Recognized Consensus Standards: Medical Devices

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Date of Entry	Specialty Task Group Area	Recognition Number	Extent of Recognition	Standards Developing Organization	Standard Designation Number and Date	Standard Title (click for recognition information)
07/12/1999	Radiology	12-51	Complete	IEC	61145 (1992-05)	Calibration and usage of ionization chamber systems for assay of radionuclides
03/08/2004	InVitro Diagnostics	7-86	Complete	CLSI	C29-A2 (Replaces C29-A)	Standardization of Sodium and Potassium Ion Selective Electrode Systems to the Flame Photometric Reference Method; Approved Standard - Second Edition
03/08/2004	InVitro Diagnostics	7-87	Complete	CLSI	C31-A2 (Replaces C31-A)	Ionized Calcium Determinations: Precollection Variables, Specimen Choice, Collection, and Handling; Approved Guideline - Second Edition.
03/08/2004	InVitro Diagnostics	7-88	Complete	CLSI	C37-A	Preparation and Validation of Commutable Frozen Human Serum Pools as Secondary Reference Materials for Cholesterol Measurement Procedures; Approved Guideline
03/08/2004	InVitro Diagnostics	7-89	Complete	CLSI	C39-A (Replaces C39-P)	A Designated Comparison Method for the Measurement of Ionized Calcium in Serum; Approved Standard
10/04/2004	InVitro Diagnostics	7-104	Complete	CLSI	H7-A3	Procedure for Determining Packed Cell Volume by the Microhematocrit Method - Second Edition; Approved Standard - Third Edition.
10/04/2004	InVitro Diagnostics	7-105	Complete	CLSI	H30-A2	Procedure for the Determination of Fibrinogen in Plasma; Approved Guideline Second Edition
10/04/2004	Radiology	12-116	Complete	ISO	13696:2002	Optics and optical instruments -- Test methods for radiation scattered by optical components
05/27/2005	Radiology	12-121	Complete	IEC	61847: 1998	Ultrasonics - Surgical systems - Measurement and declaration of the basic output characteristics Ed. 1.0
11/08/2005	InVitro Diagnostics	7-113	Complete	CLSI	I/LA23-A (Replaces I/LA23-P)	Assessing the Quality of Immunoassay Systems: Radioimmunoassays, and Enzyme, Fluorescence, and Luminescence Immunoassays; Approved Guideline
11/08/2005	Radiology	12-6	Complete	IEC	60806 First edition 1984-01	Determination of the maximum symmetrical radiation field from a rotating anode X-Ray tube for medical diagnosis
03/31/2006	Radiology	12-136	Complete	ISO	9236-1 Second edition 2004-02-01	Photography - Sensitometry of screen/film systems for medical radiography - Part 1: Determination of sensitometric curve shape, speed and average gradient
03/31/2006	Radiology	12-137	Complete	ISO	4090 Third eidition 2001-08-15	Photography - Medical radiographic cassette/screens/films and hard-copy imaging films - Dimensions and specifications
03/31/2006	Radiology	12-138	Complete	ISO	5799 Second edition 1991-08-01	Photography -- Direct-exposing medical and dental radiographic film/process systems -- Determination of ISO speed and ISO average gradient
03/31/2006	Radiology	12-141	Complete	IEEE	N42.13-2004	Calibration and Usage of "Dose Calibrator" Ionization Chambers for the Assay of Radionuclides
12/19/2007	Ophthalmic	10-39	Complete	ISO	12865 Second edition 2006-07-01	Ophthalmic instruments - Retinoscopes
12/19/2007	Radiology	12-171	Complete	ISO	14880-2:2006	Optics and photonics -- Microlens arrays -- Part 2: Test methods for wavefront aberrations
12/19/2007	Radiology	12-172	Complete	ISO	14880-3:2006	Optics and photonics -- Microlens arrays -- Part 3: Test methods for optical properties other than wavefront aberrations
12/19/2007	Radiology	12-173	Complete	ISO	14880-4:2006	Optics and photonics -- Microlens arrays -- Part 4: Test methods for geometrical properties
12/19/2007	Radiology	12-176	Complete	IEC	61223-3-2 Second eidtion 2007-07	Evaluation and routine testing in medical imaging departments - Part 3-2: Acceptance tests - Imaging performance of mammographic X-ray equipment
09/09/2008	Dental/ ENT	4-145	Complete	ISO	22803 First edition 2004-09-01	Dentistry - Membrane materials for guided tissue regeneration in oral and maxillofacial surgery - Contents of a technical file
09/09/2008	InVitro Diagnostics	7-21	Complete	CLSI	C42-A	Erythrocyte Protoporphyrin Testing; Approved Guideline
09/09/2008	InVitro Diagnostics	7-136	Complete	CLSI	I/LA2-A2 (Replaces I/LA2-A)	Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Flurescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guideline - Second Edition.
09/09/2008	InVitro Diagnostics	7-159	Complete	CLSI	H21-A5	Collection, Transport, and Processing of Blood Specimens for Testing Plasma-Based Coagulation Assays and Molecular Hemostasis Assays
09/09/2008	InVitro Diagnostics	7-163	Complete	CLSI	H56-A (Replaces H56-P)	Body Fluid Analysis for Cellular Composition; Approved Guideline.
09/09/2008	ObGyn/ Gastroenterology/ Urology	9-7	Complete	IEC	61846 First edition 1998-04	Ultrasonics - Pressure pulse lithotripters - Characteristics of fields
09/09/2008	Radiology	12-165	Complete	NEMA	XR 22-2006 (R2020)	"Quality Control Manual" Template for Manufacturers of Displays and Workstations Labeled for Final Interpretation in Full-field Digital Mammography
09/09/2008	Radiology	12-166	Complete	NEMA	XR 23-2006 (R2020)	"Quality Control Manual" Template for Manufacturers of Hardcopy Output Devices Labeled for Final Interpretation in Full-field Digital Mammography
09/09/2008	Software/ Informatics	13-9	Complete	CLSI	AUTO2-A2	Laboratory Automation: Bar Codes for Specimen Container Identification
09/09/2008	Software/ Informatics	13-10	Complete	CLSI	AUTO1-A	Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard
09/09/2008	Software/ Informatics	13-12	Complete	CLSI	AUTO4-A	Laboratory Automation: Systems Operational Requirements, Characteristics, and Information Elements; Approved Standard
09/09/2008	Software/ Informatics	13-13	Complete	CLSI	AUTO5-A	Laboratory Automation: Electromechanical Interfaces; Approved Standard
09/09/2008	Software/ Informatics	13-14	Complete	CLSI	POCT1-A2	Point-of-Care Connectivity
09/09/2008	Software/ Informatics	13-17	Complete	CLSI	LIS02-A2	Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition
09/09/2008	Software/ Informatics	13-18	Complete	CLSI	LIS03-A	Standard Guide for Selection of a Clinical Laboratory Information Management System
09/09/2008	Software/ Informatics	13-19	Complete	CLSI	LIS04-A	Standard Guide for Documentation of Clinical Laboratory Computer Systems
09/09/2008	Software/ Informatics	13-20	Complete	CLSI	LIS05-A	Standand Specification for Transferring Clinical Observations Between Independent Computer Systems
09/09/2008	Software/ Informatics	13-21	Complete	CLSI	LIS06-A	Standard Practice for Reporting Reliability of Clinical Laboratory Information Systems
09/09/2008	Software/ Informatics	13-22	Complete	CLSI	LIS07-A	Standard Specification for Use of Bar Codes on Specimen Tubes in the Clinical Laboratory
09/09/2008	Software/ Informatics	13-23	Complete	CLSI	LIS08-A	Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems
09/09/2008	Software/ Informatics	13-24	Complete	CLSI	LIS09-A	Standard Guide for Coordination of Clinical Laboratory Services within the Electronic Health Record Environment and Networked Architectures
09/09/2008	Sterility	14-142	Complete	ISO	14698-1:2003	Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 1: General Principles and Methods
09/09/2008	Sterility	14-191	Complete	ISO	13408-4 First edition 2005-11-01	Aseptic processing of health care products - Part 4: Clean-in-place technologies
09/09/2008	Sterility	14-191	Complete	ANSI AAMI ISO	13408-4:2005/(R)2014	Aseptic processing of health care products - Part 4: Clean-in-place technologies
09/09/2008	Sterility	14-239	Complete	ISO	13408-3 First edition 2006-09-15	Aseptic processing of health care products - Part 3: Lyophilization
09/09/2008	Sterility	14-239	Complete	ANSI AAMI ISO	13408-3:2006/(R)2015	Aseptic processing of health care products - Part 3: Lyophilization
09/09/2008	Sterility	14-240	Complete	ISO	13408-5 First edition 2006-11-15	Aseptic processing of health care products - Part 5: Sterilization-in-place
09/09/2008	Sterility	14-240	Complete	ANSI AAMI ISO	13408-5:2006/(R)2015	Aseptic processing of health care products - Part 5: Sterilization in place
03/18/2009	General Plastic Surgery/ General Hospital	6-215	Complete	ASTM	F2132-01 (Reapproved 2008)e1	Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps
03/18/2009	InVitro Diagnostics	7-71	Complete	CLSI	H15-A3 (Replaces H15-A2)	Reference and Selected Procedures for the Quantitative Determination of Hemoglobin in Blood; Approved Standard - Third Edition
03/18/2009	InVitro Diagnostics	7-145	Complete	CLSI	H42-A2 (Replaces H42-A)	Enumeration of Immunologically Defined Cell Populations by Flow Cytometry; Approved Guideline - Second Edition.
03/18/2009	InVitro Diagnostics	7-170	Complete	CLSI	I/LA21-A2	Clinical Evaluation of Immunoassays; Approved Guideline - Second Edition
03/18/2009	InVitro Diagnostics	7-176	Complete	CLSI	I/LA30-A (Replaces I/LA30-P)	Immunoassay Interference by Endogenous Antibodies; Approved Guideline.
03/18/2009	InVitro Diagnostics	7-180	Complete	CLSI	M34-A (Replaces M24-P)	Western Blot Assay for Antibodies to Borrelia burgdorferi; Approved Guideline.
03/18/2009	InVitro Diagnostics	7-182	Complete	CLSI	M36-A	Clinical Use and Interpretation of Serologic Tests for Toxoplasma gondii; Approved Guideline.
03/18/2009	InVitro Diagnostics	7-185	Complete	CLSI	M41-A	Viral Culture; Approved Guideline.
03/18/2009	InVitro Diagnostics	7-189	Complete	CLSI	M47-A (Replaces M47-P)	Principles and Procedures for Blood Cultures; Approved Guideline
03/18/2009	InVitro Diagnostics	7-190	Complete	CLSI	M50-A (Replaces M50-P)	Quality Control for Commercial Microbial Identification Systems; Approved Guideline
03/18/2009	InVitro Diagnostics	7-192	Complete	CLSI	MM18-A (Replaces MM18-P)	Interpretive Criteria for Indentification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline
03/18/2009	Software/ Informatics	13-25	Complete	CLSI	AUTO8-A	Managing and Validating Laboratory Information Systems; Approved Guideline
03/18/2009	Software/ Informatics	13-26	Complete	CLSI	AUTO10-A	Autoverification of Clinical Laboratory Test Results; Approved Guideline
03/18/2009	Software/ Informatics	13-28	Complete	CLSI	AUTO9-A	Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard
09/08/2009	Software/ Informatics	13-29	Complete	CLSI	LIS01-A2	Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems
05/05/2010	InVitro Diagnostics	7-205	Complete	CLSI	H47-A2	One-Stage Prothrombin Time (PT) Test and Activated Partial Thromboplastin Time (APTT) Test; Approved Guideline - Second Edition.
