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Tiêu đề Patient Handling Equipment Used In Road Ambulances Part 1: General Stretcher Systems And Patient Handling Equipment
Trường học British Standards Institution
Chuyên ngành Standards
Thể loại Standard
Năm xuất bản 2015
Thành phố Brussels
Định dạng
Số trang 40
Dung lượng 1,25 MB

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Cấu trúc

  • 4.1 General (11)
  • 4.2 Main stretcher (11)
    • 4.2.1 General (11)
    • 4.2.2 Dimensions (11)
    • 4.2.3 Mass (12)
    • 4.2.4 Loading capacity (12)
    • 4.2.5 Frame (12)
    • 4.2.6 Lying part of the stretcher (13)
    • 4.2.7 Restraint system (14)
    • 4.2.8 Flammability − Toxicity burning gases (14)
    • 4.2.9 Deformation of the frame (14)
    • 4.2.10 Fixation (14)
    • 4.2.11 Deformation of the lying area (14)
    • 4.2.12 Resistance to torsion (14)
    • 4.2.13 Splaying of the wheels (14)
  • 4.3 Chair stretcher (14)
    • 4.3.1 Dimensions (14)
    • 4.3.2 Mass (14)
    • 4.3.3 Loading capacity (15)
    • 4.3.4 Frame (15)
    • 4.3.5 Lying-sitting part (15)
    • 4.3.6 Restraint system (15)
    • 4.3.7 Flammability − Toxicity burning gases (15)
    • 4.3.8 Deformation of the frame (15)
    • 4.3.9 Fixation (15)
    • 4.3.10 Deformation of the lying-sitting area (15)
    • 4.3.11 Resistance to torsion (15)
    • 4.3.12 Splaying of the wheels (15)
  • 4.4 Transfer mattress (15)
    • 4.4.1 Dimensions (15)
    • 4.4.2 Mass (16)
    • 4.4.3 Loading capacity (16)
    • 4.4.4 Handles (16)
    • 4.4.5 Lying part (16)
    • 4.4.6 Restraint system (16)
    • 4.4.7 Flammability − Toxicity burning gases (16)
    • 4.4.8 Deformation (16)
    • 4.4.9 Fixation (16)
    • 4.4.10 Deformation of the lying area (16)
    • 4.4.11 Resistance to torsion (17)
    • 4.4.12 Splaying of the wheels (17)
  • 4.5 Carrying sheet (17)
    • 4.5.1 Dimensions (17)
    • 4.5.2 Mass (17)
    • 4.5.3 Loading capacity (17)
    • 4.5.4 Handles (17)
    • 4.5.5 Lying part (17)
    • 4.5.6 Restraint system (17)
    • 4.5.7 Flammability − Toxicity burning gases (17)
    • 4.5.8 Deformation of the handles (17)
    • 4.5.9 Fixation (17)
    • 4.5.10 Deformation of the lying area (18)
    • 4.5.11 Resistance to torsion (18)
    • 4.5.12 Splaying of the wheels (18)
  • 4.6 Pick up stretcher (18)
    • 4.6.1 Dimensions (18)
    • 4.6.2 Mass (18)
    • 4.6.3 Loading capacity (18)
    • 4.6.4 Frame (18)
    • 4.6.5 Lying part (18)
    • 4.6.6 Restraint system (18)
    • 4.6.7 Flammability − Toxicity burning gases (19)
    • 4.6.8 Deformation of the frame (19)
    • 4.6.9 Fixation (19)
    • 4.6.10 Locking (19)
    • 4.6.11 Deformation of the lying area (19)
    • 4.6.12 Resistance to torsion (19)
    • 4.6.13 Splaying of the wheels (19)
  • 4.7 Vacuum mattress (19)
    • 4.7.1 Construction (19)
    • 4.7.2 Dimensions (19)
    • 4.7.3 Mass (20)
    • 4.7.4 Loading capacity (20)
    • 4.7.5 Handles (20)
    • 4.7.6 Restraint system (20)
    • 4.7.7 Flammability − Toxicity burning gases (20)
    • 4.7.8 Deformation (20)
    • 4.7.9 Fixation (20)
    • 4.7.10 Shrinkage (20)
    • 4.7.11 Deformation of the lying area (20)
  • 4.8 Long spinal board (21)
    • 4.8.1 Dimensions (21)
    • 4.8.2 Mass (21)
    • 4.8.3 Loading capacity (21)
    • 4.8.4 Construction (21)
    • 4.8.5 Lying part (21)
    • 4.8.6 Restraint system (21)
    • 4.8.7 Flammability − Toxicity burning gases (21)
    • 4.8.8 Deformation (21)
    • 4.8.9 Fixation (21)
    • 4.8.10 Deformation of the lying area (22)
    • 4.8.11 Resistance to torsion (22)
    • 4.8.12 Splaying of the wheels (22)
  • 4.9 Foldable carrying chair (22)
    • 4.9.1 Dimensions (22)
    • 4.9.2 Mass (22)
    • 4.9.3 Loading capacity (22)
    • 4.9.4 Frame (22)
    • 4.9.5 Sitting part (22)
    • 4.9.6 Restraint system (22)
    • 4.9.7 Flammability − Toxicity burning gases (23)
    • 4.9.8 Deformation of the frame (23)
    • 4.9.9 Fixation (23)
    • 4.9.10 Locking (23)
    • 4.9.11 Deformation of the backrest lying-sitting area (23)
    • 4.9.12 Resistance to torsion (23)
    • 4.9.13 Splaying of the wheels (23)
  • 4.10 Non-foldable carrying chair (sedan chair) (23)
    • 4.10.1 Dimensions (23)
    • 4.10.2 Mass (23)
    • 4.10.3 Loading capacity (23)
    • 4.10.4 Frame (24)
    • 4.10.5 Sitting part (24)
    • 4.10.6 Restraint system (24)
    • 4.10.7 Flammability − Toxicity burning gases (24)
    • 4.10.8 Deformation of the frame (24)
    • 4.10.9 Fixation (24)
    • 4.10.10 Deformation of the sitting area (24)
    • 4.10.11 Resistance to torsion (24)
    • 4.10.12 Splaying of the wheels (24)
  • 5.1 Main stretcher (25)
    • 5.1.1 Permanent deformation of the frame (25)
    • 5.1.2 Fixation inside the ambulance (25)
    • 5.1.3 Permanent deformation of the lying area (26)
    • 5.1.4 Resistance to twisting/torsion (26)
    • 5.1.5 Splaying of the wheels (27)
  • 5.2 Chair stretcher (27)
    • 5.2.1 Permanent deformation of the frame (27)
    • 5.2.2 Permanent deformation of the lying-sitting area (27)
    • 5.2.3 Resistance to twisting/torsion (27)
    • 5.2.4 Splaying of the wheels (27)
  • 5.3 Transfer mattress (27)
    • 5.3.1 Deformation (27)
    • 5.3.2 Deformation of the lying area (29)
  • 5.4 Carrying sheet (30)
    • 5.4.1 Strength of the handles (30)
    • 5.4.2 Permanent deformation of the lying area (31)
  • 5.5 Pick up stretcher (31)
    • 5.5.1 Permanent deformation of the frame (31)
    • 5.5.2 Resistance to twisting/torsion (31)
  • 5.6 Vacuum mattress and pump (32)
    • 5.6.1 Deformation (32)
    • 5.6.2 Shrinkage (32)
    • 5.6.3 Deformation of the lying area (32)
  • 5.7 Long spinal board (33)
    • 5.7.1 Permanent deformation of the frame and lying area (33)
    • 5.7.2 Resistance to twisting/torsion (33)
  • 5.8 Foldable carrying chair (33)
    • 5.8.1 Permanent deformation of the frame and backrest lying-sitting area (33)
  • 5.9 Non-foldable carrying chair (sedan chair) (34)
    • 5.9.1 Permanent deformation of the frame and sitting area (34)
    • 5.9.2 Fixation inside the ambulance (34)
    • 5.9.3 Splaying of the wheels (34)

