|
|
|
Date of
Entry
|
Specialty Task
Group Area
|
Recognition
Number
|
Standards
Developing
Organization
|
Standard Designation
Number and Date
|
Title of Standard
|
| 08/21/2017 |
General II (ES/
EMC) |
19-22 |
AAMI |
TIR69:2017/(R2020) |
Technical Information Report Risk management of radio-frequency wireless coexistence for medical devices and systems. |
| 08/21/2017 |
General II (ES/
EMC) |
19-24 |
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) |
19-25 |
IEC |
62485-1 Edition 1.0 2015-04 |
Safety requirements for secondary batteries and battery installations - Part 1: General safety information. |
| 08/21/2017 |
General II (ES/
EMC) |
19-26 |
IEC |
62485-2 Edition 1.0 2010-06 |
Safety requirements for secondary batteries and battery installations - Part 2: Stationary batteries. |
| 08/21/2017 |
General II (ES/
EMC) |
19-27 |
IEC |
62485-3 Edition 2.0 2014-07 |
Safety requirements for secondary batteries and battery installations - Part 3: Traction batteries |
| 08/21/2017 |
General II (ES/
EMC) |
19-28 |
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 |
| 08/21/2017 |
General II (ES/
EMC) |
19-29 |
ANSI IEEE |
C63.27-2017 |
American National Standard for Evaluation of Wireless Coexistence |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-70 |
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 |
ASTM |
E1104-98 (Reapproved 2016) |
Standard Specification for Clinical Thermometer Probe Covers and Sheaths |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-125 |
ASTM |
E1965-98 (Reapproved 2016) |
Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-384 |
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 |
6-385 |
ANSI AAMI IEC |
60601-2-19:2009/(R)2014 & A1:2016 |
Medical Electrical Equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators |
| IEC |
60601-2-19 Edition 2.1 2016-04 |
CONSOLIDATED VERSION Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-386 |
ANSI AAMI IEC |
60601-2-20:2009/A1:2016 |
Medical Electrical Equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators [Including: Erratum (2012) and Amendment 1 (2016)] |
| IEC |
60601-2-20 Edition 2.1 2016-04 |
CONSOLIDATED VERSION Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators [Including: Amendment 1 (2016)] |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-387 |
ANSI AAMI IEC |
60601-2-50:2009/A1:2016 |
Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment [Including: Amendment 1 (2016)] |
| IEC |
60601-2-50 Edition 2.1 2016-04 |
CONSOLIDATED VERSION Medical electrical equipment - Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment [Including: Amendment 1 (2016)] |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-388 |
ANSI AAMI IEC |
60601-2-21:2009/A1:2016 |
Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers [Including: Amendment 1 (2016)] |
| IEC |
60601-2-21 Edition 2.1 2016-04 |
CONSOLIDATED VERSION Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers [Including: Amendment 1 (2016)] |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-390 |
ANSI AAMI IEC |
80601-2-35:2009/A1:2016 |
Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use |
| IEC |
80601-2-35 Edition 2.1 2016-04 |
CONSOLIDATED VERSION Medical electrical equipment-Part - 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use [Including: Amendment 1 (2016)] |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-400 |
ASTM |
F3212-16 |
Standard Test Method for Coring Testing of Huber Needles |
| 08/21/2017 |
InVitro Diagnostics |
7-270 |
CLSI |
I/LA-20 3rd Edition (Replaces I/LA20-A3) |
Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities |
| 08/21/2017 |
InVitro Diagnostics |
7-272 |
CLSI |
C57 1st Edition (Reaffirmed: January 2020) |
Mass Spectrometry for Androgen and Estrogen Measurements in Serum |
| 08/21/2017 |
InVitro Diagnostics |
7-273 |
CLSI |
M58 1st Edition |
Methods for Identification of Cultured Microorganisms Using Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry |
| 08/21/2017 |
Materials |
8-195 |
ASTM |
F2024-10 (Reapproved 2016) |
Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings |
| 08/21/2017 |
Materials |
8-226 |
ASTM |
F603-12 (Reapproved 2020) |
Standard Specification for High-Purity Dense Aluminum Oxide for Medical Application |
| 08/21/2017 |
Materials |
8-333 |
ASTM |
F2393-12 (Reapproved 2020) |
