INTERNATIONAL
`STANDARD
`
`ISO
`7864
`
`Third edition
`1993-05-15
`
`Sterile hypodermic needles for single use
`
`Aiguilles hypodermiques sleriles, non reut/lisables
`
`;:: C:
`
`O= = C:
`:ii -
`
`Reference number
`ISO 7864:1993(E)
`
`Regeneron Exhibit 1042.001
`
`

`

`ISO 7864:1993(E)
`
`Contents
`
`Page
`
`=
`
`....
`-
`
`1 Scope .... .. .......... ......... ................ ................ .. ... ................................... 1
`
`2 Normative references .. .. . ..... ..... .. ... .. .... .. .. ......... ....... .. ... .. .. ................ 1
`
`3 Nomenclature
`
`........... ........... ................ ...... .............. ,........ ......... .. 1
`
`4 Clean liness
`...... .. .. .. ......... ... ..... .................................... ......... ...... .. 1
`s Limits for acid ity or alkalinity
`
`....... .. ..................... ............ .......... 1
`
`6
`
`lim its for extractab le metals
`
`............. ........................ .............. .. 1
`
`7 Size designation
`
`..... ........... ..... ...... .. ........ ............... .. .................. .. 2
`
`8 Colou r coding
`
`......... , ... ,, ....... ...... ..... ... ... ,,.... .................. ............... 2
`
`9 Needle hub
`
`. ..... .. ....... .. ....... .. .... .. ... .. ............................ . ..... .. ....... .. 2
`
`10 Sheath
`
`.......... ....... ....... .. .. ....... .... ....... ......... ... ....... ... .. ... ... ... .. ... ... .. 2
`
`11 Need le tube
`
`....... ........... ... .................................... ....... ............... 3
`
`12 Need le point
`
`...... .. ... ....... ............ ...... , ................ .. ,...... ............... . 4
`
`13 Performance
`
`...... ................... ... ....... .................. ......... ........ ... ..... 4
`
`14 Packaging
`
`............... ................ , ..... ......... .............. ..... , ...... .......... 5
`
`15 Labelling
`
`,, ... ... ...... ..... .............. , ................. ............. .. . , ..... .. .... ,.... 5
`
`Annexes
`
`A Melhod for preparation of extracls
`
`..... .. .... .. .. ..... .. .... ..... ........... 7
`
`B Example of method for determination of fragment prod uction from
`rubber closures
`.. ..... .. ...... ....... .............. , ..... , .. , ...... . , .................... 8
`
`C Symbol for " do not re-use "
`
`....... ..... .......... .. ...... .. ... .... ... .. ... ...... 10
`
`D Bibliography
`
`..... ....... ... ....... ...... .. .. ........ ............... ............... .. .. ... . 11
`
`tl ISO 1993
`All rights reserved. No part of this publication may be reproduced or utilized in any form
`or by any means, electronic or mechanical, Including photocopying and mlcrornrn, wlttiout
`permission In writing from the publisher.
`International Organization Jor Standardization
`Case Postale 56 • CH-1211 Geneve 20 • Switzerland
`Printed In Switzerland
`
`ii
`
`Regeneron Exhibit 1042.002
`
`

`

`ISO 7864:1993(E)
`
`=
`
`Foreword
`
`ISO (the lnlerna!ionat Organization for Standardization) Is a worldwide
`federation of national standards bodies (ISO member bodies). The work:
`of preparing International Standards is normally carried out through ISO
`technical committees. Each member body interested in a subject for
`which a techni cal committee has been established has the right to be
`represented on that committee. International organizations, govern(cid:173)
`mental and non-governmental, in liaison with ISO, also take part in the
`work. ISO collaborates closely with the in!erna1ional Electrotechnical
`Commission (IEC) on al l matters of electrotechn ical standardization .
`
`Draft International Standards adopted by the technical committees are
`circu lated to the member bodies for voting. Publication as an Inter(cid:173)
`national Standard requires approval by at least 75 % of the member
`bodies casting a vote.
`
`International Standa rd ISO 7864 was prepared by Technical Comm ittee
`ISO/TC 84, Medical devices
`for injections , Sub-Committee SC 1,
`Syringes, needles and intravascu/ar catheters for single use.
`
`second edition
`the
`replaces
`third edition cancels and
`This
`(ISO 7864:1988). of which it constitutes a technical revision.
`
`The major differences between this edition and 1he 1988 edition are as
`follows .
`
`a) Th is International Standard specifies the use of needle tubing com(cid:173)
`ISO 9626. As
`requirements
`for metallic materials,
`plying With
`stiffness , res istance to breakage and resistance to corrosion are
`given in ISO 9626, they have been deleted from this International
`Standard. The preparation of ISO 9626 has also allowed the intro(cid:173)
`duction ot new, smaller outside diameters of needle tubing and of
`tubing of thin- and extra-thin-walled types into this lnternaUonal
`Standard , In order to avoid inh ibiting innova1ion , this International
`Standard no longer recommends combinations of needle diameter
`and length.
`
`b) Additional information and guidance have been introduced on needle
`point geometry and frag mentation properties , and the Jimjted num(cid:173)
`ber of tests for toxicity given i_n the 1988 edition has been replaced
`by an informative annex that lists a significantly greater number of
`re levant biologi.cal tests.
`
`c} This International Standard permits the use on package labell ing of
`the ISO symbol for ''do not re-use ", but continues to require the
`written word. Manufacturers a.re encouraged to use the symbol so
`as to increase familiarity wlth it among purchasers and users.
`
`Annex A forms an integral part of this International Standard. Annexes
`B. C and D are for information only.
`
`iii
`
`Regeneron Exhibit 1042.003
`
`

