Testing records - ex-as.com · The requirements given in 5.3.1 and 5.3.2 do not apply to the body...

Testing records

Testing number: 01 .O1

EN 12 182: 1998 - "Technical aids for disabled persons - general requirements and test methods"

This report should under no circumstances be reproduced, except in its total, without the permission in writing from the testing laboratory. Notice: This report is not an approval of the product lype tested, but a record of testing results for a specifie product sample

Product tested : Excellent System comfort module, standard Serial no. : Rampe + flise Flise T-lock R-lock C-lock

12506 12510 12503 12732 12742 12658 Product received : 05.01.01 Testing notified by : Excellent System

: Msllevej 2 : DK 8544 Msrke

Person to contact : Ole Frederiksen Product delivered by : Excellent System

Date F i Shbye /

Testing executive

Danish Center Testing record 01.01 page 1 of 23

Requirements and testing methods are not described in total in "Testing Records". For a full description, see the draft standard prEN 12182:1998.

The requirements of the standard are indicated by underlined text.

In the right margin the following symbols are used to indicate how the requirements of the standard are fuElled:

Y yes, the requirement of the standard is fulfilled n no, the requirement of the standard is not fumed na not applicable, the requirement of the standard is not relevant for this

product nt not tested, there are no request of the test corn comment, can be supplemented by a number

Photo:

Flise 12503 + fli& 12510 Rampe 12506 R-lock 12742 T-lock 12732 C-lock 12658

Fig. 1 Fig. 2

Brief description of the product: Rectangular t i le elements o f plastic (ref. specifications) which can be joincd together besides each other and a t top o f each other. Attachment is done by special lockers for side or top.

Material specifications: Low dendsity polyetylen (DOWLEX 2035 ELLDPE), Ref. risk analisis page 2 Ref. DT I belastningstest, 1992.07.09. 18.667 kp/m2 a t 23°C


8.6

9 10 11 12

I 13 14 15 16 17 nt

nt

Annex A

General requirements Risk analysis Intended performance and technical documentation Clinical evaluation Aids that can be dismantled Single use fasteners User mass limits Materials Flammab'dity Biocompatibility and toxicity Contaminants and residues Infection and microbiological contamination Resistance to corrosion

Noise and vibration

Electromagnetic compatibility Emissions Immunity

Electrical safety General Battery powered aids Circuit protection Electronic programmable systems Electrically heated blankets, pads and similar flexible heating appliances Aids with skin contact electrodes

Overflow, spillage and ingress of liquids Surface temperature Sterility Safety of moving parts Prevention of traps for parts of the human body Folding and adjusting mechanisms Carrying handles Aids which support users Portable and mobile aids Surfaces, corners and edges Hand held aids Grips and other handling devices Forces in soft tissues of the human body Ergonomic principles Information supplied by the manufacturer - -

Packaging

Durability test

Danish Center Testing record 01 .O1 page 3 of 23

Requirements fulfilled

General Requirements

Risk analysis

The safety of an aid shall be assessed bv identifving hazards and estimating the risks associated with them using the vrocedure sueciiied in prEN 1441 supplemented bv the reauirements of 5.2.5.4.2.5.5.6. 8.2.1, 9.4, 10,22 and 24. -

NOTE 1: The results of this assessment may be used to select !?om this standard the requirements which apply.

NOTE 2: In the case of certain disabilities there may be a need for higher levels of safety for equipment used to offset the effects of that disability

NOTE 3: Conformity with the requirements of this standard may be used to claim compliance with the requirements of clause 4.5 of prEN 1441 for those hazards and risks identified in the following clauses.

4.2 Intended performance and tecbnieal documentation

An aid shall have suilicient strength and durability to sustain all loads emected during intended use. This shall be confirmed bv using. as appropriate, references to relevant clinical and scientific literature. strenrrth andlor durabiity calculations. appropriate standards and test results.

The intended performance including. if a~orovriate, strew&, durabiitv and tioving stabilitv of an aid s h d be described in technical documentation which sets out its functional characteristics. its applicatiods) and conditions of use.

The technical documentation shall include, if appropriate. references to relevant clinical and scientific literature, any strength andlor life calculations. avvrovriate standards and test results.

