|
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)
|
12/20/2021 |
Materials |
8-575 |
Complete |
ASTM |
F3160-21 |
Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants |
12/20/2021 |
Materials |
8-576 |
Complete |
ASTM |
F451-21 |
Standard Specification for Acrylic Bone Cement |
12/20/2021 |
Materials |
8-577 |
Complete |
ISO |
13179-1 Second Edition 2021-09 |
Implants for surgery -- Coatings on metallic surgical implants -- Part 1: Plasma-sprayed coatings derived from titanium or titanium-6 aluminum-4 vanadium alloy powders |
12/20/2021 |
Materials |
8-578 |
Complete |
ASTM |
F2848-21 |
Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns |
12/20/2021 |
Materials |
8-579 |
Complete |
ISO |
13779-3 Second Edition 2018-12 |
Implants for surgery -- Hydroxyapatite -- Part 3: Chemical analysis and characterization of crystallinity ratio and phase purity [Including AMENDMENT 1 (2021)] |
05/30/2022 |
Materials |
8-583 |
Complete |
ASTM |
F562-22 |
Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035) |
05/30/2022 |
Materials |
8-584 |
Complete |
ASTM |
F2146-22 |
Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320) |
05/30/2022 |
Materials |
8-585 |
Complete |
ASTM |
F1377-21 |
Standard Specification for Cobalt-28Chromium-6Molybdenum Powder for Medical Devices (UNS R30075, UNS R31537, and UNS R31538) |
05/30/2022 |
Materials |
8-586 |
Complete |
ASTM |
F2989-21 |
Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications |
05/30/2022 |
Materials |
8-587 |
Complete |
ISO |
5832-3 Fifth Edition 2021-11 |
Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy |
05/30/2022 |
Materials |
8-588 |
Complete |
ASTM |
F560-22 |
Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400) |
05/30/2022 |
Materials |
8-589 |
Complete |
ASTM |
F1925-22 |
Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants |
05/30/2022 |
Materials |
8-590 |
Complete |
ISO |
TS 17137 Third edition 2021-09 |
Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants |
05/30/2022 |
Materials |
8-591 |
Complete |
ASTM |
F2229-21 |
Standard Specification for Wrought, Nitrogen Strengthened 23Manganese-21Chromium-1Molybdenum Low-Nickel Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S29108) |
05/30/2022 |
Materials |
8-592 |
Complete |
ASTM |
F3384-21 |
Standard Specification for Polydioxanone Polymer Resins for Surgical Implants |
05/30/2022 |
Materials |
8-593 |
Complete |
ISO |
13779-6 First Edition 2015-01-15 Corrected Version 2016-09-15 |
Implants for surgery - Hydroxyapatite - Part 6: Powders |
12/19/2022 |
Materials |
8-594 |
Complete |
ISO |
5832-6 Third Edition 2022-03 |
Implants for surgery -- Metallic materials -- Part 6:Wrought cobalt-nickel-chromium-molybdenum alloy |
12/19/2022 |
Materials |
8-595 |
Complete |
ISO |
5832-5 Fourth Edition 2022-03 |
Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel |
12/19/2022 |
Materials |
8-596 |
Complete |
ASTM |
D412-16(2021) |
Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension |
05/29/2023 |
Materials |
8-597 |
Complete |
ASTM |
F2003-02(2022) |
Standard Practice for Accelerated Aging of Ultra-High Molecular Weight Polyethylene after Gamma Irradiation in Air |
05/29/2023 |
Materials |
8-598 |
Complete |
ASTM |
F3109-22 |
Standard Test Method for Verification of Multi-Axis Force Measuring Platforms |
05/29/2023 |
Materials |
8-599 |
Complete |
ASTM |
F1295-22 |
Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700) |
05/29/2023 |
Materials |
8-600 |
Complete |
ASTM |
F1978-22 |
Standard Test Method for Measuring Abrasion Resistance of Metallic Thermal Spray Coatings by Using the Taber Abraser |
