8.7.6
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 - Dry and Hot Lips Tube Sealer must
meet the safety requirements of IEC/EN 61010-1 or relevant harmonized standards.
Within the European Union, connected equipment must be CE-marked.
8 Reference information
8.7 Regulatory information
8.7.6 Other regulations and standards
Sterile Tube Fuser - Dry and Hot Lips Tube Sealer Operating Instructions 28964139 AG
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