4.3 Clinical evaluation

If. as Dart of the oroduct conformity assessment, the clinical evaluation requires a clinical investigation, the clinical investigation shall conform to the - requirements O ~ E N 540. I

Comments:


l lfil led

4.4 Aids that can be dismantled

4.5 Single use fasteners

If it is intended that an aid can be dismantled for storaae or transportation. it shall not be ~ossible to reassemble the aid in a manner that oresents a hazard.

Y

NOTE: Single use fasteners include wood screws and self-tapping screws. I

If it is intended that an aid can be dismantled for storage or tranmortation the fasteners which are loosened or removed to allow this dismantline, shall not be s h d e use fasteners.

I

4.6 User mass limits

comO

No normative requirements.

NOTE: For guidance see 23.4 and Annex C, C.4.6

5 Materials

5.1 Flammability

NOTE: Manufacturers should, wherever possible, use materials that can be recycled for Wher use.

Manufacturers shall consider the environments and methods of use to which an Aid will be exposed and take appropriate steps to minimize any f%e hazard.

na

If an aid is not flame resistant. the manufacturer's information shall describe the precautions necessary to ensure the safety of the user and/or attendant and. v corn1 where ~ossible. the aid shall be labelled show that it is not flame resistant. I ' NOTE 1 : E v q effort should be made to use products which meet the

flammab'dity requirements as it is of particular importance to disabled persons who may not be able to escape fiom a fire. The use of non-&me retardant materials should be reviewed regularly as there is continuous development in this field.

NOTE 2: For guidance see Annex C, C.5.1. I Comments: corn: I n relation to disassemble, the instruction for use must warn of not using

lockers or holes for lockers that arc damaged.

I coml: The product is not labelled with any information about flommability. I I Danish Center Testing record 01 .O1 page 5 of 23


5.1.1 Upholstered parts, mattresses, bed bases and bedding

Upholstered parts, mattresses and bed bases and bedding shall comply with the requirements of 5.1.1 a) or 5.1.1 b).

a)ifthe manufacturer claim that an aid is resistant to smokers materials it shall comply with the appropriate requirements in 5.1.2, 5.1.3 or 5.1.4;

b) ifthe clinical requirements prevent the use of materials which comply with 5.1. la) the reasons shall be included in the technical documentation and the Aid shall be supplied with the following: 1. a w+ that it is not flame retardant, placed on the product ifwssible,

and included in the user instructions; and

2. axscription of the precautions required to offset the increased risk.

15.1.2 Upholstered parts I If the manufacturer claims that the upholstered varts are resistant to ignition by smokers materials, ~romessive smouldering ignition and flamin~ imition shall not occur when the materials used for the upholstered parts of an aid are tested in accordance with EN 1021 -1 and EN 1021-2.

5.1.3 Mattresses and bed bases

I

5.1.4 Bedding

If the manufacturer claims that mattresses andlor bed bases are resistant to ignition bv smokers materials, p r o g r imition shall not occur when tested in accordance with EN 597-1 and EN 597-

If the manufacturer claims that bedding is resistant to irmition bv cigarette, I

na

If the manufacturer claims that bedding is resistant to ignition by small flames . I

progressive smoulderine. ignition and flaming ignition sljau not occur when tested in accordance with EN 32952-1 and EN 32952-2 .

s u c h u igniti~nhall not occur when tested in accordance with EN 32952-3 and EN I

tm

Comments:


fulfilled

5.2 Biocompatibility and toxicity

Materials which come into contact with the human body shall be assessed for biocom~atibilitv using the guidance given in EN 30993-1. The assessment shall take into account the intended use and contact by those involved in user care or transportation and storage of the product.

The result of the assessment shall be incorporated in the risk analysis. (see 4.1.0

5.3 Contaminants and residues

The requirements given in 5.3.1 and 5.3.2 do not apply to the body fluids which may be collected in an aid (e.g. stomacare products) but only to those substances which are an integral part of an aid or are needed for its function (e.g. oil and grease).

5.3.1 Substances which may leak from an aid in intended use and in fault 1 I conditions.

Substances which may leak fiom the Aid shall either:

a) be assessed for biocompatibiit~ in accordance with the guidance given in EN 30993-1. The assessment shall take into account the intended use and contact by those involved in user care, transport and storape: or I

b) be provided with urotection that minimizes the possibility of such substance becoming a biological hazard

NOTE 1: Substances that can leak include lubricants and hydraulic fluids. I NOTE 2: An example of a method of protection fiom a hazardous substance is

where batteries are placed in a container made from acid resistant material.