05/29/2023 |
Materials |
8-601 |
Complete |
ASTM |
F2516-22 |
Standard Test Method for Tension Testing of Nickel-Titanium Superelastic Materials |
05/29/2023 |
Materials |
8-602 |
Complete |
ASTM |
F2503-23 |
Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment |
05/29/2023 |
Materials |
8-603 |
Complete |
ASTM |
F1472-23 |
Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400) |
05/29/2023 |
Materials |
8-604 |
Complete |
ASTM |
F2257-22 |
Standard Specification for Wrought Seamless or Welded and Drawn 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Small Diameter Tubing for Surgical Implants (UNS S31673) |
12/18/2023 |
Materials |
8-605 |
Complete |
ASTM |
F1609-23 |
Standard Specification for Calcium Phosphate Coatings for Implantable Materials |
12/18/2023 |
Materials |
8-606 |
Complete |
ASTM |
F2537-23 |
Standard Practice for Calibration of Linear Displacement Sensor Systems Used to Measure Micromotion |
12/18/2023 |
Materials |
8-607 |
Complete |
ASTM |
F2082/F2082M-23 |
Determination of Transformation Temperature of Nickel-Titanium Shape Memory Alloys by Bend and Free Recovery |
12/18/2023 |
Materials |
8-608 |
Complete |
ASTM |
F2214-23 |
Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE) |
12/18/2023 |
Materials |
8-609 |
Complete |
ASTM |
F2026-23 |
Standard Specification for Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
12/18/2023 |
Materials |
8-610 |
Complete |
ASTM |
F601-23 |
Standard Practice for Fluorescent Penetrant Inspection of Metallic Surgical Implants |
05/29/2024 |
Materials |
8-611 |
Complete |
ISO |
9584 Second edition 2023-10 |
Implants for surgery - Non-destructive testing - Radiographic examination of cast metallic surgical implants |
05/29/2024 |
Materials |
8-612 |
Complete |
ASTM |
F899-23 |
Standard Specification for Wrought Stainless Steels for Surgical Instruments |
05/29/2024 |
Materials |
8-613 |
Complete |
ASTM |
F2527-24 |
Standard Specification for Wrought Seamless and Welded and Drawn Cobalt Alloy Small Diameter Tubing for Surgical Implants |
05/29/2024 |
Materials |
8-614 |
Complete |
ASTM |
F3456-22 |
Standard Guide for Powder Reuse Schema in Powder Bed Fusion Processes for Medical Applications for Additive Manufacturing Feedstock Materials |
05/29/2024 |
Materials |
8-615 |
Complete |
ISO ASTM |
52926-1 First edition 2023-11 |
Additive manufacturing of metals - Qualification principles - Part 1: General qualification of operators |
05/29/2024 |
Materials |
8-616 |
Complete |
ISO ASTM |
52926-2 First edition 2023-11 |
Additive manufacturing of metals - Qualification principles - Part 2: Qualification of operators for PBF-LB |
05/29/2024 |
Materials |
8-617 |
Complete |
ISO ASTM |
52926-3 First edition 2023-11 |
Additive manufacturing of metals - Qualification principles - Part 3: Qualification of operators for PBF-EB |
12/23/2024 |
Materials |
8-618 |
Complete |
ASTM |
F1350-24 |
Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Surgical Fixation Wire (UNS S31673) |
12/23/2024 |
Materials |
8-619 |
Complete |
ISO |
5832-4 Fourth edition 2024-04 |
Implants for surgery - Metallic materials - Part 4: Cobalt-chromium-molybdenum casting alloy |
12/23/2024 |
Materials |
8-620 |
Complete |
ISO |
5832-11 Third edition 2024-03 |
Implants for surgery - Metallic materials - Part 11: Wrought titanium 6-aluminium 7-niobium alloy |
12/23/2024 |
Materials |
8-621 |
Complete |
ISO |
5832-1 Sixth edition 2024-04 |
Implants for surgery - Metallic materials - Part 1: Wrought stainless steel |
12/23/2024 |
