Iec 80601 2 35 2016

MEDICAL ELECTRICAL EQUIPMENT – Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mat resses and intended for he

Medical electrical equipment –

Part 2-35: Particular requirements for the basic safety and essential performance

of heating devices using blank ets, pads or mat resses and intended for heating

in medical use

Apparei s électromédicaux –

Partie 2-35: Exigences particul ères pour la sécurité de base et les performances

essentiel es des dispositifs de réchauf age uti isant des couvertures, des

coussins ou des matelas chauf ants et destinés au réchauf age des patients en

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Medical electrical equipment –

Part 2-35: Particular requirements for the basic safety and essential

performance of heating devices using blank ets, pads or mat resses and

intended for heating in medical use

Apparei s électromédicaux –

Partie 2-35: Exigences particul ères pour la sécurité de base et le

performances essentiel es des dispositifs de réchauf age uti isant des

couvertures, des coussins ou des matelas chauf ants et destinés au

réchauf age des patients en usage médical

IEC 80601 -2-35

Editio 2.1 2 16-0

Medical electrical equipment –

Part 2-35: Particular requirements for the basic safety and essential performance

of heating devices using blank ets, pads or mat resses and intended for heating

in medical use

Apparei s électromédicaux –

Partie 2-35: Exigences particul ères pour la sécurité de base et les performances

essentiel es des dispositifs de réchauf age uti isant des couvertures, des

coussins ou des matelas chauf ants et destinés au réchauf age des patients en

CONTENTS

FOREWORD 4

INTRODUCTION 7

2 1.1 Sco e, o ject an related stan ard 8

2 1.2 Normative referen es 10 2 1.3 Terms an definition 10 2 1.4 General req irements 13 2 1.5 General req irements for testin ME EQUIPMENT 14 2 1.6 Clas ification of ME EQUIPMENT an ME SYS EMS 14 2 1.7 ME EQUIPMENT identification, markin an doc ments 14 2 1.8 Protection again t electrical HAZA DS from ME EQUIPMENT 17 2 1.9 Protection again t MEC A IC L H ZA DS of ME EQUIPMENT an ME SYS EMS 2

2 1.10 Protection again t u wanted an ex es ive radiation HAZA DS 2

2 1.1 Protection again t ex es ive temp ratures an other HAZA DS 2

2 1.12 Ac urac of controls an in truments an protection again t hazardou outputs 2

2 1.13 HAZA DOUS SITU TIONS an fault con ition 3

2 1.14 PROG AMMABLE ELECTRICAL MEDIC L SYS EMS (P MS) 3

2 1.15 Con tru tion of ME EQUIPMENT 3

2 1.16 ME SYS EMS 41

2 1.17 Electromag etic comp tibi ty of ME EQUIPMENT an ME SYS EMS 41

2 2 Electromag etic comp tibi ty – Req irements an tests 4

2 8 General req irements, tests an g idan e for ALA M SYS EMS in MEDIC L ELECTRIC L EQUIPMENT an MEDICAL ELECTRICAL SYS EMS 4

210 * Req irements for the develo ment of ph siologic closed-lo p control ers 4

An ex D (informative) Symb ls on markin 4

An ex AA (informative) Partic lar g idan e an rationale 4

An ex BB (normative) Determination of the LA GIN MAT RIAL 5

An ex CC (normative) *Determination of he t tran fer toward the PATIENT 5

An ex DD (normative) *Determination of he t tran fer away from the PATIENT 5

An ex EE (normative) Con ition of adeq ate he t dis harge 6

An ex F (normative) Test proced re for maximum CONTA T SU FA E T MP R TU E for FORCED AIR DEVICE 61

An ex GG (normative) Test proced re for maximum CONTA T SU FA E T MP R TU E for FORCED AIR DEVICE u der SIN LE FA LT CON ITION 6

An ex HH (normative) Safety test proced re for average CONTA T SU FA E T MP R TU E for FORCED AIRDEVICE 6

Bibl ogra h 6

In ex of defined terms u ed in this p rtic lar stan ard 6

Fig re 2 1.101 – Positionin of temp rature sen ors on the contact s rface of the

© IEC 2 16

Fig re 2 1.10 – Example of the p sitionin of temp rature sen ors on the contact

s rface of the he ted are s of a HEATING DEVICE

havin more than one se arately

he ted are 1

Fig re 2 1.10 a) – Ap aratu for the sp rk ig ition test – Detai A: The a p ratu (se 2 1.8.8.4.101) 19 Fig re 2 1.10 b) – Ap aratu for the sp rk ig ition test – Detai B: L wer memb r of mask 2

Fig re 2 1.10 c) – Ap aratu for the sp rk ig ition test – Detai C: Up er memb r of mask 2

Fig re 2 1.10 – Ap aratu for the sp rk ig ition test 2

Fig re 2 1.10 – Ramp for the imp ct test on PA S 2

Fig re 2 1.10 – Partial coverin con ition 2

Fig re 2 1.10 – Method of foldin BLA KE S 3

Fig re 2 1.10 – Examples of fold 3

Fig re 2 1.10 – Position of a BLA KE for the R C -RE IS A CE test 41

Fig re HH.1 – Sen or location – Average CONTA T SU FA E T MP R TU E 6

Ta le 2 1.101 – *Ad itional E S NTIAL P RFORMA CE req irements 13 Ta le 2 1.10 – Temp rature l mits in de en en y to time 3

INTERNATIONAL ELECTROTECHNICAL COMMISSION

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a re me t b twe n th two org nizatio s

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th later

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DISCLAIMER

This Con ol d te v rsion is not a of icial IEC Sta dard a d ha be n prepare for

us r conv nie c Only the c r e t v rsion of the sta dard a d its ame dme t s)

are to be considere the of icial doc me ts

This Consol date v rsion of IEC 8 6 1-2-3 be rs the e ition number 2.1 It consists of

the s cond e ition (2 0 -10) [doc me ts 6 D/7 4A/FDIS a d 6 D/8 4/RVD], its

cor ig ndum 1 (2 12-0 ), its cor ige dum 2 (2 15-0 ) a d its ame dme t 1 (2 16-0 )

[doc me ts 6 D/13 8/FDIS a d 6 D/13 5/RVD] The te hnic l conte t is ide tic l to th

ba e e ition a d its ame dme t

In this Re l ne v rsion, a v rtic l l n in the margin s ows where th te h ic l conte t

is modifie by ame dme t 1 Addition are in gre n te t, deletions are in strik through

re te t A s parate Fin l v rsion with al c a ge a c pte is a ai able in this

© IEC 2 16

International Stan ard IEC 8 6 1-2-3 has b en pre ared by IEC tec nical commit e 6 D:

Electromedical eq ipment, of IEC tec nical commite 6 : Electrical eq ipment in medical

practice, an s bcommit e 1: Bre thin atac ments an ana sthetic mac ines, of ISO

tec nical commite 121: Ana sthetic an respiratory eq ipment

It is publ s ed as a double logo stan ard

This secon edition can els an re laces the first edition publ s ed in 19 6 This edition

con titutes a tec nical revision

This new edition provides con isten y with the third edition of IEC 6 6 1-1, as wel as with

the four other p rtic lar stan ard related to p ediatric eq ipment for whic the commite is

resp n ible

This publ cation has b en drafed in ac ordan e with the ISO/IEC Directives, Part 2

In this stan ard, the fol owin print typ s are u ed:

– Req irements an definition : roman typ

– Test sp e cificato s: talc ty e

– Informativ material a p arin o tsid of ta les, su h as n tes, e amples a d refere c s: in smaler ty e

Normativ te t of ta les is also in asmaler ty e

– TERMS DE INED IN CLA S 3 OF THE GENER L S A D R , IN THIS PA TICULA S A D R OR AS

NOT D: SMAL CAPITALS

In refer in to the stru ture of this stan ard, the term

– “clau e” me n one of the sevente n n mb red division within the ta le of contents,

in lu ive of al s bdivision (e.g Clau e 7 in lu es s bclau es 7.1, 7.2, etc.);

– “s bclau e” me n a n mb red s bdivision of a clau e (e.g 7.1, 7.2 an 7.2.1 are al

s bclau es of Clau e 7)

Referen es to clau es within this stan ard are preceded by the term “Clau e” fol owed by the

clau e n mb r Referen es to s bclau es within this p rtic lar stan ard are by n mb r only

In this stan ard, the conju ctive “or is u ed as an “in lu ive or so a statement is true if an

combination of the con ition is true

The verb l forms u ed in this stan ard conform to u age des rib d in An ex H of the ISO/IEC

