|
|
|
Date of
Entry
|
Specialty Task
Group Area
|
Recognition
Number
|
Standards
Developing
Organization
|
Standard Designation
Number and Date
|
Title of Standard
|
| 01/30/2014 |
Anesthesiology |
1-78 |
ASME |
PVHO-1-2007 |
Safety Standard for Pressure Vessels for Human Occupancy |
| 01/30/2014 |
Anesthesiology |
1-81 |
CGA |
V-5:2008 (Reaffirmed 2013) |
Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications) |
| 01/30/2014 |
Anesthesiology |
1-97 |
CGA |
V-7.1:2011 |
Standard Method of Determining Cylinder Valve Outlet Connections for Medical Gases |
| 01/30/2014 |
Anesthesiology |
1-98 |
ISO |
80601-2-12 First edition 2011-04-15 |
Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators [Including: Technical Corrigendum 1 (2011)] |
| 01/30/2014 |
Cardiovascular |
3-54 |
ANSI AAMI ISO |
7198:2016 Second edition |
Cardiovascular implants and extracorporeal systems--Vascular prostheses--Tubular vascular grafts and vascular patches |
| 01/30/2014 |
Cardiovascular |
3-63 |
ISO |
11318:2002 |
Cardiac Defibrillators -- Connector assembly DF-1 for implantable defibrillators - Dimensions and test requirements. |
| 01/30/2014 |
Cardiovascular |
3-118 |
ANSI AAMI |
EC57:2012 |
Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms |
| 01/30/2014 |
Dental/
ENT |
4-137 |
ANSI ADA |
Standard No. 78-2013 |
Dental obturating cones |
| ISO |
6877 Second edition 2006-04-01 |
Dentistry - Root-canal obturating points |
| 01/30/2014 |
Dental/
ENT |
4-151 |
ANSI ADA |
Standard No. 15-2008 (R2013) |
Artificial Teeth for Dental Prostheses |
| ISO |
22112 First edition 2005-11-01 |
Dentistry - Artificial teeth for dental prostheses |
| 01/30/2014 |
Dental/
ENT |
4-153 |
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 |
ISO |
9168 Third edition 2009-07-15 |
Dentistry - Hose connectors for air driven dental handpieces |
| 01/30/2014 |
Dental/
ENT |
4-181 |
ISO |
4049 Fourth edition 2009-10-01 |
Dentistry - Polymer-based restorative materials |
| 01/30/2014 |
Dental/
ENT |
4-188 |
ISO |
9917-2 Second edition 2010-04-15 |
Dentistry - Water-based cements - Part 2: Resin-modified cements |
| 01/30/2014 |
Dental/
ENT |
4-198 |
ANSI ADA |
Standard No.30-2013 (R2018) |
Dental Zinc Oxide/Eugenol & Zinc Oxide/Non-Eugenol Cements |
| ISO |
3107 Fourth edition 2011-03-01 |
Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements |
| 01/30/2014 |
Dental/
ENT |
4-199 |
ISO |
6876 Third edition 2012-06-01 |
Dentistry -- Root canal sealing materials |
| 01/30/2014 |
General I (QS/
RM) |
5-47 |
ISO |
10012 First edition 2003-01-15 |
Measurement management systems - Requirements for measurement processes and measuring equipment |
| 01/30/2014 |
General I (QS/
RM) |
5-84 |
AAMI |
TIR 49:2013/(R)2020 |
Technical Information Report Design of training and instructional materials for medical devices used in non-clinical environments |
| 01/30/2014 |
General Plastic Surgery/
General Hospital |
6-117 |
ASTM |
F2172-02 (Reapproved 2011) |
Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers |
| 01/30/2014 |
General Plastic Surgery/
General Hospital |
6-253 |
ISO |
10535 Second edition 2006-12-15 |
Hoists for the transfer of disabled persons - Requirements and test methods |
| 01/30/2014 |
General Plastic Surgery/
General Hospital |
6-273 |
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 |
| 01/30/2014 |
General Plastic Surgery/
General Hospital |
6-303 |
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 |
ISO |
10555-3 Second edition 2013-06-15 |
Intravascular catheters -- Sterile and single-use catheters -- Part 3: Central venous catheters |
| 01/30/2014 |
General Plastic Surgery/
General Hospital |
6-306 |
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 |
| 01/30/2014 |
General Plastic Surgery/
General Hospital |
6-321 |
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)] |
| 01/30/2014 |
General Plastic Surgery/
General Hospital |
6-322 |
ISO |
10555-4 Second edition 2013-06-15 |
Intravascular catheters -- Sterile and single-use catheters -- Part 4: Balloon dilatation catheters |
| 01/30/2014 |
InVitro Diagnostics |
7-152 |
CLSI |
EP12-A2 |
User Protocol for Evaluation of Qualitative Test Performance; Approved Guideline - Second Edition. |
| 01/30/2014 |
InVitro Diagnostics |
7-210 |
CLSI |
H26-A2 |
Validation, Verification, and Quality Assurance of Automated Hematology Analyzers; Proposed Standard - Second Edition |
| 01/30/2014 |
InVitro Diagnostics |
7-220 |
CLSI |
H59-A (Replaces H59-P) |
Quantitative D-dimer for the Exclusion of Venous Thromboembolic Disease; Approved Guideline. |
