PDF) format are available at (www.ansi.org/standardsaction). Questions concerning a particular ANS
should be directed to the sponsoring ANSI-Accredited Standards Developer (ASD). Some ANS are available for purchase at http://webstore.ansi.org/.
Information about proposed ANS is available in a separate document at www.ansi.org/proposedANSprojects . The procedures that govern the ANS process are
called the “ANSI Essential Requirements: Due process requirements for American National Standards” www.ansi.org/essentialrequirements. A list of all ASDs is
available at www.ansi.org/asd. Questions concerning the ANS process may be directed to [email protected]. Thank you for your interest.
ANSI H35.5-2013,Standard Nomenclature System for Aluminum Metal
3-A (3-A Sanitary Standards, Inc. )
Matrix Composite Materials (revision of ANSI H35.5-1993 (R2009))
www.3-a.org
PINS Date: Aug 17, 2012
Public Review Start: May 31, 2013
Approval Date: Nov 7, 2013
ANSI/3-A 00-00-2014,3-A® Sanitary Standards for General
Requirements (new standard)
PINS Date: Jan 27, 2012 AAMI (Association for the Advancement of Medical
Public Review Start: May 23, 2014 Instrumentation )
Approval Date: Sep 8, 2014 www.aami.org
ANSI/AAM/IEC 60601-1-2-2014,Medical electrical equipment - Part 1
AA (ASC H35) (Aluminum Association )
-2: General requirements for basic safety and essential performance -
www.aluminum.org
Collateral standard: Electromagnetic disturbances - Requirements and
tests (identical national adoption of IEC 60601-1-2 and revision of
ANSI/AAMI/IEC 60601-1-2, Ed.2-2007 (R2012))
ANSI H35.1/H35.1(M)-2013,Standard Alloy and Temper Designation
PINS Date:
Systems for Aluminum (revision of ANSI H35.1/H35.1(M)-2009)
Public Review Start: Aug 17, 2012
PINS Date: Aug 17, 2012
Approval Date: May 8, 2014
Public Review Start: May 31, 2013
Approval Date: Nov 7, 2013
ANSI/AAMI 11663-2014,Quality of dialysis fluid for haemodialysis and
related therapies (national adoption of ISO 11663:2014 with
ANSI H35.2-2013,Standard Dimensional Tolerances for Aluminum Mill
modifications and revision of ANSI/AAMI/ISO 11663-2009 (Ed1))
Products (revision of ANSI H35.2-2009)
PINS Date: Feb 8, 2013
PINS Date: Aug 17, 2012
Public Review Start: Feb 7, 2014
Public Review Start: May 31, 2013
Approval Date: Aug 8, 2014
Approval Date: Nov 7, 2013
ANSI/AAMI 13958-2014,Concentrates for haemodialysis and related
ANSI H35.2(M)-2013,Standard Dimensional Tolerances for Aluminum
therapies (national adoption of ISO 13958:2014 with modifications and
Mill Products (revision of ANSI H35.2(M)-2009)
revision of ANSI/AAMI/ISO 13958-2009)
PINS Date: Aug 17, 2012
PINS Date: Feb 8, 2013
Public Review Start: May 31, 2013
Public Review Start: Feb 14, 2014
Approval Date: Nov 7, 2013
Approval Date: Aug 15, 2014
ANSI H35.3-1997 (R2013),Standard Designation System for Aluminum
ANSI/AAMI 13959-2014,Water for haemodialysis and related therapies
Hardeners (reaffirmation of ANSI H35.3-1997 (R2009))
(national adoption of ISO 13959:2014 with modifications and revision
PINS Date: Aug 17, 2012
of ANSI/AAMI/ISO 13959-2009)
Public Review Start: May 31, 2013
PINS Date: Feb 8, 2013
Approval Date: Nov 7, 2013
Public Review Start: Feb 14, 2014
Approval Date: Aug 15, 2014
ANSI H35.4-2006 (R2013),Standard Designation System for Unalloyed
Aluminum (reaffirmation of ANSI H35.4-2006 (R2009))
ANSI/AAMI 23500-2014,Guidance for the preparation and quality
PINS Date: Aug 17, 2012
management of fluids for haemodialysis and related therapies
Public Review Start: May 31, 2013
(national adoption of ISO 23500:2014 with modifications and revision
Approval Date: Nov 7, 2013
of ANSI/AAMI/ISO 23500-2011)
PINS Date: Feb 8, 2013
Public Review Start: Feb 14, 2014
Approval Date: Aug 15, 2014
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Approved American National Standards The data in this document is reported as of Monday, September 28, 2015
ANSI/AAMI 26722-2014,Water treatment equipment for haemodialysis ANSI/AAMI EC71-2001 (R2013),Standard communications protocol -
applications and related therapies (national adoption of ISO Computer assisted electrocardiography (reaffirmation of ANSI/AAMI
26722:2014 with modifications and revision of ANSI/AAMI/ISO 26722 EC71-2001 (R2007))
-2009) PINS Date:
PINS Date: Feb 8, 2013 Public Review Start: Nov 2, 2012
Public Review Start: Feb 14, 2014 Approval Date: Sep 19, 2013
Approval Date: Aug 8, 2014
ANSI/AAMI EQ56-2013,Recommended practice for a medical
ANSI/AAMI AT6-2013,Autologous transfusion devices (revision of equipment management program (revision of ANSI/AAMI EQ56-1999
ANSI/AAMI AT6-2005 (R2011)) (R2008))
PINS Date: PINS Date: Feb 25, 2011
Public Review Start: Feb 15, 2013 Public Review Start: Jul 27, 2012
Approval Date: Aug 27, 2013 Approval Date: Mar 13, 2013
ANSI/AAMI BE83-2006 (R2011),Biological evaluation of medical ANSI/AAMI EQ89-2015,Guidance for the use of medical equipment
devices - Part 18: Chemical characterization of materials (reaffirmation maintenance strategies and procedures (new standard)
of ANSI/AAMI BE83-2006) PINS Date: Aug 3, 2012
PINS Date: Public Review Start: Jul 25, 2014
Public Review Start: Aug 12, 2011 Approval Date: Feb 12, 2015
Approval Date: Dec 2, 2011
ANSI/AAMI ES60601-1-2005 C1-2009 and A2 (R2012),Medical
ANSI/AAMI BF64-2012,Leukocyte reduction filters (revision of electrical equipment - Part 1: General requirements for basic safety and
ANSI/AAMI BF64-2002 (R2011)) essential performance (reaffirmation of ANSI/AAMI ES60601-1-2005)
