© ISO 2016 Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters Implants cardiovasculaires et organes artificiels — Systèmes de pontage cardio p[.]
INTERNATIONAL STANDARD ISO 15675 Third edition 2016-08-15 Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters Implants cardiovasculaires et organes artificiels — Systèmes de pontage cardio-pulmonaire — Filtres en ligne pour sang artériel Reference number ISO 15675:2016(E) © ISO 2016 ISO 15675:2016(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 15675:2016(E) Contents Page Foreword iv Scope Normative references Terms and definitions Requirements 4.1 4.2 4.3 Tests and measurements to determine compliance with this document 5.1 5.2 5.3 5.4 General Biological characteristics 5.2.1 Sterility and non-pyrogenicity 5.2.2 Biocompatibility Physical characteristics 5.3.1 Blood pathway integrity (sterile final assembly) 5.3.2 Blood volume 5.3.3 Connectors Performance characteristics 5.4.1 Blood cell damage 5.4.2 Filtration e fficiency 5.4.3 Filter flow rate 5.4.4 Shelf life 5.4.5 Air-handling capability Information supplied by the manufacturer 6.1 6.2 6.3 6.4 Biological characteristics 4.1.1 Sterility and non-pyrogenicity 4.1.2 Biocompatibility Physical characteristics 4.2.1 Blood pathway integrity 4.2.2 Blood volume 4.2.3 Connectors Performance characteristics 4.3.1 Blood cell damage 4.3.2 Filtration e fficiency 4.3.3 Flow rate capacity 4.3.4 Shelf life 4.3.5 Air-handling capability Information on the arterial blood line filter Information on the packaging 6.2.1 Information on the unit container 6.2.2 Information on the shipping container Information in the accompanying documents Information in the accompanying documents in a prominent form Packaging Bibliography © ISO 2016 – All rights reserved iii ISO 15675:2016(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 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 150, Implants for surgery, Subcommittee SC 2, Cardiovascular implants and extracorporeal system s This third edition cancels and replaces the second edition (ISO 15675:2009), which has been technically revised iv © ISO 2016 – All rights reserved INTERNATIONAL STANDARD ISO 15675:2016(E) Cardiovascular implants and artificial organs — Cardiopulmonary bypass systems — Arterial blood line filters Scope T h i s c u ment s p e ci fie s re qui rements for s teri le, s i ngle -u s e, ar teri a l b lo o d l i ne fi lters i ntende d to fi lter and remove emb ol i , debri s , blo o d clo ts and o ther p o tenti a l ly z ardou s s ol id and gas e ou s materia l from the b lo o d o f huma n s du ri ng c ard iopu l monar y b yp a s s s u rger y Normative references T he fol lowi ng c u ments are re ferre d to i n the tex t i n s uch a way th at s ome or a l l o f thei r content s titute s re qu i rements o f th i s c u ment For date d re ference s , on ly the e d ition cite d app l ie s For u ndate d re ference s , the late s t e d ition o f the re ference d c ument (i nclud i ng a ny amend ments) appl ie s ISO 594-2, Conical fittings with % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings ISO 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process ISO 10993-4, Biological evaluation ofmedical devices — Part 4: Selection oftests for interaction with blood ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals ISO 10993-11, Biological evaluation of medical devices — Part 11: Tests for systemic toxicity ISO 11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes ISO 14937, Sterilization ofhealth care products — General requirements for characterization ofa sterilizing agent and the development, validation and routine control of a sterilization process for medical devices ISO 17665-1, Sterilization ofhealth care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices Terms and definitions For the pu r p o s e s o f th i s c u ment, the fol lowi ng term s and defi n ition s apply ISO and IEC maintain terminological databases for use in standardization at the following addresses: — ISO Online browsing platform: available at http://www.iso.org/obp — IEC Electropedia: available at http://www.electropedia.org/ © ISO 2016 – All rights reserved ISO 15675:2016(E) 3.1 arterial blood line filter acce s s or y device u s e d as p a r t o f the c ard iopu l monar y b yp as s s ys tem i n the ar teria l blo o d re tu rn l i ne for fi lteri ng p a r ticle s s uch as blo o d clo ts , debri s a nd gas emb ol i 3.2 blood pathway paths of the arterial blood lin e filter from the blo o d (3.1) containing blood during its intended clinical use 3.3 blood cell damage loss or destruction of cellular components of the blood components 3.4 platelet reduction percentage reduction of platelets contained in a circuit, as a function of time 3.5 plasma-free haemoglobin level difference between the concentration of plasma-free haemoglobin in a circuit, as a function of time 3.5.1 normalized index of hemolysis NIH grams of plasma-free hemoglobin released after pumping 100 l of blood NIH { g / 100 L} = ∆fHb × V × 100 − Hct × 100 where f Δ Hb V Q Hct T 100 Q×T is the increase of plasma free hemoglobin concentration (g/L) over the sampling time interval; is the circuit volume (L); i s the flow rate (L/m i n) ; is the hematocrit (%); is the sampling time interval (min) 3.6 white blood cell reduction percentage reduction of white blood cells contained in a circuit, as a function of time 3.7 filtration e fficiency abi l ity o f the fi lter to remove p ar ticle s percentage from the s i mu late d blo o d s u s p en s ion te s t fluid, expre s s e d as a 3.8 blood analogue te s t s olution wh ich s i mu late s blo o d vi s co s ity b e twe en , × 10 −3 Pa· s (2 , cP) , to , × 10 −3 Pa·s (3,5 cP) 3.9 bubble eliminator device that can remove bubbles © ISO 2016 – All rights reserved ISO 15675:2016(E) 3.10 predicate arterial filter s i m i lar a r teria l fi lter to the te s t ar teri a l fi lter th at h as previou s ly b e en approve d and u s e d intended clinical use for the s a me Requirements 4.1 Biological characteristics 4.1.1 Sterility and non-pyrogenicity T he b lo o d p athway s h a l l b e s ter i le a nd no n- p yro gen ic C o mp l i a nce s h a l l b e ver i fie d i n acco rd a nce with 5.2.1 4.1.2 Biocompatibility T he p ar ts o f the b lo o d p athway s l l b e bio comp atible with re s p e c t to thei r i ntende d u s e C ompl iance sh a l l b e veri fie d i n accordance with 5.2.2 4.2 Physical characteristics 4.2.1 Blood pathway integrity When tested in accordance with 5.3.1 4.2.2 , the blo o d p athway sha l l no t le a k Blood volume T he volu me o f the blo o d p athway s l l b e with i n the tolera nce s s p e ci fie d by the manu fac tu rer (s e e 4.2.3 6.3) Connectors C on ne c tors for conne c tion to the b lo o d p athway s l l, when te s te d i n accordance with s e c u re ne c tion C on ne c tion for 5.3.3, allow a acce s s or y p or ts s l l me e t the re qu i rements o f I S O -2 C on ne c to rs o f a typ e th at a l lows co n ne c tio n o f tub e s with a n i n s ide d ia me ter o f 4, m m , , m m , NO TE 9, m m or ,7 m m , o r a typ e th at comp l ie s with I S O 7: 10 , Figu re , or a typ e th at co mp l ie s with I S O -2 , h ave b e en NO TE fo u nd s ati s fac to r y C on ne c to rs cor re s p o nd i n g to I S O 7: 010 , Figu re a re s idere d a s o ne way to comp l y with th i s requirement 4.3 Performance characteristics 4.3.1 Blood cell damage When determined in accordance with 5.4.1, the percentage change (positive or negative) of plasmaf manufacturer fre e haemo globi n, platele ts , a nd wh ite blo o d cel l s , s l l b e with i n the nge o va lue s s p e c i fie d b y the T he hemolys i s re s u lts s l l b e rep or te d a s mg/d L and N I H 4.3.2 Filtration e fficiency When tested in accordance with 5.4.2 , the fi ltration e fficienc y o f any i nd ividua l fi lter s l l b e at le a s t % when te s te d with p a r ticle s th at are % la rger tha n the nom i na l p ore s i z e o f the fi lter © ISO 2016 – All