|
Date of Entry
|
Specialty Task Group Area
|
Recognition Number
|
Standards Developing Organization
|
Standard Designation Number and Date
|
Title of Standard |
01/30/2014 |
Materials |
8-351 |
ISO |
5832-12 Second edition 2007-05-01 |
Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy [Including: Technical Corrigedum 1 (2008)] |
01/30/2014 |
Materials |
8-352 |
ISO |
5834-1 Third edition 2005-06-01 |
Implants for surgery - Ultra-high-molecular-weight polyethylene - Part 1: Powder form [Including: Technical Corrigendum 1 (2007)] |
01/30/2014 |
Materials |
8-353 |
ASTM |
F86-13 |
Standard Practice for Surface Preparation and Marking of Metallic Surgical Implants |
01/30/2014 |
Materials |
8-354 |
ASTM |
F1377-13 |
Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075) |
01/30/2014 |
Materials |
8-355 |
ASTM |
F1586/F1586M-13 |
Standard Specification for Wrought Nitrogen Strengthened 21 Chromium-10 Nickel-3 Manganese-2.5 Molybdenum Stainless Steel Bar for Surgical Implants (UNS S31675) |
01/30/2014 |
Materials |
8-358 |
ASTM |
F1855-00 (Reapproved 2019) |
Standard Specification for Polyoxymethylene (Acetal) for Medical Applications |
01/30/2014 |
Materials |
8-359 |
ASTM |
F2038-00 (Reapproved 2011) |
Standard Guide for Silicone Elastomers, Gels, and Foams Used in Medical Applications - Part 1: Formulations and Uncured Materials |
01/30/2014 |
Materials |
8-362 |
ASTM |
F2989-13 |
Standard Specification for Metal Injection Molded Unalloyed Titanium Components for Surgical Implant Applications |
01/30/2014 |
Neurology |
17-12 |
ISO |
7197 Third edition 2006-06-01 |
Neurosurgical Implants - Sterile, single-use hydrocephalus shunts and components [Including: Technical Corrigendum 1 (2007)] |
01/30/2014 |
ObGyn/ Gastroenterology/ Urology |
9-85 |
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/(R)2015 |
Cardiovascular implants and Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofilters |
ISO |
8638 Third edition 2010-07-01 |
Cadiovascular implants and extracorporeal blood circuit for hemodialyzers, hemodialfilters, and hemofilters |
01/30/2014 |
Ophthalmic |
10-81 |
ISO |
11979-7 Second edition 2006-05-01 |
Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations [Including: Amendment 1 (2012)] |
01/30/2014 |
Ophthalmic |
10-87 |
ASTM |
D882-12 |
Standard Test Methods for Tensile Properties of Thin Plastic Sheeting |
01/30/2014 |
Ophthalmic |
10-88 |
ASTM |
D790-10 |
Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials |
01/30/2014 |
Orthopedic |
11-74 |
ISO |
5838-2 First edition 1991-01-15 |
Implants for surgery -- Skeletal pins and wires -- Part 2: Steinmann skeletal pins -- Dimensions |
01/30/2014 |
Orthopedic |
11-75 |
ISO |
5838-3 First edition 1993-09-15 |
Implants for surgery -- Skeletal pins and wires -- Part 3: Kirschner skeletal wires |
01/30/2014 |
Orthopedic |
11-83 |
ISO |
13402 First edition 1995-08-01 |
Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure |
01/30/2014 |
Orthopedic |
11-232 |
ISO |
7207-1 Third edition 2007-02-01 |
Implants for surgery - Components for partial and total knee joint prostheses - Part 1: Classification, definitions and designation of dimensions |
01/30/2014 |
Orthopedic |
11-238 |
ASTM |
F2033-12 |
Standard Specification for Total Hip Joint Prosthesis and Hip Endoprosthesis Bearing Surfaces Made of Metallic, Ceramic, and Polymeric Materials |
01/30/2014 |
Orthopedic |
11-239 |
ASTM |