PINS Date: Mar 30, 2012 PINS Date:
Public Review Start: Apr 13, 2012 Public Review Start: Oct 14, 2011
Approval Date: Nov 29, 2012 Approval Date: Jan 17, 2012
ANSI/AAMI BF7-2012,Blood transfusion microfilters (revision of ANSI/AAMI ES60601-1-2005, A1-2012,Medical electrical equipment -
ANSI/AAMI BF7-1989 (R2011)) Part 1: General requirements for basic safety and essential
PINS Date: Mar 30, 2012 performance Amendment 1 (supplement to ANSI/AAMI ES60601-1
Public Review Start: Apr 27, 2012 -2005)
Approval Date: Nov 30, 2012 PINS Date:
Public Review Start: Apr 22, 2011
Approval Date: Aug 21, 2012
ANSI/AAMI BP22-1994 (R2011),Blood pressure transducers
(reaffirmation of ANSI/AAMI BP22-1994 (R2006))
PINS Date: ANSI/AAMI HA60601-1-11-2015,Medical electrical equipment - Part 1
Public Review Start: Sep 23, 2011 -11: General requirements for basic safety and essential performance -
Approval Date: Dec 14, 2011 Collateral Standard: Requirements for medical electrical equipment and
medical electrical systems used in the home healthcare environment
(national adoption of IEC 60601-1-11:2015 with modifications and
ANSI/AAMI EC12-2000 (R2010),Disposable ECG electrodes
revision of ANSI/AAMI HA60601-1-11-2011)
(reaffirmation of ANSI/AAMI EC12-2000 (R2005))
PINS Date: Nov 8, 2013
PINS Date:
Public Review Start: Mar 27, 2015
Public Review Start: Jan 22, 2010
Approval Date: Aug 25, 2015
Approval Date: Aug 24, 2010
ANSI/AAMI HE75-2009 (R2013),Human factors engineering - Design of
ANSI/AAMI EC53-2013,ECG trunk cables and patient leadwires
medical devices (reaffirmation of ANSI/AAMI HE75-2009)
(revision, redesignation and consolidation of ANSI/AAMI EC53-1995
PINS Date:
(R2008) and ANSI/AAMI EC53/A1-1998 (R2008))
Public Review Start: Jul 12, 2013
PINS Date: Mar 13, 2009
Approval Date: Nov 26, 2013
Public Review Start: Jun 3, 2011
Approval Date: Nov 19, 2013
ANSI/AAMI ID26-2004 (R2013),Medical electrical equipment, Part 2:
Particular requirements for the safety of infusion pumps and controllers
ANSI/AAMI EC57-2012,Testing and reporting performance results of
(reaffirmation of ANSI/AAMI ID26-2004 (R2009))
cardiac rhythm and ST segment measurement algorithms (revision of
PINS Date:
ANSI/AAMI EC57-1998 (R2008))
Public Review Start: Aug 16, 2013
PINS Date: Mar 13, 2009
Approval Date: Nov 26, 2013
Public Review Start: Jun 3, 2011
Approval Date: Dec 18, 2012
Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 1
Approved American National Standards The data in this document is reported as of Monday, September 28, 2015
ANSI/AAMI ID54-1996 (R2012),Enteral feeding set adapters and ANSI/AAMI ST15883-3-2012 (ISO 15883-3-2006)MOD,Washer-
connectors (reaffirmation of ANSI/AAMI ID54-1996 (R2005)) disinfectors - Part 3: Requirements and tests for washer-disinfectors
PINS Date: employing thermal disinfection for human waste containers (national
Public Review Start: May 20, 2011 adoption with modifications of ISO 15883-3:2006)
Approval Date: Jan 17, 2012 PINS Date: May 19, 2006
Public Review Start: Aug 31, 2012
Approval Date: Dec 10, 2012
ANSI/AAMI NS28-1988 (R2015),Intracranial pressure monitoring
devices (reaffirmation of ANSI/AAMI NS28-1988 (R2010))
PINS Date: ANSI/AAMI ST24-1999 (R2013),Automatic, general-purpose ethylene
Public Review Start: Apr 17, 2015 oxide sterilizers and ethylene oxide sterilant sources intended for use in
Approval Date: Aug 31, 2015 health care facilities (reaffirmation of ANSI/AAMI ST24-1999 (R2009))
PINS Date:
Public Review Start: Aug 16, 2013
ANSI/AAMI NS4-2013,Transcutaneous electrical stimulators (new
Approval Date: Nov 26, 2013
standard)
PINS Date: Aug 10, 2012
Public Review Start: Sep 21, 2012 ANSI/AAMI ST40-2004 (R2010),Table-top dry heat (heated air)
Approval Date: Mar 20, 2013 sterilization and sterility assurance in health care facilities
(reaffirmation of ANSI/AAMI ST40-2004)
PINS Date:
ANSI/AAMI PB70-2012,Liquid barrier performance and classification of
Public Review Start: Dec 18, 2009
protective apparel and drapes intended for use in health care facilities
Approval Date: Mar 24, 2010
(revision of ANSI/AAMI PB70-2003 (R2009))
PINS Date: Jan 23, 2009
Public Review Start: Jul 1, 2011 ANSI/AAMI ST41-2008 (R2012),Ethylene oxide sterilization in health
Approval Date: Jun 21, 2012 care facilities: Safety and effectiveness (reaffirmation of ANSI/AAMI
ST41-2008)
PINS Date:
ANSI/AAMI RD47-2008 (R2013),Reprocessing of hemodialyzers
Public Review Start: Aug 10, 2012
(reaffirmation of ANSI/AAMI RD47-2008)
Approval Date: Nov 29, 2012
PINS Date:
Public Review Start: May 10, 2013
Approval Date: Oct 4, 2013 ANSI/AAMI ST50-2004 (R2010),Dry heat (heated air) sterilizers
(reaffirmation of ANSI/AAMI ST50-2004)
PINS Date:
ANSI/AAMI ST15883-1-2009/A1-2014,Washer-disinfectors - Part 1:
Public Review Start: Dec 18, 2009
General requirements, terms and definitions and tests - Amendment 1
Approval Date: Mar 24, 2010
(identical national adoption of ISO 15883-1:2006/DAmd 1)
PINS Date: Sep 23, 2011
Public Review Start: May 25, 2012 ANSI/AAMI ST55-2010 (R2014),Table-top steam sterilizers
Approval Date: Jul 17, 2014 (reaffirmation of ANSI/AAMI ST55-2010)
PINS Date:
Public Review Start: Feb 14, 2014
ANSI/AAMI ST15883-1-2009/A2-2012,Washer-disinfectors - Part 1:
Approval Date: Sep 19, 2014
General requirements, terms and definitions and tests, Amendment 2
(supplement to ANSI/AAMI ST15883-1-2009)
PINS Date: Oct 28, 2011 ANSI/AAMI ST58-2013,Chemical sterilization and high-level