5.4 Infection and microbiological contamination

15.4.1 Cleaning and disinfection I If the aid is intended Lo be cleaned. the method and suitable cleaning materials shall be described in the information suuulied by the manufacturer.

If the aid is intended to be disinfected. the method and suitable materials shall be described in the information sup~lied by the manufacturer.

NOTE: For guidance see 24 and Annex C, C.5.4.1.

Comments: ComZ: The product have many sharp corners which can be difficult to keep clean.


Requirements llfilled

5.4.2 Animal Tissues

NOTE: For guidance see Annex C, C.5.4.2.

5.5 Resistance to corrosion

Manufacturers shall document the risk assessment of the product accordinrr to prrN 12442 and shall incorporate the results in the risk assessment. (see 4.1 .)

na

6 Noise and vibration

The risk of corrosion affectimp the safety of the user or an attendant shall be assessed in the risk analvsis. (see 4.1) na

NOTE: For guidance see Annex C, C.6.

7 Electromagnetic compatibility

If noise and vibration are not part of the intended performance of an aid. b d s and nuisance fiom noise and vibration, esvecially as they affect the user or an attendant, shall be assessed in the risk analysis. (see 4.1) na

7.1 Emissions

An aid containing electrical or electronic devices/comvonents shall conform to EN 60601-1-2 and shall, in addition confonn to the following:

The reauirements in EN 61000-3-2 avvlv. ifapplicable. as svecified in EN 61000-3-2. I na

na

The reauirements in EN 61000-3-3 apply, if apphcable, as soecified in EN 61000-3-3.

Comments:


7.2 Immunity

Aids shall, in addition to the reauirements in EN 60601-1 -2. Clause 36.202.2.1, also be tested with a field strength of 10 V/m (RMS value of the modulated carrier) in the kequencv range of 800 MHz to 2 GHz. The test shall be performed in accordance with EN 61000-4-3.

If as a result of the a~~lication of this test, the technical aid presents a hazard, or there is anv unintentional overation of the aid, the aid fails the test.

NOTE 1: It may be necessary to assess the risk associated with the aid when used in close proximity to (a) mobile telephone(s) or other forms of transmitter. In this case higher field strength values over a broader range of tiequency may apply.

NOTE 2: Technical aids are used in a wide range of environments and may be used in the presence of other electronic equipment. The electromagnetic compatibility (EMC) needs to be carefdly matched to the intended use of the aid.

When specifying the EMC performance of an aid, manufacturers are recommended to consider the already widely established environments:

- residential, commercial and light industrial, - industrial; - other (typically meaning more harsh environments and some specific places

such as surgical theatres or near specific machinery, e.g. transmitters)

A user should be able to use an aid in all the manufacturer's intended environments of use for the device with the minimum of l i tat ion. The manufacturer should make it clear in simple language when l i ta t ions exist by describing the circumstances that must be avoided and should explain the conseque&s of exposing the aid to a potentially dangerous environment, e.g. radio transmitters. If possible, any appropriate actions that will offset any hazard should be described.

Comments:



Electrical safety General

Electricallv wwered technical aids provided with not more than one connection to a particular su~vlv mains and intended to diagnose, treat. or monitor the patient under medical supervision and which make phvsical or electrical contact with the patient andlor transfer enerw to or from the patient and/or detect such enerm transfer to or fiom the patient, shall complv with the reauirements for electrical safety of EN 60601 -1. All other electrical aids shall comulv with the reauirements for electrical safety of EN 60335-1 and its appropriate particular reauirements.

b) Aids shall comvly with the requirements for electrical safety of Class 1 or Class U of EN 60335-1 andfor the reauirements for electrical safety of Class I. Class I1 and internally powered eauivment of EN 60601-1

c) If an aid is intended to be used in both circumstances it shall conform to the reauirements of both EN 60601-1 and EN 60335-1.

d) If the safety of a person using an aid powered fiom an electrical supply mains depends upon the continuity of the power supply the aid shall be provided with at least one of the following: . . 1) an auxhacv source of vower and a means to s i p 1 failure of the

electrical suvvlv mains: and

2) a method of non-electrical overation that reduces the risk to users to an acceptable level until they can be removed from the aid. or wwer is restored together with a means to signal power failure.

e) If the safetv of a patient US^ an internally wwered aid depends upon the . . power suo~lv a means of detemmmg the state of the wwer suvvlv shall be provided.

f) The manufacturer's information shall state the level of protection, as specified in EN 60335-1 or EN 60601-1, as approoriate (see 8.1). and shall describe the intended environment(s) of use and any safety recommendations to avoid hazards due to the ingress of liauids.

