GE AKTAprocess User Manual

International standards
Harmonized standard requirements fulfilled by this product are summarized in the table
below.
NotesDescriptionStandard
EN standard is
harmonized with
2006/95/EC
Safety requirements for electrical
equipment for measurement, control, and
laboratory use
EN 61010-1, IEC
61010-1, UL
61010-1,
CAN/CSA-C22.2
No. 61010-1
EN standard is
harmonized with
2004/108/EC
EMC emissions and immunity
requirements for electrical equipment for
measurement, control and laboratory
use. Emission according to CISPR 11,
Group 1, class A
EN 61326-1
EN ISO standard is
harmonized with
2006/42/EC
Safety of machinery. General principles
for design. Risk assessment and risk
reduction.
EN ISO 12100
Additional regulatory compliance
The table below lists additional regulatory requirements that are fulfilled by ÄKTAprocess.
NotesDescriptionRequirement
Applicable for systems
with steel piping
All steel piping welds, in-
cluding contact welds
ASME-BPE
Applicable for polymeric
materials in contact with
process stream
United States Pharma-
copia (USP)
Bio reactivity testing, In
Vivo
USP <88> class VI
Applicable for polymeric
materials in contact with
process stream
Code of Federal Regula-
tions, Food and Drugs Title
21, Part 177 FDA
CFR 21 § 177 FDA
ÄKTAprocess Operating Instructions 29-0252-49 AA 11
1 Introduction
1.3 Regulatory information

GE AKTAprocess Specifications

General

Brand	GE
Model	AKTAprocess
Category	Laboratory Equipment
Language	English