Directives, Part 2 For the purp ses of this stan ard, the au i ary verb:

– “s al” me n that compl an e with a req irement or a test is man atory for complan e

with this stan ard;

– “s ould” me n that compl an e with a req irement or a test is recommen ed but is not

man atory for compl an e with this stan ard;

– “may” is u ed to des rib a p rmis ible way to ac ieve compl an e with a req irement or

test

An asterisk (*) as the first c aracter of a title or at the b gin in of a p ragra h or ta le title

in icates that there is g idan e or rationale related to that item in An ex AA

A lst of al p rts of the IEC 6 6 1 series, publ s ed u der the general title: Medical electrical

The commit e has decided that the contents of the b se publ cation an its amen ment wi

remain u c an ed u ti the sta i ty date in icated on the IEC we site u der

"ht p:/we store.iec.c " in the data related to the sp cific publcation At this date, the

IMPORTANT – The “colour insid ” logo on the cov r pa e of this publ c tion indic te

that it contains colours whic are con idere to be us ful for the cor e t u dersta ding

of its conte ts Us rs s ould therefore print this publ c tion using a colour printer

© IEC 2 16

INTRODUCTION

The minimum safety req irements sp cified in this p rtic lar stan ard are con idered to

provide for a practical degre of safety in the o eration for he tin devices u in BLA KE S,

PA S or MAT RE S S an inten ed for he tin in medical u e

This p rtic lar stan ard amen s an s p lements IEC 6 6 1-1 ( hird edition, 2 0 ), Medical

electrical e uip me t – Part 1: G e neral re quireme ts for b asic safety a d es e tal

pe rforma ce, hereinaf er refer ed to as the general stan ard The text of this p rtic lar

stan ard relatin to forced air warmers is b sed on ASTM F219 -0 , Sta dard sp e cificato

for circulatn lqu id a d force d air p ate nt tempe rature ma ageme t de ice s

The req irements are fol owed by sp cification for the relevant tests

A "general g idan e an rationale" section givin some explanatory notes, where a pro riate,

a out the more imp rtant req irements is in lu ed in An ex AA

Whi e K (degre Kelvin) is the recog ized u it an s mb l for a solute temp rature an

temp rature diferen e, °C has b en u ed throu hout this p rtic lar stan ard b cau e al

me s rements are commonly made u in eq ipment mark d with the Celsiu temp rature

s ale

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-35: Particular requirements for the basic safety

and essential performance of heating devices using blankets,

pads or mat resses and intended for heating in medical use

201.1 Scope, object and related standards

Clau e 1 of the general stan ard

1)

a pl es, ex e t as fol ows:

Rep laceme t

This International Stan ard a pl es to the BASIC SAF TY an E S NTIAL P RFORMA CE of

HEATIN DEVICE u in BLA KE S, PA S or MAT RE S S in medical u e, also refer ed to as

ME EQUIPMENT HEATIN DEVICE inten ed to prewarm a b d are in lu ed in the s o e of this

International Stan ard

If a clau e or s bclau e is sp cifical y inten ed to b a pl ca le to ME EQUIPMENT only, or to

ME SYS EMS only, the title an content of that clau e or s bclau e wi say so If that is not the

case, the clau e or s bclau e a pl es b th to ME EQUIPMENT an to ME SYS EMS, as relevant

If a clau e or s bclau e is sp cifical y inten ed to a ply to a sp cifical y defined typ of ME

EQUIPMENT, as is the case with FORCED AIR DEVICE , then the clau e or s bclau e is entitled as

s c Clau es or s bclau es that a ply to al typ s of ME EQUIPMENT within the s o e of this

stan ard are not sp cifical y entitled

HAZA DS in erent in the inten ed ph siological fu ction of ME EQUIPMENT or ME SYS EMS

within the s o e of this stan ard are not covered by sp cific req irements in this stan ard

ex e t in 7.2.13 an 8.4.1 of the general stan ard

NOT Se also 4.2 of th g n ral sta d rd

This p rtic lar stan ard do s not a ply to:

– HEATIN DEVICE inten ed for ph siothera y;

– radiant warmers; for information, se IEC 6 6 1-2-21 [12]

2

;

– in ub tors; for information, se IEC 6 6 1-2-19 [10]

– tran p rt in ub tors, for information, se IEC 6 6 1-2-2 [1 ]

– co l n devices

2 1.1.2 Obje t

Rep laceme t

The o ject of this p rtic lar stan ard is to esta l s p rtic lar BASIC SAF TY an E S NTIAL

P RFORMA CE req irements, whic minimize H ZA DS to PATIENT , an OP R TORS for he tin

———— ——— ——

1)

Th g n ral sta d rd is IEC 6 6 1-1:2 0 , Medic al elec tric al equ ipme t – Part 1: Ge eral requ ireme ts for

b sic safety a d es e tal p rorma c e

© IEC 2 16

devices u in BLA KE S, PA S or MAT RE S S an inten ed for he tin in medical u e an to

sp cify tests for demon tratin compl an e with these req irements

2 1.1.3 Col ateral sta dards

Ad i o :

This p rtic lar stan ard refers to those a pl ca le col ateral stan ard that are l sted in

Clau e 2 of the general stan ard an Clau e 2 1.2 of this p rtic lar stan ard

In the IEC 6 6 1 series, p rtic lar stan ard may modify, re lace or delete req irements

contained in the general stan ard an col ateral stan ard as a pro riate for the p rtic lar

ME EQUIPMENT u der con ideration, an may ad other BASIC SAF TY an E S NTIAL

P RFORMA CE req irements

A req irement of a p rtic lar standard ta es priority over the general stan ard

For brevity, IEC 6 6 1-1 is refer ed to in this p rtic lar stan ard as the general stan ard

Col ateral stan ard are refer ed to by their doc ment numb r

The n mb rin of clau es an s bclau es of this p rtic lar stan ard cor esp n s to that of

the general stan ard with the prefix “2 1 (e.g 2 1.1 in this stan ard ad res es the content

of Clau e 1 of the general stan ard) or a pl ca le col ateral stan ard with the prefix “2 x”

where x is the final digit s) of the colateral stan ard doc ment n mb r (e.g 2 2.4 in this

p rtic lar stan ard ad res es the content of Clau e 4 of the 6 6 1-1-2 col ateral stan ard,

2 3.4 in this p rtic lar stan ard ad res es the content of Clau e 4 of the 6 6 1-1-3 col ateral

stan ard, etc.) The c an es to the text of the general stan ard are sp cified by the u e of

the folowin word :

"Re lacement" me n that the clau e or s bclau e of the general stan ard or a pl ca le

colateral stan ard is re laced completely by the text of this p rtic lar stan ard

"Ad ition" me n that the text of this p rtic lar stan ard is ad itional to the req irements of

the general stan ard or a pl ca le col ateral stan ard

"Amen ment" me n that the clau e or s bclau e of the general stan ard or a pl ca le

colateral stan ard is amen ed as in icated by the text of this p rtic lar stan ard

Subclau es or fig res whic are ad itional to those of the general stan ard are n mb red

startin from 2 1.101 However d e to the fact that definition in the general stan ard are

n mb red 3.1 throu h 3.13 , ad itional definition in this stan ard are n mb red b gin in

from 2 1.3.2 1 Ad itional an exes are let ered AA, BB, etc an ad itional items a ), b ),

etc

Subclau es or fig res whic are ad itional to those of a col ateral stan ard are n mb red

startin from 2 x, where “x” is the n mb r of the col ateral stan ard, e.g 2 2 for

IEC 6 6 1-1-2, 2 3 for IEC 6 6 1-1-3, etc

The term "this stan ard" is u ed to ma e referen e to the general stan ard, an a pl ca le

Where there is no cor esp n in clau e or s bclau e in this p rtic lar stan ard, the clau e or

s bclau e of the general stan ard or a pl ca le col ateral stan ard, althou h p s ibly not

relevant, a ples without modification; where it is inten ed that an p rt of the general

stan ard or a pl ca le col ateral stan ard, althou h p s ibly relevant, is not to b a pl ed, a

statement to that efect is given in this p rtic lar stan ard

201.2 Normative references

NOT Informativ refere c s are lste in th Biblo ra h

Clau e 2 of the general stan ard a pl es, ex e t as fol ows:

IEC 6 6 1-1-2:2 0 , Me dical electrical e uip me t – Part 1-2: G en ral re quireme nts for b asic

safety a d es e tal p erforma ce – Colateral sta dard: Ele ctromagnetc comp tb il y –

Re u ireme ts a d te sts

IEC 6 6 1-1-8:2 0 , Me dical electrical e uipme t – Part 1-8: G en ral re quireme ts for b asic

safety a d es e ntal p erform ance – Colate ral sta dard: G en ral re uirem ents, te sts a d

guida ce foralarm syste ms in medical ele ctrical e u ipme nt a d medical ele ctrical systems

ISO 14 71:2 0 , Me dical de ices – App licato of risk ma ageme nt to medical de ice s

Ad i o :

IEC 6 6 1-1-10:2 0 , Medical electrical e qu ipme t – Part 1-10: G ene ral re quireme ts for

b asic safety a d es e tal p erforma ce – Colateral Sta dard: Re u ireme nts for th

de velo me t ofp hysiologic closed-o p co trolers

ISO 2 3 :2 0 , Fle ib le celular p lymeric materials – Determin to ofh rdn s (inde ntato

tech iqu e)

201.3 Terms a d definitions

NOT An in e of d fin d terms use in this d c me t is fo n b gin in o p g 6

For the purp ses of this doc ment, the terms an definition given in IEC 6 6 1-1:2 0 ,

a ply, ex e t as fol ows:

Ad i o :

2 1.3.2 1

BLA KE

for FORCED AIR DEVICE , AP LIED PA T of HEATIN DEVICE inten ed to b u ed with a

CONTROL ER to tran fer thermal energ to al or p rt of the b d of a PATIENT; for other than

FOR ED AIR DEVICE , AP LIED PA T of HEATIN DEVICE, whic can b folded, for u e u der or

over a

PATIENT

2 1.3.2 2

CONDITION OF ADEQUAT HEAT DIS HA GE

con ition ac ieved when a HEATING DEVICE is s p orted an covered as sp cified in

© IEC 2 16

2 1.3.2 3

CONTA T S RFA E T MPER TU E

for FOR ED AIR DEVICE , temp rature res ltin from the he t tran fer ed to a target s rface by

the AP LIED PA T; for other than FORCED AIR DEVICE temp rature T

CON ACT S RF CE T MP RA URE refere c p int o th c nta t surfa e

Some h atin d vic s ma h v u h ate are s sh wn in th folowin fig res as:

Figure 2 1.101 – Positioning of temperature s n ors on the conta t s rfa e

of the h ate are of a HEATING DEVICE

The temp rature at the centre p int of an one of the he ted are s closest to the centre of the

HEATIN DEVICE (in the example s own a ove 2, 3, 6, or 7) is tre ted as T

R

Fig re 2 1.10 – Ex mple of the positioning of temperature s nsors

on the conta t s rfa e of the he te are s of a HEATING DEVICE ha ing

more tha on s parately he te are

FOR ED AIR DEVICE

HEATIN DEVICE that u es air as the he t tran fer medium to warm a PATIENT an is comprised

p ly rethane or p ly tyrene in ulation material u ed in the test method of this sp cification

to as ist in the determination of temp rature

NOT Sp cific tio s for LAG ING MA ERIAL are giv n in An e es B a dF

201.4 General re uirements

Clau e 4 of the general stan ard a pl es ex e t as folows:

2 1.4.3 ES ENTIAL PERFORMA CE

Ad i o :

2 1.4.3.101 Additional re uireme ts for ES ENTIAL PERFORMA CE

Ad itional E S NTIAL P RFORMA CE req irements are fou d in the s bclau es l sted in

Ta le 2 1.101

Table 2 1.101 – *Additional ES ENTIAL PERFORMA CE re uireme ts

ES E TIAL P RFO MA CE re uireme t 1 2 1.12.4.10 or g n ratio of a T CH ICAL

ALAR C N ITION in c mpla c with

2 1.12.3.10

2 1.4.5 Equiv le t s fety for MEEQUIPMENT or ME S ST MS

Ad i on:

This p rtic lar stan ard sp cifies safety req irements for HEATIN DEVICE u in BLA KE S,

PA S or MAT RE S S, but alternate method of compl an e with a sp cific clau e or s bclau e

by demon tratin eq ivalent safety wi not b ju ged non-compl ant if the MA UFA TU ER has

demon trated in his RISK MA A EMENT FILE that the RISKS presented by the H ZA DS are of an

ac e ta le level when weig ed again t the b nefits of tre tment u in the device

Ad i on l su b clause:

2 1.4.101 Combination of eq ipme t

For eq ipment whic combines several he t sources, the safety req irements of other

relevant p rtic lar stan ard s al b con idered Further, the safety req irements of this

p rtic lar stan ard s al b fulfi ed with the combination of the other eq ipment, whic is

a proved by the MA UFA TURER as stated in the in tru tion for u e ac ordin to Clau e 16 of

201.5 General re uirements for te ting ME EQUIPMENT

Clau e 5 of the general stan ard a pl es

201.6 Classification of ME EQUIPMENT and ME SY T MS

Clau e 6 of the general stan ard a pl es, ex e t as fol ows:

2 1.6.2 Prote tion a ainst ele tric s oc

Rep lace th last p ra ra h wih th folowing:

HEATIN DEVICE s al have TYP B AP LIED PA T or TYP CF AP LIED PA T

201.7 ME EQUIPMENT ide tific tion, marking a d documents

Clau e 7 of the general stan ard a pl es, ex e t as fol ows:

2 1.7.2.1 Minimum re uireme ts for marking on ME EQUIPMENT a d on

interc a g able parts

A HEATING DEVICE s al b mark d as fol ows:

a) to in icate how it is inten ed to b p sitioned in NORMAL US , whether:

– over the PATIENT;

– u der the PATIENT;

– directly in contact with the PATIENT;

– se arated from the PATIENT by an intermediate layer, or layers ( or example by a

water-b d, other typ of matres , or b d lothes);

– it has to b u ed flat ( hat is without cre ses), or whether it can b wra p d arou d the

PATIENT;

b) to warn again t p s ible H ZA DOUS SITU TIONS from p netration by s arp o jects;

c) to warn again t p s ible H ZA DOUS SITU TIONS from foldin or method of storage, other

than those sp cified by the MA UFA TU ER;

d) to warn again t the p s ibi ty of a HAZA DOUS SITU TION if a p rtial coverin is cau ed by

pi ows or other items havin go d thermal in ulation b in laid over p rt of the HEATING

DEVICE;

e) to sp cify, in the case of lq id- i ed MAT RE S S inten ed to b u ed a ove a PA , the

minimum amou t of l q id to whic the MAT RE S s ould b fi ed, an a warnin that if this

minimum amou t is not present a PATIENT could s f er a burn;

f to sp cify, in the case of a HEATIN DEVICE s p l ed or control ed by an external u it, that

the HEATIN DEVICE s al only b u ed with the external u it sp cified by the

© IEC 2 16

2 1.7.2.1.101.2 CONTROL ER

A CONTROL ER for FORCED AIR DEVICE s al b mark d as fol ows:

a) The HOS s al b mark d within 15 cm of the NOZ LE to caution that the NOZ LE ne d to

b con ected to a BLA KE The fol owin statement an the safety sig ISO 7 10-M0 2

safety sig (1 ) of IEC 6 8 8, s own in An ex D of this p rtic lar stan ard:

“CAUTION! Hose noz le MUST b con ected to a comp tible forced air blank t or thermal

injury may oc ur.”

b) A caution that al owin the HOS to contact the PATIENT can le d to thermal injury, if

a pro riate

c) A warnin again t u in the device distal to arterial cros clampin an that non

-o servan e can le d to thermal injury

2 1.7.2.1.101.3 * Temperature s n ors

A temp rature sen or whic is desig ed to b at ac ed to or in erted into a PATIENT s al

have its inten ed u e identified cle rly an u ambig ou ly on or adjacent to the sen or

2 1.7.2.1.101.4 A PLIED P RTS ( or other th n FOR ED AIR DEVICES) with a large

unh ate border

For an AP LIED PA

T havin an un e ted b rder wider than 3 mm arou d the he ted are ,

an where the req irements of 2 1.12.4.101 are not satisfied, the outer b u dary of the

he ted are s al b mark d on b th sides of the AP LIED PA T

2 1.7.4.2 Control d vic s

Ad i o :

2 1.7.4.2.101 Additional re uireme ts for control de ic s

(Se also 2 1.12)

