Recognized Consensus Standards: Medical Devices

1 to 500 of 1497 Results

Results per Page

New Search Export to Excel Standards Search Assistance
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)
07/15/2019	Anesthesiology	1-143	Complete	ISO	80601-2-79 First edition 2018-07	Medical electrical equipment - Part 2-79: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory impairment
01/14/2019	Anesthesiology	1-138	Complete	ISO	80601-2-74 First edition 2017-05	Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment
07/15/2019	Anesthesiology	1-116	Complete	ISO	5360 Fourth edition 2016-02-15	Anaesthetic vaporizers - Agent specific filling systems
07/15/2019	Anesthesiology	1-122	Complete	ISO	5364 Fifth edition 2016-09-01	Anaesthetic and respiratory equipment-Oropharyngeal airways
07/15/2019	Anesthesiology	1-144	Complete	ISO	80601-2-80 First edition 2018-07	Medical electrical equipment - Part 2-80: Particular requirements for basic safety and essential performance of ventilatory support equipment for ventilatory insufficiency
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
12/19/2022	Anesthesiology	1-160	Complete	ISO	80601-2-84 First edition 2020-07	Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
01/14/2019	Anesthesiology	1-114	Complete	ISO	18835 First Edition 2015-04-01	Inhalational Anaesthesia Systems - Draw-over Anaesthetic Systems
12/19/2022	Anesthesiology	1-158	Complete	ISO	10079-4 First edition 2021-08	Medical suction equipment - Part 4: General requirements
01/14/2019	Anesthesiology	1-120	Complete	ISO	18190 First edition 2016-11-01	Anaesthetic and respiratory equipment - General requirements for airways and related equipment
12/23/2016	Anesthesiology	1-118	Complete	ISO	5361 Third edition 2016-09-01	Anaesthetic and respiratory equipment - Tracheal tubes and connectors
12/18/2023	Anesthesiology	1-163	Complete	ISO	80601-2-72 Second edition 2023-06	Medical electrical equipment - Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
09/17/2018	Anesthesiology	1-140	Complete	ISO	80601-2-55 Second edition 2018-02	Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
01/14/2019	Anesthesiology	1-117	Complete	ISO	5366 First edition 2016-10-01	Anaesthetic and respiratory equipment - Tracheostomy tubes and connectors
05/29/2023	Anesthesiology	1-161	Complete	ISO	16628 Second edition 2022-06	Anaesthetic and respiratory equipment - Tracheobronchial tubes
08/21/2017	Anesthesiology	1-127	Complete	ISO	16628 First edition 2008-11-15	Tracheobronchial tubes-Sizing and marking
01/30/2014	Anesthesiology	1-97	Complete	CGA	V-7.1:2011	Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases
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
12/18/2023	Anesthesiology	1-162	Complete	ISO	10651-4 Second edition 2023-03	Lung ventilators - Part 4: Particular requirements for user-powered resuscitators
06/07/2018	Anesthesiology	1-135	Complete	ISO	18562-2 First edition 2017-03	Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter
06/07/2018	Anesthesiology	1-130	Complete	ISO	18082 First edition 2014-06-15	Anaesthetic and respiratory equipment - Dimensions of noninterchangeable screw-threaded (NIST) low-pressure connectors for medical gases [Including AMENDMENT 1 (2017)]
08/21/2017	Anesthesiology	1-124	Complete	ISO	8835-7 First edition 2011-11-01	Inhalational anaesthesia systems - Part 7: Anaesthetic systems for use in areas with limited logistical supplies of electricity and anaesthetic gases
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
12/18/2023	Anesthesiology	1-166	Complete	ISO	11195 Second edition 2018-01	Gas mixers for medical use - Stand-alone gas mixers
12/18/2023	Anesthesiology	1-165	Complete	ISO	80601-2-13 Second edition 2022-04	Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
07/09/2014	Anesthesiology	1-101	Complete	CGA	C-9:2013	Standard Color Marking of Compressed Gas Containers for Medical Use
06/07/2018	Anesthesiology	1-136	Complete	ISO	18562-3 First edition 2017-03	Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds
07/15/2019	Anesthesiology	1-126	Complete	ISO	11712 First edition 2009-05-15	Anaesthetic and respiratory equipment - Supralaryngeal airways and connectors
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
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
12/21/2020	Anesthesiology	1-149	Complete	ISO	7376 Third edition 2020-08	Anaesthetic and respiratory equipment - Laryngoscopes for tracheal intubation
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
07/09/2014	Anesthesiology	1-100	Complete	CGA	V-1:2013	Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connection
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
06/07/2018	Anesthesiology	1-129	Complete	ISO	5359 Fourth edition 2014-10-01	Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases [Including AMENDMENT 1 (2017)]
01/14/2019	Anesthesiology	1-141	Complete	ISO	80601-2-13 First edition 2011-08-11	Medical electrical equipment - Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation [Including: Amendment 1 (2015) and Amendment 2 (2018)]
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)
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
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
12/19/2022	Anesthesiology	1-157	Complete	ISO	10079-1 Fourth edition 2022-03	Medical suction equipment - Part 1: Electrically powered suction equipment
12/18/2023	Anesthesiology	1-164	Complete	ISO	5361 Fourth edition 2023-01	Anaesthetic and respiratory equipment - Tracheal tubes and connectors
12/23/2019	Anesthesiology	1-145	Complete	ISO	19223 First edition 2019-07	Lung ventilators and related equipment - Vocabulary and semantics.
12/19/2022	Anesthesiology	1-153	Complete	NFPA	99:2021	Health Care Facilities Code
12/19/2022	Anesthesiology	1-154	Complete	ASME	PVHO-1-2019	Safety Standard for Pressure Vessels for Human Occupancy
06/07/2021	Anesthesiology	1-151	Complete	ISO	80601-2-70 Second edition 2020-11	Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment
12/19/2022	Anesthesiology	1-159	Complete	ISO	18778 Second edition 2022-06	Respiratory equipment - Particular requirements for basic safety and essential performance of infant cardiorespiratory monitors
12/19/2022	Anesthesiology	1-155	Complete	ISO	10079-2 Fourth edition 2022-03	Medical suction equipment - Part 2: Manually powered suction equipment
12/19/2022	Anesthesiology	1-156	Complete	ISO	10079-3 Fourth edition 2022-03	Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source
12/21/2020	Anesthesiology	1-148	Complete	ISO	80601-2-69 Second edition 2020-11	Medical electrical equipment - Part 2-69: Particular requirements for the basic safety and essential performance of oxygen concentrator equipment
12/21/2020	Anesthesiology	1-147	Complete	ISO	26825 Second edition 2020-10	Anaesthetic and respiratory equipment - User-applied labels for syringes containing drugs used during anaesthesia - Colours, design and performance
12/21/2020	Anesthesiology	1-150	Complete	ISO	8836 Fifth edition 2019-12	Suction catheters for use in the respiratory tract
07/06/2020	Anesthesiology	1-146	Complete	ISO	80601-2-12 Second edition 2020-02	Medical electrical equipment - Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
05/30/2022	Anesthesiology	1-152	Complete	ISO	80601-2-87 First edition 2021-04	Medical electrical equipment - Part 2-87: Particular requirements for basic safety and essential performance of high-frequency ventilators
04/04/2016	Anesthesiology	1-106	Partial	ISO	17510 First Edition 2015-08-01	Medical devices -- Sleep apnoea breathing therapy -- Masks and application accessories
08/14/2015	Anesthesiology	1-103	Partial	ISO	5367 Fifth edition 2014-10-15	Anaesthetic and respiratory equipment - Breathing sets and connectors
06/07/2018	Anesthesiology	1-134	Partial	ISO	18562-1 First edition 2017-03	Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process
06/07/2018	Anesthesiology	1-137	Partial	ISO	18562-4 First edition 2017-03	Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate
09/17/2018	Anesthesiology	1-139	Partial	ISO	80601-2-61 Second edition 2017-12 (Corrected version 2018-02)	Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
07/15/2019	Biocompatibility	2-266	Complete	ASTM	F2382-18	Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)
12/21/2020	Biocompatibility	2-279	Complete	ASTM	F750-20	Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse
12/21/2020	Biocompatibility	2-281	Complete	ISO	TS 10993-19 Second edition 2020-03	Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
12/23/2016	Biocompatibility	2-93	Complete	ASTM	F763-04 (Reapproved 2016)	Standard Practice for Short-Term Screening of Implant Materials
12/19/2022	Biocompatibility	2-289	Complete	ISO	10993-12 Fifth edition 2021-01	Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
12/19/2022	Biocompatibility	2-297	Complete	ASTM	F763-22	Standard Practice for Short-Term Intramuscular Screening of Implantable Medical Device Materials
05/29/2023	Biocompatibility	2-300	Complete	ISO	10993-2 Third edition 2022-11	Biological Evaluation of medical devices - Part 2: Animal welfare requirements
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
09/17/2018	Biocompatibility	2-255	Complete	ISO	10993-11 Third edition 2017-09	Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
09/17/2018	Biocompatibility	2-255	Complete	ANSI AAMI ISO	10993-11: 2017	Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
09/17/2018	Biocompatibility	2-256	Complete	ASTM	F720-17	Standard Practice for Testing Guinea Pigs for Contact Allergens: Guinea Pig Maximization Test
