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Part of Applicability of DCB 0129 and DCB 0160

NHS Digital recommendation

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Terms and definitions

Defined terms are presented between apostrophes.

NHS Digital recommends that DCB 0129 and DCB 0160 are adopted in all circumstances where 'Digital products' are developed or deployed to support health or social care services.

The standards represent best practice and provide a framework for 'Clinical risk management'. The application of risk will reduce the likelihood of harm outcomes.

The only exception to this recommendation would be in the context of software which is incorporated directly into a physical 'Medical device', for example software based drug dosing calculations 'Implemented' in an infusion pump.

In no circumstances do DCB 0129 or DCB 0160 supersede / replace the regulatory requirements associated with 'Medical devices'.

Last edited: 27 May 2022 9:49 am

Previous Chapter

Background

Next Chapter

Step by step guidance

Chapters

  1. Applicability of DCB 0129 and DCB 0160
  2. Terms and definitions
  3. Background
  4. NHS Digital recommendation
  5. Step by step guidance