Nội dung

3.1 main stretcher main device for the conveyance of a sick and/or injured person or those in labour with the purpose to transport patients in safety and in comfort whilst facilitating

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BSI Standards Publication

Patient handling equipment used in road ambulances

Part 1: General stretcher systems and patient handling equipment

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This British Standard is the UK implementation of EN 1865-1:2010+A1:2015

It supersedes BS EN 1865-1:2010, which is withdrawn

The start and finish of text introduced or altered by amendment is indicated in the text by tags Tags indicating changes to CEN text carry the number of the CEN amendment For example, text altered by CEN amendment A1 is indicated by 

The UK participation in its preparation was entrusted to Technical Committee CH/239, Rescue systems

A list of organizations represented on this committee can be obtained

on request to its secretary

This publication does not purport to include all the necessary provisions

of a contract Users are responsible for its correct application

© The British Standards Institution 2015

Published by BSI Standards Limited 2015ISBN 978 0 580 87512 0

Amendments/corrigenda issued since publication

30 June 2015 Implementation of CEN amendment A1:2015

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NORME EUROPÉENNE

English Version

Patient handling equipment used in road ambulances - Part 1:

General stretcher systems and patient handling equipment

Spécifications d'équipements pour le transport de patient

dans les ambulances routières - Partie 1: Systèmes

généraux de brancards et équipement pour le transport de

patients

Krankentransportmittel im Krankenkraftwagen - Teil 1: Allgemeine Krankentragesysteme und Krankentransportmittel

This European Standard was approved by CEN on 2 July 2010 and includes Amendment 1 approved by CEN on 26 March 2015

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 Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member

This European Standard exists 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

EUROPEAN COMMITTEE FOR STANDARDIZATION

C O M IT É E U R OP É E N D E N O RM A LIS A T IO N EURO PÄ ISC HES KOM ITE E FÜR NORM UNG

CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels

© 2015 CEN All rights of exploitation in any form and by any means reserved Ref No EN 1865-1:2010+A1:2015 E