05/05/2010	InVitro Diagnostics	7-207	Complete	CLSI	GP16-A3 (Replaces GP16-A2)	Urinalysis; Approved Guideline - Third Edition
10/04/2010	InVitro Diagnostics	7-212	Complete	CLSI	EP18-A2	Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline - Second Edition
10/04/2010	Radiology	12-213	Complete	IEC	62220-1-2 Edition 1.0 2007-06	Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-2: Determination of the detective quantum efficiency - Detectors used in mammography
10/04/2010	Radiology	12-214	Complete	IEC	62220-1-3 Edition 1.0 2008-06	Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1-3: Determination of the detective quantum efficiency - Detectors used in dynamic imaging
10/04/2010	Radiology	12-215	Complete	IEC	62494-1 Edition 1.0 (2008-08)	Medical electrical equipment - Exposure index of digital X-ray imaging systems - Part 1: Definitions and requirements for general radiography
03/14/2011	Radiology	12-217	Complete	IEC	62083 Edition 2.0 2009-09	Medical electrical equipment - Requirements for the safety of radiotherapy treatment planning systems
03/14/2011	Radiology	12-221	Complete	IEC	61223-3-4 First edition 2000-03	Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray
03/14/2011	Radiology	12-226	Complete	IEC	61223-2-6 Second Edition 2006-11	Evaluation and routine testing in medical imaging departments - Part 2-6: Constancy tests - Imaging performance of computed tomography X-ray equipment
08/02/2011	InVitro Diagnostics	7-219	Complete	CLSI	I/LA28-A2	Quality Assurance for Design Control and Implementation of Immunohistochemistry Assays; Approved Guidelines-Second Edition.
08/02/2011	Ophthalmic	10-65	Complete	ISO	15752 Second edition 2010-01-15	Ophthalmic instruments - Endoilluminators - Fundamental requirements and test methods for optical radiation safety
08/02/2011	Ophthalmic	10-66	Complete	ISO	10936-2 Second edition 2010-01-15	Optics and photonics - Operation microscopes - Part 2: Light hazard from operation microscopes used in ocular surgery
03/16/2012	Anesthesiology	1-62	Complete	ISO	5356-1 Third edition 2004-05-15	Anaesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
03/16/2012	Anesthesiology	1-62	Complete	ANSI AAMI ISO	5356-1:2004	Anaesthetic and Respiratory Equipment - Conical Connectors - Part 1: Cones and Sockets
03/16/2012	Anesthesiology	1-72	Complete	ISO	10651-5 First edition 2006-02-01	Lung ventilators for medical use - Particular requirements for basic safety and essential performance - Part 5: Gas-powered emergency resuscitators
03/16/2012	Anesthesiology	1-73	Complete	ISO	10651-4 First edition 2002-03-01	Lung ventilators - Part 4: Particular requirements for operator powered resuscitators
03/16/2012	Anesthesiology	1-75	Complete	ISO	5362 Fourth edition 2006-06-01	Anaesthetic Reservoir Bags
03/16/2012	Anesthesiology	1-75	Complete	ANSI AAMI ISO	5362:2006	Anaesthetic Reservoir Bags
03/16/2012	Cardiovascular	3-96	Complete	ISO	81060-1 First edition 2007-12-01	Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
03/16/2012	Cardiovascular	3-96	Complete	ANSI AAMI ISO	81060-1:2007/(R)2013	Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type
03/16/2012	Dental/ ENT	4-173	Complete	ANSI ASA	S3.44-1996 (Reaffirmed 2006)	American National Standard for Determination of Occupational Noise Exposure and Estimation of Noise-Induced Hearing Impairment
03/16/2012	General Plastic Surgery/ General Hospital	6-177	Complete	ASTM	E1112-00(2018)	Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
03/16/2012	General Plastic Surgery/ General Hospital	6-268	Complete	ASTM	F921-10 (Reapproved 2018)	Standard Terminology Relating to Hemostatic Forceps
03/16/2012	General Plastic Surgery/ General Hospital	6-269	Complete	ASTM	F1078-10 (Reapproved 2018)	Standard Terminology for Surgical Scissors-Inserted and Non-Inserted Blades
03/16/2012	General Plastic Surgery/ General Hospital	6-271	Complete	ASTM	F1874-98 (Reapproved 2011)	Standard Test Method for Bend Testing of Needles Used in Surgical Sutures
03/16/2012	General Plastic Surgery/ General Hospital	6-272	Complete	ASTM	F2062-00 (Reapproved 2018)	Standard Specification for Square Drive Interconnections on Surgical Instruments
03/16/2012	InVitro Diagnostics	7-150	Complete	CLSI	H43-A2	Clinical Flow Cytometry Analysis of Neoplastic Hematolymphoid Cells; Approved Guideline - Second Edition
03/16/2012	InVitro Diagnostics	7-165	Complete	CLSI	H20-A2 (Replaces H20-A)	Reference Leukocyte (WBC) Differential Count (Proportional) and Evaluation of Instrumental Methods; Approved Standard - Second Edition
03/16/2012	InVitro Diagnostics	7-166	Complete	CLSI	GP20-A2 (Replaces GP20-A)	Fine Needle Aspiration Biopsy (FNAB) Techniques; Approved Guideline - Second Edition
03/16/2012	InVitro Diagnostics	7-225	Complete	CLSI	GP34-A (Replaces GP34-P)	Validation and Verfication of Tubes for Venous and Capillary Blood Specimen Collection; Approved Guidance
03/16/2012	InVitro Diagnostics	7-227	Complete	CLSI	M53-A (Replaces M53-P)	Criteria for Laboratory Testing and Diagnosis of Human Immunodeficiency Virus Infection; Approved Guideline
03/16/2012	Ophthalmic	10-70	Complete	ISO	10943 Third edition 2011-08-15	Ophthalmic instruments - Indirect ophthalmoscopes
03/16/2012	Radiology	12-105	Complete	NEMA	UD 2-2004 (R2009)	Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment Revision 3
03/16/2012	Radiology	12-106	Complete	ISO	17526 First edition 2003-06-15	Optics and optical instruments - Lasers and laser-related equipment - Lifetime of lasers
03/16/2012	Radiology	12-115	Complete	ISO	13695:2004	Optics and photonics - Lasers and laser-related equipment - Test methods for the spectral characteristics of lasers
03/16/2012	Radiology	12-117	Complete	ISO	15367-1 First edition 2003-09-15	Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 1: Terminology and fundamental aspects
03/16/2012	Radiology	12-134	Complete	ISO	11146-1 First edition 2005-01-15	Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 1: Stigmatic and simple astigmatic beams
03/16/2012	Radiology	12-142	Complete	ISO	11146-2 First edition 2005-02-15	Lasers and laser-related equipment - Test methods for laser beam widths, divergence angles and beam propagation ratios - Part 2: General astigmatic beams
03/16/2012	Radiology	12-143	Complete	ISO	15367-2 First edition 2005-03-15	Lasers and laser-related equipment - Test methods for determination of the shape of a laser beam wavefront - Part 2: Shack-Hartman sensors
03/16/2012	Radiology	12-174	Complete	ISO	13697 First edition 2006-05-15	Optics and photonics -- Lasers and laser-related equipment - Test methods for specular reflectance and regular transmittance of optical laser components
03/16/2012	Radiology	12-175	Complete	ISO	24013 First edition 2006-11-15	Optics and photonics -- Lasers and laser-related equipment - Measurement of phase retardation of optical components for polarized laser radiation
03/16/2012	Radiology	12-177	Complete	UL	122-2007 (R2011)	Standard for Photographic Equipment - Ed. 5.0
03/16/2012	Radiology	12-232	Complete	NEMA	MS 4-2010	Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
03/16/2012	Radiology	12-241	Complete	IEC	62274 First Edition 2005-05	Medical electrical equipment - Safety of radiotherapy record and verify systems
03/16/2012	Radiology	12-242	Complete	IEC	60601-2-57 Edition 1.0 2011-01	Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
03/16/2012	Radiology	12-245	Complete	ISO	21254-1 First edition 2011-07-15	Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 1: Definitions and general principles
03/16/2012	Radiology	12-246	Complete	ISO	21254-2 First edition 2011-07-15	Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 2: Threshold determination
03/16/2012	Radiology	12-248	Complete	ISO	21254-3 First edition 2011-07-15	Lasers and laser-related equipment - Test methods for laser-induced damage threshold - Part 3: Assurance of laser power (energy) handling capabilities
03/16/2012	Software/ Informatics	13-30	Complete	CLSI	AUTO3-A2	Laboratory Automation: Communications with Automated Clinical Laboratory Systems, Instruments, Devices, and Information Systems; Approved Standard
03/16/2012	Sterility	14-332	Complete	ISO	11140-5 Second edition 2007-03-15	Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick-type air removal tests
03/16/2012	Sterility	14-332	Complete	ANSI AAMI ISO	11140-5:2007/(R)2012	Sterilization of health care products - Chemical indicators - Part 5: Class 2 indicators for Bowie and Dick air removal test sheets and packs
03/16/2012	Tissue Engineering	15-31	Complete	ASTM	F2312-11 (Reapproved 2020)	Standard Terminology Relating to Tissue Engineered Medical Products
08/20/2012	Anesthesiology	1-87	Complete	IEC	60601-2-23 Edition 3.0 2011-02	Medical electrical equipment - Part 2-23: Particular requirements for the basic safety and essential performance of transcutaneous partial pressure monitoring equipment
08/20/2012	Cardiovascular	3-102	Complete	IEC	60601-2-31 Edition 2.1 2011-09	Medical electrical equipment, Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
08/20/2012	Cardiovascular	3-103	Complete	ISO	25539-3 First edition 2011-12-01	Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
08/20/2012	Cardiovascular	3-103	Complete	ANSI AAMI ISO	25539-3:2011	Cardiovascular implants - Endovascular devices - Part 3: Vena cava filters
08/20/2012	Cardiovascular	3-104	Complete	ASTM	F2914-12 (Reapproved 2018)	Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
08/20/2012	General Plastic Surgery/ General Hospital	6-242	Complete	ISO	8536-2 Third edition 2010-03-15	Infusion equipment for medical use - Part 2: Closures for infusion bottles
08/20/2012	General Plastic Surgery/ General Hospital	6-278	Complete	ISO	11040-5 Third edition 2012-02-15	Prefilled syringes - Part 5: Plunger stoppers for injectables
08/20/2012	InVitro Diagnostics	7-76	Complete	CLSI	M15-A (Replaces M15-T)	Laboratory Diagnosis of Blood-borne Parasitic Diseases; Approved Guideline
08/20/2012	InVitro Diagnostics	7-148	Complete	CLSI	M28-A2 (Replaces M28-A)	Procedures for the Recovery and Identification of Parasites from the Intestinal Tract; Approved Guideline - Second Edition.
08/20/2012	InVitro Diagnostics	7-197	Complete	CLSI	M35-A2 (Replaces M35-A)	Abbreviated Identification of Bacteria and Yeast; Approved Guideline - Second Edition.
