Proposed American National Standards Projects

The data in this document is reported as of Friday, January 18, 2019 Proposed American National Standards Projects User Guide for Proposed American National Standards (ANS) related Data Listed below are proposed projects intended to result in American National Standards (ANS) as of 1/18/2019. To review additional information about these proposed ANS you may access archived issues of ANSI s Standards Action www.ansi.org/standardsaction using the PINS Date and/or Public Review Start Date. If a PINS Date or a Public Review date is not displayed, then an announcement has not been published. Questions concerning a particular ANS should be directed to the sponsoring ANSI-Accredited Standards Developer (ASD). If your ANSI-accredited organization would like to report discrepancies or changes, please contact us at psa@ansi.org. We will provide you with a customized Excel report and instructions for how to transmit your comments or corrections. Please do not use this pdf report for reconciliation. Information about approved ANS is available in a separate document in the Approved and Proposed ANS Lists folder. Some ANS are available for purchase via ANSI s webstore http://webstore.ansi.org/. 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 psa@ansi.org. Thank you for your interest. 3-A (3-A Sanitary Standards, Inc. ) www.3-a.org BSR/3-A P3-A 004-200x, Standard For Vessels and Agitators For Use In The Manufacture of Active Pharmaceutical Ingredients (new 1/7/2005 BSR/3-A P3-A 005-200x, Standard For Mills and Classification Equipment For Use In The Manufacture of Active Pharmaceutical Ingredients (new 1/7/2005 BSR/3-A P3-A 006-200x, Standard For Process Heat Exchangers For Use In The Manufacture of Active Pharmaceutical Ingredients (new 1/7/2005 AA (ASC H35) (Aluminum Association ) www.aluminum.org BSR H35.2M-201x, Standard Dimensional Tolerances for Aluminum Mill Products (revision of ANSI H35.2M-2017) 4/6/2018 BSR H35.3-200x, Designation System for Aluminum Hardeners (revision of ANSI H35.3-1997 (R2006)) 6/9/2006 BSR H35.4-200x, Designation System for Unalloyed Aluminum (revision of ANSI H35.4-2006) 6/9/2006 BSR H35.5-200x, Nomenclature System for Aluminum Metal Matrix Composite Material (revision of ANSI H35.5-1993 (R2006)) 6/9/2006 AABC (Associated Air Balance Council ) www.aabc.com BSR H35.1-201x, Standard Alloy and Temper Designation Systems for Aluminum (revision and redesignation of ANSI H35.1/H35.1(M)-2017) 4/6/2018 BSR/AABC MN-1-201x, AABC National Standards for Total System Balance, 8th Edition (revision of ANSI/AABC MN-1-2016) 7/6/2018 BSR H35.1(M)-200x, Alloy and Temper Designation Systems for Aluminum (revision of ANSI H35.1(M)-2004) 12/9/2005 BSR H35.2-201x, Standard Dimensional Tolerances for Aluminum Mill Products (revision of ANSI H35.2-2017) 4/6/2018 AAFS (American Academy of Forensic Sciences ) www.aafs.org BSR/ASB BPR 021-201x, Best Practices for the Preparation of Test Impressions from Footwear and Tires (new 2/10/2017 Public Review Start: 11/9/2018 End: 12/24/2018 Provided by the American National Standards Institute www.ansi.org Friday, January 18, 2019 PAGE 1

BSR/ASB BPR 060-201x, Guidelines for Barrel and Overall Length Measurements for Firearms (new 10/5/2018 BSR/ASB BPR 089-201x, Best Practice Recommendation for Facial Approximation in Forensic Anthropology (new 11/2/2018 Public Review Start: 12/7/2018 End: 1/21/2019 Order from: Document will be provided electronically on AAFS Standards Board website free of charge Obtain an electronic copy from: http://www.asbstandardsboard.org/ Send comments (with copy to psa@ansi.org) to: asb@aafs.org. Document and comments template can be viewed on the AAFS Standards Board website at: http://www.asbstandardsboard.org/noticeof-standard-development-and-coordination// BSR/ASB BPR 107-201x, Best Practice Recommendation for Measuring Trigger Pull of a Firearm and Estimating Its Uncertainty (new 12/21/2018 BSR/ASB BPR 108-201x, Forensic Odontology in Disaster Victim Identification: Best Practice Recommendations for the Medicolegal Authority. (new 10/19/2018 BSR/ASB Standard 063-201x, Implementation of 3D Technologies in Forensic Firearm and Toolmark Comparison Laboratories (new 7/27/2018 BSR/ASB Std 005-201x, Mass Fatality Incident Data Management: Best Practice Recommendations for the Medicolegal Authority (new 10/14/2016 BSR/ASB Std 006-201x, Best Practice Recommendation for Planning DNA Sample Collection and Analysis for the Identification Process in Mass Fatality Incidents (new 10/14/2016 Public Review Start: 6/29/2018 End: 8/13/2018 BSR/ASB Std 008-201x, Mass Fatality Scene Processing: Best Practice Recommendations for the Medicolegal Authority (new 10/14/2016 BSR/ASB Std 009-201x, Best Practice Recommendations For The Examination Of Human Remains By Forensic Pathologists In The Disaster Victim Identification Context (new 10/14/2016 Public Review Start: 12/15/2017 End: 1/29/2018 BSR/ASB Std 011-201x, Scope of Expertise in Forensic Document Examination (new 10/28/2016 Public Review Start: 10/26/2018 End: 12/10/2018 BSR/ASB Std 012-201x, Guideline for the Articulation of the Decision Making Process Leading to an Expert Opinion of Source Identification in Friction Ridge Examination (new 12/2/2016 BSR/ASB Std 013-201x, Standard for Reporting Qualitative Source Conclusions (new 12/2/2016 BSR/ASB Std 014-201x, Standard for Training to Competency to Perform Friction Ridge Examination (new 12/2/2016 BSR/ASB Std 015-201x, Standard for the Examination of Friction Ridge Evidence (new 12/2/2016 BSR/ASB Std 018-201x, Validation Standards for Probabilistic Genotyping Systems (new 12/2/2016 Public Review Start: 9/28/2018 End: 11/12/2018 BSR/ASB Std 019-201x, Wildlife Forensics General Standards (new 12/9/2016 Public Review Start: 10/12/2018 End: 11/26/2018 BSR/ASB Std 022-201x, Standard for Forensic DNA Analysis Training Programs (new 3/17/2017 Public Review Start: 10/5/2018 End: 11/19/2018 BSR/ASB Std 023-201x, Standard for Training of Forensic DNA Isolation and Purification Methods (new 3/17/2017 Provided by the American National Standards Institute www.ansi.org Friday, January 18, 2019 PAGE 2

