EN 1617-1997 en Sterile Drainage Catheters and Accessory Devices for Single Use《一次性使用无菌引流导管和附件》.pdf

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1、 STD-BSI BS EN LbL7-ENGL 1777 lb2Libb7 Ob22740 057 = BRITISH STANDARD Sterile drainage catheters and accessory devices for single use The European Standard EN 1617 : 1997 has the status of a British Standard ICs 11.040.20 BS EN 1617 : 1997 NO COP- - c) tracheal catheters (tracheal tubes) (see prEN 1

2、782). 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 nonnative references are cited at the appropriate places in the text and the publications are listed hereaft

3、er. 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 undated references the latest edition of the publication referred to applies. EN 556 Sterilwation of medical devices

4、 - Requirements for medical devices to be iabeed Stere Infomtwn supplied by ule manufacturer for medical devices - Omphkd SmboEs fW Wdkd clknka prEN 1041 lkrminology, symbols and injinmution pmvided with rmdicd devices - Infomtion provided the mnufacturer Catheters other thun ntra-r catheters - Est

5、methods for cmmn pmperties EN 980 with medical delY4e.S supplied .y EN 1618 : 1997 3 Definitions For the purposes of this European Standard, the following defnitions apply 3.1 drainage catheter ibe designed for short or long term percutaneous or surgical insertion into a fluid collection or surgical

6、 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) and, where applicable,

7、 other accessories such as suction source(s), connecting tube(s), connector(s) or rocar(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 gravity, by negative pressure

8、generated by an external power sourcel 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. 3.6 trocar Needle, pointed rod, sleeve or any combination thereof which assists in inserting t

9、he drainage catheter into the body tissue or cavity 3.6 suction source Self contained device capable of exerting a negative pressure on a drainage deter or system. NOTE. The suction source may be the collection device. 4 Requirements 4.1 Kink stability NOTE. This subclause wiil be prepared when a te

10、st 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 manufacturer. This shall be d

11、etermined on the sterilized, ready-for-use product as described in annex k 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. Thble 1. Minimum force at break of connections I Nominal outside

12、 diameter Minimum force at break I (NI I 24 4.3.2 Drainage catheters and all other parts 4f the sustem When tested according to annex B of EN 1618 : 1997 the minimum force at break shall be as given in table 2. O BSI 1997 STD-BSI BS EN LbL7-ENGL 1997 Page 4 EN 1617 : 1997 Lb24bb7 b22747 403 Table 2.

13、 Minimum force at break of catheters and other parts of the system Nominal outside diameter force at break 124 10 I20 4.4 Radio-detectability NOTE. This clause wiii be prepared when a test method has been developed. 4.6 Freedom from leakage When tested according to annex D of EN 1618 : 1997 neither

14、the drainage system nor any components thereof shall leak at the maximum negabve pressure stated by the manufacturer. 4.6 Impact resistance The collection device shall not leak when tested in accordance with annex B. The suction source shall not show any loss of vacuum greater than 2 % when tested i

15、n 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 sha be evaluated for biocompatibiiity and shali be free from biological hazard. NOTE. Methods for evaluation for biocompatibiiity are given

16、in EN 30993. 4.8 Sterility The device shaU 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 shail not show any evidence of corrosion. 5 Labelling In addition to the requirements of EN 980 and prEN 1041 the followin

17、g product-specific detaiis shall be presented on the individual packaging: a) size of the rainage catheter (i.e. outside diameter expressed in millimetres and length expressed in millimetres or centimetres); b) radiodetectability if claimed; c) effective collection capacity of the collection device

18、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 will reh. NOTE. This may be the use until date as dened in prEN 1041. e) the maximum negative pressure in Pascals (Pa) w

19、hich 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 operating pressure of the suction sowce. O BSI 1997 Annex A (normative) %st method for resistance to deformation of a drainage sys

20、tem or any components designed to form a part thereof A.l Principle The drainage system or component(s) thereof, assembled in a ready-buse 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.

21、2 Apparatus A.2.1 Water baa, at (37 f 2) “C for the drainage caheter. A.2.2 Water bath, at (23 f 2) “C for other components. A.3 Procedure PerForm the test on the ready-for-use, sterile product. Condition those parts of the drauiage catheter that are intended for insertion into the body in an atmosp

22、here of i % RH or water at a temperature of (37 f 2) “C (A.2.1) for not less than 15 min. Condition other components at 40 % RH to 60 % RH and a temperature of (23 f 2) “C for not less than 15 min and test immediately after conditioning. Submit the non-perforated section of the drainage catheter and

23、or the entire drainage system andor the individuai components thereof (if supplied separately) to the stated negative pressure of the system for 60 s. Mainiain the pressure for at least 60 s. Examine the test specimen by normal or corrected-bnormal vision during the test for evidence of deformation.

24、 Page 5 EN 1617 : 1997 Annex B (normative) Wst method for impact resistance of collection device B.l Principle The collection device is submitted to free fali 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 sur$e, w

25、hich is: - flat, so that no more than two points on its surface differ in level by more than 2 mm; - rigid, so that it will not be deformed by more than 0,l mm when an area of 100 mm2 is loaded statically with 10 kg anywhere on the surface; - sufficiently large that the device under test falls entir

26、ely upon its surface; - has a mass of at least lobes that of the heaviest device to be tested B.2.2 Means for measung 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 de

27、vice with water to its collecting capaciw. Perform a free fall at an ambient temperature of (23 2) “C from a height of 700 mm onto a hard surface (33.2.1). Inspect for leakage by normal or corrected-bnomal vision. B.3.2 Suction source Assemble the suction source as for clinical use. Ensure the sucti

28、on source is at the maximum negative pressure and measure and record the pressure. Perform a he fall at an ambient temperature of (23 f 2) “C from a height of 700 mm onto a hard surface (B.2.1). Measure and record the pressure not less than 60 s after impact Annex C (informative) Bibliography EN 309

29、93 Bwogicc evaluatian of medical dayices O BSI 1997 STD*BSI BS EN LbL7-ENGL 1997 lbZIbb9 0b22749 28b BS EN 1617 : 1997 List of references See national foreword. O BSI 1997 BS EN 1617 : 1997 BSI 389 Chiswick High Road London w4 4AL BSI - British Standards Institution BSI is the independent national b

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