Where provided, on ME EQUIPMENT other than FOR ED AIR DEVICE , a control for set in the

CONTA T SU FA E T MP R TURE of a HEATING DEVICE s al in icate the temp rature in intervals

2 1.7.9.2.2.101 Additional re uireme ts for warning a d s fety notic s

The in tru tion for u e s al ad itional y contain the fol owin :

a) a stron recommen ation that the s rface of the HEATING DEVICE

s ould b c eck d for

fre dom from mec anical damage prior to e c a pl cation;

b) an in ication for the u e of p rts of HEATIN DEVICE whic are inten ed to b u ed

together;

c) statements, detai s an warnin s on the u e of the

HEATING DEVIC

E in combination with

d) a warnin statement that the u e of materials of go d thermal con u tivity, s c as water,

gel an simi ar s bstan es, with the HEATIN DEVIC

E not switc ed on can decre se the

temp rature of the b d of a PATIENT;

e) a warnin statement regardin the RIS

K of electrical s ock, burn or electromag etic

interferen e with u e of HF s rgical in truments or en ocardial catheters whi e a HEATING

h) a warnin that a me n for retainin a PATIENT either on or u der a HEATIN DEVICE may

ne d to b u ed an that the me n for retainin a PATIENT s ould not block the fluid

p thway of the HEATIN DEVICE;

i) a warnin that warmin tran dermal medication (p tc es) can in re se dru del very,

res ltin in p s ible H RM to the PATIENT;

j) a statement that the HEATIN DEVICE contain an ALA M SYS EM with an inter uption of

p wer s p ly/SUP LY MAINS ALA M CONDITION;

k) The in tru tion for u e for CONTROL ERS for FOR ED AIR DEVICE s al in lu e the

folowin ad itional warnin statements:

– a caution that the HOS , if al owed to contact the PATIENT, can le d to thermal injury, if

– *a statement that the HOS NOZ LE ne d to b con ected to a BLA KE The folowin

statement s al ac omp n the “NO FREE HOSING” safety sig (1 ) of IEC 6 8 8

2 1.7.9.2.9.101 Additional re uireme ts for start-up P OCED RE

The in tru tion for u e s al in lu e a method for testin the fu ction of the ALA M SYS EM for

e c of the ALA M CON ITIONS sp cified in this stan ard, if not p rformed automatical y d rin

start up

2 1.7.9.2.9.10 Additional re uireme ts for operating instructions

The folowin s al a p ar in the in tru tion for u e:

a) the a proximate time req ired for the CONTA T SU FA E T MP R TURE to he t up from 2 ±

2°C to 3 °C, when o erated u der CON ITIONS OF A EQU T HEAT DISC A GE as sp cified

in An ex EE;

b) a des ription of how an when to verify the fu ctional ty of the ALA M SYS EM

2 1.7.9.2.9.10 Additional re uireme ts for operating instructions for BLA KE S

The in tru tion for u e for BLA KE S s al contain the fol owin :

a) a des ription of s stem o eratin modes an PATIENT con ition where the s stem can b

iv) se arated from the PATIENT by an intermediate layer, or layers, of material,

v) whether it has to b u ed flat (without cre ses),

vi) whether it can b wra p d arou d the PATIENT

d) *a statement identifyin whic

(S) can b u ed safely with the

BLA KE

The

des ription s al in lu e, as a plca le, the CONTROL ER model n mb r, revision level,

prod ct version, o tion or an other element that could afect the safety of the

combination;

e) *a warnin again t u in the device distal to arterial cros clampin ;

NOT BLA K T c n b use pro imalto th clamp d artery with ut a y a ditio al RIS

f a warnin des ribin the p s ible H ZA D of u in the device with is hemic l mbs

2 1.7.9.2.9.10 Additional re uireme ts for o erating instru tions for temperature

s nsors

The in tru tion for u e for temp rature sen ors req ired for temp rature control, whic are

desig ed to b atac ed to, or in erted into, a PATIENT s al have their inten ed u e identified

2 1.7.9.2.13 Mainte a c

Ad i o :

2 1.7.9.2.13.101 Additional re uireme ts for mainte a c

The folowin s al a p ar in the doc mentation:

– p rtic lars of an neces ary cal bration proced re(s);

– information as to how to confirm that the in e en ent THERMALCUT-OUT is o erational

201.8 Protection a ainst ele tric l HAZARDS from ME EQUIPMENT

Clau e 8 of the general stan ard a pl es, ex e t as fol ows:

2 1.8.1 *Fu dame tal rule of prote tion a ainst ele tric s oc

– p rforation of the EN LOSU E of a HEATIN DEVICE se arated from the SUP LY MAINS by

a tran former (se 15.5 of the general stan ard)

2 1.8.5.1.2 MEA S OF P TIENT P OT CTION (MOP )

2 1.8.5.1.2.101 * Additional re uireme ts for

MEA S OF P TIENT P OT CTION (MOP )

An AP LIED PA T con istin of a s rface of in ulatin material is tested u in metal foi as

mentioned in 8.7.4.7 of the general stan ard

a) for an AP LIED PA T large enou h for a PATIENT not to b in contact with the whole s rface

he ted by circ lation of l q id from a remote u it the l q id is

re laced by isotonic sal ne (0,9 g sodium c loride p r l ter of water) The PATIENT LEA A E

C RRENT is me s red u in an electrode 5 mm × 5 mm p sitioned in the sal ne in contact

with the s rface whic provides he t to the l q id;

2 1.8.8 Ins lation

This s bclau e of the general stan ard do s not a ply to BLA KE S for FOR ED AIR DEVICE

that do not contain active electrical y con u tive wires

2 1.8.8.4 Ins lation other tha wire ins lation

Ad i o al su b clauses:

2 1.8.8.4.101 Me ha ic l a d thermal re ista c to dama e of the EN LOS RE of

the fle ible part of HEATING DEVICES

For BLA KE S an PA S con istin of woven material s r ou din an electrical he tin

element, the woven material is tested by the b l -pres ure test ac ordin to 8.8.4.1 a) of the

general stan ard an ad itional y by the fol owin ig ition test

Six samp le s h vin dimen sio s of 10 0 mm × 200 mm are cu t from th ENC LOS UR E The y are

sele cte d from p rts of th ENC LOS URE so th t n two samples co tain th same warp thre d or

th same weft thre d or, ifthis is n t p os ib le, th samples are sele cted so th t th sam e

thre ds do n t ap p ear in more th n two samp le s An pie ces of h atn eleme nts a d

© IEC 2 16

Th test a p aratus, as sh wn in Figure 2 1.103, h s two b ras electrode s 3 mm in diameter,

which are su p p orte d b y b ras pi ars, mounted o a b ase p late of insulatn m aterial so th t

th ir a es are algned Th b ase plate also sup ports a platform of insu latn mate rial h vin

dime sio s of 100 m m × 100 mm, which is located ce traly b etwe en th b ras p ilars

Pro isio sh l b e made forth he ig t of th platform to b e adjusted

Figure 2 1.10 b) – Apparatus for th spark ignition te t –

Detai B: lower member of ma k

Mas a proximately 10 g If neces ary the heig t may b red ced or mas ad ed, care

b in ta en not to provide a low-resistan e p th b twe n the electrodes

Figure 2 1.10 c) – Apparatus for the spark ignition te t –

Detai C: upper member of ma k

© IEC 2 16

On ofth electrode s is fix d in p osi o whie th oth r ele ctrode is m ov b le, thus alowin

th samp le to b e inse rted Th tp of th fixe d e le ctrode h s a a gle of 4 ° to is majora is