BSR/ASB Std 024-201x, Crime Scene/Death Investigation - Dogs and Sensors Pre-Scented Canines - Location Check (new 3/17/2017 BSR/ASB Std 026-201x, Crime Scene/Death Investigation - Dogs and SensorsPre-Scented Canines - Aged Trail Search (new 3/17/2017 BSR/ASB Std 027-201x, Crime Scene/Death Investigation Dogs and Sensors - Patrol Dogs: Tracking/Trailing/Area Search/Building Search/Evidence Search of One or More Persons Based on Last Known Position (new 2/9/2018 BSR/ASB Std 028-201x, Wildlife Forensics Morphology Standard (new 6/2/2017 Public Review Start: 10/12/2018 End: 11/26/2018 BSR/ASB Std 029-201x, Wildlife Forensics Report Writing Standard (new 6/2/2017 Public Review Start: 10/12/2018 End: 11/26/2018 BSR/ASB Std 030-201x, Standards for a Quality Assurance Program in Bloodstain Pattern Analysis (new 3/23/2018 BSR/ASB Std 031-201x, Guidelines for Report Writing in Bloodstain Pattern Analysis (new 3/23/2018 Public Review Start: 9/28/2018 End: 11/12/2018 BSR/ASB Std 032-201x, Standards for Minimum Training and Education Requirements for Bloodstain Pattern Analysts (new 4/27/2018 Public Review Start: 8/10/2018 End: 9/24/2018 BSR/ASB Std 035-201x, Standard for the Examination of Documents for Alterations (new 6/23/2017 Public Review Start: 12/7/2018 End: 1/21/2019 Order from: Document will be provided electronically on AAFS Standards Board website free of charge Obtain an electronic copy from: http://www.asbstandardsboard.org/ Send comments (with copy to psa@ansi.org) to: asb@aafs.org. This is a public comment period for a recirculation. Updated document, redline version, and comments can be viewed on the AAFS Standards Board website at: http://www.asbstandardsboard.org/notice-of-standarddevelopment-and-coordination/. BSR/ASB Std 036-201x, Standard Practices for Method Validation in Forensic Toxicology (new 6/9/2017 Public Review Start: 9/21/2018 End: 11/5/2018 BSR/ASB Std 038-201x, Standards for Internal Validation of Forensic DNA Testing Methods (new 7/14/2017 Public Review Start: 6/22/2018 End: 8/6/2018 BSR/ASB Std 039-201x, Standards for Internal Validation of Human Short Tandem Repeat Profiling on Capillary Electrophoresis Platforms (new 7/14/2017 BSR/ASB Std 040-201x, Standards for Forensic DNA Interpretation and Comparison Protocols (new 7/14/2017 Public Review Start: 10/5/2018 End: 11/19/2018 BSR/ASB Std 041-201x, Assigning Propositions for Likelihood Ratios in Forensic DNA Interpretations. (new 8/24/2018 BSR/ASB Std 042-201x, Standard for Disaster Live Human Detection Dogs Programsâ Training, Certification, and Documentation (new 7/28/2017 BSR/ASB Std 043-201x, Standard for Disaster Human Remains Detection Dogs Programsâ Training, Certification, and Documentation (new 7/28/2017 Provided by the American National Standards Institute www.ansi.org Friday, January 18, 2019 PAGE 3

BSR/ASB Std 044-201x, Standard for the Examination of Documents for Indentations (new 2/23/2018 Public Review Start: 10/26/2018 End: 12/10/2018 BSR/ASB Std 045-201x, Standard for Stature Estimation from Human Remains (new 8/31/2018 Public Review Start: 10/26/2018 End: 12/10/2018 BSR/ASB Std 046-201x, Wildlife Forensics Validation Standards New Tests for Validating Short Tandem Repeat (STR) Primers (new 7/28/2017 Public Review Start: 8/10/2018 End: 9/24/2018 BSR/ASB Std 047-201x, Wildlife Forensics Validation Standard Validating New Primers for Sequencing (new 7/28/2017 Public Review Start: 8/10/2018 End: 9/24/2018 BSR/ASB Std 048-201x, Wildlife Forensic DNA Standard Procedures (new 7/28/2017 Public Review Start: 8/10/2018 End: 9/24/2018 BSR/ASB Std 053-201x, Standard for Report Content in Forensic Toxicology (new 5/18/2018 Public Review Start: 9/21/2018 End: 11/5/2018 BSR/ASB Std 054-201x, Standard for a Quality Control Program in Forensic Toxicology Laboratories (new 5/18/2018 Public Review Start: 11/9/2018 End: 12/24/2018 BSR/ASB Std 056-201x, Standard for Estimation of Measurement Uncertainty in Forensic Toxicology Laboratories (new 11/17/2017 BSR/ASB Std 057-201x, Standard for the Scope and Sensitivity of Forensic Toxicological Testing (new 2/23/2018 BSR/ASB Std 058-201x, Standard Method for Blood Ethanol Identification and Quantitation in Forensic Toxicology Laboratories. (new 8/17/2018 BSR/ASB Std 061-201x, Firearms and Toolmarks 3D Measurement Systems and Measurement Quality Control (new 5/25/2018 BSR/ASB Std 062-201x, Standard for Topography Comparison Software for Firearm and Toolmark Analysis (new 10/19/2018 BSR/ASB Std 064-201x, Standard Test Method for the Forensic Physical Examination and Classification of Firearms (new 5/25/2018 BSR/ASB Std 065-201x, Standard Test Method for Function and Operability Testing of Firearms (new 7/6/2018 BSR/ASB Std 067-201x, Test Method for Measuring Trigger Pull of Firearms (new 5/25/2018 BSR/ASB Std 068-201x, Best Practice Recommendations for the Safe Handling of Firearms and Ammunition During Forensic Analysis (new 5/25/2018 BSR/ASB Std 069-201x, Test Method for Measuring Barrel and Overall Length of Firearms. (new 4/20/2018 BSR/ASB Std 070-201x, Standard for Forensic Examination of Handwritten Items (new 5/18/2018 BSR/ASB Std 072-201x, Standards for the Validation of Procedures in Bloodstain Pattern Analysis (new 4/6/2018 Public Review Start: 8/10/2018 End: 9/24/2018 BSR/ASB Std 074-201x, Agriculture Detection Canine Training, Certification, and Document Management Standards (new 8/3/2018 Provided by the American National Standards Institute www.ansi.org Friday, January 18, 2019 PAGE 4