`

`ISO 7864:1993(E)
`
`Introduction
`
`T.his International Standard covers sterile hypodermic needles intended
`for single use primarily In humans.
`
`- This International Standard does not give requ irements or test methods
`for freedom from biological hazard because international agreement
`upon the methodology and the pass/fail criteria is incomplete. Guidance
`is given
`in
`tests relevant to hypodermic needles
`on biological
`ISO 10993-1 , and it is suggested that manufacturers take th is guidance
`into account when evaluating products. Such an evaluation should in(cid:173)
`clude the effects of the process whereby the need les are sterilized .
`However, national regulat ions may exist in some countries, and these
`will override the guidance in ISO 10993-1.
`
`- Plasttcs materials to be used for t he 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(cid:173)
`vidual ma nufacturers. The materials should be compatible with injection
`fluids included in relevant pharmacopoeiae .
`
`Hypodermic needles specified in this International Standard ate in(cid:173)
`tended for use with hypodermic syringes specined in ISO 595 and
`ISO 7886-1. They will also fit syringes of types 1 and 2 specified in
`ISO 8537.
`
`In some countries, na1ional pharmacopoeiae or government regulations
`are 1egally binding and their requirements may take precedence over
`th is International Standard.
`
`Regeneron Exhibit 1042.004
`
`

`

`INTERNATIONAL STANDARD
`
`ISO 7864:1993(E)
`
`Sterile hypodermic needles for single use
`
`1 Scope
`
`This International Standard specifies requirements
`ror sterile hypodermic needles ror single use of
`nominal outside diameters 0,3 mm and 1,2 mm.
`
`It does not apply to dental needles.
`
`2 Normative references
`
`The following stahdatds contain provisions which,
`through reference In this text, constitute provisions
`of this International Standard. At the time of publi(cid:173)
`cation, the editions indicated were valid . All stan(cid:173)
`to
`dards are subject
`to
`revision, and parties
`agreements based on this International Standard
`are encouraged to investigate the possibility of ap(cid:173)
`plying the most recent editions of the standards in(cid:173)
`dicated below. Members of IEC and ISO maintain
`reg isters of currently va lid International Standards.
`
`ISO 594-1:1986 , Conical fittings with a 6 % (Luer) ta(cid:173)
`per for syringes, needles and certain other med/ca/
`equipment - Part 1: General requirements ,
`
`ISO 594-2:1991, Conical fittings with a 6 % (Luer) ta(cid:173)
`per for syringes, needles and certain other medical
`equipment - Part 2: Loci< fittings.
`
`ISO 3696:1987, Water for analylical laboratory use -
`Specification and test methods.
`
`ISO 8601:1988, Data elements and interchange for(cid:173)
`Information interchange - Representation of
`mats -
`dates and times.
`
`ISO 9626:1991, Stainless steel needle tubing for the
`manufacture of medical devices.
`
`3 Nomencjature
`
`The nomencla1ure ror components of hypodermic
`needles ror single use is shown in figure 1 together
`with the designation for length /; nomenclature for
`needle points is shown in figure 2.
`
`4 Cleanliness
`
`When inspected by normal or corrected-to-normal
`vision without magnification under .an ilfuminance
`of 300 Ix to 700 Ix, the surface of the hypodermic
`needle tube shatl appear free from particles and
`extraneous matter.
`
`When exam ined under x 2,5 magnification, the hub
`socket shall appear free from particles and extrane(cid:173)
`ous matter.
`
`5 Limits for acidity or ._,kallnlty
`
`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.
`
`ISO 6009:1992, Hypodermic needles tor single use -
`Colour coding for identification.
`
`6 Limits for extractable metals
`
`ISO 7886-1:-11, Sterile hypodermic syringes for single
`use - Part 1: Syringes for manual use.
`
`recognized microanalytical
`tested by a
`When
`method,
`for example by an atornic absorption
`
`I} To be published.
`
`1
`
`Regeneron Exhibit 1042.005
`
`