Public Review Start: Dec 23, 2011 disinfection in health care facilities (revision of ANSI/AAMI ST58-2005
Approval Date: Aug 23, 2012 (R2010))
PINS Date: Sep 10, 2010
Public Review Start: Oct 5, 2012
ANSI/AAMI ST15883-2-2013 (ISO 15883-2-2006 MOD),Washer-
Approval Date: Aug 21, 2013
disinfectors, Part 2: Requirements and tests for washer-disinfectors
employing thermal disinfection for surgical instruments, anaesthetic
equipment, bowls, dishes, receivers, utensils, glassware, etc (national ANSI/AAMI ST65-2008 (R2013),Processing of reusable surgical textiles
adoption with modifications of ISO 15883-2:2006) for use in health care facilities (reaffirmation of ANSI/AAMI ST65-2008)
PINS Date: May 19, 2006 PINS Date:
Public Review Start: Aug 31, 2012 Public Review Start: Aug 16, 2013
Approval Date: Jan 9, 2013 Approval Date: Dec 2, 2013
Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 2
Approved American National Standards The data in this document is reported as of Monday, September 28, 2015
ANSI/AAMI ST67-2011,Sterilization of health care products - ANSI/AAMI ST79-2010/A3.1-2012,Comprehensive guide to steam
Requirements and guidance for selecting a sterility assurance level sterilization and sterility assurance in health care facilities (addenda to
(SAL) for products labeled "sterile" (revision of ANSI/AAMI ST67-2003 ANSI/AAMI ST79-2010)
(R2008)) PINS Date: Feb 17, 2012
PINS Date: Jan 23, 2009 Public Review Start: Mar 9, 2012
Public Review Start: Sep 17, 2010 Approval Date: Aug 22, 2012
Approval Date: Apr 11, 2011
ANSI/AAMI ST79-2010/A3.2-2012,Comprehensive guide to steam
ANSI/AAMI ST72-2011,Bacterial endotoxin -Test methods, routine sterilization and sterility assurance in health care facilities (addenda to
monitoring and alternatives to batch testing (revision of ANSI/AAMI ANSI/AAMI ST79-2010)
ST72-2002 (R2010)) PINS Date: Feb 17, 2012
PINS Date: Jan 23, 2009 Public Review Start: Mar 9, 2012
Public Review Start: Mar 11, 2011 Approval Date: Aug 23, 2012
Approval Date: Dec 19, 2011
ANSI/AAMI ST79-2010/A3.3-2012,Comprehensive guide to steam
ANSI/AAMI ST77-2013,Containment devices for reusable medical sterilization and sterility assurance in health care facilities (addenda to
device sterilization (revision of ANSI/AAMI ST77-2006 (R2010)) ANSI/AAMI ST79-2010)
PINS Date: Dec 24, 2010 PINS Date: Feb 17, 2012
Public Review Start: Jul 13, 2012 Public Review Start: Mar 9, 2012
Approval Date: Feb 1, 2013 Approval Date: Aug 23, 2012
ANSI/AAMI ST79-2010 (R2014),Comprehensive guide to steam ANSI/AAMI ST79-2010/A3.4-2012,Comprehensive guide to steam
sterilization and sterility assurance in health care facilities sterilization and sterility assurance in health care facilities (addenda to
(reaffirmation of ANSI/AAMI ST79-2010, A1:2010, A2:2011, A3:2012, ANSI/AAMI ST79-2010)
A4:2013) PINS Date: Feb 17, 2012
PINS Date: Public Review Start: Mar 9, 2012
Public Review Start: Feb 14, 2014 Approval Date: Aug 23, 2012
Approval Date: Sep 23, 2014
ANSI/AAMI ST79-2010/A3.5-2012,Comprehensive guide to steam
ANSI/AAMI ST79-2010/A2.1-2011,Comprehensive guide to steam sterilization and sterility assurance in health care facilities (addenda to
sterilization and sterility assurance in health care facilities (addenda to ANSI/AAMI ST79-2010)
ANSI/AAMI ST79-2010) PINS Date: Feb 17, 2012
PINS Date: Feb 25, 2011 Public Review Start: Mar 9, 2012
Public Review Start: Apr 1, 2011 Approval Date: Aug 23, 2012
Approval Date: Aug 8, 2011
ANSI/AAMI ST79-2010/A3.6-2012,Comprehensive guide to steam
ANSI/AAMI ST79-2010/A2.2-2011,Comprehensive guide to steam sterilization and sterility assurance in health care facilities (addenda to
sterilization and sterility assurance in health care facilities (addenda to ANSI/AAMI ST79-2010)
ANSI/AAMI ST79-2010) PINS Date: Feb 17, 2012
PINS Date: Feb 25, 2011 Public Review Start: Mar 16, 2012
Public Review Start: Apr 1, 2011 Approval Date: Aug 23, 2012
Approval Date: Aug 8, 2011
ANSI/AAMI ST79-2010/A3.7-2012,Comprehensive guide to steam
ANSI/AAMI ST79-2010/A2.3-2011,Comprehensive guide to steam sterilization and sterility assurance in health care facilities (addenda to
sterilization and sterility assurance in health care facilities (addenda to ANSI/AAMI ST79-2010)
ANSI/AAMI ST79-2010) PINS Date: Feb 17, 2012
PINS Date: Feb 25, 2011 Public Review Start: Mar 16, 2012
Public Review Start: Apr 1, 2011 Approval Date: Aug 23, 2012
Approval Date: Aug 8, 2011
ANSI/AAMI ST79-2010/A4.1-2013,Comprehensive guide to steam
ANSI/AAMI ST79-2010/A2.5-2011,Comprehensive guide to steam sterilization and sterility assurance in health care facilities (addenda to
sterilization and sterility assurance in health care facilities (addenda to ANSI/AAMI ST79-2010)
ANSI/AAMI ST79-2010) PINS Date: Jan 18, 2013
PINS Date: Feb 25, 2011 Public Review Start: Feb 22, 2013
Public Review Start: Apr 1, 2011 Approval Date: Oct 14, 2013
Approval Date: Sep 19, 2011
Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 3
Approved American National Standards The data in this document is reported as of Monday, September 28, 2015
ANSI/AAMI ST79-2010/A4.2-2013,Comprehensive guide to steam ANSI/AAMI/IEC 60601-2-2-2009 (R2014),Medical electrical equipment
sterilization and sterility assurance in health care facilities (addenda to - Part 2-2: Particular requirements for the basic safety and essential
ANSI/AAMI ST79-2010) performance of high frequency surgical equipment and high frequency
