Proposed American National Standards Projects

Transcription

1 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 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 The procedures that govern the ANS process are called the ANSI Essential Requirements: Due process requirements for American National Standards A list of all ASDs is available at Questions concerning the ANS process may be directed to psa@ansi.org. Thank you for your interest. 3-A (3-A Sanitary Standards, Inc. ) BSR/3-A P3-A x, Standard For Vessels and Agitators For Use In The Manufacture of Active Pharmaceutical Ingredients (new 1/7/2005 BSR/3-A P3-A x, Standard For Mills and Classification Equipment For Use In The Manufacture of Active Pharmaceutical Ingredients (new 1/7/2005 BSR/3-A P3-A x, Standard For Process Heat Exchangers For Use In The Manufacture of Active Pharmaceutical Ingredients (new 1/7/2005 AA (ASC H35) (Aluminum Association ) BSR H35.2M-201x, Standard Dimensional Tolerances for Aluminum Mill Products (revision of ANSI H35.2M-2017) 4/6/2018 BSR H x, Designation System for Aluminum Hardeners (revision of ANSI H (R2006)) 6/9/2006 BSR H x, Designation System for Unalloyed Aluminum (revision of ANSI H ) 6/9/2006 BSR H x, Nomenclature System for Aluminum Metal Matrix Composite Material (revision of ANSI H (R2006)) 6/9/2006 AABC (Associated Air Balance Council ) BSR H x, 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 ) 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 H x, Standard Dimensional Tolerances for Aluminum Mill Products (revision of ANSI H ) 4/6/2018 AAFS (American Academy of Forensic Sciences ) BSR/ASB BPR x, 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 Friday, January 18, 2019 PAGE 1

2 BSR/ASB BPR x, Guidelines for Barrel and Overall Length Measurements for Firearms (new 10/5/2018 BSR/ASB BPR x, 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: Send comments (with copy to to: Document and comments template can be viewed on the AAFS Standards Board website at: BSR/ASB BPR x, Best Practice Recommendation for Measuring Trigger Pull of a Firearm and Estimating Its Uncertainty (new 12/21/2018 BSR/ASB BPR x, Forensic Odontology in Disaster Victim Identification: Best Practice Recommendations for the Medicolegal Authority. (new 10/19/2018 BSR/ASB Standard x, Implementation of 3D Technologies in Forensic Firearm and Toolmark Comparison Laboratories (new 7/27/2018 BSR/ASB Std x, Mass Fatality Incident Data Management: Best Practice Recommendations for the Medicolegal Authority (new 10/14/2016 BSR/ASB Std x, 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 x, Mass Fatality Scene Processing: Best Practice Recommendations for the Medicolegal Authority (new 10/14/2016 BSR/ASB Std x, 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 x, Scope of Expertise in Forensic Document Examination (new 10/28/2016 Public Review Start: 10/26/2018 End: 12/10/2018 BSR/ASB Std x, 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 x, Standard for Reporting Qualitative Source Conclusions (new 12/2/2016 BSR/ASB Std x, Standard for Training to Competency to Perform Friction Ridge Examination (new 12/2/2016 BSR/ASB Std x, Standard for the Examination of Friction Ridge Evidence (new 12/2/2016 BSR/ASB Std x, Validation Standards for Probabilistic Genotyping Systems (new 12/2/2016 Public Review Start: 9/28/2018 End: 11/12/2018 BSR/ASB Std x, Wildlife Forensics General Standards (new 12/9/2016 Public Review Start: 10/12/2018 End: 11/26/2018 BSR/ASB Std x, Standard for Forensic DNA Analysis Training Programs (new 3/17/2017 Public Review Start: 10/5/2018 End: 11/19/2018 BSR/ASB Std x, Standard for Training of Forensic DNA Isolation and Purification Methods (new 3/17/2017 Provided by the American National Standards Institute Friday, January 18, 2019 PAGE 2