BSR/ASB Std 075-201x, Human Remains Detection in Water (new 4/27/2018 BSR/ASB Std 076-201x, Human Remains Canine Detection on Land (new 5/11/2018 BSR/ASB Std 077-201x, Standard for the Developmental and Internal Validation of Forensic Serological Methods (new 8/24/2018 Public Review Start: 10/5/2018 End: 11/19/2018 BSR/ASB Std 078-201x, Standard for Training of Forensic Autosomal and Y STR Data Interpretation (new 8/3/2018 BSR/ASB Std 079-201x, Standard for Training of the Combined DNA Index System (new 8/3/2018 BSR/ASB Std 080-201x, Standard for Training to Perform Forensic DNA Reporting and Review (new 6/15/2018 BSR/ASB Std 081-201x, Standard for Training in the Use of Statistics in Interpretation of Forensic DNA Evidence (new 4/27/2018 BSR/ASB Std 082-201x, Canine Article Search (new 5/11/2018 BSR/ASB STD 083-201x, Contraband Canine Detection (new 5/25/2018 BSR/ASB Std 085-201x, Detection Canine Selection, Kenneling and Healthcare (new 4/27/2018 BSR/ASB Std 086-201x, Narcotic Canine Detection (new 5/11/2018 BSR/ASB Std 087-201x, Pest and Insect Canine Detection (new 4/27/2018 BSR/ASB Std 088-201x, General Guidelines for Training, Certification, and Documentation of Canine Detection Disciplines (new 5/11/2018 Public Review Start: 11/9/2018 End: 12/24/2018 BSR/ASB Std 090-201x, Standard for Sex Assessment in Forensic Anthropology (new 8/31/2018 Public Review Start: 12/14/2018 End: 1/28/2019 Order from: Document will be provided electronically on AAFS Standards Board website free of charge Obtain an electronic copy from: http://www.asbstandardsboard.org/ Send comments (with copy to psa@ansi.org) to: asb@aafs.org. Document and comments template can be viewed on the AAFS Standards Board website at: http://www.asbstandardsboard.org/notice of-standard-development-and-coordination// BSR/ASB Std 091-201x, Standard for Training of Analysis of Forensic STR Data. (new 6/1/2018 BSR/ASB STD 093-201x, Standard Test Method for the Examination and Testing of Firearms (new 7/27/2018 BSR/ASB Std 094-201x, Postmortem Fingerprint Recovery: Guidance and Best Practices for Disaster Victim Identification. (new 8/3/2018 BSR/ASB Std 095-201x, Standard for Minimum Qualifications and Training for a Footwear/Tire Forensic Science Service Provider. (new 7/20/2018 BSR/ASB STD 096-201x, Standard Test Method for the Examination and Testing of Ammunition (new 7/27/2018 Provided by the American National Standards Institute www.ansi.org Friday, January 18, 2019 PAGE 5

BSR/ASB STD 098-201x, Standard for Mass Spectral Data Acceptance in Forensic Toxicology (new 8/17/2018 BSR/ASB Std 099-201x, Standard for Footwear/Tire Examination Proficiency Testing Program (new 8/31/2018 Public Review Start: 10/19/2018 End: 12/3/2018 BSR/ASB Std 104-201x, Standard for 3D Virtual Comparison Microscopy for Firearm and Toolmark Analysis (new 8/10/2018 BSR/ASB Std 105-201x, Minimum Education Requirements for Firearm and Toolmark Examiner Trainees (new 11/9/2018 BSR/ASB Std 106-201x, Wildlife Forensic-Protein Serology Method for Taxonomic Identification. (new 9/21/2018 Public Review Start: 12/7/2018 End: 1/21/2019 Order from: Document will be provided electronically on AAFS Standards Board website free of charge Obtain an electronic copy from: http://www.asbstandardsboard.org/ Send comments (with copy to psa@ansi.org) to: asb@aafs.org. Document and comments template can be viewed on the AAFS Standards Board website at: http://www.asbstandardsboard.org/noticeof-standard-development-and-coordination// BSR/ASB Std 110-201x, Standard for Training in Forensic Serological Methods (new 12/14/2018 AAMI (Association for the Advancement of Medical Instrumentation ) www.aami.org BSR/AAMI 2700-1-201x, Medical Devices and Medical Systems Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) Part 1: General requirements and conceptual model (new 12/28/2018 BSR/AAMI 2700-1201x, Medical Devices and Medical Systems Essential safety requirements for equipment comprising the patient-centric integrated clinical environment (ICE) Part 1: General requirements and conceptual model (new 12/21/2018 BSR/AAMI BE83-2006 (R201x), Biological evaluation of medical devices - Part 18: Chemical characterization of materials (reaffirmation of ANSI/AAMI BE83-2006 (R2011)) Public Review Start: 11/18/2016 End: 1/2/2017 BSR/AAMI CN27-201x, General Requirements for small-bore connector actuated valves incorporated into medical devices (new 7/29/2016 BSR/AAMI EQ103-201x, Alternative Equipment Management in Healthcare Delivery Organizations (new 8/3/2018 BSR/AAMI EQ56-2013 (R201x), Recommended practice for a medical equipment management program (reaffirmation of ANSI/AAMI EQ56-2013) Public Review Start: 8/18/2017 End: 10/17/2017 BSR/AAMI EQ56-201x, Recommended Practice for a Medical Equipment Management Program (revision of ANSI/AAMI EQ56-2013) 8/3/2018 BSR/AAMI EQ93-201x, Medical equipment management - Vocabulary used in medical equipment programs (new 4/29/2016 Public Review Start: 7/20/2018 End: 9/3/2018 BSR/AAMI EQ94-201x, Healthcare technology acquisition (new 7/29/2016 Provided by the American National Standards Institute www.ansi.org Friday, January 18, 2019 PAGE 6