Materials |
8-622 |
Complete |
ASTM |
F2004-24 |
Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis |
12/23/2024 |
Materials |
8-623 |
Complete |
ASTM |
F1314-24 |
Standard Specification for Wrought Nitrogen Strengthened 22Chromium-13Nickel-5Manganese-2.5Molybdenum Stainless Steel Alloy Bar and Wire for Surgical Implants (UNS S20910) |
12/23/2024 |
Materials |
8-624 |
Complete |
ASTM |
F2129-24 |
Standard Test Method for Conducting Cyclic Potentiodynamic Polarization Measurements to Determine the Corrosion Susceptibility of Small Implant Devices |
12/23/2024 |
Materials |
8-625 |
Complete |
ASTM |
F1295-24 |
Standard Specification for Wrought Titanium-6 Aluminum-7Niobium Alloy for Surgical Implant Applications (UNS R56700) |
12/23/2024 |
Materials |
8-626 |
Complete |
ASTM |
E2948-24 |
Standard Test Method for Conducting Rotating Bending Fatigue Tests of Solid Round Fine Wire |
12/23/2024 |
Materials |
8-627 |
Complete |
ASTM |
F3604-23 |
Standard Practice for Validating the Additive Manufacturing (AM) Production Process for Medical Devices Produced Using Laser Powder Bed Fusion. |
09/09/2008 |
ObGyn/ Gastroenterology/ Urology |
9-7 |
Complete |
IEC |
61846 First edition 1998-04 |
Ultrasonics - Pressure pulse lithotripters - Characteristics of fields |
08/06/2013 |
ObGyn/ Gastroenterology/ Urology |
9-31 |
Complete |
ANSI AAMI |
ID54:1996/(R)2012 |
Enteral feeding set adapters and connectors |
01/27/2015 |
ObGyn/ Gastroenterology/ Urology |
9-45 |
Complete |
ASTM |
F2528-06(2023) |
Standard Test Methods for Enteral Feeding Devices with a Retention Balloon |
09/17/2018 |
ObGyn/ Gastroenterology/ Urology |
9-67 |
Complete |
ASTM |
D7661-10 (Reapproved 2017) |
Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms |
01/14/2019 |
ObGyn/ Gastroenterology/ Urology |
9-68 |
Complete |
ISO |
23409 First edition 2011-02-15 |
Male Condoms - Requirements and test methods for condoms made from synthetic materials |
01/30/2014 |
ObGyn/ Gastroenterology/ Urology |
9-85 |
Complete |
ASTM |
D6976-13R18 |
Standard Specification for Rubber Contraceptives - Vaginal Diaphragms |
01/30/2014 |
ObGyn/ Gastroenterology/ Urology |
9-86 |
Complete |
ISO |
16037 First edition 2002-05-15 (Amendment 1 2011-02-15) |
Rubber condoms for clinical trials - Measurement of physical properties [Including: Amendment (2011)] |
01/30/2014 |
ObGyn/ Gastroenterology/ Urology |
9-88 |
Complete |
ISO |
29942 First edition 2011-07-01 |
Prophylatic dams -- Requirements and test methods |
07/09/2014 |
ObGyn/ Gastroenterology/ Urology |
9-94 |
Complete |
ISO |
8600-4 Second Edition 2014-03-15 |
Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion |
08/14/2015 |
ObGyn/ Gastroenterology/ Urology |
9-108 |
Complete |
ISO |
8009 Second edition 2014-11-15 |
Mechanical contraceptives - Reusable natural and silicone rubber contraceptive diaphragms - Requirements and tests |
04/04/2016 |
ObGyn/ Gastroenterology/ Urology |
9-110 |
Complete |
ISO |
8600-1 Fourth Edition 2015-10-15 |
Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements |
01/14/2019 |
ObGyn/ Gastroenterology/ Urology |
9-111 |
Complete |
ISO |
4074 Third edition 2015-10-15 |
Natural latex rubber condoms - Requirements and test methods |
06/07/2018 |
ObGyn/ Gastroenterology/ Urology |
9-114 |
Complete |
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 |
Complete |
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 |
Complete |
ISO |
29943-2 First edition 2017-07 |
Condoms -- Guidance on clinical studies -- Part 2: Female condoms, clinical function studies based on self-reports. |
