© ISO 2016 Anaesthetic and respiratory equipment — General requirements for airways and related equipment Matériel d’anesthésie et de réanimation respiratoire — Exigences générales pour canules et équ[.]
INTERNATIONAL STANDARD ISO 18190 First edition 2016-11-01 Anaesthetic and respiratory equipment — General requirements for airways and related equipment Matériel d’anesthésie et de réanimation respiratoire — Exigences générales pour canules et équipement connexe Reference number ISO 18190:2016(E) © ISO 2016 ISO 18190:2016(E) COPYRIGHT PROTECTED DOCUMENT © ISO 2016, Published in Switzerland All rights reserved Unless otherwise specified, no part o f this publication 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 ISO’s member body in the country o f the requester ISO copyright o ffice Ch de Blandonnet • CP 401 CH-1214 Vernier, Geneva, Switzerland Tel +41 22 749 01 11 Fax +41 22 749 09 47 copyright@iso.org www.iso.org ii © ISO 2016 – All rights reserved ISO 18190:2016(E) Contents Page Foreword iv Introduction v Scope Normative references Terms and definitions General requirements for airways and related equi pment 4.1 * is management 4.3 Clinical evaluation Materials f 5.2 Intended use and environmental conditions 5.3 Leaching 5.4 Cleaning, disinfecting or sterilizing agents 5.5 Phthalates 5.6 Natural rubber (latex) f k 5.9 Resistance to deterioration 6 Design requirements for airways and related equi pment f f f 6.4 Protection against inadvertent adjustments 6.5 * Prevention of electrostatic charges 6.6 Device lifetime 7 Requirements for airways and related equi pment supplied sterile 8 Packaging Information supplied by the manufacturer k 9.1.1 General k 10 9.2 Instructions for use 10 Annex A (informative) Rationale 13 Annex B (informative) Hazard identification for ris k assessment 16 Bibliography 21 R k Us ab ility 4 B io p hys ical o r mo delling res earch B io lo gical s a ety tes ting Gas co mp atib ility * D urab ility o M agnetic res o nance imaging (M RI ) co mp atib ility 6.1 M echanical s a ety 6.2 M edical electrical equip ment s a ety 6.3 Pneumatic s a ety 7.1 S terility as s urance 9.1 M ar 9.1 mar ing ing M ar © ISO 2016 – All rights reserved ing o n co ntro ls and ins truments iii ISO 18190:2016(E) Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies) The work o f preparing International Standards is normally carried out through ISO technical committees Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee International organizations, governmental and non-governmental, in liaison with ISO, also ta ke part in the work ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters o f electrotechnical standardization The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part In particular the different approval criteria needed for the di fferent types o f ISO documents should be noted This document was dra fted in accordance with the editorial rules of the ISO/IEC Directives, Part (see www.iso.org/directives) Attention is drawn to the possibility that some o f the elements o f this document may be the subject o f patent rights ISO shall not be held responsible for identi fying any or all such patent rights Details o f any patent rights identified during the development o f the document will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents) Any trade name used in this document is in formation given for the convenience o f users and does not constitute an endorsement For an explanation on the meaning o f ISO specific terms and expressions related to formity assessment, as well as information about ISO’s adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www.iso.org/iso/foreword.html The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 2, Airways and related equipment iv © ISO 2016 – All rights reserved ISO 18190:2016(E) Introduction T h i s I nternationa l Standard provide s the genera l re qui rements for b a s ic s a fe ty and p er forma nce the de s ign, p ac k agi ng , ma r k i ng and lab el l i ng that are genera l ly appl ic able to a l l for airways and rel ated This International Standard is intended to replace or supplement the often, repetitive general f f airways and rel ated equipment The aim of this International Standard is to serve as a central catalogue of these equipment re qu i rements that a re com mon a mong the set o s ta nda rd s with i n the c ate gor y o com mon re qu i rements , a l lowi ng e ach device - s p e ci fic s ta ndard to more conc i s ely s a fe ty