EN 1865-3:2012/FprA1

Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher

This European Standard specifies minimum requirements for the design and performance of heavy duty stretchers used in road ambulances for the treatment and transportation of patients. It aims to ensure patient safety and minimize the physical effort required by staff operating the equipment.

Krankentransportmittel im Krankenkraftwagen - Teil 3: Schwerlastkrankentrage

Equipement d'ambulances pour le transport de patients - Partie 3 : Brancard bariatrique

Oprema za ravnanje s pacienti v reševalnih vozilih - 3. del: Bolniška nosila za večje obremenitve

General Information

• Status: Not Published
• ICS: 11.160 - First aid
• Technical Committee: CEN/TC 239 - Rescue systems
• Drafting Committee: CEN/TC 239/WG 1 - Medical vehicles and their equipment - Stretchers and other patient handling equipment
• Current Stage: 5060 - Closure of Vote - Formal Approval
• Start Date: 19-Nov-2014
• Due Date: 02-Aug-2015
• Completion Date: 19-Nov-2014
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 1865-3:2012/kFprA1:2014 - Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher

Relations

• Merged Into: EN 1865-3:2012+A1:2015 - Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher
• Effective Date: 18-Jan-2023
• Amends: EN 1865-3:2012 - Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher
• Effective Date: 20-Nov-2013

Overview

EN 1865-3:2012/FprA1 is a CEN draft amendment for patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher (bariatric stretcher). The standard sets minimum design and performance requirements to ensure patient safety and to reduce the physical effort required by ambulance staff when treating and transporting heavy or bariatric patients. It also aligns the stretcher requirements with medical-device safety, usability and risk-management standards and the essential requirements of EU medical device directives.

Key topics and technical requirements

• Scope and objective: Minimum requirements for heavy duty stretchers used in road ambulances, focusing on safety, ergonomics and operator effort reduction.
• Design and dimensions: The amendment updates dimensional references and clarifies sizing requirements relevant to bariatric transport (see normative clauses for exact figures).
• Mass and load considerations: A listed mass value in the document is updated (from 65 kg to 80 kg in the amendment), reflecting changes to mass-related requirements or test references.
• Power source & EMC: References updated to specific electrical and electromagnetic compatibility standards (e.g., EN 60601-1-2:2007) for electrically powered functions.
• Usability and risk management: References to usability engineering (EN 62366:2008) and risk management (EN ISO 14971:2012) are included to ensure safe operation and lifecycle risk control.
• Flammability and toxic gases: Flammability testing references updated (e.g., EN 597-1:1994) to address material safety in confined ambulance environments.
• Marking and labelling: Labelling and symbol standards updated to EN ISO 15223-1:2012 and EN 1041:2008 for medical device markings and user information.
• Regulatory linkage: The amendment clarifies relationships to EU Directive 93/42/EEC on Medical Devices and other normative documents.

Practical applications

• Ambulance manufacturers integrating heavy duty/bariatric stretchers into new vehicle builds.
• Medical device designers and R&D teams developing powered or manual heavy duty stretchers.
• Emergency Medical Services (EMS) procurement and clinical engineering evaluating compliance and compatibility with ambulance layouts.
• Test laboratories and conformity assessors verifying performance, EMC, flammability and labelling against the referenced standards.
• Regulators and compliance officers referencing the standard for conformity with EU medical device requirements.

Related standards and keywords

• Related standards: EN 1865-1:2010 (general patient handling), EN 1789:2007+A1:2010 (ambulance requirements), EN 62366:2008, EN ISO 14971:2012, EN 60601-1-2:2007, EN ISO 15223-1:2012.
• SEO keywords: heavy duty stretcher, bariatric stretcher, road ambulances, patient handling equipment, EN 1865-3:2012/FprA1, ambulance equipment standard, CEN medical device standard, EMS stretcher requirements.

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2014
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Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher
Krankentransportmittel im Krankenkraftwagen - Teil 3: Schwerlastkrankentrage
Equipement d'ambulances pour le transport de patients - Partie 3 : Brancard bariatrique
Ta slovenski standard je istoveten z: EN 1865-3:2012/FprA1
ICS:
11.160 3UYDSRPRþ First aid
43.160 Vozila za posebne namene Special purpose vehicles
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
FINAL DRAFT
EN 1865-3:2012
NORME EUROPÉENNE
EUROPÄISCHE NORM
FprA1
June 2014
ICS 11.160
English Version
Patient handling equipment used in road ambulances - Part 3:
Heavy duty stretcher
Equipement d'ambulances pour le transport de patients - Krankentransportmittel im Krankenkraftwagen - Teil 3:
Partie 3 : Brancard bariatrique Schwerlastkrankentrage
This draft amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/TC 239.
This draft amendment A1, if approved, will modify the European Standard EN 1865-3:2012. If this draft becomes an amendment, CEN
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment
into the relevant national standard without any alteration.

This draft amendment was established by CEN in three official versions (English, French, German). A version in any other language made
by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has
the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 1865-3:2012/FprA1:2014 E
worldwide for CEN national Members.

Contents Page
Foreword .3
1 Modification to the Introduction .4
2 Modifications to Clause 2, Normative References .4
3 Modification to Clause 3, Terms and definitions .4
4 Modifications to 4.1, General .4
5 Modifications to 4.2, Dimensions .4
6 Modification to 4.3, Mass .5
7 Modification to 4.5.4, Power source.
...