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Contents

Page

Foreword 6

Introduction 7

1 Scope 8

2 Normative references 8

3 Terms and definitions 8

4 Requirements 9

4.1 General 9

4.2 Main stretcher 9

4.2.1 General 9

4.2.2 Dimensions 9

4.2.3 Mass 10

4.2.4 Loading capacity 10

4.2.5 Frame 10

4.2.6 Lying part of the stretcher 11

4.2.7 Restraint system 12

4.2.8 Flammability − Toxicity burning gases 12

4.2.9 Deformation of the frame 12

4.2.10 Fixation 12

4.2.11 Deformation of the lying area 12

4.2.12 Resistance to torsion 12

4.2.13 Splaying of the wheels 12

4.3 Chair stretcher 12

4.3.1 Dimensions 12

4.3.2 Mass 12

4.3.3 Loading capacity 13

4.3.4 Frame 13

4.3.5 Lying-sitting part 13

4.3.6 Restraint system 13

4.3.7 Flammability − Toxicity burning gases 13

4.3.8 Deformation of the frame 13

4.3.9 Fixation 13

4.3.10 Deformation of the lying-sitting area 13

4.3.11 Resistance to torsion 13

4.3.12 Splaying of the wheels 13

4.4 Transfer mattress 13

4.4.1 Dimensions 13

4.4.2 Mass 14

4.4.3 Loading capacity 14

4.4.4 Handles 14

4.4.5 Lying part 14

4.4.6 Restraint system 14

4.4.7 Flammability − Toxicity burning gases 14

4.4.8 Deformation 14

4.4.9 Fixation 14

4.4.10 Deformation of the lying area 14

4.4.11 Resistance to torsion 15

4.4.12 Splaying of the wheels 15

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Contents

Page

Foreword 6

Introduction 7

1 Scope 8

2 Normative references 8

3 Terms and definitions 8

4 Requirements 9

4.1 General 9

4.2 Main stretcher 9

4.2.1 General 9

4.2.2 Dimensions 9

4.2.3 Mass 10

4.2.4 Loading capacity 10

4.2.5 Frame 10

4.2.6 Lying part of the stretcher 11

4.2.7 Restraint system 12

4.2.8 Flammability − Toxicity burning gases 12

4.2.9 Deformation of the frame 12

4.2.10 Fixation 12

4.2.11 Deformation of the lying area 12

4.2.12 Resistance to torsion 12

4.2.13 Splaying of the wheels 12

4.3 Chair stretcher 12

4.3.1 Dimensions 12

4.3.2 Mass 12

4.3.3 Loading capacity 13

4.3.4 Frame 13

4.3.5 Lying-sitting part 13

4.3.6 Restraint system 13

4.3.7 Flammability − Toxicity burning gases 13

4.3.8 Deformation of the frame 13

4.3.9 Fixation 13

4.3.10 Deformation of the lying-sitting area 13

4.3.11 Resistance to torsion 13

4.3.12 Splaying of the wheels 13

4.4 Transfer mattress 13

4.4.1 Dimensions 13

4.4.2 Mass 14

4.4.3 Loading capacity 14

4.4.4 Handles 14

4.4.5 Lying part 14

4.4.6 Restraint system 14

4.4.7 Flammability − Toxicity burning gases 14

4.4.8 Deformation 14

4.4.9 Fixation 14

4.4.10 Deformation of the lying area 14

4.4.11 Resistance to torsion 15

4.4.12 Splaying of the wheels 15

4.5 Carrying sheet 15

4.5.1 Dimensions 15

4.5.2 Mass 15

4.5.3 Loading capacity 15

4.5.4 Handles 15

4.5.5 Lying part 15

4.5.6 Restraint system 15

4.5.7 Flammability − Toxicity burning gases 15

4.5.8 Deformation of the handles 15

4.5.9 Fixation 15

4.5.10 Deformation of the lying area 16

4.5.11 Resistance to torsion 16

4.5.12 Splaying of the wheels 16

4.6 Pick up stretcher 16

4.6.1 Dimensions 16

4.6.2 Mass 16

4.6.3 Loading capacity 16

4.6.4 Frame 16

4.6.5 Lying part 16

4.6.6 Restraint system 16

4.6.7 Flammability − Toxicity burning gases 17

4.6.8 Deformation of the frame 17

4.6.9 Fixation 17

4.6.10 Locking 17

4.6.11 Deformation of the lying area 17

4.6.12 Resistance to torsion 17

4.6.13 Splaying of the wheels 17

4.7 Vacuum mattress 17

4.7.1 Construction 17

4.7.2 Dimensions 17

4.7.3 Mass 18

4.7.4 Loading capacity 18

4.7.5 Handles 18

4.7.6 Restraint system 18

4.7.7 Flammability − Toxicity burning gases 18

4.7.8 Deformation 18

4.7.9 Fixation 18

4.7.10 Shrinkage 18

4.7.11 Deformation of the lying area 18

4.8 Long spinal board 19

4.8.1 Dimensions 19

4.8.2 Mass 19

4.8.3 Loading capacity 19

4.8.4 Construction 19

4.8.5 Lying part 19

4.8.6 Restraint system 19

4.8.7 Flammability − Toxicity burning gases 19

4.8.8 Deformation 19

4.8.9 Fixation 19

4.8.10 Deformation of the lying area 20

4.8.11 Resistance to torsion 20

4.8.12 Splaying of the wheels 20

4.9 Foldable carrying chair 20

4.9.1 Dimensions 20

4.9.2 Mass 20

4.9.3 Loading capacity 20

4.9.4 Frame 20

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4.9.5 Sitting part 20

4.9.6 Restraint system 20

4.9.7 Flammability − Toxicity burning gases 21

4.9.8 Deformation of the frame 21

4.9.9 Fixation 21

4.9.10 Locking 21

4.9.11 Deformation of the backrest lying-sitting area 21

4.9.12 Resistance to torsion 21

4.9.13 Splaying of the wheels 21

4.10 Non-foldable carrying chair (sedan chair) 21

4.10.1 Dimensions 21

4.10.2 Mass 21

4.10.3 Loading capacity 21

4.10.4 Frame 22

