VDE 0750-2-13 A2 DIN EN ISO 80601-2-13 A2 2020-06 PDF

Full title and description

STB VDE 0750-2-13 A2 / DIN EN ISO 80601-2-13 A2: Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation; Amendment 2 (published June 2020). This document is the German-language VDE/DIN adoption of ISO 80601-2-13 with Amendment 2 and updates normative references and certain test/marking requirements for anaesthetic workstations.

Abstract

This amendment (A2) to EN ISO 80601-2-13 provides changes to the normative references to related IEC/ISO collateral standards, updates requirements for rough handling tests and other test apparatus, and adjusts warnings, instructions and design documentation requirements for anaesthetic workstations. It was published in June 2020 as the German version and later replaced by the consolidated 2022 edition.

General information

• Status: Withdrawn / replaced (superseded by DIN EN ISO 80601-2-13:2022-10).
• Publication date: 2020-06 (June 2020).
• Publisher: VDE Verlag (German adoption / DIN national body).
• ICS / categories: 11 — Health care technology; medical electrical equipment / medical devices (covers anaesthetic workstations and associated systems).
• Edition / version: Amendment 2 (A2) to EN ISO 80601-2-13 (ISO 80601-2-13:2011/Amd 2:2018; German version EN ISO 80601-2-13:2012/A2:2019).
• Number of pages: 9 pages (typical published amendment length).

Scope

This amendment applies to the particular safety and essential performance requirements for anaesthetic workstations used to administer inhalational anaesthesia under continuous attendance by a professional operator. A2 updates the relationships to collateral standards of the IEC 60601 series, removes a previous normative link to IEC 60601-1-9, and specifies test requirements for rough handling and related items. Note: the amendment was provided as an interim update and later consolidated into the full 2022 edition of EN ISO 80601-2-13.

Key topics and requirements

• Update of normative references to related IEC/ISO collateral standards (alignment with IEC 60601-series).
• Removal of the normative reference to IEC 60601-1-9 in this amendment.
• Specification of test requirements for rough handling of equipment and related fixtures.
• Adjustments to warnings, safety information, user instructions and technical documentation expectations.
• Clarifications to device-level requirements relevant to components of anaesthesia delivery systems (alarms, monitoring, gas delivery interfaces and safety/protection devices).

Typical use and users

Used by medical device manufacturers (design and compliance teams) of anaesthetic workstations and related subsystems, test laboratories and conformity assessment bodies, hospital biomedical engineering/procurement teams, and regulatory/compliance specialists preparing technical files or CE marking documentation in jurisdictions that use EN/ISO harmonized standards. The amendment provided interim clarifications until adoption of the consolidated 2022 edition.

Related standards

Closely related to the IEC 60601 series of collateral and particular standards for medical electrical equipment (general safety and performance, usability, EMC, alarm systems, etc.). A2 specifically adjusted references to IEC 60601 collateral standards and removed its normative link to IEC 60601-1-9. The amendment itself has been replaced by DIN EN ISO 80601-2-13:2022-10, which consolidates A1/A2 changes.

Keywords

Anaesthetic workstation, medical electrical equipment, ISO 80601-2-13, amendment A2, VDE 0750-2-13, safety requirements, essential performance, IEC 60601, rough handling tests, warnings and instructions.

FAQ

Q: What is this standard?

A: It is Amendment 2 (A2) to EN ISO 80601-2-13, adopted in the German language as VDE 0750-2-13/A2, providing specific updates to the anaesthetic workstation particular standard. Published June 2020.

Q: What does it cover?

A: Particular requirements for the basic safety and essential performance of anaesthetic workstations — including changes to normative references, specified tests (e.g., rough handling), and updates to warnings, instructions and technical documentation.

Q: Who typically uses it?

A: Device manufacturers, testing and certification laboratories, regulatory and compliance teams, hospital biomedical engineers and procurement specialists, and anyone preparing conformity documentation for anaesthetic workstations.

Q: Is it current or superseded?

A: Superseded — the A2 amendment (2020-06) has been withdrawn and replaced by the consolidated DIN EN ISO 80601-2-13:2022-10 edition; transition periods ended at the national level (for example an indicated transition end date of 2022-12-31 for the German adoption). Users should apply the 2022 consolidated edition for current compliance.

Q: Is it part of a series?

A: Yes — it is a "Part 2-13" particular standard within the ISO/IEC 80601/60601 family addressing medical electrical equipment; it is intended to be used alongside the applicable general and collateral standards of the IEC 60601 series.

Q: What are the key keywords?

A: Anaesthetic workstation, medical electrical equipment, amendment A2, VDE 0750-2-13, EN ISO 80601-2-13, safety, essential performance, IEC 60601.