a nd e s s enti a l re qu i rements For cer ta i n typ e s of for fo c u s on the un ique the e quipment , these general requirements are either airways and rel ated equipment s upplemente d or mo d i fie d b y the s p e c i fic re qui rements o f a device - s p e c i fic s tandard Where device s p e ci fic s ta nda rd s exi s t, th i s I nternationa l Sta ndard shou ld no t b e u s e d a lone For the pu r p o s e s o f clarity, the fol lowi ng convention s have b e en u s e d — de f ined terms appe ar in sm all c aps t ype; — clauses/subclauses for which a rationale is provided in Annex A — compliance checks are given in italics type © ISO 2016 – All rights reserved : i s i nd ic ate d b y a n as teri s k (*) ; v INTERNATIONAL STANDARD ISO 18190:2016(E) Anaesthetic and respiratory equipment — General requirements for airways and related equipment Scope T h i s I nternationa l Standard s p e ci fie s the genera l re qu i rements com mon to equipment airways and rel ated a nd appl ic able to tho s e device - s p e c i fic s ta nda rd s that re ference it T he re qu i rements o f a device - s p e ci fic s tanda rd ta ke priority over th i s I nternationa l Sta nda rd NO TE G enera l re qu i rements co nta i ne d i n th i s I nter n atio n a l S ta nd a rd h ave h i s tor ic a l l y b e en re ference d i n more than two other airways and rel ated equipmen t standards Normative references T he fol lowi ng i nd i s p en s able c u ments , i n whole or i n p ar t, are normatively re ference d i n th i s c u ment a nd are for its appl ic ation For date d re ference s , on ly the e d ition cite d appl ie s For u ndate d re ference s , the late s t e d ition o f the re ference d c u ment (i nclud i ng any amend ments) appl ie s NOTE See Annex A for information on the use of dated and undated normative references ISO 7396-1, Medical gas pipeline systems — Part 1: Pipeline systems for compressed medical gases and vacuum ISO 10524-1, Pressure regulators for use with medical gases — Part 1: Pressure regulators and pressure regulators with flow-metering devices ISO 10524-3, Pressure regulators for use with medical gases — Part 3: Pressure regulators integrated with cylinder valves ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11137-1:2006/Amd.1:2013, Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control o f a sterilization process for medical devices/Amendment ISO 14155:2011/Cor.1:2011, Clinical investigation of medical devices for human subjects — Good clinical practice/Technical Corrigendum ISO 15001:2010, Anaesthetic and respiratory equipment — Compatibility with oxygen ISO 80369-71) , Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance IEC 60601-1-2, Medical electrical equipment — Part 1-2: General requirements for basic safety and essential performance — Collateral standard: Electromagnetic compatibility — Requirements and tests IEC 60601-1-8:2006, Medical electrical equipment — Part 1-8: General requirements for basic safety and essential performance — Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems 1) To be published © ISO 2016 – All rights reserved ISO 81 90: 01 6(E) EN 556-1:2001, Sterilization o f medical devices — Requirements for medical devices to be designated “STERILE” — Part 1: Requirements for terminally sterilized medical devices EN 1041, In formation supplied by the manufacturer of medical devices ASTM F640, Standard test methods for determining radiopacity for medical use ASTM F2052, Standard test method for measurement of magnetically induced displacement force on medical devices in the magnetic resonance environment ASTM F2213, Standard test method for measurement of magnetically induced torque on medical devices in the magnetic resonance environment ASTM F2503, Standard practice for marking medical devices and other items for safety in the magnetic resonance environment Terms and definitions For the pu rp o s e s o f th i s c ument, the fol lowi ng term s and defi nition s apply airways and re l ated e qu i pment device s that provide an i nter face to the p atient’s r ways , either th rough d i re c t contac t, or as an i nterme d iate comp onent to o ther anae s the tic a nd re s pi rator y e qu ipment 3.2 antistatic prop er ty o f materi a l or a pro ce du re that d i s p ers e s or i n h ibits the acc u mu lation o f ele c tro s tatic cha rge s 3.3 ris k combi nation o f the prob abi l ity o f o cc u rrence o f rm and the s everity o f that rm [SOURCE: ISO 14971:2007, 2.16] ris k