Th ele ctrode is p osi o ed so th t th p oint farth st from th b ras p ilar is at th to a d at a

dista ce of ap p ro imately 3 mm from th ce ntre of th p latform Th mo ab le ele ctrode h s a

tp at right a gles to is majora is

Th lower memb e r ofa two-p art h rdwo d mask, as sh wn in detai B ofFigure 2 1.103b , is

place d o th adjustab le platform in th p osi o indicate d

Th test ap paratus, togeth r wih th u p p er m emb e r of th mask, is placed in a h atn

cab in t h vin a do r wih a inspe cto window a d wh re air is circu lated b y n tural

co ve cto

Whie in th h atn cab in t, th ele ctrodes are co n cted in se ries wih a adjustab le n

n-inductv resistor to a su p ply h vin a sinusoidal R AT D ou tp u t v la e of 10 kV a d a

characte ristc such th t th outp u t v lage do s n t de cre se b y more th n 10 0 V wh n

a curre t of 1 mA is flowing

Th temp erature of th he tn cab in t is rais ed to 6 °C ± 2 °C Th electrodes are th n

sh rtcircu ited a d th re sistoradjusted so th t a curre t of 1 mA flows Th su p p ly is the n

dis o ne cte d a d th six sam ple s are p laced in th cab in t, which is m aintain d at th

temp eratu re spe cified fora p e riod of 3 h

Wih ut remo in th ap paratus from th h atn cab in t, th mo ab le electrode is wihdrawn

a d o e e d of o e sample drawn o erth fix d ele ctrode so th t th electrode is siuate d

ce traly in th sp ace n rmaly oc upied b y th he atn e leme ts Th sample is adjuste d so

th t is e nd is ap p ro imately le el wih th edge of th adjustab le p latform Th mo ab le

electrode is th n inse rted into th othe r e d of th e lem ent sp ace a d is fix d so th t th

dista ce b etwe n th ele ctrodes is 6,0 mm ± 0 ,1 mm Th samp le is th n smo th d ou t, care

b ein ta e to e nsu re th t mate rial is n t lo p e d or caught b etwe en th ele ctrodes Th up per

memb er ofth m ask, as sh wn in detai C ofFigure 201.103b is th n placed in p si o Th

do r of th h atn cab in t is th n closed for a fu rth r p eriod of 5 min in orderto stab ilze th

temp ratu re

Th supply is th n swich d o a d sp rks are alowe d to p as b etwee n th ele ctrode s for a

p riod of 2 min If th sample ignie s, th tm e from th insta t of swichin o unt th flame

re ache s th in er edge of th mask is recorded, a y igni o of fib ers lastn n t m ore th n

3 s b ein ig ored If th samp le do s n t ig ie, a tme of 12 s is re corded

Th samp le is th n remo ed a d rep osi o e d b etwee n th electrode s wih th oth rsurface

u p p erm ost so th t th op posie e d is su b jecte d to th te st

Th ab ov te st is th n rep eated o th oth r fiv samples

If a y tme recorde d is les th n 30 s, th complete test is rep eated o a se co d set of six

samp le s In this case, n sample sh l h v a recorded tme le ss th n 30 s

Th a era e ofth 12 v lues recorde d is calculated Al v lue s dife rin b y m ore th n 30 s

from th a erage are ignore d a d, if ne ce ssary, th a erage of th rem ainin v lu es is

recalcu lated Th a era e sh l b e n t les th an 80 s

2 1.8.8.4.10 Unhe te are s

Section of the s rface of a HEATING DEVICE b twe n se arately control ed he tin are s

whic do not have he tin elements within those section an whic do not ex e d the

req irements of 2 1.12.4.101, s al not ex e d 2 mm in width, an their total are in

a) 2 % for HEATIN DEVICE whose lon est side do s not ex e d 7 0 mm; or

b) 10 % for HEATIN DEVICE whose lon est side is gre ter than 7 0 mm

HEATIN DEVICE havin the len th of the lon est side not ex e din 7 0 mm s al have no

u he ted b rder s r ou din the he ted are or are s

Compla ce is che ck d b y insp cto

2 1.8.1 MAIN P RTS, compone ts a d la out

2 1.8.1 1.101 * Isolation from the S P LY MAIN

NOT A disc n e te d vic is n t re ard d as pro idin cle r in ic tio

Compla ce is che ck d b y insp ecto a d dis o ne cto of a y co ne cto wih u tth use of

PA S are s bjected to a test on a ramp as s own in Fig re 2 1.10 The ramp is con tru ted

of plywo d or other smo th material, their

POWER SUP LY COR

S havin b en c t of at a

distan e of 10 mm from the p int where the POWER SUP LY CORD enters the PA The ramp is

set at an an le of 7 ° to the horizontal

A sto block, stron enou h to with tan the imp ct of the PA , is fixed at the lower end of the

ramp The ramp an sto block are at le st as wide as the lon est dimen ion of the PA u der

test

The PA is placed on the ramp, 1 m a ove the sto block (me s red alon the ramp) an with

the lower ed e of the PA p ralel to the sto block The PA is alowed to sl de down the ramp

so that its lower ed e imp cts again t the sto block This test is re e ted 10 times for e c

of the four ed es of the PA

Af er the test an damage s stained that res lts in u ac e ta le RISK, as determined by

in p ction of the RISK MA A EMENT fi e, con titutes a fai ure

2 1.9.1.10 * Bond d con truction

If se aration could cau e a H ZA DOUS SITU TION, HEATIN DEVICE u in b n ed con tru tion

s al have s ficient stren th an /or rigidity to with tan s c rou h han l n as can b

exp rien ed in NORMAL US , without sep ration of the layers whic are b n ed

NOT Bo d d me ns weld dor glu d

Compla ce for ME EQUIPMENT oth r th n FOR C ED AIR D EVICES is che ck d b y cu ttn six

samples of th b onded material, e ach h vin dime nsio s of 10 mm × 130 mm, from th

fle ib le p art Thre of th samples are cut in th directo of th runs of th he atn eleme nts

a d th oth r thre samp les are cut p erp endicular to this dire cto

From th side s me surin 10 0 mm, a strip of th ENC LOS UR E mate rial h vin a width of 2 mm

th o p osie face a d at th op posie e d of th samp le An h atn eleme t siuated under

th remo edstrip s is cu t awa

A clamp is atache d alo g th full le gth of e ch single la e r

Th sample is th n susp ended b y o e of th clamps a d a m as of 1,2 k is susp ended from

th oth r clamp Th test is caried out for1 h at a amb ie t temp ratu re of 2 °C, a d th n

for 1 h at a tempe rature of 6 °C Th test is re p eated o six sample s ta en from th fle ib le

p art of a n w HEATIN D EVIC E

2 1.9.8 HAZA DS a sociate with s pport s stems

2 1.9.8.3.1 *Ge eral

The normal lo d for an INFA T is red ced to 10 kg (se 2 1.3.210)

Ad i o :

For ME EQUIPMENT inten ed for u e with INFA T an havin an integral MAT RE S s ita le

b r iers s al b provided to prevent the

INFA

T from fal n of the

MAT RE S

Bar iers

inten ed to b o ened or removed to al ow ac es to the INFA T s al latc in their closed

p sition an s al remain lock d u der the test con ition

Compla ce is ch cke db y insp ecto a d th folowing test Ap ply to al th b ariers (oth r

th n th se secured wih th use ofa TOOL) a ou tward h rizo tal force of 2 N to th ce tre

of e ach b arierfor5 s Th b arie rs sh l rem ain closed

Ad i on l su b clause:

2 1.9.8.101 Supp rts a d mountin bra k ts for A CES ORIES

Sup orts an mou tin brack ts for A CE SORIE s al b s ita le an of adeq ate stren th

for their purp se

Compla ce is ch ck d b y inspe cto a d b y th folowin te st

A gradu aly incre sin force is a p lied so as to act v rtcaly throu gh th ce ter of th

su p p orts a d mountn b rack ts, e.g a ac ess ory sh lf in th e xte de d p si o wih a

MANUFAC TUR ER’S recomme de d lo d Th force is incre se d from zero in 5 s to 10 s interv ls,

u nt i e u als thre tmes th recomme de d lo d a d is sustain d for a pe riod of 1 min The re

sh l b e n e vide nce of damage to th iem (s) under test

201.10 Protection a ainst unwa ted a d exc ssive ra iation HAZARDS

Clau e 10 of the general stan ard a pl es

201.11 Protection a ainst ex essiv temperature and other HAZARDS

Clau e 1 of the general stan ard a pl es, ex e t as fol ows:

2 1.1 1.2.1.101 Re uireme ts for HEATING DEVICES other th n FOR ED AIR DEVICES

2 1.1 1.2.1.101.1 Ma imum CONTA T S RFA E T MPERATU E in NORMAL CON ITION

AP LIED PA T of ME EQUIPMENT inten ed to s p ly he t to a PATIENT s al not have a CONTA T

SU FA E T MP R TU E ex e din 4 °C in NORMAL CON ITION

Compla ce is ch ck d u nder C OND ITIONS OF AD EQUAT HEAT D ISC HARGE b y me su reme nt

usin temp erature se sors co ductv ly atach d to cop p e r p lates 6 mm × 6 mm × 0,5 mm

Th plates are p si o ed in locato s in co tact wih th AP LIE PAR T a d b elow th LAGGING

