ISO 80601-2-74-2017 Medical electrical equipment - Part 2-74 Particular requirements for basic safety and essential performance of respiratory humidifying equip.pdf

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1、 ISO 2017 Medical electrical equipment Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment Appareils lectromdicaux Partie 2-74: Exigences particulires pour la scurit de base et les performances essentielles des quipements dhumidification

2、 respiratoire INTERNATIONAL STANDARD ISO 80601-2-74 First edition 2017-05 Reference number ISO 80601-2-74:2017(E) ISO 80601-2-74:2017(E)ii ISO 2017 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2017, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this pub

3、lication may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below or ISOs member body in the cou

4、ntry of the requester. ISO copyright office Ch. de Blandonnet 8 CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 copyrightiso.org www.iso.orgISO 80601-2-74:2017(E) ISO 2017 All rights reserved iiiContents Page Fore wo rd . v Introduction . vii 201.1 Scope, objec

5、t and related standards . 1 201.2 Normative references . 3 201.3 Terms and definitions 5 201.4 General requirements 7 201.5 General requirements for testing of ME EQUIPMENT . 10 201.6 Classification of ME EQUIPMENT and ME SYSTEMS 11 201.7 ME EQUIPMENT identification, marking and documents 11 201.8 P

6、rotection against electrical HAZARDS form ME EQUIPMENT 19 201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS . 19 201.10 Protection against unwanted and excessive radiation HAZARDS 21 201.11 Protection against excessive temperatures and other HAZARDS 21 201.12 Accuracy of con

7、trols and instruments and protection against hazardous outputs 24 201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT 27 201.14 Programmable electrical medical systems (pems) 28 201.15 Construction of ME EQUIPMENT . 28 201.16 ME SYSTEMS . 29 201.17 Electromagnetic compatibility of ME E

8、QUIPMENT and ME SYSTEMS 29 201.101 BREATHING SYSTEM connectors and ports . 29 201.102 Requirements for the BREATHING SYSTEM and ACCESSORIES . 32 201.103 LIQUID CONTAINER 33 201.104 FUNCTIONAL CONNECTION 34 202 Electromagnetic disturbances Requirements and tests . 34 206 Usability . 35 208 General re

9、quirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 36 211 Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment . 36 Annex C (informative) Guide to marking and labelling requir

10、ements for ME EQUIPMENT and ME SYSTEMS . 38 Annex D (informative) Symbols on Marking 44 Annex AA (informative) Particular guidance and rationale 45 Annex BB (normative) * Determination of the accuracy of the displayed MEASURED GAS TEMPERATURE . 61 Annex CC (normative) * Determination of the HUMIDIFI

11、CATION OUTPUT 63 Annex DD (normative) * Specific enthalpy calculations 67 ISO 80601-2-74:2017(E) iv ISO/IEC 2016 All rights reservedAnnex EE (normative) Removable temperature sensors and mating ports . 69 Annex FF (normative) * Standard temperature sensor . 73 Annex GG (informative) Saturation vapou

12、r pressure . 76 Annex HH (informative) Reference to the essential principles of safety and performance of medical devices in accordance with ISO 16142-1:2016 777 Annex II (informative) Terminology Alphabetized index of defined terms 81 Bibliography . 85 ISO 80601-2-74:2017(E) ISO 2017 All rights res

13、erved vForeword ISO (the I nt ernatio n al O rgani z atio n f o r Standardization) i s a w orldwide f ederation of n ational standards bodies (ISO member b odies). The work o f preparing Int ernation al S tandards is n o r m a l l y c a r r i e d o u t t h r o u g h I S O t e c h n i c a l c o m m i

14、 t t e e s . E a c h m e m ber body i nterested in a subject for which a technical co m m it tee h a s b een e stablished has the ri ght to b e repres ented o n that c o mmit tee. I n tern a t i onal or gani zations, governmental a nd n on government al, in l iaison with I SO, also take part in the

