|
|
|
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)
|
| 12/18/2023 |
Dental/
ENT |
4-320 |
Complete |
ISO |
13402 First edition 1995-08-01 |
Surgical and dental hand instruments -- Determination of resistance against autoclaving, corrosion and thermal exposure |
| 12/18/2023 |
Dental/
ENT |
4-321 |
Complete |
ISO |
23450 First edition 2021-03 |
Dentistry - Intraoral camera |
| 12/18/2023 |
Dental/
ENT |
4-322 |
Complete |
ISO |
18675 First edition 2022-05 |
Dentistry - Machinable ceramic blanks |
| 12/18/2023 |
Dental/
ENT |
4-323 |
Complete |
ISO |
5139 First edition 2023-05 |
Dentistry - Polymer-based composite machinable blanks |
| 12/18/2023 |
Dental/
ENT |
4-324 |
Complete |
ISO |
TS 16506 First edition 2018-03 |
Dentistry - Polymer-based luting materials containing adhesive components |
| 09/17/2018 |
General I (QS/
RM) |
5-42 |
Complete |
ASTM |
D903-98 (Reapproved 2017) |
Standard Test Methods for Peel or Stripping Strength of Adhesive Bonds |
| 01/30/2014 |
General I (QS/
RM) |
5-47 |
Complete |
ISO |
10012 First edition 2003-01-15 |
Measurement management systems - Requirements for measurement processes and measuring equipment |
| 01/27/2015 |
General I (QS/
RM) |
5-48 |
Complete |
ANSI |
Z1.9-2003 (R2018) |
Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming |
| 06/27/2016 |
General I (QS/
RM) |
5-57 |
Partial |
ANSI AAMI |
HE75:2009/(R)2018 |
Human factors engineering - Design of medical devices |
| 01/27/2015 |
General I (QS/
RM) |
5-62 |
Complete |
ANSI ASQ |
Z1.4-2003 (R2018) |
Sampling Procedures and Tables for Inspection by Attributes |
| 01/30/2014 |
General I (QS/
RM) |
5-84 |
Complete |
AAMI |
TIR 49:2013/(R)2020 |
Technical Information Report Design of training and instructional materials for medical devices used in non-clinical environments |
| 07/09/2014 |
General I (QS/
RM) |
5-88 |
Complete |
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)] |
| 08/14/2015 |
General I (QS/
RM) |
5-97 |
Complete |
ISO |
80369-20 First edition 2015-05-15 |
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods |
| ANSI AAMI ISO |
80369-20:2015 |
Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods |
| 04/04/2016 |
General I (QS/
RM) |
5-98 |
Complete |
ANSI ESD |
S20.20-2014 |
Standard for the Development of an Electrostatic Discharge Control Program for Protection of Electrical and Electronic Parts, Assemblies and Equipment (Excluding Electrically Initiated Explosive Devices) |
| 06/15/2016 |
General I (QS/
RM) |
5-102 |
Complete |
IEC |
60417:2002 DB |
Graphical symbols for use on equipment |
| 08/21/2017 |
General I (QS/
RM) |
5-107 |
Complete |
IEC |
80369-5: Edition 1.0 2016-03 |
Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications.[Including Corrigendum 1 (2017) and Corrigendum 2 (2021)] |
| ANSI AAMI ISO |
80369-5:2016 |
Small-bore connectors for liquids and gases in healthcare applications - Part 5: Connectors for limb cuff inflation applications |
| 06/27/2016 |
General I (QS/
RM) |
5-108 |
Complete |
ISO |
80369-6 First Edition 2016-03-15 |
Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications. |
| 12/23/2016 |
General I (QS/
RM) |
5-113 |
Complete |
ASTM |
D7386-16 |
Standard Practice for Performance Testing of Packages for Single Delivery Systems |
| 01/14/2019 |
General I (QS/
RM) |
5-120 |
Complete |
IEC |
60812 Edition 3.0 2018-08 |
Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) |
| 01/14/2019 |
General I (QS/
RM) |
5-121 |
Complete |
ISO |
80369-1 Second edition 2018-11 |
Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements |
| 01/14/2019 |
General I (QS/
RM) |
5-122 |
Complete |
ASME |
V&V 40-2018 |
Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices |
| 07/15/2019 |
General I (QS/
RM) |
5-123 |
Complete |
ISO |
80369-3 First Edition 2016-07-01 |
Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications [Including AMENDMENT 1 (2019)]. |
| 12/23/2019 |
General I (QS/
RM) |
5-124 |
Complete |
ISO |
7000 Sixth edition 2019-07 |
Graphical symbols for use on equipment - Registered symbols |
| 12/23/2019 |
General I (QS/
RM) |
5-125 |
Complete |
ISO |
14971 Third Edition 2019-12 |
Medical devices - Application of risk management to medical devices |
| ANSI AAMI ISO |
14971: 2019 |
Medical devices - Applications of risk management to medical devices |
| 07/06/2020 |
General I (QS/
RM) |
5-126 |
Complete |
ISTA |
3A 2018 |
Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less |
| 07/06/2020 |
General I (QS/
RM) |
5-127 |
Complete |
ISTA |
3B 2017 |
Packaged-Products for Less-Than-Truckload (LTL) Shipment |
| 07/06/2020 |
General I (QS/
RM) |
5-128 |
Complete |
ISTA |
3E 2017 |
Similar Packaged-Products in Unitized Loads of Truckload Shipment |
| 07/06/2020 |
General I (QS/
RM) |
5-129 |
Complete |
IEC |
62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION |
Medical devices - Part 1: Application of usability engineering to medical devices |
| ANSI AAMI IEC |
62366-1:2015+AMD1:2020 (Consolidated Text) |
Medical devices Part 1: Application of usability engineering to medical devices, including Amendment 1 |
| 07/06/2020 |
General I (QS/
RM) |
5-130 |
Complete |
ISO |
7010 Third edition 2019-07 |
Graphical symbols - Safety colours and safety signs - Registered safety signs |
| 12/21/2020 |
General I (QS/
RM) |
5-131 |
Complete |
IEC |
60601-1-8 Edition 2.2 2020-07 CONSOLIDATED VERSION |
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 |
| ANSI AAMI IEC |
60601-1-8:2006 and A1:2012 [Including AMD 2:2021] |
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 [Including Amendment 2 (2021)] |
| 12/21/2020 |
General I (QS/
RM) |
5-132 |
Complete |
IEC |
60601-1-6 Edition 3.2 2020-07 CONSOLIDATED VERSION |
Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
| 12/21/2020 |
General I (QS/
RM) |
5-133 |
Complete |
ISO |
80369-7 Second edition 2021-05 |
Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications |
| 12/20/2021 |
General I (QS/
RM) |
5-134 |
Complete |
ISO |
15223-1 Fourth edition 2021-07 |
Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements |
| 12/19/2022 |
General I (QS/
RM) |
5-135 |
Complete |
ISO |
20417 First edition 2021-04 Corrected version 2021-12 |
Medical devices - Information to be supplied by the manufacturer |
| 12/19/2022 |
General I (QS/
RM) |
5-136 |
Complete |
ASTM |
D4332-22 |
Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing |
| 12/19/2022 |
General I (QS/
RM) |
5-137 |
Complete |
IEC |
TR 60878 Ed. 4.0 2022-11 |
Graphical symbols for electrical equipment in medical practice |
| 12/19/2022 |
General I (QS/
RM) |
5-138 |
Complete |
AAMI |
TIR66: 2017/(R)2020 |
Guidance for the creation of physiologic data and waveform databases to demonstrate reasonable assurance of the safety and effectiveness of alarm system algorithms |
| 12/19/2022 |
General I (QS/
RM) |
5-139 |
Complete |
ISO |
18250-3 First edition 2018-06 |
Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 3: Enteral application |
| 12/19/2022 |
General I (QS/
RM) |
5-140 |
Complete |
ASME |
V&V 10-2019 |
