BS EN ISO 7886-2-1996 Sterile hypodermic syringes for single use Syringes for use with power-driven syringe pumps《一次性使用无菌皮下注射器 动力驱动注射器泵的注射器》.pdf

1、BRITISH STANDARD BS EN ISO 7886-2:1997 Incorporating Amendment No. 1 to BS ISO 7886-2:1996 (renumbers the BS as BS EN ISO 7886-2: 1997) Sterile hypodermic syringes for single use Part 2: Syringes for use with power-driven syringe pumps The European Standard EN ISO 7886-2:1997 has the status of a Bri

2、tish Standard ICS 11.040.20BSENISO7886-2:1997 This British Standard, having been prepared under the directionof the Health and Environment Sector Board, was published under the authority ofthe Standards Board and comesinto effect on 15September1996 BSI 04-2000 The following BSI references relate to

3、the work on this standard: Committee reference CH/2 Draft for comment 94/508351 DC ISBN 0 580 26323 1 Committees responsible for this British Standard The preparation of this British Standard was entrusted to Technical Committee CH/2, Hypodermic equipment, upon which the following bodies were repres

4、ented: Association of British Healthcare Industries British Diabetic Association British Glass Manufacturers Confederation British Surgical Trades Association Department of Health Disposable Hypodermic and Allied Equipment Manufacturers Association(UK) Medical Sterile Products Association Royal Phar

5、maceutical Society of Great Britain Amendments issued since publication Amd. No. Date Comments 9835 November 1997 Indicated by a sideline in the marginBSENISO7886-2:1997 BSI 04-2000 i Contents Page Committees responsible Inside front cover National foreword ii Foreword 2 Foreword iii Text of ISO 788

6、6-2 1BSENISO7886-2:1997 ii BSI 04-2000 National foreword This British Standard is the English language version of EN ISO 7886-2:1997. This British Standard is published under the direction of the Health and Environment Sector Board whose Technical Committee CH/2 has the responsibility to: aid enquir

7、ers to understand the text; present to the responsible international committee any enquiries on interpretation, or proposals for change, and keep UK interests informed; monitor related international and European developments and promulgate them in the UK. NOTEInternational and European Standard, as

8、well as overseas standards, are available from Customer Services, BSI, 389 Chiswick High Road, London W4 4AL. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British

9、 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, theEN ISO title page, page 2, the ISO title page, pages ii to iv, pages 1 to 12, aninsideback cover and a back cover. This standard has

10、been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover.EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 7886-2 September 1997 ICS 11.040.20 Descriptors: See ISO document English version Sterile hypod

11、ermic syringes for single use Part2:Syringes for use with power-driven syringe pumps (ISO 7886-2:1996) Seringues hypodermiques striles, non rutilisables Partie 2: Seringues pour pousse-seringues ms par un moteur (ISO 7886-2:1996) Sterile Einmalspritzen fr medizinische Zwecke Teil 2: Spritzen zur Ver

12、wendung mit Spritzenpumpen (ISO 7886-2:1996) This European Standard was approved by CEN on 1997-08-23. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.

13、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 European Standard exists in three official versions (English, French, German). A version in any other language made by translation u

14、nder 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 national standards bodies of Austria, Belgium, CzechRepublic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Lu

15、xembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and UnitedKingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1997 CEN All rights of exploitation in any form and

16、 by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 7886-2:1997 EENISO7886-2:1997 BSI 04-2000 2 Foreword The text of the International Standard from Technical Committee ISO/TC 84, Medical devices for injections, of the International Organization for Standardization (ISO) has b

17、een taken over as a European Standard 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, either by publication of an identical text or by endorsement, at the latest by March19

18、98, and conflicting national standards shall be withdrawn at the latest by March1998. According to CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, CzechRepublic, Denmark, Finland, Franc

19、e, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the UnitedKingdom. Endorsement notice The text of the International Standard ISO 7886-2:1996 has been approved by CEN as a European Standard without any modification. NOTENormative

20、references to International Standards are listed in Annex ZA (normative).BSENISO7886-2:1997 ii BSI 04-2000 Contents Page Foreword iii Introduction 1 1 Scope 1 2 Normative references 1 3 Definitions 2 4 Nomenclature 2 5 Cleanliness 2 6 Limits for acidity or alkalinity 2 7 Limits for extractable metal

21、s 2 8 Lubricant 2 9 Tolerance on graduated capacity 2 10 Graduated scale 2 11 Syringe design 2 12 Piston/plunger assembly 2 13 Nozzle 2 14 Performance 2 15 Packaging 4 16 Labelling 4 Annex A (normative) Determination of flow characteristics 5 Annex B (normative) Determination of compliance of syring

22、e 9 Annex C (normative) Determination of forces required to move the piston 10 Annex D (informative) Rationale for flowrate characteristics 12 Annex E (informative) Bibliography 12 Annex ZA (normative) Normative references to international publications with their relevant European publications Insid

23、e back cover Figure 1 Designation of dimensions 3 Figure A.1 Test apparatus for determination of flowrate characteristics 6 Figure A.2 Example of data gathered during first two hours of test 6 Figure A.3 Example of plot of data gathered during second hour of test 7 Figure B.1 Apparatus for determina

