DIN EN ISO 7886-2-1997 Sterile hypodermic syringes for single use - Part 2 Syringes for use with power-driven syringe pumps (ISO 7886-2 1997) German version EN ISO 7886-2 1997《无菌皮下.pdf

1、DEUTSCHE NORM November 1997 I DIN Sterile hypodermic syringes for single use Part 2: Syringes for use with power-driven syringe pumps EN IS0 7886-2 (IS0 7886-2 : 1996) English version of DIN EN IS0 7886-2 ICs 11.040.20 Supersedes DIN 13098-2, November 1988 edition. Descriptors: Syringes, hypodermic

2、syringes, medical equipment. Sterile Einmalspritzen fr medizinische Zwecke - Teil 2: Spritzen zur Verwendung mit Spritzenpumpen (IS0 7886-2 : 1996) European Standard EN IS0 7886-2 : 1997 has the status of a DIN Standard. A comma is used as the decimal marker. National foreword This standard has been

3、 published in accordance with a decision taken by CEN/TC 205 to adopt, without alteration, International Standard IS0 7886-2 as a European Standard. The responsible German body involved in its preparation was the Normenausschu Medizin (Medical Standards Committee). The DIN Standards corresponding to

4、 the International Standards referred to in clause 2 of the EN are as follows: IS0 Standard DIN Standard IS0 594-1 DIN EN 20594-1 IS0 594-2 DIN EN 1707*) IS0 3696 DIN IS0 3696 IS0 7864 IS0 8601 DIN EN 28601 DIN EN IS0 7864 IS0 7886-1 DIN EN IS0 7886-1 Amendments DIN 13098-2, November 1988 edition, h

5、as been superseded by the specifications of EN IS0 7886-2, which is identical to IS0 7886-2. Previous edition DIN 13098-2: 1988-11 National Annex NA Standards referred to (and not included in Normative references and Annex ZA) DIN EN 1707 DIN EN 20594-1 DIN EN 28601 DIN EN IS0 7864 DIN EN IS0 7886-1

6、 Sterile hypodermic needles for single use - Part 1: Syringes for manual use Conical fittings with a 6 YO (Luer) taper for syringes, needles and certain other medical equipment - Lock fittings*) Conical fittings with a 6 YO (Luer) taper for syringes, needles and certain other medical equipment - Gen

7、eral requirements (IS0 594-1 : 1986) Data elements and interchange formats - Information interchange - Representation of dates and times (IS0 8601 : 1988 and Corr 1 : 1991) Sterile hypodermic needles for single use (IS0 7864 : 1993) (IS0 7864 : 1993) *) At present at the stage of draft. EN comprises

8、 17 pages. No pari of this standard may be reproduced without the prior permission of Ref. No. DIN EN IS0 7886-2 : 1997-1 Y Deutsches Institut fr Normung e. V., Berlin. wth Verlag GmbH, D-10772 Berlin, has the exclusive right of sale for German Standards (DIN-Normen). English pricegroup 12 Sales No.

9、 1112 04.98 EUROPEAN STANDARD NORME EUFIOPEENNE EUROPISCHE NORM EN IS0 7886-2 September 1997 ICs 11.040.20 Descriptors: Syringes, hypodermic syringes, medical equipment. English version Sterile hypodermic syringes for single use Part 2: Syringes for use with power-driven syringe pumps (IS0 7886-2 :

10、1996) Seringues hypodermiques striles, non rutilisables - Partie 2: Seringues pour pousse-seringues ms par un Sterile Einmalspritzen fr medizini- sche Zwecke - Teil 2: Spritzen zur Verwendung mit Spritzenpumpen moteur (IS0 7886-2 : 1996) (IS0 7886-2 : 1996) This European Standard was approved by CEN

11、 on 1997-08-23. CEN members are bound to comply with the CENKENELEC 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 b

12、e obtained on application to the Central Secretariat or to any CEN member. The European Standards exist 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

13、 Secretariat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and the Uni

14、ted Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels O 1997. CEN - All rights of exploitation in any form and by any means reserved worldwide for CEN national members. Ref. No. E

15、N IS0 7886-2 : 1997 E Page 2 EN IS0 7886-2 : 1997 Foreword International Standard IS0 7886-2 : 1996 Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps, which was prepared by ISO/TC 84 Medical devices for injections of the International Organization

16、for Standardization, has been adopted by Technical Committee CEN/TC 205 Non-active medical devices, the Secretariat of which is held by BSI, as a European Standard. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement,

17、and conflicting national standards withdrawn, by March 1998 at the latest. In accordance with the CENKENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, the Czech Republic, Denmark, Finland, Fr

18、ance, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and the United Kingdom. Endorsement notice The text of the International Standard IS0 7886-2 : 1996 was approved by CEN as a European Standard without any modification. NOTE: No

19、rmative references to international publications are listed in Annex ZA (normative). Contents 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 . . . . . . . . Normative references . Definitions . . , . . . . _. . . . . . . . . . . . . . . . . . . . . . . , Nomenclature . . . . . . . , . . . . . . . . . . . .