Standard Specification for High-Purity Dense Magnesia Partially Stabilized Zirconia (Mg-PSZ) for Surgical Implant Applications |
| 08/21/2017 |
Materials |
8-428 |
ASTM |
F1581-08 (Reapproved 2020) |
Standard Specification for Composition of Anorganic Bone for Surgical Implants |
| 08/21/2017 |
Materials |
8-447 |
ISO |
5832-3 Fourth edition 2016-10-15 |
Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy |
| 08/21/2017 |
Materials |
8-449 |
ASTM |
F1058-16 |
Standard Specification for Wrought 40Cobalt-20Chromium-16Iron-15Nickel-7Molybdenum Alloy Wire, Strip, and Strip Bar for Surgical Implant Applications (UNS R30003 and UNS R30008) |
| 08/21/2017 |
Materials |
8-451 |
ASTM |
F2214-16 |
Standard Test Methods for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE) |
| 08/21/2017 |
Materials |
8-452 |
ASTM |
F1635-16 |
Standard Test Method for in vitro Degradation Testing of Hydrolytically Degradable Polymer Resins and Fabricated Forms for Surgical Implants |
| 08/21/2017 |
Materials |
8-453 |
ASTM |
F1295-16 |
Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700) |
| 08/21/2017 |
Materials |
8-455 |
ASTM |
F2902-16 |
Standard Guide for Assessment of Absorbable Polymeric Implants |
| 08/21/2017 |
Materials |
8-457 |
ISO |
13175-3 First edition 2012-10-01 |
Implants for surgery -- Calcium phosphates -- Part 3: Hydroxyapatite and beta-tricalcium phosphate bone substitutes |
| 08/21/2017 |
Materials |
8-458 |
ASTM |
G5-14 |
Standard Reference Test Method for Making Potentiodynamic Anodic Polarization Measurements |
| 08/21/2017 |
Materials |
8-459 |
SAE |
/AMS2750 Rev. E 2012-07 |
Pyrometry |
| 08/21/2017 |
Ophthalmic |
10-103 |
ANSI |
Z80.18-2016 (R2021) |
American National Standard for Ophthalmics - Contact Lens Care Products - Vocabulary, Performance Specifications, and Test Methodology |
| 08/21/2017 |
Ophthalmic |
10-104 |
ANSI |
Z80.20-2016 (R2021) |
American National Standard for Ophthalmics - Contact Lenses - Standard Terminology, Tolerances, Measurements and Physicochemical Properties |
| 08/21/2017 |
Orthopedic |
11-175 |
ASTM |
F1582-98 (Reapproved 2016) |
Standard Terminology Relating to Spinal Implants |
| 08/21/2017 |
Orthopedic |
11-242 |
ASTM |
F1839-08 (Reapproved 2016) |
Standard Specification for Rigid Polyurethane Foam for Use as a Standard Material for Testing Orthopaedic Devices and Instruments |
| 08/21/2017 |
Orthopedic |
11-269 |
ASTM |
F2423-11 (Reapproved 2020) |
Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses |
| 08/21/2017 |
Orthopedic |
11-280 |
ASTM |
F2624-12 (Reapproved 2020) |
Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs |
| 08/21/2017 |
Orthopedic |
11-309 |
ASTM |
F116-12 (Reapproved 2016) |
Standard Specification for Medical Screwdriver Bits |
| 08/21/2017 |
Orthopedic |
11-321 |
ASTM |
F2887-17 |
Standard Specification for Total Elbow Prostheses |
| 08/21/2017 |
Radiology |
12-306 |
NEMA |
MS 12-2016 |
Quantification and Mapping of Geometric Distortion for Special Applications |
| 08/21/2017 |
Software/
Informatics |
13-67 |
IEEE ISO |
11073-10418 First edition 2014-03-01 |
Health informatics - Personal health device communication - Part 10418: Device specialization - International Normalized Ratio (INR) monitor [including TECHNICAL CORRIGENDUM 1 (2016)] |
| 08/21/2017 |
Software/
Informatics |
13-88 |
IEEE ISO |
11073-10417 Third edition 2017-04 |
Health informatics - Personal health device communication - Part 10417: Device specialization - Glucose meter |
| 08/21/2017 |
Software/
Informatics |
13-89 |
IEEE ISO |
11073-10406 First edition 2012-12-01 |
Health informatics - Personal health device communication - Part 10406: Device specialization - Basic electrocardiograph (ECG) (1- to 3-lead ECG) |
| 08/21/2017 |
Software/
Informatics |
13-90 |
IEEE |
Std 11073-10417-2015 |
Health Informatics - Personal Health Device Communication, Part 10417: Device Specialization - Glucose Meter |
| 08/21/2017 |
Software/
Informatics |
13-91 |
IEEE ISO |
11073-10419 First edition 2016-06-15 |
Health informatics - Personal health device communication - Part 10419: Device specialization - Insulin pump |
| 08/21/2017 |
Software/
Informatics |
13-92 |
IEEE ISO |
11073-10421 First edition 2012-11-01 |
Health informatics - Personal health device communication - Part 10421: Device specialization - Peak expiratory flow monitor (peak flow) |
| 08/21/2017 |
Software/
Informatics |
13-93 |
IEEE |
Std 11073-10422-2016 |