3 BSR/ASB Std x, Crime Scene/Death Investigation - Dogs and Sensors Pre-Scented Canines - Location Check (new 3/17/2017 BSR/ASB Std x, Crime Scene/Death Investigation - Dogs and SensorsPre-Scented Canines - Aged Trail Search (new 3/17/2017 BSR/ASB Std x, 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 x, Wildlife Forensics Morphology Standard (new 6/2/2017 Public Review Start: 10/12/2018 End: 11/26/2018 BSR/ASB Std x, Wildlife Forensics Report Writing Standard (new 6/2/2017 Public Review Start: 10/12/2018 End: 11/26/2018 BSR/ASB Std x, Standards for a Quality Assurance Program in Bloodstain Pattern Analysis (new 3/23/2018 BSR/ASB Std x, 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 x, 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 x, 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: 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: BSR/ASB Std x, 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 x, 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 x, Standards for Internal Validation of Human Short Tandem Repeat Profiling on Capillary Electrophoresis Platforms (new 7/14/2017 BSR/ASB Std x, 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 x, Assigning Propositions for Likelihood Ratios in Forensic DNA Interpretations. (new 8/24/2018 BSR/ASB Std x, Standard for Disaster Live Human Detection Dogs Programsâ Training, Certification, and Documentation (new 7/28/2017 BSR/ASB Std x, Standard for Disaster Human Remains Detection Dogs Programsâ Training, Certification, and Documentation (new 7/28/2017 Provided by the American National Standards Institute Friday, January 18, 2019 PAGE 3

4 BSR/ASB Std x, 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 x, Standard for Stature Estimation from Human Remains (new 8/31/2018 Public Review Start: 10/26/2018 End: 12/10/2018 BSR/ASB Std x, 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 x, 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 x, Wildlife Forensic DNA Standard Procedures (new 7/28/2017 Public Review Start: 8/10/2018 End: 9/24/2018 BSR/ASB Std x, Standard for Report Content in Forensic Toxicology (new 5/18/2018 Public Review Start: 9/21/2018 End: 11/5/2018 BSR/ASB Std x, 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 x, Standard for Estimation of Measurement Uncertainty in Forensic Toxicology Laboratories (new 11/17/2017 BSR/ASB Std x, Standard for the Scope and Sensitivity of Forensic Toxicological Testing (new 2/23/2018 BSR/ASB Std x, Standard Method for Blood Ethanol Identification and Quantitation in Forensic Toxicology Laboratories. (new 8/17/2018 BSR/ASB Std x, Firearms and Toolmarks 3D Measurement Systems and Measurement Quality Control (new 5/25/2018 BSR/ASB Std x, Standard for Topography Comparison Software for Firearm and Toolmark Analysis (new 10/19/2018 BSR/ASB Std x, Standard Test Method for the Forensic Physical Examination and Classification of Firearms (new 5/25/2018 BSR/ASB Std x, Standard Test Method for Function and Operability Testing of Firearms (new 7/6/2018 BSR/ASB Std x, Test Method for Measuring Trigger Pull of Firearms (new 5/25/2018 BSR/ASB Std x, Best Practice Recommendations for the Safe Handling of Firearms and Ammunition During Forensic Analysis (new 5/25/2018 BSR/ASB Std x, Test Method for Measuring Barrel and Overall Length of Firearms. (new 4/20/2018 BSR/ASB Std x, Standard for Forensic Examination of Handwritten Items (new 5/18/2018 BSR/ASB Std x, 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 x, Agriculture Detection Canine Training, Certification, and Document Management Standards (new 8/3/2018 Provided by the American National Standards Institute Friday, January 18, 2019 PAGE 4