05/29/2023	Biocompatibility	2-299	Complete	ASTM	F1904-23	Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products in vivo
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
12/20/2021	Biocompatibility	2-293	Complete	USP-NF	M98833_01_01	<87> Biological Reactivity Test, In Vitro - Elution Test
12/20/2021	Biocompatibility	2-292	Complete	USP-NF	M98833_01_01	<87> Biological Reactivity Test, In Vitro - Direct Contact Test
06/07/2018	Biocompatibility	2-250	Complete	ASTM	F756-17	Standard Practice for Assessment of Hemolytic Properties of Materials
08/21/2017	Biocompatibility	2-248	Complete	ISO	10993-4 Third edition 2017-04	Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
08/21/2017	Biocompatibility	2-248	Complete	ANSI AAMI ISO	10993-4: 2017	Biological evaluation of medical devices--Part 4: Selection of tests for interactions with blood
08/21/2017	Biocompatibility	2-155	Complete	ASTM	F2147-01 (Reapproved 2016)	Standard Practice for Guinea Pig: Split Adjuvant and Closed Patch Testing for Contact Allergens
08/21/2017	Biocompatibility	2-247	Complete	ISO	10993-6 Third edition 2016-12-01	Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
05/29/2023	Biocompatibility	2-301	Complete	ASTM	F1983-23	Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
06/07/2018	Biocompatibility	2-249	Complete	ISO	10993-16 Third edition 2017-05	Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables
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	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
08/21/2017	Biocompatibility	2-246	Complete	ASTM	F1877-16	Standard Practice for Characterization of Particles
01/14/2019	Biocompatibility	2-141	Complete	ASTM	F1984-99 (Reapproved 2018)	Standard Practice for Testing for Whole Complement Activation in Serum by Solid Materials
07/26/2016	Biocompatibility	2-227	Complete	ASTM	F1983-14	Standard Practice for Assessment of Compatibility of Absorbable/Resorbable Biomaterials for Implant Applications
12/23/2016	Biocompatibility	2-189	Complete	ASTM	F895-11 (Reapproved 2016)	Standard Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
12/18/2023	Biocompatibility	2-302	Complete	ASTM	F981-23	Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
01/14/2019	Biocompatibility	2-136	Complete	ASTM	E1262-88 (Reapproved 2018)	Standard Guide for Performance of the Chinese Hamster Ovary Cell/Hypoxanthine Guanine Phosphoribosyl Transferase Gene Mutation Assay
01/14/2019	Biocompatibility	2-145	Complete	ASTM	F1439-03 (Reapproved 2018)	Standard Guide for Performance of Lifetime Bioassay for the Tumorigenic Potential of Implant Materials
07/06/2020	Biocompatibility	2-275	Complete	ISO	10993-7 Second edition 2008-10-15	Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1: Applicability of allowable limits for neonates and infants (2019)]
12/21/2020	Biocompatibility	2-277	Complete	ASTM	F813-20	Standard Practice for Direct Contact Cell Culture Evaluation of Materials for Medical Devices
07/15/2019	Biocompatibility	2-265	Complete	ASTM	F2901-19	Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of 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
12/21/2020	Biocompatibility	2-280	Complete	ASTM	F1408-20a	Standard Practice for Subcutaneous Screening Test for Implant Materials
07/15/2019	Biocompatibility	2-264	Complete	ASTM	F2148-18	Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA).
12/21/2020	Biocompatibility	2-282	Complete	ISO	14155 Third edition 2020-07	Clinical investigation of medical devices for human subjects - Good clinical practice
07/15/2019	Biocompatibility	2-263	Complete	ASTM	F1903-18	Standard Practice for Testing for Cellular Responses to Particles in vitro
12/21/2020	Biocompatibility	2-278	Complete	ASTM	F719-20 e1	Standard Practice for Testing Materials in Rabbits for Primary Skin Irritation
07/15/2019	Biocompatibility	2-267	Complete	ASTM	F2888-19	Standard Practice for Platelet Leukocyte Count - An In-Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials.
12/21/2020	Biocompatibility	2-283	Complete	ASTM	F619-20	Standard Practice for Extraction of Materials Used in Medical Devices
07/06/2020	Biocompatibility	2-273	Complete	ISO	10993-9 Third edition 2019-11	Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products
07/15/2019	Biocompatibility	2-268	Complete	ISO	TS 21726 First edition 2019-02	Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents
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	2-191	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
12/20/2021	Biocompatibility	2-294	Partial	USP-NF	M98834_01_01	<88> Biological Reactivity Tests, In Vivo
12/19/2022	Biocompatibility	2-298	Partial	ISO	10993-18 Second edition 2020-01 Amendment 1 2022-05	Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process [Including Amendment 1 (2022)].
12/19/2022	Biocompatibility	2-296	Partial	ISO	10993-10 Fourth edition 2021-11	Biological evaluation of medical devices - Part 10: Tests for skin sensitization
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
12/18/2023	Biocompatibility	2-303	Partial	ISO	10993-17 Second edition 2023-09	Biological evaluation of medical devices - Part 17: Toxicological risk assessment of medical device constituents
12/23/2016	Biocompatibility	2-244	Partial	ASTM	F748-16	Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
07/06/2020	Biocompatibility	2-276	Partial	ISO	10993-18 Second edition 2020-01	Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process.
12/20/2021	Biocompatibility	2-295	Partial	USP-NF	M98900_01_01	<151> Pyrogen Test (USP Rabbit Test)
06/07/2021	Biocompatibility	2-290	Partial	ISO	TS 37137-1 First edition 2021-03	Biological evaluation of absorbable medical devices - Part 1: General requirements.
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
12/21/2020	Biocompatibility	2-288	Partial	ISO	10993-15 Second edition 2019-11	Biological evaluation of medical devices - Part 15: Identification and quantification of degradation products from metals and alloys
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
06/07/2021	Biocompatibility	2-291	Partial	ISO	10993-23 First edition 2021-01	Biological evaluation of medical devices - Part 23: Tests for irritation
01/14/2019	Biocompatibility	2-258	Partial	ISO	10993-1 Fifth edition 2018-08	Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
01/14/2019	Biocompatibility	2-258	Partial	ANSI AAMI ISO	10993-1: 2018	Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
07/06/2020	Biocompatibility	2-274	Complete	ASTM	F749-20	Standard Practice for Evaluating Material Extracts by Intracutaneous Injection in the Rabbit
12/20/2021	Cardiovascular	3-180	Complete	ASTM	F3505-21	Standard Test Method for Stent and Endovascular Prosthesis Kink Resistance
12/20/2021	Cardiovascular	3-176	Complete	ISO	18193 First edition 2021-08	Cardiovascular implants and artificial organs - Cannulae for extracorporeal circulation
12/20/2021	Cardiovascular	3-177	Complete	ASTM	F2606-08 (Reapproved 2021)	Standard Guide for Three-Point Bending of Balloon-Expandable Vascular Stents and Stent Systems
06/07/2021	Cardiovascular	3-170	Complete	ISO	14708-5 Second edition 2020-05	Implants for surgery - Active implantable medical devices - Part 5: Circulatory support devices
07/06/2020	Cardiovascular	3-167	Complete	ISO	TS 81060-5 First edition 2020-02	Non-invasive sphygmomanometers - Part 5: Requirements for the repeatability and reproducibility of NIBP simulators for testing of automated non-invasive sphygmomanometers
07/06/2020	Cardiovascular	3-164	Complete	ASTM	F1830-19	Standard Practice for Collection and Preparation of Blood for Dynamic In Vitro Evaluation of Blood Pumps
01/14/2019	Cardiovascular	3-158	Complete	ASTM	F3320-18	Standard Guide forCoating Characterization of Drug Coated Balloons
08/21/2017	Cardiovascular	3-149	Complete	ISO	25539-1 Second edition 2017-02	Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
05/30/2022	Cardiovascular	3-182	Complete	ASTM	F3036-21	Standard Guide for Testing Absorbable Stents
01/14/2019	Cardiovascular	3-79	Complete	ASTM	F2079-09 (Reapproved 2017)	Standard Test Method for Measuring Intrinsic Elastic Recoil of Balloon-Expandable Stents
05/29/2023	Cardiovascular	3-186	Complete	ISO	14708-2 Third edition 2019-09	Implants for surgery - Active implantable medical devices - Part 2: Cardiac pacemakers
05/29/2023	Cardiovascular	3-184	Complete	ASTM	F2477-23	Standard Test Methods for in vitro Pulsatile Durability Testing of Vascular Stents and Endovascular Prostheses
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
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
01/14/2019	Cardiovascular	3-66	Complete	ASTM	F2081-06 (Reapproved 2017)	Standard Guide for Characterization and Presentation of the Dimensional Attributes of Vascular Stents
09/17/2018	Cardiovascular	3-153	Complete	ASTM	F2743-11	Standard Guide for Coating Inspection and Acute Particulate Characterization of Coated Drug-Eluting Vascular Stent Systems
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
05/29/2023	Cardiovascular	3-187	Complete	ISO	14708-6 Second edition 2019-09	Implants for surgery - Active implantable medical devices - Part 6: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (including implantable defibrillators)
06/07/2018	Cardiovascular	3-150	Complete	ISO	7199 Third edition 2016-11-15	Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators).
06/07/2018	Cardiovascular	3-150	Complete	ANSI AAMI ISO	7199:2016	Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators).
