8.6.7
Other regulations and standards
Introduction
This section describes the standards that apply to the product.
Additional design considerations
For additional design considerations, such as ASME-BPE, GMP and cGMPs information
refer to the product-specific specification information provided in the documentation
package delivered with each equipment.
Regulatory compliance of connected
equipment
Any equipment connected to Sterile Tube Fuser - Wet must meet the safety require-
ments of IEC/EN 61010-1 or relevant harmonized standards. Within the European
Union, connected equipment must be CE-marked.
8 Reference information
8.6 Regulatory information
8.6.7 Other regulations and standards
84
Sterile Tube Fuser - Wet Operating Instructions 29024010 AD
