1、 STD.BS1 BS EN IS0 788b-1-ENGL L997 m Lb211bb3 Ob4LL5b 93T BRITISH STANDARD Sterile hypodermic syringes for single use Part 1. Syringes for manual use The European Standard EN IS0 7-1 : 1997 has the status of a British Standard ICs 11.040.20 BS EN IS0 7886-1 : 1997 COPYRIGHT European Committee for S
2、tandardizationLicensed by Information Handling ServicesBS EN IS0 7886-1 : 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 September 1997 O BSI 1997 IS
3、BN O 580 28015 2 National foreword This British Standard is the English language version of EN IS0 7886-1 : 1997. It is identical with IS0 7m1: 1993 including Technical Corrigendum 1, November 1995. It supersedes BS 5081 : Part 1 : 1994 which is withdrawn. The UK participation in its preparation was
4、 entsusted to Technical Committee Cw2, Hypodermic equipment, which has the responsibility to: - aid enquirers to understand the text, - present to the responsible internatio - monitor related international and European developments and promulgate them in the UK. A list of organizations represented o
5、n this committee can be obtained on request to its secretary. Cross-references Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex which lists normative references to intedonal publications with their corresponding European publications. The British Standards whic
6、h implement these international or European publications may be found in the BSI Standards Catalogue under the section entitled International Standards Correspondence Index, or by using the Find facility of the BSI Standards Electronic Catalogue. Compliance with a British Standard does not of itself
7、 confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, the EN IS0 title page, the EN IS0 foreword page, the IS0 title page, pages ii to vi, pages 1 to 23, the annex ZA page, an inside back cover and a back cover. Amendments issued sinc
8、e publication Amd.No* I Date I Te* affected COPYRIGHT European Committee for StandardizationLicensed by Information Handling ServicesEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM May 1997 ICs 11.040.20 Descriptors: see IS0 document English version Sterile hypodermic syringes for single use - Par
9、t 1 : Syringes for manual use (IS0 7886-1 : 1993, including Technical Corrigendum 1 : 1995) Seringues hypodermiques steriles, non utilisation manuelle (IS0 7886-1:1993, rutilisables - Partie 1: Seringues pour Rectificatif Technique 1:1995 inclus) Sterile Eimlspritzen fr medizinische Zwecke - Teil 1:
10、 Spritzen zun manuellen Gebrauch (IS0 7886-1:1993, einschlieBlich Technische Korrektur 1 : 1995) 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. The European Standards exist in three of
11、ficial versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its aun language and notified to the Central Secretariat has the same status as the official versions. CEN members arethe national standards bodies of Austria,
12、 Belgiun, Czech Republic, Denmerk, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Ki ngdom . European Comnittee for Standardization Comitb EuropCen de Normalisation Europisches Komitee fr Normung Central Sec
13、retariat: rue de Steturt.36 B-1050 Brlffscls Members. Ref. No. EN IS0 7886-1:1997 E COPYRIGHT European Committee for StandardizationLicensed by Information Handling ServicesEN IS0 7886-1 : 1997 Fomword The text of ,the International Standard from ISO/TC 84 Medical devices for injections of the Inter
14、national Organization for .Standarditation (SO) has been taken over as a European. Standard by the 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
15、 identical text or by endorsement, at the latest by November 1997, and conflicting national standards shall be withdrawn at the latest by November 1997. According to the CENICENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this Euro
16、pean Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard IS0 7886-1 : 1993, including Te
17、chnical Corrigendum 1:1995, has been approved by CEN as a European Standard without any modification. NOTE : Normative references to international publications are listed in annex ZA (normative). COPYRIGHT European Committee for StandardizationLicensed by Information Handling ServicesINTERNATIONAL S
18、TANDARD IS0 7886-1 First edition 1993-1 0-01 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use Seringues hypodermiques st the use of smaller scale numbers for the extra graduation lines; i 0.1 0.2 0.3 0,4 0.5 0.6 0.7 0.8 0.9 1 ml 1 2 ml 1 2 ml 1 2 3 4 5 ml C) d) the use of
19、 shorter graduation lines for the extra graduation lines; the use of a broken line for the optional vertical line of the extra scale length. 10.1.3 The graduation lines shall be of uniform thickness. They shall lie in planes at right angles to the axis of the barrel. 10.1.4 The graduation lines shal
20、l be evenly spaced along the longitudinal axis between the zero gradu- ation line and the line for the total graduated capacity. 10.1.5 When the syringe is held vertically, the ends of all graduation lines of similar length shall be verti- cally beneath each other. 10.1.6 The lengths of the short gr
21、aduation lines on each scale shall be approximately half the length of the long tines. Examples of scales and the numbering of graduation lines are shown in figure2. F S 10 ml 10 20 ml t 10 20 30 ml - - - 10 - - 20 - - 30 - - CO - - SO - - 60 ml NOTE - The vertical line of the scale may be omitted.
