Steris InnoWave Pro, Operator'S Manual

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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 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 14971:2019 Medical devices — Application of risk management to
medical devices.
ISO 15223-1:2021 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 15883-2:2006 Washer-disinfectors — Part 2: Requirements and tests for
washer-disinfectors employing thermal disinfection for
surgical instruments, anesthetic equipment, bowls, dishes,
receivers, utensils, glassware, etc.
ISO 17664:2017 Processing of health care products — Information to be
provided by the medical device manufacturer for the
processing of medical devices.
ISO 20417:2021 Medical devices — Information supplied by the
manufacturer of medical devices.
IEC
61010-1:2010+AMD1:2016 Safety requirements for electrical equipment for
measurement, control, and laboratory use — Part 1:
General requirements.
UL 61010-1, 3rd Edition May
11 2012, Revised July 19 2019 Safety requirements for electrical equipment for
measurement, control, and laboratory use — Part 1:
General requirements.
Table 2.1 Applied Standards
1
Complies with FCC and ISED official limits. Testing in accordance with CFR Title 47:
Telecommunication, Part 15 - Radio Frequency Devices, Subpart A - General.
GENERAL INFORMATION 17
InnoWave Pro Sonic Irrigator Operator Manual