24、tion of compliance 9 Figure C.1 Apparatus for determination of force to move piston 11 Table 1 2 Table 2 3 Table 3 3 Table 4 3BSENISO7886-2:1997 BSI 04-2000 iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies

25、). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and no

26、n-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are circulated to the member bodies

27、 for voting. Publication as an International Standard requires approval by at least75% of the member bodies casting a vote. International Standard ISO 7886-2 was prepared by Technical Committee ISO/TC 84, Medical devices for injections, Subcommittee SC 1, Syringes, needles and intravascular catheter

28、s for single use. ISO 7886 consists of the following parts, under the general title Sterile hypodermic syringes for single use: Part 1: Syringes for manual use; Part 2: Syringes for use with power-driven syringe pumps. Annex A, Annex B and Annex C form an integral part of this part of ISO 7886. Anne

29、x D and Annex E are for information only. ISO 7886 was first published in 1984. It was subsequently decided to divide it into two parts, ISO 7886-1 retaining essentially the scope of ISO 7886:1984, andISO 7886-2 being applicable to sterile, single-use syringes for use with power-driven pumps.iv blan

30、kBSENISO7886-2:1997 BSI 04-2000 1 Introduction 1 General In the preparation of this part of ISO 7886, it was recognized at an early stage that the absolute criterion of performance is achieved by the combination of the power-driven syringe pump and the syringe working as a complete system. The depen

31、dence of one element of the system on the performance of the other is a key factor. It is essential for the manufacturer of one of these components to liaise with the manufacturer of the other when considering changes in design, in order to ensure satisfactory operation of the system. In particular,

32、 when requested by a pump manufacturer, a syringe manufacturer should give information on tolerances and relationships between the syringe dimensions specified in this part of ISO 7886 and on performance characteristics, such as force to move the plunger, and the variations which might be expected.

33、2 Design criteria The use of syringes which were initially designed and used as manually-operated devices in syringe pumps now makes it desirable to achieve much tighter tolerances on syringe dimensions than normally required for manual use. It is understood that the degree of investment worldwide b

34、y all syringe manufacturers in moulding and manufacturing equipment is such that a change such as modifying diameters of push-buttons or the 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 particularly critic

35、al dimension. Its tolerances are ordinarily relatively loose. The hard-height dimension is a function of not only the total length of plunger rod and the barrel, but also the thickness of the piston and finger grips. The piston thickness, by virtue of its relatively unsophisticated manufacturing pro

36、cess, can vary considerably. Because all these components are manufactured in multicavity moulds from many moulds around the world, the cumulative extreme tolerance buildup from cavity to cavity and mould to mould and location to location is such that these previously noncritical dimensions cannot b

37、e instantly tightened. 3 Syringe identification It is important that when a syringe is fitted to a syringe pump, the pump is correctly programmed to perform satisfactorily with the particular syringe installed. In view of the consequences of incorrect syringe identification by the pump, the need for

38、 an automatic system is recognized. Methods already in use, such as mechanical sensing of the syringe outside diameter, are not deemed 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 ou

39、tside and inside diameters of a syringe. It is also recognized that standardization of syringe barrel diameters across the industry is 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

40、, plunger force and occlusion alarm settings is seen as the next stage of this part of ISO7886. A possible method of recognition is to identify the syringe 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 programme the p

41、ump automatically. It is recommended that development of such a system be worked on as soon as possible. 1 Scope This part of ISO 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-driv

42、en syringe pumps. This part of ISO 7886 does not apply to syringes for use with insulin (specified in ISO 8537), single-use syringes made of glass (specified in ISO 595), syringes prefilled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a phar

43、macist. It does not address compatibility with injection fluids. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this part of ISO7886. At the time of publication, the editions indicated were valid. All standards are su

44、bject to revision, and parties to agreements based on this part of ISO7886 are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 594-1:1986, Conica

45、l fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment Part 1: General requirements. ISO 594-2:1990, Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings. BSENISO7886-2:1997 2 BSI 04-2000 ISO 3696

46、:1987, Water for analytical laboratory use Specification and test methods. ISO 7864:1993, Sterile hypodermic needles for single use. ISO 7886-1:1993, Sterile hypodermic syringes for single use Part 1: Syringes for manual use. ISO 8601:1988, Data elements and interchange formats Information interchan

47、ge Representation of dates and times. IEC 601-2-24:, Medical electrical equipment Part 2: Particular requirements for safety of infusion pumps and controllers 1) . 3 Definitions For the purposes of this part of ISO 7886, the definitions given in ISO7886-1 apply. 4 Nomenclature Clause 4 of ISO 7886-1

48、:1993 shall apply. 5 Cleanliness Clause 5 of ISO 7886-1:1993 shall apply. 6 Limits for acidity or alkalinity Clause 6 of ISO 7886-1:1993 shall apply. 7 Limits for extractable metals Clause 7 of ISO 7886-1:1993 shall apply. 8 Lubricant Clause 8 of ISO 7886-1:1993 shall apply. 9 Tolerance on graduated

49、 capacity Clause 9 of ISO 7886-1:1993 shall apply. 10 Graduated scale Clause 10 of ISO 7886-1:1993 shall apply. 11 Syringe design Critical dimensions for the fit of the syringe in a syringe 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 ISO 7886-1. The push-button should be of such a design as to inhibit neither the fit in a syringe pump driver mechanism designed to accept a flat push-button nor detection by a built-