4.10.5 Sitting part 22

4.10.6 Restraint system 22

4.10.7 Flammability − Toxicity burning gases 22

4.10.8 Deformation of the frame 22

4.10.9 Fixation 22

4.10.10 Deformation of the sitting area 22

4.10.11 Resistance to torsion 22

4.10.12 Splaying of the wheels 22

5 Test methods 23

5.1 Main stretcher 23

5.1.1 Permanent deformation of the frame 23

5.1.2 Fixation inside the ambulance 23

5.1.3 Permanent deformation of the lying area 24

5.1.4 Resistance to twisting/torsion 24

5.1.5 Splaying of the wheels 25

5.2 Chair stretcher 25

5.2.1 Permanent deformation of the frame 25

5.2.2 Permanent deformation of the lying-sitting area 25

5.2.3 Resistance to twisting/torsion 25

5.2.4 Splaying of the wheels 25

5.3 Transfer mattress 25

5.3.1 Deformation 25

5.3.2 Deformation of the lying area 27

5.4 Carrying sheet 28

5.4.1 Strength of the handles 28

5.4.2 Permanent deformation of the lying area 29

5.5 Pick up stretcher 29

5.5.1 Permanent deformation of the frame 29

5.5.2 Resistance to twisting/torsion 29

5.6 Vacuum mattress and pump 30

5.6.1 Deformation 30

5.6.2 Shrinkage 30

5.6.3 Deformation of the lying area 30

5.7 Long spinal board 31

5.7.1 Permanent deformation of the frame and lying area 31

5.7.2 Resistance to twisting/torsion 31

5.8 Foldable carrying chair 31

5.8.1 Permanent deformation of the frame and backrest lying-sitting area 31

5.9 Non-foldable carrying chair (sedan chair) 32

5.9.1 Permanent deformation of the frame and sitting area 32

5.9.2 Fixation inside the ambulance 32

5.9.3 Splaying of the wheels 32

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4.9.5 Sitting part 20

4.9.6 Restraint system 20

4.9.7 Flammability − Toxicity burning gases 21

4.9.8 Deformation of the frame 21

4.9.9 Fixation 21

4.9.10 Locking 21

4.9.11 Deformation of the backrest lying-sitting area 21

4.9.12 Resistance to torsion 21

4.9.13 Splaying of the wheels 21

4.10 Non-foldable carrying chair (sedan chair) 21

4.10.1 Dimensions 21

4.10.2 Mass 21

4.10.3 Loading capacity 21

4.10.4 Frame 22

4.10.5 Sitting part 22

4.10.6 Restraint system 22

4.10.7 Flammability − Toxicity burning gases 22

4.10.8 Deformation of the frame 22

4.10.9 Fixation 22

4.10.10 Deformation of the sitting area 22

4.10.11 Resistance to torsion 22

4.10.12 Splaying of the wheels 22

5 Test methods 23

5.1 Main stretcher 23

5.1.1 Permanent deformation of the frame 23

5.1.2 Fixation inside the ambulance 23

5.1.3 Permanent deformation of the lying area 24

5.1.4 Resistance to twisting/torsion 24

5.1.5 Splaying of the wheels 25

5.2 Chair stretcher 25

5.2.1 Permanent deformation of the frame 25

5.2.2 Permanent deformation of the lying-sitting area 25

5.2.3 Resistance to twisting/torsion 25

5.2.4 Splaying of the wheels 25

5.3 Transfer mattress 25

5.3.1 Deformation 25

5.3.2 Deformation of the lying area 27

5.4 Carrying sheet 28

5.4.1 Strength of the handles 28

5.4.2 Permanent deformation of the lying area 29

5.5 Pick up stretcher 29

5.5.1 Permanent deformation of the frame 29

5.5.2 Resistance to twisting/torsion 29

5.6 Vacuum mattress and pump 30

5.6.1 Deformation 30

5.6.2 Shrinkage 30

5.6.3 Deformation of the lying area 30

5.7 Long spinal board 31

5.7.1 Permanent deformation of the frame and lying area 31

5.7.2 Resistance to twisting/torsion 31

5.8 Foldable carrying chair 31

5.8.1 Permanent deformation of the frame and backrest lying-sitting area 31

5.9 Non-foldable carrying chair (sedan chair) 32

5.9.1 Permanent deformation of the frame and sitting area 32

5.9.2 Fixation inside the ambulance 32

5.9.3 Splaying of the wheels 32

6 Marking 32

Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC concerning Medical Devices 33

Bibliography 35

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at the latest by November 2015

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights This document includes Amendment 1, approved by CEN on 2015-03-26

The start and finish of text introduced or altered by amendment is indicated in the text by tags ! "

!This document supersedes EN 1865-1:2010"

This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association, and supports essential requirements of EU Directive(s)

For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document

!This European Standard is a part of EN 1865, Patient handling equipment used in road ambulances, which

consists of the following parts:

— Part 1: General stretcher systems and patient handling equipment [the present document];

— Part 2: Power assisted stretcher;

— Part 3: Heavy duty stretcher;

— Part 4: Foldable patient transfer chair;

— Part 5: Stretcher support."