5 BSR/ASB Std x, Human Remains Detection in Water (new 4/27/2018 BSR/ASB Std x, Human Remains Canine Detection on Land (new 5/11/2018 BSR/ASB Std x, 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 x, Standard for Training of Forensic Autosomal and Y STR Data Interpretation (new 8/3/2018 BSR/ASB Std x, Standard for Training of the Combined DNA Index System (new 8/3/2018 BSR/ASB Std x, Standard for Training to Perform Forensic DNA Reporting and Review (new 6/15/2018 BSR/ASB Std x, Standard for Training in the Use of Statistics in Interpretation of Forensic DNA Evidence (new 4/27/2018 BSR/ASB Std x, Canine Article Search (new 5/11/2018 BSR/ASB STD x, Contraband Canine Detection (new 5/25/2018 BSR/ASB Std x, Detection Canine Selection, Kenneling and Healthcare (new 4/27/2018 BSR/ASB Std x, Narcotic Canine Detection (new 5/11/2018 BSR/ASB Std x, Pest and Insect Canine Detection (new 4/27/2018 BSR/ASB Std x, 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 x, 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: 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: of-standard-development-and-coordination// BSR/ASB Std x, Standard for Training of Analysis of Forensic STR Data. (new 6/1/2018 BSR/ASB STD x, Standard Test Method for the Examination and Testing of Firearms (new 7/27/2018 BSR/ASB Std x, Postmortem Fingerprint Recovery: Guidance and Best Practices for Disaster Victim Identification. (new 8/3/2018 BSR/ASB Std x, Standard for Minimum Qualifications and Training for a Footwear/Tire Forensic Science Service Provider. (new 7/20/2018 BSR/ASB STD x, Standard Test Method for the Examination and Testing of Ammunition (new 7/27/2018 Provided by the American National Standards Institute Friday, January 18, 2019 PAGE 5

6 BSR/ASB STD x, Standard for Mass Spectral Data Acceptance in Forensic Toxicology (new 8/17/2018 BSR/ASB Std x, 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 x, Standard for 3D Virtual Comparison Microscopy for Firearm and Toolmark Analysis (new 8/10/2018 BSR/ASB Std x, Minimum Education Requirements for Firearm and Toolmark Examiner Trainees (new 11/9/2018 BSR/ASB Std x, 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: Send comments (with copy to to: Document and comments template can be viewed on the AAFS Standards Board website at: BSR/ASB Std x, Standard for Training in Forensic Serological Methods (new 12/14/2018 AAMI (Association for the Advancement of Medical Instrumentation ) BSR/AAMI x, 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 x, 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 BE (R201x), Biological evaluation of medical devices - Part 18: Chemical characterization of materials (reaffirmation of ANSI/AAMI BE (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 EQ x, Alternative Equipment Management in Healthcare Delivery Organizations (new 8/3/2018 BSR/AAMI EQ (R201x), Recommended practice for a medical equipment management program (reaffirmation of ANSI/AAMI EQ ) 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 EQ ) 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 Friday, January 18, 2019 PAGE 6

7 BSR/AAMI HA , 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 HA ) 7/28/2017 IEC Adoption BSR/AAMI HIT x, Health IT Software and Systems - Part 1: Fundamental concepts and principles (new 7/28/2017 BSR/AAMI HIT x, Health IT software and systems - Part 2: Application of quality systems principles and practices (new 7/28/2017 BSR/AAMI HIT x, Health IT software and systems - Part 3: Application of risk management (new 7/28/2017 BSR/AAMI HIT x, 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 PB ) 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 RD (R201x), Reprocessing of hemodialyzers (reaffirmation of ANSI/AAMI RD (R2013)) Public Review Start: 2/9/2018 End: 3/26/2018 BSR/AAMI RD (R201x), Concentrates for hemodialysis (reaffirmation of ANSI/AAMI RD ) Public Review Start: 10/22/2010 End: 12/6/2010 BSR/AAMI RD (R201x), Water treatment equipment for hemodialysis applications (reaffirmation of ANSI/AAMI RD ) Public Review Start: 10/22/2010 End: 12/6/2010 BSR/AAMI RD62/A (R201x), Water treatment equipment for hemodialysis applications, Amendment , 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 ST x, End-to-End Sterility Assurance (new 8/3/2018 BSR/AAMI ST x, Washer-disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermo-labile endoscopes (national adoption with modifications of ISO :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 ST (R2017)) 11/18/2016 Public Review Start: 8/31/2018 End: 10/15/2018 Provided by the American National Standards Institute Friday, January 18, 2019 PAGE 7

