© ISO 2016 Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information Tubes trachéaux destinés aux opérations laser — Exigences relatives au marquage et aux info[.]
INTERNATIONAL STANDARD ISO 14408 Third edition 2016-02-15 Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information Tubes trachéaux destinés aux opérations laser — Exigences relatives au marquage et aux informations d’accompagnement Reference number ISO 14408:2016(E) © ISO 2016 ISO 14408:2016(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 14408:2016(E) Page Contents Foreword iv Introduction v Scope Normative references Terms and definitions Marking and labelling 4.2 4.3 4.4 Marking Labelling of packs Labelling of shelf or multi-unit containers Us e o f symb o ls Information to be supplied by the manufacturer 5.1 5.2 5.3 5.4 Instructions for preparation and use of laser-resistant tracheal tube and tracheal tube treatments Indications for use Warnings and precautions about the use of the tube Graph showing test results for laser resistance Bibliography © ISO 2016 – All rights reserved iii ISO 14408:2016(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 take 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 WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary in formation The committee responsible for this document is ISO/TC 121, Anaesthetic and respiratory equipment, Subcommittee SC 2, Airways and related Equipment This third edition cancels and replaces the second edition (ISO 14408:2005), which has been technically revised Major changes include an update on the normative re ferences to ISO 11990-1, Lasers and laser-related equipment — Determination of laser resistance of tracheal tubes — Part Tracheal tube shaft and ISO 11990-2, Lasers and laser-related equipment — Determination of laser resistance of tracheal tubes — Part 2: Tracheal tube cuffs The attention of Member Bodies is drawn to the fact that equipment manufacturers and testing organizations may need a transitional period following publication o f a new, amended, or revised ISO publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests It is the recommendation of the committee that the content o f this publication be adopted for implementation nationally not earlier than years from the date o f publication for equipment newly designed and not earlier than years from the date o f publication for equipment already in production iv © ISO 2016 – All rights reserved ISO 14408:2016(E) Introduction This International Standard is intended to provide requirements for marking, labelling, and information f f been tested for laser resistance in accordance with ISO 11990-1 and ISO 11990-2 including a standard format for reporting results obtained when tested in accordance with ISO 11990-1 and ISO 11990-2 It f f with standard test methods, the manufacturer will be allowed maximum use of alternatives in design and materials s uppl ie d or trache a l tub e s wh ich a re de s igne d or re s i s tance to ign ition b y a l as er and wh ich have i s i ntende d that, b y l i m iti ng the re qu i rements to d i s clo s u re o © ISO 2016 – All rights reserved i n ormation de term i ne d i n accordance v INTERNATIONAL STANDARD ISO 14408:2016(E) Tracheal tubes designed for laser surgery — Requirements for marking and accompanying information Scope This I nter n atio n a l S ta nd a rd s p e c i fie s m a rki n g , l ab e l l i n g , a nd i n fo r m atio n to be s up p l ie d b y the manufacturer for cuffed and uncuffed tracheal tubes and related materials designed to resist i g n i ti o n b y a l a s e r Normative references fol lowi ng T he 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 ISO 7000 1) , Graphical symbols for use on equipment — Registered symbols ISO 15223-1:2012, Medical devices — Symbols to be used with medical device information to be supplied — Part 1: General requirements labels, labelling and ISO 11990-1, Lasers and laser-related equipment — Determination of laser resistance of tracheal tubes — Part 1: Tracheal tube shaft ISO 11990-2, Lasers and laser-related equipment — Determination of laser resistance of tracheal