F2345-03 (Reapproved 2013) |
Standard Test Methods for Determination of Static and Cyclic Fatigue Strength of Ceramic Modular Femoral Heads |
01/30/2014 |
Orthopedic |
11-258 |
ASTM |
F2083-12 |
Standard Specification for Total Knee Prosthesis |
01/30/2014 |
Orthopedic |
11-264 |
ASTM |
F1820-13 |
Standard Test Method for Determining the Forces for Disassembly of Modular Acetublar Devices |
01/30/2014 |
Orthopedic |
11-270 |
ASTM |
F2502-11 |
Standard Specification and Test Methods for Methods for Absorbable Plates and Screws for Internal Fixation Implants |
01/30/2014 |
Orthopedic |
11-274 |
ISO |
18192-2 First edition 2010-06-15 |
Implants for surgery - Wear of total intervertebral spinal disc prostheses - Part 2: Nucleus replacements |
01/30/2014 |
Physical Medicine |
16-25 |
ISO |
7176-13 First edition 1989-08-01 |
Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces |
01/30/2014 |
Physical Medicine |
16-27 |
ISO |
7176-15 First edition 1996-11-15 |
Wheelchairs - Part 15: Requirements for information disclosure, documentation and labeling |
01/30/2014 |
Physical Medicine |
16-162 |
ISO |
7176-4 Third edition 2008-10-01 |
Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range |
01/30/2014 |
Physical Medicine |
16-163 |
ISO |
7176-5 Second edition 2008-06-01 |
Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space |
01/30/2014 |
Physical Medicine |
16-164 |
ISO |
7176-10 Second edition 2008-11-01 |
Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs |
01/30/2014 |
Physical Medicine |
16-165 |
ISO |
7176-14 Second edition 2008-02-15 |
Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods |
01/30/2014 |
Physical Medicine |
16-166 |
ISO |
7176-21 Second edition 2009-04-01 |
Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers |
01/30/2014 |
Physical Medicine |
16-167 |
ISO |
7176-9 Third edition 2009-11-15 |
Wheelchairs - Part 9: Climatic tests for electric wheelchairs |
01/30/2014 |
Radiology |
12-59 |
IEC |
61168:1993 |
Radiotherapy simulators - Functional performance characteristics |
01/30/2014 |
Radiology |
12-228 |
IEC |
61391-2 Edition 1.0 2010-01 |
Ultrasonics - Pulse-echo scanners - Part 2: Measurement of maximum depth of penetration and local dynamic range |
01/30/2014 |
Radiology |
12-259 |
IEC |
61674 Edition 2.0 2012-11 |
Medical electrical equipment -- Dosimeters with ionization chambers and/or semiconductor detectors as used in X-ray diagnostic imaging |
01/30/2014 |
Radiology |
12-260 |
IEC |
60336 Fourth edition 2005-04 |
Medical electrical equipment - X-ray tube assemblies for medical diagnosis - Characteristics of focal spots [Including: Technical Corrigendum 1 (2006)] |
01/30/2014 |
Radiology |
12-261 |
IEC ISO |
10918-1 First edition 1994-02-15 |
Information technology - Digital compression and coding of continuous-tone still images: Requirements and guidelines [Including: Technical Corrigendum 1 (2005)] |
01/30/2014 |
Radiology |
12-262 |
ISO |
11670 Second edition 2003-04-01 |
Lasers and laser-related equipment - Test methods for laser beam parameters - Beam positional stability [Including: Technical Corrigendum 1 (2004)] |
01/30/2014 |
Radiology |
12-264 |
NEMA |
MS 11-2010 |
Determination of Gradient-Induced Electric Fields in Diagnostic Magnetic Resonance Imaging |
01/30/2014 |
Radiology |
12-266 |
IEC |
61689 Edition 3.0 2013-02 |
Ultrasonics - Physiotherapy systems - Field specifications and methods of measurement in the frequency range 0.5 MHz to 5 MHz |