Health informatics - Personal health device communication, Part 10422: Device Specialization - Urine Analyzer |
| 08/21/2017 |
Software/
Informatics |
13-94 |
IEEE ISO |
11073-10424 First edition 2016-06-15 |
Health informatics - Personal health device communication - Part 10424: Device specialization - Sleep Apnoea Breathing Therapy Equipment (SABTE) [Including TECHNICAL CORRIGENDUM 1 (2018)] |
| 08/21/2017 |
Software/
Informatics |
13-95 |
IEEE ISO |
11073-10425 First edition 2016-06-15 |
Health informatics - Personal health device communication - Part 10425: Device specialization - Continuous glucose monitor (CGM) |
| 08/21/2017 |
Software/
Informatics |
13-96 |
ANSI UL |
2900-1 First Edition 2017 |
Standard for Safety, Standard for Software Cybersecurity Network-Connectable Products, Part 1: General Requirements |
| 08/21/2017 |
Software/
Informatics |
13-97 |
IEC |
82304-1 Edition 1.0 2016-10 |
Health software - Part 1: General requirements for product safety |
| 08/21/2017 |
Sterility |
14-501 |
ASTM |
F1886/F1886M-16 |
Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection |
| 08/21/2017 |
Sterility |
14-502 |
ANSI AAMI ISO |
11138-1:2017 |
Sterilization of health care products - Biological indicators - Part 1: General requirements |
| ISO |
11138-1 Third edition 2017-03 |
Sterilization of health care products - Biological indicators - Part 1: General requirements |
| 08/21/2017 |
Tissue Engineering |
15-49 |
ASTM |
F2027-16 |
Standard Guide for Characterization and Testing of Raw or Starting Materials for Tissue-Engineered Medical Products |
| 12/04/2017 |
Radiology |
12-307 |
AAMI |
RT2:2017 |
Radiation therapy readiness check |
| 12/04/2017 |
Software/
Informatics |
13-98 |
IEC INCITS ISO |
646 Third edition 1991-12-15 (R2018) |
Information technology - IS0 7-bit coded character set for information interchange |
| INCITS ISO IEC |
646:1991[R2018] |
Information technology - IS0 7-bit coded character set for information interchange |
| 12/04/2017 |
Software/
Informatics |
13-99 |
IEC ISO |
15459-2 Third edition 2015-03-01 |
Information technology - Automatic identification and data capture techniques - Unique identification - Part 2: Registration procedures |
| 12/04/2017 |
Software/
Informatics |
13-100 |
IEC ISO |
15459-4 Third edition 2014 Corrected 2016 |
Information technology - Automatic identification and data capture techniques - Unique identification - Part 4: Individual products and product packages |
| 12/04/2017 |
Software/
Informatics |
13-101 |
IEC ISO |
15459-6 Second edition 2014 Corrected 2016 |
Information technology - Automatic identification and data capture techniques - Unique identification - Part 6: Groupings |
| 12/04/2017 |
Software/
Informatics |
13-102 |
IEC |
TR 80001-2-8 Edition 1.0 2016-05 |
Application of risk management for IT-networks incorporating medical devices - Part 2-8: Application guidance - Guidance on standards for establishing the security capabilities identified in IEC TR 80001-2-2 |
| 12/04/2017 |
Software/
Informatics |
13-103 |
IEC |
TR 80001-2-9 Edition 1.0 2017-01 |
Application of risk management for it-networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities |
| 06/07/2018 |
Anesthesiology |
1-129 |
ISO |
5359 Fourth edition 2014-10-01 |
Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases [Including AMENDMENT 1 (2017)] |
| 06/07/2018 |
Anesthesiology |
1-130 |
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)] |
| 06/07/2018 |
Anesthesiology |
1-132 |
ISO |
10079-2 Third Edition 2014-05-01 |
Medical suction equipment - Part 2: Manually powered suction equipment |
| 06/07/2018 |
Anesthesiology |
1-133 |
ISO |
10079-3 Third Edition 2014-05-01 |
Medical suction equipment - Part 3: Suction equipment powered from a vacuum or positive pressure gas source |
| 06/07/2018 |
Anesthesiology |
1-134 |
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 |
1-135 |
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 |
1-136 |
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 |
| 06/07/2018 |
Anesthesiology |
1-137 |
ISO |
18562-4 First edition 2017-03 |
Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate |
| 06/07/2018 |
Biocompatibility |
2-249 |
ISO |
10993-16 Third edition 2017-05 |
Biological evaluation of medical devices - Part 16: Toxicokinetic study design for degradation products and leachables |
| 06/07/2018 |
Biocompatibility |