According to the CEN-CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this European Standard: 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 the United Kingdom

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Foreword

This document (EN 1865-1:2010+A1:2015) has been prepared by Technical Committee CEN/TC 239 “Rescue

systems”, the secretariat of which is held by DIN

This European Standard shall be given the status of a national standard, either by publication of an identical

text or by endorsement, at the latest by November 2015, and conflicting national standards shall be withdrawn

at the latest by November 2015

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent

rights CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights

This document includes Amendment 1, approved by CEN on 2015-03-26

The start and finish of text introduced or altered by amendment is indicated in the text by tags ! "

!This document supersedes EN 1865-1:2010"

This document has been prepared under a mandate given to CEN by the European Commission and the

European Free Trade Association, and supports essential requirements of EU Directive(s)

For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document

!This European Standard is a part of EN 1865, Patient handling equipment used in road ambulances, which

consists of the following parts:

— Part 1: General stretcher systems and patient handling equipment [the present document];

— Part 2: Power assisted stretcher;

— Part 3: Heavy duty stretcher;

— Part 4: Foldable patient transfer chair;

— Part 5: Stretcher support."

According to the CEN-CENELEC Internal Regulations, the national standards organisations of the following

countries are bound to implement this European Standard: 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 the United Kingdom

Introduction

This European Standard incorporates specifications for:

— main stretcher − undercarriage;

— chair stretcher;

— transfer mattress;

— carrying sheet;

— pick up stretcher;

— vacuum mattress and pump;

— long spinal board;

— foldable carrying chair;

— non-foldable carrying chair

Stretcher systems and patient handling equipment covered by this standard EN 1865-1 are for use in road ambulances

In this standard reference is made to !EN 1789:2007+A2:2014"which specifies design requirements and test methods for road ambulances, which are relevant for checking requirements for such handling equipment

compromising continuity of patient care and the safety of staff

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1 Scope

This European Standard defines minimum requirements for the design and performance of stretchers and other patient handling equipment used in road ambulances for the handling and carrying of patients It aims to ensure patient safety and minimize the physical effort required by staff operating the equipment

2 Normative references

The following referenced documents are indispensable for the application 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 597-1:1994", Furniture - Assessment of the ignitability of mattresses and upholstered bed bases -

Part 1: Ignition source: Smouldering cigarette

!deleted text"

!EN 1021-1:2014", Furniture - Assessment of the ignitability of upholstered furniture - Part 1: Ignition

source smouldering cigarette

!EN 1041:2008+A1:2013", Information supplied by the manufacturer of medical devices

!EN 1789:2007+A2:2014", Medical vehicles and their equipment - Road ambulances

!EN ISO 14971:2012", Medical devices - Application of risk management to medical devices (ISO

14971:2007, Corrected version 2007-10-01)

!EN ISO 15223-1:2012, Medical devices - Symbols to be used with medical device labels, labelling and

information to be supplied - Part 1: General requirements (ISO 15223-1:2012)"

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply

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1 Scope

This European Standard defines minimum requirements for the design and performance of stretchers and

other patient handling equipment used in road ambulances for the handling and carrying of patients It aims to

ensure patient safety and minimize the physical effort required by staff operating the equipment

2 Normative references

The following referenced documents are indispensable for the application 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 597-1:1994", Furniture - Assessment of the ignitability of mattresses and upholstered bed bases -

Part 1: Ignition source: Smouldering cigarette

!deleted text"

!EN 1021-1:2014", Furniture - Assessment of the ignitability of upholstered furniture - Part 1: Ignition

source smouldering cigarette

!EN 1041:2008+A1:2013", Information supplied by the manufacturer of medical devices

!EN 1789:2007+A2:2014", Medical vehicles and their equipment - Road ambulances

!EN ISO 14971:2012", Medical devices - Application of risk management to medical devices (ISO

14971:2007, Corrected version 2007-10-01)

!EN ISO 15223-1:2012, Medical devices - Symbols to be used with medical device labels, labelling and

information to be supplied - Part 1: General requirements (ISO 15223-1:2012)"

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply

3.1

main stretcher

main device for the conveyance of a sick and/or injured person or those in labour with the purpose to transport

patients in safety and in comfort whilst facilitating treatment

lifting device, intended to be used for movement of seriously injured people on to other transport devices

3.6 vacuum mattress

device intended primarily to provide immobilization for the patient during transportation

3.7 long spinal board

device designed for lifting and immobilising patients

3.8 foldable carrying chair

device intended to handle and carry a patient in a sitting position to the road ambulance but not to be used to transport a patient within the ambulance

3.9 non-foldable carrying chair

device intended to handle and carry a patient in a sitting position to the road ambulance and to be used to transport a patient within the ambulance

4 Requirements

4.1 General

When lifting and carrying devices are operated and maintained in accordance with manufacturer instructions they shall not present any high level of risk Any identified risk shall be reduced to an acceptable level by using risk management principles in accordance with !EN ISO 14971:2012"taking account of normal and single fault condition

