DIN EN ISO 13485 Berichtigung 1 2017-07 PDF

Full title and description

DIN EN ISO 13485 — Berichtigung 1:2017‑07. Corrigendum to DIN EN ISO 13485:2016 (Medical devices — Quality management systems — Requirements for regulatory purposes). This document contains the first official correction sheet (Berichtigung 1) published in July 2017 to amend and clarify the German/EN adoption of ISO 13485:2016.

Abstract

This corrigendum (Berichtigung 1:2017‑07) modifies DIN EN ISO 13485:2016 by issuing editorial corrections and clarifications to the published 2016 text. It does not constitute a full revision of the standard but provides corrections that were subsequently incorporated into later national/adopted editions. The corrigendum has since been incorporated into the consolidated 2021 edition of DIN EN ISO 13485.

General information

• Status: Withdrawn / replaced (corrigendum to 2016 edition; later incorporated into the 2021 edition).
• Publication date: 2017-07 (July 2017).
• Publisher: Deutsches Institut für Normung (DIN) — national adoption of EN/ISO text.
• ICS / categories: 03.100.70 (Management systems), 11.040.01 (Medical equipment in general).
• Edition / version: Berichtigung 1 to DIN EN ISO 13485:2016 (Corrigendum 1:2017‑07).
• Number of pages: 23 (typical DIN pagination for the corrigendum PDF).

Scope

This document is a corrigendum that amends the German/EN adoption of ISO 13485:2016. Its scope is limited to correcting, clarifying and aligning text in the published EN/ISO 13485:2016 edition (German version), ensuring the adopted text accurately reflects the intended ISO/EN content for regulatory and conformity assessment purposes. It is not a technical revision introducing new normative requirements.

Key topics and requirements

• Editorial corrections to the published DIN EN ISO 13485:2016 text (typos, cross‑references, minor clarifications).
• Clarifications to wording that affect interpretation of clauses for regulatory alignment (no substantive normative changes to core requirements reported).
• Formal adoption as a correction sheet to be used alongside DIN EN ISO 13485:2016 until consolidated in a later edition (later integrated into the 2021 consolidated edition).

Typical use and users

Used by medical device manufacturers, regulatory affairs professionals, conformity assessment bodies, notified bodies, certification bodies, and quality managers to ensure the national/EN text of ISO 13485:2016 is followed accurately where editorial corrections apply. It served as a reference during the transition from the 2016 text toward the consolidated 2021 edition.

Related standards

Main related documents include ISO 13485:2016 (base international standard), the EN/EN‑ISO adoption EN ISO 13485:2016 and subsequent Amendment/Corrigenda (e.g., EN ISO 13485:2016/AC and consolidated editions), and the later DIN EN ISO 13485:2021 which incorporated corrigenda and editorial updates. National adoption/corrigenda from other bodies (NEN, NSAI, etc.) mirror the same corrections.

Keywords

ISO 13485, DIN EN ISO 13485, Berichtigung 1, corrigendum, medical devices, quality management systems, regulatory requirements, correction sheet, 2017‑07.

FAQ

Q: What is this standard?

A: It is the first corrigendum (Berichtigung 1:2017‑07) published to the German/EN adoption of ISO 13485:2016, providing official corrections and clarifications to the text of DIN EN ISO 13485:2016.

Q: What does it cover?

A: It covers editorial corrections and clarifications to the adopted 2016 EN/ISO text (DIN EN ISO 13485:2016). The corrigendum addresses wording, cross‑references and similar non‑substantive issues to ensure accuracy of the national/EN published text.

Q: Who typically uses it?

A: Medical device manufacturers, quality and regulatory managers, notified bodies and certification bodies consult corrigenda like this to ensure their QMS documentation and compliance activities reference the corrected national/EN text.

Q: Is it current or superseded?

A: The corrigendum itself has been superseded/assembled into the consolidated DIN EN ISO 13485:2021 edition; users should refer to the 2021 consolidated edition for the current consolidated text. The corrigendum remains a historical amendment to the 2016 edition.

Q: Is it part of a series?

A: Yes — it is a correction sheet associated with the EN/ISO 13485:2016 family (corrigenda/amendments and later consolidated editions). National bodies produced equivalent corrigen‑da (e.g., NEN correction sheets) as part of the EN/ISO publication process.

Q: What are the key keywords?

A: ISO 13485, corrigendum, Berichtigung, medical devices, quality management, regulatory requirements, DIN, EN ISO, 2017‑07.