01/30/2014 |
Radiology |
12-267 |
IEC |
61217 Edition 2.0 2011-12 |
Radiotherapy equipment - Coordinates, movements, and scales |
01/30/2014 |
Radiology |
12-270 |
IEC |
61223-3-5 First edition 2004-08 |
Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2006)] |
01/30/2014 |
Software/ Informatics |
13-63 |
ANSI AAMI IEC |
TIR 80001-2-4:2012 |
Application of risk management for IT-networks incorporating medical devices - Part 2-4: General implementation guidance for healthcare delivery organizations |
IEC |
TR 80001-2-4 Edition 1.0 2012-11 |
Application of risk management for IT-networks incorporating medical devices -- Part 2-4: Application guidance - General implementation guidance for healthcare delivery organization |
01/30/2014 |
Sterility |
14-334 |
ANSI AAMI ISO |
15882:2008/(R)2013 |
Sterilization of health care products - Chemical indicators - Guidance for selection, use, and interpretation of results |
ISO |
15882 Second edition 2008-09-01 |
Sterilization of health care products - Chemical indicators - Guidance for selection, use and interpretation of results |
01/30/2014 |
Sterility |
14-336 |
ANSI AAMI ISO |
14161-2009/(R)2014 |
Sterilization of health care products - Biological indicators: Guidance for the selection, use and interpretation of results |
ISO |
14161 Second edition 2009-09-15 |
Sterilization of health care products - Biological indicators - Guidance for the selection, use and interpretation of results |
01/30/2014 |
Sterility |
14-395 |
ISO |
14698-2 First edition 2003-09-15 |
Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 2: Evaluation and Interpretation of Biocontamination Data [Including: Technical Corrigendum 1 (2004)] |
01/30/2014 |
Sterility |
14-397 |
AOAC |
6.2.04:2013 |
Official Method 955.15, Testing Disinfectants Against Staphylococcus aureus,Use-Dilution Method |
01/30/2014 |
Sterility |
14-398 |
AOAC |
6.3.05:2013 |
Official Method 966.04, Sporicidal Activity of Disinfectants Method I |
01/30/2014 |
Sterility |
14-399 |
AOAC |
6.3.06:2012 |
Official Method 965.12 Tuberculocidal Activity of Disinfectants |
01/30/2014 |
Sterility |
14-400 |
ASTM |
F2203-13 (Reapproved 2018) |
Standard Test Method for Linear Measurement Using Precision Steel Rule |
01/30/2014 |
Sterility |
14-401 |
ASTM |
F2217/F2217M-13 (Reapproved 2018) |
Standard Practice for Coating/Adhesive Weight Determination |
01/30/2014 |
Sterility |
14-402 |
ASTM |
F1140/F1140M-13 (Reapproved 2020)e1 |
Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages |
01/30/2014 |
Sterility |
14-403 |
ASTM |
F2054/F2054M-13 (Reapproved 2020) |
Standard Test Method for Burst Testing of Flexible Package Seals Using Internal Air Pressurization Within Restraining Plates |
01/30/2014 |
Sterility |
14-404 |
ASTM |
F2250-13 (Reapproved 2018) |
Standard Practice for Evaluation of Chemical Resistance of Printed Inks and Coatings on Flexible Packaging Materials |
01/30/2014 |
Sterility |
14-405 |
ASTM |
F2252/F2252M-13 (Reapproved 2018) |
Standard Practice for Evaluating Ink or Coating Adhesion to Flexible Packaging Materials Using Tape |
01/30/2014 |
Sterility |
14-406 |
ANSI AAMI |
ST8:2013/(R)2018 |
Hospital steam sterilizers |
01/30/2014 |
Sterility |
14-412 |
AOAC |
6.2.01:2013 |
Official Method 955.14, Testing Disinfectants Against Salmonella choleraesuis, Use-Dilution Method |
01/30/2014 |
Sterility |
14-413 |
AOAC |
6.2.06:2013 |