8 BSR/AAMI ST72-201x, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing (revision of ANSI/AAMI ST (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 ST ) 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 ST (R201x), Flexible and semi-rigid endoscope processing in health care facilities (revision of ANSI/AAMI ST ) 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 , 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 ) 7/28/2017 IEC Adoption BSR/AAMI/IEC x, 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 and revision of ANSI/AAMI/IEC , Ed ) 12/23/2016 Public Review Start: 2/24/2017 End: 4/10/2017 IEC Adoption BSR/AAMI/IEC /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 x) 8/28/2015 IEC Adoption BSR/AAMI/IEC x, 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 ) 3/24/2017 IEC Adoption BSR/AAMI/IEC x, Medical electrical equipment - Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment (identical national adoption of IEC/CDV ) 12/23/2016 Public Review Start: 2/24/2017 End: 4/10/2017 IEC Adoption BSR/AAMI/IEC /Amd 1-201x, Medical device software - Software life cycle processes - Amendment 1 (addenda to ANSI/AAMI/IEC 62304, Ed (R2013)) 7/17/2015 IEC Adoption BSR/AAMI/IEC x, Medical device software - Software life cycle processes (identical national adoption of IEC and revision of ANSI/AAMI/IEC 62304, Ed ) 2/11/2011 IEC Adoption BSR/AAMI/IEC , Amendment 1-201x, Medical devices - Part 1: Application of usability engineering to medical devices - Amendment 1 (addenda to ANSI/AAMI/IEC ) 8/25/2017 Public Review Start: 9/28/2018 End: 11/12/2018 IEC Adoption Provided by the American National Standards Institute Friday, January 18, 2019 PAGE 8

9 BSR/AAMI/IEC x, Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors (identical national adoption of IEC :2018) 1/5/2018 IEC Adoption BSR/AAMI/IEC x, 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 ) 1/11/2019 IEC Adoption BSR/AAMI/IEC x, 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 ) 1/11/2019 IEC Adoption BSR/AAMI/IEC x, Health Software - Part 1: General requirements for product safety (identical national adoption of IEC ) 12/2/2011 Public Review Start: 9/25/2015 End: 11/9/2015 IEC Adoption BSR/AAMI/ISO x, Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process (identical national adoption of ISO and revision of ANSI/AAMI/ISO (R2013)) 7/8/2016 Public Review Start: 4/27/2018 End: 6/11/2018 BSR/AAMI/ISO x, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity (national adoption of ISO (in development) with modifications and revision of ANSI/AAMI/ISO (R2014)) 11/27/2015 Public Review Start: 1/29/2016 End: 3/14/2016 BSR/AAMI/ISO (R201x), Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (reaffirmation of ANSI/AAMI/ISO ) Public Review Start: 6/23/2017 End: 8/7/2017 BSR/AAMI/ISO x, Biological evaluation of medical devices -- Part 16: Toxicokinetic study design for degradation products and leachables (identical national adoption of ISO (current version) and revision of ANSI/AAMI/ISO (R2014)) 2/26/2016 Public Review Start: 4/8/2016 End: 5/23/2016 BSR/AAMI/ISO x, 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 :2002 (R2013)) 12/18/2015 Public Review Start: 2/05/2016 End: 3/21/2016 BSR/AAMI/ISO x, 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 x, 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 & ISO and revision of ANSI/AAMI/ISO ) Public Review Start: 10/7/2011 End: 11/21/2011 BSR/AAMI/ISO x 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 Amd 1-200x, Biological evaluation of medical devices - Part 12 : Sample preparation and reference materials (Amendment 1) (supplement to ANSI/AAMI/ISO ) Public Review Start: 2/18/2005 End: 4/19/2005 Provided by the American National Standards Institute Friday, January 18, 2019 PAGE 9