BSR/AAMI HA60601-1-11, Amendment 1-201x, Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment, Amendment 1 (addenda to ANSI/AAMI HA60601-1-11-2015) 7/28/2017 IEC Adoption BSR/AAMI HIT1000-1-201x, Health IT Software and Systems - Part 1: Fundamental concepts and principles (new 7/28/2017 BSR/AAMI HIT1000-2-201x, Health IT software and systems - Part 2: Application of quality systems principles and practices (new 7/28/2017 BSR/AAMI HIT1000-3-201x, Health IT software and systems - Part 3: Application of risk management (new 7/28/2017 BSR/AAMI HIT1000-4-201x, Health IT software and systems - Part 4: Application of human factors engineering (new 7/28/2017 BSR/AAMI IT51-199x, Transport Infant Incubators (new Public Review Start: 11/10/1995 End: 1/9/1996 BSR/AAMI MC84-200x, Mechanical circulatory support device evaluation - Preclinical testing (new 12/2/2011 BSR/AAMI PB70-201x, Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities (revision of ANSI/AAMI PB70-2012) 1/4/2019 BSR/AAMI PC76-201x, Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and implantable cardioverter defibrillators exposed to magnetic resonance imaging (new 4/15/2011 BSR/AAMI PC85-200x, Active implantable medical devices - Test protocols for transvenous leads for implantable cardiac pacemakers and implantable cardioverter defibrillators (ICD) (new 4/17/2009 BSR/AAMI RD47-2008 (R201x), Reprocessing of hemodialyzers (reaffirmation of ANSI/AAMI RD47-2008 (R2013)) Public Review Start: 2/9/2018 End: 3/26/2018 BSR/AAMI RD61-2006 (R201x), Concentrates for hemodialysis (reaffirmation of ANSI/AAMI RD61-2006) Public Review Start: 10/22/2010 End: 12/6/2010 BSR/AAMI RD62-2006 (R201x), Water treatment equipment for hemodialysis applications (reaffirmation of ANSI/AAMI RD62-2006) Public Review Start: 10/22/2010 End: 12/6/2010 BSR/AAMI RD62/A1-2009 (R201x), Water treatment equipment for hemodialysis applications, Amendment 1-4.2.6, Deionization (reaffirmation of ANSI/AAMI RD62/A1-2009) Public Review Start: 10/22/2010 End: 12/6/2010 BSR/AAMI RT2-201x, Radiation therapy readiness check (new 11/6/2015 Public Review Start: 11/11/2016 End: 12/26/2016 BSR/AAMI ST100-201x, End-to-End Sterility Assurance (new 8/3/2018 BSR/AAMI ST15883-4-200x, Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermo-labile endoscopes (national adoption with modifications of ISO 15883-4:2006) 5/19/2006 BSR/AAMI ST67-201X, Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled sterile (revision of ANSI/AAMI ST67-2011 (R2017)) 11/18/2016 Public Review Start: 8/31/2018 End: 10/15/2018 Provided by the American National Standards Institute www.ansi.org Friday, January 18, 2019 PAGE 7

BSR/AAMI ST72-201x, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing (revision of ANSI/AAMI ST72-2011 (R2016)) 6/24/2016 Public Review Start: 9/1/2017 End: 10/16/2017 BSR/AAMI ST77-201x and Amendment A.1-201x, Containment devices for reusable medical device sterilization (addenda to ANSI/AAMI ST77-2013) Public Review Start: 5/22/2015 End: 7/6/2015 BSR/AAMI ST84-200x, Sterilization of health care products - Radiation - Substantiation of a selected sterilization dose - Method Vdmax (new 1/30/2009 BSR/AAMI ST91-2015 (R201x), Flexible and semi-rigid endoscope processing in health care facilities (revision of ANSI/AAMI ST91-2015) 11/18/2016 BSR/AAMI ST98-201x, Cleaning validation of health care products -- Requirements for development and validation of a cleaning process for medical devices (new 4/20/2018 BSR/AAMI SU01-201x, Sustainability of medical devices - Purchasing requirements (new 6/2/2017 BSR/AAMI SU1-201x, Elements of a Responsible Medical Device Product Lifecycle (new 4/26/2013 BSR/AAMI/IEC 60601-1-08, Amendment 2-201x, Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems, Amendment 2 (addenda to ANSI/AAMI/IEC 60601-1-8-2013) 7/28/2017 IEC Adoption BSR/AAMI/IEC 60601-2-16-201x, Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of hemodialysis, hemodiafiltration and hemofiltration equipment (identical national adoption of IEC/CDV 60601-2-16 and revision of ANSI/AAMI/IEC 60601-2-16, Ed. 4-2012) 12/23/2016 Public Review Start: 2/24/2017 End: 4/10/2017 IEC Adoption BSR/AAMI/IEC 60601-2-19/A1-201x, Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators (Amendment 1) (addenda to BSR/AAMI/IEC 60601-2-19-201x) 8/28/2015 IEC Adoption BSR/AAMI/IEC 60601-2-24-201x, Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers (identical national adoption of IEC 60601-2-24) 3/24/2017 IEC Adoption BSR/AAMI/IEC 60601-2-39-201x, Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment (identical national adoption of IEC/CDV 60601-2-39) 12/23/2016 Public Review Start: 2/24/2017 End: 4/10/2017 IEC Adoption BSR/AAMI/IEC 62304-2006/Amd 1-201x, Medical device software - Software life cycle processes - Amendment 1 (addenda to ANSI/AAMI/IEC 62304, Ed.1-2006 (R2013)) 7/17/2015 IEC Adoption BSR/AAMI/IEC 62304-201x, Medical device software - Software life cycle processes (identical national adoption of IEC 62304 and revision of ANSI/AAMI/IEC 62304, Ed.1-2006) 2/11/2011 IEC Adoption BSR/AAMI/IEC 62366-1, Amendment 1-201x, Medical devices - Part 1: Application of usability engineering to medical devices - Amendment 1 (addenda to ANSI/AAMI/IEC 62366-1-2015) 8/25/2017 Public Review Start: 9/28/2018 End: 11/12/2018 IEC Adoption Provided by the American National Standards Institute www.ansi.org Friday, January 18, 2019 PAGE 8