Carrying handles on devices for handling of patients shall permit fixation in extended positions

All equipment for the handling of patients shall be free of any sharp edges The minimum radius should be 0,5 mm

All patient restraint-systems shall have a quick release system

The lying-sitting part shall be made of a strong material which is bacterial resistant, fungal resistant, stain resistant, putrid resistant, easy to clean and disinfect, washable, waterproof and petrol-oil resistant

4.2 Main stretcher

4.2.1 General

The main stretcher shall consist of a stretcher part that can be used either alone or in combination with an integrated or detachable undercarriage

It shall be designed so that the full weight of the patient and the carried stretcher part will only be lifted/carried

by the personnel for the minimum period of time

4.2.2 Dimensions

Dimensions shall be measured from the outermost edges

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— Stretcher part: length: (1 950 20

50

+

− ) mm;

width: (550 ± 20) mm;

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 undercarriage when located in the

ambulance shall not exceed length and width of the stretcher part

4.2.3 Mass

The mass excluding mattress and patient restraints shall not be more than:

— Undercarriage including stretcher: 51 kg max (combined weight);

— Stretcher part with integrated undercarriage: monoblock 45 kg

c) The stretcher shall either have a water and scratch resistant paint finish or be manufactured of corrosion resistant material Both shall be unaffected by disinfectants

d) If intended to be used without undercarriage there shall be four wheels with a minimum diameter of

100 mm suitably placed to ensure stability

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— Stretcher part: length: (1 950 20

50

+

− ) mm;

width: (550 ± 20) mm;

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 undercarriage when located in the

ambulance shall not exceed length and width of the stretcher part

4.2.3 Mass

The mass excluding mattress and patient restraints shall not be more than:

— Undercarriage including stretcher: 51 kg max (combined weight);

— Stretcher part with integrated undercarriage: monoblock 45 kg

4.2.4 Loading capacity

The loading capacity shall be a minimum of 150 kg

4.2.5 Frame

4.2.5.1 General

The frame shall be a sturdy lightweight non twisting construction enabling use of cardiopulmonary

resuscitation All corners of the frame shall be radiused for greater safety

It shall be possible to lock and secure the stretcher and undercarriage against lateral, longitudinal, vertical

movements

All mechanisms shall be constructed to prevent damage to the user and the patient

4.2.5.2 Stretcher parts

a) If swing-down side rails are mounted, they shall have a minimum length of 500 mm and a minimum height

between 150 mm and 200 mm measured from the top of the stretcher frame to the top of the side rail

b) If longitudinal handles are incorporated they shall be fitted to the ends of the longitudinal frame such that

they lock and do not twist when they are stowed or in use They shall be designed to minimise the risk of

injuries to hands and wrists when being operated or when the stretcher is carried in a non-horizontal

position The stretcher shall allow the fixation and use of a carrying harness

c) The stretcher shall either have a water and scratch resistant paint finish or be manufactured of corrosion

resistant material Both shall be unaffected by disinfectants

d) If intended to be used without undercarriage there shall be four wheels with a minimum diameter of

100 mm suitably placed to ensure stability

e) If intended to be used with undercarriage the stretcher shall be able to be fixed to the undercarriage without using supplementary means A safe handling and lowering of the undercarriage shall be ensured f) The fixed stretcher shall be easy to release from the stretcher fastener

4.2.5.3 Undercarriage

a) The undercarriage shall be fitted with four wheels with a diameter of at least 100 mm At the foot end there shall be a minimum of two wheels that swivel 360° and at least two wheels shall be fitted with a brake

b) The undercarriage shall be suitable for a road ambulance loading and unloading with a maximum height

of 750 mm

c) The undercarriage shall have a simple mechanism for height adjustment and shall have a minimum of two levels (car position and fully unfolded)

d) The supporting mechanism shall automatically stay in place when fully unfolded

e) The operating controls shall be ergonomically designed to take into consideration human body dimensions and physical strength, and anatomical and physiological requirements of human beings The operating controls shall be clearly and permanently labelled, preferably with graphical symbols, indicating their positions and settings If the controls can initiate movements which could be dangerous to persons, they shall be secured against unintentional operation

f) All functions of the stretcher shall remain completely unimpaired when it is connected to the undercarriage

g) The undercarriage shall have either a water and scratch resistant paint finish or be manufactured of corrosion resistant material Both shall be unaffected by disinfectants

h) If the undercarriage is used with a detachable stretcher it shall be possible to connect or disconnect them easily The stretcher shall be secured in such a manner that unintentional separation of undercarriage and stretcher cannot occur It shall be possible to load and unload the undercarriage and stretcher to ensure the safety and comfort of the patient and the operators

4.2.6 Lying part of the stretcher

a) The lying area shall be flat over the complete surface and shall be made of sturdy lightweight construction The thorax area shall be manufactured of sturdy lightweight material which allows cardiopulmonary resuscitation without acting as a spring or giving way The materials shall be unaffected

by disinfectants

b) The lying area shall be non-slip and shall be covered with a transfer mattress, or a mattress that shall provide for patient comfort It shall be firm enough to enable cardiopulmonary resuscitation to be undertaken The mattress shall be able to conform to the various treatment configurations provided by the stretcher The mattress shall have welded seams to prevent the ingress of patient fluids and facilitate infectious control cleaning; in addition, the materials shall be unaffected by disinfectants The mattress shall be fixed securely to the lying part of the stretcher

c) The lying area shall have an adjustable head-end/-backrest with a minimum length of 600 mm It shall be possible to raise the backrest at least 75° and there shall be at least five fixing positions within this range