08/20/2012	Radiology	12-249	Complete	IEC	62471 First edition 2006-07	Photobiological safety of lamps and lamp systems
08/20/2012	Software/ Informatics	13-31	Complete	CLSI	AUTO12-A	Specimen Labels: Content and Location, Fonts, and Label Orientation; Approved Standard
01/15/2013	General Plastic Surgery/ General Hospital	6-122	Complete	ISO	8536-5 Second edition 2004-02-01	Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed
01/15/2013	InVitro Diagnostics	7-233	Complete	CLSI	EP17-A2	Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition
01/15/2013	InVitro Diagnostics	7-235	Complete	CLSI	EP25-A (Replaces EP25-P)	Evaluation of Stability of In Vitro Diagnostic Reagents; Approved Guideline.
01/15/2013	InVitro Diagnostics	7-237	Complete	CLSI	MM01-A3 (Replaces MM01-A2)	Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline - Third Edition
01/15/2013	InVitro Diagnostics	7-238	Complete	CLSI	MM06-A2 (Replaces MM06-A)	Quantitative Molecular Methods for Infectious Diseases; Approved Guideline - Second Edition
01/15/2013	Software/ Informatics	13-33	Complete	AAMI	TIR 36:2007	Validation of software for regulated processes
01/15/2013	Software/ Informatics	13-34	Complete	ANSI AAMI IEC	TIR80002-1:2009	Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
01/15/2013	Software/ Informatics	13-34	Complete	IEC	TR 80002-1 Edition 1.0 2009-09	Medical device software - Part 1: Guidance on the application of ISO 14971 to medical device software
01/15/2013	Software/ Informatics	13-35	Complete	ANSI AAMI	SW87:2012	Application of quality management system concepts to medical device data systems
01/15/2013	Software/ Informatics	13-36	Complete	AAMI	TIR 45:2012	Guidance on the use of AGILE practices in the development of medical device software
01/15/2013	Sterility	14-212	Complete	AOAC	6.2.02:2006	Official Method 991.47, Testing Disinfectants Against Salmonella choleraesuis, Hard Surface Carrier Test Method
01/15/2013	Sterility	14-213	Complete	AOAC	6.2.03:2006	Official Method 991.48, Testing Disinfectants Against Staphylococcus aureus, Hard Surface Carrier Test Method
01/15/2013	Sterility	14-215	Complete	AOAC	6.2.05:2006	Official Method 991.49, Testing Disinfectants Against Pseudomonas aeruginosa,Hard Surface Carrier Test Method
01/15/2013	Sterility	14-217	Complete	AOAC	6.3.02:2006	Official Method 955.17, Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes
01/15/2013	Sterility	14-359	Complete	ASTM	F2096-11 (Reapproved 2019)	Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
01/25/2013	Cardiovascular	3-89	Complete	ISO	27186 First edition 2010-03-15	Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
01/25/2013	Cardiovascular	3-89	Complete	ANSI AAMI ISO	27186:2010	Active implantable medical devices - Four-pole connector system for implantable cardiac rhythm management devices - Dimensional and test requirements
08/06/2013	Cardiovascular	3-87	Complete	ASTM	F2477-07 (Reapproved 2013)	Standard Test Methods for in vitro Pulsatile Durability
08/06/2013	Cardiovascular	3-115	Complete	IEC	60601-2-34 Edition 3.0 2011-05	Medical electrical equipment - Part 2-34: Particular requirements for the basic safety, including essential performance, of invasive blood pressure monitoring equipment
08/06/2013	Dental/ ENT	4-90	Complete	ANSI ASA	S3.39:1987 (Reaffirmed 2020)	American National Standard Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance)
08/06/2013	Dental/ ENT	4-167	Complete	ANSI ASA	S3.21-2004 (Reaffirmed 2019)	American National Standard Methods for Manual Pure-Tone Threshold Audiometry
08/06/2013	Dental/ ENT	4-204	Complete	ANSI ASA	S3.42-2012/Part 2/ IEC 60118-15:2012 (R2020)	American National Standard Testing Hearing Aids - Part 2: Methods for characterizing signal processing in hearing aids with a speech-like signal (a nationally adopted international standard)
08/06/2013	General Plastic Surgery/ General Hospital	6-147	Complete	ASTM	D6978-05(2023)	Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs
08/06/2013	General Plastic Surgery/ General Hospital	6-179	Complete	ISO	21649 First edition 2006-06-01	Needle-free injectors for medical use -- Requirements and test methods
08/06/2013	General Plastic Surgery/ General Hospital	6-216	Complete	ISO	8536-7 Third edition 2009-01-15	Infusion equipment for medical use - Part 7: Caps made of aluminum-plastics combinations for infusion bottles
08/06/2013	General Plastic Surgery/ General Hospital	6-240	Complete	ISO	8536-3 Third edition 2009-06-01	Infusion equipment for medical use - Part 3: Aluminum caps for infusion bottles
08/06/2013	General Plastic Surgery/ General Hospital	6-276	Complete	ISO	8536-1 Fourth edition 2011-09-01	Infusion equipment for medical use - Part 1: Infusion glass bottles
08/06/2013	General Plastic Surgery/ General Hospital	6-295	Complete	AAMI ANSI	BF7:2012	Blood transfusion microfilters
08/06/2013	General Plastic Surgery/ General Hospital	6-296	Complete	ANSI AAMI	PB70:2012	Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
08/06/2013	InVitro Diagnostics	7-234	Partial	CLSI	EP24-A2 (Replaces GP 10-A)	Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition
08/06/2013	InVitro Diagnostics	7-242	Complete	CLSI	C56-A	Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline
08/06/2013	InVitro Diagnostics	7-243	Partial	CLSI	M51-A (Replaces M51-P)	Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline
08/06/2013	Materials	8-153	Complete	ASTM	F2119-07 (Reapproved 2013)	Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants
08/06/2013	Materials	8-158	Complete	ASTM	F1713-08 (Reapproved 2013)	Standard Specification for Wrought Titanium-13 Niobium-13 Zirconium Alloy for Surgical Implant Applications (UNS R58130)
08/06/2013	ObGyn/ Gastroenterology/ Urology	9-31	Complete	ANSI AAMI	ID54:1996/(R)2012	Enteral feeding set adapters and connectors
08/06/2013	Ophthalmic	10-77	Complete	ISO	9394 Third edition 2012-10-01	Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes
08/06/2013	Ophthalmic	10-78	Complete	ISO	11979-3 Third edition 2012-12-01	Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods
08/06/2013	Orthopedic	11-252	Complete	ISO	5838-1 Third edition 2013-03-01	Implants for surgery -- Metallic skeletal pins and wires -- Part 1: General requirements
08/06/2013	Orthopedic	11-254	Complete	ISO	14630 Fourth edition 2012-12-01	Non-active surgical implants -- General requirements
08/06/2013	Physical Medicine	16-190	Complete	ISO	7176-11 Second edition 2012-12-01	Wheelchairs - Part 11: Test dummies
08/06/2013	Physical Medicine	16-192	Complete	ISO	7176-3 Third edition 2012-12-15	Wheelchairs - Part 3: Determination of effectiveness of brakes
08/06/2013	Radiology	12-205	Complete	IEC	60601-2-5: Edition 3.0 2009-07	Medical electrical equipment - Part 2-5: Particular requirements for the basic safety and essential performance of ultrasonic physiotherapy equipment
08/06/2013	Radiology	12-211	Complete	IEC	60601-2-29 Edition 3.0 2008-06	Medical electrical equipment - Part 2-29: Particular requirements for the basic safety and essential performance of radiotherapy simulators
08/06/2013	Radiology	12-253	Complete	IEC	60976 Edition 2.0 2007-10	Medical electrical equipment - Medical electron accelerators - Functional performance characteristics
08/06/2013	Radiology	12-255	Complete	IEC	60601-2-11 Edition 3.0 2013-01	Medical electrical equipment - Part 2-11: Particular requirements for the basic safety and essential performance of gamma beam therapy equipment
08/06/2013	Software/ Informatics	13-37	Complete	CLSI	AUTO7-A	Laboratory Automation: Data Content for Specimen Identification; Approved Standard
08/06/2013	Software/ Informatics	13-38	Complete	IEC	80001-1 Edition 1.0 2010-10	Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities
08/06/2013	Software/ Informatics	13-38	Complete	ANSI AAMI IEC	80001-1:2010	Application of risk management for IT Networks incorporating medical devices - Part 1: Roles, responsibilities and activities
08/06/2013	Software/ Informatics	13-40	Complete	ANSI AAMI IEC	TIR 80001-2-1 2012	Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks; Practical applications and examples
08/06/2013	Software/ Informatics	13-40	Complete	IEC	TR 80001-2-1 Edition 1.0 2012-07	Application of risk management for IT- networks incorporating medical devices - Part 2-1: Step-by-step risk management of medical IT-networks - Practical applications and examples
08/06/2013	Software/ Informatics	13-42	Complete	ANSI AAMI IEC	TIR 80001-2-2:2012	Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
08/06/2013	Software/ Informatics	13-42	Complete	IEC	TR 80001-2-2 Edition 1.0 2012-07	Application of risk management for IT Networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
08/06/2013	Software/ Informatics	13-44	Complete	ANSI AAMI IEC	TIR 80001-2-3:2012	Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks
08/06/2013	Software/ Informatics	13-44	Complete	IEC	TR 80001-2-3 Edition 1.0 2012-07	Application of risk management for IT Networks incorporating medical devices - Part 2-3: Guidance for wireless networks
08/06/2013	Software/ Informatics	13-49	Complete	ISO IEEE	11073-20101 First edition 2004-12-15	Health informatics - Point-of-care medical device communication - Part 20101: Application Profiles - Base Standard
08/06/2013	Software/ Informatics	13-52	Complete	ISO IEEE	11073-10408 First edition 2010-05-01	Health informatics - Point-of-care medical device communication - Part 10408: Device specialization - Thermometer
08/06/2013	Software/ Informatics	13-53	Complete	ISO IEEE	11073-10415 First edition 2010-05-01	Health informatics - Point-of-care medical device communication - Part 10415: Device specialization - Weighing scale
08/06/2013	Software/ Informatics	13-54	Partial	ISO IEEE	11073-10404 First edition 2010-05-01	Health informatics - Personal health device communication - Part 10404: Device specialization - Pulse oximeter
08/06/2013	Software/ Informatics	13-55	Complete	IEEE	Std 11073-10421-2010	Health informatics - Personal health device communication Part 10421: Device specialization - Peak expiratory flow monitor (peak flow)
08/06/2013	Software/ Informatics	13-56	Complete	IEEE	Std 11073-10406-2011	Health informatics - Personal health device communication Part 10406: Device specialization - Basic electrocardiograph
08/06/2013	Software/ Informatics	13-57	Complete	ISO IEEE	11073-10407 First edition 2010-05-01	Health informatics - Personal health device communication - Part 10407: Device Specialization - Blood pressure monitor
08/06/2013	Software/ Informatics	13-59	Complete	ISO IEC IEEE	15026-4 First edition 2021-10-01	Systems and software engineering - Systems and software assurance - Part 4: Assurance in the life cycle
08/06/2013	Software/ Informatics	13-60	Complete	IEC	TS 62443-1-1 Edition 1.0 2009-07	Industrial communication networks - Network and system security - Part 1-1: Terminology, concepts and models
08/06/2013	Software/ Informatics	13-61	Complete	IEC	62443-2-1 Edition 1.0 2010-11	Industrial communication networks - Network and system security - Part 2-1: Establishing an industrial automation and control system security program
08/06/2013	Software/ Informatics	13-62	Complete	IEC	TR 62443-3-1 Edition 1.0 2009-07	Industrial communication networks - Network and system security - Part 3-1: Security technologies for industrial automation and control systems
08/06/2013	Sterility	14-381	Complete	ISO ASTM	51261 Second edition 2013-04-15	Practice for calibration of routine dosimetry systems for radiation processing
08/06/2013	Sterility	14-383	Complete	ISO ASTM	51702 Third edition 2013-04-15	Practice for dosimetry in a gamma facility for radiation processing
08/06/2013	Sterility	14-388	Complete	ISO	13408-7 First edition 2012-08-01	Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products
08/06/2013	Sterility	14-388	Complete	ANSI AAMI ISO	13408-7:2012 (R2018)	Aseptic processing of health care products - Part 7: Alternate processes for medical devices and combination products
08/06/2013	Tissue Engineering	15-14	Complete	ASTM	F2603-06 (Reapproved 2020)	Standard Guide for Interpreting Images of Polymeric Tissue Scaffolds
01/14/2014	Radiology	12-268	Complete	IEC	60601-2-22 Edition 3.1 2012-10	Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
01/30/2014	Anesthesiology	1-81	Complete	CGA	V-5:2008 (Reaffirmed 2013)	Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications)
01/30/2014	Anesthesiology	1-97	Complete	CGA	V-7.1:2011	Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases
01/30/2014	Cardiovascular	3-54	Complete	ANSI AAMI ISO	7198:2016 Second edition	Cardiovascular implants and extracorporeal systems--Vascular prostheses--Tubular vascular grafts and vascular patches
01/30/2014	Cardiovascular	3-63	Complete	ISO	11318:2002	Cardiac Defibrillators -- Connector assembly DF-1 for implantable defibrillators - Dimensions and test requirements.