22、Not to scale. Figure 2 - Examples of scale graduations 4 COPYRIGHT European Committee for StandardizationLicensed by Information Handling Services10.2 Numbering of scale 10.2.1 The graduation lines shall be numbered at the volume increments given in table l. In addition, the line denoting the nomina
23、l capacity or the lines denot- ing the nominal capacity and the total graduated ca- pacity, if these differ, shall be numbered. Examples of scale numbering are shown in figurez. 10.2.2 When the syringe is held vertically with the conical tip uppermost and with the scale to the front, the numbers sha
24、ll appear vertical on the scale and in a position such that they would be bisected by a prolongation of the graduation lines to which they re- late. The numbers shall be close to, but shall not touch, the ends of the graduation lines to which they relate. 10.3 Overall length of scale to nominal capa
25、city line The overall length of the scale shall be as given in ta- ble l. 10.4 Position of scale When the plunger is fully inserted, that is as near to - graduation line of the scale shall coincide with the - the nozzle end of the barrel as it will go, the zero “ fiducial line on the piston to withi
26、n a quarter of the 1- :E smallest scale interval. 11 Barrel 11.1 Dimensions The length of the barrel shall be such that the syringe than the nominal capacity. has a maximum usable capacity of at least 1 O % more 11.2 Finger grips The open end of the barrel shall be provided with fin- ger grips that
27、shall ensure that the syringe will not roll more than 180“ when it is placed on a flat surface at an angle of lo“ to the horizontal. The finger grips shall be free from flash and sharp edges. Finger grips should be of adequate size, shape and strength for the intended purpose and should enable the s
28、yringe to be held securely during use. 12 Pistonlplunger assembly 12.1 Design The design of the plunger and push-button of the syringe shall be such that, when the barrel is held in one hand, the plunger can be depressed by the thumb of that hand. When tested in accordance with annex B , the piston
29、shall not become detached from the plunger. The plunger should be of a length adequate to allow the piston to traverse the full length of the barrel, but it should not be possible easily to withdraw the plunger completely from the barrel. The projection of the plunger and the configuration of the pu
30、sh-button should be such as to allow the plunger to be operated without difficulty. When the fiducial line of the piston coincides with the zero graduation line, the preferred minimum length of the plunger from the surface of the finger grips nearer to the push-button should be: a) 8 mm for syringes
31、 of nominal capacity up to but excluding 2 ml; b) 9 mm for syringes of nominal capacity of 2 ml up to but excluding 5 ml; c) 12,5 mm for syringes of nominal capacity of 5 ml and greater. 12.2 Fit of piston in barrel When the syringe is filled with water and held verti- cally with first one end and t
32、hen the other end up- permost, the plunger shall not move by reason of its own mass. NOTE 5 A suggested test method and performance cri- teria for the forces required to move the plunger are given in annex G. It is recommended that this test be used to generate data on which to decide whether to mak
33、e this test mandatory in a future revision of this part of IS0 7886. 12.3 Fiducial line There shall be a visible and defined edge serving as the fiducial line at the end of the piston. The fiducial line shall be in contact with the inner surface of the barrel. 13 Nozzle 13.1 Conical fitting The male
34、 conical fitting of the syringe nozzle shall be in accordance with IS0 594-1. If the syringe has a locking fitting, it shall be in ac- cordance with IS0 594-2. 13.2 Position of nozzle on end of barrel 13.2.1 On syringes of nominal capacity up to but not including 5 ml, the syringe nozzle shall t 3 s
35、ituated centrally, .e. it shall be coaxial with the barrel. 5 COPYRIGHT European Committee for StandardizationLicensed by Information Handling Services13.2.2 On syringes of nominal capacity 5 ml and greater, the syringe nozzle shall be situated either centrally or eccentrically. 13.2.3 If the syring