12/23/2019	Cardiovascular	3-162	Complete	ASTM	F3374-19	Standard Guide for Active Fixation Durability of Endovascular Prostheses
01/14/2019	Cardiovascular	3-138	Complete	ASTM	F2942-13	Standard Guide for the In Vitro Axial, Bending, and Rotational Durability Test of Vascular Stents
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
12/18/2023	Cardiovascular	3-189	Complete	ASTM	F2942-19	Standard Guide for in vitro Axial, Bending, and Torsional Durability Testing of Vascular Stents
12/18/2023	Cardiovascular	3-190	Complete	ISO	PAS 7020 First edition 2023-05	Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2
01/14/2019	Cardiovascular	3-157	Complete	ANSI AAMI ISO	25539-1: 2017	Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses
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	3-104	Complete	ASTM	F2914-12 (Reapproved 2018)	Standard Guide for Identification of Shelf-life Test Attributes for Endovascular Devices
09/17/2018	Cardiovascular	3-156	Complete	ISO	14708-1 Second edition 2014-08-15	Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
09/17/2018	Cardiovascular	3-156	Complete	ANSI AAMI ISO	14708-1:2014	Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
08/06/2013	Cardiovascular	3-87	Complete	ASTM	F2477-07 (Reapproved 2013)	Standard Test Methods for in vitro Pulsatile Durability
09/17/2018	Cardiovascular	3-110	Complete	AAMI	TIR 41:2011/(R)2017	Technical Information Report Active implantable medical devices - Guidance for designation of left ventricle and implantable cardioverter defibrillator lead connectors and pulse generator connector cavities for implantable pacemakers and implantable cardioverter defibrillators
12/19/2022	Cardiovascular	3-183	Complete	ISO	11658 First edition 2012-05-15	Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
12/19/2022	Cardiovascular	3-183	Complete	ANSI AAMI ISO	11658: 2012	Cardiovascular implants and extracorporeal systems - Blood/tissue contact surface modifications for extracorporeal perfusion systems
01/30/2014	Cardiovascular	3-63	Complete	ISO	11318:2002	Cardiac Defibrillators -- Connector assembly DF-1 for implantable defibrillators - Dimensions and test requirements.
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
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
12/20/2021	Cardiovascular	3-173	Complete	ISO	5840-3 Second edition 2021-01	Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
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
12/20/2021	Cardiovascular	3-171	Complete	ASTM	F2514-21	Standard Guide for Finite Element Analysis (FEA) of Metallic Vascular Stents Subjected to Uniform Radial Loading
12/23/2019	Cardiovascular	3-161	Complete	ISO	14117 Second edition 2019-09	Active implantable medical devices - Electromagnetic compatibility - EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices.
12/20/2021	Cardiovascular	3-172	Complete	AAMI	TIR42:2021	Evaluation of Particulates Associated with Vascular Medical Devices
05/30/2022	Cardiovascular	3-181	Complete	ISO	25539-2 Third edition 2020-09	Cardiovascular implants - Endovascular devices - Part 2: Vascular stents
12/20/2021	Cardiovascular	3-175	Complete	ISO	5840-2 Second edition 2021-01	Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
12/20/2021	Cardiovascular	3-178	Complete	ASTM	F3067-14 (Reapproved 2021)	Standard Guide for Radial Loading of Balloon-Expandable and Self-Expanding Vascular Stents
12/20/2021	Cardiovascular	3-179	Complete	ASTM	F3172-15 (Reapproved 2021)	Standard Guide for Design Verification Device Size and Sample Size Selection for Endovascular Devices
01/30/2014	Cardiovascular	3-118	Complete	ANSI AAMI	EC57:2012	Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms
01/14/2019	Cardiovascular	3-44	Complete	ANSI AAMI	BP22:1994 (R2016)	Blood pressure transducers
09/17/2018	Cardiovascular	3-154	Complete	ASTM	F3211-17	Standard Guide for Fatigue-to-Fracture (FtF) Methodology for Cardiovascular Medical Devices
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
07/06/2020	Cardiovascular	3-155	Complete	IEC	60601-2-47 Edition 2.0 2012-02	Medical electrical equipment - Part 2-47: Particular requirements for the basic safety and essential performanceof ambulatory electrocardiographic systems
07/06/2020	Cardiovascular	3-155	Complete	ANSI AAMI IEC	60601-2-47:2012/(R)2016	Medical electrical equipment -- Part 2-47: Particular requirements for the basic safety and essential performance of ambulatory electrocardiographic systems
07/06/2020	Cardiovascular	3-165	Complete	ASTM	F1841-19	Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps
06/07/2021	Cardiovascular	3-166	Partial	ISO	81060-2 Third edition 2018-11	Non-invasive sphygmomanometers - Part 2: Clinical investigation of intermittent automated measurement type [Including: Amendment 1 (2020)]
06/07/2021	Cardiovascular	3-129	Partial	ANSI AAMI	EC53:2013/(R)2020	ECG trunk cables and patient leadwires
07/06/2020	Cardiovascular	3-123	Partial	IEC	80601-2-30: Edition 2.0 2018-03	Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
07/06/2020	Cardiovascular	3-123	Partial	ANSI AAMI IEC	80601-2-30:2018	Medical electrical equipment - Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers
12/23/2019	Cardiovascular	3-163	Partial	ISO	18242 First edition 2016-09-01	Cardiovascular implants and extracorporeal systems - Centrifugal blood pumps.
12/18/2023	Cardiovascular	3-126	Partial	IEC	60601-2-27 Edition 3.0 2011-03	Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment [Including: Corrigendum 1 (2012)]
12/18/2023	Cardiovascular	3-126	Partial	ANSI AAMI IEC	60601-2-27:2011(R)2016	Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment
01/14/2019	Cardiovascular	3-86	Partial	ASTM	F2394-07 (Reapproved 2017)	Standard Guide for Measuring Securement of Balloon Expandable Vascular Stent Mounted on Delivery System
05/29/2023	Cardiovascular	3-188	Partial	ISO	81060-3 First edition 2022-12	Non-invasive sphygmomanometers - Part 3: Clinical investigation of continuous automated measurement type
05/29/2023	Cardiovascular	3-185	Partial	ANSI AAMI	PC76:2021	Active implantable medical devices - Requirements and test protocols for safety of patients with pacemakers and ICDs exposed to magnetic resonance imaging
01/14/2019	Cardiovascular	3-52	Partial	ANSI AAMI	EC12:2000/(R)2015	Disposable ECG electrodes
12/20/2021	Cardiovascular	3-174	Partial	ISO	5840-1 Second edition 2021-01	Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
06/07/2021	Cardiovascular	3-168	Partial	IEEE	Std 1708-2014	Standard for Wearable, Cuffless Blood Pressure Measuring Devices [Including: Amendment 1 (2019)]
01/14/2019	Cardiovascular	3-159	Partial	ISO	5910 First edition 2018-06	Cardiovascular implants and extracorporeal systems - Cardiac valve repair devices
12/21/2020	Cardiovascular	3-169	Partial	IEC	60601-2-4 Edition 3.1 2018-02 CONSOLIDATED VERSION	Medical electrical equipment - Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators
12/21/2020	Cardiovascular	3-169	Partial	ANSI AAMI IEC	60601-2-4:2010/A1:2018 (Consolidated Text)	Medical electrical equipment Part 2-4: Particular requirements for the basic safety and essential performance of cardiac defibrillators, including Amendment 1
06/27/2016	Cardiovascular	3-143	Partial	ISO	12417 First edition 2015-10-01	Cardiovascular implants and extracorporeal systems - Vascular device-drug combination products
12/18/2023	Cardiovascular	3-105	Partial	IEC	60601-2-25 Edition 2.0 2011-10	Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
12/18/2023	Cardiovascular	3-105	Partial	ANSI AAMI IEC	60601-2-25:2011/(R)2016	Medical electrical equipment - Part 2-25: Particular requirements for the basic safety and essential performance of electrocardiographs
06/07/2021	Dental/ ENT	4-277	Complete	ANSI IEEE	C63.19-2019	American National Standard Methods of Measurement of Compatibility between Wireless Communication Devices and Hearing Aids
12/19/2022	Dental/ ENT	4-294	Complete	ANSI ADA	Standard No. 139-2020	Dental Base Polymers
12/19/2022	Dental/ ENT	4-295	Complete	ANSI ADA	Standard No. 41-2020	Evaluation of Biocompatibility of Medical Devices Used in Dentistry
06/07/2021	Dental/ ENT	4-278	Complete	ISO	4823 Fifth edition 2021-02	Dentistry - Elastomeric impression and bite registration materials
