oSIST prEN 1865-3:2026

• Abstract:

  This document 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.

• Status: Not Published
• Public Enquiry End Date: 30-Jul-2026
• ICS: 11.160 - First aid
• ICS: 43.160 - Special purpose vehicles
• Technical Committee: VAZ - Healthcare
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 05-Jun-2026
• Due Date: 23-Oct-2026
• Completion Date: 03-Aug-2026
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Mandate: M/575 AMD 2 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medicial devices in support of Regulation (EU) 2017746
• Ref Project: prEN 1865-3 - Patient handling equipment used in ambulances - Part 3: Heavy duty stretcher

• Revises: SIST EN 1865-3:2012+A1:2015 - Patient handling equipment used in road ambulances - Part 3: Heavy duty stretcher
• Effective Date: 20-Apr-2022

oSIST prEN 1865-3:2026 is the Slovenian adoption of the CEN draft European standard prEN 1865-3 for patient handling equipment used in ambulances. It specifies minimum design and performance requirements for a heavy duty stretcher used in road ambulances, with the aim of protecting the patient and reducing the physical effort needed from staff.

What does oSIST prEN 1865-3:2026 specify?

oSIST prEN 1865-3:2026 covers heavy duty stretchers for treatment and transport of patients in road ambulances. The document is organized into scope, normative references, terms and definitions, and a main requirements clause that also contains the verification methods.

Annex	What it covers
Annex ZA	Relationship between this European standard and the General Safety and Performance Requirements of Regulation (EU) 2017/745

Clause 4 is the technical core. It covers the general safety approach, the stretcher itself, dimensions and mass, loading capacity, frame and undercarriage, power source, lying part, restraint system, flammability, deformation and torsion checks, fixation, and wheel splaying. For a buyer or engineer, that means the document is mainly about product design, ambulance compatibility, and testable performance.

What are the key requirements of oSIST prEN 1865-3:2026?

oSIST prEN 1865-3:2026 requires a heavy duty stretcher that can be used safely in daily ambulance work and that supports patient care while limiting manual lifting. The most important points are the overall safety concept, the physical configuration of the stretcher, and the verification tests that prove the structure can withstand use.

Safety, ergonomics and patient handling

Clause 4.1 requires the stretcher to present no high level of risk when used and maintained according to the instructions for use, and any identified risk has to be reduced as far as possible. The stretcher must be mechanically assisted or power operated, free of sharp edges, and designed with patient restraint systems that secure the patient while still allowing treatment. It also requires design in line with EN 62366-1 for usability engineering, which matters because controls, layout and handling must be understandable and practical for ambulance crews.

Size, mass and loading capability

Clause 4.2.2 specifies the stretcher dimensions, and Clause 4.2.3 limits the mass of the stretcher system depending on whether the undercarriage is integrated, detachable or combined with the loading system. Clause 4.2.4 sets a minimum loading capacity and requires the maximum load to be stated. In practice, this tells a buyer whether the stretcher fits the vehicle layout, how much manual handling is involved, and whether it is intended for heavier patients.

Frame, undercarriage and power source

Clause 4.2.5 requires a sturdy, lightweight, non-twisting frame that can be locked against movement in several directions. The undercarriage needs stable wheels, braking, variable height and secure attachment to the stretcher, while Clause 4.2.6 requires fail-safe lowering, manual override if battery power is used, and charging from the vehicle or an external AC supply. For procurement and maintenance teams, this is the section that determines mechanical robustness and emergency fallback behavior.

Lying part, restraint system and cleaning

Clause 4.2.7 requires a flat, non-slip lying area with adjustable backrest and footrest, plus materials that support CPR and resist disinfectants and contamination. Clause 4.2.8 requires a harness and quick-release patient restraint(s) that meet the restraint test requirements referenced from EN 1789. In practice, these points affect patient comfort, access for treatment, infection control and safe transport.

Verification and durability tests

Clauses 4.2.9 to 4.2.14 combine requirements with test methods for flammability, permanent deformation of the frame and lying area, torsion resistance and wheel splaying. These tests show whether the stretcher keeps its shape and function under load, which matters for acceptance testing, type testing and product qualification.

What terms does oSIST prEN 1865-3:2026 define?

• Heavy duty stretcher - A stretcher designed for patients whose weight and/or dimensions exceed the operating capability of the stretchers defined in prEN 1865-1:2026 and EN 1865-2:2024.
• Cardiopulmonary resuscitation (CPR) - The document uses this as the treatment action the lying area and thorax area must still support during use.
• Medical Device Regulation (MDR) - Regulation (EU) 2017/745, which is the legal framework referenced in Annex ZA.
• Medical Device Directive (MDD) - The older framework named in the foreword as the previous basis for Annex ZA.
• Monoblock - An integrated stretcher and undercarriage system mentioned for mass and height-related requirements.
• European Committee for Standardization (CEN) - The organization that prepared the draft European standard.