ana lysis s ys tematic u s e o f ava i l able i n formation to identi fy z a rd s and to e s ti mate the ris k (3.3) [S O U RC E : I S O 149 71 : 0 7, 17, mo d i fie d] analysis includes examination of different sequences of events that can produce hazardous situations and harm (see Annex B and ISO 14971:2007, Clause 4) N o te to entr y: R is k 3.5 ris k assessment overall process comprising a ris [SOURCE: ISO 14971:2007, 2.18] k analysis (3.4) and a ris k e valuation (3.6) ris k e va luation process of comparing the estimated ris (3.3) against given ris of the ris [SOURCE: ISO 14971:2007, 2.21] k k criteri a to de term i ne the accep tabi l ity k © ISO 2016 – All rights reserved ISO 18190:2016(E) 3.7 ris mana ement k g s ys tematic appl ication o f m anagement p ol icie s , pro ce du re s a nd prac tice s to the tas k s o f ana lys i ng , evaluating, controlling and monitoring ris (3.3) [SOURCE: ISO 14971:2007, 2.22] k 3.8 ris mana ement f i e k g l s e t o f re cord s a nd o ther c uments that a re pro duce d by ris k m anagement [SOURCE: ISO 14971:2007, 2.23] (3.7) 3.9 sin e fa t condition condition in which a single means for reducing a ris (3.3) is defective or a single abnormal condition is present [SOURCE: IEC 60601-1:2005, 3.116] g l u l k 3.10 a idation v l fi rmation th rough the provi s ion o f obj e c tive evidence that the re qu i rements u s e or appl ic ation have b e en for a s p e ci fic i ntende d fu l fi l le d N o te to entr y: T he ter m “va l id ate d” i s u s e d to de s ign ate the cor re s p o nd i n g s tatu s N o te to entr y: T he u s e co nd ition s for validation can be real or simulated General requirements for air a s and re ated e w y l q u i ment p 4.1 * is mana ement R 4.1.1 k This g I nternatio nal S tandard s p ecifies requirements that are generally ap p licab le to ris ks associated with airways and related equipment An established ris management process shall be applied to the design of airways and related equipment The ris management process shall include the following elements: — ris analysis; — ris e valuation; — ris control - production and post-production information k k k k k EXAMPLE ISO 14971 NOTE See Annex B for a list of hazards that can be used as guidance in the ris k assessmen t Check compliance by inspection of the risk management file 4.2 Usability T he manu fac tu rer s l l apply a u s abi l ity engi ne eri ng pro ce s s to a s s e s s and m itigate any ris k s caused b y u s abi l ity problem s as s o c i ate d with corre c t u s e (i e norma l us e) and u s e errors (s e e I E C 6 01-1- and IEC 62366-1) Check compliance by inspection o f the usability engineering file © ISO 2016 – All rights reserved ISO 18190:2016(E) 4.3 Clinical evaluation Where appropriate, clinical studies shall be performed under the conditions for which performance is claimed and documented in the ris k m anagement f ile The clinical studies shall comply with the requirements of ISO 14155 NOTE Clinical data may be sourced from — clinical investigation(s) of the device concerned, — clinical investigation(s) or other studies reported in the scientific literature, o f a similar device for which equivalence to the device in question can be demonstrated, or — published and/or unpublished reports on other clinical experience with either the device in question or a similar device for which equivalence to the device in question can be demonstrated Check compliance by inspection of the risk management file 4.4 Biophysical or modelling research Where appropriate, validated biophysical or modelling research shall be per formed under the conditions for which performance is claimed, and documented in the ris k m anagement f ile NOTE Biophysical or modelling research is the application o f validated physical methods and theories to biological problems Examples include the use o f a combination o f models (i.e mathematical, computer, physical, cell and tissue culture, and animal) in a complementary and interactive manner to simulate the per formance o f medical devices [29] Check compliance by inspection o f the technical file Materials 5.1 Biological safety testing A irways and rel ated equipmen t, in their ready-to-use state a fter any preparation for use recommended by the manu facturer, shall satis fy appropriate biological sa fety testing (e.g ISO 10993-1) Check compliance by inspection o f the technical file 5.2 Intended use and environmental conditions A irways and rel ated equipment shall be made