1、BSI BS*EN*L283 9b Lb24bb9 0568993 342 m BRITISH STANDARD Haemodialysers, haemodiafilters, haemofilters, haemoconcentrators and their extracorporeal circuits The European Standard EN 1283 : 1996 has the status of a British standard ICs 11.040.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED B
2、Y COPYRIGHT LAW BS EN 1283 : 1996 BS EN 1283 : 1996 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 16 November 1996 O BSI 1996 Committees responsible for thi
3、s British Standard The preparation of this British Standard was entrusted to Technical Committee Cw23, Cardiovascuiar implants, diaiysis systems and oxygenators, upon which the foilowing bodies were represena Association of Ameshetists of Great Britain and Ireland Association of British Heaith-care
4、Industries Association of Red Technicians British Cardiac Society British TeMe Technology Group Depment of Heaith Institute of Physics and Engineering in Medicine and Biology Medical Sterile Products Association National Heart and Lung Institute Renal Association Royal Coilege of Nursing Royal UROPE
5、mJ flANDm NORME EUROPEENNE EuRopAIscHE NORM EN 1283 April 1996 ICs 11.040.20 Descriptom. Medical equipment, dialysis apparatus, haemodialysers, filters, disposable equipment, definition, specifications, performance evaiuation, physical properties, tests, information English version Haemodmlysm, haer
6、nodiafjhrs, haernoflhs, haemoconcentmbm and their extmorporeal circuits Hm-w, hmodialtres, hmoitres, HamodiaZysatoren, Hamodianlter, Ofjltr, Hmokonzenlmhn und danigehnge Blukhlaudqmteme hmoconcentsateurs et leurs circuits extracorporels This European Standard was approved by CEN on 19!X-%14. CEN mem
7、bers are bound to comply with the CEN/CENEL.EC Internal Ftegdations which stipuhk the conditions for giving this European Standard the status of a national standard without any alteration. Upto-date lists and bibliographical references concerning such national standars may be obtained on application
8、 to the Centrai Secretariat or to any CEN member. This European standard exists in three official versions (English, French, German). A version in any other language made by tmndation under the responsibility of a CEN member into its own language and notied to the Cenbd Secretariat has the same stat
9、us as the official versions. GEN membeis are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, I*, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. European Committee for Standarmon Comitk Europen
10、de Nonnalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1060 Brussels O 1996 AU rights of reproduction and communication in any form and by any means reserved in ali countries to CEN and its members. Ref. No. EN 1283 : 1996 E Page 2 EN 1283 : 1996 Foreword This Eur
11、opean Standard has been prepared by Rchnicai Committee CENRC 205, Non-active medicai devices, the Secrea of which is held by BSI. This European Standard sitali be given the status of a national standard, either by publication of an identicai text or by endorsement, at the latest by October 1996, and
12、 cocting national standards shall be withdrawn at the Mest by October 1996. According to the CENKENELEC Internal Regulations, the national standards organizations of the foliowing countries are bound to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Ic
13、eland, ireland, I*, Luxembourg, Netherlands, Norway, Portugai, Spain, Sweden, Switzerland, United Kingdom. O BSI 1996 * * rn O Introduction This European Standard contains requirements and acceptance criteria (including test methods) for safety-related parametem for haemodialysem, hamnodiafiltem, ha
14、emotem, haemoconcentrators and the extracorporeal circuits for these devices. This European Standard contains oniy those requirements that are specific to the devices concerned. Non-specific requirements are covered by references to other European or Intedonal Stan-, listed in the nonnative referenc
15、es section. Since non-toxicity is anticipated to be the subject of a future stanard, this standard does not cover non-toxiciw. 1 scope This European Standard specifies requirements for sterile, single use haemodialysers, haemodiafilters, haemofiitm, haemoconcentrators and the extracorporeal circuits
16、 for these devices (including any integral accessory lines, such as fluid and infusion lines and lines for connection to pressure monitors) intended for renai care and cardiovascular use on humans. This European Standard does not apply to extracorporeal circuits for cardiovascuar use or to other ext
17、racorporeal blood exchange devices, such as plasmafilters, haemoperh4on devices, vascular access devices, oxygenators, acve medid devices or devices for peritoneai dialysis. 2 Normative references This European Standard incorporates by dated or undated reference, provisions hm other publications. Th
18、ese normative references are cited at the appropriate piaces in the text and the publications are listed hereafter For dated references, subsequent amendments to or revisions of any of these publications apply to this European Standard oniy when incorporated in it by amendment or revision. For undat
19、ed references the latest edition of the publication referred to applies. EN 556 Sterilization of naedical devices - Rt?quimnents for medical derices to be laoelled sterile infomultion provided with medical devices - Gmphical sl/mbols for use in the la0el.lin.g of medical devices infomultion provided
20、 with dical devices - Infomu;ct2on supplied by the manufacturer with naed.ical delYices prEN 980 Tmimbgy, symbols and prEN 1041 Termim!ogy, symbols and EN 309931 prEN 309937 prEN 30993-11 EN 46001 EN 46002 HD 3952-16 Page 3 ENl283:1996 Biobgical 1988 Sterile hypoa!#mic needles for single use 3 Defin
21、itions For the purposes of this European Standard, the following definitions apply 3.1 blood compartment Part of haemodialysem, haemodiafilters, haemofitem and haemoconcentrators through which blood is intended to pass. 3.2 clearance Volume of a solution from which a solute is completely removed per
22、 unit time. 3.3 dialysing fluid; dialysate; dialysis fluid Solution which is intended to exchange solutes andor water with blood during haemodialysis or haemodiafiltsation. 3.4 dialysing fluid compartment Part of a haemodialyser or haemodiafilter through which dialysing fluid is intended to pass. 3.