Who uses oSIST prEN 1865-3:2026?

Manufacturers and designers use oSIST prEN 1865-3:2026 to design heavy duty stretchers that fit road ambulances and pass performance tests. Ambulance fleet buyers and quality managers use it to compare products, check ambulance compatibility and confirm stated load capacity. Test laboratories use it for verification tests, and ambulance operators use it to understand handling effort, restraint behavior and cleaning expectations.

What changed in oSIST prEN 1865-3:2026 from the previous edition?

Compared with EN 1865-3:2012+A1:2015, the foreword states these main changes:

• the series title was broadened from “road ambulances” to “ambulances”
• normative references were updated
• Annex ZA was revised from MDD to MDR
• mass distribution was specified
• the word label was removed from one requirement while the intent stayed the same
• the maximum height of the undercarriage for loading and unloading was removed
• a second battery became mandatory in case of power loss
• restraint system requirements were revised
• the requirements were aligned with other parts of the series
• clause numbering was updated throughout
• the flammability title was changed
• verification methods were moved into Clause 4
• the marking clause was deleted

Which standards are used with oSIST prEN 1865-3:2026?

Standard	What it contributes
EN 597-1:2015	Flammability test for the mattress material
EN 1789:2020+A1:2023	Road ambulance requirements and restraint test reference points
prEN 1865-1:2026	Baseline stretcher capability used for comparison
EN 1865-2:2024	Power assisted stretcher capability used for comparison
EN 62366-1:2015	Usability engineering for design and user interfaces

What does the oSIST prEN 1865-3:2026 document contain?

The document contains requirements that are paired with verification methods, especially in Clauses 4.2.10 to 4.2.14. It also includes Figures 1 to 3 showing the test setups for frame deformation, lying-area deformation and torsion resistance. Annex ZA contains Table ZA.1, which maps selected clauses to the General Safety and Performance Requirements of Regulation (EU) 2017/745.

SLOVENSKI STANDARD
01-julij-2026
Oprema za ravnanje s pacienti v reševalnih vozilih - 3. del: Bolniška nosila za večje
obremenitve
Patient handling equipment used in ambulances - Part 3: Heavy duty stretcher
Krankentransportmittel in Rettungsdienstfahrzeugen - Teil 3: Schwerlastkrankentrage
Équipements pour le transport de patients dans les ambulances - Partie 3 : Brancard
bariatrique
Ta slovenski standard je istoveten z: prEN 1865-3
ICS:
11.160 Prva pomoč 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.

DRAFT
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2026
ICS 11.160 Will supersede EN 1865-3:2012+A1:2015
English Version
Patient handling equipment used in ambulances - Part 3:
Heavy duty stretcher
Équipements pour le transport de patients dans les Krankentransportmittel in Rettungsdienstfahrzeugen -
ambulances - Partie 3 : Brancard bariatrique Teil 3: Schwerlastkrankentrage
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee
CEN/TC 239.
If this draft becomes a European Standard, CEN members are bound to comply with the CEN/CENELEC Internal Regulations
which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

This draft European Standard 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye 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: Rue de la Science 23, B-1040 Brussels
© 2026 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 1865-3:2026 E
worldwide for CEN national Members.

Contents Page
European foreword . 3
Introduction . 5
1 Scope . 6
2 Normative references . 6
3 Terms and definitions . 6
4 Requirements . 6
4.1 General. 6
4.2 Heavy duty stretcher . 7
4.2.1 General. 7
4.2.2 Dimensions. 7
4.2.3 Mass . 8
4.2.4 Loading capacity . 8
4.2.5 Frame . 8
4.2.6 Power source . 9
4.2.7 Lying part of the stretcher . 9
4.2.8 Restraint system . 10
4.2.9 Flammability . 10
4.2.10 Deformation of the frame . 10
4.2.11 Fixation . 11
4.2.12 Deformation of the lying area . 11
4.2.13 Resistance to torsion . 11
4.2.14 Splaying of the wheels . 12
Annex ZA (informative) Relationship between this European standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/745 aimed to be covered . 13
Bibliography . 15

