+1.1. The harmonised software components of an EHR system shall achieve the performance intended by …

1.1. The harmonised software components of an EHR system shall achieve the performance intended by …

1.1.

The harmonised software components of an EHR system shall achieve the performance intended by its manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose and their use does not put at risk patient safety.

1. Overview

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Summary Regulation

1.1 References

1.2 Identified Requirements

1.3 Related Standards

2. Identified Requirements

Requirements
Source Requirement

3. Related Standards

Standards
Source Requirement