01/30/2014	Cardiovascular	3-118	Complete	ANSI AAMI	EC57:2012	Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms
01/30/2014	Dental/ ENT	4-137	Complete	ISO	6877 Second edition 2006-04-01	Dentistry - Root-canal obturating points
01/30/2014	Dental/ ENT	4-137	Complete	ANSI ADA	Standard No. 78-2013	Dental obturating cones
01/30/2014	Dental/ ENT	4-151	Complete	ISO	22112 First edition 2005-11-01	Dentistry - Artificial teeth for dental prostheses
01/30/2014	Dental/ ENT	4-151	Complete	ANSI ADA	Standard No. 15-2008 (R2013)	Artificial Teeth for Dental Prostheses
01/30/2014	Dental/ ENT	4-153	Complete	ISO	9917-1 Second edition 2007-10-01	Dentistry - Water-based cements - Part 1: Powder/liquid acid-base cements
01/30/2014	Dental/ ENT	4-180	Complete	ISO	9168 Third edition 2009-07-15	Dentistry - Hose connectors for air driven dental handpieces
01/30/2014	Dental/ ENT	4-181	Complete	ISO	4049 Fourth edition 2009-10-01	Dentistry - Polymer-based restorative materials
01/30/2014	Dental/ ENT	4-188	Complete	ISO	9917-2 Second edition 2010-04-15	Dentistry - Water-based cements - Part 2: Resin-modified cements
01/30/2014	Dental/ ENT	4-198	Complete	ISO	3107 Fourth edition 2011-03-01	Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements
01/30/2014	Dental/ ENT	4-198	Complete	ANSI ADA	Standard No. 30-2013 (R2018)	Dental Zinc Oxide-Eugenol and Zinc Oxide
01/30/2014	Dental/ ENT	4-199	Complete	ISO	6876 Third edition 2012-06-01	Dentistry -- Root canal sealing materials
01/30/2014	General I (QS/ RM)	5-47	Complete	ISO	10012 First edition 2003-01-15	Measurement management systems - Requirements for measurement processes and measuring equipment
01/30/2014	General I (QS/ RM)	5-84	Complete	AAMI	TIR 49:2013/(R)2020	Technical Information Report Design of training and instructional materials for medical devices used in non-clinical environments
01/30/2014	General Plastic Surgery/ General Hospital	6-117	Complete	ASTM	F2172-02 (Reapproved 2011)	Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers
01/30/2014	General Plastic Surgery/ General Hospital	6-253	Complete	ISO	10535 Second edition 2006-12-15	Hoists for the transfer of disabled persons - Requirements and test methods
01/30/2014	General Plastic Surgery/ General Hospital	6-273	Complete	ISO	23908 First edition 2011-06-11	Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
01/30/2014	General Plastic Surgery/ General Hospital	6-303	Complete	ISO	10555-5 Second edition 2013-06-15	Intravascular catheters -- Sterile and single-use catheters -- Part 5: Over-needle peripheral catheters
01/30/2014	General Plastic Surgery/ General Hospital	6-305	Complete	ISO	10555-3 Second edition 2013-06-15	Intravascular catheters -- Sterile and single-use catheters -- Part 3: Central venous catheters
01/30/2014	General Plastic Surgery/ General Hospital	6-306	Complete	ASTM	F1671/F1671M-13	Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174 Bacteriophage Penetration as a Test System
01/30/2014	General Plastic Surgery/ General Hospital	6-321	Complete	IEC	60601-2-52 Edition 1.0 2009-12	Medical electrical equipment - Part 2-52: Particular requirements for basic safety and essential performance of medical beds [Including: Technical Corrigendum 1 (2010)]
01/30/2014	General Plastic Surgery/ General Hospital	6-322	Complete	ISO	10555-4 Second edition 2013-06-15	Intravascular catheters -- Sterile and single-use catheters -- Part 4: Balloon dilatation catheters
01/30/2014	InVitro Diagnostics	7-152	Complete	CLSI	EP12-A2	User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition.
01/30/2014	InVitro Diagnostics	7-210	Partial	CLSI	H26-A2	Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Proposed Standard - Second Edition
01/30/2014	InVitro Diagnostics	7-220	Partial	CLSI	H59-A (Replaces H59-P)	Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline.
01/30/2014	InVitro Diagnostics	7-223	Complete	CLSI	QMS06-A3 (Formerly GP22-A3)	Quality Management System: Continual Improvement; Approved Guideline - Third Edition
01/30/2014	InVitro Diagnostics	7-224	Complete	CLSI	EP28-A3c (Formerly C28-A3c)	Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline - Third Edition
01/30/2014	InVitro Diagnostics	7-239	Complete	CLSI	EP32-R (Formerly X05-R)	Metrological Traceability and Its Implementation; A Report
01/30/2014	InVitro Diagnostics	7-244	Complete	CLSI	NBS01-A6 (Replaces LA04-A5)	Blood Collection on Filter Paper for Newborn Screening Programs: Approved Standard - Sixth Edition
01/30/2014	Materials	8-157	Complete	ISO	9583 First edition 1993-10-15	Implants for surgery -- Non-destructive testing -- Liquid penetrant inspection of metallic surgical implants
01/30/2014	Materials	8-159	Complete	ISO	9584 First edition 1993-10-15	Implants for surgery -- Non-destructive testing -- Radiographic examination of cast metallic surgical implants
01/30/2014	Materials	8-344	Complete	ISO	7153-1 Second edition 1991-04-01	Surgical instruments -- Metallic materials -- Part 1: Stainless steel [Including: Amendment 1 (1999)]
01/30/2014	Materials	8-358	Complete	ASTM	F1855-00 (Reapproved 2019)	Standard Specification for Polyoxymethylene (Acetal) for Medical Applications
01/30/2014	Neurology	17-12	Complete	ISO	7197 Third edition 2006-06-01	Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components [Including: Technical Corrigendum 1 (2007)]
01/30/2014	ObGyn/ Gastroenterology/ Urology	9-85	Complete	ASTM	D6976-13R18	Standard Specification for Rubber Contraceptives - Vaginal Diaphragms
01/30/2014	ObGyn/ Gastroenterology/ Urology	9-86	Complete	ISO	16037 First edition 2002-05-15 (Amendment 1 2011-02-15)	Rubber condoms for clinical trials - Measurement of physical properties [Including: Amendment (2011)]
01/30/2014	ObGyn/ Gastroenterology/ Urology	9-88	Complete	ISO	29942 First edition 2011-07-01	Prophylatic dams -- Requirements and test methods
01/30/2014	Orthopedic	11-74	Complete	ISO	5838-2 First edition 1991-01-15	Implants for surgery -- Skeletal pins and wires -- Part 2: Steinmann skeletal pins -- Dimensions
01/30/2014	Orthopedic	11-75	Complete	ISO	5838-3 First edition 1993-09-15	Implants for surgery -- Skeletal pins and wires -- Part 3: Kirschner skeletal wires
01/30/2014	Orthopedic	11-232	Complete	ISO	7207-1 Third edition 2007-02-01	Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions
01/30/2014	Orthopedic	11-274	Complete	ISO	18192-2 First edition 2010-06-15	Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 2: Nucleus replacements
01/30/2014	Physical Medicine	16-25	Complete	ISO	7176-13 First edition 1989-08-01	Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
01/30/2014	Physical Medicine	16-27	Complete	ISO	7176-15 First edition 1996-11-15	Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling
01/30/2014	Physical Medicine	16-162	Complete	ISO	7176-4 Third edition 2008-10-01	Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
01/30/2014	Physical Medicine	16-163	Complete	ISO	7176-5 Second edition 2008-06-01	Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
01/30/2014	Physical Medicine	16-164	Complete	ISO	7176-10 Second edition 2008-11-01	Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
01/30/2014	Physical Medicine	16-165	Complete	ISO	7176-14 Second edition 2008-02-15	Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
01/30/2014	Physical Medicine	16-167	Complete	ISO	7176-9 Third edition 2009-11-15	Wheelchairs - Part 9: Climatic tests for electric wheelchairs
01/30/2014	Radiology	12-59	Complete	IEC	61168:1993	Radiotherapy simulators - Functional performance characteristics
01/30/2014	Radiology	12-228	Complete	IEC	61391-2 Edition 1.0 2010-01	Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range
01/30/2014	Radiology	12-259	Complete	IEC	61674 Edition 2.0 2012-11	Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging
01/30/2014	Radiology	12-261	Complete	ISO IEC	10918-1 First edition 1994-02-15	Information technology - Digital compression and coding of continuous-tone still images: Requirements and guidelines [Including: Technical Corrigendum 1 (2005)]
01/30/2014	Radiology	12-262	Complete	ISO	11670 Second edition 2003-04-01	Lasers and laser-related equipment - Test methods for laser beam parameters - Beam positional stability [Including: Technical Corrigendum 1 (2004)]
01/30/2014	Radiology	12-264	Complete	NEMA	MS 11-2010	Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging
01/30/2014	Radiology	12-266	Complete	IEC	61689 Edition 3.0 2013-02	Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz
01/30/2014	Radiology	12-267	Complete	IEC	61217 Edition 2.0 2011-12	Radiotherapy equipment - Coordinates, movements, and scales
01/30/2014	Software/ Informatics	13-63	Complete	ANSI AAMI IEC	TIR 80001-2-4:2012	Application of risk management for IT-networks incorporating medical devices - Part 2-4: General implementation guidance for healthcare delivery organizations
01/30/2014	Software/ Informatics	13-63	Complete	IEC	TR 80001-2-4 Edition 1.0 2012-11	Application of risk management for IT-networks incorporating medical devices -- Part 2-4: Application guidance - General implementation guidance for healthcare delivery organization
01/30/2014	Sterility	14-334	Partial	ISO	15882 Second edition 2008-09-01	Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results
01/30/2014	Sterility	14-334	Partial	ANSI AAMI ISO	15882:2008/(R)2013	Sterilization of health care products - Chemical indicators - Guidance for selection, use, and interpretation of results
01/30/2014	Sterility	14-336	Partial	ISO	14161 Second edition 2009-09-15	Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results
01/30/2014	Sterility	14-336	Partial	ANSI AAMI ISO	14161-2009/(R)2014	Sterilization of health care products - Biological indicators: Guidance for the selection, use and interpretation of results
01/30/2014	Sterility	14-395	Complete	ISO	14698-2 First edition 2003-09-15	Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 2: Evaluation and Interpretation of Biocontamination Data [Including: Technical Corrigendum 1 (2004)]
01/30/2014	Sterility	14-397	Complete	AOAC	6.2.04:2013	Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus,Use-Dilution Method
01/30/2014	Sterility	14-398	Complete	AOAC	6.3.05:2013	Official Method 966.04, Sporicidal Activity of Disinfectants Method I
01/30/2014	Sterility	14-399	Complete	AOAC	6.3.06:2012	Official Method 965.12 Tuberculocidal Activity of Disinfectants
