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1、| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | BRITISH STANDARD BS EN 1617 : 1997 The Eur
2、opean Standard EN 1617 : 1997 has the status of a British Standard ICS 11.040.20 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAW Sterile drainage catheters and accessory devices for single use Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:37 GMT+00:00 2006, Unco
3、ntrolled Copy, (c) BSI BS EN 1617 : 1997 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 15 July 1997 BSI 1997 The following BSI references relate to the work
4、 on this standard: Committee reference CH/27 Draft for comment 94/506465 DC ISBN 0 580 27653 8 Amendments issued since publication Amd. No.DateText affected Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee CH/27, Medical p
5、lastics tubing, upon which the following bodies were represented: Association of Anaesthetists of Great Britain and Ireland Association of British Health-care Industries British Dietetic Association (PENG) British Surgical Trades Association Department of Health Disposable Hypodermic and Allied Equi
6、pment Manufacturers Association (UK) Guild of Hospital Pharmacists Institution of Physics and Engineering in Medicine and Biology Intensive Care Society Medical Sterile Products Association National Association of Theatre Nurses Royal College of Paediatrics and Child Health Royal Pharmaceutical Soci
7、ety of Great Britain Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:37 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN 1617 : 1997 BSI 1997i Contents Page Committees responsibleInside front cover National forewordii Foreword2 1Scope3 2Normative references3 3Definitions3 4Requirements3
8、 5Labelling4 Annexes A(normative) Test method for resistance to deformation of a drainage system or any components designed to form a part thereof5 B(normative) Test method for impact resistance of collection device5 C(informative) Bibliography5 Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17
9、 08:03:37 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii BSI 1997 BS EN 1617 : 1997 National foreword This British Standard has been prepared by Technical Committee CH/27 and is the English language version of EN 1617 : 1997 Sterile drainage catheters and accessory devices for single use, published b
10、y the European Committee for Standardization (CEN). Cross-references Publication referred toCorresponding British Standard EN 556 : 1994BS EN 556 : 1995 Sterilization of medical devices Requirements for terminally-sterilized devices to be labelled Sterile EN 980 : 1996BS EN 980 : 1997 Graphical symb
11、ols for use in the labelling of medical devices EN 1618 : 1997BS EN 1618 : 1997 Catheters other than intravascular catheters Test methods for common properties The Technical Committee has reviewed the provisions of prEN 1041, to which reference is made in the text, and has decided that they are acce
12、ptable for use in conjunction with this British standard. 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, pages i and ii, the EN title page, pages 2 to 6, an inside back cover
13、 and a back cover. Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:37 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ? 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 199
14、7 Copyright reserved to CEN members Ref. No. EN 1617 : 1997 E EUROPEAN STANDARDEN 1617 NORME EUROPE ENNE EUROPA ISCHE NORM February 1997 ICS 11.040.20 Descriptors: Medical equipment, disposable equipment, catheters, definitions, mechanical strength, shock resistance, tests, labelling English version
15、 Sterile drainage catheters and accessory devices for single use Sondes et dispositifs accessoires ste riles de drainage, non re utilisables Sterile Drainagekatheter und Zubeho r zur einmaligen Verwendung This European Standard was approved by CEN on 1997-01-10. CEN members are bound to comply with
16、the CEN/CENELEC Internal Regulations 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
17、 or to any CEN member. This European 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 ve
18、rsions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:37 GMT
19、+00:00 2006, Uncontrolled Copy, (c) BSI ? Page 2 EN 1617 : 1997 BSI 1997 Foreword This European Standard has been prepared by 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,
20、either by publication of an identical text or by endorsement, at the latest by August 1997, and conflicting national standards shall be withdrawn at the latest by August 1997. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound
21、 to implement this European Standard: Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Annexes A and B form normative parts of this standard. Annex C is given for inform
22、ation only. Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:37 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ? Page 3 EN 1617 : 1997 BSI 1997 1 Scope This European Standard specifies requirements for sterile, single use drainage catheters, wound drainage systems and components thereof desi
23、gned for drainage of fluids to the exterior by means of gravity or negative pressure. This European Standard does not apply to: a) catheters of less than 2 mm outside diameter; b) suction catheters for use in the respiratory tract (see prEN 1733); c) tracheal catheters (tracheal tubes) (see prEN 178
24、2). NOTE. Urinary tract catheters are covered in EN 1616. 2 Normative references This European Standard incorporates by dated or undated reference, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter
25、. 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 latest edition of the publication referred to applies. EN 556Sterilization of medical devices R
26、equirements for medical devices to be labelled Sterile EN 980Information supplied by the manufacturer for medical devices Graphical symbols for medical devices prEN 1041Terminology, symbols and information provided with medical devices Information provided with medical devices supplied by the manufa
27、cturer EN 1618 : 1997Catheters other than intravascular catheters Test methods for common properties 3 Definitions For the purposes of this European Standard, the following definitions apply. 3.1 drainage catheter Tube designed for short or long term percutaneous or surgical insertion into a fluid c
28、ollection or surgical wound. 3.2 collection device Bag, bellows, bottle or other container constituting a part of a drainage system designed for collecting liquids and connected to the drainage catheter directly or via a connecting tube. 3.3 drainage system Drainage catheter and collection device(s)