20、. . . . . . . . . . . . . . . . . . , . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Limits for acidity or alkalinity . Limits for extractable metals Lubricant . . . . . . . Tolerance on graduated capacity Graduated scale . Syringe design Piston/plunger assembly

21、_. . . Nozzle Performance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Packaging Labelling . . . . Annexes A Determination of flow characteristics B Determination of compliance of syringe C D

22、etermination of forces required to move the piston D Rationale for flowrate characteristics . E Bibliography Page 4 4 4 4 4 4 5 5 5 5 5 5 6 6 6 7 8 13 14 16 16 Page 3 EN IS0 7886-2 : 1997 Introduction 1 General In the preparation of this part of IS0 7886, it was recognized at an early stage that the

23、 absolute criterion of performance is achieved by the combi- nation of the power-driven syringe pump and the syringe working as a complete system. The dependence of one element of the system on the performance of the other is a key factor. It is essential for the manufac- turer of one of these compo

24、nents to liaise with the manufacturer of the other when considering changes in design, in order to ensure satisfactory operation of the system. In particular, when requested by a pump manu- facturer, a syringe manufacturer should give information on tolerances and relationships between the syringe d

25、imensions specified in this part of IS0 7886 and on performance characteristics, such as force to move the plunger, and the variations which might be expected. 2 Design criteria The use of syringes which were initially designed and used as manually- operated devices in syringe pumps now makes it des

26、irable to achieve much tighter tolerances on syringe dimensions than normally required for manual use. It is understood that the degree of investment worldwide by all syringe manufacturers in moulding and manufacturing equipment is such that a change such as modifying diameters of push-buttons or th

27、e barrel inside diameter is largely out of reach of the syringe industry. Typically the hard height of a syringe has never been regarded as a particu- larly critical dimension. Its tolerances are ordinarily relatively loose. The hard-height dimension is a function of not only the total length of plu

28、nger rod and the barrel, but also the thickness of the piston and finger grips. The piston thickness, by virtue of its relatively unsophisticated manufacturing process, can vary considerably. Because all these components are manu- factured in multicavity moulds from many moulds around the world, the

29、 cumulative extreme tolerance buildup from cavity to cavity and mould to mould and location to location is such that these previously noncritical dimensions cannot be instantly tightened. 3 Syringe identification It is important that when a syringe is fitted to a syringe pump, the pump is correctly

30、programmed to perform satisfactorily with the particular syringe installed. In view of the consequences of incorrect syringe identification by the pump, the need for an automatic system is recognized. Methods already in use, such as mechanical sensing of the syringe outside diameter, are not deemed

31、feasible in the long term. This is due to overlapping ranges of diameter of syringes produced by different manufacturers, and the lack of relationship between the outside and inside diameters of a syringe. It is also recognized that standardization of syringe barrel diameters across the industry is

32、not a realistic option. A means by which the pump could automatically identify the syringe model and use this to programme such information as barrel inside diameter, plunger force and occlusion alarm settings is seen as the next stage of this part of IS0 7886. A possible method of recognition is to

33、 identify the syr- inge and nominal capacity by means of a marking code on the barrel, printed at the same time as the syringe scale, and to use this to pro- gramme the pump automatically. It is recommended that development of such a system be worked on as soon as possible. Page 4 EN IS0 7886-2 : 19

34、97 1 Scope This part of IS0 7886 specifies requirements for sterile single-use hypodermic syringes of nominal capacity 5 ml and above, made of plastics materials and intended for use with power-driven syringe pumps. This part of IS0 7886 does not apply to syringes for use with insulin (specified in

35、IS0 8537). single-use syringes made of glass (specified in IS0 5951, syr- inges prefilled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmacist. It does not address compati- bility with injection fluids. 2 Normative references The follow

36、ing standards contain provisions which, through reference in this text, constitute provisions of this part of IS0 7886. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this part of IS0 7886 are encouraged to inv