10 BSR/AAMI/ISO /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 and 11.2 (addenda to ANSI/AAMI/ISO (R2015)) 9/15/2017 Public Review Start: 11/16/2018 End: 12/31/2018 BSR/AAMI/ISO , third edition-2013 (R201x), Sterilization of health care products -- Radiation -- Part 2: Establishing the sterilization dose (reaffirmation of ANSI/AAMI/ISO , third edition-2013) Public Review Start: 7/20/2018 End: 9/3/2018 BSR/AAMI/ISO x, Sterilization of health care products - Biological indicators - Part 6: Biological indicators for hydrogen peroxide vapour sterilization processes (identical national adoption of ISO ) 10/23/2009 BSR/AAMI/ISO x, Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection,use and interpretation of results (identical national adoption of ISO/DIS and revision of ANSI/AAMI/ISO (R2014)) 9/8/2017 BSR/AAMI/ISO x, 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 x, 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 ) 10/23/2009 BSR/AAMI/ISO , A1-201x, Amendment 1 to ANSI/AAMI/ISO :2006, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems, and packaging (supplement to ANSI/AAMI/ISO (R2010)) 8/3/2012 BSR/AAMI/ISO x, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging (identical national adoption of ISO and revision of ANSI/AAMI/ISO (R2010)) 12/28/2018 BSR/AAMI/ISO , A1-201x, Amendment 1 to ANSI/AAMI/ISO :2006, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing, and assembly processes (supplement to ANSI/AAMI/ISO (R2010)) 8/3/2012 BSR/AAMI/ISO x, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (identical national adoption of ISO and revision of ANSI/AAMI/ISO (R2010)) 12/28/2018 BSR/AAMI/ISO x, Packaging for terminally sterilized medical devices - Part 3: Guidance on the application of ISO and ISO (identical national adoption of ISO ) 10/30/2009 BSR/AAMI/ISO x/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 ) 9/21/2018 BSR/AAMI/ISO x, 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 (in development) and revision of ANSI/AAMI/ISO (R2014)) 9/22/2017 Public Review Start: 5/18/2018 End: 7/2/2018 BSR/AAMI/ISO x, 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 Friday, January 18, 2019 PAGE 10

11 BSR/AAMI/ISO (R201x), Medical products containing viable human cells -- Application of risk management and requirements for processing practices (reaffirmation of ANSI/AAMI/ISO ) Public Review Start: 3/10/2017 End: 4/24/2017 BSR/AAMI/ISO (R201x), Aseptic processing of health care products - Part 1: General requirements (reaffirmation of ANSI/AAMI/ISO (R2011)) Public Review Start: 11/25/2016 End: 1/9/2017 BSR/AAMI/ISO x, Aseptic processing of health care products - Part 6: Isolator systems (identical national adoption of ISO (in development) and revision of ANSI/AAMI/ISO (R2013) ANSI/AAMI/ISO /A1-2013) 9/8/2017 BSR/AAMI/ISO x, Aseptic processing of health care products - Part 7: Cell based health care products (identical national adoption of ISO (under development)) 9/11/2009 BSR/AAMI/ISO (R201x), Clinical investigation of medical devices for human subjects - Good clinical practice (reaffirmation of ANSI/AAMI/ISO ) Public Review Start: 2/5/2016 End: 3/21/2016 BSR/AAMI/ISO x, 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 and revision of ANSI/AAMI/ISO ) 2/2/2007 Public Review Start: 5/2/2008 End: 6/16/2008 BSR/AAMI/ISO x, 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 (R2016)) 5/25/2018 Public Review Start: 7/13/2018 End: 8/27/2018 BSR/AAMI/ISO x, Tracheal tubes designed for laser surgery -- Requirements for marking and accompanying information (revision and redesignation of ANSI/ASTM/ISO ) 5/2/2014 Public Review Start: 6/6/2014 End: 7/21/2014 BSR/AAMI/ISO x, Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pump (identical national adoption of ISO , 2nd edition (under development) and revision of ANSI/AAMI/ISO ) 10/28/2011 BSR/AAMI/ISO x, Medical devices Application of risk management to medical devices (identical national adoption of ISO 14971/Ed.3 and revision of ANSI/AAMI/ISO (Ed 2, vers 2) (R2016)) 12/16/2016 Public Review Start: 8/3/2018 End: 9/17/2018 BSR/AAMI/ISO x, 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 /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 /Ed.3 and revision of ANSI/AAMI/ISO ) 12/11/2015 Provided by the American National Standards Institute Friday, January 18, 2019 PAGE 11

