|
|
|
Date of
Entry
|
Specialty Task
Group Area
|
Recognition
Number
|
Standards
Developing
Organization
|
Standard Designation
Number and Date
|
Title of Standard
|
| 12/21/2020 |
Materials |
8-541 |
ASTM |
F1537-20 |
Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
| 12/21/2020 |
Materials |
8-542 |
ASTM |
F138-19 |
Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) |
| 12/21/2020 |
Materials |
8-543 |
ASTM |
F755-19 |
Standard Specification for Selection of Porous Polyethylene for Use in Surgical Implants |
| 12/21/2020 |
Materials |
8-544 |
ASTM |
F961-20 |
Standard Specification for 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy Forgings for Surgical Implants (UNS R30035) |
| 12/21/2020 |
Materials |
8-545 |
ASTM |
F2977-20 |
Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants |
| 12/21/2020 |
Materials |
8-546 |
ASTM |
F3044-20 |
Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants |
| 12/21/2020 |
Materials |
8-547 |
ASTM |
F629-20 |
Standard Practice for Radiography of Cast Metallic Surgical Implants |
| 12/21/2020 |
Materials |
8-548 |
ASTM ISO |
52915 Third edition 2020-03 |
Specification for additive manufacturing file format (AMF) Version 1.2 |
| 12/21/2020 |
Materials |
8-549 |
ASTM |
F3208-20 |
Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices |
| 12/21/2020 |
Materials |
8-550 |
ASTM |
F2181-20 |
Standard Specification for Wrought Seamless Stainless Steel Tubing for Surgical Implants |
| 12/21/2020 |
Materials |
8-551 |
ASTM |
F2895-20 |
Standard Practice for Digital Radiography of Cast Metallic Implants |
| 12/21/2020 |
Materials |
8-552 |
ASTM |
F3434-20 |
Guide for Additive manufacturing - Installation/Operation and Performance Qualification (IQ/OQ/PQ) of Laser-Beam Powder Bed Fusion Equipment for Production Manufacturing |
| 12/21/2020 |
Materials |
8-553 |
ASTM ISO |
52903-1 First edition 2020-04 |
Additive manufacturing - Material extrusion-based additive manufacturing of plastic materials - Part 1: Feedstock materials |
| 12/21/2020 |
Materials |
8-554 |
ASTM ISO |
TR 52912 First edition 2020-09 |
Additive manufacturing - Design - Functionally graded additive manufacturing |
| 06/07/2021 |
Materials |
8-555 |
ASTM |
F1472-20a |
Standard Specification for Wrought Titanium-6Aluminum-4Vanadium Alloy for Surgical Implant Applications (UNS R56400) |
| 06/07/2021 |
Materials |
8-556 |
ASTM |
F640-20 |
Standard Test Methods for Determining Radiopacity for Medical Use |
| 06/07/2021 |
Materials |
8-557 |
ASTM |
F3268-18a |
Standard Guide for in vitro Degradation Testing of Absorbable Metals |
| 06/07/2021 |
Materials |
8-558 |
ASTM |
F3333-20 |
Standard Specification for Chopped Carbon Fiber Reinforced (CFR) Polyetheretherketone (PEEK) Polymers for Surgical Implant Applications |
| 06/07/2021 |
Materials |
8-559 |
ASTM |
D412-16e1 |
Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension |
| 06/07/2021 |
Materials |
8-560 |
ASTM |
D1415-18 |
Standard Test Method for Rubber Property - International Hardness |
| 06/07/2021 |
Materials |
8-561 |
ASTM ISO |
52950 First edition 2021-01 |
Additive manufacturing - General principles - Overview of data processing |
| 06/07/2021 |
Materials |
8-562 |
ASTM ISO |
52904 First edition 2019-08 |
Additive manufacturing - Process characteristics and performance - Practice for metal powder bed fusion process to meet critical applications |
| 12/20/2021 |
Materials |
8-563 |
ASTM |
F1801-20 |
Standard Practice for Corrosion Fatigue Testing of Metallic Implant Materials |
| 12/20/2021 |
Materials |
8-564 |
ASTM |
F2005-21 |
Standard Terminology for Nickel-Titanium Shape Memory Alloys |
| 12/20/2021 |
Materials |
8-565 |
ASTM |
F2754/F2754M-21 |
Standard Test Method for Measurement of Camber, Cast, Helix and Direction of Helix of Coiled Wire |
| 12/20/2021 |
Materials |
8-566 |
ASTM |
F1813-21 |
Standard Specification for Wrought Titanium - 12 Molybdenum - 6 Zirconium - 2 Iron Alloy for Surgical Implant (UNS R58120) |
| 12/20/2021 |
Materials |
8-567 |
ASTM |
F86-21 |
Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants |
| 12/20/2021 |
Materials |
8-568 |
ASTM |
F1586-21 |
Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675) |
| 12/20/2021 |
Materials |
8-569 |
ASTM |
F648-21 |
Standard Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants |
| 12/20/2021 |
Materials |
8-570 |
ASTM |
F1108-21 |
Standard Specification for Titanium-6Aluminum-4Vanadium Alloy Castings for Surgical Implants (UNS R56406) |
| 12/20/2021 |
Materials |
8-571 |
ASTM |
F2052-21 |
Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment |
| 12/20/2021 |
Materials |
8-572 |
ASTM |
F2565-21 |
Standard Guide for Extensively Irradiation-Crosslinked Ultra-High Molecular Weight Polyethylene Fabricated Forms for Surgical Implant Applications |
| 12/20/2021 |
Materials |
8-573 |
ASTM |
F2695-12(2020) |
Standard Specification for Ultra-High Molecular Weight Polyethylene Powder Blended With Alpha-Tocopherol (Vitamin E) and Fabricated Forms for Surgical Implant Applications |
| 12/20/2021 |
Materials |
8-574 |
ASTM |
F2820-12(2021)e1 |
Standard Specification for Polyetherketoneketone (PEKK) Polymers for Surgical Implant Applications |
| 12/20/2021 |
Materials |
8-575 |
ASTM |
F3160-21 |
Standard Guide for Metallurgical Characterization of Absorbable Metallic Materials for Medical Implants |
| 12/20/2021 |
Materials |
8-576 |
ASTM |
F451-21 |
Standard Specification for Acrylic Bone Cement |
| 12/20/2021 |
Materials |
8-577 |
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 |
ASTM |
F2848-21 |
Standard Specification for Medical-Grade Ultra-High Molecular Weight Polyethylene Yarns |
| 12/20/2021 |
Materials |
8-579 |
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)] |
| 12/20/2021 |
Materials |
8-580 |
IEC |
63145-20-10 Edition 1.0 2019-08 |
Eyewear display -- Part 20-10: Fundamental measurement methods -- Optical properties |
| 12/20/2021 |
Materials |
8-581 |
IEC |
63145-20-20 Edition 1.0 2019-09 |
Eyewear display -- Part 20-20: Fundamental measurement methods -- Image quality |
| 12/20/2021 |
Materials |
8-582 |
IEC |
63145-22-10 Edition 1.0 2020-01 |
Eyewear display -- Part 22-10: Specific measurement methods for AR type -- Optical properties |
| 05/30/2022 |
Materials |
8-583 |
ASTM |
F562-22 |
Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035) |
| 05/30/2022 |
Materials |
8-584 |
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 |
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 |
ASTM |
F2989-21 |
Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications |
| 05/30/2022 |
Materials |
8-587 |
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 |
ASTM |
F560-22 |
Standard Specification for Unalloyed Tantalum for Surgical Implant Applications (UNS R05200, UNS R05400) |
| 05/30/2022 |
Materials |
8-589 |
ASTM |
F1925-22 |
Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants |
| 05/30/2022 |
Materials |
8-590 |
ISO |
TS 17137 Third edition 2021-09 |
Cardiovascular implants and extracorporeal systems - Cardiovascular absorbable implants |
| 05/30/2022 |
Materials |
8-591 |
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 |
ASTM |
F3384-21 |
Standard Specification for Polydioxanone Polymer Resins for Surgical Implants |
| 05/30/2022 |
Materials |
8-593 |
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 |
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 |
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 |
ASTM |
D412-16(2021) |
Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers - Tension |
| 09/09/2008 |
ObGyn/
Gastroenterology/
Urology |
9-7 |
IEC |
61846 First edition 1998-04 |
Ultrasonics - Pressure pulse lithotripters - Characteristics of fields |
| 08/06/2013 |
ObGyn/
Gastroenterology/
Urology |
9-31 |
ANSI AAMI |
ID54:1996/(R)2012 |
Enteral feeding set adapters and connectors |
| 01/27/2015 |
ObGyn/
Gastroenterology/
Urology |
9-45 |
ASTM |
F2528-06 (Reapproved 2014) |
Standard Test Methods for Enteral Feeding Devices with a Retention Balloon |
| 09/17/2018 |
ObGyn/
Gastroenterology/
Urology |
9-67 |
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 |
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 |
ASTM |
D6976-13R18 |
Standard Specification for Rubber Contraceptives - Vaginal Diaphragms |
| 01/30/2014 |
ObGyn/
Gastroenterology/
Urology |
9-86 |
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 |
ISO |
29942 First edition 2011-07-01 |
Prophylatic dams -- Requirements and test methods |
| 01/30/2014 |
ObGyn/
Gastroenterology/
Urology |
9-89 |
ANSI AAMI ISO |
8638:2010 (R2017) |
Cardiovascular implants and Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofilters |
| ISO |
8638 Third edition 2010-07-01 |
Cardiovascular implants and extracorporeal systems -- Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofilters |
| 07/09/2014 |
ObGyn/
Gastroenterology/
Urology |
9-94 |
ISO |
8600-4 Second Edition 2014-03-15 |
Endoscopes - Medical endoscopes and certain accessories - Part 4: Determination of maximum width of insertion portion |
| 10/17/2014 |
ObGyn/