37、estigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and IS0 maintain registers of currently valid International Standards. IS0 594-1 : 1986, Conical fittings with a 6 % (Luerl taper for syringes, needles and certain other medical equipment -

38、 Part 1: General requirements. IS0 594-2:1990, Conical fittings with a 6 % (Luerl taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings. IS0 3696:1987, Water for analytical laboratory use - Specification and test methods. IS0 7864: 1993, Sterile hypodermic needles f

39、or single use. IS0 7886-1 :I 993, Sterile hypodermic syringes for single use - Part 7: Syringes for manual use. IS0 8601 :I 988, Data elements and interchange formats - Information interchange - Representation of dates and times. I EC 601 -2-24:-1), Medical electrical equipment - Part 2: Particular

40、requirements for safety of infusion pumps and controllers. 3 Definitions For the purposes of this part of IS0 7886, the defi- nitions given in IS0 7886-1 apply. 4 Nomenclature Clause 4 of IS0 7886-1:1993 shall apply 5 Cleanliness Clause 5 of IS0 7886-1:1993 shall apply 6 Limits for acidity or alkali

41、nity Clause 6 of IS0 7886-1:1993 shall apply. 1) To be published. Page 5 EN IS0 7886-2 : 1997 7 Limits for extractable metals Clause 7 of IS0 7886-1 :I 993 shall apply. 8 Lubricant Clause 8 of IS0 7886-1:1993 shall apply. 9 Tolerance on graduated capacity Clause 9 of IS0 7886-1 :I 993 shall apply. 1

42、0 Graduated scale Clause 10 of IC0 7886-1:1993 shall apply 11 Syringe design Critical dimensions for the fit of the syringe in a syr- inge pump shall be designated as shown in figure 1 and shall be as given in table 1. All other dimensional and design requirements shall be as specified in IS0 7886-1

43、. The push-button should be of such a design as to inhibit neither the fit in a syringe pump driver mech- anism designed to accept a flat push-button nor de- tection bv a built-in detection device. 12 Piston/plunger assembly 12.1 Design The components of the syringe should be designed in such a mann

44、er that it is not possible easily to with- draw the plunger completely from the barrel. Nominal capacity rnl 3 5 and c 1 O 3 10 and 30 and 50 a 50 Table 1 Syringe dimensions Toler- ance on A I% 1 1 1 0,5 0.5 $ 3,5 4 3,5 f“ 10 10 10 max mm 3 3 4 4 4 - - A B C D E F G H J K Dimensions in rnillimetres

45、7 c J Mean inside diameter of the barrel over the swept volume. Distance of the projection of the finger grips from the outside surface of the barrel. Thickness of the finger grips NOTE -The finger grips should not be tapered Distance from the surface of the finger grips nearer to the push-button to

46、 the surface of the push-button further from the finger grips when the fiducial line of the piston coincides with the zero line of the scale. Projection of the push-button beyond the outer dimen- sion of the plunger ribs. Overall thickness of the push-button (including ribs, etc., if present). Outsi

47、de diameter of the barrel measured at a distance of 1 O mm from the underside of the finger grips. Hard height (C + D). Diameter of push-button. Luer lock fitting. Figure 1 - Designation of dimensions Page 6 EN IS0 7886-2 : 1997 Observation-time window min 12.2 Fit of the piston in the barrel Subcla

48、use 12.2 of IS0 7886-1 :I 993 shall apply. The fit of the piston on the plunger should be such that relative axial movement between the two is kept to a minimum in order to reduce the possibility of siphoning. I Maximum variation in flowrate YO 13 Nozzle 2 5 and 10 2 10 and 20 a 20 and 30 3 30 and 5

49、0 Z= 50 13.1 Conical fitting 0.03 0,l 0.15 0,2 0,25 0,l 0.2 0,3 0,35 0,4 0.1 0.4 0,6 0.8 0.9 0.1 0.4 0.6 0.8 0.9 0.4 1,2 1,5 1,8 2,l The male conical fitting of the syringe nozzle shall be in accordance with IS0 594-1 and shall have a locking fitting in accordance with IS0 594-2. Flowrate 13.2 Nozzle lumen Total Force to initiate Sustaining variation in movement force, max. sustaining force, rnax. The nozzle lumen shall have a diameter of not less than 1,2 mm. 14 Performance 14.1 Dead space Subclause 14.1 of IS0 7886-1:1993 shall apply. 14.2 Freedom from air and liquid le