12 BSR/AAMI/ISO x/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 x) 8/18/2006 BSR/AAMI/ISO /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 x) 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 x, Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (identical national adoption of ISO ) 11/17/2000 BSR/AAMI/ISO x, 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 (R201x), Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results (reaffirmation of ANSI/AAMI/ISO (R2013)) Public Review Start: 3/17/2017 End: 5/1/2017 BSR/AAMI/ISO x, Washer disinfectors - Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (identical national adoption of ISO/CD ) 4/7/2017 BSR/AAMI/ISO x, 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 x, Packaging for terminally sterilized medical devices - Part 3: Guidance on the application of ISO and ISO (identical national adoption of ISO TR 16775) 8/3/2012 BSR/AAMI/ISO x, Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants (identical national adoption of ISO/AWI TS 17137) 7/6/2012 BSR/AAMI/ISO x, 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 and revision of ANSI/AAMI/ISO ) 6/30/2000 BSR/AAMI/ISO x, 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 x, Connectors for reservoir delivery systems for healthcare applications -- Part 1: General requirements and common test methods (identical national adoption of ISO/CD ) 9/18/2015 Public Review Start: 3/24/2017 End: 5/8/2017 BSR/AAMI/ISO x, Medical devices -- Connectors for reservoir delivery systems for healthcare applications -- Part 3: Enteral applications (identical national adoption of ISO ) 10/10/2014 Public Review Start: 4/20/2018 End: 6/4/2018 Provided by the American National Standards Institute Friday, January 18, 2019 PAGE 12

13 BSR/AAMI/ISO x, Connectors For Reservoir Delivery Systems For Healthcare Applications - Part 6: Neural Applications (identical national adoption of ISO ) 7/8/2016 Public Review Start: 6/1/2018 End: 7/16/2018 BSR/AAMI/ISO x, Connectors for reservoir delivery systems for healthcare applications - Part 7: Conectors for Intravascular Infusion (identical national adoption of ISO ) 7/8/2016 Public Review Start: 7/7/2017 End: 8/21/2017 BSR/AAMI/ISO x, Connectors for reservoir delivery systems for healthcare applications - Part 8: Citrate-based anticoagulant solution for apheresis applications (identical national adoption of ISO ) 10/10/2014 Public Review Start: 6/1/2018 End: 7/16/2018 BSR/AAMI/ISO x, Sterilization of health care products - Biological and chemical indicators - Test equipment (identical national adoption of ISO/DIS and revision of ANSI/AAMI/ISO (R2015)) Public Review Start: 11/25/2016 End: 1/9/2017 BSR/AAMI/ISO x, Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 1: Evaluation and testing within a risk management process (identical national adoption of ISO ) 7/8/2016 Public Review Start: 11/11/2016 End: 12/26/2016 BSR/AAMI/ISO x, Biocompatibility evaluation of breathing gas pathways in healthcare applications -- Part 2: Tests for emissions of particulate matter (identical national adoption of ISO/FDIS ) 7/8/2016 Public Review Start: 11/11/2016 End: 12/26/2016 BSR/AAMI/ISO x, 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 ) 7/8/2016 Public Review Start: 11/11/2016 End: 12/26/2016 BSR/AAMI/ISO x, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (identical national adoption of ISO/FDIS ) 7/8/2016 Public Review Start: 11/11/2016 End: 12/26/2016 BSR/AAMI/ISO x, 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 x, 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 x, Medical Devices - Information to be provided by the manufacturer (identical national adoption of ISO 20417) 12/15/2017 BSR/AAMI/ISO x, 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 x, Sharps injury protection -- Requirements and test methods -- Sharps containers (national adoption with modifications of ISO 23907) 3/1/2013 BSR/AAMI/ISO x, 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 (in development) and revision of ANSI/AAMI/ISO (R2017)) 10/6/2017 Provided by the American National Standards Institute Friday, January 18, 2019 PAGE 13

