2.5 Applied Standards
Standards that are applicable, subject to regional requirements and model variants made
available in those regions, are shown below.
Standard Title
ANSI C63.4-2014
1
American National Standard for Methods of Measurement of
Radio-Noise Emissions from Low-Voltage Electrical and
Electronic Equipment in the Range of 9 kHz to 40 GHz.
EN 1041:2008+AMD1:2013 Information supplied by the manufacturer of medical devices.
EN 1717:2000 Protection against pollution of potable water in water installations
and general requirements of devices to prevent pollution by back
flow.
ISO 13485:2016 Medical devices — Quality management systems.
ISO 14971:2007
ISO 14971:2019
Medical devices — Application of risk management to medical
devices.
ISO 15223-1:2016 Medical devices — Symbols to be used with medical device
labels, labeling and information to be supplied — Part 1: General
requirements
ISO 15883-1:2006 +AMD1:2014 Washer-disinfectors — Part 1: General requirements, terms and
definitions and tests
ISO 17664:2017 Processing of health care products — Information to be provided
by the medical device manufacturer for the processing of medical
devices.
IEC 61010-1:2010+AMD1:2016
UL 61010-1, 3rd Edition 2015
Safety requirements for electrical equipment for measurement,
control, and laboratory use — Part 1: General requirements.
CAN/CSA-C22.2
No. 61010-1-12, 3rd Edition 2015
Safety requirements for electrical equipment for measurement,
control, and laboratory use — Part 1: General requirements.
IEC 61010-2-040:2015 Safety requirements for electrical equipment for measurement,
control, and laboratory use — Part 2-040: Particular requirements
for sterilizers and washer-disinfectors used to treat medical
materials.
Table 2.1 Applied Standards
1
Complies with FCC and ISED official limits. Testing in accordance with CFR Title 47: Telecommunication,
Part15 - Radio Frequency Devices, Subpart A - General.
14 GENERAL INFORMATION
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