tubes — Part 2: Tracheal tube cuffs Terms and definitions For the pu r p o s e s o f th i s c u ment, the 3.1 tracheal tube tub e de s igne d for fol lowi ng term s and defi n ition s apply i n s er tion th rough the lar yn x i nto the trache a to convey ga s e s and vap ou rs to a nd from the trachea [SOURCE: ISO 4135:2001] 3.2 cuff i n flatable b a l lo on p ermanently attache d arou nd the trache a l tub e ne a r the p atient end to provide an effective seal between the tube and the trachea [S OU RC E : I S O 41 : 01 , mo d i fie d] 3.3 laser-resistant tracheal tube trache a l tub e s p e c i fic a l ly de s igne d b y the manu fac tu rer for u s e du ri ng la s er s u rger y o f the r way No te to entr y: T h i s i nclude s device s s old pre a s s emble d or i n kit form 1) http://www.iso.org/iso/publications_and_e-products/databases.htm?= The grap hical symb o ls in I S O 0 are als o availab le o n line in the I S O web s to re Fo r mo re in fo rmatio n, co ns ult © ISO 2016 – All rights reserved ISO 14408:2016(E) 3.4 laser-resistant tracheal tube treatment covering and/or sur face treatment that adapts or modifies non-laser-resistant tracheal tubes for use in laser surgery o f the airway 3.5 upper anatomical airway upper airway airway above the laryngotracheal junction 3.6 laser-resistant portion portion o f the tracheal tube intended by the manu facturer to be laser-resistant Marking and labelling 4.1 Use of symbols The requirements given in 4.2, 4.3, and 4.4 may be met by the use of the appropriate symbols in accordance with ISO 7000 or ISO 15223-1 4.2 Marking 4.2.1 Marking o f tracheal tubes, connectors, packages, inserts and in formation to be supplied by the manufacturer should comply with EN 1041 4.2 The following shall be permanently marked on or a ffixed to the tracheal tube or tracheal tube treatment: a) the name and/or trademark of the manufacturer or supplier; b) the nominal inside diameter in millimetres designated by the manu facturer for the tracheal tube; c) model identification, i f necessary to distinguish between similar products from the same manufacturer; d) or cu ffed tracheal tubes, a reference to any preparation designated by the manu facturer as essential or protection o f the cu ff from ignition (e.g “inflate the cu ff with saline or water be fore use”) f f 4.2.3 Additional marks may be provided (optional) to assist in positioning the tracheal tube within the 4.2.4 Any component o f a laser-resistant tracheal tube treatment that is affixed to, or protects the trachea treatment covering or material until it is applied to the tracheal tube, shall be marked with a reference to any preparatory steps designated by the manufacturer as essential to the laser resistance o f the tube (e.g “saturate covering with saline solution”) 4.2.5 I f the laser-resistant portion is not visually obvious, this shall be marked 4.2.6 I f any marks are applied to the laser-resistant area o f the tracheal tube, the test to determine 4.2.7 All markings shall be o f su fficient size and contrast to be legible 4.2.8 All markings shall be non-toxic and tissue-compatible Marking materials shall resist deterioration laser-resistance values required for the graph in 5.4 shall be carried out directly upon these markings by anaesthetic agents The markings shall be durable and remain legible during use o f the tube I f the © ISO 2016 – All rights reserved ISO 14408:2016(E) tracheal tube is intended for reuse, the materials shall resist deterioration by the recommended agents and procedures used to clean and disinfect or sterilize the device 4.3 Labelling of packs The following information shall be on the laser-resistant tracheal tube or laser-resistant tracheal tube treatment pack: a) a description of contents, including wording to indicate that the tracheal tube is intended for use in laser surgery; b) the name and/or trademark of the manufacturer or supplier; c) the product code or catalogue number; d) the largest outside diameter after preparations for use; e) the nominal internal diameter in millimetres designated by the manu facturer for the tracheal tube; f ) the