15、work. ISO collaborates closely with the I nternation al Electrotechn ical Commis s ion (IEC ) o n all m a tters o f electro tech nical stand a rdization. The procedu r es u sed to d evelop this document a nd those i nt ended f o r i t s f u r t h e r m a i n t e n a n c e a r e d e s c r i b e d i n

16、 t h e I S O / I E C D i r e c t i v e s , P a r t 1 . I n p a r t i c u l a r the different approval criteria needed f or t he d iffer e nt types o f ISO documents s hould b e not ed . This d ocument was drafted in accordance w ith the editorial rul e s o f t h e I S O / I E C D i r e c t i v e s ,

17、 Pa rt 2 (see www.iso.org/directives). Attention is d rawn to th e possibility that some o f the elements o f t h i s d o c u m e n t m a y b e t h e subject of p atent righ ts. ISO shall not b e h e ld r esponsible f or i dentifying a ny o r all such patent r i g h t s . D e t a i l s o f a n y p a

18、 t e n t r i g h t s i d e n t i f i e d d u r i n g t h e d e v e l o p m e n t o f t h e d o c u m e n t w i l l b e i n the Introd uction and / or on th e ISO list o f pat e n t d eclarations received ( see www.iso.org/patents). A n y t r a d e n a m e u s e d i n t h i s d o c u m e n t i s i n

19、f o r m a t i o n g i v e n f o r t h e c o n v e n i e n c e o f u s e r s a n d does not con stitute an en d orsement. For an e xplanation o n the meanin g of I SO s pecific terms and exp ressions r elated to co nformit y assessment, a s well as information a bout I SOs a dherenc e to the W orld T

20、 rade O rganization (WTO) principles in t he Technical B a r r i e r s t o T r a d e ( T B T ) s e e t h e f o l l o w i n g U R L : www.iso.org/iso/foreword.html. The committee responsible for this d ocument is I SO/TC 121, Anaesthetic and respiratory equipment , Subcommittee SC 3, Lung ventilators

21、 and related equipment a n d I E C / T C 6 2 , Electrical equipment in medical practice , Subcommittee SC 62D, Electromedical equipment. T h i s f i r s t e d i t i o n o f I S O 8 0 6 0 1 2 7 4 c a n c e l s a n d r e p l a c e s t h e t hird e dition o f ISO 81 8 5 :2 00 7 1 , w h i c h h a s b e

22、e n t e c h n i c a l l y r e v i s e d . I t a l s o i n c o r p o r a t e s t h e t h ird edition of I EC 606011, including a mendment 1 , the fourth e dition of I EC 606011 2, the t h i r d e d i t i o n o f I E C 6 0 6 0 1 1 6 , including a mendment 1 , the seco nd e dition o f I EC 606011 8, i

23、nc luding a mendment 1 , and the second editi on o f IEC 60601111. The most significant chan g es are th e following mo d ifications: ext e nding th e scope to i n clude t he HUMIDIFIER a n d i t s ACCES S ORI ES , where th e characteris tics of t hos e A CCE SSORIES c a n a f f e c t t h e BA SI C

24、SAF E TY a n d ESSENTIAL PE RFORMANCE o f t h e HU M I D I FIE R , and thus not only th e HU MIDIFIER itself; identification of E SSENTI A L PERF ORMAN C E f or a HUMI DIFIER and its ACCESSORIES; modificati on o f t he hu midification test PRO C E DURE a nd t he d isclosure o f humidification perfor

25、mance; ISO 80601-2-74:2017(E) vi ISO 2017 All rights reserved more f ully di m ensio n ing t he re mov a bl e te mper atu r e sensor p o r t and se n so r; removal of r equirements for socalled “bubble” HU M I D I FIE R S a s a s e p a r a t e d o c u m e n t i s b e i n g prepared for the m 8 ; and

26、 the following additions: requirem ent s for m ech a n i cal strengt h ( via IEC 6 0 6 011 11) ; new symbol s; requirem ent s for a HUMIDIFIER as a co mpon ent of an ME SY STEM ; requirem ent s for ENCLOSU R E int egrity ( water in gres s via IEC 6 0 6 011 11) ; requirement s for cleanin g and disin