Requirements lidfilled

Comments:


8.2 Battery powered Aids 8.2.1 Battery housings

a) The need for, and the design of. batterv housings shall be based on the risk analysis (see 4.1) and shall identify the hazards and evaluating the risks associated with : - leakage of acid andlor other substances fiom the batterv(ies) - ventilation of gases generated during charging and/or use. - short circuits of the batten(ies1 when operated in the intended conditions of use

b) Housings containing batteries fiom which gases can escape during charging or discharging, shall be ventilated.

NOTE: The ventilation should minimize the risk of accumulation and ignition of flammable gases.

c) If a short circuit of a batterv could result in a safetv hazard. the battery shall be contained in a housinp/compartment that prevents the risk of accidentally short circuiting the battery(ies).

d) Anv batterv housinrr/compartment shall collect and store anv fluids andlor substances (other than gases) which may leak fiom the battery(ies1 specified by the manufacturer.

e) The materials used in the manufacture of batterv housings shall be resistant to the substances that might leak fiom the battery(ies) specified bv the manufacturer.

8.2.2 Connection

If a safetv hazard can develop from the incorrect connection or replacement of a battery. an aid shall be fitted with a means of preventing incorrect polaritv.

8.2.3 Charge level indicator

If the safetv of the user of an aid depends upon power being available fiom a b a t t e ~ , the aid shall be equipped with a means of indicating the state of the power supply before the critical state at which safetv is no longer guaranteed.

8.3 Circuit protection

No normative requirement in addition to 8.1

I NOTE: For guidance see Annex C, C.8.3.

Comments:

Danish Center Testing record 01.01 page 1 1 of 23


8.4 Electronic programmable systems

Aids which are required to comply with the requirements of EN 60601-1 (8. la) and which have an electronic programmable system shall complv with the requirements of EN 60601-1-4.

8.5 Electrically heated blankets, pads and similar flexible heating appliances

No normative requirement in addition to 8.1

I NOTE: For guidance see Annex C, C.8.5 I 8.6 Aids with skin contact electrodes

Aids with skin contact electrodes shall comolv with the requirements of EN 6060 1- 1 for continuous leakaze currents and patient auxiliarv currents.

NOTE: European standards exist for some types of medical device with skin contact electrodes. In such cases this standard may not apply. (see

9 Overflow, spillage, leakage, and ingress of liquids 9.1 Overflow

If an aid incorporates a reservoir or liquid storage chamber that may be overfilled or may overflow in the manufacturer's intended use, liquid overflowing fiom the reservoir or chamber shall not wet electrical insulation and live parts which are liable to be adverselv affected bv such a liauid, nor shall a safetv hazard be created. Unless restricted by a marking or bv the instructions for use, no safetv hazards shall develop if aids are tilted through an angle of 15" fiom the position of intended use.

Test method

Fi the reservoir to the maximum level specified by the manufacturer and, if possible, add further liquid equal to 15% of the capacity of the reservoir or until the reservoir is full.

Tilt the aid through an angle of 15 +200 in each of the least favourable direction(s) starting fiom the position of the manufacturer's intended use or the maximum angle of intended use, whichever is the most severe. If necessary, refill the reservoir between tests.

These procedures shall not wet parts of the aid that will cause a hazard. In particular, an aid shall show no signs of wetting of un-insulated live parts or electrical insulation of parts which may cause a safety hazard. For electrical insulation, in case of doubt, the aid shall be subjected to the dielectric strength test as described in EN 60601-1, Clause 20.


Aids reauiring the use of liquids in the manufacturer's intended use shall be so constructed that s~i lhge do not wet parts which may cause a safetv hazard in the product. na

Test method

Position the equipment as in the manufacturer's intended use. Pour 200 ml +5/-0 ml of water steadily on an arbitrary point on the top surface of the aid.

After the test, the aid shall function as speczed by the manufacturer - 9.3 Leakage

Aids shall be so constructed that liauid which might escaoe in single fault condition does not cause a safetv hazard. Y

I NOTE: See Annex C, C. 9.2. I I

9.4 Ingress of liquids

The hazards that can be caused bv the mgress of liauids to non-electrically powered aids shall be assessed in the risk analvsis. (see 4.1).

na

I NOTE: For requirements for electrically powered aids see 8.1

10 Surface temperature

The risk analysis (see 4.1) shall ident* hazards and evaluate the risks associated with the surface temperature of parts which can come into contact with human skin durinn the intended conditions of use.