06/07/2021	Dental/ ENT	4-278	Complete	ANSI ADA	Standard No. 19-2022	Elastomeric Impression and Bite Registration
01/14/2019	Dental/ ENT	4-254	Complete	ANSI ADA	Standard No. 99-2001 (R2013)	Athletic Mouth Protectors and Materials
12/20/2021	Dental/ ENT	4-287	Complete	ANSI ADA	Standard No. 116-2020	Oral Rinses (Modified adoption of ISO 16408:2015, Dentistry Oral Care Products -Oral Rinses)
06/07/2021	Dental/ ENT	4-273	Complete	ANSI ASA	S3.7-2016 (Reaffirmed 2023)	American National Standard Method for Coupler Calibration of Earphones
06/07/2021	Dental/ ENT	4-275	Complete	ANSI ASA	S3.6-2018	American National Standard for Specification for Audiometers
05/30/2022	Dental/ ENT	4-293	Complete	ANSI ADA	Standard No. 119-2021	Manual Toothbrushes
12/20/2021	Dental/ ENT	4-284	Complete	ISO	10873 Second edition 2021-07	Dentistry - Denture adhesives
12/19/2022	Dental/ ENT	4-296	Complete	ISO	9873 Fourth edition 2019-03	Dentistry - Intra-oral mirrors
12/19/2022	Dental/ ENT	4-296	Complete	ANSI ADA	Standard No. 191-2020	Intra-Oral Mirrors
12/19/2022	Dental/ ENT	4-297	Complete	ISO	20126 Third edition 2022-03	Dentistry - Manual toothbrushes - General requirements and test methods
12/20/2021	Dental/ ENT	4-288	Complete	ISO	7488 Second edition 2018-04	Dentistry - Mixing machines for dental amalgam
12/20/2021	Dental/ ENT	4-288	Complete	ANSI ADA	Standard No. 43-2020	Electrically Powered Dental Amalgamators
12/20/2021	Dental/ ENT	4-289	Complete	ISO	18556 Frist edition 2016-04	Dentistry - Intraoral spatulas
12/20/2021	Dental/ ENT	4-290	Complete	ISO	28158 Second edition 2018-09	Dentistry - Integrated dental floss and handles
12/20/2021	Dental/ ENT	4-290	Complete	ANSI ADA	Standard No. 185-2020	Integrated Dental Floss and Handles
12/20/2021	Dental/ ENT	4-286	Complete	ANSI ADA	Standard No. 87-1995 (R2014)	Dental Impression Trays
12/21/2020	Dental/ ENT	4-269	Complete	ISO	3964 Third edition 11-2016	Dentistry - Coupling dimensions for handpiece connectors [Including AMENDMENT 1 (2018)]
05/29/2023	Dental/ ENT	4-298	Complete	ISO	4049 Fifth edition 2019-05	Dentistry - Polymer-based restorative materials
05/29/2023	Dental/ ENT	4-298	Complete	ANSI ADA	Standard No. 27-2022	Polymer-based Restorative Materials
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
05/29/2023	Dental/ ENT	4-301	Complete	ISO	21563 Second edition 2021-08	Dentistry - Hydrocolloid impression materials
05/29/2023	Dental/ ENT	4-301	Complete	ANSI ADA	Standard No. 128-2022	Hydrocolloid Impression Materials
06/07/2018	Dental/ ENT	4-240	Complete	ISO	21563 First edition 2013-08-15	Dentistry - Hydrocolloid impression materials
06/07/2018	Dental/ ENT	4-240	Complete	ANSI ADA	Standard No. 128-2015	Hydrocolloid Impression Materials
05/29/2023	Dental/ ENT	4-302	Complete	ISO	10477 Fourth edition 2020-10	Dentistry - Polymer-based crown and veneering materials
05/29/2023	Dental/ ENT	4-302	Complete	ANSI ADA	Standard No. 53-2022	Polymer-Based Crown and Veneering Materials
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
12/18/2023	Dental/ ENT	4-315	Complete	ISO	24234 Third edition 2021-08	Dentistry - Dental Amalgam
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
05/29/2023	Dental/ ENT	4-299	Complete	ISO	3107 Fifth edition 2022-09	Dentistry - Zinc oxide-eugenol cements and non-eugenol zinc oxide cements
05/29/2023	Dental/ ENT	4-299	Complete	ANSI ADA	Standard No. 30-2023	Dental - Zinc Oxide-eugenol Cements and Non-eugenol Zinc Oxide 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	4-181	Complete	ISO	4049 Fourth edition 2009-10-01	Dentistry - Polymer-based restorative materials
04/04/2016	Dental/ ENT	4-224	Complete	ISO	24234 Second edition 2015-05-01	Dentistry - Dental Amalgam
08/21/2017	Dental/ ENT	4-238	Complete	ISO	20127 First edition 2005-03-15	Dentistry - Powered toothbrushes - General requirements and test methods
08/21/2017	Dental/ ENT	4-238	Complete	ANSI ADA	Standard No.120-2009 (R2014)	Powered Toothbrushes
09/17/2018	Dental/ ENT	4-244	Complete	ISO	8325 Second edition 2004-09-15	Dentistry - Test methods for rotary instruments
12/18/2023	Dental/ ENT	4-318	Complete	ISO	20749 Second edition 2023-06	Dentistry - Pre-capsulated dental amalgam
09/17/2018	Dental/ ENT	4-246	Complete	ISO	20749 First edition 2017-03	Dentistry - Pre-capsulated dental amalgam
09/17/2018	Dental/ ENT	4-246	Complete	ANSI ADA	Standard No. 144-2018	Alloy for Dental Amalgam
12/18/2023	Dental/ ENT	4-316	Complete	ISO	20127 Second edition 2020-08	Dentistry - Physical properties of powered toothbrushes
12/18/2023	Dental/ ENT	4-316	Complete	ANSI ADA	Standard No.120-2022	Dentistry - Physical Properties of Powered Toothbrushes
12/18/2023	Dental/ ENT	4-317	Complete	ISO	8325 Third edition 2023-03	Dentistry - Test methods for rotary instruments
12/20/2021	Dental/ ENT	4-292	Complete	ISO	28888 First edition 2013-10	Dentistry - Screening method for erosion potential of oral rinses on dental hard tissues
12/20/2021	Dental/ ENT	4-292	Complete	ANSI ADA	Standard No. 151-2015 (R2020)	Screening Method for Erosion Potential of Oral Rinses on Dental Hard Tissues
12/18/2023	Dental/ ENT	4-321	Complete	ISO	23450 First edition 2021-03	Dentistry - Intraoral camera
12/18/2023	Dental/ ENT	4-322	Complete	ISO	18675 First edition 2022-05	Dentistry - Machinable ceramic blanks
12/18/2023	Dental/ ENT	4-323	Complete	ISO	5139 First edition 2023-05	Dentistry - Polymer-based composite machinable blanks
12/18/2023	Dental/ ENT	4-324	Complete	ISO	TS 16506 First edition 2018-03	Dentistry - Polymer-based luting materials containing adhesive components
12/18/2023	Dental/ ENT	4-314	Complete	ISO	7494-2 Third edition 2022-07	Dentistry - Stationary dental units and dental patient chairs - Part 2: Air, water, suction and wastewater systems
06/27/2016	Dental/ ENT	4-202	Complete	ANSI ADA	Standard No. 58-2010 (R2015)	Root Canal Files, Type H (Hedstrom)
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
01/30/2014	Dental/ ENT	4-199	Complete	ISO	6876 Third edition 2012-06-01	Dentistry -- Root canal sealing materials
06/07/2021	Dental/ ENT	4-281	Complete	ISO	1797 Third Edition 2017-05	Dentistry - Shanks for rotary and oscillating instruments
06/07/2021	Dental/ ENT	4-281	Complete	ANSI ADA	Standard No. 179-2020	Shanks for Rotary and Oscillating Instruments
01/27/2015	Dental/ ENT	4-219	Complete	ISO	29022 First edition 2013-06-01	Dentistry - Adhesive - Notched-edge sheer bond strength test
04/04/2016	Dental/ ENT	4-222	Complete	ISO	6874 Third edition 2015-09-01	Dentistry - Polymer-based pit and fissure sealants
06/07/2018	Dental/ ENT	4-241	Complete	ISO	7491 Second edition 2000-09-01	Dental materials - Determination of colour stability
06/07/2018	Dental/ ENT	4-241	Complete	ANSI ADA	Standard No. 80-2001 (R2020)	Dental Materials-Determination of Color Stability
01/14/2019	Dental/ ENT	4-217	Complete	ANSI ASA	S3.36-2012 (Reaffirmed 2022)	American National Standard Specification for a Manikin for Simulated in-situ Airborne Acoustic Measurements
01/14/2019	Dental/ ENT	4-171	Complete	ANSI ASA	S3.37-1987 (Reaffirmed 2020)	American National Standard Preferred Earhook Nozzle Thread for Postauricular Hearing Aids
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
06/27/2016	Dental/ ENT	4-228	Complete	ANSI ASA	S3.20-2015 (Reaffirmed 2020)	American National Standard Bioacoustical Terminology
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
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
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	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)
08/21/2017	Dental/ ENT	4-233	Complete	ISO	20795-2 Second edition 2013-03-01	Dentistry - Base polymers - Part 2: Orthodontic base polymers
08/14/2015	Dental/ ENT	4-130	Complete	ANSI ADA	Standard No. 17-1983 (R2014)	Denture Base Temporary Relining Resins
12/18/2023	Dental/ ENT	4-320	Complete	ISO	13402 First edition 1995-08-01	Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure
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
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
12/21/2020	Dental/ ENT	4-268	Complete	ISO	15841 Second edition 2014-08	Dentistry - Wires for use in orthodontics [Including AMENDMENT 1 (2020)]
12/21/2020	Dental/ ENT	4-268	Complete	ANSI ADA	Standard No. 32-2017	Orthodontic Wires
12/20/2021	Dental/ ENT	4-291	Complete	ISO	28399 First edition 2011-01	Dentistry - Products for external tooth bleaching
