EN ISO 7864-1995 Sterile Hypodermic Needles for Single Use《一次性消毒皮下注射器针头》.pdf

1、BSI BS*EN*ISO 7864 96 Lb24bh 0550b40 137 = A BRITISH STANDARD Sterile hypodermic needles for single use * I) * The European Standard EN IS0 7864 : 1995 has the status of a Brih Standard UDC 616.473.2.014.45 NO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMIITED BY COPYRIGHT LAW BS EN IS0 7864 : 1996

2、9s 5081 : Part 2 : 199.9 .enzl?tlbered Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-A BSI BS*EN*ISO 7864 96 m 1b2Ybb9 0550641 075 m Amd. No. k! BSENISO7864:1996 Date I i hue 2

3、, July 1996 This British Standard, having lwn prepared under the direction of the Health Care Standards Poliq Committee, vas published under the authority of the Standards Board and conies into effect on 1.3 November 1993 Z BSI 1993 First published January 1987 .Secoiid edition November 1993 The fol

4、lowing EI references relate to the work on this standard: Coinmittee reference 13CC/2 Draft for coinitient 91/53L-?e Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-ES1 BS*EN*ISO

5、 71964 96 1624669 0550642 TOI he 1, July 1!B6 BS EN IS0 7864 : 1996 A Summary of pages The following table identifies the current issue of each page. Issue 1 indicates that a page has been introduced for the first time by amendment. Subsequent issue numbers indicate an updated page. Vertical sidelin

6、ing on replacement pages indicates the most recent changes (amendment, addition, deletion). Front cover Inside front cover a b i U EN cover page iib iii iv 1 2 Issue 2 2 1 blank 2 2 1 1 blank Original Original Original 3 4 5 6 7 8 9 10 11 12 Inside back cover Back cover issue Original original Origi

7、nal Original Orighd Original Original Original Original 1 2 2 Change of identifier Wherever BS 5081 : Part 2 : 1993 appears in this standard, it should be read as BS EN IS0 7864 : 1996. O BSI 1996 a Copyright European Committee for Standardization Provided by IHS under license with CENNot for Resale

8、No reproduction or networking permitted without license from IHS-,-,-BSI BS*EN*ISO 7Bb4 96 m lb24669 O550643 948 m A Issue 2, July 1996 BS EN IS0 7864 : 1996 Contents Committees responsible Page inside front cover National foreword 11 I Foreword iib Specification 1 scope 1 2 Normative references 1 3

9、 Nomenclature 4 Cleanliness 5 Limits for acidity or alkalinity 6 Limits for extractable metals 1 7 Size designation 2 8 Colourcoding 2 9 Needle hub 2 10 Sheath 2 11 Needle tube 4 12 Needle point 4 13 Performance 4 14 Packaging 5 15 Labelling 5 Annexes A Method for preparation of extracts 7 B Example

10、 of method for determination of fragment production from rubber closures 8 C Symbol for “do not re-use 10 D Bibliography 11 ZA (normative) Normative references to international publications with their I relevant European publications 12 I Copyright European Committee for Standardization Provided by

11、IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,- BSI BSxEN+ISB 7864 96 Lb24bb9 0550644 884 = ABS EN IS0 7864 : 1996 Issue 2, July 1996 National foreword This British Standard has been prepared under the direction of the Health Care Standar

12、ds Policy Committee. It is identical with IS0 7864 : 1993, Stemle hypodmic needles for single use, published by the International Organization for Standardization (ISO). It supersedes BS 5081 : Part 2 : 1987 which is withdrawn. In 1995, the European Committee for Standardization (CEN) accepted IS0 7

13、864 : 1993 as European standard EN IS0 7864 : 1995. As a consequence of implementing the European Standard, this British Standard is renumbered as BS EN IS0 7864 : 1996. BS 5081 was first published in 1976 and specified requirements for sterile hypodermic syringes and needles for single use. A two-p

14、art revision was published in 1987, Part 1 covering sterile, single-use hypodermic syringes and Part 2 covering sterile single-use hypodermic needles. Hypodermic needles specified in this Part of BS 5081 are suitable for use with hypodermic syringes specified in BS 5081 : Part 1 : 1987, which is exp