The risk analysis shall take account of:

a) the rawe of ambient temperatures to be expected during the intended use and foreseeable misuse

NOTE: These temperatures could include direct exposure to sunshine, extreme cold, saunas, etc..

b) temoeratures that mav result ftom single fault conditions.

c) the ergonomic data on acceutable temperatures of touchable surfaces in EN 563.

d) the use of aids bv peovle with insensitive skin (ie cannot feel heat) and/or damaeed skin. In this case the maximum temverature shall not exceed 41- C when measured by the methods of test in EN 563. Except that:



I. if a rnanuhturer cannot meet this reauirement without im~a.iring the intended ~erformance of the aid, each device should be supplied with a warn& ident ikg which surfaces mav reach a higher tem~erature than that specified and a descri~tion of the precautions necessarv to offkt the increased risk.

and, .. n. if a manufacturer cannot meet the surface temperature reauirement the reasons shall be set out in the technical documentation (see 4.2).

11 Sterility I 11.1 Sterility requirements I 11.2 Sterilization processes

Aids which are labelled "STERILE" shall conform to the requirements of EN $56.

Sterilization Drocesses shall be validated and routinely controlled.

M

If an aid is sterilized bv ethylene oxide the process shall wnform to the reauirements of EN 550.

If an aid is sterilized bv steam the process shall conform to the reauirements of EN 554.

If an aid is sterilized bv irradiion the process shall wnform to the reauirements of EN 552.

11.3 Maintenance of sterility in transit

The ~ackagim shall conform to the re~l~uirements of EN 868-1.

12 Safety of moving parts

12.1 Unless the intended purpose of an aid, or part of an aid, is to grip, cut, squeeze etc.: or if the intended use cannot be achieved without a hazard such as risk of squeezing (e.g. the elbow or knee flexion of a limb prosthesis):

a) anv moving Darts that constitute a safetv hazard shall be provided with guards that can onlv be removed by the use of a tool.

b) the gap between exnosed parts of an aid that move relative to each other shall be maintained throughout the range of movement at less than the minimum value or more than the maximum value set out in table 1.


or, c). if cords (ropes). chains and drive belts are used. thev shall either be

confined so that thev cannot run off or iunm out of their miding devices, or a safetv hazard shall be orevented bv other means. Mechanical means a~plied for this purpose shall be removable onlv bv the use of a took

d). the aid shall incomrate a control device which initiates the movement when it is ouerated and stops the movement when it is released (e.g. a suring loaded control device that returns to the s t o ~ oosition when released);

or,

e). the aid shall incornorate a means for detecting that a person is in darner of being trao~ed and automatically activating a means of vreventing iniury (e.g. bv stopping movement):

f). the aid shall incomrate a control device which initiates a small movement when it is o~erated and which then s t o ~ s and reauires further initiation for each subsequent increment of movement:

12.2 If the intended ~umose of an aid cannot be met without a hazard such as wueezine. a warning and instructions on how to ooerate the aid safehr shall be provided in the manufacturers instructions.

12.3 Parts subiect to mechanical wear likehr to result in a d e t v hazard shall be accessible for insuection

12.4 If an aid incomrates an emergencv stoo feature. it shall conform to the requirements of EN 41 8.


Requirements hlfilled

13 Prevention of traps for parts of the human body

Holes in and clearances between stationary parts that are accessible to the user and/or attendant duriw the intended use of an aid shall be as specified in Table 2,

If the intended pumose of an aid cannot be met without a hazard caused bv the size of holes and the clearance between moving oarts. a warning and instructions on how to o~erate the aid safely shall be vrovided in the manufacturers instructions.

14 Folding and adjusting mechanisms

NOTE: Fold i i and adjusting mechanisms may cause a hazard if parts of the body can enter a gap between parts and be trapped when the gap is closed.

If an aid incorporates folding andlor adjusting mechanisms:

14.1 The mechanisms shall be ca~able of being securely locked when the aid is in any fixed workin~ configuration and

14.2 Either:

a) the aid shall incorporate guards to Drotect the user ffom trav and/or squeeze hazards.

b) the zav between exposed Darts of an aid that move relative to each other shall be maintained throughout the range of movement at less than the minimum value or more than the maximum value set out in table 1.