BSR/AAMI/IEC 80601-2-49-201x, Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors (identical national adoption of IEC 80601-2-49:2018) 1/5/2018 IEC Adoption BSR/AAMI/IEC 80601-2-77-201x, Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment (identical national adoption of IEC 80601-2-77) 1/11/2019 IEC Adoption BSR/AAMI/IEC 80601-2-78-201x, Medical electrical equipment - Part 2-78: Particular requirements for the basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation (identical national adoption of IEC 80601-2 -78) 1/11/2019 IEC Adoption BSR/AAMI/IEC 82304-1-201x, Health Software - Part 1: General requirements for product safety (identical national adoption of IEC 82304-1) 12/2/2011 Public Review Start: 9/25/2015 End: 11/9/2015 IEC Adoption BSR/AAMI/ISO 10993-1-201x, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (identical national adoption of ISO 10993-1 and revision of ANSI/AAMI/ISO 10993-1-2009 (R2013)) 7/8/2016 Public Review Start: 4/27/2018 End: 6/11/2018 BSR/AAMI/ISO 10993-11-201x, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (national adoption of ISO 10993-11 (in development) with modifications and revision of ANSI/AAMI/ISO 10993-11-2006 (R2014)) 11/27/2015 Public Review Start: 1/29/2016 End: 3/14/2016 BSR/AAMI/ISO 10993-12-2012 (R201x), Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (reaffirmation of ANSI/AAMI/ISO 10993-12-2012) Public Review Start: 6/23/2017 End: 8/7/2017 BSR/AAMI/ISO 10993-16-201x, Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables (identical national adoption of ISO 10993-16 (current version) and revision of ANSI/AAMI/ISO 10993-16-2010 (R2014)) 2/26/2016 Public Review Start: 4/8/2016 End: 5/23/2016 BSR/AAMI/ISO 10993-4-201x, Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood (identical national adoption of ISO and revision of ANSI/AAMI/ISO 10993-4:2002 (R2013)) 12/18/2015 Public Review Start: 2/05/2016 End: 3/21/2016 BSR/AAMI/ISO 11135-200x, Sterilization Of Health Care Products - Ethylene Oxide - Requirements For Development, Validation And Routine Control Of A Sterilization Process For Medical Devices (identical national adoption of ISO 11135) 6/16/2000 Public Review Start: 6/11/2004 End: 8/10/2004 BSR/AAMI/ISO 11135-201x, Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (identical national adoption of ISO 11135-1 & ISO 11135-2 and revision of ANSI/AAMI/ISO 11135-1-2007) Public Review Start: 10/7/2011 End: 11/21/2011 BSR/AAMI/ISO 11135-201x Amd.1, Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices AMENDMENT 1: Revision of Annex E, Single batch release (identical national adoption of ISO 11135:2014/DAM 1) 9/8/2017 BSR/AAMI/ISO 10993-12 Amd 1-200x, Biological evaluation of medical devices - Part 12 : Sample preparation and reference materials (Amendment 1) (supplement to ANSI/AAMI/ISO 10993-12-2002) Public Review Start: 2/18/2005 End: 4/19/2005 Provided by the American National Standards Institute www.ansi.org Friday, January 18, 2019 PAGE 9

BSR/AAMI/ISO 11137-1/Amd2-201x, Sterilization of health care products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices -- Amendment 2: Revision to 4.3.4 and 11.2 (addenda to ANSI/AAMI/ISO 11137-1-2006 (R2015)) 9/15/2017 Public Review Start: 11/16/2018 End: 12/31/2018 BSR/AAMI/ISO 11137-2, third edition-2013 (R201x), Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose (reaffirmation of ANSI/AAMI/ISO 11137-2, third edition-2013) Public Review Start: 7/20/2018 End: 9/3/2018 BSR/AAMI/ISO 11138-6-201x, Sterilization of health care products - Biological indicators - Part 6: Biological indicators for hydrogen peroxide vapour sterilization processes (identical national adoption of ISO 11138-6) 10/23/2009 BSR/AAMI/ISO 11138-7-201x, Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection,use and interpretation of results (identical national adoption of ISO/DIS 11138-7 and revision of ANSI/AAMI/ISO 14161-2009 (R2014)) 9/8/2017 BSR/AAMI/ISO 11139-201x, Sterilization of health care products -- Vocabulary -- Terms used in sterilization and related equipment and process standards (identical national adoption of ISO 11139) 5/26/2017 Public Review Start: 9/8/2017 End: 10/23/2017 BSR/AAMI/ISO 11140-6-201x, Sterilization of health care products - Chemical indicators - Part 6: Class 2 indicators and process challenge devices for use in performance testing of steam sterilizers (identical national adoption of ISO 11140-6) 10/23/2009 BSR/AAMI/ISO 11607-1-2006, A1-201x, Amendment 1 to ANSI/AAMI/ISO 11607-1:2006, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging (supplement to ANSI/AAMI/ISO 11607-1-2006 (R2010)) 8/3/2012 BSR/AAMI/ISO 11607-1-201x, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging (identical national adoption of ISO 11607-1 and revision of ANSI/AAMI/ISO 11607-1-2006 (R2010)) 12/28/2018 BSR/AAMI/ISO 11607-2-2006, A1-201x, Amendment 1 to ANSI/AAMI/ISO 11607-1:2006, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing, and assembly processes (supplement to ANSI/AAMI/ISO 11607-2-2006 (R2010)) 8/3/2012 BSR/AAMI/ISO 11607-2-201x, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (identical national adoption of ISO 11607-2 and revision of ANSI/AAMI/ISO 11607-2-2006 (R2010)) 12/28/2018 BSR/AAMI/ISO 11607-3-201x, Packaging for terminally sterilized medical devices - Part 3: Guidance on the application of ISO 11607-1 and ISO 11607-2 (identical national adoption of ISO 11607-3) 10/30/2009 BSR/AAMI/ISO 11737-1-201x/Amendment 1, Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products - Amendment 1 (addenda to ANSI/AAMI/ISO 11737-1-2018) 9/21/2018 BSR/AAMI/ISO 11737-2-201x, Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (identical national adoption of ISO 11737-2 (in development) and revision of ANSI/AAMI/ISO 11737-2-2009 (R2014)) 9/22/2017 Public Review Start: 5/18/2018 End: 7/2/2018 BSR/AAMI/ISO 12417-201x, Cardiovascular implants and extracorporeal systems -- Vascular device-drug combination products (identical national adoption of ISO 12417) 7/6/2012 Provided by the American National Standards Institute www.ansi.org Friday, January 18, 2019 PAGE 10