15、ected to be revised by implementing the revision of IS0 7886 : 1984, currently in preparation. The needles will also fit with the syringes specified in BS 1263, BS 1619 and BS 7548. Cross-references international standard IS0 594-1 1986 IS0 594-2 1991 IS0 3696 : 1987 IS0 6009 : 1992 IS0 8601 : 1988

16、IS0 9626 : 1991 Corresponding British Standard BS 3930 Conical fittings with u 6 % (Lue?-) tape?. for syringes, needles and otlw medical equipmmtl Part 1 : 1987 Specificxatioa for general requiremetits (Identical) part 2 : 1991 Specification for lock fittings (Identical) BS 3978 : 1987 Specification

17、 for water for laborutory use (Identical) BS 7128 : 1993 Specifzcation for colour coding of hypodemzic nt?ea!es for single we (Identical) BS EN 28601 : 1992 Srnication for representation of dates and times in information interchange (Identical) BS 7547 : 1991 SpecVicution for stainless steel needle

18、tubing for the munufacture of medical devices (Identical) The %chnical Committee has reviewed the provisions of IS0 7886- 1 to which reference is made in the text and has decided that they are acceptable for use in conjunction with this Part of BS 5081. It is expected that IS0 7886-1 (revision of IS

19、0 7886 : 1984), when published, will be implemented as a revision of BS 5081 : lart 1 : 1987. It is recommended that needles be manufactured and sterilized in accordance with the recommendations in Quality system for sterile medical devices and su?yical products 1990. Good mnufucturiizg pructid). Co

20、mpliance with a British Standard does not of itself confer immunity from iegai obligations. I) Published by the Deparment of Health aiid Social Security. aiid available from IfMSO, 49 High Holbom, London WCl for personal callers. or by post froiii IIMSO. P.O. Rox 276, London SW8 5M: ii Copyright Eur

21、opean Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-BSI BS*EN*ISO 7864 96 Lb24bb9 0550645 il10 A EUROPEAN STANDARD EN IS 7864 NORME EUR0PEE”E EUROP- NORM December 1995 ICs 11.040.20 Descriptors:

22、Medical equipment, hypodermic needles, specifications, dimensions, tests, designation, colour marking, packaging, labelling English version Sterile hypodermic needles for se use (IS3 7864: 1993) Aiguiiles hypodermiques striles, non rutilisables (Is0 7864: 1993) Sterile Euunal-InJektionskanulen (rso

23、7864: 1993) This European Standard was approved by CEN on 1995-10-28. 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. Upto-date lists and bibliographica

24、l references concerning such national standards may be obtil,.ied on application to the Central Secretariat or to any CEN member. “hiis European Standard exists in three officiai versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN

25、 member into its own language and notified to the Central Secretanat has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Denmark, Fnland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, S

26、weden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1060 Brussels O 1995 All righls o ieproduction and communication in any form and by any means reserved in all cou

27、ntries to CEN and its members Ref. No. EN Is0 7864 : 1995 E Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,- BSI BS*EN*ISO 7864 96 m I1624669 0550646 657 m AEN IS0 7864 : 1995 Is

28、sue 1, July 1996 Foreword The text of the International Standard from ISO/M= $4, Medical dewices for injections, of the international Organization for Standarmon WO) has been taken over as a European Standard by the Technical Committee CENPM= 205, Non-active medical devices. This Europem Standard sh

29、all be given the satus of a national standard, either by publication of an identical text or by endomment, at the latest by June 1996, and the latest by June 1996. According to the CENEENELEX Internal Regulations, the foliowing countries are bound to implement this European Standank Austria, Belgium

30、, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and the United Kingdom. conflicting national standards shall be withdrawn at rib O BSI 1996 Copyright European Committee for Standardization Provided by IHS un

31、der license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,- BSI BSrENxISO 7864 96 I 1624667 0550647 593 I Is0 7864A 993(E) Introduction This International Standard covers sterile hypodermic needles intended for single use primarily in humans. This Internat

32、ional Standard does not give requirements or test methods for freedom from biological hazard because international agreement upon the methodology and the pass/fail criteria is incomplete. Guidance on biological tests relevant to hypodermic needles is given in IS0 10993-1, and it is suggested that ma

