.. _dhf-index:

=======================================
Design History File — Master Index
=======================================

.. list-table:: Document Control
   :widths: 25 75
   :stub-columns: 1

   * - Document ID
     - DHF-001
   * - Version
     - 1.0
   * - Date
     - 2026-03-22
   * - Author
     - camt053 Engineering
   * - Status
     - Released
   * - Classification
     - Internal

Purpose
-------

This Design History File (DHF) provides ISO 13485:2016-equivalent documentation
rigor for the **camt053** library — a Python library that reads ISO 20022 camt
Bank-to-Customer Cash Management messages (camt.052 Account Report, camt.053
Bank to Customer Statement, camt.054 Debit Credit Notification), extracts booked
entries by return reason code, and generates validated reversing entries.

While camt053 is financial infrastructure software rather than a medical device,
this DHF applies the same systematic design control discipline required by
ISO 13485:2016 clause 7.3 to demonstrate that the software was developed under
a controlled, traceable, and verified process. This approach satisfies
institutional audit requirements and establishes readiness for regulated
deployment environments, including Banking-as-a-Service (BaaS) and embedded
finance platforms.

Scope
-----

- **Product:** camt053 Python library
- **Version:** 0.0.5
- **Message standard:** ISO 20022 camt.052/053/054 Bank-to-Customer Cash Management (read; reversing entries emitted as camt.053.001.14)
- **IEC 62304 safety classification:** Class A (voluntary Class C processes applied)

Document Set
------------

.. list-table::
   :header-rows: 1
   :widths: 10 15 45 30

   * - #
     - ID
     - Document
     - ISO 13485 Clause
   * - 1
     - DHF-001
     - :ref:`dhf-index` (this document)
     - 7.3.10 (DHF overview)
   * - 2
     - DHF-002
     - :ref:`dhf-design-development-plan`
     - 7.3.1, 7.3.2
   * - 3
     - DHF-003
     - :ref:`dhf-software-requirements`
     - 7.3.3
   * - 4
     - DHF-004
     - :ref:`dhf-software-architecture`
     - 7.3.4
   * - 5
     - DHF-005
     - :ref:`dhf-risk-management`
     - 7.3.4, ISO 14971, IEC 62304
   * - 6
     - DHF-006
     - :ref:`dhf-verification-validation`
     - 7.3.5, 7.3.6, 7.3.7
   * - 7
     - DHF-007
     - :ref:`dhf-traceability-matrix`
     - 7.3.10
   * - 8
     - DHF-008
     - :ref:`dhf-design-review-change-control`
     - 7.3.4, 7.3.9
   * - 9
     - DHF-009
     - :ref:`dhf-configuration-management`
     - 7.3.8, 4.2.3

.. toctree::
   :maxdepth: 2
   :caption: DHF Documents

   design-development-plan
   software-requirements-specification
   software-architecture-document
   risk-management-file
   verification-validation-plan
   traceability-matrix
   design-review-change-control
   configuration-management-design-transfer

Standards Compliance Cross-Reference
-------------------------------------

.. list-table::
   :header-rows: 1
   :widths: 30 20 50

   * - Standard
     - Clause
     - DHF Coverage
   * - ISO 13485:2016
     - 7.3.1
     - DHF-002 Design and Development Planning
   * - ISO 13485:2016
     - 7.3.2
     - DHF-002 Design and Development Inputs
   * - ISO 13485:2016
     - 7.3.3
     - DHF-003 Software Requirements Specification
   * - ISO 13485:2016
     - 7.3.4
     - DHF-004 Software Architecture, DHF-005 Risk Management
   * - ISO 13485:2016
     - 7.3.5
     - DHF-006 Verification and Validation Plan
   * - ISO 13485:2016
     - 7.3.6
     - DHF-006 Design Validation
   * - ISO 13485:2016
     - 7.3.7
     - DHF-008 Design Review and Change Control
   * - ISO 13485:2016
     - 7.3.8
     - DHF-009 Configuration Management and Design Transfer
   * - ISO 13485:2016
     - 7.3.9
     - DHF-008 Design Changes
   * - ISO 13485:2016
     - 7.3.10
     - DHF-001 (this document), DHF-007 Traceability Matrix
   * - ISO 13485:2016
     - 4.2.3
     - DHF-009 Document Control
   * - ISO 14971:2019
     - All
     - DHF-005 Risk Management File
   * - IEC 62304:2006+A1
     - All
     - DHF-002 through DHF-009

Approval Signatures
-------------------

.. list-table::
   :header-rows: 1
   :widths: 25 25 25 25

   * - Role
     - Name
     - Signature
     - Date
   * - Lead Engineer
     -
     -
     -
   * - Quality Assurance
     -
     -
     -
   * - Regulatory Affairs
     -
     -
     -