36、e nozzle is eccentric, its axis shall be vertically below the axis of the barrel when the syringe is lying on a flat surface with the scale up- permost. The distance between the axis of the nozzle and the nearest point on the internal surface of the bore of the barrel shall be not greater than 4,5 m
37、m. 13.3 Nozzle lumen The nozzle lumen shall have a diameter of not less than 1.2 mm. 14 Performance 14.1 Dead space When tested in accordance with annex C, the volume of liquid contained in the barrel and the nozzle when the piston is fully inserted shall be as given in table l. 14.2 Freedom from ai
38、r and liquid leakage past piston When tested in accordance with annex D, there shall be no leakage of water past the piston or seal(s1. When tested in accordance with annex B, there shall be no leakage of air past the piston or seal(s), and there shall be no fall in the manometer reading. 15 Packagi
39、ng 15.1 Primary container Each hypodermic syringe shall be sealed in a primary container. The materials of the container should not have detri- mental effects on the contents. The material and de sign of the container should be such as to ensure: a) the maintenance of sterility of the contents under
40、 dry, clean and adequately ventilated storage con- ditions; b) the minimum risk of contamination of the contents during opening of the container and removal of the contents; c) adequate protection of the contents during normal handling, transit and storage; d) that once opened, the container cannot
41、be easily resealed, and it should be obvious that the con- tainer has been opened. 15.2 Secondary container One or more primary containers shall be packaged in a secondary container. The secondary container should be sufficiently robust to protect the contents during handling, transit and storage. O
42、ne or more secondary containers may be packaged in a storage and/or transit container. 16 Labelling 16.1 Primary container The primary container shall be marked with at least the following information: a) a description of the contents, including the nomi- nal capacity and the type of nozzle; b) the
43、word “STERILE”; c) the words “FOR SINGLE USE“ or equivalent (ex- cepting the term ”disposable”); the symbol given in annex H may also be given; d) a warning of solvent incompatibility if necessary, for example “Not to be used with paraldehyde” (see remarks on compatibility given in the Intro- ductio
44、n); e) the lot number, prefixed by the word “LOT”; f) the name, trademark, trade name or logo of the manufacturer or supplier. 16.2 Secondary container The secondary container shall be marked with at least the following information: a) a description of the contents, including the nomi- nal capacity,
45、 the type of nozzle and the number; b) the word “STERILE“; c) the words “FOR SINGLE USE” or equivalent (ex- cepting the term ”disposable”); the symbol given in annex H may also be given; d) a warning to check the integrity of each primary container before use; e) the lot number, prefixed by the word
46、 “LOT”; f) the date (year and month expressed as specified in subclause 5.2.1.1 of IS0 8601:1988) of sterilization (the date of sterilization may be incor- 6 COPYRIGHT European Committee for StandardizationLicensed by Information Handling ServicesSTD-BSI BS EN IS0 788b-1-ENGL L997 m Lb24bb7 Ob41172
47、O82 m EN IS0 7886-1 : 1997 porated in the first several digits of the lot num- b) ber); C) g) the name and address of the manufacturer or supplier; h) information for handling, tation. 16.3 Storage container If secondaw containers are d) storage and transpor- e) f) aackaned in a storaae the lot numb
48、er, prefixed by the word “LOT“; the word “STERILE“; the date of sterilization as specified in 16.2 f); the name and address of the manufacturer or supplier; information for handling, storage and transpor- tation of the contents. container, the storage container shal be marked wkh 16.4 Transport wrap
49、ping at least the following information: If a storage container is not used but the secondary a) a description of the contents as specified in containers are wrapped for transportation, the infor- 16.2 a); rnation required by 16.3 shall either be marked on the wrapping or shall be visible through the wrapping. 7 COPYRIGHT European Committee for StandardizationLicensed by Information Handling ServicesAnnex A (normative) Method for preparation of extracts A.l Principle A.3 Procedure The syringe is filled with water in order to extract A.3.1 FiIl at least three syringe
