Page 9 of 75 Pages
3.2
Operating Conditions
The autoclave is intended to work in ‘indoor’ conditions only.
Only autoclavable materials shall be used.
The environment shall not exceed an ambient temperature range of
5
º
C (41
º
F)-40
º
C (104
º
F) and a relative humidity of 85%
respectively.
The operation altitude shall not be over 2000 meters (6561 feet)
(ambient pressure shall not be lower than 80 kPa (11.6 psi)).
The autoclave shall not be used in a manner not specified in this
manual!
Do not use the autoclave in the presence of dangerous gases.
The packed or unpacked device shall be stored in ‘indoor’ conditions.
Operate the autoclave only in the manner specified in the manual. If
the equipment is used in a manner not specified by the manufacturer,
the protection provided by the equipment may be impaired.
Caution!
Waste water should be brought into the public net in accordance with
the local rules or requirements i.e. only non-hazardous liquids shall
be disposed in public sewage!
3.3
Directives and Standards
Every autoclave meets the provisions of the following Directives and is
constructed in compliance with the following Standards:
3.3.1
Technical Standards
1. AAMI/ANSI ST 8.
2. ASME Code Sec. VIII for Pressure Vessels.
3. Pressure Equipment Directive 97/23/EEC.
4. EN
285:2006 ―
Sterilization , Steam sterilizers , Large
sterilizers
5. IEC/UL 61010A-
1 ― electrical equipment for laboratory
use; general requirements.
6.
IEC 61010-2-
040 ― particular requirements for sterilizers
and washer disinfectors used to treat medical materials.
7.
ISO 17665 ― 1:2006
Sterilization of health care products
moist heat.
3.3.2
Quality standards
The manufacturing plant meets the following quality standards:
1. EN ISO 9001:2008– Quality System
2. ISO 13485:2003 – Quality systems – Medical devices.
Summary of Contents for 3840 ELVG-D
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