2-250 |
ASTM |
F756-17 |
Standard Practice for Assessment of Hemolytic Properties of Materials |
| 06/07/2018 |
Cardiovascular |
3-150 |
ANSI AAMI ISO |
7199:2016 |
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators). |
| ISO |
7199 Third edition 2016-11-15 |
Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators). |
| 06/07/2018 |
Dental/
ENT |
4-240 |
ANSI ADA |
Standard No. 128-2015 |
Hydrocolloid Impression Materials |
| ISO |
21563 First edition 2013-08-15 |
Dentistry - Hydrocolloid impression materials |
| 06/07/2018 |
Dental/
ENT |
4-241 |
ANSI ADA |
Standard No. 80-2001 (R2020) |
Dental Materials-Determination of Color Stability |
| ISO |
7491 Second edition 2000-09-01 |
Dental materials - Determination of colour stability |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-214 |
ASTM |
D6355-07 (Reapproved 2017) |
Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-270 |
ASTM |
F1840-10 (Reapproved 2016) |
Standard Terminology for Surgical Suture Needles |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-401 |
ASTM |
D7160-16 |
Standard Practice for Determination of Expiration Dating for Medical Gloves |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-402 |
ASTM |
F1670/F1670M-17 |
Standard Test Method for Resistance of Materials Used in Protective Clothing to Penetration by Synthetic Blood |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-404 |
ISO |
7886-1 Second edition 2017-05 |
Sterile hypodermic syringes for single use - Part 1: Syringes for manual use |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-405 |
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 |
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) |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-407 |
ASTM |
F3186-17 |
Standard Specification for Adult Portable Bed Rails and Related Products |
| 06/07/2018 |
Materials |
8-113 |
ASTM |
F1147-05 (Reapproved 2017)e1 |
Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings |
| 06/07/2018 |
Materials |
8-337 |
ASTM |
F621-12 (Reapproved 2017) |
Standard Specification for Stainless Steel Forgings for Surgical Implants |
| 06/07/2018 |
Materials |
8-356 |
ASTM |
F67-13 (Reapproved 2017) |
Standard Specification for Unalloyed Titanium, for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700) |
| 06/07/2018 |
Materials |
8-463 |
ASTM ISO |
52901 First edition 2017-08 |
Standard Guide for Additive Manufacturing - General Principles - Requirements for Purchased AM Parts |
| 06/07/2018 |
Materials |
8-464 |
ISO |
/TS 10974 Second edition 2018 |
Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device |
| 06/07/2018 |
Nanotechnology |
18-9 |
ISO |
/TR 13014 First edition 2012-05-15 |
Nanotechnologies - Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment [Including CORRIGENDUM 1 (2012)]. |
| 06/07/2018 |
Nanotechnology |
18-10 |
ISO |
29701 First edition 2010-09-15 |
Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test. |
| 06/07/2018 |
Neurology |
17-1 |
AAMI |
NS28:1988/(R) 2015 |
Intracranial pressure monitoring devices |
| 06/07/2018 |
Neurology |
17-15 |
ISO |
14708-3 Second edition 2017-04 |
Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators |
| 06/07/2018 |
Neurology |
17-16 |
IEC |
60601-2-10 Edition 2.1 2016-04 |
Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators |
| 06/07/2018 |
ObGyn/
Gastroenterology/
Urology |
9-114 |
IEC |
60601-2-18: Edition 3.0 2009-08 |
Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment |
| 06/07/2018 |
ObGyn/
Gastroenterology/
Urology |
9-115 |
ISO |
29943-1 First edition 2017-07. |
Condoms -- Guidance on clinical studies -- Part 1: Male condoms, clinical function studies based on self-reports |
| 06/07/2018 |
ObGyn/
Gastroenterology/
Urology |
9-116 |
ISO |
29943-2 First edition 2017-07 |
Condoms -- Guidance on clinical studies -- Part 2: Female condoms, clinical function studies based on self-reports. |
| 06/07/2018 |
Ophthalmic |
10-105 |
ISO |
11979-8 Third edition 2017-04 |
Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements |
| 06/07/2018 |
Ophthalmic |
10-106 |
ISO |
18369-3 Second edition 2017-08 |
Ophthalmic optics - Contact lenses - Part 3: Measurement Methods |
| 06/07/2018 |
Ophthalmic |
10-107 |
ISO |
18369-4 Second edition 2017-08 |
Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials |
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