1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 12022:1999 The Euro
2、pean Standard EN 12022:1999 has the status of a British Standard ICS 11.040.10 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Blood-gas exchangersThis British Standard, having been prepared under the direction of the Health and Environment Sector Committee, was published unde
3、r the authority of the Standards Committee and comes into effect on 15 June 1999 BSI 06-1999 ISBN 0 580 29320 3 BS EN 12022:1999 Amendments issued since publication Amd. No. Date Comments National foreword This British Standard is the English language version of EN 12022:1998. The UK participation i
4、n its preparation was entrusted to Technical Committee CH/23, Cardiovascular implants, dialysis systems and oxygenators, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposal
5、s for change, and keep the UK interests informed; monitor related international and European developments and promulgate them in the UK. A list of organizations represented on this committee can be obtained on request to its secretary. Cross-references The British Standards which implement internati
6、onal or European publications referred to in this document may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electronic Catalogue. A British Standard does not purport to include
7、all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN ti
8、tle page, pages 2 to 8, an inside back cover and a back cover.CEN European Committee for Standardization Comite Europe en de Normalisation Europa isches Komitee fu r Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1999 CEN All rights of exploitation in any form and by any means rese
9、rved worldwide for CEN national Members. Ref. No. EN 12022:1999 E EUROPEAN STANDARD EN 12022 NORME EUROPE ENNE EUROPA ISCHE NORM January 1999 ICS 11.040.10 Descriptors: medical equipment, oxygenators, disposable equipment, definitions, specifications, physical properties, performance evaluation, flo
10、w rate, gases, blood, tests, testing conditions, information, packing, marking English version Blood-gas exchangers Echangeurs gaz/sang extra corporels Blutgasaustauscher This European Standard was approved by CEN on 10 June 1998. CEN members are bound to comply with the CEN/CENELEC Internal Regulat
11、ions which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the Central Secretariat or to any CEN member. This Euro
12、pean Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official versions. CEN members are the nati
13、onal standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.Page 2 EN 12022:1999 BSI 06-1999 Foreword This European Standard has been prepared b
14、y Technical Committee CEN/TC 205, Non-active medical devices, the Secretariat of which is held by BSI. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by July 1999, and conflicting national standards
15、 shall be withdrawn at the latest by July 1999. This European Standard is based on ISO 7199 Cardiovascular implants and artificial organs Blood-gas exchangers (oxygenators), prepared by Technical Committee TC 150 of the International Organization for Standardization. According to the CEN/CENELEC Int
16、ernal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerlan
17、d and the United Kingdom. Contents Page Foreword 2 Introduction 3 1 Scope 3 2 Normative references 3 3 Definitions 3 4 Requirements 4 4.1 Biological characteristics 4 4.2 Physical characteristics 4 4.3 Performance characteristics 4 5 Compliance tests and measurements 5 5.1 General 5 5.2 Biological c
18、haracteristics 5 5.3 Physical characteristics 5 5.4 Performance characteristics 5 6 Information supplied by the manufacturer 7 6.1 Information to be given on the blood-gas exchanger 7 6.2 Information to be given on the packaging 7 6.3 Information to be given in the accompanying documents 7 7 Packagi
19、ng 7 Annex A (informative) Bibliography 8Page 3 EN 12022:1999 BSI 06-1999 Introduction This European Standard is intended to ensure that devices designed to effect the exchange of gases in support of, or as a substitution for the normal respiratory function of the lungs have been adequately tested f
20、or both their safety and function, and that extracorporeal device characteristics are appropriately disclosed when labelling the device. This European Standard therefore contains recommended procedures to be used for evaluation of extracorporeal blood-gas exchangers. Type test procedures for determi
21、nation of the gas transfer, blood cell damage and heat exchanger performance are described, although limits for these characteristics are not specified. Ready identification of the performance characteristics should, however, assist the user in the selection of a blood-gas exchanger which will suit
22、the needs of the patient. This European Standard also includes minimum reporting requirements, which will allow the user to compare performance characteristics of blood-gas exchangers of different designs in a standard way. This European Standard makes reference to other standards where methods for
23、determination of characteristics common to medical devices can be found. No provisions have been made for quantification of microbubble generation or for non-formed elements of bovine blood, due to the fact that there is currently no consensus regarding satisfactorily reproducible test methods. Requ
24、irements for animal and clinical studies have not been included in this European Standard. Such studies can be part of a manufacturers quality system. This European Standard contains only those requirements that are specific to blood-gas exchangers. Non-specific requirements are covered by reference
25、s to other standards listed in the normative references section. Since non-toxicity is anticipated to be the subject of a future standard, this European Standard does not cover non-toxicity. 1 Scope This European Standard specifies requirements for sterile, single-use, extracorporeal blood-gas excha
26、ngers intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans. This European Standard also applies to heat exchangers that are integral parts of blood-gas exchangers and to external equipment unique to the use of the device. This European Standard does not apply to:
27、 implanted blood-gas exchangers; liquid exchangers; extracorporeal circuits (blood tubing); separate heat exchangers; separate ancillary devices. 2 Normative references This European Standard incorporates, by dated or undated reference, provisions from other publications. These normative references
28、are cited at the appropriate places 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 only when incorporated in it by amendment or revision. For undated references, the lates