BSR/AAMI/ISO 13022-2012 (R201x), Medical products containing viable human cells -- Application of risk management and requirements for processing practices (reaffirmation of ANSI/AAMI/ISO 13022-2012) Public Review Start: 3/10/2017 End: 4/24/2017 BSR/AAMI/ISO 13408-1-2008 (R201x), Aseptic processing of health care products - Part 1: General requirements (reaffirmation of ANSI/AAMI/ISO 13408-1-2008 (R2011)) Public Review Start: 11/25/2016 End: 1/9/2017 BSR/AAMI/ISO 13408-6-201x, Aseptic processing of health care products - Part 6: Isolator systems (identical national adoption of ISO 13408-6 (in development) and revision of ANSI/AAMI/ISO 13408-6-2005 (R2013) ANSI/AAMI/ISO 13408-6-2005/A1-2013) 9/8/2017 BSR/AAMI/ISO 13708-7-200x, Aseptic processing of health care products - Part 7: Cell based health care products (identical national adoption of ISO 13408-7 (under development)) 9/11/2009 BSR/AAMI/ISO 14155-2010 (R201x), Clinical investigation of medical devices for human subjects - Good clinical practice (reaffirmation of ANSI/AAMI/ISO 14155-2010) Public Review Start: 2/5/2016 End: 3/21/2016 BSR/AAMI/ISO 14160-200x, Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (identical national adoption of ISO 14160 and revision of ANSI/AAMI/ISO 14160-1998) 2/2/2007 Public Review Start: 5/2/2008 End: 6/16/2008 BSR/AAMI/ISO 14160-201x, Sterilization of health care products -- Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives -- Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (identical national adoption of ISO 14160:201X (to be published) and revision of ANSI/AAMI/ISO 14160-2011 (R2016)) 5/25/2018 Public Review Start: 7/13/2018 End: 8/27/2018 BSR/AAMI/ISO 14408-201x, Tracheal tubes designed for laser surgery -- Requirements for marking and accompanying information (revision and redesignation of ANSI/ASTM/ISO 14408-2009) 5/2/2014 Public Review Start: 6/6/2014 End: 7/21/2014 BSR/AAMI/ISO 14708-4-201x, Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump (identical national adoption of ISO 14708-4, 2nd edition (under development) and revision of ANSI/AAMI/ISO 14708-4-2008) 10/28/2011 BSR/AAMI/ISO 14971-201x, Medical devices Application of risk management to medical devices (identical national adoption of ISO 14971/Ed.3 and revision of ANSI/AAMI/ISO 14971-2007 (Ed 2, vers 2) (R2016)) 12/16/2016 Public Review Start: 8/3/2018 End: 9/17/2018 BSR/AAMI/ISO 15002-201x, Flow-metering devices for connection to terminal units of medical gas pipeline systems (identical national adoption of ISO 15002:2008) 5/8/2015 Public Review Start: 10/2/2015 End: 11/16/2015 BSR/AAMI/ISO 15223-01/Ed.3-201x, Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (identical national adoption of ISO 15223-01/Ed.3 and revision of ANSI/AAMI/ISO 15223-1-2012) 12/11/2015 Provided by the American National Standards Institute www.ansi.org Friday, January 18, 2019 PAGE 11

BSR/AAMI/ISO 15223-1-200x/A1, Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements - Amendment 1 (supplement to ANSI/AAMI/ISO 15223-1-200x) 8/18/2006 BSR/AAMI/ISO 15223-1/A1-200x, Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements - Amendment 1 (supplement to BSR/AAMI/ISO 15223-1-200x) Public Review Start: 8/18/2006 End: 10/17/2006 BSR/AAMI/ISO 15223/A2-200x, Medical Devices - Symbols to be Used With Medical Device Labels, Labelling and Information to be Supplied - Amendment 2 (identical national adoption of ISO 15223/A2) 8/15/2003 BSR/AAMI/ISO 15539-1-199x, Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (identical national adoption of ISO 15539-1) 11/17/2000 BSR/AAMI/ISO 15621-199x, Urine Absorbing Aids - General Guidance on Evaluation (identical national adoption of ISO 15621:1999) Public Review Start: 6/4/1999 End: 8/3/1999 BSR/AAMI/ISO 15882-2008 (R201x), Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (reaffirmation of ANSI/AAMI/ISO 15882-2008 (R2013)) Public Review Start: 3/17/2017 End: 5/1/2017 BSR/AAMI/ISO 15883-5-201x, Washer disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (identical national adoption of ISO/CD 15883-5) 4/7/2017 BSR/AAMI/ISO 16342-201x, Sterilization of health care products - Biological indicators - Method for validation of a reduced incubation time for a biological indicator (identical national adoption of ISO 16342) 12/2/2011 BSR/AAMI/ISO 16775-201x, Packaging for terminally sterilized medical devices - Part 3: Guidance on the application of ISO 11607-1 and ISO 11607-2 (identical national adoption of ISO TR 16775) 8/3/2012 BSR/AAMI/ISO 17137-201x, Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants (identical national adoption of ISO/AWI TS 17137) 7/6/2012 BSR/AAMI/ISO 17665-200x, Sterilization Of Health Care Products - Requirements For The Development, Validation And Routine Control Of A Sterilization Process For Medical Devices - Moist Heat (identical national adoption of ISO 17665 and revision of ANSI/AAMI/ISO 11134-1993) 6/30/2000 BSR/AAMI/ISO 18190-201x, Anaesthetic and respiratory equipment - General requirements for airways and related equipment (identical national adoption of ISO 18190:2016) 5/29/2015 Public Review Start: 11/11/2016 End: 12/26/2016 BSR/AAMI/ISO 18250-1-201x, Connectors for reservoir delivery systems for healthcare applications -- Part 1: General requirements and common test methods (identical national adoption of ISO/CD 18250-1 ) 9/18/2015 Public Review Start: 3/24/2017 End: 5/8/2017 BSR/AAMI/ISO 18250-3-201x, Medical devices -- Connectors for reservoir delivery systems for healthcare applications -- Part 3: Enteral applications (identical national adoption of ISO 18250-3) 10/10/2014 Public Review Start: 4/20/2018 End: 6/4/2018 Provided by the American National Standards Institute www.ansi.org Friday, January 18, 2019 PAGE 12