PINS Date: Jan 18, 2013 surgical accessories (reaffirmation of ANSI/AAMI/IEC 60601-2-2-2009)
Public Review Start: Jun 28, 2013 PINS Date:
Approval Date: Oct 14, 2013 Public Review Start: Apr 18, 2014
Approval Date: Dec 10, 2014
ANSI/AAMI ST8-2013,Hospital steam sterilizers (revision of ANSI/AAMI
ST8-2008) ANSI/AAMI/IEC 60601-2-20-2009,Medical electrical equipment - Part 2
PINS Date: Aug 19, 2011 -20: Particular requirements for basic safety and essential performance
Public Review Start: Aug 31, 2012 of transport incubators (identical national adoption of IEC 60601-2-20
Approval Date: Apr 25, 2013 and revision of ANSI/AAMI II51-2004)
PINS Date: Oct 20, 2006
Public Review Start: Jul 6, 2007
ANSI/AAMI ST81-2004 (R2010),Sterilization of medical devices -
Approval Date: Apr 3, 2009
Information to be provided by the manufacturer for the processing of
resterilizable medical devices (reaffirmation of ANSI/AAMI ST81-2004)
PINS Date: ANSI/AAMI/IEC 60601-2-20-2009 (R2014),Medical electrical
Public Review Start: Dec 18, 2009 equipment - Part 2-20: Particular requirements for the basic safety and
Approval Date: Mar 24, 2010 essential performance of infant transport incubators (reaffirmation of
ANSI/AAMI/IEC 60601-2-20-2009)
PINS Date:
ANSI/AAMI ST91-2015,Flexible and semi-rigid endoscope reprocessing
Public Review Start: Apr 18, 2014
in health care facilities (new standard)
Approval Date: Dec 10, 2014
PINS Date: May 16, 2014
Public Review Start: Aug 1, 2014
Approval Date: Apr 8, 2015 ANSI/AAMI/IEC 60601-2-21-2009 (R2014),Medical electrical
equipment - Part 2-21: Particular requirements for the basic safety and
essential performance of infant radiant warmers (reaffirmation of
ANSI/AAMI SW87-2012,Application of Quality Management System
ANSI/AAMI/IEC 60601-2-21-2009)
concepts to Medical Device Data Systems (MDDS) (new standard)
PINS Date:
PINS Date: Apr 22, 2011
Public Review Start: Apr 18, 2014
Public Review Start: Jan 20, 2012
Approval Date: Dec 10, 2014
Approval Date: May 23, 2012
ANSI/AAMI/IEC 60601-2-25-2011,Medical electrical equipment - Part 2
ANSI/AAMI/IEC 60601-1-8-2013,Medical electrical equipment - Part 1
-25: Particular requirements for the basic safety and essential
-8: General requirements for basic safety and essential performance -
performance of electrocardiographs (national adoption of IEC 60601-2
Collateral Standard: General requirements, tests and guidance for
-25:2011 with modifications and revision of ANSI/AAMI EC11-1991
alarm systems in medical electrical equipment and medical electrical
(R2007))
systems (identical national adoption of IEC 60601-1-08:2006 and IEC
PINS Date: Nov 30, 2007
60601-1-08:2006/A1:2012)
Public Review Start: Mar 9, 2012
PINS Date: Mar 1, 2013
Approval Date: May 23, 2012
Public Review Start: Apr 19, 2013
Approval Date: Oct 21, 2013
ANSI/AAMI/IEC 60601-2-27-2011,Medical electrical equipment - Part 2
-27: Particular requirements for the basic safety and essential
ANSI/AAMI/IEC 60601-2-16, Ed. 4-2012,Medical electrical equipment -
performance of electrocardiographic monitoring equipment (identical
Part 2-16: Particular requirements for basic safety and essential
national adoption of IEC 60601-2-27:200x and revision of ANSI/AAMI
performance of haemodialysis, haemodiafiltration and haemofiltration
EC13-2002 (R2007))
equipment (identical national adoption of IEC 60601-2-16, Edition 4.0
PINS Date: Nov 16, 2007
(2012-03-08))
Public Review Start: Mar 6, 2009
PINS Date: Mar 11, 2011
Approval Date: Jun 24, 2011
Public Review Start: Feb 18, 2011
Approval Date: Sep 5, 2012
ANSI/AAMI/IEC 60601-2-4-2010,Medical electrical equipment - Part 2
-4: Particular requirements for basic safety and essential performance
ANSI/AAMI/IEC 60601-2-19-2009 (R2014),Medical electrical
of cardiac defibrillators (identical national adoption of IEC 60601-2
equipment - Part 2-19: Particular requirements for the basic safety and
-4:200X and revision of ANSI/AAMI DF80-2003 (R2010))
essential performance of infant incubators (reaffirmation of
PINS Date: Feb 16, 2007
ANSI/AAMI/IEC 60601-2-19-2009)
Public Review Start: Mar 6, 2009
PINS Date:
Approval Date: Nov 18, 2010
Public Review Start: Apr 18, 2014
Approval Date: Dec 16, 2014
Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 4
Approved American National Standards The data in this document is reported as of Monday, September 28, 2015
ANSI/AAMI/IEC 60601-2-47-2012,Medical electrical equipment - Part 2 ANSI/AAMI/IEC 80601-2-30-2009/A1-2013,Amendment 1 to Medical
-47: Particular requirements for the basic safety and essential electrical equipment - Part 2-30: Particular requirements for the basic
performance of ambulatory electrocardiographic systems (identical safety and essential performance of automated type non-invasive
national adoption of IEC 60601-2-47:2012 and revision of ANSI/AAMI sphygmomanometers (addenda to ANSI/AAMI/IEC 80601-2-30-2009)
EC38-2007) PINS Date: Apr 15, 2011
PINS Date: Jan 4, 2008 Public Review Start: Mar 9, 2012
Public Review Start: Mar 9, 2012 Approval Date: Nov 8, 2013
Approval Date: Aug 1, 2012
ANSI/AAMI/IEC 80601-2-30-2009/C1-2009,Medical electrical
ANSI/AAMI/IEC 60601-2-50-2009 (R2014),Medical electrical equipment - Part 2-30: Particular requirements for basic safety and
equipment - Part 2-50: Particular requirements for the basic safety and essential performance of automated type non-invasive
essential performance of infant phototherapy equipment (reaffirmation sphygmomanometers (supplement to ANSI/AAMI/IEC 80601-2-30