12/20/2021	Dental/ ENT	4-291	Complete	ANSI ADA	Standard No. 136-2015 (R2020)	Products for External Tooth Bleaching
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
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
08/14/2015	Dental/ ENT	4-220	Complete	ANSI ASA	S3.22-2014 (Reaffirmed 2020)	American National Standard Specification of Hearing Aid Characteristics
07/09/2014	Dental/ ENT	4-97	Complete	ANSI ADA	Standard No. 57-2000 (R2012)	Endodontic Sealing Material
08/21/2017	Dental/ ENT	4-215	Complete	ANSI ADA	Standard No. 96-2012	Dental Water-based Cements
09/17/2018	Dental/ ENT	4-242	Complete	ISO	10139-1 Third edition 2018-03	Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use
09/17/2018	Dental/ ENT	4-242	Complete	ANSI ADA	Standard No. 75-2020	Resilient Lining Materials for Removable Dentures - Part 1: Short-Term Materials
09/17/2018	Dental/ ENT	4-247	Complete	ISO	28319 Second edition 2018-04	Dentistry - Laser welding and filler materials
09/17/2018	Dental/ ENT	4-247	Complete	ANSI ADA	Standard No. 84-2020	Laser Welding and Filler Materials in Dentistry
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
12/18/2023	Dental/ ENT	4-310	Complete	ISO	22112 Second edition 2017-08	Dentistry - Artificial teeth for dental prostheses
12/18/2023	Dental/ ENT	4-310	Complete	ANSI ADA	Standard No. 15-2021	Artificial Teeth for Dental Prostheses
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	4-188	Complete	ISO	9917-2 Second edition 2010-04-15	Dentistry - Water-based cements - Part 2: Resin-modified cements
12/18/2023	Dental/ ENT	4-313	Complete	ISO	27020 Second edition 2019-06	Dentistry - Brackets and tubes for use in orthodontics
12/18/2023	Dental/ ENT	4-313	Complete	ANSI ADA	Standard No.100-2020	Orthodontic Brackets and Tubes
05/29/2023	Dental/ ENT	4-307	Complete	ISO	13504 First edition 2012-07	Dentistry - General requirements for instruments and related accessories used in dental implant placement and treatment
05/29/2023	Dental/ ENT	4-308	Complete	ISO	14708-7 Second edition 2019-12	Implants for surgery - Active implantable medical devices - Part 7: Particular requirements for cochlear and auditory brainstem implant systems
01/14/2019	Dental/ ENT	4-248	Complete	ISO	10477 Third edition 2018-06	Dentistry - Polymer-based crown and veneering materials
12/21/2020	Dental/ ENT	4-265	Complete	ISO	10271 Third edition 2020-08	Dentistry - Corrosion test methods for metallic materials
12/21/2020	Dental/ ENT	4-265	Complete	ANSI ADA	Standard No. 97-2020	Corrosion Test Methods for Metallic Materials
01/27/2015	Dental/ ENT	4-185	Complete	ANSI ASA	S3.45-2009 (Reaffirmed 2019)	American National Standard Procedures for Testing Basic Vestibular Function
12/18/2023	Dental/ ENT	4-312	Complete	ANSI ASA	S3.35-2021	American National Standard Method for Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions
08/21/2017	Dental/ ENT	4-232	Complete	ISO	20795-1 Second edition 2013-03-01	Dentistry - Base polymers - Part 1: Denture base polymers
12/18/2023	Dental/ ENT	4-311	Complete	ISO	9917-2 Third edition 2017-09	Dentistry - Water-based cements - Part 2: Resin-modified cements
12/21/2020	Dental/ ENT	4-264	Complete	ISO	9333 Second edition 2006-07	Dentistry - Brazing materials
12/21/2020	Dental/ ENT	4-264	Complete	ANSI ADA	Standard No. 88-2019	Dental Brazing Alloys
05/29/2023	Dental/ ENT	4-304	Complete	ISO	21606 Second edition 2022-08	Dentistry - Elastomeric auxiliaries for use in orthodontics
12/21/2020	Dental/ ENT	4-267	Complete	ISO	21606 First edition 2007-06	Dentistry - Elastomeric auxiliaries for use in orthodontics
12/21/2020	Dental/ ENT	4-267	Complete	ANSI ADA	Standard No. 105-2010 (R2015)	Orthodontic Elastomeric Materials
12/18/2023	Dental/ ENT	4-309	Complete	ISO	6877 Third edition 2021-09	Dentistry - Endodontic obturating materials
12/18/2023	Dental/ ENT	4-309	Complete	ANSI ADA	Standard No. 78-2021	Dentistry - Endodontic Obturating Materials
08/21/2017	Dental/ ENT	4-239	Complete	ANSI AAMI	CI86:2017	Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting
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
12/21/2020	Dental/ ENT	4-270	Complete	ANSI ADA	Technical Report No. 146-2018	CAD/CAM Abutments in Dentistry
05/29/2023	Dental/ ENT	4-300	Complete	ISO	22674 Third edition 2022-08	Dentistry - Metallic materials for fixed and removable restorations and appliances
01/14/2019	Dental/ ENT	4-163	Complete	ANSI ASA	S3.5-1997 (Reaffirmed 2020)	American National Standard Methods for Calculation of the Speech Intelligibility Index
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
12/21/2020	Dental/ ENT	4-266	Complete	ISO	19023 First edition 2018-02	Dentistry - Orthodontic anchor screws
12/21/2020	Dental/ ENT	4-266	Complete	ANSI ADA	Standard No. 178-2019	Orthodontic Anchor Screws
05/29/2023	Dental/ ENT	4-303	Complete	ISO	9333 Third edition 2022-08	Dentistry - Brazing materials
12/23/2019	Dental/ ENT	4-262	Complete	IEC	80601-2-60 Edition 2.0 2019-06	Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
01/14/2019	Dental/ ENT	4-255	Complete	ANSI ADA	Standard No. 131-2015 (R2020)	Dental CAD/CAM Machinable Zirconia Blanks
01/14/2019	Dental/ ENT	4-162	Complete	ANSI ASA	S3.4-2007 (Reaffirmed 2020)	American National Standard Procedure for the Computation of Loudness of Steady Sounds
01/14/2019	Dental/ ENT	4-250	Complete	ISO	7494-1 Third edition 2018-06	Dentistry - Stationary dental units and dental patient chairs - Part 1: General requirements
01/14/2019	Dental/ ENT	4-251	Complete	ISO	6872 Fourth edition 2015-06-01 [including AMENDMENT 1 2018-04]	Dentistry - Ceramic materials
01/14/2019	Dental/ ENT	4-251	Complete	ANSI ADA	Standard No. 69-2020	Dental Ceramic
12/23/2019	Dental/ ENT	4-260	Complete	ANSI ASA	S12.2-2019	American National Standard for Criteria for Evaluating Room Noise
07/15/2019	Dental/ ENT	4-258	Complete	ISO	10139-2 Third edition 2016-06-15	Dentistry - Soft lining materials for removable dentures - Part 2: Materials for long-term use
07/15/2019	Dental/ ENT	4-258	Complete	ANSI ADA	Standard No. 160-2020	Soft Lining Materials for Removable Dentures - Part 2: Materials for Long-Term Use
12/23/2019	Dental/ ENT	4-261	Complete	ISO	7405 Third edition 2018-10 Corrected version 2018-12	Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
06/07/2021	Dental/ ENT	4-279	Complete	ANSI ADA	Standard No. 85-2004 (R2009)	Part 1: Disposable Prophy Angles
06/07/2021	Dental/ ENT	4-283	Complete	ISO	16409 Second edition 2016-10	Dentistry - Oral care products - Manual interdental brushes
06/07/2021	Dental/ ENT	4-283	Complete	ANSI ADA	Standard No. 125-2018	Manual Interdental Brushes
12/21/2020	Dental/ ENT	4-271	Complete	ANSI ADA	Standard No. 34-2013	Dental Cartridge Syringes
12/21/2020	Dental/ ENT	4-272	Complete	ANSI ADA	Standard No. 63-2013	Root Canal Barbed Broaches and Rasps
06/07/2021	Dental/ ENT	4-274	Complete	ANSI ASA	S3.2-2020	American National Standard Method for Measuring the Intelligibility of Speech over Communication Systems
12/20/2021	Dental/ ENT	4-285	Complete	ANSI ADA	Standard No. 37-1986 (R2020)	Dental Abrasive Powders
12/18/2023	Dental/ ENT	4-319	Partial	ISO	17730 Second edition 2020-09	Dentistry - Fluoride varnishes
12/18/2023	Dental/ ENT	4-319	Partial	ANSI ADA	Standard No. 117-2022	Dentistry - Fluoride Varnishes
06/07/2021	Dental/ ENT	4-280	Partial	ANSI ADA	Standard No. 117-2018	Fluoride varnishes
06/07/2021	Dental/ ENT	4-276	Partial	ISO	14457 Second edition 2017-10	Dentistry - Handpieces and motors
06/07/2021	Dental/ ENT	4-276	Partial	ANSI ADA	Standard No. 35-2019	Dental Handpieces and Motors
07/15/2019	Dental/ ENT	4-259	Partial	ISO	14801 Third edition 2016-11-01	Dentistry - Implants - Dynamic loading test for endosseous dental implants
07/15/2019	Dental/ ENT	4-259	Partial	ANSI ADA	Standard No. 127-2018	Dynamic Loading Test for Endosseous Dental Implants
05/29/2023	Dental/ ENT	4-306	Partial	ISO	22052 First edition 2020-06	Dentistry - Compressed air source equipment
05/29/2023	Dental/ ENT	4-306	Partial	ANSI ADA	Standard No. 94-2021	Central Compressed Air Source Equipment
01/14/2019	Dental/ ENT	4-257	Partial	ISO	17730 First edition 2014-11-01	Dentistry - Fluoride varnishes
05/29/2023	Dental/ ENT	4-305	Partial	ISO	10637 Second edition 2018-05	Dentistry - Central suction source equipment