01/30/2014	Sterility	14-400	Complete	ASTM	F2203-13 (Reapproved 2022)	Standard Test Method for Linear Measurement Using Precision Steel Rule
01/30/2014	Sterility	14-401	Complete	ASTM	F2217/F2217M-13 (Reapproved 2018)	Standard Practice for Coating/Adhesive Weight Determination
01/30/2014	Sterility	14-402	Complete	ASTM	F1140/F1140M-13 (Reapproved 2020)e1	Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
01/30/2014	Sterility	14-403	Complete	ASTM	F2054/F2054M-13 (Reapproved 2020)	Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates
01/30/2014	Sterility	14-404	Complete	ASTM	F2250-13 (Reapproved 2018)	Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials
01/30/2014	Sterility	14-405	Complete	ASTM	F2252/F2252M-13 (Reapproved 2018)	Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape
01/30/2014	Sterility	14-406	Complete	ANSI AAMI	ST8:2013/(R)2018	Hospital steam sterilizers
01/30/2014	Sterility	14-412	Complete	AOAC	6.2.01:2013	Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method
01/30/2014	Sterility	14-413	Complete	AOAC	6.2.06:2013	Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method
01/30/2014	Sterility	14-427	Complete	ISO	13408-1 Second edition 2008-06-15	Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)]
01/30/2014	Sterility	14-429	Complete	ISO ASTM	51275 Third edition 2013-06-01	Practice for use of a radiochromic film dosimetry system
01/30/2014	Sterility	14-430	Complete	ISO ASTM	51607 Third edition 2013-06-01	Practice for use of an alanine-EPR dosimery system
07/09/2014	Anesthesiology	1-99	Complete	ASTM	G175-13 (Reapproved 2021)	Standard Test Method for Evaluating the Ignition Sensitivity and Fault Tolerance of Oxygen Regulators Used for Medical and Emergency Applications
07/09/2014	Anesthesiology	1-100	Complete	CGA	V-1:2013	Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connection
07/09/2014	Anesthesiology	1-101	Complete	CGA	C-9:2013	Standard Color Marking of Compressed Gas Containers for Medical Use
07/09/2014	Dental/ ENT	4-97	Complete	ANSI ADA	Standard No. 57-2000 (R2012)	Endodontic Sealing Material
07/09/2014	Dental/ ENT	4-149	Complete	ANSI ADA	Standard No. 39-2006 (R2011)	Pit and Fissure Sealants
07/09/2014	Dental/ ENT	4-160	Complete	ANSI ASA	S3.1-1999 (Reaffirmed 2023)	American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms
07/09/2014	Dental/ ENT	4-165	Complete	ANSI ASA	S3.13-1987 (Reaffirmed 2020)	American National Standard Mechanical Coupler for Measurement of Bone Vibrators
07/09/2014	Dental/ ENT	4-177	Complete	ANSI ASA	S12.65-2006 (Reaffirmed 2020)	American National Standard For Rating Noise with Respect to Speech Interference
07/09/2014	Dental/ ENT	4-211	Complete	ANSI ASA	S3.46-2013 (Reaffirmed 2023)	American National Standard Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids
07/09/2014	General I (QS/ RM)	5-88	Complete	ISO	2859-1 Second edition 1999-11-15	Sampling procedures for inspection by attributes - Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection [Including: Technical Corrigendum 1 (2001), Amendment 1 (2011)]
07/09/2014	General II (ES/ EMC)	19-10	Complete	UL	1642 5th Edition	Lithium Batteries
07/09/2014	General II (ES/ EMC)	19-11	Complete	UL	2054 2nd Edition	Household and Commercial Batteries
07/09/2014	InVitro Diagnostics	7-48	Complete	CLSI	C60-A	Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline
07/09/2014	InVitro Diagnostics	7-175	Complete	CLSI	C59-A	Apoplipoprotein Immunoassays: Development and Recommended Performance Characteristics; Approved Guideline
07/09/2014	InVitro Diagnostics	7-213	Complete	CLSI	GP44-A4 (Formerly H18-A4)	Procedures for the Handling and Processing of Blood Specimens for Common Laboratory Tests; Approved Guideline-Fourth Edition
07/09/2014	InVitro Diagnostics	7-221	Complete	CLSI	GP39-A6 (Formerly H01-A6)	Tubes and Additives for Venous Blood Specimen Collection; Approved Standard-Sixth Edition
07/09/2014	Materials	8-377	Complete	ASTM	F136-13	Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)
07/09/2014	Materials	8-378	Complete	ASTM	D792-13	Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
07/09/2014	Materials	8-379	Complete	ISO	11542-2 First edition 1998-11-15	Plastics - Ultra-high-molecular-weight polyethyelene (PE-UHMW) moulding and extrusion materials - Part 2: Preparation of test specimens and determination of properties [Including: Technical Corrigendum 1 (2007)]
07/09/2014	ObGyn/ Gastroenterology/ Urology	9-94	Complete	ISO	8600-4 Second Edition 2014-03-15	Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion
07/09/2014	Orthopedic	11-276	Complete	ASTM	F1798-13	Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
07/09/2014	Orthopedic	11-277	Complete	ISO	7206-6 Second edition 2013-11-15	Implants for surgery - Partial and total hip joint prostheses - Part 6: Determination of endurance properties of head and neck region of stemmed femoral components
07/09/2014	Radiology	12-194	Complete	ANSI HPS	N43.6-2007 (R2013)	Sealed Radioactive Sources - Classification
07/09/2014	Radiology	12-272	Complete	IEC	60601-2-17 Edition 3.0 2013-11	Medical electrical equipment - Part 2-17: Particular requirements for the safety of automatically-controlled brachytherapy afterloading equipment
07/09/2014	Radiology	12-273	Complete	IEC	60825-1 Edition 2.0 2007-03	Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
07/09/2014	Radiology	12-275	Complete	IEC	61161 Edition 3.0 2013-01	Ultrasonics -- Power measurement -- Radiation force balances and performance requirements
07/09/2014	Radiology	12-279	Complete	IEC	62127-03 Edition 1.1 2013-05	Ultrasonics -- Hydrophones -- Part 3: Properties of hydrophones for ultrasonic fields up to 40 MHz
07/09/2014	Radiology	12-280	Complete	IEC	62555 Edition 1.0 2013-11	Ultrasonics -- Power measurement -- High intensity therapeutic ultrasound (HITU) transducers and systems
07/09/2014	Radiology	12-281	Complete	IEC	60601-2-62 Edition 1.0 2013-07	Medical electrical equipment - Part 2-62: Particular requirements for the basic safety and essential performance of high intensity therapeutic ultrasound (HITU) equipment
07/09/2014	Radiology	12-282	Complete	ISO	12609-1 First edition 2013-07-15	Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 1: Specification for products
07/09/2014	Radiology	12-283	Complete	ISO	12609-2 First edition 2013-07-15	Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications -- Part 2: Guidance for use
07/09/2014	Software/ Informatics	13-15	Complete	CLSI	AUTO13-A2 (Formerly GP19-A2)	Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline - Second Edition
07/09/2014	Software/ Informatics	13-65	Complete	UL ANSI	1998 Third Edition 2013	Standards for Safety Software in Programmable Components, Second Edition. [This Standard contains revisions through and including October 28, 2008]
07/09/2014	Software/ Informatics	13-68	Complete	ISO	11073-90101 First edition 2008-01-15	Health informatics - Point-of-care medical device communication - Part 90101: Analytical instruments -- Point-of-care test
07/09/2014	Software/ Informatics	13-69	Complete	ISO IEEE	11073-10472 First edition 2012-11-01	Health informatics - Personal health device communication -- Part 10472: Device specialization - Medication monitor
07/09/2014	Sterility	14-256	Complete	ASTM	F2095-07 (Reapproved 2021)	Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates
07/09/2014	Sterility	14-257	Complete	ASTM	D3078-02 (Reapproved 2021)e1	Standard Test Method for Determination of Leaks in Flexible Packaging by Bubble Emission
07/09/2014	Sterility	14-282	Complete	ASTM	F2338-09 (Reapproved 2020)	Standard Test Method for Nondestructive Detection of Leaks in Packages by Vacuum Decay Method
07/09/2014	Sterility	14-286	Complete	ANSI AAMI	ST65:2008/(R)2018	Processing of reusable surgical textiles for use in health care facilities
07/09/2014	Sterility	14-290	Complete	ANSI AAMI	ST24:1999/(R)2018	Automatic, general purpose ethylene oxide sterilizers and ethylene oxide sterilant sources intended for use in health care facilities, 3ed.
07/09/2014	Sterility	14-432	Complete	ANSI AAMI	ST58:2013/(R)2018	Chemical sterilization and high-level disinfection in health care facilities
07/09/2014	Sterility	14-433	Complete	ASTM	F2227-13 (Reapproved 2021)	Standard Test Method for Non-Destructive Detection of Leaks in Non-sealed and Empty Packaging Trays by CO2 Tracer Gas Method
07/09/2014	Sterility	14-434	Complete	ASTM	F2228-13 (Reapproved 2021)	Standard Test Method for Non-Destructive Detection of Leaks in Medical Packaging Which Incorporates Porous Barrier Material by C02 Tracer Gas Method
07/09/2014	Sterility	14-435	Complete	ASTM	F2251-13 (Reapproved 2023)	Standard Test Method for Thickness Measurement of Flexible Packaging Material
07/09/2014	Sterility	14-437	Complete	ISO ASTM	52701 First edition 2013-11-15 (R2020)	Guide for performance characterization of dosimeters and dosimetry systems for use in radiation processing
07/09/2014	Tissue Engineering	15-40	Complete	ASTM	F2211-13	Standard Classification for Tissue Engineered Medical Products (TEMPs)
10/17/2014	ObGyn/ Gastroenterology/ Urology	9-95	Partial	CEN	EN 1615:2000	Enteral Feeding Catheters and Enteral Giving Sets for Single Use and their Connectors-Design and Testing
01/27/2015	Dental/ ENT	4-136	Complete	ASTM	F2504-05 (Reapproved 2022)	Standard Practice for Describing System Output of Implantable Middle Ear Hearing Devices
01/27/2015	Dental/ ENT	4-185	Complete	ANSI ASA	S3.45-2009 (Reaffirmed 2019)	American National Standard Procedures for Testing Basic Vestibular Function
01/27/2015	Dental/ ENT	4-218	Complete	ISO	27020 First edition 2010-12-15	Dentistry - Brackets and tubes for use in orthodontics
01/27/2015	Dental/ ENT	4-218	Complete	ANSI ADA	Standard No.100-2012	Orthodontic Brackets and Tubes
01/27/2015	Dental/ ENT	4-219	Complete	ISO	29022 First edition 2013-06-01	Dentistry - Adhesive - Notched-edge sheer bond strength test
01/27/2015	General I (QS/ RM)	5-48	Complete	ANSI	Z1.9-2003 (R2018)	Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming
01/27/2015	General I (QS/ RM)	5-62	Complete	ANSI ASQ	Z1.4-2003 (R2018)	Sampling Procedures and Tables for Inspection by Attributes
01/27/2015	InVitro Diagnostics	7-250	Partial	CLSI	M40-A2 (Reaffirmed: September 2019)	Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition.