European foreword
This document (prEN 1865-3:2026) has been prepared by Technical Committee CEN/TC 239 “Rescue
systems”, the secretariat of which is held by DIN.
This document is currently submitted to the CEN Enquiry.
This document will supersede EN 1865-3:2012+A1:2015.
Compared to EN 1865-3:2012+A1:2015, the following main technical changes were made:
a) Main title of EN 1865 series changed from “Patient handling equipment used in road ambulances” to
“Patient handling equipment used in ambulances”;
b) Normative references updated;
c) Annex ZA revised to show relationship to Medical Device Regulations (MDR) instead of Medical
Device Directive (MDD);
d) Distribution of mass (4.2.3) specified;
e) The use of the word label removed, intent of requirement remains unchanged (4.2.4);
f) Maximum height of undercarriage for loading and unloading removed (4.2.5.3);
g) A second battery is now mandatory in case of power loss (4.2.6);
h) Requirements for the restraint system (4.2.8) revised;
i) Requirements aligned with other parts of this standard series;
j) Clause numbering updated throughout the whole document;
k) Contents updated to change titles of “Flammability – Toxicity of Burning Gasses” to “Flammability
l) Verification methods in Clause 5 moved into Clause 4 requirements that previously referenced them.
In these cases, the requirement and test methods were combined to form the following: 5.1 now in
4.2.10, 5.3 now 4.2.12, 5.4 is now 4.2.13, 5.5 now 4.2.14;
m) Clause on “Marking” (5) deleted.
This document has been prepared under a standardization request addressed to CEN by the European
Commission. The Standing Committee of the EFTA States subsequently approves these requests for its
Member States.
For the relationship with EU Legislation, see informative Annex ZA, which is an integral part of this
document.
This document is a part of EN 1865, Patient handling equipment used in ambulances, which consists of the
following parts:
— Part 1: Specification for general stretcher systems and patient handling equipment;
— Part 2: Power assisted stretcher;
— Part 3: Heavy duty stretcher (this document);
— Part 4: Foldable patient transfer chair;
— Part 5: Stretcher support;
— Part 6: Powered chairs;
— Part 7: Isolation transport system (preliminary work item under development).
Introduction
In this document, reference is made to EN 1789:2020+A1:2023, which specifies design requirements and
test methods for road ambulances which are relevant for checking requirements for such handling
equipment.
1 Scope
This document 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.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
EN 597-1:2015, Furniture — Assessment of the ignitability of mattresses and upholstered bed bases —
Part 1: Ignition source smouldering cigarette
EN 1789:2020+A1:2023, Medical vehicles and their equipment — Road ambulances
prEN 1865-1:2026, Patient handling equipment used in ambulances — Part 1: Specification for general
stretcher systems and patient handling equipment
EN 1865-2:2024, Patient handling equipment used in ambulances — Part 2: Power assisted stretcher
EN 62366-1:2015, Medical devices — Part 1: Application of usability engineering to medical devices (IEC
62366-1:2015)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— IEC Electropedia: available at https://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp/
3.1
heavy duty stretcher
stretcher designed for the treatment and transportation of patients where the weight and/or dimensions
of the patient exceed those of the operating capability of the defined stretcher in prEN 1865-1:2026 and
EN 1865-2:2024
4 Requirements
4.1 General
When operated and maintained in accordance with the instructions for use, heavy duty stretchers shall
not present any high level of risk. Any identified risk shall be reduced as far as possible.
Heavy duty stretchers shall also:
— be mechanical assisted or power operated;
— allow patients to be secured so that any movement during ambulance transport is minimized;

As impacted by EN 62366-1:2015/AC:2015, EN 62366-1:2015/AC:2016-09 and EN 62366-1:2015/A1:2020.
— be free of sharp edges that could cause injury to persons or damage to other equipment on board.
The minimum radius should be 0,5 mm.
For all patients transported in the patient compartment, patient restraint-systems shall be available. All
patient restraint-systems shall have quick release systems.
Patient restraint-systems for all patient handling equipment shall secure the patient, but at the same time
shall permit treatment of the patient.
The lying-sitting part shall be made of a strong material which is bacterial resistant, fungal resistant, stain
resistant, putrid resistant, easy to clean, washable, waterproof and petrol-oil resistant.
EN 62366-1:2015 shall be followed in the design, ergonomics, and user interfaces implemented.
The heavy duty stretcher shall be designed to transport patients with a weight that exceeds the load
capacity of the main stretcher in prEN 1865-1:2026 and EN 1865-2:2024.
4.2 Heavy duty stretcher
4.2.1 General
The heavy duty stretcher shall consist of a stretcher part that can be used either alone or in combination
with an integrated or detachable undercarriage.
For assisting the loading and unloading process, the stretcher shall be compatible with a loading system
device installed on the vehicle and / or on the stretcher device itself.
The heavy duty stretcher and its loading system shall be compatible. It physically shall support the crew,
so no manual lifting should be done to load and unload the stretcher under normal daily use.
4.2.2 Dimensions
Dimensions shall be measured from the outermost edges.
+120
— Stretcher part: length:
(1 950 ) mm;
−50
To accommodate tall patients, it may be possible to increase
the length of the stretcher by a further 200 mm.
+60
width:
(550 ) mm;
−20
It shall be possible to increase the width of the lying part to a
minimum of 750 mm at least in the side rail area.
height: Maximum 300 mm from loading holding assembly to unloaded
lying part. This height dimension does not apply to stretchers
with monoblock undercarriages. If a monoblock is not
available, the stretcher shall be constructed such that it is
detachable from the undercarriage. Where a stretcher support
is used the measurement shall be taken from the top surface of
the stretcher support to the lying part of the stretcher.
— Undercarriage:  Length and width of the frame of the undercarr
...