23、6 haemoconcentration Process whereby excess fluid, and possibly electrolytes, are removed from diluted blood across a semipermeable membrane. O BSI 1996 BSI BS*EN*L283 96 m L624669 0569000 LBO m Page 4 ENl283:1996 3.6 haemoconcentrator 4.1.2 Biocompatibility Device intended to perform haemoconcentra
24、tion. Parts of haemodhiysers, haemodiaflters, haemofiiters, 3.7 haemodianlter Device intended to perform haemodiafiltration. 3.8 haemodialtration Process whereby solute imbalances in a patients blood are corrected by means of Sundtaneous fibation and diffusion arroas a Semipermeable membrane and rep
25、lacement with an appropriate physiological fluid NOTE. This process normaiiy includes fluid removal. 3.9 haemodialyser Device intended to perform haemodialysis. 3.10 haemoialysis procesS whereby solute imbalances in a patients blood are corrected, mainiy by diffusion across a semipermeable membrane.
26、 NOTE. This process normaiiy includes fluid removal. 3.11 haemonlter Device intended to perform haemoltmtion. 3.12 haemonltration Process whereby solute imbalances in a patients blood are corrected, mainiy by fiitmtion across a semipermeable membrane and replacement with an appropb physiological flu
27、id NOTE. This process normaiiy includes fluid removal. 3.13 transmembrane pressure Hydrostatic pressure exerted across a semipermeable membrane. NOTE. For practical reasons the mean transmembrane pressure is generally expressed as either: a) the difference between the arithmetic means of inlet and o
28、utlet pressures of the blood and diaiysing fluid compartments of a haemodialyser or a haemodiafUteq or b) the difference between the aithmetic mean of the inlet and outlet pressures of the blood compartment and the fjlmte pressure of a haemoiter or a haemoconcenhator. 3.14 access port Component inte
29、nded to provide access to the interior of the extracorporeal circuit NOTE. Access can be for sampiing and/or injection purposes. 3.16 sieving coefficient Ratio of a solute concentration in the filtrate to the simdtaneous concentration of the same solute in the P- 4 Requirements 4.1 Biological charac
30、teristics 4.1.1 Sterility and non-pyrogenicity Pathways for blood and other fluids shall be sterile and non-pymgenic. NOTE. The fact that it is common practice to make aseptic connections to blood compartments andor pathways should be considered. haemoconcentrators and the extracorporeai circuit tha
31、t wiU come into direct or indirect contact with blood during their intended clinid use shall be biocompatible with resped to their intended use. Compliance shall be verified in accordance with 6.2.2. 4.2 Physical characteristics 4.2.1 Structural integritg When tested in accordance with 6.3.1, haemod
32、ialysers, haemodkdilters, haemonlters, haemoconcent-satois and extracorporeal circuits shall not leak. NOTE. This requirement refers to the extemai integriw of the device. 4.2.2 Blood compartment integrity When tested in accordance with 6.3.2, the blood compartments of haemodialysers, haemodiafilter
33、s, haemonlters and haemoconcentntors shall not show leakage under the transmembrane pressures stated by the manufacturer for their intended clinical use (see 7.2.11). 4.2.3 Connectors and ports 4.2.3.1 Cmmtions to the blood compamnmt Except if haemodialysers, haemodiafjiters, haemofilters, haemoconc
34、entrators and the extracorporeal circuit are designed as an integral system, the dimensions of the blood inlet and outlet connectors of haemodialysers, haemodiafilters, haemofiiters and haemoconcentrators shall be as given in gures 1 and 3 and the dimensions of the connectors of the extracorporeai c
35、ircuit shall be as given in figures 2 and 3. Compliance shall be verified by inspection. 4.2.3.2 Connections for diaiysingjuid m ftmte Except if haemodialysers, haemodianlters, haemofiiters, haemoconcentsators and the dialysihg fluid andor filtrate lines are designed as an integrai system, the dimen
36、sions of the ports of haemodialysers, haernodiafiiters, haemofiiters and haemoconcentmhm shall be as given in figure 4. Compliance shall be verified by inspection. 4.2.3.3 Cmmcions to vascular access devices Except if the extracorporeal circuit and the vascular access device are designed as an integ
