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PD IEC TS 81001-2-2:2025 Health software and health IT systems safety, effectiveness and security - Coordination. Guidance for the implementation, disclosure and communication of security needs, risks and controls >
PD IEC TS 81001-2-2:2025 Health software and health IT systems safety, effectiveness and security - Coordination. Guidance for the implementation, disclosure and communication of security needs, risks and controls, 2025
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- CONTENTS
- FOREWORD
- INTRODUCTION
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Use of security capabilities [Go to Page]
- 5 Security capabilities [Go to Page]
- 6 Additional supporting information [Go to Page]
- 7 Examples of some security capabilities [Go to Page]
- Figure 2 – Sample Structure for “Medical device2”
- 8 References and other resources [Go to Page]
- Table 1 – Example SBOM for “Medical device2” [Go to Page]
- Annex A (informative) Sample scenario showing the exchange of security information [Go to Page]
- Annex B (informative) Examples of regional specification on a few security capabilities
- Annex C (informative) Guidance for selecting security controls to satisfy the security capabilities [Go to Page]
- Annex D (informative) Security capability and additional security information mapping to C-I-A-A-A
- Table D.1 – Sample mapping by a hypothetical HDO
- Bibliography
- Alphabetized index of defined terms
- Figure 1 – Health software Field of Application as shown in IEC 81001-5-1 [3] [Go to Page]