rights reserved ISO 15675:2016(E) 4.3.3 Flow rate capacity When tested in accordance with 5.4.3 , te s t re s u lts wi l l demon s trate the flow rate and pre s s u re l i m itation(s) to en s u re s a fe a nd e ffe c tive p er forma nce, a s s p e ci fie d b y the manu fac tu rer 4.3.4 Shelf life When tested in accordance with 5.4.4 the manufacturer 4.3.5 , te s t re s u lts sha l l demon s trate the rate d shel f l i fe, a s s p e ci fie d b y Air-handling capability When tested in accordance with 5.4.5 , te s t re s u lts s l l demon s trate the r-ha nd l i ng c ap abi l ity, as s p e c i fie d b y the ma nu fac turer Tests and measurements to determine compliance with this document 5.1 General 5.1.1 Tes ts and meas urements s hall b e p er fo rmed with the device in its terminally s terilized 5.1.2 O p erating variab les s hall b e tho s e s p ecified by the manu facturer prepared according to the manufacturer’s instructions for intended clinical use fo r fo rm and intended clinical us e, unles s o therwis e s p ecified 5.1.3 Unless otherwise stated, the temperature of test liquids shall be 37 °C ± °C 5.1.4 I f the relatio ns hip b etween variab les is no nlinear, s u fficient determinatio ns s hall b e made to permit valid interpolation between data points 5.1.5 The test or measurement procedures shall be regarded as reference procedures Other procedures can be accepted, provided that the alternative procedure has been shown to be of comparable precision 5.2 Biological characteristics 5.2.1 Sterility and non-pyrogenicity C ompl iance sha l l b e veri fie d b y i n s p e c tion o f the ma nu fac turer ’s c u mentation on s teri l i z ation and pyro gen te s ti ng , i n accordance with I S O 176 65 -1 , I S O 11 , I S O 111 7-1 , I S O 149 or I S O 10 9 -1 , as applicable 5.2.2 Biocompatibility C ompl iance sha l l bio comp atibi l ity be for veri fie d by te s t or by i n s p e c tion of the manu fac tu rer ’s c umentation on the fi n i she d device, i n accordance with I S O 10 9 -1 and I S O 10 9 -7, as appl ic able 5.3 Physical characteristics 5.3.1 Blood pathway integrity (sterile final assembly) Fi l l the blo o d p athway o f the device with water and s ubj e c t it to a p o s itive pre s s u re o f , × the manufacturer’s rated pressure or, if none is given, to a pressure of 152 kPa (22 psi) gauge and maintain f f f f device for evidence of water leakage the pre s s u re or h or or the i ntende d ti me o u s e s p e c i fie d b y the manu ac tu rer Vi s ua l ly i n s p e c t the © ISO 2016 – All rights reserved ISO 15675:2016(E) 5.3.2 Blood volume The test liquid shall be anticoagulated whole blood or water The volume o f the blood pathway shall be determined as specified by the manu facturer 5.3.3 Connectors The connection shall be made in accordance with the manufacturer’s instructions for use The connection shall withstand a pull force of 15 N for 15 s without separating 5.4 Performance characteristics 5.4.1 5.4.1.1 Blood cell damage Test media The test liquid for the blood pathway shall be heparinized blood 5.4.1.2 Procedure Two sets of appropriate, identical circuit components, including a pump, connecting tubing, a reservoir exchanger, shall be assembled The device under test shall be placed in one of the circuits A predicate (as specified by the manu facturer and o f suitable size relative to the device under test), and a heat device shall be placed in the second test circuit Priming and debubbling o f the circuits by recirculating with an appropriate solution is recommended be fore blood is added The blood pathway test-liquid volumes shall, at the initiation of the test, be within % of each other Perform the test in vitro using the conditions given in Table A su fficient number of paired tests should be performed to support a statistical analysis The predicate filter should be tested under the same conditions Compliance shall be verified by test or by inspection o f the manu facturer’s documentation on blood cell damage for