37、ral part, the extracorporeai circuit shall terminate in a de 6 % (Luer) taper lock fitting in accordance with Is0 594-2. Compliance shall be verified by inspection. 4.2.3.4 Cmmctions to awiimy cm,ts Except if the extracoqmeal circuit and any ancillary components are designed as integrai parts and ex
38、cept for connectors for substitution fluid containers, the extracorporeal circuits shall terminak in a female 6 % (Luer) taper lock fitting in accordance with Is0 594-2. Compliance shall be verified in accordance with 6.2.1. Compliance shall be verified by inspection. Q BSI 1996 4.2.3.6 Access ports
39、 When tested in accordance with 6.3.3, any access ports which incorporate a membrane intended to be pierced by a needle and which are incorporated in the extracorporeai circuit, shall not leak. Any access ports shall be designed so as to minimize the risk of the needle piercing the extracorporeal ci
40、rcuit completely and/or causing potential leakage. Access ports shall not be located dowmtream of the intended location for any air detection device. 4.2.4 Volume When tested in accordance with 6.3.4, the volume of the blood compartments of haemodialysers, haemodiafiiters, haemoltets, haemoconcentmt
41、ors and the volume of the extracoqmreal circuit shal be within the range of values stated by the manufacturer (see 7.2.2). 4.2.6 Pressure drops When tested in accordance with 6.3.6, the pressure drops across the blood compartments of haemodiaiysexs, haemodianlters, haemofiltem and haernoconcentratms
42、 and the dialyshg fluid compartments of haemodiaiysem and haemodhkm shall be within the range of vaiues stated by the manufacturer (see 7.2.7). Page 6 EN 1283 : 1996 4.3 Performance characteristics 4.3.1 Clearance afhaemodialysers un haernodiqjllters When measured in accordance with 6.4.1, the clear
43、ance rates of urea, Creatinine, phosphate, cyanocobalamin and, for haemodianlters, inulin shall be within the range of vaiues stated by the manufacturer (see 7.2.6a). 4.3.2 Sieving celent for haenuMclters, haemfllters and hamaoconcentrators When measured in accordance with 6.4.2, the sieving coeffic
44、ients for albumin, in c) Continue circulating the test liquid) for 30 min During this time either: 6.3.2.2 procedure 1) pass the dialysiing fluid leaving the device through a blood leak detector, accordmg to HD 3952-16; or 2) inspect the filtrate visually for evidence of the presence of blood. NOTE.
45、 The composition of the blood (5.3.2.1a) should be monitored and, if necessary, corrected. 6.3.3 Access ports 6.3.3.1 Equipment Hypodermic needle, as stated by the manufacturer (see 7.3.6) or, if the manufaclmer gives no details, of outside diameter 0,8 mm and in accordance with IS0 7864. 6.3.3.2 Pr
46、ocedure Fill the portion of the extracorporeal circuit that contains the access port with water and apply a pressure 1,5 times the maximum stated by the manufacturer (see 7.3.1). Puncture the access port with the needle, and insert and withdraw the needle a further five times through the puncture. M
47、aintain the pressure for 6 h, and visually inspect the device for the emergence of water. NOTE. The water may be circulated through the device. 6.3.4 Volume 6.3.4.1 Test liquids a) A non-ultrafilterable liquid. b) Any aqueous solution. 6.3.4.2 Procedure 6.3.4.2.1 Blood cmparhnent Fill the dialwing f
48、luid/fllmk compartment with an aqueous solution (6.3.4.lb). Do not circulate the aqueous solution. Fill the blood compartment gradually with a non-ultrafilterable iquid (6.3.4.la). Measure the volume of non-ultraiterable liquid necessary to fiil the blood compartment. Make measurements over the rang
49、e of trammembrane pressures stated by the manufacturer (see 7.2.1). 6.3.4.2.2 Extmcorporeal cimit Attach the extracorporeal circuit to an appropriate machine to support the circuit., Fill with an aqueous solution (6.3.4.lb) those portions of the extracorporeal circuit, including drip and expansion chambers, which may be fdled with blood during their intended clinical use. Measure the volume of aqueous solution necessary to fill the circuit NOTE. The volumes of any drip and expansion chambers may be measured separately 6.3.6 Pressure drops 6.
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