C) if the intended ~urpose of an aid cannot be met without a hazard such as squeezing. a warning and instructions on how to oDerate the aid safelv shall be provided in the manufacturers instructions.

Comments: com3: I t is recommended to warn of holes and clearness between system

elements and also system elements and other construction parts. Ref. table 2 in the standord. foot traps for adults and children.


Reouirements

15 Carrying handles

15.1 If an aid incorwrates carrving handles or grips. thev shall not become detached fiom the aid and there shall not be anv permanent distortion, cracking or other evidence of failure when tested as s~ecified in 15.2.

After the cornletion of the test the aid shall owrate as intended bv the manufacturer.

15.2 Test method If an aid has one handle or grip, or if an aid can readily be carried or lifted by one of a number of handles or grips, determine the force on each handle or grip when it is carried or lifted

If an aid has more than one handle or grip, determine the force on each handle or grip when the aid is carried or lifted in the intended manner.

Apply a force to each handle or grip, equal to twice that determined above with a tolerance of +5/-0%, uniformly distributed over a 70 mrn + 5 mrn length in the centre of the handle or grip, avoiding shock.

Maintain the force for between 60 and 70 s.

Remove the force and inspect the aid for damage and satisfactory operation

16 Aids which support users 16.1 If an aid is intended to suport a disabled Derson andlor an attendant. no part

of the aid shall become detached, exhibit cracking. Dermanent deformation. loss of stability or anv other failure when tested as specified in 16.2. After the test, the aid shall omate as intended by the manufacturer.

If an aid is intended to fold for transport andlor storage. it shall not fold when tested as s~ecified in 16.2.

16.2 Test method Position the support system in the least favourable position of intended use.

Apply a test load, equal to 1.5 times the maximum rated load intended by the manufacturer (including any accessories) with a tolerance of +5/-0 %, to the support surface in the worst case position, in a manner that ensures that there is negligible dynamic loading.

Maintain the test load for between 60 s and 70 s. Remove the test load and inspect the aid for damage and satisfactory operation.

Comments: com5:Ref diagram for loadings in D l l belastningstest, 1992.07.09.

short time loading (one houer) 18.667 kp/m2 at 2 3 O C , I


17 Portable and mobile aids

No normative requirement.

I NOTE: For guidance see Annex C, C.16 I nt 18 Surfaces, corners and edges

If not required for the intended function of an aid. all accessible edges. corners and surfaces shall be smooth and be free from burrs and sharp cd~es.

Y If not reauired for the intended function, aids shall not have projections. Where possible necessarv pro-iections shall have protection to vrevent iniuw andlor damape. Y

I

19 Hand held aids

No normative requirement.

I NOTE: For guidance see Annex C, C. 18 I I

20 Grips and other handling devices

NOTE: Manufacturers should note that national and other requirements may demand test loads in excess of the following.

a) If an aid or parts of an aid have a mass of more than 20 kg and need to be handled in the manufacturer's intended use, they shall:

either be vrovided with suitable handling devices (e.e. handles. liftmg eves2

& manufacturers information shall indicate the points wkrc aids can bc lifted safelv and describe how thev should be handled during lifting, assemblv andlor canvine. 1f vracGcal the component varts~hall be labelled to indicate where the aid can be lifted safelv and/or how it can be handled during assembly andlor canuinn.

b) If an aid is intended bv the manufacturer to be portable and it has a mass of more than 20 kg. it shall have one or more canving-handles suitably vlaced which enable the aid to be carried bv two or more oersons.

Comments:com6: It is recommended t o inform of how t o lift and handle a construction of elements too difficult t o carry by hands.



21 Forces in soft tissues of the human body

The hazards that can be. caused bv forces aoolied to the soft tissues of the body shall be assessed in the risk analysis. (see 4.1)


Ergonomic principles

An aid shall he desimed to the ergonomic ~rincivles set out in EN 614-1 taking into account the soecial needs of the disabled persons for whom the device is intended.


Information supplied by the manufacturer

The information applied to, and supplied with, aids shall conform to prEN 1041 together with, but not limited to, the following requirements.

1) The information shall include advice on which other devices andtor tvpes of device can be used in combination and anv precautions or limitations needed to ensure user safktv. includii the following:

Waminrrs and advice about precautions relating to hieh and /or low temDerature surfaces (see 10).