Gastroenterology/
Urology |
9-95 |
CEN |
EN 1615:2000 |
Enteral Feeding Catheters and Enteral Giving Sets for Single Use and their Connectors-Design and Testing |
| 08/14/2015 |
ObGyn/
Gastroenterology/
Urology |
9-108 |
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 |
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 |
ISO |
4074 Third edition 2015-10-15 |
Natural latex rubber condoms - Requirements and test methods |
| 04/04/2016 |
ObGyn/
Gastroenterology/
Urology |
9-113 |
CEN |
EN 1618:1997 |
Catheters other than intravascular catheters - Test methods for common properties |
| 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. |
| 09/17/2018 |
ObGyn/
Gastroenterology/
Urology |
9-117 |
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 |
ANSI AAMI ISO |
8637-1:2017 |
Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
| ISO |
8637-1 First edition 2017-11 |
Extracorporeal systems for blood purification -- Part 1: Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
| 09/17/2018 |
ObGyn/
Gastroenterology/
Urology |
9-119 |
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 |
ASTM |
D3492-16 |
Standard Specification for Rubber Contraceptives (Male Condoms) |
| 01/14/2019 |
ObGyn/
Gastroenterology/
Urology |
9-121 |
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 |
| 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 |
| 01/14/2019 |
ObGyn/
Gastroenterology/
Urology |
9-122 |
ISO |
25841 Third edition 2017-08 |
Female condoms -- Requirements and test methods |
| 12/23/2019 |
ObGyn/
Gastroenterology/
Urology |
9-123 |
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 |
CIE ISO |
11664-1:2019 |
Colorimetry - Part 1: CIE standard colorimetric observers |
| 07/06/2020 |
ObGyn/
Gastroenterology/
Urology |
9-125 |
CIE ISO |
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 |
CIE ISO |
11664-3 First edition 2019-06 |
Colorimetry - Part 3: CIE tristimulus values |
| 07/06/2020 |
ObGyn/
Gastroenterology/
Urology |
9-127 |
CIE ISO |
11664-4 First edition 2019-06 |
Colorimetry - Part 4: CIE 1976 L*a*b* colour space |
| 07/06/2020 |
ObGyn/
Gastroenterology/
Urology |
9-128 |
CIE ISO |
11664-6 First edition 2014-02-01 |
Colorimetry - Part 6: CIEDE2000 colour-difference formula |
| 07/06/2020 |
ObGyn/
Gastroenterology/
Urology |
9-129 |
CIE ISO |
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 |
ISO |
8600-6 Second edition 2020-09 |
Endoscopes - Medical endoscopes and endotherapy devices - Part 6: Vocabulary |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-131 |
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 |
ASTM |
F623-19 |
Standard Performance Specification for Foley Catheter |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-133 |
ANSI AAMI ISO |
23500-1:2019 |
Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements |
| ISO |
23500-1 First edition 2019-02 |
Preparation and Quality Management of Fluids for Haemodialysis and Related Therapies - Part 1: General Requirements |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-134 |
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 |
| 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 |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-135 |
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 |
| 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 |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-136 |
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 |
| 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 |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-137 |
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 |
| 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 |
| 06/07/2021 |
ObGyn/
Gastroenterology/
Urology |
9-138 |
ISO |
20695 First edition 2020-03 |
Enteral feeding systems - Design and testing |
| 05/30/2022 |
ObGyn/
Gastroenterology/
Urology |
9-139 |
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 |
ANSI AAMI ISO |
8637-2:2018 |
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters |
| ISO |
8637-2 First Edition 2018-07 |
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood circuit for hemodialyzers, hemodiafilters and hemofilters |
| 12/19/2022 |
ObGyn/
Gastroenterology/
Urology |
9-141 |
ISO |
8637-3 First Edition 2018-07 |
Extracorporeal systems for blood purification - Part 3: Plasmafilters |
| 12/19/2022 |
ObGyn/
Gastroenterology/
Urology |
9-142 |
ASTM |
D1894-14 |
Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting |
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