BSR/AAMI/ISO 18250-6-201x, Connectors For Reservoir Delivery Systems For Healthcare Applications - Part 6: Neural Applications (identical national adoption of ISO 18250-6) 7/8/2016 Public Review Start: 6/1/2018 End: 7/16/2018 BSR/AAMI/ISO 18250-7-201x, Connectors for reservoir delivery systems for healthcare applications - Part 7: Conectors for Intravascular Infusion (identical national adoption of ISO 18250-7) 7/8/2016 Public Review Start: 7/7/2017 End: 8/21/2017 BSR/AAMI/ISO 18250-8-201x, Connectors for reservoir delivery systems for healthcare applications - Part 8: Citrate-based anticoagulant solution for apheresis applications (identical national adoption of ISO 18250-8) 10/10/2014 Public Review Start: 6/1/2018 End: 7/16/2018 BSR/AAMI/ISO 18472-201x, Sterilization of health care products - Biological and chemical indicators - Test equipment (identical national adoption of ISO/DIS 18472 and revision of ANSI/AAMI/ISO 18472-2010 (R2015)) Public Review Start: 11/25/2016 End: 1/9/2017 BSR/AAMI/ISO 18562-1-201x, Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 1: Evaluation and testing within a risk management process (identical national adoption of ISO 18562-1) 7/8/2016 Public Review Start: 11/11/2016 End: 12/26/2016 BSR/AAMI/ISO 18562-2-201x, Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 2: Tests for emissions of particulate matter (identical national adoption of ISO/FDIS 18562-2) 7/8/2016 Public Review Start: 11/11/2016 End: 12/26/2016 BSR/AAMI/ISO 18562-3-201x, Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 3: Tests for emissions of volatile organic compounds (VOCs) (identical national adoption of ISO/FDIS 18562-3) 7/8/2016 Public Review Start: 11/11/2016 End: 12/26/2016 BSR/AAMI/ISO 18562-4-201x, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (identical national adoption of ISO/FDIS 18562-4) 7/8/2016 Public Review Start: 11/11/2016 End: 12/26/2016 BSR/AAMI/ISO 19211-201x, Anaesthetic and respiratory equipment - Automatic fire safety valves for use during oxygen therapy (identical national adoption of ISO 19211) 4/1/2016 BSR/AAMI/ISO 19223-201x, Lung ventilators and related equipment -- Vocabulary and semantics (identical national adoption of ISO/DIS 19223) 4/1/2016 Public Review Start: 7/1/2016 End: 8/15/2016 BSR/AAMI/ISO 20417-201x, Medical Devices - Information to be provided by the manufacturer (identical national adoption of ISO 20417) 12/15/2017 BSR/AAMI/ISO 20695-201x, Enteral feeding systems - Design and testing (identical national adoption of ISO/DIS 20695) 9/30/2016 Public Review Start: 5/26/2017 End: 7/10/2017 BSR/AAMI/ISO 23907-201x, Sharps injury protection -- Requirements and test methods -- Sharps containers (national adoption with modifications of ISO 23907) 3/1/2013 BSR/AAMI/ISO 27185-201x, Cardiac rhythm management devices -- Symbols to be used with cardiac rhythm management device labels, and information to be supplied -- General requirements (identical national adoption of ISO 27185 (in development) and revision of ANSI/AAMI/ISO 27185-2012 (R2017)) 10/6/2017 Provided by the American National Standards Institute www.ansi.org Friday, January 18, 2019 PAGE 13

BSR/AAMI/ISO 27186-201x, Active implantable medical devices - Fourpole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements (identical national adoption of ISO 27186 (under development) and revision of ANSI/AAMI/ISO 27186-2010) 3/29/2013 BSR/AAMI/ISO 30993-200x, Biological evaluation of medical devices - Terminology (identical national adoption of ISO 30993) Public Review Start: 3/25/2005 End: 5/24/2005 BSR/AAMI/ISO 5361-201x, Anaesthetic and respiratory equipment -- Tracheal tubes and connectors (revision and redesignation of ANSI/ISO 5361-2014) 5/2/2014 Public Review Start: 6/6/2014 End: 7/21/2014 BSR/AAMI/ISO 5364-201x, Anaesthetic and respiratory equipment -- Oropharyngeal airways (revision and redesignation of ANSI/ASTM/ISO 5364-2009) 5/2/2014 Public Review Start: 6/6/2014 End: 7/21/2014 BSR/AAMI/ISO 5366-201x, Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (identical national adoption of ISO 5366:2016 and revision of ANSI/AAMI/ISO 5366-1-2003 (R2014) ANSI/ISO 5366-3-2009 (R2014)) 11/11/2016 Public Review Start: 2/10/2017 End: 3/27/2017 BSR/AAMI/ISO 5840-3-201x, Cardiovascular implants - Cardiac valve prostheses - Part 3:Heart valve substitutes implanted by transcatheter techniques (identical national adoption of ISO/DIS 5840-3 and revision of ANSI/AAMI/ISO 5840-3-2012) 1/27/2017 BSR/AAMI/ISO 5910-201x, Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices (identical national adoption of ISO/DIS 5910) 11/18/2016 Public Review Start: 12/30/2016 End: 2/13/2017 BSR/AAMI/ISO 594-1-199x, Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment Part 1: General Requirements (identical national adoption of ISO 594-1) Public Review Start: 2/14/1997 End: 4/15/1997 BSR/AAMI/ISO 594-2-199x, Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment Part 2: Lock Fittings (identical national adoption of ISO 594-2) Public Review Start: 2/14/1997 End: 4/15/1997 BSR/AAMI/ISO 595-1-199x, Reusable All-Glass or Metal-and-Glass Syringes for Medical Use Part 1: Dimensions (identical national adoption of ISO 595-1) Public Review Start: 2/14/1997 End: 4/15/1997 BSR/AAMI/ISO 595-2-199x, Reusable All-Glass or Metal-and-Glass Syringes for Medical Use Part 2: Design, Performance Requirements and Tests (identical national adoption of ISO 595-2) Public Review Start: 2/14/1997 End: 4/15/1997 BSR/AAMI/ISO 6009-199x, Hypodermic Needles for Single Use Color Coding for Identification (identical national adoption of ISO 6009) Public Review Start: 2/14/1997 End: 4/15/1997 BSR/AAMI/ISO 7198-200x, Cardiovascular implants - Tubular vascular prostheses (identical national adoption of ISO 7198, ed. 2 (currently at ISO/PWI stage) and revision of ANSI/AAMI/ISO 7198-2001 (R2004)) 9/11/2009 BSR/AAMI/ISO 7864-199x, Sterile Hypodermic Needles for Single Use (identical national adoption of ISO 7864) Public Review Start: 2/14/1997 End: 4/15/1997 BSR/AAMI/ISO 7886-1-199x, Sterile Hypodermic Syringes for Single Use Part 1: Syringes for Manual Use (identical national adoption of ISO 7886-1) Public Review Start: 2/14/1997 End: 4/15/1997 Provided by the American National Standards Institute www.ansi.org Friday, January 18, 2019 PAGE 14