MAT R IAL wh re ma imum temp eratures are e p ected

Th le ds of th temp erature se sors are p osi o ed so as to a oid a y ad i o al h at

dis h rge

Tests are rep e ate d wih th HEATIN D VIC E p rtaly co ere d in turn as sh wn in Figure

201.10 , e xcep t th t th p rtal co erin co di o i ustrated in "g" of th t figure is used o ly

for PAD S wh se lo g st side is les th n 1 m in le gth An p art of a cop p er p late which would

n t b e co e red b y insu lato in a p artal co e rin siuato is se arate ly co ered b y lagging

IE 198/0

The p rtial coverin con ition mark d “g” is con idered relevant for PA S whic can b

p sitioned acros the width of a b d, an can only have, for example, p rt of one leg of a

PATIENT acros the he ted are

Figure 2 1.10 – Partial cov ring condition

2 1.1 1.2.1.101.2 Se sor

An sen or whose p sition can b c an ed without the u e of a TOOL s al not b u ed to

control the maximum temp rature whic the HEATIN DEVICE can atain

Comp lia ce is che ck d b y insp ecto

2 1.1 1.2.1.101.3 Ma imum CONTA T S RFACE T MPER TU E in single fa lt condition

The s rface temp rature of a HEATING DEVICE s al not ex e d 41 °C in SIN LE FA LT

CON ITION

Compla ce is ch ck d unde r th co di o s of 20 1.12.1.101 b y re pe tn th tests for

On fau lt is ap ple d at a tme, a d th n th ste dy surface te mpe rature re ch d is me sure d

in e ch case

2 1.1 1.2.1.10 Re uireme ts for FOR ED AIR DEVICES

2 1.1 1.2.1.10 1 * Ma imum CONTA T S RFA E T MPERATU E in NORMAL CONDITION

When tested ac ordin to the method des rib d in An exes FF an HH, the maximum

CONTA T SURFA E T MP R TU E s al not ex e d 4 ,0 °C an the average CONTA T SU FA E

The FOR ED AIR DEVICE s al b eq ip ed with an ALA M SYS EM that in lu es at le st a LOW

PRIORITY T CH IC L ALA M CON ITION that in icates when the THERMAL CUT-OUT has activated

Con ideration s al b given to lower l mits or diferent RISK CONTROL me s res for FORCED AIR

DEVICE inten ed for INFA T

ME EQUIPMENT req irin the u e of l q id in NORMAL US s al b so con tru ted that spi age

do s not wet p rts whic can cau e an u ac e ta le RISK

Compla ce is ch cke d b y th folowin te st

Th ME EQUIPMENT is p osi o ed as in NOR MAL US E A quant y of 200 ml of isoto ic saln

(0,9 g sodium chloride p r l er ofwater) is p ou red ste diy o a arb itrary p oint o th to

su rface ofth ME EQUIPMENT from a h ig t n t e xcee din 5 cm for ap p ro imately 15 s (se

also 5.4 of th gen ral sta dard)

After th test, th ME EQ IPMENT sh l comply wih th re u ireme nts of this sta dard for

NOR MAL C OND ITION

2 1.1 6.5 Ingre s of water or partic late mat er into ME EQUIPMENT a d ME S ST MS

Ad i o :

The EN LOSU E of an HEATIN DEVICE s al provide the degre of protection again t moisture

in ac ordan e with the clas ification of the HEATIN DEVICE

2 1.1 8 Inter uption of the power s pply/S P LY MAIN to ME EQUIPMENT

Ad i o :

2 1.1 8.101 * Inter uption of p wer s pply/S P LY MAINS ALARM CON ITION

Ex e t for LOW HEAT TR NS ER HEATIN DEVICE (se An exes CC an DD) an FOR ED AIR

DEVICE , the HEATING DEVICE s al b eq ip ed with an ALA M SYS EM that in lu es at le st a

MEDIUM PRIORITY T C NIC L ALA M CON ITION d rin an p riod of inter uption of the SUP LY

MAINS to the HEATING DEVICE, or for 10 min, whic ever is s orter (se also rationale)

Comp lia ce is ch ck d b y dis o ne cto from th S UP LY MAINS wih th HEATING DEVIC E

swich d o

2 1.1 8.10 *Pre et v lue af er re toration of power s p ly/S P LY MAIN

For ME EQUIPMENT other than FORCED AIR DEVICE the eq ipment s al b desig ed so that

inter uption an restoration of the p wer s p ly/SUP LY MAINS up to 10 min do s not c an e

the control temp rature or other preset values

For

FOR ED AIR DEVICE , if the eq ipment is desig ed to res me o eration afer inter uption

an restoration of the p wer s p ly/SUP LY MAINS up to 10 min, it s al not s p ly he t at an

temp rature hig er or lower than the OP R TOR-selected temp rature setin prior to

inter uption of the p wer s p ly/SUP LY MAINS

Compla ce is che ck db y swichin th S UP LYMAINS of a d th n swichin i o again wihin

10 min, a d inspe ctn th ME EQUIPMENT

201.12 Accura y of controls and instruments a d protection against

hazardous outputs

Clau e 12 of the general stan ard a pl es, ex e t as fol ows:

2 1.12.1 Ac ura y of controls a d instrume ts

Ad i o :

2 1.12.1.101 Additional re uireme ts for a c ra y of controls a d instrume ts

a) an in ication of the temp rature control setin ;

b) for ME EQUIPMENT other than FOR ED AIR DEVICE , a display s owin the CONTA T SU FA E

Compla ce is ch cke d b y insp cto

2 1.12.1.101.3 * Weighing s ale for INFA TS

If a weig in s ale is s p l ed as an integral p rt of the ME EQUIPMENT or as an A CE SOR

sp cifical y for u e with the ME EQUIPMENT, the value displayed on the s ale s al not difer

from the test lo d by more than the MA UFA TU ER’S sp cification in the A COMPA YING

value me s red s al remain latc ed on the s ale display at the con lu ion of an in ivid al

me s rement c cle an b retained u ti dis arded by the OP R TOR If the s ale may b

exp sed to an ox gen-enric ed en ironment in u e, it s al comply with the req irements of

6.5 of the general stan ard

NOT It c n b p s ible for th

OP RA O

to v rify a d u d te th c lbratio of th d vic d rin use

Compla ce is che ck d b y th folowin test

Test lo d me surem ents sh l b e demo strated usin v lue s of 500 g a d 2 000 g (± 1 g)

Tests sh l b e co ducte d wih th ME EQUIPMENT op eratn wih a MAT R ES S temp erature of

36 °C ± 0 ,2 °C

Th ac uracy of me sureme t is ve rified wih th te st lo ds p si o ed in locato s as sh wn

in Figure 2 1.101 Place th test lo d o four difere nt p osi o s o th h rizo tal MAT R ES S at

th ce tres of e ch of four recta gle s formed b y b ise ctn th le gth a d width of th

MAT R ES S as sh wn in Figure 201.101 Place th test lo d o th fifth p osi o o th midp oint

of th MAT RES S

2 1.12.3 Alarm s stems

Ad i o :

2 1.12.3.101 Ov rtemperature ALA M CONDITION

Ex e t for FORCED AIR DEVICE , the HEATIN DEVICE s al b eq ip ed with an ALA M SYS EM

Compla ce is che ck d b y insp ecto of th ac omp an in docu me ts a d functo al testng.

