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Standards and compliance
This device conforms to the following Safety and Performance Standards:
This infrared thermometer meets requirements established in ASTM Standard E 1965–
98 (for the thermometer system [thermometer with probe cover]). Full responsibility for the
conformance of the product to the standard is assumed by Welch Allyn, Inc.
4341 State Street Road, Skaneateles Falls, NY, USA 13153.
ASTM laboratory accuracy requirements in the display range of 37 °C to 39 °C (98 °F to 102 °F)
for infrared thermometers is ± 0.2 °C (± 0.4 °F), whereas for mercury-in-glass and electronic
thermometers, the requirement per ASTM Standards E 667-86 and E 1112-86 is ± 0.1 °C
(± 0.2 °F).
This product conforms to the provisions of the EC directive 93/42/EEC (Medical Device
Directive).
A clinical summary is available upon request.
ANSI/AAMI STD ES60601-1, UL STD 60601-1, CAN/CSA STD C22.2 No. 60601.1, IEC 60601-1
and EN 60601-1; 2nd and 3.1 Editions.
Medical electrical equipment— Part 1: General requirements for basic safety and essential
performance
Meets CB Scheme
BS EN 60601-1-2:2015, IEC 60601-1-2:2014
Medical electrical equipment—Part 1–2: General requirements for basic safety and essential
performance—Collateral standard: Electromagnetic compatibility—Requirements and test
IEC/EN 62304:2006 +A1: 2015 Medical device software—Software life cycle processes
IEC/EN 62366-1:2015 (IEC 60601-1-6:2010+A1: 2013) Medical devices—Application of usability
engineering to medical devices
ISO 14971:2012 Medical devices—Application of risk management to medical devices
ISO 80601-2-56:2009 (EN 80601-2-56: 2012) Medical electrical equipment—Part 2–56: Particular
requirements for basic safety and essential performance of clinical thermometers for body
temperature measurement
ISO 10993-1:2009 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing
(includes US FDA Blue book memo G95-1-100 Title)
GBT 21417.1:2008
MEDICAL ELECTRICAL EQUIPMENT needs special precautions regarding EMC. For detailed
description of EMC requirements please contact an authorized local Service Centre.
Portable and mobile RF communications equipment can affect MEDICAL ELECTRICAL
EQUIPMENT
Internally powered ME equipment.
Continuous operation.
Not protected against ingress of water.
IPX0
32


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