| 01/30/2014 |
InVitro Diagnostics |
7-223 |
CLSI |
QMS06-A3 (Formerly GP22-A3) |
Quality Management System: Continual Improvement; Approved Guideline - Third Edition |
| 01/30/2014 |
InVitro Diagnostics |
7-224 |
CLSI |
EP28-A3c (Formerly C28-A3c) |
Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory; Approved Guideline - Third Edition |
| 01/30/2014 |
InVitro Diagnostics |
7-239 |
CLSI |
EP32-R (Formerly X05-R) |
Metrological Traceability and Its Implementation; A Report |
| 01/30/2014 |
InVitro Diagnostics |
7-244 |
CLSI |
NBS01-A6 (Replaces LA04-A5) |
Blood Collection on Filter Paper for Newborn Screening Programs: Approved Standard - Sixth Edition |
| 01/30/2014 |
Materials |
8-123 |
ISO |
5832-5 Third edition 2005-10-15 |
Implants for surgery -- Metallic materials -- Part 5: Wrought cobalt-chromium-tungsten-nickel alloy |
| 01/30/2014 |
Materials |
8-157 |
ISO |
9583 First edition 1993-10-15 |
Implants for surgery -- Non-destructive testing -- Liquid penetrant inspection of metallic surgical implants |
| 01/30/2014 |
Materials |
8-159 |
ISO |
9584 First edition 1993-10-15 |
Implants for surgery -- Non-destructive testing -- Radiographic examination of cast metallic surgical implants |
| 01/30/2014 |
Materials |
8-344 |
ISO |
7153-1 Second edition 1991-04-01 |
Surgical instruments -- Metallic materials -- Part 1: Stainless steel [Including: Amendment 1 (1999)] |
| 01/30/2014 |
Materials |
8-347 |
ASTM |
F2146-13 |
Standard Specification for Wrought Titanium-3Aluminum-2.5Vanadium Alloy Seamless Tubing for Surgical Implant Applications (UNS R56320) |
| 01/30/2014 |
Materials |
8-348 |
ASTM |
F138-13 |
Standard Specification for Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673) |
| 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 |
8-358 |
ASTM |
F1855-00 (Reapproved 2019) |
Standard Specification for Polyoxymethylene (Acetal) for Medical Applications |
| 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 |
|
Standard |
| ISO |
8638 Third edition 2010-07-01 |
Cardiovascular implants and extracorporeal systems -- Extracorporeal blood circuit for hemodialyzers, hemodiafilters, and hemofilters |
| 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 |
11-264 |
ASTM |
F1820-13 |
Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices |
| 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 |
16-167 |
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 |
12-261 |
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 |
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 2022) |
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 |
14-427 |
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 |
| 07/09/2014 |
Anesthesiology |
1-99 |
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 |
| 07/09/2014 |
Anesthesiology |
1-100 |
CGA |
V-1:2013 |
Standard for Compressed Gas Cylinder Valve Outlet and Inlet Connection |
| 07/09/2014 |
Anesthesiology |
1-101 |
CGA |
C-9:2013 |
Standard Color Marking of Compressed Gas Containers for Medical Use |
| 07/09/2014 |
Dental/
ENT |
4-97 |
ANSI ADA |
Standard No. 57-2000 (R2012) |
Endodontic Sealing Material |
| 07/09/2014 |
Dental/
ENT |
4-149 |
ANSI ADA |
Standard No. 39-2006 (R2011) |
Pit and Fissure Sealants |
| 07/09/2014 |
Dental/
ENT |
4-160 |
ANSI ASA |
S3.1-1999 (Reaffirmed 2018) |
American National Standard Maximum Permissible Ambient Noise Levels for Audiometric Test Rooms |
| 07/09/2014 |
Dental/
ENT |
4-165 |
ANSI ASA |
S3.13-1987 (Reaffirmed 2020) |
American National Standard Mechanical Coupler for Measurement of Bone Vibrators |
| 07/09/2014 |
Dental/
ENT |
4-177 |
ANSI ASA |
S12.65-2006 (Reaffirmed 2020) |
American National Standard For Rating Noise with Respect to Speech Interference |
| 07/09/2014 |
Dental/
ENT |
4-211 |
ANSI ASA |
S3.46-2013 (Reaffirmed 2018) |
American National Standard Methods of Measurement of Real-Ear Performance Characteristics of Hearing Aids |
| 07/09/2014 |
General I (QS/
RM) |
5-88 |
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)] |
| 07/09/2014 |
General II (ES/
EMC) |
19-4 |
ANSI AAMI |
ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) |
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) |
| 07/09/2014 |
General II (ES/
EMC) |
19-9 |
IEC |
60601-1-10 Edition 1.1 2013-11 |
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 |
| 07/09/2014 |
General II (ES/
EMC) |
19-10 |
UL |
1642 5th Edition |
Lithium Batteries |
| 07/09/2014 |
General II (ES/
EMC) |
19-11 |
UL |
2054 2nd Edition |
Household and Commercial Batteries |
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