2 1.12.3.10 * CONTA T S RFA E T MPER TU E v riation ALA M CON ITION

Ex e t for FOR ED AIR DEVICE , HEATIN DEVICE with HIGH HEAT TRA S ER to the PATIENT (se

An exes CC an DD) s al b eq ip ed with an ALA M SYS EM that in lu es at le st a MEDIUM

PRIORITY T C NICAL ALA M CON ITION if the average value of the CONTA T SU FA E

T MP R TU E

dif ers from the control setin by more than either:

a) ± 1 °C in the case of HEATIN DEVICE havin HIGH HEAT TR NS ER b th inward toward an

outward from the PATIENT; or

b) +1 °C in the case of HEATIN DEVICE havin HIGH HEAT TR NS ER inward toward the

PATIENT but LOW HEAT TR NS ER outward from the PATIENT

A HEATIN DEVICE havin HIGH HEAT TR NS ER in b th direction may b eq ip ed with an

A DIO PA S for up to 4 h d ration whie the HEATIN DEVICE is b in he ted from COLD

CON ITION to the set temp rature

Compla ce is ch cke d b y insp cto a d fu ncto al testng

2 1.12.3.10 Vis al a d a ditory ALA M SIGN LS

Whi e vis al ALA M SIGN LS s al b desig ed with se arate vis al in icators, au itory ALA M

SIGN LS may b combined

Comp lia ce is che ck d b y inspe cto a d op erato of th ME EQUIPMENT

2 1.12.3.10 Dis onne tion or s ort-circ iting of s n ors ALA M CON ITION

The HEATING DEVICE s al switc of automatical y if the le d to either the temp rature control

sen ors or the THERMAL C T-OUT sen ors are damaged or otherwise dis on ected from the

control u it

The HEATING DEVICE s al b eq ip ed with an ALA M SYS EM that in lu es at le st a MEDIUM

PRIORITY T C NIC L ALA M CON ITION for HIGH HEAT TRA S ER DEVICE an at le st a LOW

PRIORITY ALA M for LOW HEAT TR NS ER DEVICE an FORCED AIR DEVICE that in icates when

le d to either the temp rature control sen ors or the THERMAL C T-OUT sen ors are damaged

or otherwise dis on ected from the control u it

Compla ce is ch ck d b y insp cto a d, if ap plcab le, b y th dis o n ecto of th se sors

o e at a tme

2 1.12.4 Prote tion a ainst hazardou output

Ad i o al su b clause s:

2 1.12.4.101 * Variation of temperature a ros th conta t s rfa e

Ex e t for FOR ED AIR DEVICE , the diferen e b twe n the average value of the CONTA T

In the case of HEATIN DEVICE havin more than one se arately control ed he tin are (se

Fig re 2 1.10 ), the variation of temp rature b twe n T

R

an the temp rature at the other

centre p ints an the other me s rin p ints in e c he ted are s al not ex e d the values

given a ove

For the purp se of isolation from en ironmental condition an to simulate con ition

u favora le to the PATIENT, the test s al b made u der CON ITIONS OF A EQU T HEAT

DISCH RGE (se An ex EE)

Compla ce is ch cke d b y insp cto a d th folowin test

Th HEATIN D VIC E a d is co tact surface are tested in a draught fre ro m in which th

amb ie t tempe rature is maintaine d at 2 °C ± 2 °C Four temp rature se sors co ductv ly

atach d to cop p er p lates 6 mm × 6 mm × 0 ,5 mm, are placed o th co tact surface at th

midp oints of th four re cta gles formed b y b isectn th le gth a d th width of th co tact

su rface as sh wn in Figu re 201.101 A fifth tempe rature se sor is p laced at th midp oint of

th co tact su rface

Oth r me su rin p oints wihin th h atn are , in ad i o to th se sh wn in Figure 201.101,

shou ld b e used (for e xample as in Figure 2 1.102), e ce t th t n p art of th m easurin

plate s sh l b e p osi o e d:

– le ss tha 30 mm from th ou teredg s of th HEATIN D EVIC E;

– o e r th sup ply cord e try p si o ;

– o e r n n-h ated secto s b etwe n sep arately co troled h ated are s (se Figu re

2 1.102)

Th temp erature co trol is set so th t th C ONTAC T S UR FAC E T MP R ATUR E re ch s 36 °C

Temp erature re din s are ta e n at le st e very 10 min for6 min From th se th v lues of

th individuala erage temp eratu res at T

1

to T

4

are calcu lated a d comp red wih th a erage

v lu e s of th C ONTAC T SUR FAC E T MP R ATUR E

2 1.12.4.10 Variation of the CONTA T S RFA E T MPER TU E

Ex e t for

FORCED AIR DEVICE

, af er a ste d temp rature has b en re c ed, the

CONTA T

SU FA E T MP R TU E s al not vary from the me n value by more than:

a) ± ,5 °C in the case of HIGH HEAT TR NS ER HEATING DEVICE ; or

b) ±1 °C in the case of LOW HEAT TR NS ER HEATINGDEVICE

Compla ce is ch ck d b y th folowin test

Unde r th co di o s sp ecified in 20 1.12.4.101, th temp e rature co trol is set so th t th

C ONTAC T S UR FAC E T MP R ATUR E re ch s 36 °C Th temp erature is th n re corde d for 1 h,

usin sufficie ty se si v ap paratus (at le st ab le to dis rimin te a v riato of 0 ,1 °C)

2 1.12.4.10 Temperature ov rs oot whe the temperature control is s t to its

ma imum s t ing

Ex e t for FORCED AIR DEVICE , the temp rature overs o t of the CONTA T SU FA E

T MP R TU E s al not ex e d 1 °C when the control is c an ed to its maximum temp rature

setin from a lower set in at whic a ste d temp rature of 3 °C was first at ained

Compla ce is che ck d b y fu ncto al testng

© IEC 2 16

2 1.12.4.10 Ac ura y of the control of the

CONTA T S RFA E T MPER TU E

Ex e t for FOR ED AIR DEVICE , the average value of the CONTA T SU FA E T MP R TURE s al

not difer from the value of the temp rature in icated by the temp rature control set in by

more than ±1 °C but not ex e din 41 °C Se 2 1.1 1.2.1.101

Compla ce is ch cke d b y th folowin te st

Under th co di o s sp e cifie d in 201.1 1.2.1.101, th C ONTAC T S UR FAC E T MPERATUR E is

me sured wih th temp erature co trol set to 36 °C

2 1.12.4.10 Temperature indic tor

If provided, the in ication of the CONTA T SU FA E T MP R TU E s al b CLEA LY LEGIBLE

Ex e t for FORCED AIR DEVICE , within the ran e of the control setin , the temp rature

in ication s al not dif er from the CONTA T SU FA E T MP R TU E by more than ± 0,7 °C

For FORCED AIR DEVICE :

a) If provided, the temp rature in icator s al b CLEA LY LEGIBLE; an

b) If provided, an alpha-n meric temp rature in icator s al b ac urate to ± 1°C of the

me s red temp rature Method of confirmin the ac urac of the display s al b

provided in the ac omp n in doc ments

Compla ce is ch cke d b y inspe cto

The ran e of in ication s al b at le st from 2 °C to 4 °C

Ex e t for FORCED AIR DEVICE , if the sen or of the temp rature indicator is p sitioned at a

p int where the me s red temp rature is diferent from the temp rature whic would have

b en me s red if the sen or had b en at the centre of the HEATING DEVICE that is, at the

p sition T

R

(se Fig res 2 1.101 an 2 1.10 ), the in icator s al in icate the actual

CONTA T SU FA E T MP RATU E

Compla ce is ch ck d b y insp ecto a d b y m easureme t u nder th co di o s sp e cifie d in

2 1.12.4.101 (e nsurin th t a y n ces ary calb rato is corect

2 1.12.4.10 * Avoida c of incor e t conne tion of parts

Ex e t for the practice or con ition of FRE HOSIN , if omis ion of a p rt, or interc an e of

p rts of a multi-p rt HEATIN DEVICE, can cau e an u ac e ta le RISK, the HEATING DEVICE

s al b desig ed s c that he t is s p l ed only if al p rts of the HEATIN DEVICE are

cor ectly p sitioned

For FOR ED AIR DEVICE , adeq ate warnin la els s al b provided on the CONTROL ER an

p rtic lar atention s al b directed to caution statements again t the practice of FRE HOSING

in 2 1.7.2.1.101.2 a) an 2 1.7.9.2.2.101 k)

Compla ce is che ck d b y insp ecto

2 1.12.4.10 * Ina v rte t c a ging of control s t ing

In the case of HIGH HEAT TR NS ER HEATIN DEVICE , the control s al b desig ed or g arded

to prevent u intentional c an in of the setin , for example by an interlockin device or an

ad itional safety control

2 1.12.4.10 Ma imum conta t s rfa e temperature

For

FOR ED AIR DEVICE , the maximum CONTA T SU FA E T MP R TURE, as determined u in

the test method in An ex F , s al b re orted in the ac omp n in doc ments

Compla ce is ch cke d b y insp cto

201.13 HAZARDOUS SITUATIONS and fault conditions

Clau e 13 of the general stan ard a pl es, ex e t as fol ows:

2 1.13.1 Spe ific hazardous situ tions

2 1.13.1.2 Emis ions, deformation of EN LOS RE or e c e ing ma imum temperature

Ad i o :