of materials suitable for their intended use and the environmental conditions that they may be subjected to during transport, storage or when in use Check compliance by inspection o f the technical file 5.3 Leaching A irways and rel ated equipment shall be manufactured to reduce, to a minimum, the ris k s posed by substances leaching from the materials NOTE Attention is drawn to substances, which are carcinogenic, mutagenic or toxic to reproduction Check compliance by inspection of the risk management file 5.4 Cleaning, disinfecting or sterilizing agents The recommended cleaning, disin fecting or sterilizing agents shall not alter the specified per formance of the device throughout the claimed use life © ISO 2016 – All rights reserved ISO 18190:2016(E) 9.1.2 Marking on controls and instruments 9.1.2.1 The marking on controls and instruments shall meet the requirements o f IEC 60601-1:2005, 7.4.1 and 7.4.2 9.1.2.2 The units of measurement shall be as given in Table Table — Units of measurement Parameter Pressures - gas supply Pressures - breathing systems Flows Air entrainment/oxygen dilution controls Check compliance of Unit of measurement k ilopascals ( kPa) hectopascals (hPa) (cm H 0) litres per minute (l/min) percent oxygen (% O ) 9.1 by inspection 9.2 Instructions for use 9.2.1 Airways and related equipment shall be provided with instructions for use unless the airways can be used safely without any such instructions and related equipment Check compliance by inspection of the instructions for use or the risk management file Instructions for use shall include the information required in 9.1.1.4 and the following: a) the date of issue or the date of the latest revision of the instructions for use; b) the purpose and the intended use of the airways and rel ated equipment and parts thereof, including the power or control devices; c) the interdependence of controls, if applicable; 9.2.2 d) specific instructions and the level o f training needed for the sa fe use o f the airways and rel ated equipment ; e) for airways and rel ated equipment intended to be connected to an electrical power source, the maximum temperature, above ambient, reached in the gas pathways under all operating conditions; f) for airways and rel ated equipment intended to be connected to a power source (electrical or pneumatic), the maximum A-weighted sound pressure level, as derived from the test method in IEC 60601-1:2005, 9.6.2.1 Check compliance of 9.2.2 by inspection 9.2.3 Materials compatibility information In formation on the compatibility o f materials shall include the following: a) in formation about any precautions to be ta ken i f there is a residual ris k associated with the compatibility between the materials o f the airways and rel ated equipment and any dispensed liquids; b) i f applicable, a statement to the e ffect that “the materials used in the airways and rel ated equipment may not be compatible with anaesthetic or respirable gases, solutions/suspensions/ emulsions that have not been evaluated”; 10 © ISO 2016 – All rights reserved ISO 18190:2016(E) c) , if phthalates are incorporated in parts of the airways and airways and related equipment are used in the treatment of children or pregnant or nursing women; a s tatement identi fyi ng the res idua l related equipment d) ris k com i ng d i re c tly or i nd i re c tly i nto contac t with the p atient and i f the * i f appl ic able, a wa rn i ng s tatement to the e ffe c t that “T here i s a ris k o f fi re as s o c i ate d with ox ygen e qu ipment a nd therap y D o no t u s e ne ar s p ar k s or op en flame s ”; e) * i f appl ic able, a wa rni ng s tatement to the e ffe c t that “s mo k i ng du ri ng ox ygen therap y i s dangerou s a nd i s l i kely to re s u lt i n s eriou s i nj u r y f) fi re”; * i f appl ic able, a warn i ng s tatement to the e ffe c t that “u s e on ly lo tion s or s a lve s th at are lab el le d a s ox ygen- comp atible to avoid the g) from ris k o f fi re and bu rn s ”; * i f appl ic able, a warn i ng s tatement to the e ffe c t th at “do no t lubric ate fitti ngs , ne c tion s , tubi ng or other accessories to avoid the ris k o f fi re and burn s ”; 9.2.4 Cleaning, disinfection and sterilization information 9.2.4.1 Unless the airways and related equipment are intended for single use, the instructions for use shall include the following: f ff airways and rel ated equipmen t must be disconnected from the power source (electrical or pneumatic), prior to