Standard for Verification and Validation in Computational Solid Mechanics |
| 12/19/2022 |
General I (QS/
RM) |
5-141 |
Complete |
ASME |
V&V 20-2009 (R2021) |
Standard for Verification and Validation in Computational Fluid Dynamics and Heat Transfer |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-70 |
Complete |
ASTM |
E825-98 (Reapproved 2016) |
Standard Specification for Phase Change-Type Disposable Fever Thermometer for Intermittent Determination of Human Temperature |
| 08/14/2015 |
General Plastic Surgery/
General Hospital |
6-110 |
Complete |
ASTM |
F1441-03 (Reapproved 2014) |
Standard Specification for Soft-Tissue Expander Devices |
| 01/30/2014 |
General Plastic Surgery/
General Hospital |
6-117 |
Complete |
ASTM |
F2172-02 (Reapproved 2011) |
Standard Specification for Blood/Intravenous Fluid/Irrigation Fluid Warmers |
| 01/15/2013 |
General Plastic Surgery/
General Hospital |
6-122 |
Complete |
ISO |
8536-5 Second edition 2004-02-01 |
Infusion equipment for medical use - Part 5: Burette infusion sets for single use, gravity feed |
| 09/17/2018 |
General Plastic Surgery/
General Hospital |
6-123 |
Complete |
ASTM |
E667-98 (Reapproved 2017) |
Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-124 |
Complete |
ASTM |
E1104-98 (Reapproved 2016) |
Standard Specification for Clinical Thermometer Probe Covers and Sheaths |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-125 |
Complete |
ASTM |
E1965-98 (Reapproved 2016) |
Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature |
| 08/06/2013 |
General Plastic Surgery/
General Hospital |
6-147 |
Complete |
ASTM |
D6978-05(2023) |
Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs |
| 03/16/2012 |
General Plastic Surgery/
General Hospital |
6-177 |
Complete |
ASTM |
E1112-00(2018) |
Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature |
| 07/06/2020 |
General Plastic Surgery/
General Hospital |
6-178 |
Partial |
ASTM |
D6124-06(2022) |
Standard Test Method for Residual Powder on Medical Gloves |
| 08/06/2013 |
General Plastic Surgery/
General Hospital |
6-179 |
Complete |
ISO |
21649 First edition 2006-06-01 |
Needle-free injectors for medical use -- Requirements and test methods |
| 08/14/2015 |
General Plastic Surgery/
General Hospital |
6-185 |
Complete |
ASTM |
F881-94 (Reapproved 2014) |
Standard Specification for Silicone Elastomer Facial Implants |
| 08/14/2015 |
General Plastic Surgery/
General Hospital |
6-200 |
Complete |
ASTM |
E1061-01(2022) |
Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-214 |
Complete |
ASTM |
D6355-07(2022) |
Standard Test Method for Human Repeat Insult Patch Testing of Medical Gloves |
| 03/18/2009 |
General Plastic Surgery/
General Hospital |
6-215 |
Complete |
ASTM |
F2132-01 (Reapproved 2008)e1 |
Standard Specification for Puncture Resistance of Materials Used in Containers for Discarded Medical Needles and Other Sharps |
| 08/06/2013 |
General Plastic Surgery/
General Hospital |
6-216 |
Complete |
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 |
Complete |
ISO |
8536-3 Third edition 2009-06-01 |
Infusion equipment for medical use - Part 3: Aluminum caps for infusion bottles |
| 08/20/2012 |
General Plastic Surgery/
General Hospital |
6-242 |
Complete |
ISO |
8536-2 Third edition 2010-03-15 |
Infusion equipment for medical use - Part 2: Closures for infusion bottles |
| 01/30/2014 |
General Plastic Surgery/
General Hospital |
6-253 |
Complete |
ISO |
10535 Second edition 2006-12-15 |
Hoists for the transfer of disabled persons - Requirements and test methods |
| 03/16/2012 |
General Plastic Surgery/
General Hospital |
6-268 |
Complete |
ASTM |
F921-10 (Reapproved 2018) |
Standard Terminology Relating to Hemostatic Forceps |
| 03/16/2012 |
General Plastic Surgery/
General Hospital |
6-269 |
Complete |
ASTM |
F1078-10 (Reapproved 2018) |
Standard Terminology for Surgical Scissors-Inserted and Non-Inserted Blades |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-270 |
Complete |
ASTM |
F1840-10 (Reapproved 2016) |
Standard Terminology for Surgical Suture Needles |
| 03/16/2012 |
General Plastic Surgery/
General Hospital |
6-271 |
Complete |
ASTM |
F1874-98 (Reapproved 2011) |
Standard Test Method for Bend Testing of Needles Used in Surgical Sutures |
| 03/16/2012 |
General Plastic Surgery/
General Hospital |
6-272 |
Complete |
ASTM |
F2062-00 (Reapproved 2018) |
Standard Specification for Square Drive Interconnections on Surgical Instruments |
| 01/30/2014 |
General Plastic Surgery/
General Hospital |
6-273 |
Complete |
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 |
| 08/06/2013 |
General Plastic Surgery/
General Hospital |
6-276 |
Complete |
ISO |
8536-1 Fourth edition 2011-09-01 |
Infusion equipment for medical use - Part 1: Infusion glass bottles |
| 08/20/2012 |
General Plastic Surgery/
General Hospital |
6-278 |
Complete |
ISO |
11040-5 Third edition 2012-02-15 |
Prefilled syringes - Part 5: Plunger stoppers for injectables |
| 08/06/2013 |
General Plastic Surgery/
General Hospital |
6-295 |
Complete |
AAMI ANSI |
BF7:2012 |
Blood transfusion microfilters |
| 08/06/2013 |
General Plastic Surgery/
General Hospital |
6-296 |
Complete |
ANSI AAMI |
PB70:2012 |
Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities |
| 01/30/2014 |
General Plastic Surgery/
General Hospital |
6-303 |
Complete |
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 |
Complete |
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 |
Complete |
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 |
Complete |
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 |
Complete |
ISO |
10555-4 Second edition 2013-06-15 |
Intravascular catheters -- Sterile and single-use catheters -- Part 4: Balloon dilatation catheters |
| 01/14/2019 |
General Plastic Surgery/
General Hospital |
6-338 |
Complete |
ASTM |
D7866-14 |
Standard Specification for Radiation Attenuating Protective Gloves |
| 08/14/2015 |
General Plastic Surgery/
General Hospital |
6-353 |
Complete |
ASTM |
F2051-00 (Reapproved 2014) |
Standard Specification for Implantable Saline Filled Breast Prosthesis |
| 08/14/2015 |
General Plastic Surgery/
General Hospital |
6-354 |
Complete |
ASTM |
D7907-14 (Reapproved 2019) |
Standard Test Methods for Determination of Bactericidal Efficacy on the Surface of Medical Examination Gloves |
| 04/04/2016 |
General Plastic Surgery/
General Hospital |
6-355 |
Complete |
ASTM |
D3772-15(2021) |
Standard Specification for Industrial Rubber Finger Cots |
| 04/04/2016 |
General Plastic Surgery/
General Hospital |
6-356 |
Complete |
ASTM |
D5712-15(2020) |
Standard Test Method for Analysis of Aqueous Extractable Protein in Natural Rubber in Latex, Natural Rubber, and Elastomeric Products Using the Modified Lowry Method |
| 04/04/2016 |
General Plastic Surgery/
General Hospital |
6-357 |
Complete |
ISO |
10555-6 First edition 2015-04-15 |
Intravascular catheters - Sterile and single-use catheters - Part 6: Subcutaneous implanted ports |
| 04/04/2016 |
General Plastic Surgery/
General Hospital |
6-358 |
Partial |
ISO |
8536-8 Second Edition 2015-06-15 |
Infusion Equipment for Medical Use - Part 8: Infusion Sets for Single Use with Pressure Infusion Apparatus |
| 04/04/2016 |
General Plastic Surgery/
General Hospital |
6-359 |
Partial |
ISO |
8536-9 Second Edition 2015-06-15 |
Infusion Equipment for Medical Use - Part 9: Fluid Lines for Single Use with Pressure Infusion Equipment |
| 04/04/2016 |
General Plastic Surgery/
General Hospital |
6-360 |
Partial |
ISO |
8536-10 Second Edition 2015-06-15 |
Infusion Equipment for Medical Use - Part 10: Accessories for Fluid Lines for Single Use with Pressure Infusion Equipment |
| 04/04/2016 |
General Plastic Surgery/
General Hospital |
6-361 |
Partial |
ISO |
8536-11 Second Edition 2015-06-15 |
Infusion Equipment for Medical Use - Part 11: Infusion Filters for Single Use with Pressure Infusion Equipment |
| 06/27/2016 |
General Plastic Surgery/
General Hospital |
6-363 |
Complete |
ISO |
11810 Second edition 2015-12-15 |
Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Primary ignition, penetration, flame spread and secondary ignition |
| 06/27/2016 |
General Plastic Surgery/
General Hospital |
6-364 |
Partial |
ISO |
8537 Third edition 2016-03-15 |
Sterile single-use syringes, with or without needle, for insulin |
| 09/21/2016 |
General Plastic Surgery/
General Hospital |
6-379 |
Complete |
ISO |
7864 Fourth edition 2016-08-01 |
Sterile hypodermic needles for single use - Requirements and test methods |
| 09/21/2016 |
General Plastic Surgery/
General Hospital |
6-380 |
Complete |
ISO |
9626 Second edition 2016-08-01 |
Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods |
| 09/21/2016 |
General Plastic Surgery/
General Hospital |
6-381 |
Complete |
ISO |
6009 Fourth edition 2016-08-01 |
Hypodermic needles for single use - Colour coding for identification. |
| 09/21/2016 |
General Plastic Surgery/
General Hospital |
6-382 |
Complete |
ISO |
11608-7 First edition 2016-08-01 |
Needle-based injection systems for medical use - Requirements and test methods - Part 7: Accessibility for persons with visual impairment |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-384 |
Complete |
ISO |
1135-4 Sixth edition 2015-12-01 |
Transfusion equipment for medical use-Part 4: Transfusion sets for single use, gravity feed |
| 06/07/2021 |
General Plastic Surgery/
General Hospital |
6-389 |
Partial |
IEC |
60601-2-2 Edition 6.0 2017-03 |
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
| ANSI AAMI IEC |
60601-2-2:2017 |
Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories |
| 08/21/2017 |
General Plastic Surgery/
General Hospital |
6-400 |
Complete |
ASTM |
F3212-16(2023) |
Standard Test Method for Coring Testing of Huber Needles |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-401 |
Complete |
ASTM |
D7160-16 |
Standard Practice for Determination of Expiration Dating for Medical Gloves |
| 06/07/2018 |
General Plastic Surgery/
General Hospital |
6-402 |
Complete |
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 |
Complete |
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 |
Complete |
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 |
Complete |
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 |
Complete |
ASTM |
F3186-17 |
Standard Specification for Adult Portable Bed Rails and Related Products |
| 09/17/2018 |
General Plastic Surgery/
General Hospital |
6-408 |
Partial |
ISO |
10555-1 Second edition 2013-06-15 |
Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)] |
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