means to ensure traceability such as type, batch or serial number or year o f manu facture or symbols 5.1.5 from ISO 15223-1:2012/ISO 7000-2492, 5.1.6 from ISO 15223-1:2012/ISO 7000-2493 or 5.1.7 from ISO 15223-1:2012/ISO 2498 or 5.1.3 from ISO 15223-1:2012/ISO 7000-2497; g) the word “STERILE” or “NON-STERILE”, as appropriate or symbols 5.2.1 rom f ISO 15223-1:2012/ISO 7000-2499 (or as appropriate for sterilization method) or 5.2.7 from ISO 15223-1/ISO 7000-2609; h) or tracheal tubes not intended for reuse, the words “SINGLE USE” or equivalent or symbol 5.4.2 f from ISO 15223-1/ISO 7000; i) for cuffed tracheal tubes, the cuff resting diameter, expressed in millimetres; j) any storage instructions, including a statement o f known conditions o f storage likely to result in rapid deterioration o f the materials (e.g high temperature, ultraviolet light or fluorescent lighting) or appropriate symbols in ISO 15223-1:2012, 5.3; or appropriate symbols in ISO 15223-1:2012, 5.3 or appropriate symbols in ISO 15223-1:2012, 5.3 symbol 5.1.4 from ISO 15223-1:2012/ISO 7000-2607; k) an instruction to re fer to in formation describing laser resistance, including type(s) and nominal wavelength(s), considered by the manu facturer as appropriate for use and contraindications l) an indication of the presence of natural rubber (latex), if present in the device with the word “LATEX”, or symbol 5.4.5 from ISO 15223-1:2012/ISO 7000-2725 4.4 Labelling of shelf or multi-unit containers The following information shall be on shelf or multi-unit containers: a) the descriptive name of the device (trademark, etc.) ; b) the name and/or trademark and address of — the manufacturer or supplier, and — where the manufacturer does not have an address within the locale, an authorized representative within the locale to which the responsible organization can refer; c) the product code or catalogue number; d) the nominal outside diameter of the tube; © ISO 2016 – All rights reserved ISO 14408:2016(E) e) the nominal inside diameter of the tube; f) the b atch nu mb er or s ymb ol “S T E RI LE ” or h) from ISO 15223-1/ISO 7000; i) the “u s e by” date e xpre s s e d as ( Y Y Y Y-M M ) or s ymb ol j) the quantity o f u n it p ackage s i n the contai ner; trache a l tub e s no t i ntende d “NO N- S T E RI LE ”, for as appropri ate or s ymb ol s from ISO 15223-1:2012/ISO 7000-2499 (or as appropriate for sterilization method) or 5.2.7 from ISO 15223-1/ISO 7000-2609; for word(s) I S O 2 -1 /I S O 70 0 ; g) k) the from reu s e, the word s “S I NGLE US E ” or e qu iva lent or s ymb ol from I S O 2 -1 : 01 2/I S O 70 0 -2 7; any s torage i n s tr uc tion s , i nclud i ng a s tatement o f known cond ition s o f s torage l i kely to re s u lt i n rapid de terioration o f the materia l s (e g u ltraviole t l ight or fluore s cent l ighti ng) ; or l) an i n s tr uc tion to re fer to i n formation de s cribi ng la s er re s i s tance, i nclud i ng typ e(s) and nom i na l waveleng th(s) s idere d b y the manu fac tu rer a s appropriate for u s e and contra i nd ic ation s Information to be supplied by the manufacturer 5.1 Instructions for preparation and use of laser-resistant tracheal tube and tracheal tube treatments For laser-resistant tracheal tube treatments that require set-up and maintenance steps to achieve the stated laser resistance, explicit information shall be provided, including applicable 5.1.1 p re cautio nary s tatements Unless the tracheal tube is intended and marked as being for single use, recommended methods of cleaning and disinfection or sterilization shall be provided 5.1.2 5.1.3 5.2 The manufacturer shall indicate the presence of natural rubber (latex), if present in the device Indications for use I n fo r m atio n o n t y p e (s) o f l a s er a nd no m i n a l wave le n g th(s) c o n s idere d b y the m a nu fac tu re r to b e appropriate for use with the laser-resistant tracheal tube and information on contraindications shall be provided 5.3 Warnings and precautions about the use of the tube D e s crip tion s o f damage to tub e s a nd e ffe c ts on tub e s that may re s u lt from contac t with las ers