Bsi bs en 01970 2000 scan

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 December 2000, and conflicting nat

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BS EN 19702000

This British Standard, having

been prepared under the

direction of the Health and

Environment Sector Committee,

was published under the

authority of the Standards

Committee and comes into effect

on 15 August Zoo0

6 BSI û8-2ûûû

ISBN O 680 36036 9

This British Standard is the official English language version of E N 19702000

The UK participation in its preparation was entrusted by Technical Committee Cw31, Hospital furniture, to Subcommittee Cw31/1, Hospital bedsteads, which has

the responsibility to:

- aid enquirers to undeistand the text;

- present to the responsible European committee any enquiries on the

- monitor related i n t e d o m l and European developments and promulgate interpretation, or proposals for change, and keep the UK interests informed;

“F”’ facility of the BSI Standards Electronic Catalogue

A British Standard does not purport to include all the necessary provisions of a contract Users of British standards are responsible for their correct application

Compliance with a British Standard does not of itself confer immunity from legal obligations

Summary of pages

This document comprises a front cover, an inside front cover, the EN title page, pages 2 to 41 and a back cover

The BSI copyright notice displayed in this document indicates when the document

was last issued

Amendments issued since publication

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This European Standard was approved by CEN on 11 May 2000

CEN members are bound to comply with the CENKENELEC 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 sich national standards may be obtained on application to the Central Secretariat or to any CEN member

This European Standard exists in three official versions (English French, German) A version in any other language made by trarslation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as h e official versions

CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom

EUROPEAN COMMITTEE FOR STANDARDIZATION

COMITE EUROPEEN D E N O R M A L I S A T I O N

E U R O P Ä I S C H E S K O M I T E E FOR N O R M U N G

Central Secretariat: rue da Stassart, 36 8-1050 Brussels

Q 2000 CEN All rights of exploitation in any form and by any means reserved

worldwide for CEN national Members

Ref No EN 1970:2000 E

Page 4

EN 1970:2000

Foreword

This European Standard has been prepared by Technical Committee CENTTC 293, Technical aids

for disabled persons, the Secretariat of which is held by SIS

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 December 2000, and conflicting national

standards shall be withdrawn at the latest by December 2000

This European Standard 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

standard

According to the CENKENELEC Internal Regulations, the national standards organizations of the

following countries are bound to implement this European Standard: Austria, Belgium, Czech

Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg,

Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom

This standard provides one means to demonstrate that adjustable beds for disabled persons,

which are also medical devices, conform to the essential requirements outlined in general terms in

Annex 1 of the EU Directive 93/42/EEC It is not intended to provide a means to show conformity

with the requirements of any other directive

There are three levels of European Standards dealing with technical aids for disabled persons

These are as follows, with level 1 being the highest:

Where standards for particular aids or groups of aids exist (level 2 or 3), the requirements of lower

level standards take presedence over higher level standards Therefore, to address all

requirements for a particular aid, it is necessary to start with standards of the lowest available

standard

This is a combined level 2- and 3- standard (lowest possible) for adjustable beds for disabled

persons, which are also medical devices, as specified in the scope

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question The risk analysis should be used for determining if further or other requirements should

be addressed for each specific product

Due to the dissimilarity of disabilities to be alleviated, it is not possible to specify requirements for adjustable beds for disabled persons in such a way that any bed of this type is covered The

present standard is therefore intended to cover the major part of adjustable beds for disabled persons Certain beds, e.g those designed to meet special needs, might need to fulfil other or further requirements, e.g regarding ergonomics or EMC, than specified in this standard

Beds covered by the present standard differ from beds covered by the IEC standard on electrically operated hospital beds, e g due the following characteristics:

- beds for disabled persons are intended to be used instead of domestic beds for permanent use, with the intention of alleviating or compensating for a disability or handicap and to facilitate better working conditions for attendants;

- beds for disabled persons do not require the same level of strength and cleaning as

hospital beds, due to the different application;

- beds for disabled persons do not require the same electrical performance as hospital beds due to the different application