cleaning, disinfection and a) i appl ic ab le, a wa rni ng to the e ect that “the s teri l i z ation”; b) for airways and rel ated equipment intended for single-patient reuse, the recommended methods of cleaning and, if indicated, disinfection prior to reuse; c) for airways and rel ated equipmen t intended for multi-patient reuse, the recommended methods of cleaning and either disinfection or sterilization prior to reuse; d) an indication of the useful life of the airways and rel ated equipment if processing, in accordance with the instructions, leads to a degree of degradation in performance; e) where such degradation is established, the manufacturer shall provide an indication of the number of repro ces s ing c ycles that can be tolerated or some other indication o f the end o f the device’s use ful li fe Check compliance by inspection of the risk management file and accompanying documents 9.2.4.2 For airways and related equipment intended for single use, the instructions for use shall include 4.1 associated — the residual ris s ris m anagement with cleaning and disinfection or sterilization prior to reuse Check compliance by inspection of the risk management file and accompanying documents k 9.2.5 de eme d unaccep table b y the k pro ce s s s p e ci fie d i n Dismantling and reassembling information The instructions for use shall include the following: a) if applicable, procedures for disconnecting the airways and rel ated equipment from the power s ou rce (ele c tric a l or pneumatic) and b) the re com mende d c) if fu nc tiona l for d i s ma ntl i ng and re as s embly; te s t(s) to b e c arrie d out a fter re a s s embly and b e fore u s e; ff airways and rel ated equipmen t must be disconnected from the power source (electrical or pneumatic), prior to dismantling and appl ic ab le, a wa rni ng to the e ect that “the re as s embl i ng” © ISO 2016 – All rights reserved 11 ISO 18190:2016(E) 9.2.6 Monitoring, alarm and protection devices The instructions for use shall include the following: a) in formation required by IEC 60601-1-8:2006, 5.2.1; b) details and characteristics o f non-return valves and pressure-relie f valves, i f fitted EXAMPLE Opening pressure EXAMPLE Lea kage rate 9.2.7 Electromagnetic compatibility information I f applicable, a warning statement to the e ffect that “the functioning o f the device may be a ffected by electromagnetic inter ference exceeding the levels specified in IEC 60601-1-2 9.2.8 Device disposal information The instructions for use shall include — in formation about any precautions to be ta ken i f there are any residual disposal of airways and related equipment 9.2.9 Parts not integral to the air a s and re ated e w y l q u k ris s associated with i ment p A list of the parts that are not integral parts of the airways and rel ated equipment but are necessary for correct use shall be included in the instructions for use Check compliance of 9.2.3 to 9.2.9 by inspection of the labelling 12 © ISO 2016 – All rights reserved ISO 18190:2016(E) Annex A (informative) Rationale A.1 General This Annex provides a concise rationale for the important requirements of this International Standard have not participated in its development An understanding of the reasons for the main requirements is considered essential for its proper application Furthermore, as clinical practices and technologies and is intended for use by those who are familiar with the subject o f this International Standard but who change, it is believed that rationales for the present requirements will facilitate any revisions o f this International Standard necessitated by those developments The clauses and subclauses in this Annex have been so numbered to correspond to the clauses and subclauses in this International Standard to which they re fer The numbering is, there fore, not consecutive A.2 Normative references Use of dated or undated references are in accordance with the following principles Dated references are required when — re ference made in text is to a specific edition (or a specific DIS or FDIS) and/or a specific element in the re ferenced document (obligatory to put the date); EXAMPLE … in accordance with ISO 6142-1:2015, Clause NOTE Re ference to a term which is recited from the source does not ma ke it a dated normative re ference i f that normative re ference is not cited anywhere else in the document as a requirement — subsequent amendments to, or revisions o f, dated re ferences will need to be incorporated