DIN EN ISO 8835-4 2009-07 PDF

Full title and description

STB DIN EN ISO 8835-4:2009-07 — Inhalational anaesthesia systems — Part 4: Anaesthetic vapour delivery devices. This designation is the European / national adoption (DIN / STB) of ISO 8835-4, giving specific safety and performance requirements for anaesthetic vapour delivery devices (AVDDs) intended as components of anaesthetic systems and to be operator‑attended during use.

Abstract

Specifies particular requirements that supplement the general requirements of IEC 60601-2-13 for the basic safety and essential performance of anaesthetic vapour delivery devices (AVDDs). Includes electrical, mechanical, labelling and performance tests, plus normative/informative annexes (for example guidance on colour coding and flammability testing). The EN/DIN adoption was published in 2009 and has since been superseded by newer work on anaesthetic workstations and related medical electrical equipment standards.

General information

• Status: Withdrawn / Superseded (replaced by ISO 80601-2-13 series for anaesthetic workstations and related particular requirements).
• Publication date: DIN EN ISO adoption published July 2009 (designation shown as 2009-07 / 01‑07‑2009 in national lists). The original ISO edition is ISO 8835‑4:2004 (published June 2004).
• Publisher: International Organization for Standardization (base text ISO 8835-4:2004); national adoption published via DIN / CEN member bodies (DIN EN ISO designation).
• ICS / categories: 11.040.10 — Anaesthesia, respiratory and resuscitation equipment.
• Edition / version: ISO edition 1 (ISO 8835-4:2004); EN / DIN adoption shown as EN ISO 8835-4:2009 (national publication 2009-07).
• Number of pages: ISO 8835-4:2004 original document listed as 18 pages (ISO record); national EN/DIN PDF publications list variable pagination for the adopted text (commonly reported in national catalogues as approximately 27–35 pages for the EN/DIN publication).

Scope

This part of ISO 8835 specifies particular requirements for the essential performance and safety of anaesthetic vapour delivery devices (AVDDs) that form part of inhalational anaesthesia systems and are intended to be continuously operator‑attended. It is intended to be used alongside and to supplement the general requirements of IEC 60601-2-13; it excludes AVDDs for use with flammable anaesthetics (see annexes) and certain draw‑over vaporizers intended for breathing systems.

Key topics and requirements

• Essential performance and functional requirements for AVDDs (accuracy, delivery range, controls and indicators).
• Electrical safety and applied parts requirements where they modify or replace clauses of IEC 60601-1 and IEC 60601-2-13.
• Mechanical strength, moving parts, housings, protection against leakage and contamination.
• Labelling, user information, and recommended colour coding for anaesthetic vapour devices.
• Flammability testing and exclusion criteria for use with flammable anaesthetics (normative annex guidance).
• Bio‑compatibility, cleaning/sterilization guidance, electromagnetic compatibility (EMC) and alarm/performance verification tests.

Typical use and users

Primary users are medical device manufacturers (vaporizers/AVDDs), design and regulatory engineers, test laboratories, hospital biomedical engineering teams, procurement and compliance officers, and notified bodies assessing conformity to European Medical Device Regulations and safety standards for anaesthesia equipment. Clinicians (anaesthetists) may consult the standard for device labelling and performance expectations.

Related standards

Closely related and successor standards include ISO 8835 series (other parts), IEC 60601-1 (general electrical safety), IEC 60601-2-13 (particular requirements for anaesthetic workstations — referenced), and the newer ISO/EN series for anaesthetic workstations and medical electrical equipment, notably ISO 80601-2-13 (which superseded ISO 8835-4 requirements for many applications). National EN adoptions (EN ISO 8835-2/3/5:2009 etc.) are part of the same family.

Keywords

anaesthetic vapour delivery device, AVDD, inhalational anaesthesia systems, vaporizers, ISO 8835-4, EN ISO 8835-4, IEC 60601-2-13, medical electrical equipment, anaesthesia safety, colour coding, flammability testing.

FAQ

Q: What is this standard?

A: ISO 8835-4 (adopted as EN/DIN EN ISO 8835-4:2009) is the part of the ISO 8835 series that sets specific requirements for anaesthetic vapour delivery devices (AVDDs) used in inhalational anaesthesia systems.

Q: What does it cover?

A: It covers essential performance, safety, electrical and mechanical requirements, labelling and user information, recommended colour coding, and specified tests (including guidance on flammability) for AVDDs that are components of anaesthesia systems and are continuously operator‑attended. It is to be used together with applicable IEC 60601 series requirements.

Q: Who typically uses it?

A: Device manufacturers (vaporizers/AVDDs), design and test engineers, conformity assessment bodies, biomedical engineering teams, hospital procurement and regulatory affairs specialists, and clinicians referencing device performance and labelling.

Q: Is it current or superseded?

A: The ISO 8835-4 text (ISO 8835-4:2004 / EN ISO 8835-4:2009 adoption) has been withdrawn and its scope has been overtaken by newer particular requirements for anaesthetic workstations and equipment (notably ISO 80601-2-13 and later EN/ISO adoptions). Users should consult ISO 80601-2-13 and the latest EN/ISO publications for current essential performance and safety requirements.

Q: Is it part of a series?

A: Yes — it is Part 4 of the ISO 8835 series (system for inhalational anaesthesia). Other parts of the series address different components of anaesthesia systems; the EN/ISO adoptions for parts 1–5 and related amendments are typically listed alongside this part in national standards catalogues.

Q: What are the key keywords?

A: Anaesthetic vapour delivery device (AVDD), vaporizers, inhalational anaesthesia, ISO 8835-4, EN ISO 8835-4, IEC 60601-2-13, ISO 80601-2-13, medical device safety, colour coding, flammability.