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EN 1970:2000

This standard specifies essential requirements and related test methods for non-electrically and

electrically operated adjustable beds, including detachable bed boards, bed lifts, side rails, grab

handles and lifting poles intended to be used by disabled persons to alleviate or compensate for a

disability or handicap

The standard also applies to stand up beds

The standard does not apply to lateral tilt beds

The standard does not apply to beds intended for use in the diagnosis, treatment or monitoring of

patients under medical supervision (covered by EN 60601 -2-38 for electrically operated hospital

beds)

The standard does not apply to ordinary domestic beds, beds intended for children under 12 years

of age, and mattresses

The requirements in this standard do not take into account extreme heavy duty use of the bed

2 Normative references

This European Standard incorporates by dated or undated reference, provisions from other

publications These normative references are cited at the appropriate places in the text and the

publications are listed hereafter For dated references, subsequent amendments to or revisions of

any of these publications apply to this European Standard, only when incorporated in it by

amendment or revision For undated references the latest edition of the publication referred to

applies (including amendments)

Medical devices - Risk analysis

Degrees of protection provided by enclosures (IP code) (IEC 60529:1989)

Medical electrical equipment - Part 1 General requirements for safety Medical electrical equipment - Part 1 : General requirements for safety - Section 2: Collateral standard: Electromagnetic compatibility - Requirements and test methods

Electromagnetic compatibility (EMC) - Part 3: Limits - Section 2: Limits for

harmonic current emissions (equipment input current 5 16 A per phase) Electromagnetic compatibility (EMC) - Part 3: Limits - Section 3: Limitation of voltage fluctuation and flicker in low-voltage supply systems for equipment

input current i 16 A

Electromagnetic compatibility (EMC) - Part 4: Testing and measurement techniques - Section 3: Radiated radio-frequency, electromagnetic field immunity test

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S T D = B S I BS EN 1970-ENGL 2000 m L b 2 4 b b 9 OBb5984 325

Page 7

EN 1970:2000

EN I S 0 3746 Acoustics - Determination of sound power levels of noise sources using

sound pressure - Survey method using an enveloping measurement surface over a reflecting plane (IS0 3746:1995)

EN I S 0 14253-1 Geometrical Product Specifications (GPS) - Inspection by measurement of

workpieces and measuring equipment - Part 1 : Decision rules for proving conformance or non-conformance with specifications (IS0 14253-1 :1998)

I S 0 2439 Flexible cellular polymeric materials - Determination of hardness (indentation

technique)

GUM Guide to the Expression of Uncertainty in Measurement - GUM - 1 st edition

1995 issued by BIPM, IEC, ISO, IUPAC, IUPAP, OIML -

ISBN 92-67-1 O1 88-9

3 Terms and definitions

For the purposes of this standard the following terms and definitions apply:

Safe working load (SWL)

Maximum permissible load (of disabled person, mattress, bed linen and accessories and those parts of the bed intended to be lifted by the bed lift) to operate the bed safely

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EN 1970:2000

3.8

Lifting pole: Device suspended above the bed intended to enable the disabled person to change

position by gripping it

3.9

Control unit: Device that controls the drives that activate various functions of electrically operated

beds

3.1 O

Hold-to-run control device: Control device which initiates and maintains operation of operating

elements, only as long as the manual control (actuator) is actuated The manual control (actuator)

returns automatically to the stop position when released

3.1 1

Under bed clearance: Space beneath the bedstead base which is not occupied by the castors,

legs or other constructional parts

3.12

Normal reach for fingers: Parts of the upper bed and parts under the bed (see figure 1) which are

placed at a distance of less than 200 mm from upper/lower part of the outer edge of the bed board

as shown in figure 1

3.1 3

Normal reach for feet: Parts under the bed which are placed at a distance of less than 120 mm

from the vertical line of the outer edge of the bed board

3.1 4

Moving parts: Parts that are movable in relation to each other or in relation to a fixed part

3.1 5

Bed board: Mattress support platform and its frame, if any

The nomenclature is given in figures 2 to 5 (the figures are only intended to illustrate the

STD-BSI BS EN L970-ENGL 2000

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EN 1970:2000

2

1 Head and panel

2 High side panel

3 Foot and panel

S T D - B S I BS EN 1970-ENGL 2000 I I 1b24bb9 0865987 034

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EN 1970:2000

2

1 Bed board frame

2 Head rest section

3 Back rest section

4 Seat section

5 Upper leg section

6 Lower leg section

Figure 3 - Nomenclature of detachable bed board (example, schematic presentation only)