14 BSR/AAMI/ISO x, Active implantable medical devices - Fourpole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements (identical national adoption of ISO (under development) and revision of ANSI/AAMI/ISO ) 3/29/2013 BSR/AAMI/ISO x, 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 x, Anaesthetic and respiratory equipment -- Tracheal tubes and connectors (revision and redesignation of ANSI/ISO ) 5/2/2014 Public Review Start: 6/6/2014 End: 7/21/2014 BSR/AAMI/ISO x, Anaesthetic and respiratory equipment -- Oropharyngeal airways (revision and redesignation of ANSI/ASTM/ISO ) 5/2/2014 Public Review Start: 6/6/2014 End: 7/21/2014 BSR/AAMI/ISO x, Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors (identical national adoption of ISO 5366:2016 and revision of ANSI/AAMI/ISO (R2014) ANSI/ISO (R2014)) 11/11/2016 Public Review Start: 2/10/2017 End: 3/27/2017 BSR/AAMI/ISO x, Cardiovascular implants - Cardiac valve prostheses - Part 3:Heart valve substitutes implanted by transcatheter techniques (identical national adoption of ISO/DIS and revision of ANSI/AAMI/ISO ) 1/27/2017 BSR/AAMI/ISO x, 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 x, 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 x, 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 x, 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 x, 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 x, 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 x, Cardiovascular implants - Tubular vascular prostheses (identical national adoption of ISO 7198, ed. 2 (currently at ISO/PWI stage) and revision of ANSI/AAMI/ISO (R2004)) 9/11/2009 BSR/AAMI/ISO x, 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 x, Sterile Hypodermic Syringes for Single Use Part 1: Syringes for Manual Use (identical national adoption of ISO ) Public Review Start: 2/14/1997 End: 4/15/1997 Provided by the American National Standards Institute Friday, January 18, 2019 PAGE 14