27、fection PROC ED URES ( via IE C 60 60 11 11 ); requirem ent s for BIOCOMP A TIBILITY ; requirem ent s for US A BILITY . ISO 80601-2-74:2017(E) ISO 2017 All rights reserved viiIntroduction This d ocument specifies requirements f or r espiratory h umidi f yin g equip m ent inte nded f or use on PATIEN

28、TS in HOME HEAL T HCARE ENV I RONMENT a nd in he a lthca re f a cilitie s. H UMIDIFIERS a re use d to raise the water content of g ases d elivered to PAT I ENTS . Gases avail a ble for medical use do not c o n t a i n s u f f i c i e n t m o i s t u r e a n d c a n d a m a g e o r i r r i t a t e t

29、h e r e s p iratory tract or d esiccate secretions o f PATIENT S w h o s e u p p e r a i r w a y s h a v e b e e n b y p a s s e d . I n a d e q u a t e h u m i d i t y a t t h e PATIENT CON NECTION P ORT c an c ause d rying of t he u pper airway, or d esiccation of trache o bronchial s ecretions i

30、n t he trach e al o r tracheost o my t ube, w hich can cause narrowing o r even obstruction of th e airway 192 0 . Heat is employ ed to incre ase t he wat e r o ut p ut of the HU MIDIFIER. I n a d d i t i o n , m a n y HUMIDIFIERS u t i l i z e h e a t e d BREATHING TUBES i n order to i ncrease o p

31、eratin g effici ency a nd r educe water loss (condensat e ) as w ell as heat l oss i n the BREAT HING TUBE . Ventil ator a nd a naesthesia BREATHING TUBES i n common us e might not w ithstand the heat gen e rat e d by HUMIDIFIERS a nd BREATHI N G TUBE heat i ng m ech a ni sms. Man y HUMI D I F I ER

32、M ANUF ACTURE RS u s e o ffthesh e lf e lectrical connectors for their el ectrically heat ed BREATHING TUBES . However, s ince d iffer e nt MANUF A CTUR ERS h a v e u s e d t h e s a m e e l e c t r i c a l connector f o r d ifferent p ower o utput s , electrically heated BREATHING TUBES c a n b e p

33、 h y s i c a l l y , b u t not e l e ctrically, interchangeable . Use of improper electrically h e a t e d BREATHING TUBES h a s c a u s e d overheating, c ircuit m elting, PATIENT a n d OPERATOR b u r n s a n d f i r e s . I t w a s n o t f o u n d p r a c t i c a l t o specify the interface req u

34、irements f or e lectrical connectors to e nsure compati b ility between HUMIDIFIERS and BREATHI N G TUBES produced by different MANUF A CTURE RS. Since the safe use o f a HU M I D I FIE R d epends on th e interacti o n of t he HU M I D I FIE R w i t h i t s m a n y ACCE SSORIE S , this d ocument set

35、s t ot al s ystem p e rformance requirement s u p t o th e PATIENT CONNECTION PORT . These requirem en ts a re a pplicable to A C C ESSORI E S s u c h a s BREATH ING TUBES (both heat ed a nd nonheated), tem perature s ensors a nd e quipment intended to c ontrol the environ m e n t within th e se BRE

36、ATHING TUBES . Humidification can also b e used b y respirator y support ME EQUIP M EN T t o i n c r e a s e PA TIE N T comfort and compliance w ith the therapy. E xamples are obstructi ve s leep a pno e a and nasal hi gh f l o w t h e r a p y e q u i p m e n t . T h e H U MIDIFICATION OUTP U T r e

37、q u i r e m e n t s o f s u c h ME EQUIP M EN T i s less demanding as the PA TIE N T S u pper airway is not b ypassed. H UMIDIFIERS a re c o m m o n l y used w ith air and airo x y g en m i x tu res and any HUMIDIFIER s h o u l d b e a b l e t o o p e r a t e w i t h t h e s e g a s e s . C a r e s

