Steris InnoWave PCF Sonic Irrigator, Operator'S Manual

Page: 27 / 168

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 —
Requirements for regulatory purposes (ISO 13485:2016)
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 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.
CAN/CSA-C22.2
No. 61010-1-12 (2012-05), 3rd
Edition, with revisions through
2018-11 Safety requirements for electrical equipment for
measurement, control, and laboratory use — Part 1:
General requirements.
IEC 61010-2-040:2020, Ed. 3.0 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 2.2 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 19
InnoWave PCF Sonic Irrigator Operator Manual