29、 and, where applicable, other accessories such as suction source(s), connecting tube(s), connector(s) or trocar(s). NOTE. A drainage system may be supplied either in the ready-for-use state or in a state requiring the assembly of some components by the user. Drainage may be achieved either by gravit
30、y, by negative pressure generated by an external power source, by manipulation by the user, or by the pre-evacuation of the collection device. 3.4 connecting tube Tube designed for the assembly of components of a drainage system. 3.5 trocar Needle, pointed rod, sleeve or any combination thereof whic
31、h assists in inserting the drainage catheter into the body tissue or cavity. 3.6 suction source Self contained device capable of exerting a negative pressure on a drainage catheter or system. NOTE. The suction source may be the collection device. 4 Requirements 4.1 Kink stability NOTE. This subclaus
32、e will be prepared when a test method has been developed. 4.2 Resistance to deformation The drainage system or any component thereof intended to operate under negative pressure shall not show deformation sufficient to impair the function of the device at the maximum negative pressure stated by the m
33、anufacturer. This shall be determined on the sterilized, ready-for-use product as described in annex A. 4.3 Force at break 4.3.1 Connections When tested according to annex F of EN 1618 : 1997 the minimum force at break for connections shall be as given in table 1. Table 1. Minimum force at break of
34、connections Nominal outside diameterMinimum force at break (mm)(N) 2 to 45 415 4.3.2 Drainage catheters and all other parts of the system When tested according to annex B of EN 1618 : 1997 the minimum force at break shall be as given in table 2. Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17
35、 08:03:37 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ? Page 4 EN 1617 : 1997 BSI 1997 Table 2. Minimum force at break of catheters and other parts of the system Nominal outside diameterMinimum force at break (mm)(N) 2 to 410 420 4.4 Radio-detectability NOTE. This clause will be prepared when a test
36、method has been developed. 4.5 Freedom from leakage When tested according to annex D of EN 1618 : 1997 neither the drainage system nor any components thereof shall leak at the maximum negative pressure stated by the manufacturer. 4.6 Impact resistance The collection device shall not leak when tested
37、 in accordance with annex B. The suction source shall not show any loss of vacuum greater than 2 % when tested in accordance with annex B. 4.7 Biocompatibility The drainage catheter and any other component of the drainage system intended to channel fluid into the patient shall be evaluated for bioco
38、mpatibility and shall be free from biological hazard. NOTE. Methods for evaluation for biocompatibility are given in EN 30993. 4.8 Sterility The device shall comply with EN 556. 4.9 Corrosion test When tested in accordance with the method given in annex A of EN 1618 : 1997, the test specimen shall n
39、ot show any evidence of corrosion. 5 Labelling In addition to the requirements of EN 980 and prEN 1041 the following product-specific details shall be presented on the individual packaging: a) size of the drainage catheter (i.e. outside diameter expressed in millimetres and length expressed in milli
40、metres or centimetres); b) radio-detectability if claimed; c) effective collection capacity of the collection device expressed in millilitres; d) the vacuum stability of any pre-evacuated suction source, given as the date when at least 80 % of the initial negative pressure as stated on the label wil
41、l remain. NOTE. This may be the use until date as defined in prEN 1041. e) the maximum negative pressure in Pascals (Pa) which the drainage system, or any component thereof supplied separately, can withstand. NOTE. If the suction source is supplied with the system, this figure is the maximum operati
42、ng pressure of the suction source. Licensed Copy: sheffieldun sheffieldun, na, Fri Nov 17 08:03:37 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ? Page 5 EN 1617 : 1997 BSI 1997 Annex A (normative) Test method for resistance to deformation of a drainage system or any components designed to form a part
43、thereof A.1 Principle The drainage system or component(s) thereof, assembled in a ready-to-use state, are exposed to the negative pressure stated on the label. The test specimen is inspected while under the negative pressure for evidence of deformation. A.2 Apparatus A.2.1 Water bath, at (372) C for
44、 the drainage catheter. A.2.2 Water bath, at (232) C for other components. A.3 Procedure Perform the test on the ready-for-use, sterile product. Condition those parts of the drainage catheter that are intended for insertion into the body in an atmosphere of 100 % RH or water at a temperature of (372
45、) C (A.2.1) for not less than 15 min. Condition other components at 40 % RH to 60 % RH and a temperature of (232) C for not less than 15 min and test immediately after conditioning. Submit the non-perforated section of the drainage catheter and/or the entire drainage system and/or the individual com
46、ponents thereof (if supplied separately) to the stated negative pressure of the system for 60 s. Maintain the pressure for at least 60 s. Examine the test specimen by normal or corrected-to-normal vision during the test for evidence of deformation. Annex B (normative) Test method for impact resistan
47、ce of collection device B.1 Principle The collection device is submitted to free fall onto a hard surface and is then examined for evidence of damage in the form of leakage or loss of vacuum. B.2 Apparatus B.2.1 A test surface, which is: flat, so that no more than two points on its surface differ in
48、 level by more than 2 mm; rigid, so that it will not be deformed by more than 0,1 mm when an area of 100 mm2is loaded statically with 10 kg anywhere on the surface; sufficiently large that the device under test falls entirely upon its surface; has a mass of at least 10 times that of the heaviest dev
49、ice to be tested. B.2.2 Means for measuring vacuum, capable of showing a difference of 1 % of the maximum vacuum. B.3 Procedure B.3.1 Collection device Assemble the collection device as for clinical use. Fill the collection device with water to its collecting capacity. Perform a free fall at an ambient temperature of (232) C from a height of 700 mm onto a hard surface (B.2.1). Inspect for leakage by normal or corrected-to-normal vision. B.3.2 Suction source Assemble the suc