2 1.13.1.2.101 Fai ure of comp ne ts

2 1.13.1.2.101.1 *Ele tronic compone t fai ure in a A PLIED P RT

For AP LIED PA T in orp ratin electronic comp nents, the folowin fault con ition s al b

con idered an , if neces ary, a pl ed one at a time Con eq ential faults also s al b ta en

into con ideration:

a) s ort circ it of C E PA E DIS A CE an AIR CLEA A CE b twe n l ve p rts of diferent

p larity, if these distan es are les than the values sp cified in 8.9 of the general

stan ard;

b) s ort circ it of l ve p rts of dif erent p larity acros in ulation, whic do s not with tan

the tests of 8.8.3 of the general stan ard;

c) o en-circ it at the terminals of an comp nent;

d) s ort circ it of ca acitors, u les they comply with IEC 6 3 4-14;

e) s ort circ it of an two terminals of an electronic comp nent, other than integrated

circ its;

f faiure of an integrated circ it In this case the p s ible H ZA DOUS SITU TIONS of the

HEATIN DEVICE s al b as es ed to en ure that safety do s not rely on the cor ect

fu ctionin of s c a comp nent

Al p s ible output sig als s al b con idered u der fault con ition within the integrated

circ it If it can b s own that a p rtic lar output sig al is u l k ly to oc ur, then the relevant

fault s al not b con idered

NOT Micro ro es ors are re ard d as inte rate circ its

2 1.13.1.2.101.2 * Ex e siv temperature

Ex es ive temp ratures may res lt with HEATIN DEVICE in orp ratin he tin elements or

internal wirin con istin of stran ed con u tors, u der a normal or careles u e, in lu in

that whic could cau e one or more stran s of a he tin element or internal con u tor to

bre k

An u s e thed core of a flexible cord within the AP LIED PA T exten in b yon 10 mm

from the cord an horage is con idered to b internal wirin

Compla ce is ch ck d as folows:

a) B LANKE S, other th n R UC K-R ES IS TANT B LANKE S, b y Te sts 1 to 3

© IEC 2 16

Unle ss othe rwise sp ecified, th HEATIN DEVIC E is sup p lied wih a v lage re su ltn in th

most unfa orab le co di o s, b ut wihin th folowin ra ge:

– for in ere ty co troled HEATING D EVIC ES, 0 ,9 to 1,1 tmes RAT D v lage:

– for oth r HEATIN D EVIC ES, 0 ,85 to 1,2 tme s R AT D inp u t

Th te sts are co tnu ed u nt ste dy co di o s are estab lish d

Ensure th t th C ONTACT S UR FAC E T MP R ATUR E do s n t e ce d 41 °C as sp e cified in

2 1.1 1.2.1.101.3

Compla ce is che ck d under C OND ITIONS OF AD EQUAT HEAT DIS C HAR GE If, in a y ofth

te sts, a S ELF-R ES ET IN THER MAL CUT-OUT, or a NON-S ELF-R ES ET IN THER MAL C UT-OUT

op erates, a h atn eleme t or a inte to aly we k p art ruptures, or if th curre t is

oth rwise interupted b efore ste dy co di o s are e stab lish d wih u t th p os ib il y of

au tomatc restorato , th h atn p eriod sh l b e e ded Howe er, if th interup tio is

due to th ru pture ofa h atn eleme t or of a inte to aly we ak p art, th te st sh l b e

rep eated o a se co d sample Op en circu itn ofa he atn eleme t or of a inte to aly

we k p rt in th se co d sample doe s n t in iselfe tai a faiu re to comply Both sam ples

sh l com ply wih th co di o s sp ecified in 13.1.2 of th gen ral sta dard Fuses,

THER MAL C UT-OUTs, o er-curre t rele ase s or th lk , incorp rate d into th HEATIN D VIC E,

ma b e used to p ro ide th ne ces ary p rotecto If m ore th n o e of th tests is

ap plcab le forth same HEATING D VIC E, the se tests ma b e p rformed co se cu tiv ly For

Te sts 1 to 3, th folds in th B LANKE S ma b e secu red b y st ching

NOT 1 Ru ture of a h atin eleme t or of a inte tio aly we k p rt in th se o d sample d es n t in itself

e tai a reje tio

NOT 2 An inte tio aly we k p rt is a p rt d sig e to fai u d r c n itio s of a n rmal o eratio so as to

pre e t th o c re c of a c n itio whic is u safe within th me nin of this Intern tio al Sta d rd Su h a

p rt c n b a re la e ble c mp n nt, su h as a restrictor, c p citor or th rmal fuse or p rt of a c mp n nt to b

re la e

Te s t 1

BLAN E S, othe r th n R UC K-RESIS TANT BLAN E S, pro ided wih THER MOS TAT or THER MAL C

UT-OUT are op erated underth C OND ITIONS OF AD EQUAT HEAT D IS C HAR G E sp ecified in An e x EE,

e ce pt th t th B LAN E is folde d wih a thre - hick e ss fold, 6 mm wide a d 4 0 mm lo g at

th most unfa orab le p lace, as sh wn in Figu re 201.106 Th fold is pe rp endicular to th

dire cto ofth runs of th h atn eleme t a d is fa n d ou t at th e ds Th upp er sh et of

LAGGIN MAT R IAL, h vin dime sio s of 30 0 mm × 4 0 mm a d a thick e ss d as spe cified in

An e BB, is placed o th folded B LAN E in th most unfa orab le p osi o

© IEC 2 16

For al B LAN E S othe r th n R UC K-RES IS ANT B LAN E S, this te st is also caried ou tu nder th

C ONDITIONS OF AD QUAT HEATD ISC HAR GE sp e cified in An e x EE

Te s t 2

UND ER-B LAN E S, othe r th n R UC K-RES IS TANT B LAN E S, are o e rate dunder th C OND ITIONS OF

AD EQUAT HEAT D IS CHARGE sp ecified in An e x EE e ce pt th t th B LAN E is folded wih a five

-fold thick e ss fold 10 0 mm wide a d 40 0 mm lo g at th most unfa orab le place Th fold is

pe rp ndicu lar to th directo of th runs of th h atn eleme t a d is fa n d out at th

e ds Th upp er sh e t of LAG GING MAT R IAL, h vin dime sio s of 300 mm × 4 0 mm a d

thick es d as sp ecified in An e BB, is placed o th folded B LAN E

Th HEATING D VIC E is supp lied wih a v lage or inp u t at th upp er lmi of th ra ge sp ecified

in this su b clause

Te st 3

OVE -B LAN E S, othe r th n R UC K-RES IS TANT B LAN E S, are op erated unde r th C ONDITIONS OF

AD EQUAT HEAT D IS C HARGE sp ecified in An e EE e ce t th t th B LAN E is folded wih a fiv

-thick e ss fold wih a width of 6 mm a d a le ngth of 40 0 m m Th fold is fa n d ou tat th

e ds Th p osi o a d width of th folds are ch se so as to produce th m ost unfa orab le

result

Th test is made wih th B LANKE co e red orunco ered, which v r is more unfa orab le

Th LAG GIN MAT R IAL h s a thick es of ap p ro imately 0 ,2 d as sp ecified in An e x BB I h s

a le gth e ual to th width ofth B LANKE a d a width e qu al to h lfth le gth of th h ated

are b efore th folds are made I is ap ple d wih is le gth p arale l to th sh rter edg ofth

B LAN E in th most unfa orab le p osi o th t alows th folds to b e comp letely co e red

Tes t 4

RUC K-R ES IS TANT B LANKE S a d PAD S are op erated u nde r th C ONDITIONS OF ADEQUAT HEAT

D IS C HAR GE as spe cified in An e x EE a d th fle xib le p art folded in such a ma n r th t

produce s th e most unfa orab le doub le- hick e ss fold Th folds are p aralel to o e of th

edges of th fle ib le p art, th p osi o of th folds a d th ir width ch se n so as to p roduce th

most unfa orab le result

Th upp e r su rface of th fle ib le p rt is unco e red or p rtaly co ered b y a she et ofLAGG ING

MAT R IAL, which ve r is th more unfa orab le Th le gth of this co e rin is e ual to th

le gth ofth t edge which is p aralel to th fold a d th width is e qu al to o e-hird of th le ngth

of th adjace t e dge

Th LAGG IN MAT R IAL h s a thick e ss of ap p ro imately 0 ,5 d as sp ecified in An e BB I is

place d in th most unfa orab le p si o th t completely co ers th fle ib le p rt in th dire cto

p ralel to th folds a dp artaly co ers i in th directo acros th folds

Ex mp le s of th wa in which th fle ib le p art is folded a d co ered are sh wn in Figure

2 1.107