38、h o u l d b e t a k e n i f u s i n g o t h e r g a s m i x e s s u c h a s h e l i u m o x y g e n m i x t u r e s , a s t h e d i f f e r e n t physical and thermal properti es o f th ese gases m a y disturb the operatio n o f the HUMIDIFIER. In this docu ment, th e fol l owing print types ar e us

39、 ed: R equire ments and d e finitio ns: ro m an typ e; Test specifications: italic type ; In form at ive m a terial a ppearin g o utside of t ab les, s uch as n otes, exam ples a nd r efe r ences: i n smaller type. No rmati v e t e xt of ta bles i s also in a s m aller t y p e; Terms defined in C LA

40、USE 3 o f the general standard, in this document o r as noted: small capitals; ISO 80601-2-74:2017(E) viii ISO 2017 All rights reservedIn referring to the structure of this doc u ment, the t e rm “cla use” m ea ns o n e o f the fi ve n u m ber e d divisions w ithin th e t a ble of c ontents, inc l u

41、sive o f all subdivisions (e.g. Cl a use 20 1 include s subcla use s 2 01 .7 , 20 1.8, etc.); “su bclau s e” m eans a n umber e d subdivision o f a clause (e.g. 201.7, 2 0 1 .8 a nd 2 0 1 .9 a re a ll subclauses of Clause 201). Refere nces t o clauses w i thin this d oc ume n t ar e p r eceded b y t

42、 he t e r m “ C l a u s e ” f o l l o w e d b y t h e clause nu mb er. Refer e nc es to su bclau s es within th is document ar e b y numb e r only. In this document, the conjunctive “or” is used a s an “ inclusive o r ” s o a s t a t e m e n t i s t r u e i f a n y combin ation of the condit ions is

43、 true. T h e v e r b a l f o r m s u s e d i n t h i s d o c u m e n t c o n f o r m t o u s a g e d e s c r i b e d i n A n n e x H o f t h e I S O / I E C Directives, Part 2. Fo r th e purposes of this document, the auxi liary verb: “shall” m eans that compliance w ith a requirement or a test is m

44、 a n d a t o ry f o r c o m p l i a n c e w i t h this document; “should” m eans that compliance w ith a requirement or a test i s recommended b ut i s not mand atory for compliance with this document; “ m a y ” i s u s e d t o d e s c r i b e a p e r m i s s i b l e w a y t o a c h i e v e c o m p

45、l i ance w ith a req uirem e n t or test. A n a s t e r i s k ( * ) a s t h e f i r s t c h a r a c t e r o f a t i t l e o r a t t h e b e g in ning of a p a ragraph or t able t itle indicates th a t there is guidance or rati onale relat e d to tha t i tem in Annex AA. The attentio n of M ember Bod

46、ies a nd N ational Co mmittees is drawn t o t h e f a c t t h a t e q u i p m e n t man u facturers and testing organiz a ti ons m ay n eed a transitional p eriod fo llowing p ubl i cation of a n e w , a m e n d e d o r r e v i s e d I S O o r I E C p u b l i c a t i o n i n w h i c h t o m a ke pro

47、d u cts in a ccor d ance w ith the n e w re q u ireme n ts a nd to equip themselv es f or c onductin g n ew o r revised tests. I t is t he recommend a tion of th e c ommittees that t he content of this publi cation be a dopted f o r implementat i on n a tion ally not e arlier than 3 year s from the

48、d at e of p ublic a tion f or e q uipment n e w l y d e s i g n e d a n d n o t e a r l i e r t h a n 5 y e a r s f r o m t h e d a t e o f p u blication for equipment already in production. INTERNATIONAL STANDARD ISO 80601-2-74:2017(E) ISO 2017 All rights reserved 1Medical electrical equipment Part

49、 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment 201.1 Scope, object and related standards IEC 60 60 11 : 20 05 +A MD 1:2 0 1 2 , Cla u se 1 a pplies, e xcept as f oll ows . 201.1.1 * Scope Replacement: This d ocument applies to the BA SI C SAF E TY a n d ESSENTIAL PERFORMANCE o f a HUMIDI FIER , also hereafter referred to a s ME EQUIP M EN T , in c ombination with