09/17/2018 |
ObGyn/ Gastroenterology/ Urology |
9-117 |
Complete |
ISO |
16038 Second edition 2017-11 |
Male condoms - Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms |
09/17/2018 |
ObGyn/ Gastroenterology/ Urology |
9-118 |
Partial |
ISO |
8637-1 First edition 2017-11 |
Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
ANSI AAMI ISO |
8637-1:2017 |
Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
09/17/2018 |
ObGyn/ Gastroenterology/ Urology |
9-119 |
Complete |
IEC |
60601-2-36 Edition 2.0 2014-04 |
Medical electrical equipment - Part 2-36: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy |
09/17/2018 |
ObGyn/ Gastroenterology/ Urology |
9-120 |
Complete |
ASTM |
D3492-16 |
Standard Specification for Rubber Contraceptives (Male Condoms) |
01/14/2019 |
ObGyn/ Gastroenterology/ Urology |
9-121 |
Complete |
IEC |
60601-2-16 Edition 5.0 2018-4 |
Medical electrical equipment - Part 2-16: Particular requirements for the basic safety and essential performance of haemodialysis, haemodiafiltration and haemonfiltration equipment |
ANSI AAMI IEC |
60601-2-16:2018 |
Medical electrical equipment - Part 2-16: Particular requirements for basic safety and essential performance of haemodialysis, haemodiafiltration and haemofiltration equipment |
01/14/2019 |
ObGyn/ Gastroenterology/ Urology |
9-122 |
Complete |
ISO |
25841 Third edition 2017-08 |
Female condoms -- Requirements and test methods |
12/23/2019 |
ObGyn/ Gastroenterology/ Urology |
9-123 |
Partial |
ISO |
8600-3 Second edition 2019-08 |
Endoscopes - Medical endoscopes and endotherapy devices Part 3: Determination of field of view and direction of view of endoscopes with optics. |
07/06/2020 |
ObGyn/ Gastroenterology/ Urology |
9-124 |
Complete |
CIE ISO |
11664-1:2019 |
Colorimetry - Part 1: CIE standard colorimetric observers |
07/06/2020 |
ObGyn/ Gastroenterology/ Urology |
9-125 |
Complete |
ISO CIE |
11664-2 S 014-2/E First edition 2007-10-15 Corrected version 2008-11-01 |
Colorimetry - Part 2: CIE standard illuminants |
07/06/2020 |
ObGyn/ Gastroenterology/ Urology |
9-126 |
Complete |
ISO CIE |
11664-3 First edition 2019-06 |
Colorimetry - Part 3: CIE tristimulus values |
07/06/2020 |
ObGyn/ Gastroenterology/ Urology |
9-127 |
Complete |
ISO CIE |
11664-4 First edition 2019-06 |
Colorimetry - Part 4: CIE 1976 L*a*b* colour space |
07/06/2020 |
ObGyn/ Gastroenterology/ Urology |
9-128 |
Complete |
ISO CIE |
11664-6 First edition 2014-02-01 |
Colorimetry - Part 6: CIEDE2000 colour-difference formula |
07/06/2020 |
ObGyn/ Gastroenterology/ Urology |
9-129 |
Complete |
ISO CIE |
61966-2-1 First edition 1999-10 |
Multimedia systems and equipment - Colour measurement and management - Part 2-1: Colour management - Default RGB colour space - sRGB [Including: Amendment 1 (2003) and Corrigendum 1 (2014)] |
12/21/2020 |
ObGyn/ Gastroenterology/ Urology |
9-130 |
Complete |
ISO |
8600-6 Second edition 2020-09 |
Endoscopes - Medical endoscopes and endotherapy devices - Part 6: Vocabulary |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-131 |
Complete |
ISO |
8600-5 Second Edition 2020-10 |
Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-132 |
Complete |
ASTM |
F623-19 |
Standard Performance Specification for Foley Catheter |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-133 |
Partial |
ISO |
23500-1 First edition 2019-02 |
Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements |
ANSI AAMI ISO |
23500-1:2019 |
Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-134 |
Complete |
ISO |