the finished device, in accordance with ISO 10993-4, as applicable Table — Conditions for in vitro testing of blood cell damage Item Blood flow rate Blood glucose Haemoglobin Level Maximum variation the manufacturer for intended clinical use (see 6.3) 10 mmol/l 12 g/dl ±5 % The maximum specified by ±5 mmol/l ±1 g/dl The sampling schedule shall be in accordance with Table More frequent sampling times are optional Table — Sampling schedule Time, after initiation of test Parameter Plasma-free haemoglobin White blood cell Platelets Haemoglobin Glucose © ISO 2016 – All rights reserved Prior to test X X X X X 30 X X X X (min) 180 X X X X 360 X X X X ISO 15675:2016(E) Table (continued) Time, after initiation of test Parameter Activated clotting time Temperature Flow rates 5.4.2 5.4.2.1 Prior to test X X X 30 (min) X X X 180 X X X 360 X X X Filtration e fficiency Test liquid T he te s t l iqu id s l l b e a glyceri n s olution or water T he te s t l iquid sha l l conta i n to 0 p a r ticle s p er m l that a re % to % la rger tha n the nom i na l p ore s i z e o f the fi lter 5.4.2.2 Procedure Pass 500 ml of the test liquid at room temperature (20 °C to 22 °C) through the arterial blood line fi lter at a flow rate o f no le s s than 10 m l/m i n a nd a pre s s u re no t exce e d i ng kPa (2 p s i) gauge D e term i ne the pre - a nd p o s t-fi ltration me a n numb er o f p ar ticle s T he te s t sh a l l b e p er forme d at the ma nu fac tu rer ’s re com mende d flow rate s C a lc u late the fi ltration e fficienc y, u s i ng the re ad i ngs s i z e nge o f the te s t p ar ticle s u s e d o f p ar ticle s from for e ach from the te s t s a mple, b y s ub trac ti ng the p o s t-fi ltration me an nu mb er the pre -fi ltration me a n, d ivid i ng the quo tient b y the pre -fi ltration me an nu mb er o f p ar ticle s , a nd mu ltiplyi ng b y 10 to ob tai n a p ercentage 5.4.3 5.4.3.1 Filter flow rate Test liquid The test liquid shall be anticoagulated whole blood or a blood analogue 5.4.3.2 Procedure Place the device u nder te s t i n an appropri ate te s t c i rc u it S e t the flow rate at the ma xi mum rate d flow and mon itor the i n le t and outle t pre s s u re s acro s s the fi lter for h Me a s u re the flow rate u s i ng a ca l ibrate d flowme ter No te a ny pre s s u re cha nge s du ri ng the te s t If anticoagulated whole blood is used, this test shall not take into account the effects of formed elements or proteinaceous aggregates 5.4.4 Shelf life Us i ng a va l idate d me tho d , agei ng shou ld b e p er forme d on fi na l, fi n i s he d, s teri l i z e d, device s i n pri ma r y packaging in order to determine nominal shelf life 5.4.5 5.4.5.1 Air-handling capability Test liquid The test liquid shall be heparinized blood with a haemoglobin content of (12 ± 1) g/dl 5.4.5.2 Procedure Us e fi lter vent tubi ng a s s p e ci fie d i n the I F U T he leng th and i nterna l d i ame ter o f the vent tubi ng s l l b e s p e c i fie d T he b ack pre s s u re at the ma xi mu m te s t flow sh a l l b e , kPa (3 ,9 p s i) ± % Us e a bubble © ISO 2016 – All rights reserved ISO 15675:2016(E) eliminator to measure any air downstream o f the filter accumulated over a period o f from bolus injection At flow rates o f 33 %, 67 %, and 100 % o f the specified maximum rated flow rate, 30 ml (for paediatric or in fant arterial filter with a maximum flow rate o f less than 500 ml/min, the bolus shall be 2,5 ml and for maximum flow rates higher than 500 ml/min, the bolus shall be increased by 2,5 ml for every 500 ml/min maximum flow rate; the maximum bolus shall be 10 ml) shall be injected as a single bolus Indication o f the air bolus injection point in the test circuit, rate o f injection, and type o f pump utilized to circulate test liquid should be provided in the test protocol 5.4.5.3 Test results The results shall be reported as the percentage e fficiency o f gross air removal Information supplied by the manufacturer 6.1 In formation on the arterial blood line