of ANSI/AAMI/IEC 60601-2-50-2009) -2009)
PINS Date: PINS Date: Oct 30, 2009
Public Review Start: Apr 18, 2014 Public Review Start: Jul 24, 2009
Approval Date: Dec 16, 2014 Approval Date: Dec 10, 2009
ANSI/AAMI/IEC 62304, Ed.1-2006 (R2013),Medical device software - ANSI/AAMI/IEC 80601-2-35-2011,Medical electric equipment – Part 2
Software life cycle processes (reaffirmation of ANSI/AAMI/IEC 62304, -35: Particular requirements for basic safety and essential performance
Ed.1-2006) of heating devices using blankets, pads or mattresses and intended for
PINS Date: heating in medical use (new standard)
Public Review Start: Oct 14, 2011 PINS Date: Nov 19, 2010
Approval Date: Jun 14, 2013 Public Review Start: Jan 21, 2011
Approval Date: Mar 8, 2011
ANSI/AAMI/IEC 62366-1-2015,Medical devices - Application of
usability Engineering to medical devices (identical national adoption of ANSI/AAMI/IEC 80601-2-58-2008,Medical electrical equipment - Part 2
IEC 62366-1 (in development) and revision of ANSI/AAMI/IEC 62366 -58: Particular requirements for basic safety and essential performance
-2007 (R2013)) of lens removal devices and vitrectomy device for ophthalmic surgery
PINS Date: (identical national adoption of IEC 80601-2-58)
Public Review Start: Jan 3, 2014 PINS Date: Nov 2, 2007
Approval Date: Feb 23, 2015 Public Review Start: Nov 2, 2007
Approval Date: Dec 10, 2008
ANSI/AAMI/IEC 62366-2007/A1-2014,Medical devices - Application of
usability engineering to medical devices - Amendment 1 (identical ANSI/AAMI/IEC 80601-2-58-2014,Medical electrical equipment - Part 2
national adoption of IEC 62366:2007/A1 (in development)) -58: Particular requirements for the basic safety and essential
PINS Date: Aug 17, 2012 performance of lens removal devices and vitrectomy devices for
Public Review Start: Oct 19, 2012 ophthalmic surgery (identical national adoption of IEC 80601-2-58)
Approval Date: Jan 7, 2014 PINS Date: May 24, 2013
Public Review Start: Jun 21, 2013
Approval Date: Sep 10, 2014
ANSI/AAMI/IEC 80001-1-2010,Application of risk management for IT
Networks incorporating medical devices - Part 1: Roles, responsibilities
and activities (identical national adoption of IEC 80001-1) ANSI/AAMI/ISO 10079-1-2003 (R2014),Medical suction equipment –
PINS Date: Aug 7, 2009 Part 1: Electrically powered suction equipment – Safety requirements
Public Review Start: Aug 21, 2009 (reaffirmation of ANSI/ASTM ISO 10079-1-2003)
Approval Date: Oct 6, 2010 PINS Date:
Public Review Start: Dec 20, 2013
Approval Date: Feb 4, 2014
ANSI/AAMI/IEC 80601-2-30-2009,Medical electrical equipment - Part 2
-30: Particular requirements for the basic safety and essential
performance of automated non-invasive sphygmomanometers ANSI/AAMI/ISO 10079-2-2002 (R2014),Medical suction equipment –
(identical national adoption of IEC 80601-2-30 (current revision project Part 2: Manually powered suction equipment (reaffirmation of
in IEC) and revision of ANSI/AAMI SP10-2002, ANSI/AAMI SP10 ANSI/ASTM ISO 10079-2-2002)
-2002/A1-2003, and ANSI/AAMI SP10-2002/A2-2006) PINS Date:
PINS Date: May 18, 2007 Public Review Start: Dec 20, 2013
Public Review Start: Nov 30, 2007 Approval Date: Feb 4, 2014
Approval Date: Jul 24, 2009
ANSI/AAMI/ISO 10079-3-2002 (R2014),Medical suction equipment –
Part 3: Suction equipment powered from a vacuum or pressure source
(reaffirmation of ANSI/ASTM ISO 10079-3-2002)
PINS Date:
Public Review Start: Dec 20, 2013
Approval Date: Feb 4, 2014
Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 5
Approved American National Standards The data in this document is reported as of Monday, September 28, 2015
ANSI/AAMI/ISO 10651-4-2002 (R2014),Lung ventilators – Part 4: ANSI/AAMI/ISO 10993-15-2000 (R2011),Biological evaluation of
Particular requirements for operator-powered resuscitators medical devices - Part 15: Identification and quantification of
(reaffirmation of ANSI/ASTM/ISO 10651-4-2002) degradation products from metals and alloys (reaffirmation of
PINS Date: ANSI/AAMI/ISO 10993-15-2000 (R2006))
Public Review Start: Dec 20, 2013 PINS Date:
Approval Date: Feb 4, 2014 Public Review Start: Jun 17, 2011
Approval Date: Nov 16, 2011
ANSI/AAMI/ISO 10651-5-2006 (R2014),Lung ventilators for medical use
– Particular requirements for basic safety and essential performance – ANSI/AAMI/ISO 10993-16-2010 (R2014),Biological evaluation of
Part 5: Gas-powered emergency resuscitators (reaffirmation of medical devices - Part 16: Toxicokinetic study design for degradation
ANSI/ASTM/ISO 10651-5-2006) products and leachables (reaffirmation of ANSI/AAMI/ISO 10993-16
PINS Date: -2010)
Public Review Start: Dec 20, 2013 PINS Date:
Approval Date: Feb 4, 2014 Public Review Start: Jul 11, 2014
Approval Date: Oct 8, 2014
ANSI/AAMI/ISO 10993-1-2009 (R2013),Biological evaluation of medical
devices - Part 1: Evaluation and testing within a risk management ANSI/AAMI/ISO 10993-17-2002 (R2012),Biological evaluation of
process (reaffirmation of ANSI/AAMI/ISO 10993-1-2009) medical devices - Part 17: Establishment of allowable limits for
PINS Date: leachable substances (reaffirmation of ANSI/AAMI/ISO 10993-17-2002
Public Review Start: Aug 16, 2013 (R2008))
Approval Date: Dec 2, 2013 PINS Date:
Public Review Start: Aug 17, 2012
Approval Date: Nov 30, 2012
ANSI/AAMI/ISO 10993-10:2010 (R2014),Biological evaluation of
medical devices - Part 10: Tests for irritation and skin sensitization
(reaffirmation of ANSI/AAMI/ISO 10993-10:2010) ANSI/AAMI/ISO 10993-2-2006 (R2010),Biological evaluation of medical