15 BSR/AAMI/ISO x, Sterile Hypodermic Syringes for Single Use Part 1: Syringes for Manual Use (identical national adoption of ISO ) Public Review Start: 2/14/1997 End: 4/15/1997 BSR/AAMI/ISO x, Sterile Hypodermic Syringes for Single Use Part 2: Syringes for Use with Power-Driven Syringe Pumps (identical national adoption of ISO ) Public Review Start: 2/14/1997 End: 4/15/1997 BSR/AAMI/ISO x, Small-bore connectors for liquids and gases in healthcare applications -- Part 1: General requirements (revision of ANSI/AAMI/ISO ) 10/4/2013 Public Review Start: 9/22/2017 End: 11/6/2017 BSR/AAMI/ISO x, 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 /Amd1-201x, ISO :2016 Small-bore connectors for liquids and gases in healthcare applications -- Part 3: Connectors for enteral applications/amd1 (addenda to ANSI/AAMI/ISO ) 11/16/2018 Public Review Start: 12/21/2018 End: 2/4/2019 Obtain an electronic copy from: org/higherlogic/ws/public/documents?view= Send comments (with copy to to: Colleen Elliott, (703) , BSR/AAMI/ISO /Amd2-201x, Small-bore connectors for liquids and gases in healthcare applications -- Part 3: Connectors for enteral applications/amd2 (identical national adoption of ISO :2016/Amd2) 3/24/2017 Public Review Start: 5/12/2017 End: 6/26/2017 BSR/AAMI/ISO x, Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators (identical national adoption of ISO :2011) 9/30/2016 Public Review Start: 11/11/2016 End: 12/26/2016 BSR/AAMI/ISO :201x, Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment (identical national adoption of ISO :2011) 9/30/2016 Public Review Start: 11/11/2016 End: 12/26/2016 BSR/AAMI/ISO x, 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 :2015) 9/30/2016 Public Review Start: 11/11/2016 End: 12/26/2016 BSR/AAMI/ISO x, Non-invasive sphygmomanometers: Part 2: Clinical investigation of intermittent automated measurement type (identical national adoption of ISO and revision of ANSI/AAMI/ISO :2013) 11/16/2018 Public Review Start: 1/11/2019 End: 2/25/2019 Order from: Hae Choe, (703) , standards@aami.org Obtain an electronic copy from: hchoe@aami.org Send comments (with copy to psa@ansi.org) to: same BSR/AAMI/ISO x, 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 x, Extracorporeal systems for blood purification - Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators (identical national adoption of ISO/DIS and revision of ANSI/AAMI/ISO (R2015), AM1-2013(R2015) ) 03/11/2016 Public Review Start: 04/15/2016 End: 5/30/2016 BSR/AAMI/ISO x, Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters (identical national adoption of ISO/DIS and revision of ANSI/AAMI/ISO (R2015)) 03/11/2016 Public Review Start: 04/15/2016 End: 5/30/2016 BSR/AAMI/ISO x, Extracorporeal systems for blood purification - Part 3: Plasmafilters (identical national adoption of ISO/DIS ) 03/11/2016 Public Review Start: 4/15/2016 End: 5/30/2016 Provided by the American National Standards Institute Friday, January 18, 2019 PAGE 15

16 BSR/AAMI/ISO CDV x, 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 (in development) and revision of ANSI/AAMI/ISO ) 10/31/2014 Public Review Start: 4/20/2018 End: 6/4/2018 BSR/AAMI/ISO/CDV x, Guidance for the preparation and quality management of fluids for haemodialysis andrelated therapies - Part 1: General requirements (identical national adoption of ISO/DIS and revision of ANSI/AAMI ) 7/1/2016 Public Review Start: 3/17/2017 End: 5/1/2017 BSR/AAMI/ISO/CDV x, 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 and revision of ANSI/AAMI ) 7/1/2016 Public Review Start: 3/17/2017 End: 5/1/2017 BSR/AAMI/ISO/CDV x, 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 and revision of ANSI/AAMI ) 7/1/2016 Public Review Start: 3/17/2017 End: 5/1/2017 BSR/AAMI/ISO/CDV x, 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 and revision of ANSI/AAMI ) 7/1/2016 Public Review Start: 3/17/2017 End: 5/1/2017 BSR/AAMI/ISO/CDV x, 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 and revision of ANSI/AAMI ) 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 DAM1-200x, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity (draft Amendment 1) (supplement to ANSI/AAMI BE ) Public Review Start: 3/26/2004 End: 5/25/2004 AARST (American Association of Radon Scientists and Technologists ) BSR/AARST CCAH-201x, Reducing Radon In New Construction of 1 & 2 Family Dwellings and Townhouses (revision of ANSI/AARST CCAH /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 Friday, January 18, 2019 PAGE 16