01/27/2015	Materials	8-171	Complete	ASTM	F1609-08 (Reapproved 2014)	Standard Specification for Calcium Phosphate Coatings for Implantable Materials
01/27/2015	Materials	8-383	Complete	ASTM	F1926/F1926M-14	Standard Test Method for Evaluation of the Environmental Stability of Calcium Phosphate Granules, Fabricated Forms, and Coatings
01/27/2015	Nanotechnology	18-3	Partial	ISO	TS 14101 First edition 2012-11-01	Surface characterization of gold nanoparticles for nanomaterial specific toxicity screening: FT-IR method
01/27/2015	Neurology	17-13	Complete	IEEE	Std 2010-2012	Recommended Practice for Neurofeedback Systems
01/27/2015	ObGyn/ Gastroenterology/ Urology	9-45	Complete	ASTM	F2528-06(2023)	Standard Test Methods for Enteral Feeding Devices with a Retention Balloon
01/27/2015	Orthopedic	11-281	Complete	ASTM	F1672-14 (Reapproved 2019)	Standard Specification for Resurfacing Patellar Prosthesis
01/27/2015	Orthopedic	11-283	Complete	ASTM	F2943-14 (Reapproved 2019)	Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthroplasty
01/27/2015	Radiology	12-230	Complete	NEMA	XR 24-2008 (R2014)	Primary user controls for interventional angiography x-ray equipment
01/27/2015	Radiology	12-286	Complete	NEMA	XR 27 Amendment 1-2013	X-ray equipment for interventional procedures - User Quality Control Mode
01/27/2015	Software/ Informatics	13-70	Complete	ANSI AAMI IEC	TIR80001-2-5:2014	Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
01/27/2015	Software/ Informatics	13-70	Complete	IEC	TR 80001-2-5 Edition 1.0 2014-12	Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems
01/27/2015	Software/ Informatics	13-71	Partial	RII	Version 2.48	Logical Observation Identifiers Names and Codes (LOINC)
01/27/2015	Software/ Informatics	13-72	Complete	IEEE	Std 11073-10425-2014	Health informatics - Personal health device communication, Part 10425: Device Specialization - Continuous Glucose Monitor (CGM)
01/27/2015	Sterility	14-141	Complete	ISO	14644-4 First edition 2001-04-01	Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up
01/27/2015	Sterility	14-165	Complete	ISO	14644-5 First edition 2004-08-15	Cleanrooms and associated controlled environments - Part 5: Operations
01/27/2015	Sterility	14-166	Complete	ISO	14644-7 First edition 2004-10-01	Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments)
01/27/2015	Sterility	14-242	Complete	ISO	14644-3 First edition 2005-12-15	Cleanrooms and associated controlled environments - Part 3: Test methods
01/27/2015	Sterility	14-243	Complete	ISO	14644-6 First edition 2007-07-15	Cleanrooms and associated controlled environments - Part 6: Vocabulary
01/27/2015	Sterility	14-379	Complete	ISO	14644-8 Second edition 2013-02-15	Cleanrooms and associated controlled environments - Part 8: Classification of air cleanliness by chemical concentration (ACC)
01/27/2015	Sterility	14-389	Complete	ISO	14644-9 First edition 2012-08-15	Cleanrooms and associated controlled environments - Part 9: Classification of surface cleanliness by particle concentration
01/27/2015	Sterility	14-390	Complete	ISO	14644-10 First edition 2013-03-01	Cleanrooms and associated controlled environments - Part 10: Classification of surface cleanliness by chemical concentration
01/27/2015	Sterility	14-456	Complete	ANSI AAMI ISO	TIR16775:2014	Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
01/27/2015	Sterility	14-456	Complete	ISO	TS 16775 First edition 2014-05-15	Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2
06/27/2015	Sterility	14-484	Complete	ASTM	F1929-15	Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
08/14/2015	Anesthesiology	1-103	Partial	ISO	5367 Fifth edition 2014-10-15	Anaesthetic and respiratory equipment - Breathing sets and connectors
08/14/2015	Anesthesiology	1-105	Complete	ISO	80601-2-72 First edition 2015-04-11	Medical electrical equipment - Part 2-72: Particular requirements for basic safely and essential performance of home healthcare environment ventilators for ventilator-dependent patients
08/14/2015	Dental/ ENT	4-130	Complete	ANSI ADA	Standard No. 17-1983 (R2014)	Denture Base Temporary Relining Resins
08/14/2015	Dental/ ENT	4-184	Complete	ANSI ASA	S3.25-2009 (Reaffirmed 2019)	American National Standard For an Occluded Ear Simulator
08/14/2015	Dental/ ENT	4-220	Complete	ANSI ASA	S3.22-2014 (Reaffirmed 2020)	American National Standard Specification of Hearing Aid Characteristics
08/14/2015	General I (QS/ RM)	5-97	Complete	ISO	80369-20 First edition 2015-05-15	Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
08/14/2015	General I (QS/ RM)	5-97	Complete	ANSI AAMI ISO	80369-20:2015	Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods
08/14/2015	General Plastic Surgery/ General Hospital	6-110	Complete	ASTM	F1441-03 (Reapproved 2014)	Standard Specification for Soft-Tissue Expander Devices
08/14/2015	General Plastic Surgery/ General Hospital	6-185	Complete	ASTM	F881-94 (Reapproved 2014)	Standard Specification for Silicone Elastomer Facial Implants
08/14/2015	General Plastic Surgery/ General Hospital	6-200	Complete	ASTM	E1061-01(2022)	Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers
08/14/2015	General Plastic Surgery/ General Hospital	6-353	Complete	ASTM	F2051-00 (Reapproved 2014)	Standard Specification for Implantable Saline Filled Breast Prosthesis
08/14/2015	General Plastic Surgery/ General Hospital	6-354	Complete	ASTM	D7907-14 (Reapproved 2019)	Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves
08/14/2015	InVitro Diagnostics	7-251	Complete	CLSI	EP05-A3 (Reaffirmed: September 2019)	Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition
08/14/2015	InVitro Diagnostics	7-252	Complete	CLSI	EP14-A3	Evaluation of Commutability of Processed Samples; Approved Guideline - Third Edition
08/14/2015	InVitro Diagnostics	7-253	Complete	CLSI	EP15-A3 (Reaffirmed: September 2019)	User Verification of Precision and Estimation of Bias; Approved Guideline - Third Edition
08/14/2015	InVitro Diagnostics	7-255	Partial	CLSI	MM09-A2 (Replaces MM09-A)	Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine: Approved Guideline -- Second Edition
08/14/2015	InVitro Diagnostics	7-257	Complete	CLSI	M56-A	Principles and procedures for Detection of Anaerobes in Clinical Specimens; Approved Guideline
08/14/2015	Materials	8-389	Complete	ISO	15309 First edition 2013-12-01	Implants for surgery - Differential scanning calorimetry of poly ether ether ketone (PEEK) polymers and compounds for use in implantable medical devices
08/14/2015	Neurology	17-4	Partial	ASTM	F647-94 (Reapproved 2014)	Standard Practice for Evaluating and Specifying Implantable Shunt Assemblies for Neurosurgical Application
08/14/2015	ObGyn/ Gastroenterology/ Urology	9-108	Complete	ISO	8009 Second edition 2014-11-15	Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms - Requirements and tests
08/14/2015	Ophthalmic	10-94	Complete	ISO	14730 Second edition 2014-10-01	Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date
08/14/2015	Ophthalmic	10-95	Complete	ISO	11979-6 Third edition 2014-10-01	Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing
08/14/2015	Ophthalmic	10-96	Partial	ANSI	Z80.10-2014	American National Standard for Ophthalmics - Ophthalmic Instruments - Tonometers
08/14/2015	Ophthalmic	10-97	Complete	ISO	13212 Third edition 2014-09-01	Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life
08/14/2015	Ophthalmic	10-98	Complete	ISO	11979-2 Second edition 2014-08-15	Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods
08/14/2015	Ophthalmic	10-99	Complete	ISO	4311 First edition 1979-06-01	Anionic and non-ionic surface active agents - Determination of critical micellization concentration - Method by measuring surface tension with a plate, stirrup, or ring
08/14/2015	Orthopedic	11-183	Complete	ASTM	F1875-98 (Reapproved 2022)	Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
08/14/2015	Orthopedic	11-290	Complete	ISO	8828 Second edition 2014-11-15	Implants for surgery -- Guidance on care and handling of orthopaedic implants
08/14/2015	Orthopedic	11-294	Complete	ASTM	F1357-14 (Reapproved 2019)	Standard Specification for Articulating Total Wrist Implants
08/14/2015	Physical Medicine	16-194	Complete	ISO	7176-25 First edition 2013-07-15	Wheelchairs - Part 25: Batteries and chargers for powered wheelchairs
08/14/2015	Radiology	12-289	Complete	IEC	62220-1-1 Edition 1.0 2015-03	Medical electrical equipment-Characteristics of digital X-ray imaging devices Part 1-1: Determination of the detective quantum efficiencyDetectors used in radiographic imaging
08/14/2015	Radiology	12-290	Complete	IEC	61910-1 Edition 1.0 2014-09	Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy
08/14/2015	Radiology	12-291	Complete	IEC	62127-2 Edition 1.2 2017-03 CONSOLIDATED VERSION	Ultrasonics -- Hydrophones -- Part 2: Calibration for ultrasonic fields up to 40 MHz
08/14/2015	Radiology	12-292	Complete	IEEE	Std 3333.2.1-2015	IEEE Recommended Practice for Three-Dimensional (3D) Medical Modeling
08/14/2015	Software/ Informatics	13-73	Partial	IHTSDO	SNOMED-CT RF2 Release 2015	Systematized Nomenclature of Medicine - Clinical Terms
08/14/2015	Software/ Informatics	13-74	Complete	IEEE	Std 11073-10424-2014	Health informatics - Personal health device communication, Part 10424: Device Specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE)
08/14/2015	Software/ Informatics	13-75	Complete	ISO IEEE	11073-10102 First edition 2014-03-01	Health informatics - Point-of-care medical device communication - Part 10102: Nomenclature - Annotated ECG
08/14/2015	Software/ Informatics	13-76	Complete	ISO	11073-91064 First edition 2009-05-01	Health informatics - Standard communication protocol - Computer-assisted electrocardiography
08/14/2015	Software/ Informatics	13-77	Complete	ISO IEC	29147 First edition 2014-02-15	Information technology - Security techniques - Vulnerability disclosure
08/14/2015	Software/ Informatics	13-78	Complete	INCITS ISO IEC	30111 First edition 2013-11-01 (R2019)	Information technology - Security techniques - Vulnerability handling processes
08/14/2015	Sterility	14-460	Partial	ISO	11140-1 Third edition 2014-11-01	Sterilization of health care products - Chemical indicators - Part 1: General requirements
08/14/2015	Sterility	14-460	Partial	ANSI AAMI ISO	11140-1:2014	Sterilization of health care products - Chemical indicators - Part 1: General requirements
08/14/2015	Sterility	14-463	Complete	ISO ASTM	51608 Second edition 2015-03-15	Practice for dosimetry in an X-ray (bremsstrahlung) facility for radiation processing at energies between 50 KeV and 7.5 MeV
08/14/2015	Sterility	14-464	Complete	ISO ASTM	51649 Third edition 2015-03-15	Practice for dosimetry in an electron beam facility for radiation processing at energies between 300 keV and 25 MeV
08/14/2015	Sterility	14-465	Complete	ISO ASTM	51707 Third edition 2015-03-15	Guide for estimating uncertainties in dosimetry for radiation processing
04/04/2016	Anesthesiology	1-106	Partial	ISO	17510 First Edition 2015-08-01	Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories
04/04/2016	Anesthesiology	1-115	Complete	ISO	80601-2-70 First Edition 2015-01-15	Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
04/04/2016	Cardiovascular	3-125	Complete	ISO	5841-3 Third edition 2013-04-15	Implants for surgery - Cardiac pacemakers - Part 3: Low-profile connectors [IS-I] for implantable pacemakers