29、t edition of the publications referred to applies. EN 550, Sterilization of medical devices Validation and routine control of ethylene oxide sterilization. EN 552, Sterilization of medical devices Validation and routine control of sterilization by radiation. EN 554, Sterilization of medical devices
30、Validation and routine control of sterilization by moist heat. EN 556, Sterilization of medical devices Requirements for medical devices to be labelled “Sterile”. EN ISO 10993-1, Biological evaluation of medical devices Part 1: Evaluation and testing. (ISO 10993-1:1997) EN ISO 10993-7, Biological ev
31、aluation of medical devices Part 7: Ethylene oxide sterilization residuals. (ISO 10993-7:1995) EN ISO 10993-11, Biological evaluation of medical devices Part 11: Test for systemic toxicity. (ISO 10993-11:1993) EN 46001, Quality systems Medical devices: Particular requirements for the application of
32、EN ISO 9001. EN 46002, Quality systems Medical devices: Particular requirements for the application of EN ISO 9002. 3 Definitions For the purposes of this European Standard, the following definitions apply. 3.1 blood-gas exchanger extracorporeal device designed to temporarily supplement, or be a sub
33、stitute for, the respiratory function of the lung 3.2 blood pathway paths of the blood-gas exchanger containing blood during intended clinical use 3.3 bovine blood whole, or diluted with physiological saline solution, anticoagulated blood from cattlePage 4 EN 12022:1999 BSI 06-1999 3.4 gas pathway p
34、arts of the blood-gas exchanger containing the ventilation gas during intended clinical use 3.5 heat exchanger component that is intended to control the temperature of the circulating blood and/or priming solution 3.6 heat exchanger performance factor ratio R of the difference between the temperatur
35、e of blood at the outlet and inlet of the blood-gas exchanger, and the difference between the temperature of the blood at the inlet of the blood-gas exchanger and the temperature of the water at the inlet of the heat exchanger, using the following equation: R = B To 2 B Ti W Ti 2 B Ti where: B To is
36、 the temperature of the blood at the outlet of the blood-gas exchanger; B Ti is the temperature of the blood at the inlet of the blood-gas exchanger; and W Ti is the temperature of the water at the inlet of the heat exchanger. 3.7 integral part part that is connected to the blood-gas exchanger so th
37、at it cannot normally be separated by the user 3.8 operating variables setting of parameters which affect the function of the device 3.9 platelet percentage reduction percentage reduction of platelets, compared to a baseline level, contained in a circuit incorporating a blood-gas exchanger less the
38、percentage reduction in an identical control circuit without a blood-gas exchanger as a function of time 3.10 plasma-free haemoglobin generation concentration of plasma-free haemoglobin in a circuit incorporating a blood-gas exchanger less the concentration in an identical control circuit without a
39、blood-gas exchanger as a function of time 3.11 white blood cell percentage reduction percentage reduction of white blood cells contained in a circuit incorporating a blood-gas exchanger less the percentage reduction in an identical control circuit without a blood-gas exchanger as a function of time
40、4 Requirements 4.1 Biological characteristics 4.1.1 Sterility and non-pyrogenicity The blood pathway shall be sterile and non-pyrogenic. Compliance shall be verified in accordance with 5.2.1. 4.1.2 Biocompatibility Parts of the blood pathway shall be biocompatible with respect to their intended use.
41、 Compliance shall be verified in accordance with 5.2.2. 4.2 Physical characteristics 4.2.1 Blood pathway integrity When tested in accordance with 5.3.1, the blood pathway shall not leak. 4.2.2 Heat exchanger fluid pathway integrity When tested in accordance with 5.3.2, the heat exchanger fluid pathw
42、ay shall not leak. 4.2.3 Blood volumes When tested in accordance with 5.3.3, the volume of the blood pathway shall be within the tolerance specified by the manufacturer (see 6.3). 4.2.4 Connectors Connectors for connection to the blood pathway shall, when tested in accordance with 5.3.4, allow a sec
43、ure connection. NOTE 1 Connectors of a type that allows connection of tubes with an inner diameter of 4,8 mm, 6,3 mm, 9,5 mm or 12,7 mm, or a type that complies with Figure 1 of EN 1283:1996, or a type that complies with EN 1707 have been used. When tested in accordance with 5.3.4, the gas inlet con
44、nection to the gas pathway shall not separate. Connectors for the heat exchanger fluid pathway shall be capable of connection using fast couplings. NOTE 2 Connectors corresponding to Figure 3 of EN 1283:1996 are considered as one way to comply with this requirement. 4.3 Performance characteristics 4
45、.3.1 Blood-gas exchanger oxygen and carbon dioxide transfer rates When determined in accordance with 5.4.1, the oxygen and carbon dioxide transfer rates shall be within the range of values specified by the manufacturer (see 6.3). 4.3.2 Heat exchanger performance factor When determined in accordance
46、with 5.4.2, the heat exchanger performance factors shall be within the range of values specified by the manufacturer (see 6.3). 4.3.3 Blood cell damage When determined in accordance with 5.4.3, the increased concentration of plasma-free haemoglobin and the percentage reduction of platelets and white
47、 blood cells shall be within the range of values specified by the manufacturer (see 6.3).Page 5 EN 12022:1999 BSI 06-1999 4.3.4 Time-dependent performance changes When determined in accordance with 5.4.1, the oxygen and carbon dioxide transfer rates shall be within the range of values specified by t
48、he manufacturer (see 6.3). 5 Compliance tests and measurements 5.1 General Compliance tests and measurements shall be performed with the device under test prepared according to the manufacturers instructions for intended clinical use. Operating variables shall be those specified by the manufacturer
49、for intended clinical use unless otherwise specified in this European Standard. Unless otherwise stated in this European Standard, the temperature of test liquids shall be (37 1)8C. If the relationship between variables is non-linear, sufficient determinations shall be made to permit valid interpolation between data points. The test or measurement procedures are to be regarded as reference procedures. Other procedures can be accepted provided that the alternative procedure has been shown to be of comparable precision and reproducibi