O BSI 08-2000

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a risk analysis in accordance with EN 1441 shall be carried out

In particular, the following requirements apply:

distances between moving parts within normal reach for fingers of the disabled person, the attendant or other persons shall always be either maximum 8 mm or more than 25 mm; distances between moving parts and the floor within normal reach for feet of the disabled person, the attendant or other persons, shall always be either maximum 20 mm or fulfil the dimensional requirements given in figure 6;

Dimensions in millimetres

Figure 6 - Minimum distances between moving parts and the floor

distances between elements in end panels shall comply with the requirements for distances between elements in side rails (see 5.5.5);

which shall be checked by measurements, and:

open ends of tubular components shall be capped or otherwise closed,

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S T D * B S I BS EN L970-ENGL 2000 I I Lb24bb9 0 8 b 5 9 9 1 5 b 5

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EN 1970:2000

which shall be checked by visual inspection, and:

all edges and corners shall be smooth and shall have no burrs or sharp edges and protruding parts shall be avoided;

- the design of the foot end panel shall prevent feet slipping through holes in the panel;

the design of the bed shall allow mounting of side rails and lifting pole;

the design of the bed shall prevent incorrect assembly of knock-down parts and accessories;

the design of the bed shall prevent unintentional activation of moving parts and accessories;

single use components, e.g wood screws or self tapping screws, shall not be used for the assembly of any components that are intended to be removed when disassembling for the purposes of transportation and storage;

- in case of malfunction in the drive system, it shall be possible to bring the back rest section

to the horizontal position;

a control unit shall be reachable by the disabled person and the attendant;

- a control unit shall have a hold-to-run function;

it shall not be possible to position the bed in a hazardous position for the disabled person

The position of Trendelenburg for medical treatment (see EN 60601 -2-38) shall not be

possible;

which shall be checked by inspection

4.1 Safe working load

The safe working load shall be not less than 1 700 N for beds and not less than 2 200 N for bed

lifts

The minimum safe working load shall consist of the sum of the following minimum forces:

- 1 350 N (corresponding approximately to a mass of 135 kg of the disabled person);

200 N (corresponding approximately to a mass of 20 kg of the mattress);

150 N (corresponding approximately to a mass of 15 kg of accessories);

- 500 N (corresponding approximately to a mass of 50 kg of those parts of the bed intended

to be lifted by the bed lift)

If any of the individual masses mentioned above is known to be higher than the masses mentioned

in the brackets above, the actual safe working load used for testing shall be the given minimum

safe working load plus the force calculated as being the difference in mass (kg) between the

minimum mass (kg) and the actual known mass (kg) multiplied by 10 N/kg

If the loading is applied by loads, the mass of the loads shall be calculated by using the correct

value of gravity

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S T D - B S I BS EN L970-ENGL 2000 L b 2 4 b b 9 0665992 4Tl =

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EN 1970:2000

4.2 Maximum mass of knock-down parts

If a bed is of a knock-down type, the maximum mass of any main part shall be either less than

50 kg or the part shall be labelled with the actual mass which shall be mentioned in the instructions for use

5 Specific safety requirements and related test methods

The requirements and test methods are specified in the following subclauses

5.1 General test conditions

5.1.3 Uncertainty of measurements and conformance with specifications

The uncertainty of measurements shall be evaluated and expressed by the laboratory performing the test in accordance with Guide to the Expression of Uncertainty in Measurement (GUM)

The conformance with specification is proven in accordance with EN I S 0 14253-1

Conformance with specification is proved when the result of a measurement, complete statement, falls within the tolerance zone of a bed characteristic

The same conformance can be proven similarly when the result of a measurement falls within the tolerance zone of a bed characteristic

5.1.4 Sequence of testing

The tests shall be carried out in the sequence of the subclauses in the clause of the standard, if

not otherwise stated

All tests specified shall be carried out on the same sample

5.1.5 Visual inspection

Visual inspection shall be carried out with normal or corrected to normal vision

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EN 1970:2000

5.2 Test environment and apparatus

5.2.1 Ambient conditions

Unless otherwise specified the tests shall be carried out in indoor ambient conditions:

- with temperatures between 15°C and 3OoC;

with humidity between 20 RH and 85 RH

5.2.2 Floor surface

A rigid, horizontal and flat surface

NOTE: Uncertainty in rigidity, level and flatness influence the uncertainty of measurement for

specific characteristics

5.2.3 Test mattress

The mattress recommended for use with the bed by the manufacturer shall be used for testing

Alternatively a test mattress as specified below shall be used

The test mattress shall be of flexible polyether foam Its thickness shall be 100 mm, its density

shall be (30 i 2) kg/m3 and its indentation hardness index shall be (1 70 * 20) with A40 according

to I S 0 2439 The size of the mattress shall be more or less the same as the size of the mattress

support platform tested

The test mattress shall have a cover with the following characteristics:

Composition: pure cotton;

- Weave in plain: 1/1;

- Mass per unit area: (100 to 200) gim2;

- Warp and weft: Finishing: (20 to 30) threadskm;

- Cover make up: tight fit, but no restriction on the foam

washed, no finishing agents;

Each test mattress shall be used for no more than five complete bed tests

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STD-BSI BS EN 3970-ENGL 2000 Lb24bb9 08b5994 274

Page 17

EN 1970:2000 5.2.4 Loading pad

A rigid circular object, (355 i 5) mm in diameter, the face of which has a convex spherical

curvature of 800 mm radius with a 20 mm front edge radius (see figure 7)

of the striking surface

The body and associated parts minus the springs shall have a mass of (17 i 0,l) kg and the whole apparatus, including mass, springs and striking surface, shall have a mass of

(2510,l) kg

5.2.5.2 Springs

Springs, which shall be such that the combined spring systems have a nominal spring rate of

(6,9 f 1) N/mm and the total friction resistance of the moving parts is between 0,25 N and 0,45 N

The spring system shall be compressed to an initial load of (1 040 * 5) N, measured statically, and the amount of spring compression movement available from the initial compression point to the point where the springs become fully closed shall be not less than 60 mm

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STD-BSI BS EN L770-ENGL 2000 D Lb24669 Oô65995 100 m

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EN 1970:2000

5.2.5.3 Striking surface

The striking surface shall be a rigid circular object, (200 * 5) mm in diameter, the face of which has

a convex spherical curvature of 300 mm radius with a 12 mm front edge radius

Page 19

EN 1970:2000 5.2.6 Cones for determining distances between elements

Cones (see figure 9) with an external diameter of 60 mm and 120 mm made of plastics or other hard, smooth material mounted on a force-measuring device

Dimensions in millimetres

0=600r

0 = 120

I Figure 9 - Test cones 5.2.7 lest bed board

A flat, rigid loading board with a length of (2 O00 * 10) mm and a width of minimum 700 mm and maximum 1 050 mm with intervals of (50 f 5) mm

5.3 Stability

5.3.1 Requirements for stability

When tested in accordance with 5.3.2 the bedbed lift shall not overbalance

5.3.2 Test methods for stability

5.3.2.1 Loading onto the bed/bed lift

Depending on the device to be tested, use one of the following procedures:

If the bed is with fixed height, place the bed, with the test mattress (see 5.2.3), onto the floor Position any wheel in the most adverse position

If the bed is with adjustable height, place the bed, with the test mattress (see 5.2.3), onto the floor Adjust the height to, and position any wheel in, the most adverse position

If the bed lift is intended for bed boards greater in width than that supplied, replace the bed board with the widest test bed board possible (see 5.2.7) Place the bed lift with the test bed board onto the floor Adjust the height to, and position any wheel in, the most adverse position

If the bed lift is supplied without a bed board, mount it with the widest test bed board possible (see 5.2.7) Place the bed lift with the test bed board onto the floor Adjust the height to, and position any wheel in, the most adverse position

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EN 1970:2000

The tilting tendencies shall not be restrained

Distribute uniformly a force of 2 250 N over the whole length of the side of the bed board with the

centre of the force 125 mm from the outer edge of the bed board (see figure 10)

Examine whether the bedbed lift overbalances during the test

tt il

250 mm

1 Uniformly destributed force

2 Outer edge of bed board

Figure 10 - Stability test by loading the side of the bed board

O BSI 08-2000

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