04/04/2016	Dental/ ENT	4-190	Complete	ANSI ASA	S3.35-2010 (Reaffirmed 2020)	American National Standard Method for Measurement of Performance Characteristics of Hearing Aids under Simulated Real-Ear Working Conditions
04/04/2016	Dental/ ENT	4-221	Complete	ISO	7494-2 Second edition 2015-04-01	Dentistry - Dental units - Part 2: Air, water, suction and waste water systems
04/04/2016	Dental/ ENT	4-222	Complete	ISO	6874 Third edition 2015-09-01	Dentistry - Polymer-based pit and fissure sealants
04/04/2016	Dental/ ENT	4-224	Complete	ISO	24234 Second edition 2015-05-01	Dentistry - Dental Amalgam
04/04/2016	General I (QS/ RM)	5-98	Complete	ANSI ESD	S20.20-2014	Standard for the Development of an Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices)
04/04/2016	General II (ES/ EMC)	19-17	Complete	IEEE ANSI	C63.18-2014	American National Standard Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Electromagnetic Immunity of Medical Devices to Radiated Radio-Frequency (RF) Emissions from RF Transmitters
04/04/2016	General Plastic Surgery/ General Hospital	6-355	Complete	ASTM	D3772-15(2021)	Standard Specification for Industrial Rubber Finger Cots
04/04/2016	General Plastic Surgery/ General Hospital	6-356	Complete	ASTM	D5712-15(2020)	Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method
04/04/2016	General Plastic Surgery/ General Hospital	6-357	Complete	ISO	10555-6 First edition 2015-04-15	Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports
04/04/2016	General Plastic Surgery/ General Hospital	6-358	Partial	ISO	8536-8 Second Edition 2015-06-15	Infusion Equipment for Medical Use - Part 8: Infusion Sets for Single Use with Pressure Infusion Apparatus
04/04/2016	General Plastic Surgery/ General Hospital	6-359	Partial	ISO	8536-9 Second Edition 2015-06-15	Infusion Equipment for Medical Use - Part 9: Fluid Lines for Single Use with Pressure Infusion Equipment
04/04/2016	General Plastic Surgery/ General Hospital	6-360	Partial	ISO	8536-10 Second Edition 2015-06-15	Infusion Equipment for Medical Use - Part 10: Accessories for Fluid Lines for Single Use with Pressure Infusion Equipment
04/04/2016	General Plastic Surgery/ General Hospital	6-361	Partial	ISO	8536-11 Second Edition 2015-06-15	Infusion Equipment for Medical Use - Part 11: Infusion Filters for Single Use with Pressure Infusion Equipment
04/04/2016	InVitro Diagnostics	7-259	Partial	CLSI	GP23-A2 (Replaces GP23-A)	Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline - Second Edition
04/04/2016	InVitro Diagnostics	7-260	Complete	CLSI	MM03-3rd Edition (Replaces MM03-A2)	Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline
04/04/2016	Materials	8-107	Complete	ASTM	F746-04 (Reapproved 2014)	Standard Test Method for Pitting or Crevice Corrosion of Metallic Surgical Implant Materials
04/04/2016	Materials	8-114	Complete	ASTM	F2255-05 (Reapproved 2015)	Standard Test Method for Strength Properties of Tissue Adhesives in Lap Shear by Tension Loading
04/04/2016	Materials	8-115	Complete	ASTM	F2256-05 (Reapproved 2015)	Standard Test Method for Strength Properties of Tissue Adhesives in T-Peel by Tension Loading
04/04/2016	Materials	8-116	Complete	ASTM	F2258-05 (Reapproved 2015)	Standard Test Method for Strength Properties of Tissue Adhesives in Tension
04/04/2016	Materials	8-135	Complete	ASTM	F2392-04 (Reapproved 2015)	Standard Test Method for Burst Strength of Surgical Sealants
04/04/2016	Materials	8-136	Complete	ASTM	F2458-05 (Reapproved 2015)	Standard Test Method for Wound Closure Strength of Tissue Adhesives and Sealants
04/04/2016	Materials	8-200	Complete	ASTM	F2003-02 (Reapproved 2015)	Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air
04/04/2016	Materials	8-393	Complete	ASTM	F1350-15	Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673)
04/04/2016	Materials	8-394	Complete	ASTM	F1472-14	Standard Specification for Wrought Titanium -6Aluminum -4Vanadium Alloy for Surgical Implant Applications (UNS R56400)
04/04/2016	Materials	8-399	Complete	ASTM	F90-14	Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy for Surgical Implant Applications (UNS R30605)
04/04/2016	Materials	8-400	Complete	ASTM	F1854-15	Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
04/04/2016	Materials	8-401	Complete	ASTM	F2118-14 (Reapproved 2020)	Standard Test Method for Constant Amplitude of Force Controlled Fatigue Testing of Acrylic Bone Cement Materials
04/04/2016	Materials	8-403	Complete	ASTM	D638-14	Standard Test Method for Tensile Properties of Plastics
04/04/2016	Materials	8-404	Complete	ASTM	E647-15	Standard Test Method for Measurement of Fatigue Crack Growth Rates
04/04/2016	Materials	8-405	Complete	ISO	5832-4 Third edition 2014-09-15	Implants for surgery -- Metallic materials -- Part 4: Cobalt-chromium-molybdenum casting alloy
04/04/2016	Materials	8-406	Complete	ISO	5832-11 Second edition 2014-09-15	Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy
04/04/2016	Materials	8-408	Complete	ASTM	F3122-14	Standard Guide for Evaluating Mechanical Properties of Metal Materials Made via Additive Manufacturing Processes
04/04/2016	Materials	8-409	Partial	ASTM	F2924-14	Standard Specification for Additive Manufacturing Titanium-6 Aluminum-4 Vanadium with Powder Bed Fusion
04/04/2016	Materials	8-413	Complete	ASTM	F2819-10 (Reapproved 2015)	Standard Test Methods for Measurement of Straightness of Bar, Rod, Tubing and Wire to be used for Medical Devices
04/04/2016	Materials	8-415	Complete	ASTM	F2778-09 (Reapproved 2020)	Standard Test Method for Measurement of Percent Crystallinity of Polyetheretherketone (PEEK) Polymers by Means of Specular Reflectance Fourier Transform Infrared Spectroscopy (R-FTIR)
04/04/2016	Nanotechnology	18-1	Complete	ASTM	E2490-09 (Reapproved 2021)	Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS)
04/04/2016	ObGyn/ Gastroenterology/ Urology	9-110	Complete	ISO	8600-1 Fourth Edition 2015-10-15	Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements
04/04/2016	ObGyn/ Gastroenterology/ Urology	9-113	Complete	CEN	EN 1618:1997	Catheters other than intravascular catheters - Test methods for common properties
04/04/2016	Ophthalmic	10-100	Complete	ISO	18259 First Edition 2014-10-01	Ophthalmic optics - Contact lens care products - Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organisms
04/04/2016	Orthopedic	11-247	Complete	ASTM	F2789-10 (Reapproved 2020)	Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
04/04/2016	Orthopedic	11-299	Complete	ASTM	F2068-15	Standard Specification for Femoral Prostheses - Metallic Implants
04/04/2016	Orthopedic	11-301	Complete	ASTM	F2091-15	Standard Specification for Acetabular Prostheses
04/04/2016	Orthopedic	11-303	Complete	ASTM	F3047M-15	Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-hard Articulations
04/04/2016	Orthopedic	11-304	Complete	ASTM	F3107-14	Standard Test Method for Measuring Accuracy after Mechanical Disturbances on Reference Frames of Computer Assisted Surgery Systems
04/04/2016	Physical Medicine	16-195	Complete	ISO	7176-1 Third edition 2014-10-01	Wheelchairs - Part 1: Determination of static stability
04/04/2016	Physical Medicine	16-196	Complete	ISO	7176-7 First Edition 1998-05-15	Wheelchairs - Part 7: Measurement of seating and wheel dimensions
04/04/2016	Physical Medicine	16-197	Complete	ISO	7176-8 Second editon 2014-12-15	Wheelchairs - Part 8: Requirements and test methods for static, impact and fatigue strengths
04/04/2016	Physical Medicine	16-198	Complete	ISO	7176-22 Second edition 2014-09-01	Wheelchairs - Part 22: Set-up procedures
04/04/2016	Radiology	12-187	Complete	NEMA	MS 3-2008 (R2020)	Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
04/04/2016	Radiology	12-188	Complete	NEMA	MS-1-2008 (R2020)	Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging
04/04/2016	Radiology	12-195	Complete	NEMA	MS 6-2008 (R2014, R2020)	Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
04/04/2016	Radiology	12-196	Complete	NEMA	MS 2-2008 (R2020)	Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
04/04/2016	Radiology	12-288	Complete	NEMA	MS 9-2008 (R2020)	Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
04/04/2016	Software/ Informatics	13-81	Complete	IEEE	Std 11073-10419:2015	Health informatics - Personal health device communication - Part 10419: Device Specialization - Insulin Pump
04/04/2016	Sterility	14-277	Complete	ANSI AAMI ISO	TIR 17665-2:2009	Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO ANSI/AAMI/ISO 17665-1
04/04/2016	Sterility	14-277	Complete	ISO	TS 17665-2 First edition 2009-01-15	Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1
04/04/2016	Sterility	14-333	Complete	ISO	17665-1 First edition 2006-08-15	Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
04/04/2016	Sterility	14-333	Complete	ANSI AAMI ISO	17665-1:2006/(R)2013	Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
04/04/2016	Sterility	14-337	Complete	ISO	14937 Second edition 2009-10-15	Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
04/04/2016	Sterility	14-337	Complete	ANSI AAMI ISO	14937:2009/(R)2013	Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process for medical devices
04/04/2016	Sterility	14-340	Complete	ISO	20857 First edition 2010-08-15	Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
04/04/2016	Sterility	14-340	Complete	ANSI AAMI ISO	20857:2010/(R)2015	(Revision of ANSI/AAMI/ST63:2002) Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices
04/04/2016	Tissue Engineering	15-24	Complete	ASTM	F2721-09 (Reapproved 2014)	Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
04/04/2016	Tissue Engineering	15-43	Complete	ASTM	F2791-15	Standard Guide for Assessment of Surface Texture of Non-Porous Biomaterials in Two Dimensions
04/04/2016	Tissue Engineering	15-44	Partial	ASTM	F2529-13	Standard Guide for in vivo Evaluation of Osteoinductive Potential for Materials Containing Demineralized Bone (DBM)
06/15/2016	Cardiovascular	3-132	Complete	ISO	27185 First edition 2012-02-15	Cardiac Rhythm Management Devices - Symbols to be Used With Cardiac Rhythm Management Device Labels, and Information to be Supplied - General Requirements
06/15/2016	Cardiovascular	3-132	Complete	ANSI AAMI ISO	27185:2012	Cardiac Rhythm Management Devices -- Symbols to be Used With Cardiac Rhythm Managment Device Labels, and Information to be Supplied -- General Requirements
06/15/2016	General I (QS/ RM)	5-102	Complete	IEC	60417:2002 DB	Graphical symbols for use on equipment
06/27/2016	Cardiovascular	3-143	Partial	ISO	12417 First edition 2015-10-01	Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products
06/27/2016	Dental/ ENT	4-202	Complete	ANSI ADA	Standard No. 58-2010 (R2015)	Root Canal Files, Type H (Hedstrom)
06/27/2016	Dental/ ENT	4-227	Complete	ISO	22674 Second edition 2016-01-15	Dentistry - Metallic materials for fixed and removable restorations and appliances
06/27/2016	Dental/ ENT	4-227	Complete	ANSI ADA	Standard No. 134-2018	Metallic Materials for Fixed and Removable Restorations and Appliances
06/27/2016	Dental/ ENT	4-228	Complete	ANSI ASA	S3.20-2015 (Reaffirmed 2020)	American National Standard Bioacoustical Terminology
06/27/2016	General I (QS/ RM)	5-57	Partial	ANSI AAMI	HE75:2009/(R)2018	Human factors engineering - Design of medical devices
06/27/2016	General I (QS/ RM)	5-108	Complete	ISO	80369-6 First Edition 2016-03-15	Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications.