by amendment of the document referring to them Undated references are permitted when — re ference is not to a specific edition nor to any specific element in re ferenced document (so, re ference to a complete document or a part thereof); — all future changes (Amendments, Technical Corrigenda, new editions) to the referenced document are included EXAMPLE “… as specified in ISO/IEC Guide 21-1…” or “… the terms and definitions given in ISO 10414-2 and ISO 15403-1, and the following apply.” So in summary, it is possible to date all the re ferences, but the committee will need to watch that the specific edition has not been revised or amended I f this happens, then the document will need to be revised or amended to reflect the new normative re ference The committee will need to be vigilant to ma ke sure that the dated re ference is not cancelled and replaced or amended so that a device no longer complies with this International Standard Therefore, the committee needs to watch the International Standard re ferred to and react i f it is modified Otherwise, i f all future revisions would apply, then to ma ke sure that the user can always comply with the normative re ference © ISO 2016 – All rights reserved 13 ISO 18190:2016(E) A.4.1 General requirements for airways and re lated equi pment The need for a ris k m anagement f ile is a well-recognized process through which the manufacturer o f a medical device can identi fy hazards associated with a medical device, estimate and evaluate the ris k s associated with these hazards, control these ris k s and monitor the effectiveness of that control Clinical evaluation may also be necessary to confirm the adequacy o f the controls (see ISO 14971 for additional information) A.5.8 Durability of marking Although material biocompatibility is important for all airways and rel ated equipmen t, it was considered o f special importance for airways that might remain in situ for weeks Anaesthetic agents would not be in contact with the tube marking materials for such long periods o f time, but these agents might be damaging to marking materials [26] A.6.1.3 The subcommittee understood that it is necessary to be able to quickly and safely inflate and deflate the cu ff using a means that is readily available to all operators, under all conditions, especially in airway emergencies The common intravenous syringe with a Luer connector was chosen because it is readily available to all healthcare providers worldwide and this provides a wide margin o f safety and usability The ris ks associated with misconnection was considered and judged to be very low due to low frequency Use o f unique small-bore connectors designed to prevent misconnection was considered, but the subcommittee believed that the residual ris k associated with a requirement for special inflation devices that employ these unique connectors was greater than the ris k of misconnection NOTE ISO 594-1 is expected to be replaced by ISO 80369-7 when it is published A.6.1.4 The requirement for radiopaque markers is intended to allow visualization o f certain airways when verification o f the depth o f intubation is required and related equipment A.6.5 Prevention of electrostatic charges A ntistatic airways and rel ated equipment should be su fficiently conductive to allow any charge to dissipate, but not conductive enough to allow a potentially harm ful current to flow There is a need to distinguish between levels o f conductivity A device could be: — conductive – able to conduct significant amounts o f current; — an tis tatic – able to dissipate charge over time to prevent static build-up IEC 60601-1:2005, 8.7.3.c defines a limit o f touch current o f as a maximum o f 500 µA in single fault condi tion The upper limit o f 000 MΩ is suggested to ensure that su fficient conductivity is present to still allow static charges to dissipate be fore they can build up and potentially cause a spark A.9.1.1.4 o) Patient category, Table The definition for patient category is harmonized with the intended delivered volumes for the requirements and tests in ISO 80601-2-12 A.9.2.3 d), e), f) and g) Material com p atibi l ity, fire safety warnin gs Fire sa fety warnings that are similar to the warnings proposed for oxygen concentrator equipment (see ISO 80601-2-69) have been added to the instructions for use See also A.4.1 regarding the rationale for warnings on any use that may deviate from the currently accepted practice 14 © ISO 2016 – All rights reserved