Warnings and advice about precautions relating to safe distances between moviw and stationary parts (see 12 and 13).

Instructions on how to fold andlor adiust aids and warnings and advice about precautions needed to avoid hazards. (see 14)

Advice on safe W i and hand@ (see 201,

The level of protection of electrical equioment against the ingress of liquids and advice on the intended environments of use and related safety recommendations (see 9).

Information about daneerous combinations shall be highlighted ( e . ~ cushions for the orevention of decubitus ulcers often onlv work on the correct seat surface, spreader bars for s h s for hoists are often only suitable for specific products).

2) information applied to, and suvolied with aids intended bv the manufacturer for use bv oeoole with readinq difficultics shall bc in a form that thev can comprehend.

Danish Center Testing record 01 .O1 Page


I

Aids intended bv the manufacturer for use bv people with visual impairment shall be in a tactile (ex. Braille) or audio form.

3) The information shall include anv maintenance and cleaning instructions.

4) If the strength and durabilitv of an aid is related to the bodv mass of a disabled person and/or attendant. the manufacturer's information and labelling shall specifv that mass as a limiting value for use.

5) If the aid is not flame resistant andlor does not complv with the flamrnab'ity re~uirements of 5.1 the precautions necessan, to ensure the safetv of the user andlor attendant and, if possible. the aid shall be labelled to show that it is not flame resistant. (see 5.1)

6) If the aid may be affected by electromagnetic emissions, the information shall include:

a) advice on the intended environments of use, anv environments known to be hazardous. (e.g. close proximity to radio transmitters) and a description of the hazard(s).

and b) guidance on how to correct any malfimctions.

7) If the aid is intended to be cleaned. a description of the method and suitable cleaning materials. including any precautions needed to avoid corrosion.

8) If the aid is intended to be disinfected. a description of the method and suitable materials. including any rec cautions needed to avoid corrosion.

9) If the aid can create a noise hazard, warnings and advice about precautions relating to high output sound levels.

NOTE 1: Most countries require that information is in one or more of their official languages.

NOTE 2: The guidance document ISO/IEC Guide 37: Instructions for consumer products should be considered when preparing this information.

NOTE 3: Manufacturers are recommended to present their information in separate parts that cover use, prescription, technical and/or paramedical aspects and medical aspects

Comments: comb: Instruction informs of that the product is not flame resistant.

I


Danish Center Testing record 01 .O1 page 2 1 of 23

Requirements

24 Packaging

The hazards that can be caused bv inadequate protective vackaging shall be assessed in the risk analysis. (see 4.1)


Comments:

fulfilled

nt

Annex A: Durability test

A r c l m p ~ o b r a a d o f l ~ ~ m ~ a l l c h g t h Q f 1 ~ ~ ~ i n a ~ w S t h a h u g h t o f . 1 ~ m m a b s t m b k i d w ~ l ~ o n d f a s t d ~ i o t h c f k o ~ o t i b c d i n i r v c S r u c t i m f o r LHC YQS tasted, ref. fig 3. A whd chair withatolalwcightof 2Wkgm~1drivwupmddorm~ramp lW3 c y e k total.

The speed war app. 0,4 mls

After the tcst there were no specific sign of damage or loosen elements or lockers. The romp hod not moved in relotion to its fundament.

at' Fig. 3


Supplementary comments:

The rise of a ramp element is 9 . 5 O The rise of a ramp build as shown in fig. I in instruction for use and the tested ramp fig. 3 is app. 8.3"

banish standards and recommendations:

Ref. 05 3028 "Tilgamgelighed for alle", section 8.2.6 'Nivcauforskelle p ldende for boligbyggeri for c~ ldre og hondicappede med plejebehov" and 'Bygningsreglemcntet 1995". The max. rise o f a ramp must not exceed 2.9". For ramps with a rise of more than 2.3" they shall be equipped with rails.

Ref,"Bygningsreglementet for frittiggcnde enfamilicshuse" In this case the excellent ramp is able to fulfil the reccomandations.

It is reecommcndcd to inform of these facts in instruction for use.

European standards and ncommcndations:

There are not existing any European standard for ramps.

Different countries have like Denmark their own standards and recommendations.


Testing records - ex-as.com · The requirements given in 5.3.1 and 5.3.2 do not apply to the body...

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Transcript of Testing records - ex-as.com · The requirements given in 5.3.1 and 5.3.2 do not apply to the body...