05/29/2023	Dental/ ENT	4-305	Partial	ANSI ADA	Standard No. 177-2020	Central Suction Source Equipment
08/14/2015	Dental/ ENT	4-184	Complete	ANSI ASA	S3.25-2009 (Reaffirmed 2019)	American National Standard For an Occluded Ear Simulator
07/06/2020	Dental/ ENT	4-263	Complete	ISO	9693 Third edition 2019-10	Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems
07/06/2020	Dental/ ENT	4-263	Complete	ANSI ADA	Standard No. 38-2020	Dentistry - Compatibility testing for metal-ceramic and ceramic-ceramic systems
01/14/2019	Dental/ ENT	4-252	Complete	ISO	10650 Second edition 2018-08	Dentistry - Powered polymerization activators
01/14/2019	Dental/ ENT	4-252	Complete	ANSI ADA	Standard No. 48-2020	Curing Lights (Powered Polymerization Activators)
01/14/2019	Dental/ ENT	4-256	Complete	ANSI ADA	Standard No. 132-2015	Scanning Accuracy of Dental Chairside and Laboratory CAD/CAM Systems
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)
12/20/2021	General I (QS/ RM)	5-134	Complete	ISO	15223-1 Fourth edition 2021-07	Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
07/06/2020	General I (QS/ RM)	5-127	Complete	ISTA	3B 2017	Packaged-Products for Less-Than-Truckload (LTL) Shipment
07/06/2020	General I (QS/ RM)	5-128	Complete	ISTA	3E 2017	Similar Packaged-Products in Unitized Loads of Truckload Shipment
12/19/2022	General I (QS/ RM)	5-137	Complete	IEC	TR 60878 Ed. 4.0 2022-11	Graphical symbols for electrical equipment in medical practice
12/19/2022	General I (QS/ RM)	5-136	Complete	ASTM	D4332-22	Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing
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
12/23/2019	General I (QS/ RM)	5-124	Complete	ISO	7000 Sixth edition 2019-07	Graphical symbols for use on equipment - Registered symbols
12/23/2019	General I (QS/ RM)	5-125	Complete	ISO	14971 Third Edition 2019-12	Medical devices - Application of risk management to medical devices
12/23/2019	General I (QS/ RM)	5-125	Complete	ANSI AAMI ISO	14971: 2019	Medical devices - Applications of risk management to medical devices
07/15/2019	General I (QS/ RM)	5-123	Complete	ISO	80369-3 First Edition 2016-07-01	Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications [Including AMENDMENT 1 (2019)].
01/14/2019	General I (QS/ RM)	5-122	Complete	ASME	V&V 40-2018	Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices
12/21/2020	General I (QS/ RM)	5-131	Complete	IEC	60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
12/21/2020	General I (QS/ RM)	5-131	Complete	ANSI AAMI IEC	60601-1-8:2006 and A1:2012 [Including AMD 2:2021]	Medical Electrical Equipment - Part 1-8: General requirements for basic safety and essential performance ¿ Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems [Including Amendment 2 (2021)]
12/21/2020	General I (QS/ RM)	5-132	Complete	IEC	60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
12/23/2016	General I (QS/ RM)	5-113	Complete	ASTM	D7386-16	Standard Practice for Performance Testing of Packages for Single Delivery Systems
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
09/17/2018	General I (QS/ RM)	5-42	Complete	ASTM	D903-98 (Reapproved 2017)	Standard Test Methods for Peel or Stripping Strength of Adhesive Bonds
01/14/2019	General I (QS/ RM)	5-120	Complete	IEC	60812 Edition 3.0 2018-08	Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA)
08/21/2017	General I (QS/ RM)	5-107	Complete	IEC	80369-5: Edition 1.0 2016-03	Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications.[Including Corrigendum 1 (2017) and Corrigendum 2 (2021)]
08/21/2017	General I (QS/ RM)	5-107	Complete	ANSI AAMI ISO	80369-5:2016	Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications
01/14/2019	General I (QS/ RM)	5-121	Complete	ISO	80369-1 Second edition 2018-11	Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
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)]
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
01/27/2015	General I (QS/ RM)	5-62	Complete	ANSI ASQ	Z1.4-2003 (R2018)	Sampling Procedures and Tables for Inspection by Attributes
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.
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
12/19/2022	General I (QS/ RM)	5-141	Complete	ASME	V&V 20-2009 (R2021)	Standard for Verification and Validation in Computational Fluid Dynamics and Heat Transfer
06/15/2016	General I (QS/ RM)	5-102	Complete	IEC	60417:2002 DB	Graphical symbols for use on equipment
12/19/2022	General I (QS/ RM)	5-139	Complete	ISO	18250-3 First edition 2018-06	Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application
12/19/2022	General I (QS/ RM)	5-140	Complete	ASME	V&V 10-2019	Standard for Verification and Validation in Computational Solid Mechanics
12/19/2022	General I (QS/ RM)	5-135	Complete	ISO	20417 First edition 2021-04 Corrected version 2021-12	Medical devices - Information to be supplied by the manufacturer
12/19/2022	General I (QS/ RM)	5-138	Complete	AAMI	TIR66: 2017/(R)2020	Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms
12/21/2020	General I (QS/ RM)	5-133	Complete	ISO	80369-7 Second edition 2021-05	Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
07/06/2020	General I (QS/ RM)	5-130	Complete	ISO	7010 Third edition 2019-07	Graphical symbols - Safety colours and safety signs - Registered safety signs
07/06/2020	General I (QS/ RM)	5-126	Complete	ISTA	3A 2018	Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less
07/06/2020	General I (QS/ RM)	5-129	Complete	IEC	62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION	Medical devices - Part 1: Application of usability engineering to medical devices
07/06/2020	General I (QS/ RM)	5-129	Complete	ANSI AAMI IEC	62366-1:2015+AMD1:2020 (Consolidated Text)	Medical devices Part 1: Application of usability engineering to medical devices, including Amendment 1
06/27/2016	General I (QS/ RM)	5-57	Partial	ANSI AAMI	HE75:2009/(R)2018	Human factors engineering - Design of medical devices
06/07/2021	General II (ES/ EMC)	19-40	Complete	IEC	60086-4 Edition 5.0 2019-04	Primary batteries - Part 4: Safety of lithium batteries [Including: Corrigendum 1 (2019) and Corrigendum 2 (2020)]
05/30/2022	General II (ES/ EMC)	19-46	Complete	ANSI AAMI	ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) [Including Amendment 2 (2021)]
02/07/2022	General II (ES/ EMC)	19-45	Complete	AIM	Standard 7351731 Rev. 3.00 2021-06-04	Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard
12/20/2021	General II (ES/ EMC)	19-44	Complete	IEEE ANSI	C63.24-2021	American National Standard - Recommended Practice for In Situ RF Immunity Evaluation of Electronic Devices and Systems
12/19/2022	General II (ES/ EMC)	19-48	Complete	IEEE ANSI	USEMCSC C63.27-2021	American National Standard for Evaluation of Wireless Coexistence
12/23/2019	General II (ES/ EMC)	19-33	Complete	IEC	62133-2 Edition1.0 2017-02	Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
08/21/2017	General II (ES/ EMC)	19-27	Complete	IEC	62485-3 Edition 2.0 2014-07	Safety requirements for secondary batteries and battery installations - Part 3: Traction batteries
12/23/2019	General II (ES/ EMC)	19-13	Complete	IEC	62133 Edition 2.0 2012-12	Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications [Including: Corrigendum 1 (2013)]
08/21/2017	General II (ES/ EMC)	19-24	Complete	IEC	60086-5 Edition 4.0 2016-07	Primary batteries - Part 5: Safety of batteries with aqueous electrolyte
08/21/2017	General II (ES/ EMC)	19-28	Complete	IEC	62485-4 Edition 1.0 2015-01	Safety requirements for secondary batteries and battery installations - Part 4: Valve-regulated lead-acid batteries for use in portable appliances
07/09/2014	General II (ES/ EMC)	19-11	Complete	UL	2054 2nd Edition	Household and Commercial Batteries
08/21/2017	General II (ES/ EMC)	19-26	Complete	IEC	62485-2 Edition 1.0 2010-06	Safety requirements for secondary batteries and battery installations - Part 2: Stationary batteries.
09/17/2018	General II (ES/ EMC)	19-31	Complete	IEEE ANSI	C63.15-2017 (Revision of ANSI C63.15-2010)	American National Standard Recommended Practice for the Immunity Measurement of Electrical and Electronic Equipment
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
08/21/2017	General II (ES/ EMC)	19-25	Complete	IEC	62485-1 Edition 1.0 2015-04	Safety requirements for secondary batteries and battery installations - Part 1: General safety information.