PINS Date: devices - Part 2: Animal welfare requirements (reaffirmation of
Public Review Start: Jul 11, 2014 ANSI/AAMI/ISO 10993-2-2006)
Approval Date: Oct 8, 2014 PINS Date:
Public Review Start: Jul 23, 2010
Approval Date: Dec 14, 2010
ANSI/AAMI/ISO 10993-11-2006 (R2014),Biological evaluation of
medical devices - Part 11: Tests for systemic toxicity (reaffirmation of
ANSI/AAMI/ISO 10993-11-2006 (R2010)) ANSI/AAMI/ISO 10993-2-2006 (R2014),Biological evaluation of medical
PINS Date: devices - Part 2: Animal welfare requirements (reaffirmation of
Public Review Start: Apr 18, 2014 ANSI/AAMI/ISO 10993-2-2006 (R2010))
Approval Date: Sep 24, 2014 PINS Date:
Public Review Start: Jul 11, 2014
Approval Date: Oct 8, 2014
ANSI/AAMI/ISO 10993-12-2012,Biological evaluation of medical
devices - Part 12: Sample preparation and reference materials
(identical national adoption of ISO 10993-12 and revision of ANSI/AAMI/ISO 10993-3-2014,Biological evaluation of medical devices
ANSI/AAMI/ISO 10993-12-2007) - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
PINS Date: Aug 7, 2009 (identical national adoption of and revision of ANSI/AAMI/ISO 10993-3
Public Review Start: Jun 25, 2010 -2003 (R2013))
Approval Date: Jul 26, 2012 PINS Date: Feb 9, 2007
Public Review Start: Mar 8, 2013
Approval Date: Aug 14, 2014
ANSI/AAMI/ISO 10993-13-2010 (R2014),Biological evaluation of
medical devices - Part 13: Identification and quantification of
degradation products from polymeric medical devices (reaffirmation of ANSI/AAMI/ISO 10993-4-Amd1-2006 (R2009),Biological evaluation of
ANSI/AAMI/ISO 10993-13-2010) medical devices - Part 4: Selection of test for interactions with blood
PINS Date: (Amendment 1) (reaffirmation of ANSI/AAMI/ISO 10993-4-Amd1-2006)
Public Review Start: Jul 11, 2014 PINS Date:
Approval Date: Oct 8, 2014 Public Review Start: Oct 10, 2008
Approval Date: Mar 5, 2009
ANSI/AAMI/ISO 10993-14-2001 (R2011),Biological evaluation of
medical devices - Part 14: Identification and quantification of ANSI/AAMI/ISO 10993-4:2002 (R2013),Biological evaluation of medical
degradation products from ceramics (reaffirmation of ANSI/AAMI/ISO devices - Part 4: Selection of tests for interactions with blood
10993-14-2001 (R2006)) (reaffirmation of ANSI/AAMI/ISO 10993-4-2002 (R2009))
PINS Date: PINS Date:
Public Review Start: Jun 17, 2011 Public Review Start: Aug 16, 2013
Approval Date: Nov 16, 2011 Approval Date: Nov 26, 2013
Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 6
Approved American National Standards The data in this document is reported as of Monday, September 28, 2015
ANSI/AAMI/ISO 10993-5-2009 (R2014),Biological evaluation of medical ANSI/AAMI/ISO 11137-3-2006 (R2010),Sterilization of health care
devices - Part 5: Tests for in vitro cytotoxicity (reaffirmation of products - Radiation - Part 3: Guidance on dosimetric aspects
ANSI/AAMI/ISO 10993-5-2009) (reaffirmation of ANSI/AAMI/ISO 11137-3-2006)
PINS Date: PINS Date:
Public Review Start: Aug 16, 2013 Public Review Start: Jul 3, 2009
Approval Date: Feb 6, 2014 Approval Date: Apr 20, 2010
ANSI/AAMI/ISO 10993-6-2007 (R2014),Biological evaluation of medical ANSI/AAMI/ISO 11138-1-2006 (R2010),Sterilization of health care
devices - Part 6: Tests for local effects after implantation (reaffirmation products - Biological indicators - Part 1: General requirements
of ANSI/AAMI/ISO 10993-6-2007 (R2010)) (reaffirmation of ANSI/AAMI/ISO 11138-1-2006)
PINS Date: PINS Date:
Public Review Start: Apr 18, 2014 Public Review Start: Sep 11, 2009
Approval Date: Sep 24, 2014 Approval Date: Apr 22, 2010
ANSI/AAMI/ISO 10993-7-2008 (R2012),Biological evaluation of medical ANSI/AAMI/ISO 11138-2-2006 (R2010),Sterilization of health care
devices - Part 7: Ethylene oxide sterilization residuals (reaffirmation of products - Biological indicators - Part 2: Biological indicators for
ANSI/AAMI/ISO 10993-7-2008) ethylene oxide sterilization processes (reaffirmation of ANSI/AAMI/ISO
PINS Date: 11138-2-2006)
Public Review Start: Dec 16, 2011 PINS Date:
Approval Date: Jun 1, 2012 Public Review Start: Sep 11, 2009
Approval Date: Apr 22, 2010
ANSI/AAMI/ISO 10993-9-1999 (R2014),Biological evaluation of medical
devices - Part 9: Framework for identification and quantification of ANSI/AAMI/ISO 11138-3-2006 (R2010),Sterilization of health care
potential degradation products (reaffirmation of ANSI/AAMI/ISO 10993 products - Biological indicators - Part 3: Biological indicators for moist
-9-2009) heat sterilization processes (reaffirmation of ANSI/AAMI/ISO 11138-3
PINS Date: -2006)
Public Review Start: Apr 18, 2014 PINS Date:
Approval Date: Sep 23, 2014 Public Review Start: Sep 11, 2009
Approval Date: Apr 22, 2010
ANSI/AAMI/ISO 11135-2015,Sterilization of health care products -
Ethylene oxide - Requirements for the development, validation and ANSI/AAMI/ISO 11138-4-2006 (R2010),Sterilization of health care
routine control of a sterilization process for medical devices (identical products - Biological indicators - Part 4: Biological indicators for dry
national adoption of ISO 11135:2014 and revision of ANSI/AAMI/ISO heat sterilization processes (reaffirmation of ANSI/AAMI/ISO 11138-4
11135-1-2007) -2006)
PINS Date: PINS Date:
Public Review Start: Jul 25, 2014 Public Review Start: Sep 11, 2009
Approval Date: Jul 27, 2015 Approval Date: Apr 22, 2010
ANSI/AAMI/ISO 11137-1-2006 (R2010),Sterilization of health care ANSI/AAMI/ISO 11138-5-2006 (R2010),Sterilization of health care
