— A Word from STERIS
4
920515770_J
Vision® 1300 Series
Operator Manual
• Particular Requirements for Sterilizers and Washer/Disinfectors used to Treat Medical Materials:
◻ Canadian Standards Association (CSA): CAN/CSA-C22.2 No. 61010-2-040, Second Edition (2007).
◻ EN/IEC 61010-2-040, First Edition (2005).
The Vision 1321 Cart and Utensil Washer/Disinfector, the Vision 1327 Cart and Utensil Washer/Disinfector and the
Vision 1330L Cart and Utensil Washer/Disinfector meet the following performance requirements:
• General requirements, terms, definitions and tests:
◻ EN ISO 15883-1:2006.
◻ ANSI/AAMI ST15883-1:2009.
◻ CAN/CSA Z15883-1:2009.
• Requirements and tests for washer/disinfectors employing thermal disinfection for surgical instruments,
anesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc.:
1
◻ EN ISO 15883-2:2006.
◻ ANSI/AAMI ST15883-2:2013.
◻ CAN/CSA Z15883-2:2009.
• Requirements and tests for general purpose washer-disinfectors employing thermal disinfection for non-invasive
medical devices, washbowls, utensils, transit containers, etc.:
◻ EN ISO 15883-6:2011.
The Vision 1321 Cart and Utensil Washer/Disinfector, the Vision 1327 Cart and Utensil Washer/Disinfector and the
Vision 1330L Cart and Utensil Washer/Disinfector meet the following EMC/EMI regulations:
• Code of Federal Regulation, CFR 47 (2012) – FCC PART 15, SUBPART B Class A – Unintentional Radiators for Use
in Commercial and Industrial Areas.
• Industry Canada, ICES-001 – Industrial, Scientific and Medical (ISM) Radio Frequency Generators, Issue 4, June
2006.
• EN 61326-1: 2006 – Electrical Equipment for Measurement, Control and Laboratory Use - EMC Requirements,
Part 1: General Requirements.
• CISPR 11:2009 +A1:2010 / EN 55011:2009 +A1:2010, Class A, Group 1 – Limits and methods of measurements of
radio disturbance characteristics of industrial, scientific and medical (ISM) radio-frequency equipment.
The Vision 1321 Cart and Utensil Washer/Disinfector, the Vision 1327 Cart and Utensil Washer/Disinfector and the
Vision 1330L Cart and Utensil Washer/Disinfector meet the following Governing Directives for affixing of the CE mark:
• Medical Device Directive 93/42/EEC as amended by 2007/47/EC.
• Machinery Directive 2006/42/EC.
• EMC Directive 2004/108/EC - Class A, Group 1 ISM Equipment.
• RoHS Directive 2011/65/EU.
1. On INSTRUMENT cycles only (Instrument Washing option).
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