33、nufacturers take this guidance into account when evaluating products. Such an evaluation should in- clude the effects of the process whereby the needles are sterilized. However, national regulations may exist in some countries, and these will override the guidance in IS0 10993-1. Plastics materials

34、to be used for the construction of needles are not specified as their selection will depend to some extent upon the design, process of manufacture and method of sterilization employed by indi- vidual manufacturers. The materials should be compatible with injection fluids included in relevant pharmac

35、opoeiae. Hypodermic needles specified in this International Standard are in- tended for use with hypodermic syringes specified in IS0 595 and IS0 7886-1. They will also fit syringes of types 1 and 2 specified in IS0 8537. In some countries, national pharmacopoeiae or government regulations are legal

36、ly binding and their requirements may take precedence over this International Standard. iii Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,-SI BS*EN*ISO 7864 96 1624669 _ 0550648

37、 42T = INTERNATIONAL STANDARD IS0 78641993(E) Sterile hypodermic needles for single use 1 Scope This International Standard specifies requirements for sterile hypodermic needles for single use of nominal outside diameters 0,3 mm and 1,2 mm. IS0 8601:1988, Data elements and interchange for- mats - In

38、formation interchange - Representation of dates and times. IS0 9626:1991, Stainless steel needle tubing for the manufacture of medical devices. It does not apply to dental needles. 3 Nomenclature 2 Normative references The following standards contain provisions which, through reference in this text,

39、 constitute provisions of this international Standard. At the time of publi- cation, the editions indicated were valid. All stan- dards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of ap- plying the most recent

40、editions of the standards in- dicated below. Members of IEC and IS0 maintain registers of currently valid International Standards. IS0 594-1:1986, Conical fittings with a 6 % (Luer) ta- per for syringes, needles and certain other medical equipmenf - Part I: General requirements. IS0 594-2:1991, Coni

41、cal fittings with a 6 % (Luer) ta- per- 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 6009:1992, Hypodermic needles for single use - Colour coding for identification. IS0 788

42、6-1 :-I), Sterile hypodermic syringes for single use - Part I: Syringes for manual use. 1) To be published. The nomenclature for components of hypodermic needles for single use is shown in figure1 together with the designation for length k nomenclature for needle points is shown in figure2. 4 Cleanl

43、iness When inspected by normal or corrected-to-normal vision without magnification under an illuminance of 300 Ix to 700 Ix, the surface of the hypodermic needle tube shall appear free from particles and extraneous matter. When examined under x 2,s magnification, the hub socket shall appear free fro

44、m particles and extrane- ous matter. 5 Limits for acidity or alkalinity When determined with a laboratory pH meter and using a general purpose electrode, the pH value of an extract prepared in accordance with annex A shall be within one unit of pH of that of the control fluid. 6 Limits for extractab

45、le metals When tested by a recognized microanalytical method, for example by an atomic absorption Copyright European Committee for Standardization Provided by IHS under license with CENNot for ResaleNo reproduction or networking permitted without license from IHS-,-,- BSI BSxENUISO 7864 9b Lb24bb9 0

46、550b49 3bb IS0 7864:1993(E) method, an extract prepared in accordance with an- nex A shall, when corrected for the metals content of the control fluid, contain not greater than a com- bined total of 5 mg/l of lead, tin, zinc and iron. The cadmium content of the extract shall, when cor- rected for th

47、e cadmium be lower than 0,l mg/l. 7 Size deslgnation The size of hypodermic by the following: content of the control fluid, needle shall be designated a) the nominal outside diameter of the needle tube, expressed in millimetres; b) the nominal length of the needle tube, expressed The size shall be r

48、eferred to as “the designated metric size” and shall be expressed in millimetres. EXAMPLE in millimetres. 0,8 x 40 8 Coiour coding The nominal outside diameter of hypodermic nee- dles shall be identified by colour coding in accord- ance with IS0 6009 applied to the unit container and/or pari of the

49、needle assembly such as the needle hub or the sheath. 9 Needle hub 9.1 Conical fitting The conical socket of the hypodermic needle hub shall be in accordance with IS0 594-1. If the hub has a locking fitting, it shall be in accord- ance with IS0 594-2. 9.2 Colour of hub The hub shall be made either of pigmented or of unpigmented material. If pigmented, the colour shall be in acco