12/23/2016	General II (ES/ EMC)	19-20	Complete	IEEE ANSI	C63.16-2016 (Revision of ANSI C63.16-1993)	American National Standard Guide for Electrostatic Discharge Test Methodologies and Acceptance Criteria for Electronic Equipment
12/20/2021	General II (ES/ EMC)	19-41	Complete	ANSI UL	61010-1 3rd Ed, dated May 12, 2012 with revision through July 19, 2019	Standard for Safety for Electrical Equipment For Measurement, Control and Laboratory Use; Part 1: General Requirements
07/09/2014	General II (ES/ EMC)	19-10	Complete	UL	1642 5th Edition	Lithium Batteries
05/30/2022	General II (ES/ EMC)	19-47	Complete	ANSI AAMI	HA60601-1-11:2015 [Including AMD1:2021]	Medical Electrical Equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral Standard: Requirements for medical electrical equipment and medical electrical equipment and medical electrical systems used in the home healthcare environment (IEC 60601-1-11:2015 MOD) [Including Amendment1 (2021)]
04/03/2023	General II (ES/ EMC)	19-34	Complete	IEC	61010-1 Edition 3.1 2017-01 CONSOLIDATED VERSION	Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements [Including: Corrigendum 1 (2019)] - Note: This standard is recognized with relevant US national differences applied, see reference #1 in Relevant FDA Guidance and/or Supportive Publication section
07/15/2019	General II (ES/ EMC)	19-35	Complete	UL	Standard for Standby Batteries	1989 Edition 5, 2013-10-02, ANSI November 2018
12/23/2019	General II (ES/ EMC)	19-32	Complete	IEC	62133-1 Edition 1.0 2017-02	Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 1: Nickel systems
08/21/2017	General II (ES/ EMC)	19-22	Complete	AAMI	TIR69:2017/(R2020)	Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems.
04/03/2023	General II (ES/ EMC)	19-49	Complete	IEC	60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION	Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Note: This standard is recognized with relevant US national differences applied, see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below.
12/21/2020	General II (ES/ EMC)	19-37	Complete	IEC	60601-1-10 Edition 1.2 2020-07 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
12/21/2020	General II (ES/ EMC)	19-39	Complete	IEC	60601-1-12 Edition 1.1 2020-07 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
12/21/2020	General II (ES/ EMC)	19-39	Complete	ANSI AAMI IEC	60601-1-12:2016 [Including AMD 1:2021]	Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency [Including Amendment 1(2021)]
09/17/2018	General II (ES/ EMC)	19-19	Partial	IEC	TR 60601-4-2 Edition 1.0 2016-05	Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
12/21/2020	General II (ES/ EMC)	19-36	Partial	IEC	60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
12/21/2020	General II (ES/ EMC)	19-36	Partial	ANSI AAMI IEC	60601-1-2:2014 [Including AMD 1:2021]	Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests [Including Amendment 1 (2021)]
12/21/2020	General II (ES/ EMC)	19-38	Partial	IEC	60601-1-11 Edition 2.1 2020-07 CONSOLIDATED VERSION	Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
12/20/2021	General II (ES/ EMC)	19-42	Partial	IEC	61326-1 Edition 3.0 2020-10	Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
12/20/2021	General II (ES/ EMC)	19-43	Partial	IEC	61326-2-6 Edition 3.0 2020-10	Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
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
05/30/2022	General Plastic Surgery/ General Hospital	6-480	Complete	ISO	11608-6:2022	Needle-based injection systems for medical use - Requirements and test methods - Part 6: On-body delivery
12/19/2022	General Plastic Surgery/ General Hospital	6-485	Complete	ISO	7886-4 Second Edition 2018-11	Sterile hypodermic syringes for single use - Part 4: Syringes with re-use prevention feature
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.
12/23/2019	General Plastic Surgery/ General Hospital	6-438	Complete	IEC	80601-2-77 Edition 1.0 2019-07	Medical electrical equipment - Part 2-77: Particular requirements for the BASIC SAFETY and essential performance of ROBOTICALLY ASSISTED SURGICAL EQUIPMENT
12/23/2019	General Plastic Surgery/ General Hospital	6-438	Complete	ANSI AAMI IEC	80601-2-77:2020	Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
08/14/2015	General Plastic Surgery/ General Hospital	6-200	Complete	ASTM	E1061-01(2022)	Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers
12/20/2021	General Plastic Surgery/ General Hospital	6-465	Complete	USP-NF	M76090_03_01	Sodium Chloride Irrigation
06/07/2021	General Plastic Surgery/ General Hospital	6-463	Complete	IEC	60601-2-21 Edition 3.0 2020-09	Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers
06/07/2018	General Plastic Surgery/ General Hospital	6-214	Complete	ASTM	D6355-07(2022)	Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves
12/23/2019	General Plastic Surgery/ General Hospital	6-424	Complete	ASTM	D5151-19(2023)	Standard Test Method for Detection of Holes in Medical Gloves
07/06/2020	General Plastic Surgery/ General Hospital	6-439	Complete	ISO	7886-2 Second edition 2020-04	Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps
12/20/2021	General Plastic Surgery/ General Hospital	6-469	Complete	USP-NF	M99650_02_01	<861> Sutures - Diameter
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
05/30/2022	General Plastic Surgery/ General Hospital	6-478	Complete	ISO	11608-1:2022	Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
01/14/2019	General Plastic Surgery/ General Hospital	6-410	Complete	ISO	8536-6 Third edition 2016-12-01	Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles
07/06/2020	General Plastic Surgery/ General Hospital	6-441	Complete	ISO	7886-3 Second edition 2020-05	Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization
07/15/2019	General Plastic Surgery/ General Hospital	6-421	Complete	ISO	80601-2-56 Second edition 2017-03	Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)].
06/07/2021	General Plastic Surgery/ General Hospital	6-461	Complete	IEC	60601-2-19 Edition 3.0 2020-09	Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators
07/15/2019	General Plastic Surgery/ General Hospital	6-422	Complete	AAMI	TIR38:2019	Medical device safety assurance case guidance
05/29/2023	General Plastic Surgery/ General Hospital	6-491	Complete	ASTM	F1670/F1670M-17a	Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
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
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
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
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
05/29/2023	General Plastic Surgery/ General Hospital	6-489	Complete	IEC	60601-2-52 Edition 1.1 2015-03 CONSOLIDATED VERSION	Medical electrical equipment - Part 2-52: Particular requirements for the basic safety and essential performance of medical beds
07/06/2020	General Plastic Surgery/ General Hospital	6-447	Complete	ISO	8536-4 Sixth edition 2019-09	Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
05/29/2023	General Plastic Surgery/ General Hospital	6-488	Complete	ASTM	F1671/F1671M-22	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
09/17/2018	General Plastic Surgery/ General Hospital	6-409	Complete	ASTM	F703-18	Standard Specification for Implantable Breast Prostheses
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
09/17/2018	General Plastic Surgery/ General Hospital	6-123	Complete	ASTM	E667-98 (Reapproved 2017)	Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers
06/07/2018	General Plastic Surgery/ General Hospital	6-401	Complete	ASTM	D7160-16	Standard Practice for Determination of Expiration Dating for Medical Gloves
08/14/2015	General Plastic Surgery/ General Hospital	6-110	Complete	ASTM	F1441-03 (Reapproved 2014)	Standard Specification for Soft-Tissue Expander Devices
01/14/2019	General Plastic Surgery/ General Hospital	6-338	Complete	ASTM	D7866-14	Standard Specification for Radiation Attenuating Protective Gloves
06/07/2018	General Plastic Surgery/ General Hospital	6-270	Complete	ASTM	F1840-10 (Reapproved 2016)	Standard Terminology for Surgical Suture Needles
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
08/14/2015	General Plastic Surgery/ General Hospital	6-353	Complete	ASTM	F2051-00 (Reapproved 2014)	Standard Specification for Implantable Saline Filled Breast Prosthesis
12/23/2019	General Plastic Surgery/ General Hospital	6-425	Complete	ASTM	F2100-19	Standard Specification for Performance of Materials Used in Medical Face Masks
06/07/2018	General Plastic Surgery/ General Hospital	6-404	Complete	ISO	7886-1 Second edition 2017-05	Sterile hypodermic syringes for single use - Part 1: Syringes for manual use
01/14/2019	General Plastic Surgery/ General Hospital	6-411	Complete	ASTM	D6499-18	Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products
06/07/2018	General Plastic Surgery/ General Hospital	6-407	Complete	ASTM	F3186-17	Standard Specification for Adult Portable Bed Rails and Related Products
12/20/2021	General Plastic Surgery/ General Hospital	6-467	Complete	USP-NF	M80200_04_01	Nonabsorbable Surgical Suture
06/07/2018	General Plastic Surgery/ General Hospital	6-405	Complete	IEC	80601-2-59 Edition 2.0 2017-09	Medical electrical equipment - Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening
06/07/2018	General Plastic Surgery/ General Hospital	6-406	Complete	ASTM	F1862/F1862M-17	Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
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
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
06/07/2018	General Plastic Surgery/ General Hospital	6-402	Complete	ASTM	F1670/F1670M-17	Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood
05/29/2023	General Plastic Surgery/ General Hospital	6-492	Complete	ASTM	F2100-23	Standard Specification for Performance of Materials Used in Medical Face Masks
04/04/2016	General Plastic Surgery/ General Hospital	6-355	Complete	ASTM	D3772-15(2021)	Standard Specification for Industrial Rubber Finger Cots
05/29/2023	General Plastic Surgery/ General Hospital	6-493	Complete	ASTM	F2101-23	Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