It shall be possible to maintain the angle of adjustment under all normal conditions of loading and unloading

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d) The lying area shall have an adjustable footrest with a minimum length of 900 mm It shall be possible to raise the leg section (shock position) by at least 15° It shall be possible to maintain the angle of adjustment under all normal conditions of loading and unloading

NOTE It is desirable to have a system to minimise the lifting effort of the operator

4.2.7 Restraint system

The stretcher shall have a minimum of two quick-release patient restraints capable of accepting a device for restraining children

4.2.8 Flammability − Toxicity burning gases

There shall be no progressive smouldering or flaming ignition when tested in accordance with

!EN 597-1:1994"

4.2.9 Deformation of the frame

The frame shall not bend or break when tested in accordance with 5.1.1

4.2.10 Fixation

The fixation shall be in accordance with 4.5.9 of !EN 1789:2007+A2:2014" There shall be no deformation of the fixation when tested in accordance with 5.1.2 in this document

4.2.11 Deformation of the lying area

There shall be no deformation of the lying area when tested in accordance with 5.1.3

4.2.12 Resistance to torsion

There shall be no remaining deformation due to torsion when tested in accordance with 5.1.4

4.2.13 Splaying of the wheels

The wheels shall not splay more than 2 mm in total during the test specified in 5.1.5 and there shall be no permanent deformation

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d) The lying area shall have an adjustable footrest with a minimum length of 900 mm It shall be possible to

raise the leg section (shock position) by at least 15° It shall be possible to maintain the angle of

adjustment under all normal conditions of loading and unloading

NOTE It is desirable to have a system to minimise the lifting effort of the operator

4.2.7 Restraint system

The stretcher shall have a minimum of two quick-release patient restraints capable of accepting a device for

restraining children

4.2.8 Flammability − Toxicity burning gases

There shall be no progressive smouldering or flaming ignition when tested in accordance with

!EN 597-1:1994"

4.2.9 Deformation of the frame

The frame shall not bend or break when tested in accordance with 5.1.1

4.2.10 Fixation

The fixation shall be in accordance with 4.5.9 of !EN 1789:2007+A2:2014" There shall be no

deformation of the fixation when tested in accordance with 5.1.2 in this document

4.2.11 Deformation of the lying area

There shall be no deformation of the lying area when tested in accordance with 5.1.3

4.2.12 Resistance to torsion

There shall be no remaining deformation due to torsion when tested in accordance with 5.1.4

4.2.13 Splaying of the wheels

The wheels shall not splay more than 2 mm in total during the test specified in 5.1.5 and there shall be no

1) If the chair stretcher is a structural part of the main stretcher, the requirements of 4.2 apply

4.3.7 Flammability − Toxicity burning gases

There shall be no progressive smouldering or flaming ignition when tested in accordance with

!EN 1021-1:2014"

4.3.8 Deformation of the frame

The frame of the chair stretcher shall not open spontaneously or bend when tested in accordance with 5.2.1

4.3.9 Fixation

Not applicable

4.3.10 Deformation of the lying-sitting area

There shall be no remaining deformation of the lying-sitting area when tested in accordance with 5.2.2

4.3.11 Resistance to torsion

There shall be no remaining deformation to torsion when tested in accordance with 5.2.3

4.3.12 Splaying of the wheels

The wheels shall not splay more than 2 mm in total during the test specified in 5.2.4 and there shall be no permanent deformation

4.4 Transfer mattress

4.4.1 Dimensions

The dimensions of the transfer mattress of the lying area shall be as follows:

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The mass shall be not more than 10 kg

4.4.3 Loading capacity

The loading capacity shall be a minimum of 150 kg

4.4.4 Handles

The transfer mattress shall be equipped with at least four handles on each longitudinal side, the handles shall

be designed to give a comfortable and safe grip

4.4.5 Lying part

Both sides of the transfer mattress shall have a different function: one side shall provide a lying comfort equivalent to a foam filling of minimum 40 mm with density 30 kg/m³ to 40 kg/m³, the other side shall provide the mattress with sufficient rigidity to transfer the patient with at least two persons, one at each longitudinal side

The mattress shall be capable of being adapted to form the lying part of the stretcher

The lying part shall be constructed in such a way that prevents the ingress of fluids The material shall be easy

to clean, washable, petrol-oil resistant and allow preliminary x-ray diagnostics It shall withstand temperatures ranging from - 30 °C to + 70 °C

4.4.6 Restraint system

Not applicable

4.4.7 Flammability − Toxicity burning gases

There shall be no progressive smouldering or flaming ignition when tested in accordance with

4.4.10 Deformation of the lying area

There shall be no remaining deformation of the lying area when tested in accordance with 5.3.2

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The mass shall be not more than 10 kg