products - Radiation - Part 1: Requirements for the development, products - Biological indicators - Part 5: Biological indicators for low-
validation and routine control of a sterilization process for medical temperature steam and formaldehyde sterilization processes
devices (reaffirmation of ANSI/AAMI/ISO 11137-1-2006) (reaffirmation of ANSI/AAMI/ISO 11138-5-2006)
PINS Date: PINS Date:
Public Review Start: Jul 3, 2009 Public Review Start: Sep 11, 2009
Approval Date: Apr 20, 2010 Approval Date: Apr 22, 2010
ANSI/AAMI/ISO 11137-1:2006/Amd 1-2013,Sterilization of health care ANSI/AAMI/ISO 11140-1-2014,Sterilization of health care products -
products - Radiation - Part 1: Requirements for development, Chemical indicators - Part 1: General requirements (identical national
validation and routine control of a sterilization process for medical adoption of ISO/DIS 11140-1 and revision of ANSI/AAMI/ISO 11140-1
devices - Amendment 1 (identical national adoption of ISO 11137 -2005 (R2010))
-1:2006/DAmd 1) PINS Date: Dec 2, 2011
PINS Date: Jul 20, 2012 Public Review Start: Sep 7, 2012
Public Review Start: Oct 26, 2012 Approval Date: Sep 10, 2014
Approval Date: Dec 30, 2013
ANSI/AAMI/ISO 11140-3-2007 (R2012),Sterilization of health care
ANSI/AAMI/ISO 11137-2, third edition-2013,Sterilization of health care products - Chemical indicators - Part 3: Class 2 indicator systems for use
products - Radiation - Part 2: Establishing the sterilization dose in the Bowie and Dick-type steam penetration test (reaffirmation of
(revision of ANSI/AAMI/ISO 11137-2-2012) ANSI/AAMI/ISO 11140-3-2007)
PINS Date: Feb 22, 2013 PINS Date:
Public Review Start: Feb 22, 2013 Public Review Start: Oct 21, 2011
Approval Date: Jul 10, 2013 Approval Date: Aug 7, 2012
Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 7
Approved American National Standards The data in this document is reported as of Monday, September 28, 2015
ANSI/AAMI/ISO 11140-4-2007 (R2012),Sterilization of health care ANSI/AAMI/ISO 11712-2014,Anaesthetic and respiratory equipment –
products - Chemical indicators - Part 4: Class 2 indicators as an supralaryngeal airways and connectors (identical national adoption of
alternative to the Bowie and Dick-type test for detection of steam ISO 11712)
penetration (reaffirmation of ANSI/AAMI/ISO 11140-4-2007) PINS Date: Nov 22, 2013
PINS Date: Public Review Start: Jan 3, 2014
Public Review Start: Oct 21, 2011 Approval Date: Feb 18, 2014
Approval Date: Aug 7, 2012
ANSI/AAMI/ISO 11737-1-2006 (R2011),Sterilization of medical devices
ANSI/AAMI/ISO 11140-5-2007 (R2012),Sterilization of health care - Microbiological methods - Part 1: Determination of a population of
products - Chemical indicators - Part 5: Class 2 indicators for Bowie and microorganisms on products (reaffirmation of ANSI/AAMI/ISO 11737-1
Dick-type air removal tests (reaffirmation of ANSI/AAMI/ISO 11140-5 -2006)
-2007) PINS Date:
PINS Date: Public Review Start: Jun 3, 2011
Public Review Start: Oct 21, 2011 Approval Date: Nov 16, 2011
Approval Date: Aug 7, 2012
ANSI/AAMI/ISO 11737-2-2009 (R2014),Sterilization of medical devices
ANSI/AAMI/ISO 11195-2009,Gas mixers for medical use – stand-alone - Microbiological methods - Part 2: Tests of sterility performed in the
gas mixers (national adoption with modifications of ISO 11195) definition, validation and maintenance of a sterilization process
PINS Date: Apr 3, 2009 (reaffirmation of ANSI/AAMI/ISO 11737-2-2009)
Public Review Start: May 15, 2009 PINS Date:
Approval Date: Jun 30, 2009 Public Review Start: Jan 31, 2014
Approval Date: Oct 13, 2014
ANSI/AAMI/ISO 11607-1-2006 (R2010),Packaging for terminally
sterilized medical devices - Part 1: Requirements for materials, sterile ANSI/AAMI/ISO 13022-2012,Medical products containing viable
barrier systems, and packaging (reaffirmation of ANSI/AAMI/ISO 11607 human cells -- Application of risk management and requirements for
-1-2006) processing practices (identical national adoption of ISO 13022)
PINS Date: PINS Date: May 8, 2009
Public Review Start: Aug 14, 2009 Public Review Start: Oct 29, 2010
Approval Date: Dec 14, 2010 Approval Date: Jun 18, 2012
ANSI/AAMI/ISO 11607-1:2006, A1-2014,Amendment 1 to ANSI/AAMI/ISO 13408-1-2008 (R2011),Aseptic processing of health
ANSI/AAMI/ISO 11607-1:2006, Packaging for terminally sterilized care products - Part 1: General requirements (reaffirmation of
medical devices - Part 1: Requirements for materials, sterile barrier ANSI/AAMI/ISO 13408-1-2008)
systems, and packaging (addenda to ANSI/AAMI/ISO 11607-1:2006) PINS Date:
PINS Date: Public Review Start: Aug 5, 2011
Public Review Start: Apr 19, 2013 Approval Date: Dec 14, 2011
Approval Date: Sep 10, 2014
ANSI/AAMI/ISO 13408-1-2008/A1-2013,Aseptic processing of health
ANSI/AAMI/ISO 11607-2-2006 (R2010),Packaging for terminally care products - Part 1: General requirements - Amendment 1 (addenda
sterilized medical devices - Part 2: Validation requirements for forming, to ANSI/AAMI/ISO 13408-1-2008)
sealing and assembly processes (reaffirmation of ANSI/AAMI/ISO PINS Date: Jul 22, 2011
11607-2-2006) Public Review Start: Oct 14, 2011
PINS Date: Approval Date: Mar 27, 2013
Public Review Start: Aug 14, 2009
Approval Date: Dec 14, 2010
ANSI/AAMI/ISO 13408-2-2003 (R2013),Aseptic processing of health
care products - Part 2: Filtration (reaffirmation of ANSI/AAMI/ISO
ANSI/AAMI/ISO 11607-2:2006, A1-2014,Amendment 1 to 13408-2-2003)