BSR/AAMI/ISO 7886-1-199x, Sterile Hypodermic Syringes for Single Use Part 1: Syringes for Manual Use (identical national adoption of ISO 7886-1) Public Review Start: 2/14/1997 End: 4/15/1997 BSR/AAMI/ISO 7886-2-199x, Sterile Hypodermic Syringes for Single Use Part 2: Syringes for Use with Power-Driven Syringe Pumps (identical national adoption of ISO 7886-2) Public Review Start: 2/14/1997 End: 4/15/1997 BSR/AAMI/ISO 80369-1-201x, Small-bore connectors for liquids and gases in healthcare applications -- Part 1: General requirements (revision of ANSI/AAMI/ISO 80369-1-2010) 10/4/2013 Public Review Start: 9/22/2017 End: 11/6/2017 BSR/AAMI/ISO 80369-2-201x, Small-bore connectors for liquids and gases in healthcare applications -- Part 2: Connectors for breathing systems and driving gases applications (new 8/7/2009 Public Review Start: 8/21/2015 End: 10/5/2015 BSR/AAMI/ISO 80369-3/Amd1-201x, ISO 80369-3:2016 Small-bore connectors for liquids and gases in healthcare applications -- Part 3: Connectors for enteral applications/amd1 (addenda to ANSI/AAMI/ISO 80369-3-2016) 11/16/2018 Public Review Start: 12/21/2018 End: 2/4/2019 Obtain an electronic copy from: https://standards.aami. org/higherlogic/ws/public/documents?view= Send comments (with copy to psa@ansi.org) to: Colleen Elliott, (703) 253-8261, celliott@aami.org BSR/AAMI/ISO 80369-3/Amd2-201x, Small-bore connectors for liquids and gases in healthcare applications -- Part 3: Connectors for enteral applications/amd2 (identical national adoption of ISO 80369-3:2016/Amd2) 3/24/2017 Public Review Start: 5/12/2017 End: 6/26/2017 BSR/AAMI/ISO 80601-2-12-201x, Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (identical national adoption of ISO 80601-2 -12:2011) 9/30/2016 Public Review Start: 11/11/2016 End: 12/26/2016 BSR/AAMI/ISO 80601-2-61:201x, Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (identical national adoption of ISO 80601-2-61:2011) 9/30/2016 Public Review Start: 11/11/2016 End: 12/26/2016 BSR/AAMI/ISO 80601-2-72-201x, Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients (identical national adoption of ISO 80601-2-72:2015) 9/30/2016 Public Review Start: 11/11/2016 End: 12/26/2016 BSR/AAMI/ISO 81060-2-201x, Non-invasive sphygmomanometers: Part 2: Clinical investigation of intermittent automated measurement type (identical national adoption of ISO 81060-2 and revision of ANSI/AAMI/ISO 81060-2:2013) 11/16/2018 Public Review Start: 1/11/2019 End: 2/25/2019 Order from: Hae Choe, (703) 253-8268, standards@aami.org Obtain an electronic copy from: hchoe@aami.org Send comments (with copy to psa@ansi.org) to: same BSR/AAMI/ISO 8537-199x, Sterile Single-Use Syringes, with or without Needle, for Insulin (identical national adoption of ISO 8537) Public Review Start: 2/14/1997 End: 4/15/1997 BSR/AAMI/ISO 8637-1-201x, Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (identical national adoption of ISO/DIS 8637-1 and revision of ANSI/AAMI/ISO 8637-2010 (R2015), AM1-2013(R2015) ) 03/11/2016 Public Review Start: 04/15/2016 End: 5/30/2016 BSR/AAMI/ISO 8637-2-201x, Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (identical national adoption of ISO/DIS 8637-2 and revision of ANSI/AAMI/ISO 8638-2010 (R2015)) 03/11/2016 Public Review Start: 04/15/2016 End: 5/30/2016 BSR/AAMI/ISO 8637-3-201x, Extracorporeal systems for blood purification - Part 3: Plasmafilters (identical national adoption of ISO/DIS 8637-3) 03/11/2016 Public Review Start: 4/15/2016 End: 5/30/2016 Provided by the American National Standards Institute www.ansi.org Friday, January 18, 2019 PAGE 15

BSR/AAMI/ISO CDV-2 14117-201x, Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization devices (identical national adoption of ISO 14117 (in development) and revision of ANSI/AAMI/ISO 14117-2012) 10/31/2014 Public Review Start: 4/20/2018 End: 6/4/2018 BSR/AAMI/ISO/CDV-1 23500-1-201x, Guidance for the preparation and quality management of fluids for haemodialysis andrelated therapies - Part 1: General requirements (identical national adoption of ISO/DIS 23500 and revision of ANSI/AAMI 23500-2014) 7/1/2016 Public Review Start: 3/17/2017 End: 5/1/2017 BSR/AAMI/ISO/CDV-1 23500-2-201x, Guidance for the preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies (identical national adoption of ISO/DIS 23500-2 and revision of ANSI/AAMI 26722-2014) 7/1/2016 Public Review Start: 3/17/2017 End: 5/1/2017 BSR/AAMI/ISO/CDV-1 23500-3-201x, Guidance for the preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies (identical national adoption of ISO/DIS 23500-3 and revision of ANSI/AAMI 13959-2014) 7/1/2016 Public Review Start: 3/17/2017 End: 5/1/2017 BSR/AAMI/ISO/CDV-1 23500-4-201x, Guidance for the preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies (identical national adoption of ISO/DIS 23500-4 and revision of ANSI/AAMI 13958-2014) 7/1/2016 Public Review Start: 3/17/2017 End: 5/1/2017 BSR/AAMI/ISO/CDV-1 23500-5-201x, Guidance for the preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies (identical national adoption of ISO/DIS 23500-5 and revision of ANSI/AAMI 11663-2014) 7/1/2016 Public Review Start: 3/17/2017 End: 5/1/2017 BSR/AAMI/RT3-201x, Machine Characterization (new 11/6/2015 BSR/AAMI/SW96-201x, Medical Devices - Application of security risk management to medical devices (new 3/17/2017 BSR/ISO 10993-10 DAM1-200x, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (draft Amendment 1) (supplement to ANSI/AAMI BE78-2002) Public Review Start: 3/26/2004 End: 5/25/2004 AARST (American Association of Radon Scientists and Technologists ) www.aarst.org BSR/AARST CCAH-201x, Reducing Radon In New Construction of 1 & 2 Family Dwellings and Townhouses (revision of ANSI/AARST CCAH-2013 11/2/2018 BSR/AARST MAH-201x, Protocol for Conducting Measurements of Radon and Radon Decay Products in Homes (revision of ANSI/AARST MAH-2014) Public Review Start: 11/2/2018 End: 12/17/2018 BSR/AARST MS-QA-201x, Radon Measurement Systems Quality Assurance (new 4/24/2015 Public Review Start: 7/20/2018 End: 9/3/2018 BSR/AARST MW-RN-201x, Protocol for the Collection, Transfer and Measurement of Radon in Water (new 3/24/2017 BSR/AARST RMS-W-201x, Radon Mitigation Standards for Radon in Water (new 3/24/2017 BSR/AARST RRNC-201x, Rough-in of Radon Control Components in New Construction of 1 & 2 Family Dwellings and Townhouses. (new 1/4/2019 Provided by the American National Standards Institute www.ansi.org Friday, January 18, 2019 PAGE 16