filter The following in formation shall be given on the arterial blood line filter: a) the manu facturer’s identity; b) the model designation; c) the direction o f blood flow 6.2 Information on the packaging 6.2.1 Information on the unit container The following shall be visible through or given on the unit container: a) the manufacturer’s name and address; b) the description of contents; c) the model designation; d) the statement on sterility and method o f sterilization and non-pyrogenicity; e) the expiry date; f) the batch, lot or serial number designation; g) the words, “Read instructions be fore use” or equivalent symbol; h) any special handling or storage conditions; i) the statement on single-use 6.2.2 Information on the shipping container The following information shall appear on the shipping container: a) the manufacturer’s name and address; b) the description of contents, including number of units; c) the model designation; d) the expiry date; © ISO 2016 – All rights reserved ISO 15675:2016(E) e) any s p e c i a l nd l i ng , s torage or u np acki ng i n s tr uc tion s 6.3 Information in the accompanying documents E ach shel f b ox sh a l l conta i n a n “I n s truc tion s for Us e” le a fle t with the fol lowi ng i n formation: a) the manufacturer’s address and telephone or telefax numbers; b) the model designation; c) the re qu i re d anci l l ar y e qu ipment; d) the i n s truc tion s on ne ce s s ar y, s p e ci a l or un ique pro ce dure s , a s appl icable; e) the d i re c tion s f) the placement, typ e a nd s e c u ri ng o f tubi ng ne c tion s; g) the lo c ation and pur p o s e o f add itiona l entr y or exit p or ts; for pl aci ng the fi lter i n a s upp or t or op erationa l fi xtu re; h) the priming procedure; i) the d i re c tion o f blo o d flow; j) the genera l op erati ng pro ce dure s k) the r-ha nd l i ng c ap abi l ity; l) the ma xi mu m and m i n i mu m re com mende d blo o d flow rate s; for norma l u s e; m) the priming volume; n) a statement that the following are available upon request: 1) a l i s t o f materi a l s o f the b lo o d p athway; 2) blo o d p athway pre s s u re d rop over manufacturer; 3) data related to blood cell damage; 4) relevant tolerances for data presented; o) the nge of b lo o d flow rate s as s p e ci fie d by the the s tatement on s teri l ity, me tho d o f s teri l i z ation, a nd non-p yro gen ic ity 6.4 Information in the accompanying documents in a prominent form T he fol lowi ng i n formation s l l b e given i n accomp a nyi ng c u ments i n a prom i nent a) the flow rate l i m itation s; b) o ther device l i m itation s , for form: example, materi a l i ncomp atibi l ity with known vol ati le anae s the tic agents, solvents or disinfectants Packaging Packagi ng s l l comply with the appropri ate re qu i rements o f I S O 16 7-1 and I S O 116 7-2 © ISO 2016 – All rights reserved ISO 15675:2016(E) Bibliography [1] [2] [3] [4] [5] [6] [7] [8] [9] ISO 7199, Cardiovascular implants and artificial organs — Blood-gas exchangers (oxygenators) ISO 8637:2010, Cardiovascular implants and extracorporeal systems — Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators ISO 10993-10, Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization ISO 13485, Medical devices — Quality management systems — Requirements for regulatory purposes ISO 14971, Medical devices — Application of risk management to medical devices ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and in formation to be supplied — Part 1: General requirements ISO 15223-2, Medical devices — Symbols to be used with medical device labels, labelling, and in formation to be supplied — Part 2: Symbol development, selection and validation ISO/TS 23810, Cardiovascular implants and artificial organs — Checklist for preoperative extracorporeal circulation equipment setup ANSI/AAMI AT6, Autologous transfusion devices © ISO 2016 – All rights reserved ISO 675 : 01 6(E) ICS 11.040.40 Price based on pages © ISO 2016 – All rights reserved