ANSI/AAMI/ISO 11607-2:2006, Packaging for terminally sterilized PINS Date:
medical devices - Part 2: Validation requirements for forming, sealing Public Review Start: Sep 6, 2013
and assembly processes (addenda to ANSI/AAMI/ISO 11607-2:2006) Approval Date: Dec 4, 2013
PINS Date:
Public Review Start: Apr 19, 2013
ANSI/AAMI/ISO 13408-3-2012 (R2015),Aseptic processing of health
Approval Date: Sep 10, 2014
care products - Part 3: Lyophilization (reaffirmation of ANSI/AAMI/ISO
13408-3-2006 (R2012))
ANSI/AAMI/ISO 11658-2012,Cardiovascular implants and PINS Date:
extracorporeal systems - Blood/tissue contact surface modifications for Public Review Start: Feb 13, 2015
extracorporeal perfusion systems (identical national adoption of ISO Approval Date: Jul 13, 2015
11658)
PINS Date: Oct 23, 2009
Public Review Start: May 6, 2011
Approval Date: Aug 20, 2012
Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 8
Approved American National Standards The data in this document is reported as of Monday, September 28, 2015
ANSI/AAMI/ISO 13408-4-2005 (R2012),Aseptic processing of health ANSI/AAMI/ISO 14155-1-2003 (R2008),Clinical investigation of medical
care products - Part 4: Clean-in-place technologies (reaffirmation of devices for human subjects - Part 1: General requirements
ANSI/AAMI/ISO 13408-4-2005) (reaffirmation of ANSI/AAMI/ISO 14155-1-2003)
PINS Date: PINS Date:
Public Review Start: Aug 17, 2012 Public Review Start: Sep 19, 2008
Approval Date: Nov 30, 2012 Approval Date: Dec 19, 2008
ANSI/AAMI/ISO 13408-4-2005 (R2014),Aseptic processing of health ANSI/AAMI/ISO 14155-2-2003 (R2008),Clinical investigation of medical
care products - Part 4: Clean-in-place technologies (reaffirmation of devices for human subjects - Part 2: Clinical investigation plans
ANSI/AAMI/ISO 13408-4-2005 (R2012)) (reaffirmation of ANSI/AAMI/ISO 14155-2-2003)
PINS Date: PINS Date:
Public Review Start: Jan 31, 2014 Public Review Start: Sep 19, 2008
Approval Date: Oct 13, 2014 Approval Date: Dec 19, 2008
ANSI/AAMI/ISO 13408-5-2012 (R2015),Aseptic processing of health ANSI/AAMI/ISO 14155-2010,Clinical investigation of medical devices
care products - Part 5: Sterilization in place (reaffirmation of for human subjects - Good clinical practice (identical national
ANSI/AAMI/ISO 13408-5-2006 (R2012)) adoption of ISO 14155)
PINS Date: PINS Date: Jan 23, 2009
Public Review Start: May 1, 2015 Public Review Start: Nov 13, 2009
Approval Date: Aug 3, 2015 Approval Date: Dec 30, 2010
ANSI/AAMI/ISO 13408-6-2005 (R2013),Aseptic processing of health ANSI/AAMI/ISO 14160-2011,Sterilization of health care products -
care products - Part 6: Isolator systems (reaffirmation of Liquid chemical sterilizing agents for single-use medical devices utilizing
ANSI/AAMI/ISO 13408-6-2005) animal tissues and their derivatives - Requirements for
PINS Date: characterization, development, validation and routine control of a
Public Review Start: Aug 16, 2013 sterilization process for medical devices (identical national adoption of
Approval Date: Nov 26, 2013 ISO 14160 and revision of ANSI/AAMI/ISO 14160-1998 (R2008))
PINS Date: Jan 23, 2009
Public Review Start: Apr 24, 2009
ANSI/AAMI/ISO 13408-6-2005/A1-2013,Aseptic processing of health
Approval Date: Dec 5, 2011
care products - Part 6: Isolator systems - Amendment 1 (addenda to
ANSI/AAMI/ISO 13408-6-2005)
PINS Date: Sep 23, 2011 ANSI/AAMI/ISO 14161-2009 (R2014),Sterilization of health care
Public Review Start: May 4, 2012 products - Biological indicators - Guidance for the selection, use and
Approval Date: Mar 11, 2013 interpretation of results (reaffirmation of ANSI/AAMI/ISO 14161-2009)
PINS Date:
Public Review Start: Nov 8, 2013
ANSI/AAMI/ISO 13408-7-2012,Aseptic processing of health care
Approval Date: Apr 2, 2014
products - Part 7: Alternative processes for atypical medical devices and
combination products (identical national adoption of ISO 13408-7
(under development)) ANSI/AAMI/ISO 14408-2009,Tracheal tubes designed for laser surgery
PINS Date: – requirements for marking and accompanying information (identical
Public Review Start: Mar 18, 2011 national adoption of ISO 14408:2005)
Approval Date: Jul 26, 2012 PINS Date: Jul 18, 2008
Public Review Start: Mar 6, 2009
Approval Date: Apr 21, 2009
ANSI/AAMI/ISO 13485-2003 (R2013),Medical devices - Quality
management systems - Requirements for regulatory purposes
(reaffirmation of ANSI/AAMI/ISO 13485-2003 (R2009)) ANSI/AAMI/ISO 14708-3-2008 (R2011),Implants for surgery - Active
PINS Date: implantable medical devices - Part 3: Implantable neurostimulators
Public Review Start: Aug 30, 2013 (reaffirmation of ANSI/AAMI/ISO 14708-3-2008)
Approval Date: Oct 23, 2013 PINS Date:
Public Review Start: Jun 3, 2011
Approval Date: Nov 16, 2011
ANSI/AAMI/ISO 14117-2012,Active implantable medical devices -
Electromagnetic compatibility - EMC test protocols for implantable
cardiac pacemakers, implantable cardioverter defibrillators and cardiac ANSI/AAMI/ISO 14708-4-2008 (R2011),Implants for surgery - Active
resynchronization devices (identical national adoption of ISO 14117 implantable medical devices - Part 4: Implantable infusion pumps
and revision of ANSI/AAMI PC69-2007) (reaffirmation of ANSI/AAMI/ISO 14708-4-2008)
PINS Date: Jul 23, 2010 PINS Date:
Public Review Start: Jun 29, 2012 Public Review Start: Jun 17, 2011
Approval Date: Nov 30, 2012 Approval Date: Nov 16, 2011
Provided by American National Standards Institute www.ansi.org Monday, September 28, 2015 PAGE | 9