and which could result in harm to the patient or healthcare personnel shall be provided These warnings shall include a description of events (other than ignition) reported during testing for laser resistance in accordance with ISO 11990-1 5.4 5.4.1 Graph showing test results for laser resistance Fo r each typ e o f las er co ns idered by the manu facturer to b e ap p ro p riate fo r us e with the tracheal tube as determined in accordance with ISO 11990-1, a graphic presentation of the results shall be given Fo r cu ffed tub es where a manu facturer b elieves that the las er res is tance o f the cu ff to clinically relevant las er s etting and wis hing to co nvey this in fo rmatio n to the us er then the cu ff s hall b e tes ted in acco rdance with ISO 11990-2 and a separate graphic presentation of the results shall be given For cuffed tubes where the manu facturer es no t b elieve that the las er res is tance o f the cu ff to clinically relevant las er © ISO 2016 – All rights reserved ISO 4408: 01 6(E) s etting can b e grap hically s hown, then as p er cu ff that may res ult fro m 5.3 a description of damage to the cuff and effects on the co ntact with las ers and which co uld res ult in harm to the p atient o r healthcare personnel shall be provided 4.2 4.2 The graph shall take the form shown in Figure and s hall co mp ly with 5.4.2.1 to 5.4.2.6 The title of the graph showing test results of the shaft shall be “Maximum power settings at which ignitio n o f the s ft did no t o ccur when tes ted us ing a s p o t s ize o f , mm” The title o f the grap h s howing tes t res ults o f the cu ff, i f p rovided by the manu facturer, s hall b e “M aximum p o wer s ettings at which damage to the cu ff did no t o ccur when tes ted us ing a s p o t s ize o f , mm” 4.2 Power shall be plotted on the vertical axis from W to 100 W Power levels greater than 100 W may b e s ho wn i f warranted by tes t res ults 4.2 The duratio n o f las er energy s hall b e p lo tted o n the ho rizo ntal axis fro m s to s The length of the horizontal axis shall be (160 ± 10) % of the height of the vertical axis at 100 W Data shall be provided for durations of s and 10 s Additional data shall be included to limit f f greater No data shall be included for durations less than s or greater than 10 s 4.2 the change 4.2 ro m adj acent data p o ints to no mo re than % o Power/duratio n curves s hall b e s hown us ing s traight lines b etween data p o ints Las er typ es and no minal wavelengths s hall b e identified 4.2 the larger value o r W, whichever is The fo llo wing fo r each curve s tatements s hall ap p ear in p roximity to the tracheal tub e s ft tes t res ults grap h and i f ap p licab le the cu ff tes t res ults grap h, and they s hall indicate that the s tatements ap p ly to the data presented in the graph: a) a s tatement that the data ob ta i ne d apply on ly to the l as er-re s i s tant p or tion o f the trache a l tub e s ft a nd that o ther comp onents o f the s ys tem, s uch a s the i n flation s ys tem h ave no t b e en te s te d; b) a s tatement that the data ob tai ne d appl ie s on ly to the c u ff o f the trache a l tub e; c) a c autionar y s tatement ma ki ng cle ar that the cl i n ic a l releva nce o f the te s ts s no t b e en d) a c autionar y s tatement that la s er re s i s tance u nder s u rgic a l cond ition s may d i ffer established; from fu l ly the va lue s given, due to the pre s ence o f water, blo o d or b o dy flu id s © ISO 2016 – All rights reserved ISO 14408:2016(E) Key X laser energy duration, s Nd:YAG laser (1,06 µm) CO laser (10,6 µm) KTP laser (0,532 µm) argon laser (0,5 µm) power, W Y Figure — Example of graphic presentation of maximum power settings at which ignition did not occur when tested using a spot size of 0,5 mm © ISO 2016 – All rights reserved ISO 14408:2016(E) Bibliography [1] [2] [3] ISO 4135:2001, Anaesthetic and respiratory equipment — Vocabulary ISO 5361, Tracheal tubes EN 1041, Information supplied by the manufacturer with medical devices © ISO 2016 – All rights reserved ISO 4408: 01 6(E) ICS 1 040.1 Price based on pages © ISO 2016 – All rights reserved