23500-2 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies |
ANSI AAMI ISO |
23500-2:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 2: Water treatment equipment for haemodialysis applications and related therapies |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-135 |
Complete |
ISO |
23500-3 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies |
ANSI AAMI ISO |
23500-3:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 3: Water for haemodialysis and related therapies |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-136 |
Complete |
ISO |
23500-4 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies |
ANSI AAMI ISO |
23500-4:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 4: Concentrates for haemodialysis and related therapies |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-137 |
Complete |
ISO |
23500-5 First edition 2019-02 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies |
ANSI AAMI ISO |
23500-5:2019 |
Preparation and quality management of fluids for haemodialysis and related therapies - Part 5: Quality of dialysis fluid for haemodialysis and related therapies |
06/07/2021 |
ObGyn/ Gastroenterology/ Urology |
9-138 |
Complete |
ISO |
20695 First edition 2020-03 |
Enteral feeding systems - Design and testing |
05/30/2022 |
ObGyn/ Gastroenterology/ Urology |
9-139 |
Complete |
CIE ISO |
11664-5:2016 |
Colorimetry - Part 5: CIE 1976 L*u*v* colour space and u',v' uniform chromaticity scale diagram |
12/19/2022 |
ObGyn/ Gastroenterology/ Urology |
9-140 |
Partial |
ISO |
8637-2 First Edition 2018-07 |
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters |
ANSI AAMI ISO |
8637-2:2018 |
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters |
12/19/2022 |
ObGyn/ Gastroenterology/ Urology |
9-141 |
Complete |
ISO |
8637-3 First Edition 2018-07 |
Extracorporeal systems for blood purification - Part 3: Plasmafilters |
12/19/2022 |
ObGyn/ Gastroenterology/ Urology |
9-142 |
Complete |
ASTM |
D1894-14 |
Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting |
05/29/2023 |
ObGyn/ Gastroenterology/ Urology |
9-143 |
Partial |
ISO |
20696 First edition 2018-06; Corrected 2019-12 |
Sterile urethral catheters for single use |
12/19/2022 |
ObGyn/ Gastroenterology/ Urology |
9-144 |
Complete |
ISO |
20697 First edition 2018-06; Corrected 2018-09 |
Sterile drainage catheters and accessory devices for single use |
05/29/2023 |
ObGyn/ Gastroenterology/ Urology |
9-145 |
Complete |
ASTM |
D7661-18 |
Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms |
05/29/2023 |
ObGyn/ Gastroenterology/ Urology |
9-146 |
Complete |
ISO |
8600-4 Third Edition 2023-01 |
Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion |
05/29/2023 |
ObGyn/ Gastroenterology/ Urology |
9-147 |
Complete |
ISO CIE |
11664-2 First edition 2022-08 |
Colorimetry - Part 2: CIE standard illuminants |
05/29/2023 |
ObGyn/ Gastroenterology/ Urology |
9-148 |
Complete |
ISO CIE |
11664-6 Second edition 2022-08 |
Colorimetry - Part 6: CIEDE2000 colour-difference formula |
05/29/2023 |
ObGyn/ Gastroenterology/ Urology |
9-149 |
Complete |
IEC |
60601-2-39 Edition 3.0 2018-04 |
Medical electrical equipment Part 2-39: Particular requirements for basic safety and essential performance of peritoneal dialysis equipment
|
12/18/2023 |
ObGyn/ Gastroenterology/ Urology |
9-150 |
Complete |
ISO |
7439 Fourth edition 2023-04 |
Copper-bearing contraceptive intrauterine devices - Requirements and tests |
12/19/2007 |
Ophthalmic |
10-39 |
Complete |
ISO |
12865 Second edition 2006-07-01 |
Ophthalmic instruments - Retinoscopes |