Official Method 964.02, Testing Disinfectants Against Pseudomonas aeruginosa, Use-Dilution Method |
01/30/2014 |
Sterility |
14-424 |
ANSI AAMI ISO |
13408-6:2005/(R) 2013 & A1:2013 |
Aseptic processing of health care products - Part 6: Isolator systems [Including AMENDMENT1 (2013)] |
ISO |
13408-6 First edition 2005-06-15 |
Aseptic processing of health care products - Part 6: Isolator systems [Including: Amendment 1 (2013)] |
01/30/2014 |
Sterility |
14-427 |
ANSI AAMI ISO |
13408-1:2008 (R2011) |
Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)] |
ISO |
13408-1 Second edition 2008-06-15 |
Aseptic processing of health care products - Part 1: General requirements [Including: Amendment 1 (2013)] |
01/30/2014 |
Sterility |
14-429 |
ASTM ISO |
51275 Third edition 2013-06-01 |
Practice for use of a radiochromic film dosimetry system |
01/30/2014 |
Sterility |
14-430 |
ASTM ISO |
51607 Third edition 2013-06-01 |
Practice for use of an alanine-EPR dosimery system |
01/14/2014 |
Radiology |
12-268 |
IEC |
60601-2-22 Edition 3.1 2012-10 |
Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
01/14/2014 |
Radiology |
12-269 |
IEC |
60601-1-3 Edition 2.1 2013-04 |
Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment |
08/06/2013 |
Cardiovascular |
3-87 |
ASTM |
F2477-07 (Reapproved 2013) |
Standard Test Methods for in vitro Pulsatile Durability |
08/06/2013 |
Cardiovascular |
3-115 |
IEC |
60601-2-34 Edition 3.0 2011-05 |
Medical electrical equipment - Part 2-34: Particular requirements for the basic safety, including essential performance, of invasive blood pressure monitoring equipment |
08/06/2013 |
Cardiovascular |
3-116 |
ANSI AAMI ISO |
25539-2:2012 |
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents |
ISO |
25539-2 Second edition 2012-12-01 |
Cardiovascular implants - Endovascular devices - Part 2: Vascular stents |
08/06/2013 |
Dental/ ENT |
4-90 |
ANSI ASA |
S3.39:1987 (Reaffirmed 2020) |
American National Standard Specifications for Instruments to Measure Aural Acoustic Impedance and Admittance (Aural Acoustic Immittance) |
08/06/2013 |
Dental/ ENT |
4-167 |
ANSI ASA |
S3.21-2004 (Reaffirmed 2019) |
American National Standard Methods for Manual Pure-Tone Threshold Audiometry |
08/06/2013 |
Dental/ ENT |
4-203 |
ANSI ASA |
S3.6-2010 |
American National Standard Specification for Audiometers |
08/06/2013 |
Dental/ ENT |
4-204 |
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 |
4-206 |
ISO |
14457 First edition 2012-09-15 |
Dentistry - Handpieces and motors |
08/06/2013 |
General I (QS/ RM) |
5-76 |
ANSI AAMI IEC |
60601-1-8:2006 and A1:2012 |
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. |
IEC |
60601-1-8 Edition 2.1 2012-11 |
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 |
08/06/2013 |
General Plastic Surgery/ General Hospital |
6-147 |
ASTM |
D6978-05 (Reapproved 2019) |
Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs |
08/06/2013 |
General Plastic Surgery/ General Hospital |
6-174 |
ISO |
11608-4 First edtion 2006-03-15 |
Pen-injectors for medical use -- Part 4: Requirements and test methods for electronic and electromechanical pen-injectors |
08/06/2013 |
General Plastic Surgery/ General Hospital |
6-179 |
ISO |
21649 First edition 2006-06-01 |
Needle-free injectors for medical use -- Requirements and test methods |
08/06/2013 |
General Plastic Surgery/ General Hospital |
6-216 |
ISO |
8536-7 Third edition 2009-01-15 |