4.4.3 Loading capacity

The loading capacity shall be a minimum of 150 kg

4.4.4 Handles

The transfer mattress shall be equipped with at least four handles on each longitudinal side, the handles shall

be designed to give a comfortable and safe grip

4.4.5 Lying part

Both sides of the transfer mattress shall have a different function: one side shall provide a lying comfort

equivalent to a foam filling of minimum 40 mm with density 30 kg/m³ to 40 kg/m³, the other side shall provide

the mattress with sufficient rigidity to transfer the patient with at least two persons, one at each longitudinal

side

The mattress shall be capable of being adapted to form the lying part of the stretcher

The lying part shall be constructed in such a way that prevents the ingress of fluids The material shall be easy

to clean, washable, petrol-oil resistant and allow preliminary x-ray diagnostics It shall withstand temperatures

ranging from - 30 °C to + 70 °C

4.4.6 Restraint system

Not applicable

4.4.7 Flammability − Toxicity burning gases

There shall be no progressive smouldering or flaming ignition when tested in accordance with

4.4.10 Deformation of the lying area

There shall be no remaining deformation of the lying area when tested in accordance with 5.3.2

The dimensions of the carrying sheet shall be as follows:

— Length: minimum 1 850 mm;

— Width: minimum 570 mm

4.5.2 Mass

The mass shall be not more than 5 kg

4.5.6 Restraint system

Not applicable

4.5.7 Flammability − Toxicity burning gases

There shall be no progressive smouldering or flaming ignition when tested in accordance with

!EN 597-1:1994"

4.5.8 Deformation of the handles

There shall be no remaining deformation of the handles when tested in accordance with 5.4.1

4.5.9 Fixation

Not applicable

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4.5.10 Deformation of the lying area

There shall be no remaining deformation of the lying area when tested in accordance with 5.4.2

The dimensions of the pick up stretcher shall be as follows:

The usable length shall be a minimum of 1 650 mm and extendable to a minimum of 2 010 mm

— Thickness folded: maximum 90 mm;

— Length folded: maximum 1 200 mm

4.6.2 Mass

The mass shall be not more than 11 kg

4.6.3 Loading capacity

The loading capacity shall be a minimum of 150 kg

4.6.4 Frame

The frame of the pick up stretcher shall be made of a sturdy lightweight construction with built-in handholds

It shall be adjustable lengthways to accommodate all sizes of patients with the dimension of 4.6.1 It shall be constructed so that the two parts can be separated and closed in normal use

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4.5.10 Deformation of the lying area

There shall be no remaining deformation of the lying area when tested in accordance with 5.4.2

The dimensions of the pick up stretcher shall be as follows:

The usable length shall be a minimum of 1 650 mm and extendable to a minimum of 2 010 mm

— Thickness folded: maximum 90 mm;

— Length folded: maximum 1 200 mm

4.6.2 Mass

The mass shall be not more than 11 kg

4.6.3 Loading capacity

The loading capacity shall be a minimum of 150 kg

4.6.4 Frame

The frame of the pick up stretcher shall be made of a sturdy lightweight construction with built-in handholds

It shall be adjustable lengthways to accommodate all sizes of patients with the dimension of 4.6.1 It shall be

constructed so that the two parts can be separated and closed in normal use

4.6.5 Lying part

The surfaces shall be concaved to cradle the patient to provide support and minimize lateral movement The

concaved surfaces shall be fixed rigidly to the frame Joints and openings shall be sealed

The lying part shall be made of a strong material which is bacterial resistant, fungal resistant, stain resistant,

putrid resistant, easy to clean, washable and petrol-oil resistant

4.6.6 Restraint system

There shall be a minimum of three quick-release patient restraints

4.6.7 Flammability − Toxicity burning gases

There shall be no progressive smouldering or flaming ignition when tested in accordance with

!EN 597-1:1994"

4.6.8 Deformation of the frame

The frame of the pick up stretcher shall not bend or break when tested in accordance with 5.5.1

4.6.9 Fixation

Not applicable

4.6.10 Locking

The hinges and locks shall not open spontaneously or bend when tested in accordance with 5.1.2

4.6.11 Deformation of the lying area

There shall be no remaining deformation of the lying area when tested in accordance with 5.1.3

4.6.12 Resistance to torsion

There shall be no remaining deformation when tested in accordance with 5.5.2

4.6.13 Splaying of the wheels

Not applicable

4.7 Vacuum mattress

4.7.1 Construction

The vacuum mattress consists of a mattress part and a vacuum pump The mattress shall be made of strong material which is disinfectable, washable, putrid resistant, waterproof, petrol-oil resistant and allow preliminary x-ray diagnostics The valve air inlets or outlets shall not disturb the patient

The pump shall be able to reduce the pressure by 500 hPa within 4 min

The vacuum mattress including the filling shall have the following minimum properties:

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— Width: minimum 800 mm in flat position 2)

4.7.3 Mass

The mass including the pump shall be not more than 15 kg

During transportation the mattress shall be in accordance with 4.5.9 of !EN 1789:2007+A2:2014"

When a patient is being conveyed outside of the vehicle or craft, a system shall be available to ensure that the patient can be carried in a safe manner

with the stretcher

4.7.7 Flammability − Toxicity burning gases

There shall be no progressive smouldering or flaming ignition when tested in accordance with

4.7.11 Deformation of the lying area

There shall be no remaining deformation of the lying area when tested in accordance with 5.6.3

2) A greater width should be aimed at

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