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	6-303	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
01/15/2013	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
05/29/2023	General Plastic Surgery/ General Hospital	6-490	Complete	ISO	10555-6 First edition 2015-04-15 [Including AMD1:2019]	Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports [Including AMENDMENT 1 (2019)]
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
05/29/2023	General Plastic Surgery/ General Hospital	6-495	Complete	ISO	20698 First Edition 2018-07	Catheter systems for neuraxial application - Sterile and single-use catheters and accessories
12/20/2021	General Plastic Surgery/ General Hospital	6-468	Complete	USP-NF	M99670_02_01	<881> Tensile Strength
05/29/2023	General Plastic Surgery/ General Hospital	6-494	Complete	ASTM	F3352/F3352M-23a	Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
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
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
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	6-295	Complete	AAMI ANSI	BF7:2012	Blood transfusion microfilters
08/21/2017	General Plastic Surgery/ General Hospital	6-70	Complete	ASTM	E825-98 (Reapproved 2016)	Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature
08/21/2017	General Plastic Surgery/ General Hospital	6-124	Complete	ASTM	E1104-98 (Reapproved 2016)	Standard Specification for Clinical Thermometer Probe Covers and Sheaths
08/21/2017	General Plastic Surgery/ General Hospital	6-384	Complete	ISO	1135-4 Sixth edition 2015-12-01	Transfusion equipment for medical use-Part 4: Transfusion sets for single use, gravity feed
08/21/2017	General Plastic Surgery/ General Hospital	6-125	Complete	ASTM	E1965-98 (Reapproved 2016)	Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
08/21/2017	General Plastic Surgery/ General Hospital	6-400	Complete	ASTM	F3212-16(2023)	Standard Test Method for Coring Testing of Huber Needles
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)]
12/20/2021	General Plastic Surgery/ General Hospital	6-470	Complete	USP-NF	M99660_03_01	<871> Sutures - Needle Attachment
12/20/2021	General Plastic Surgery/ General Hospital	6-472	Complete	USP-NF	M36660_04_01	Heparin Lock Flush Solution
12/20/2021	General Plastic Surgery/ General Hospital	6-473	Complete	USP-NF	M80190_04_01	Absorbable Surgical Suture
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
08/14/2015	General Plastic Surgery/ General Hospital	6-185	Complete	ASTM	F881-94 (Reapproved 2014)	Standard Specification for Silicone Elastomer Facial Implants
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
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
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	6-382	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
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
12/19/2022	General Plastic Surgery/ General Hospital	6-483	Complete	IEC	60601-2-35 Edition 2.0 2020-09	Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads and mattresses and intended for heating in medical use
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
12/23/2019	General Plastic Surgery/ General Hospital	6-427	Complete	ASTM	F2101-19	Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
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
05/29/2023	General Plastic Surgery/ General Hospital	6-486	Complete	ISO	10535 Third edition 2021-10	Assistive products - Hoists for the transfer of disabled persons - Requirements and test methods
12/20/2021	General Plastic Surgery/ General Hospital	6-464	Complete	ISO	11040-4 Third edition 2015-04-01	Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling [Including AMENDMENT 1 (2020)]
12/20/2021	General Plastic Surgery/ General Hospital	6-466	Complete	USP-NF	M76070_03_01	Sodium Chloride Injection
12/23/2019	General Plastic Surgery/ General Hospital	6-437	Complete	ISO	23907-2 First edition 2019-11	Sharps injury protection - Requirements and test methods - Part 2: Reusable sharps containers.
07/15/2019	General Plastic Surgery/ General Hospital	6-423	Complete	IEC	60601-2-6 Edition 2.1 2016-04	CONSOLIDATED VERSION Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
05/30/2022	General Plastic Surgery/ General Hospital	6-481	Complete	ANSI AAMI	CN27:2021	General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
05/30/2022	General Plastic Surgery/ General Hospital	6-482	Complete	AAMI	TIR101:2021	Fluid delivery performance testing for infusion pumps
05/30/2022	General Plastic Surgery/ General Hospital	6-477	Complete	ISO	11608-3:2022	Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths
05/30/2022	General Plastic Surgery/ General Hospital	6-475	Complete	ISO	11608-4:2022	Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics
12/20/2021	General Plastic Surgery/ General Hospital	6-471	Complete	USP-NF	M88880_05_01	Sterile Water for Irrigation
12/19/2022	General Plastic Surgery/ General Hospital	6-484	Complete	ASTM	F3502-22a	Standard Specification for Barrier Face Coverings
05/30/2022	General Plastic Surgery/ General Hospital	6-476	Complete	ISO	11608-2:2022	Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles
12/21/2020	General Plastic Surgery/ General Hospital	6-450	Complete	IEC	60601-2-50 Edition 3.0 2020-09	Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment
06/07/2021	General Plastic Surgery/ General Hospital	6-462	Complete	IEC	60601-2-20 Edition 3.0 2020-09	Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators
06/07/2021	General Plastic Surgery/ General Hospital	6-389	Partial	IEC	60601-2-2 Edition 6.0 2017-03	Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
06/07/2021	General Plastic Surgery/ General Hospital	6-389	Partial	ANSI AAMI IEC	60601-2-2:2017	Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
12/21/2020	General Plastic Surgery/ General Hospital	6-449	Partial	ASTM	F1169-19	Standard Consumer Safety Specification for Full-Size Baby Cribs
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
12/21/2020	General Plastic Surgery/ General Hospital	6-448	Partial	ASTM	F2407-20	Standard Specification for Surgical Gowns Intended for Use in Healthcare Facilities
05/29/2023	General Plastic Surgery/ General Hospital	6-496	Partial	ASTM	F739-20	Standard Test Method for Permeation of Liquids and Gases Through Protective Clothing Materials Under Conditions of Continuous Contact
12/20/2021	General Plastic Surgery/ General Hospital	6-474	Partial	ASTM	F3352-19	Standard Specification for Isolation Gowns Intended for Use in Healthcare Facilities
12/18/2023	General Plastic Surgery/ General Hospital	6-497	Partial	ASTM	D7866-23	Standard Specification for Radiation Attenuating Protective Gloves
07/06/2020	General Plastic Surgery/ General Hospital	6-440	Partial	ASTM	D3578-19(2023)	Standard Specification for Rubber Examination Gloves
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	6-360	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
07/06/2020	General Plastic Surgery/ General Hospital	6-442	Partial	ASTM	D6977-19(2023)	Standard Specification for Polychloroprene Examination Gloves for Medical Application
07/06/2020	General Plastic Surgery/ General Hospital	6-178	Partial	ASTM	D6124-06(2022)	Standard Test Method for Residual Powder on Medical Gloves
07/06/2020	General Plastic Surgery/ General Hospital	6-445	Partial	ASTM	D5250-19(2023)	Standard Specification for Poly(vinyl chloride) Gloves for Medical Application
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	6-361	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
09/17/2018	General Plastic Surgery/ General Hospital	6-408	Partial	ISO	10555-1 Second edition 2013-06-15	Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)]
05/29/2023	General Plastic Surgery/ General Hospital	6-487	Partial	ANSI AAMI	PB70:2022	Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities
07/06/2020	General Plastic Surgery/ General Hospital	6-443	Partial	ASTM	D3577-19	Standard Specification for Rubber Surgical Gloves
07/06/2020	General Plastic Surgery/ General Hospital	6-446	Partial	ASTM	D6319-19(2023)	Standard Specification for Nitrile Examination Gloves for Medical Application
07/06/2020	General Plastic Surgery/ General Hospital	6-444	Complete	ASTM	D7103-19(2023)	Standard Guide for Assessment of Medical Gloves
05/30/2022	General Plastic Surgery/ General Hospital	6-479	Complete	ISO	11608-5:2022	Needle-based injection systems for medical use - Requirements and test methods - Part 5: Automated functions
12/23/2019	General Plastic Surgery/ General Hospital	6-426	Complete	ISO	23907-1 First edition 2019-01	Sharps injury protection - Requirements and test methods - Sharps containers
01/14/2019	InVitro Diagnostics	7-285	Complete	CLSI	M48-A 2nd Edition	Laboratory Detection and Identification of Mycobacteria
07/06/2020	InVitro Diagnostics	7-297	Complete	ISO	TS 20914 First edition 2019-07	Medical laboratories - Practical guidance for the estimation of measurement uncertainty
12/21/2020	InVitro Diagnostics	7-299	Complete	CLSI	POCT14 2nd Edition	Point-of-Care Coagulation Testing and Anticoagulation Monitoring
12/23/2016	InVitro Diagnostics	7-267	Complete	CLSI	C24 4th Edition (Replaces C24-A3)	Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions
05/30/2022	InVitro Diagnostics	7-312	Complete	CLSI	M39 5th Edition	Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data
12/20/2021	InVitro Diagnostics	7-309	Complete	ISO	17099 First edition 2014-11-15	Radiological protection - Performance criteria for laboratories using the cytokinesis block micronucleus (CBMN) assay in peripheral blood lymphocytes for biological dosimetry
12/19/2022	InVitro Diagnostics	7-313	Complete	CLSI	EP27 2nd Edition	Constructing and Interpreting an Error Grid for Quantitative Measurement Procedures
07/09/2014	InVitro Diagnostics	7-48	Complete	CLSI	C60-A	Blood Alcohol Testing in the Clinical Laboratory; Approved Guideline

Recognized Consensus Standards: Medical Devices

Links on this page:

Links on this page: