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ASTM F2333-04(2017) - Standard Test Method for Traction Characteristics of the Athletic Shoe-Sports Surface Interface

Friday, March 15, 2024 10:21 AM

Michaela Calhoun
ISO 10328: 2016 Prosthetics — Structural testing of lower-limb prostheses — Requirements and test methods

Friday, February 02, 2024 4:27 PM

Michaela Calhoun
ISO/TS 16955:2016(E) - Prosthetics — Quantification of physical parameters of ankle foot devices and foot units

Thursday, November 09, 2023 12:05 PM

Michaela Calhoun
ANSI Z136.1 - 2014 American National Standard for Safe Use of Lasers

Friday, February 17, 2023 8:33 AM

Marilee Dizon
IEC 60825-1 Edition 3.0 2014-05 INTERNATIONAL STANDARD NORME INTERNATIONALE Safety of laser products – Part 1: Equipment classification and requirements

Friday, February 17, 2023 8:13 AM

Marilee Dizon
CEI IEC INTERNATIONAL STANDARD 62471 CIE S 009:2002 Première édition First edition 2006-07 Sécurité photobiologique des lampes et des appareils utilisant des lampes Photobiological safety of lamps and lamp systems

Friday, February 17, 2023 8:10 AM

Marilee Dizon
IEC 60601-2-41 Edition 3.0 2021-09 Medical electrical equipment – Part 2-41: Particular requirements for the basic safety and essential performance of surgical luminaires and luminaires for diagnosis

Friday, December 02, 2022 10:24 AM

Marilee Dizon
IEEE Std C95.3™-2002 (R2008) (Revision of IEEE Std C95.3-1991) IEEE Recommended Practice for Measurements and Computations of Radio Frequency Electromagnetic Fields With Respect to Human Exposure to Such Fields, 100 kHz–300 GHz

Thursday, December 01, 2022 11:22 AM

Marilee Dizon
ASTM F2276 − 10 (Reapproved 2015) Standard Specification for Fitness Equipment 1

Wednesday, October 26, 2022 5:00 PM

Marilee Dizon
ISO 20957-2 Second edition 2020-08 Stationary training equipment — Part 2: Strength training equipment, additional specific safety requirements and test methods

Wednesday, October 26, 2022 4:57 PM

Marilee Dizon
ISO 20957-1 Second edition 2013-09-15 Stationary training equipment — Part 1: General safety requirements and test methods

Wednesday, October 26, 2022 4:53 PM

Marilee Dizon
ISO 20957-5 Second edition 2016-12-01 Stationary training equipment — Part 5: Stationary exercise bicycles and upper body crank training equipment, additional specific safety requirements and test methods

Wednesday, October 26, 2022 4:51 PM

Marilee Dizon
EN 45502-1 May 2015 Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

Wednesday, October 26, 2022 4:29 PM

Marilee Dizon
EN 45502-2-2 March 2008 Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)

Wednesday, October 26, 2022 12:03 PM

Marilee Dizon
ISO 13485 Third edition 2016-03-01 Medical devices — Quality management systems — Requirements for regulatory purposes

Wednesday, October 26, 2022 11:50 AM

Marilee Dizon
ISO 14708-1 Second edition 2014-08-15 Implants for surgery — Active implantable medical devices — Part 1: General requirements for safety, marking and for information to be provided by the manufacturer

Wednesday, October 26, 2022 11:48 AM

Marilee Dizon
ISO 10079-4 First edition 2021-08 Medical suction equipment — Part 4: General requirements

Wednesday, October 19, 2022 5:02 PM

Marilee Dizon
ISO 10079-3 Fourth edition 2022-03 Medical suction equipment — Part 3: Suction equipment powered from a vacuum or positive pressure gas source

Wednesday, October 19, 2022 5:00 PM

Marilee Dizon
ISO 10079-1 Fourth edition 2022-03 Medical suction equipment — Part 1: Electrically powered suction equipment

Wednesday, October 19, 2022 4:59 PM

Marilee Dizon
ISO 16890-1 First Edition 2016-12 – Air filters for general ventilation – Part 1 Technical specifications, requirements and classification system based upon particulate matter efficiency (ePM)

Tuesday, June 30, 2020 4:12 PM

Sondra Hernandez
ISO 15197 Second Ed. (2013-05 ) In vitro diagnostic test systems -- Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

Monday, May 18, 2020 11:06 AM

Sondra Hernandez
EP27-A (2012-09) How to Construct and Interpret an Error Grid for Quantitative Diagnostic Assays; Approved Guideline

Monday, May 18, 2020 11:03 AM

Sondra Hernandez
IEC 60601-1-2 Edition 4.0 (2014-02) Medical electrical equipment Part 1-2 - General requirements for basic safety and essential performance - Collateral Standard - Electromagnetic disturbances - Requirements and tests

Monday, November 25, 2019 4:43 PM

Sondra Hernandez
IEC 60529 Edition 2.2 (2013-08 [1998+ A1 1999 + A2 2013] ) Degrees of Protection by enclosures (IP Code)

Monday, November 25, 2019 4:42 PM

Sondra Hernandez
ISO 15223-1 Third Edition (2016-11) Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1 - General requirements

Friday, November 08, 2019 11:37 AM

Sondra Hernandez
ISO 18113-3 First Edition (2009-12) In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 3 - In vitro diagnostic instruments for professional use

Friday, November 08, 2019 11:36 AM

Sondra Hernandez
ISO 18113-1 First Edition (2009-12) In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1 - Terms, definitions, and general requirements

Friday, November 08, 2019 11:35 AM

Sondra Hernandez
ISO 17511 First Edition (2003-08) In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials

Friday, October 18, 2019 2:54 PM

Sondra Hernandez
IEC 61326-2-6 Edition 2.0 (2012-07) Electrical equipment for measurement, control and laboratory use - (EMC) Part 2-6 - Particular requirements - In vitro diagnostic (IVD) medical equipment

Friday, October 18, 2019 2:52 PM

Sondra Hernandez
IEC 61010-2-101 Edition 3.0 (2018-10) Safety requirements for electrical equipment for measurement, control and laboratory use - Part 2-101 - Particular requirements for in vitro diagnostic (IVD) medical equipment

Friday, October 18, 2019 2:51 PM

Sondra Hernandez
EN 13612 (2002-08) ICS 11.100 Performance evaluation of in vitro diagnostic medical devices

Friday, October 18, 2019 2:49 PM

Sondra Hernandez
IEC 60068-3-7 Edition 1.0 b (2001-08) Environmental Testing - Part 3-7 - Supporting Documentation and Guidance - Measurements in temperature chambers for tests A and B (with load)

Wednesday, September 25, 2019 2:58 PM

Sondra Hernandez
IEC 60068-3-6 Edition 2.0. RLV (2018-01) Environmental Testing - Part 3-6 - Supporting documentation and guidance - Confirmation of the performance of temperature-humidity chambers

Wednesday, September 25, 2019 2:57 PM

Sondra Hernandez
IEC 60068-3-5 Edition 2.0 RLV (2018-01) Environmental Testing - Part 3-5 - Supporting documentation and guidance - Confirmation of the performance of temperature chambers

Wednesday, September 25, 2019 2:56 PM

Sondra Hernandez
ISO/TS 18340: Endoscopes — Trocar pins, trocar sleeves and endotherapy devices for use with trocar sleeves

Monday, August 12, 2019 3:04 PM

Amy Kavalewitz Dern
ISO 8600-1:2015 Endoscopes — Medical endoscopes and endotherapy devices

Monday, August 12, 2019 3:03 PM

Amy Kavalewitz Dern
ISO 80601-2-69 : Medical electrical equipment – Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO 80601-2-69:2014)

Monday, August 12, 2019 3:03 PM

Amy Kavalewitz Dern
ISO 80601-2-61 Medical electrical equipment — Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment

Monday, August 12, 2019 3:01 PM

Amy Kavalewitz Dern
ISO 80601-2-56: Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

Monday, August 12, 2019 3:00 PM

Amy Kavalewitz Dern
ISO 10993-1: Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process

Monday, August 12, 2019 2:59 PM

Amy Kavalewitz Dern
ISO 7174-2:1992: Furniture - Chairs -Determination of stability - Part 2: Chairs with tilting or reclining mechanisms when fully reclined, and rocking chairs

Monday, August 12, 2019 2:59 PM

Amy Kavalewitz Dern
ISO 5361:2012(E) - Anaesthetic and respiratory equipment - Tracheal tubes and connectors

Monday, August 12, 2019 2:58 PM

Amy Kavalewitz Dern
ISO 28620: Medical devices - Non-electrically driven portable infusion devices

Monday, August 12, 2019 2:58 PM

Amy Kavalewitz Dern
ISO 23908-1:2011 - Sharps injury protection — Requirements and test methods — Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

Monday, August 12, 2019 2:57 PM

Amy Kavalewitz Dern
ISO 8185:2007 - Respiratory tract humidifiers for medical use -- Particular requirements for respiratory humidification systems

Monday, August 12, 2019 2:55 PM

Amy Kavalewitz Dern
ISO 7886-4:2006 - Sterile hypodermic syringes for single use -- Part 4: Syringes with re-use prevention feature

Monday, August 12, 2019 2:54 PM

Amy Kavalewitz Dern
ISO 7886-1:1993 - Sterile hypodermic syringes for Single use - Part 1: Syringes for manual use TECHNICAL CORRIGENDUM 1

Monday, August 12, 2019 2:54 PM

Amy Kavalewitz Dern
ISO 7886-1:1993 - Sterile hypodermic syringes for single use -- Part 1: Syringes for manual use

Monday, August 12, 2019 2:53 PM

Amy Kavalewitz Dern
ISO 17510-2:2007 - Sleep apnea breathing therapy -- Part 2: Masks and application accessories

Monday, August 12, 2019 2:52 PM

Amy Kavalewitz Dern
ISO 17510-1:2007 - Sleep apnea breathing therapy -- Part 1: Sleep apnea breathing therapy equipment

Monday, August 12, 2019 2:51 PM

Amy Kavalewitz Dern
ISO 15193:2009 - In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Requirements for content and presentation of reference measurement procedures

Monday, August 12, 2019 2:51 PM

Amy Kavalewitz Dern
ISO 10079-3:1999 - Medical suction equipment -- Part 3: Suction equipment powered from a vacuum or pressure source

Monday, August 12, 2019 2:49 PM

Amy Kavalewitz Dern
ISO 10079-2:1999 - Medical suction equipment -- Part 2: Manually powered suction equipment

Monday, August 12, 2019 2:48 PM

Amy Kavalewitz Dern
ISO 10079-1:1999 - Medical suction equipment -- Part 1: Electrically powered suction equipment -- Safety requirements

Monday, August 12, 2019 2:48 PM

Amy Kavalewitz Dern
IEEE 1789-2015 Recommended Practices for Modulating Current in High-Brightness LEDs for Mitigating Health Risks to Viewers

Monday, August 12, 2019 2:39 PM

Amy Kavalewitz Dern
IEEE 1184-2006 (R2011) Guide for Batteries for Uninterruptible Power Supply Systems

Monday, August 12, 2019 2:35 PM

Amy Kavalewitz Dern
IEC 60665: Audio, video and similar electronic apparatus – Safety requirements

Monday, August 12, 2019 2:33 PM

Amy Kavalewitz Dern
IEC 62304-2006-05 - Medical device software – Software life cycle processes

Monday, August 12, 2019 2:30 PM

Amy Kavalewitz Dern
IEC 80601-2-35: Medical electrical equipment – Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

Monday, August 12, 2019 2:29 PM

Amy Kavalewitz Dern
IEC 61000-4-28-01 First Edition (1999-11) Electromagnetic Compatibility

Monday, August 12, 2019 2:24 PM

Amy Kavalewitz Dern
IEC 60068-2-30:2005 Environmental testing - Part 2-30: Tests - Test Db: Damp heat, cyclic (12 h + 12 h cycle)

Monday, August 12, 2019 2:21 PM

Amy Kavalewitz Dern
IEC 60068-2-2:2007 Environmental testing - Part 2-2: Tests - Test B: Dry heat

Monday, August 12, 2019 2:20 PM

Amy Kavalewitz Dern
IEC 61000-4-14:1999+AMD1:2001 CSV Consolidated version Electromagnetic compatibility (EMC) - Part 4-14: Testing and measurement techniques - Voltage fluctuation immunity test

Monday, August 12, 2019 2:18 PM

Amy Kavalewitz Dern
IEC 60068-2-68:1994 Environmental testing - Part 2-68: Tests - Test L: Dust and sand

Monday, August 12, 2019 2:15 PM

Amy Kavalewitz Dern
IEC 61000-4-14 Edition 1.1 (2002-07) Electromagnetic compatibility (EMC) - Part 4-14 Testing and measurement techniques - Voltage fluctuation immunity test.pdf (501.33 KB)

Monday, August 12, 2019 2:11 PM

Amy Kavalewitz Dern
IEC 60601-2-50 Medical electrical equipment – Part 2-50: Particular requirements for the basic safety and essential performance of infant phototherapy equipment

Monday, August 12, 2019 2:05 PM

Amy Kavalewitz Dern
IEC 60601-2-49 ed2.0 (2011-02) - Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitoring equipment

Monday, August 12, 2019 2:04 PM

Amy Kavalewitz Dern
IEC 60601-2-27 ed3.0 (2011-03) - Medical electrical equipment - Part 2-27: Particular requirements for the basic safety and essential performance of electrocardiographic monitoring equipment

Monday, August 12, 2019 2:03 PM

Amy Kavalewitz Dern
IEC 60601-2-26 ed3.0 (2012-05) - Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs

Monday, August 12, 2019 2:03 PM

Amy Kavalewitz Dern
IEC 60601-2-24 ed2.0 (2012-10) - Medical electrical equipment - Part 2-24: Particular requirements for the basic safety and essential performance of infusion pumps and controllers

Monday, August 12, 2019 2:02 PM

Amy Kavalewitz Dern
IEC 60601-2-21 ed2.0 (2009-02) - Medical electrical equipment - Part 2-21: Particular requirements for the basic safety and essential performance of infant radiant warmers

Monday, August 12, 2019 2:01 PM

Amy Kavalewitz Dern
IEC 60601-2-19 ed2.0 (2009-02) - Medical electrical equipment - Part 2-19: Particular requirements for the basic safety and essential performance of infant incubators

Monday, August 12, 2019 2:01 PM

Amy Kavalewitz Dern
IEC 60601-2-18 ed3.0 (2009-08) - Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipment

Monday, August 12, 2019 2:00 PM

Amy Kavalewitz Dern
IEC 60601-1-10 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

Monday, August 12, 2019 2:00 PM

Amy Kavalewitz Dern
IEC 60601-1-8, Medical electrical equipment – Part 1-8: General requirements for safety - Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems

Monday, August 12, 2019 1:59 PM

Amy Kavalewitz Dern
IEC 60601-1-6 Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance –Collateral standard: Usability

Monday, August 12, 2019 1:58 PM

Amy Kavalewitz Dern
IEC 60601-1 ed3.1 Consol. with am1 (2012-08) - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

Monday, August 12, 2019 1:57 PM

Amy Kavalewitz Dern
API Standard 53 - Fourth Edition, November 2012 - Blowout Prevention Equipment Systems for Drilling Wells

Monday, August 12, 2019 1:57 PM

Amy Kavalewitz Dern
ASME PTC 19.5-2010 Pressure Measurement - Instruments and Apparatus Supplement

Monday, August 12, 2019 1:56 PM

Amy Kavalewitz Dern
ASME PTC 19.5-2004 Flow Measurement - Performance Test Codes

Monday, August 12, 2019 1:55 PM

Amy Kavalewitz Dern
ANSI/AAMI ST67:2011 - Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled 'sterile'

Monday, August 12, 2019 1:55 PM

Amy Kavalewitz Dern
ANSI/AAMI/ISO TIR16142:2005 Medical devices— Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices

Monday, August 12, 2019 1:54 PM

Amy Kavalewitz Dern
ANSI/AAMI HE75:2009/ (R)2013 Human factors engineering – Design of medical devices

Monday, August 12, 2019 1:53 PM

Amy Kavalewitz Dern
ANSI/AAMI/ IEC 62366- 1:2015 Medical devices – Part 1: Application of usability engineering to medical devices

Monday, August 12, 2019 1:44 PM

Amy Kavalewitz Dern
API Specification 16D - Second Edition, July 2004 - Specification for Control Systems for Drilling Well Control Equipment and Control Systems for Diverter Equipment

Monday, August 12, 2019 1:43 PM

Amy Kavalewitz Dern
ANSI/AAMI/ ISO 81060- 2:2013 Non-invasive sphygmomanometers — Part 2: Clinical investigation of automated measurement type

Monday, August 12, 2019 1:34 PM

Amy Kavalewitz Dern
ANSI/AAMI/ ISO 80601- 2-30:2009 & A1:2013 Medical electrical equipment — Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers American National Standard

Monday, August 12, 2019 1:32 PM

Amy Kavalewitz Dern

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ANSI/AAMI ST67:2011 - Sterilization of health care products - Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled 'sterile'	Monday, August 12, 2019 1:55 PM Amy Kavalewitz Dern (Administrator)	—
ANSI/AAMI/ISO TIR16142:2005 Medical devices— Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices	Monday, August 12, 2019 1:54 PM Amy Kavalewitz Dern (Administrator)	—
ANSI/AAMI HE75:2009/ (R)2013 Human factors engineering – Design of medical devices	Monday, August 12, 2019 1:53 PM Amy Kavalewitz Dern (Administrator)	—
ANSI/AAMI/ IEC 62366- 1:2015 Medical devices – Part 1: Application of usability engineering to medical devices	Monday, August 12, 2019 1:44 PM Amy Kavalewitz Dern (Administrator)	—
API Specification 16D - Second Edition, July 2004 - Specification for Control Systems for Drilling Well Control Equipment and Control Systems for Diverter Equipment	Monday, August 12, 2019 1:43 PM Amy Kavalewitz Dern (Administrator)	—
ANSI/AAMI/ ISO 81060- 2:2013 Non-invasive sphygmomanometers — Part 2: Clinical investigation of automated measurement type	Monday, August 12, 2019 1:34 PM Amy Kavalewitz Dern (Administrator)	—
ANSI/AAMI/ ISO 80601- 2-30:2009 & A1:2013 Medical electrical equipment — Part 2-30: Particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers American National Standard	Monday, August 12, 2019 1:32 PM Amy Kavalewitz Dern (Administrator)	—

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