06/27/2016	General Plastic Surgery/ General Hospital	6-363	Complete	ISO	11810 Second edition 2015-12-15	Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Primary ignition, penetration, flame spread and secondary ignition
06/27/2016	General Plastic Surgery/ General Hospital	6-364	Partial	ISO	8537 Third edition 2016-03-15	Sterile single-use syringes, with or without needle, for insulin
06/27/2016	InVitro Diagnostics	7-264	Partial	CLSI	MM21-1st Edition (Reaffirmed: January 2020)	Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications
06/27/2016	Materials	8-426	Complete	ASTM	F3087-15	Standard Specification for Acrylic Molding Resins for Medical Implant Applications
06/27/2016	Materials	8-427	Complete	ASTM	F1185-03 (Reapproved 2014)	Standard Specification for Composition of Hydroxylapatite for Surgical Implants
06/27/2016	Materials	8-429	Complete	ASTM	F2224-09 (Reapproved 2020)	Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants
06/27/2016	Materials	8-430	Complete	ISO	13356:2015 Third Edition 2015-09-15	Implants for surgery -- Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)
06/27/2016	Materials	8-431	Complete	ASTM	F2971-13	Standard Practice for Reporting Data for Test Specimens Prepared by Additive Manufacturing
06/27/2016	Materials	8-432	Complete	ISO ASTM	52921 First Edition 2013-06-01	Standard Terminology for Additive Manufacturing-Coordinate Systems and Test Methodologies.
06/27/2016	Materials	8-434	Complete	ISO ASTM	52900 First Edition 2015-12-15	Additive manufacturing -- General principles - Terminology
06/27/2016	Orthopedic	11-307	Complete	ASTM	F2385-15 (Reapproved 2019)	Standard Practice for Determining Femoral Head Penetration into Acetabular Components of Total Hip Replacement Using Clinical Radiographs
06/27/2016	Orthopedic	11-308	Complete	ASTM	F3161-16	Standard Test Method for Finite Element Analysis (FEA) of Metallic Orthopaedic Total Knee Femoral Components under Closing Conditions
06/27/2016	Radiology	12-293	Complete	IEC	60601-2-37 Edition 2.1 2015	Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
06/27/2016	Radiology	12-294	Complete	IEC	60601-2-45 Edition 3.1 2015	Medical electrical equipment - Part 2-45: Particular requirements for the basic safety and essential performance of mammographic X-ray equipment and mammographic stereotactic devices
06/27/2016	Radiology	12-295	Partial	IEC	60601-2-33 Ed. 3.2 b:2015	Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
06/27/2016	Radiology	12-297	Complete	ANSI IES	RP-27.1-2015	Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements
06/27/2016	Radiology	12-298	Complete	NEMA	MS 10-2010	Determination of Local Specific Absorption Rate (SAR) in Diagnostic Magnetic Resonance Imaging
06/27/2016	Radiology	12-301	Complete	IEC	60601-2-8 Edition 2.1 b:2015	Medical electrical equipment - Part 2-8: Particular requirements for the safety of therapeutic X-ray equipment operating in the range 10 kV to 1 MV
06/27/2016	Radiology	12-302	Partial	IEC	60601-2-44 Edition 3.2: 2016	Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
06/27/2016	Software/ Informatics	13-82	Complete	ANSI AAMI ISO	TIR 80001-2-6:2014	Application of risk management for IT networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements
06/27/2016	Software/ Informatics	13-83	Complete	AAMI	TIR57:2016	Principles for medical device security - Risk management.
06/27/2016	Software/ Informatics	13-84	Complete	ISO IEEE	11073-10103 First edition 2014-03-01	Health informatics - Point-of-care medical device communication - Part 10103: Nomenclature - Implantable device, cardiac
06/27/2016	Sterility	14-481	Complete	ISO	14644-2 Second edition 2015-12-15	Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by particle concentration
06/27/2016	Sterility	14-483	Complete	ISO ASTM	52303 First edition 2015-07-15	Guide for absorbed-dose mapping in radiation processing facilities
07/26/2016	Biocompatibility	2-169	Partial	ISO	10993-13 Second edition 2010-06-15	Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
07/26/2016	Biocompatibility	2-169	Partial	ANSI AAMI ISO	10993-13:2010/(R)2014	Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices
07/26/2016	Biocompatibility	2-170	Complete	ISO	10993-14 First edition 2001-11-15	Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
07/26/2016	Biocompatibility	2-170	Complete	ANSI AAMI ISO	10993-14:2001/(R) 2011	Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products form ceramics
07/26/2016	Biocompatibility	2-174	Complete	ISO	10993-10 Third Edition 2010-08-01	Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
07/26/2016	Biocompatibility	2-174	Complete	ANSI AAMI ISO	10993-10:2010/(R)2014	Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
07/26/2016	Biocompatibility	2-191	Partial	ISO	10993-12 Fourth edition 2012-07-01	Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
07/26/2016	Biocompatibility	2-191	Partial	ANSI AAMI ISO	10993-12:2012	Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
07/26/2016	Biocompatibility	2-213	Complete	ASTM	F1904-14	Standard Practice for Testing the Biological Responses to Particles In Vivo
07/26/2016	Biocompatibility	2-222	Complete	ISO	10993-2 Second edition 2006-07-15	Biological Evaluation of medical devices - Part 2: Animal welfare requirements
07/26/2016	Biocompatibility	2-222	Complete	ANSI AAMI ISO	10993-2:2006/(R)2014	Biological Evaluation of medical devices - Part 2: Animal welfare requirements
07/26/2016	Biocompatibility	2-227	Complete	ASTM	F1983-14	Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
07/26/2016	Biocompatibility	2-228	Partial	ISO	10993-3 Third edition 2014-10-1	Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
07/26/2016	Biocompatibility	2-228	Partial	ANSI AAMI ISO	10993-3:2014	Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity
07/26/2016	Biocompatibility	2-237	Partial	ISO	10993-17 First edition 2002-12-01	Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
07/26/2016	Biocompatibility	2-237	Partial	ANSI AAMI ISO	10993-17:2002/(R)2012	Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
07/26/2016	Biocompatibility	2-240	Partial	ANSI AAMI ISO	TIR 10993-20:2006	Biological Evaluation of Medical Devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
07/26/2016	Biocompatibility	2-240	Partial	ISO	TS 10993-20 First edition 2006-08-01	Biological evaluation of medical devices - Part 20: Principles and methods for immunotoxicology testing of medical devices
07/26/2016	Biocompatibility	2-243	Partial	ISO	TR 10993-33 First Edition 2015-03-01	Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3
09/21/2016	General Plastic Surgery/ General Hospital	6-379	Complete	ISO	7864 Fourth edition 2016-08-01	Sterile hypodermic needles for single use - Requirements and test methods
09/21/2016	General Plastic Surgery/ General Hospital	6-380	Complete	ISO	9626 Second edition 2016-08-01	Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
09/21/2016	General Plastic Surgery/ General Hospital	6-381	Complete	ISO	6009 Fourth edition 2016-08-01	Hypodermic needles for single use - Colour coding for identification.
09/21/2016	General Plastic Surgery/ General Hospital	6-382	Complete	ISO	11608-7 First edition 2016-08-01	Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment
09/21/2016	InVitro Diagnostics	7-265	Partial	CLSI	C62-A	Liquid Chromatography-Mass Spectrometry Methods; Approved Guideline.
09/21/2016	InVitro Diagnostics	7-266	Complete	CLSI	EP19 2nd Edition (Replaces EP19-R)	A Framework for Using CLSI Documents to Evaluate Clinical Laboratory Measurement Procedures
09/21/2016	Ophthalmic	10-101	Complete	ISO	18189 First edition 2016-06-01	Ophthalmic optics - Contact lenses and contact lens care products - Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions
12/23/2016	Anesthesiology	1-118	Complete	ISO	5361 Third edition 2016-09-01	Anaesthetic and respiratory equipment - Tracheal tubes and connectors
12/23/2016	Anesthesiology	1-119	Complete	ISO	14408 Third edition 2016-02-15	Tracheal tubes designed for laser surgery - Requirements for marking and accompanying information
12/23/2016	Biocompatibility	2-93	Complete	ASTM	F763-04 (Reapproved 2016)	Standard Practice for Short-Term Screening of Implant Materials
12/23/2016	Biocompatibility	2-94	Complete	ASTM	F981-04 (Reapproved 2016)	Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone
12/23/2016	Biocompatibility	2-189	Complete	ASTM	F895-11 (Reapproved 2016)	Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
12/23/2016	Biocompatibility	2-244	Partial	ASTM	F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
12/23/2016	Biocompatibility	2-245	Complete	ISO	10993-5 Third edition 2009-06-01	Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
12/23/2016	Biocompatibility	2-245	Complete	ANSI AAMI ISO	10993-5:2009/(R)2014	Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
12/23/2016	Cardiovascular	3-144	Complete	ISO	7198 Second edition 2016-08-01	Cardiovascular implants and extracorporeal systems - Vascular prostheses - Tubular vascular grafts and vascular patches

Recognized Consensus Standards: Medical Devices

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