Infusion equipment for medical use - Part 7: Caps made of aluminum-plastics combinations for infusion bottles |
08/06/2013 |
General Plastic Surgery/ General Hospital |
6-240 |
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 |
6-275 |
ISO |
11608-2 Second edition 2012-04-01 |
Needle-based injection systems for medical use - Requirements and test methods - Part 2: Needles |
08/06/2013 |
General Plastic Surgery/ General Hospital |
6-276 |
ISO |
8536-1 Fourth edition 2011-09-01 |
Infusion equipment for medical use - Part 1: Infusion glass bottles |
08/06/2013 |
General Plastic Surgery/ General Hospital |
6-294 |
ISO |
11608-3 Second edition 2012-10-01 |
Needle based injection systems for medical use - Requirements and test methods - Part 3: Finished containers |
08/06/2013 |
General Plastic Surgery/ General Hospital |
6-295 |
ANSI AAMI |
BF7:2012 |
Blood transfusion microfilters |
08/06/2013 |
General Plastic Surgery/ General Hospital |
6-296 |
ANSI AAMI |
PB70:2012 |
Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities |
08/06/2013 |
InVitro Diagnostics |
7-234 |
CLSI |
EP24-A2 (Replaces GP 10-A) |
Assessment of the Diagnostic Accuracy of Laboratory Tests Using Receiver Operating Characteristic Curves; Approved Guideline - Second Edition |
08/06/2013 |
InVitro Diagnostics |
7-242 |
CLSI |
C56-A |
Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicators of Interference in Clinical Laboratory Analysis; Approved Guideline |
08/06/2013 |
InVitro Diagnostics |
7-243 |
CLSI |
M51-A (Replaces M51-P) |
Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline |
08/06/2013 |
Materials |
8-153 |
ASTM |
F2119-07 (Reapproved 2013) |
Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants |
08/06/2013 |
Materials |
8-158 |
ASTM |
F1713-08 (Reapproved 2013) |
Standard Specification for Wrought Titanium-13 Niobium-13 Zirconium Alloy for Surgical Implant Applications (UNS R58130) |
08/06/2013 |
Materials |
8-336 |
ASTM |
F562-13 |
Standard Specification for Wrought 35Cobalt-35Nickel-20Chromium-10Molybdenum Alloy for Surgical Implant Applications (UNS R30035) |
08/06/2013 |
Materials |
8-338 |
ASTM |
F139-12 |
Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Sheet and Strip for Surgical Implants (UNS S31673) |
08/06/2013 |
Materials |
8-339 |
ASTM |
F1091-12 |
Standard Specification for Wrought Cobalt-20 Chromium-15 Tungsten-10 Nickel Alloy Surgical Fixation Wire (UNS R30605) |
08/06/2013 |
Materials |
8-342 |
ASTM |
F1537-11 |
Standard Specification for Wrought Cobalt-28-Chromium-6-Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539) |
08/06/2013 |
Materials |
8-343 |
ASTM |
F899-12b |
Standard Specification for Wrought Stainless Steels for Surgical Instruments |
08/06/2013 |
ObGyn/ Gastroenterology/ Urology |
9-31 |
ANSI AAMI |
ID54:1996/(R)2012 |
Enteral feeding set adapters and connectors |
08/06/2013 |
Ophthalmic |
10-77 |
ISO |
9394 Third edition 2012-10-01 |
Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes |
08/06/2013 |
Ophthalmic |
10-78 |
ISO |
11979-3 Third edition 2012-12-01 |
Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods |
08/06/2013 |
Ophthalmic |
10-79 |
ISO |
11979-1 Third edition 2012-09-15 |
Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary |
08/06/2013 |
Orthopedic |
11-252 |
ISO |
5838-1 Third edition 2013-03-01 |
Implants for surgery -- Metallic skeletal pins and wires -- Part 1: General requirements |