`

`ISO 7864:1993(E)
`
`method, an extract prepared in accordance with an(cid:173)
`nex A shal l, when corrected for the metals content
`of the control Ouid, contain not greater than a com(cid:173)
`bined total of 5 mg/I of lead, tin, zinc and iron. The
`cadm ium content of the extract shall , when cor(cid:173)
`rected for the cadmium content of the control fluid,
`be lower than 0,1 mg/I.
`
`7 Size designation
`
`ance with ISO 6009 applied to the unit conta iner
`and/or part of the needle assembly such as the
`needle hub or the sheath .
`
`9 Needle hub
`
`9.1 Conical fitting
`
`The size of hypodermic needle shall be designated
`by the following :
`
`=
`
`a) lhe nominal outside diameter of the needle tube ,
`expressed in mill imetres;
`
`The conica l socket or the hypoderm ic needle hub
`shall be in accordance with ISO 594-1,
`
`If the hub has a locking fitting. It shal l be In accord(cid:173)
`ance with ISO 594-2.
`
`b) the nominal length of the needle tube, expressed
`in millimetres.
`
`9.2 Colour of hub
`
`The size shall be referred to as "the designated
`metric size " and shaJI be expressed in mill imetres.
`
`The hub shall be made either of pigmented or of
`unpigmented materia l. If plgrnen1ed, the colour shall
`be in accordance with ISO 6009.
`
`EXAMPLE
`
`0,8 X 40
`
`8 Colour coding
`
`The nomina l outside diameter of hypodermic nee(cid:173)
`dles shall be identified by colour coding in accord-
`
`10 Sheath
`
`If a separate needle sheath is provided, it sha ll be
`made either of pigmen1ed or of unplgmented ma(cid:173)
`terial. If pigmented , the colour shall be in accord(cid:173)
`ance with ISO 6009.
`
`1
`
`2
`
`3
`
`4
`
`Key
`
`1
`2
`3
`4
`
`Hub
`Jointing medlum
`Needle tube
`Sheath
`
`Figure 1 - Example of typical hypodermic needle and sheath for single use
`
`2
`
`Regeneron Exhibit 1042.006
`
`

`

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`•J j_::-,,. =-~'J1.1111u I..J1•.lJ
`
`da
`
`d1
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`' t-
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`Co
`
`C2
`
`Bo
`
`82
`
`t
`
`View showing Vlll'lant when primary
`bevel Intersects needle tip
`
`·--·
`
`Neede rotated by llJ'lgl.e GO
`
`Key
`d O outside diameter of needle tube
`d 1 Inside dla.meter of needle tube
`A Point length
`B0 Pr1mn.ry bevel nominal Length Bo• (A-CO )
`8 1 Rlght !Jrllllllry bevel length
`82 Left primary bevel Length
`CO Secandclry bevel nom/no.l length
`C, Right secondary be11el length
`
`A
`
`C 2 Lett secondary bevel length
`a. Primary benl angle
`!II Secondary bevel angle
`(J Tip angle
`81 Right Sl!lconda.ry bevel rctn tlon angle
`8z Lett secondary bevel. rotation angle
`1 Camblned secondlll"y bevel angle
`
`~
`:.i.
`
`CJ>
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`(.)
`
`

`

`ISO 7864:1993(E)
`
`11 Needle tube
`
`11 .1 General
`
`The needle shall be made of tubing in accordance
`with ISO 9626.
`
`11.2 Tolerance.son length
`
`The actual length of the need le tube (see dimension
`I in figure 1) shall equa l the nominal length within the
`= tolerances given in table 1.
`
`needle points shown are of configurations com(cid:173)
`mon ly manufactured: other configurations may be
`equally satisfactory. It may not be necessary to use
`all the dimensions when describing the point con·
`figuration .
`
`The needle point should be designed so as to mini(cid:173)
`mize coreing and fragmentation when penetrating
`vial closures . This International Standard does not
`specify requirements or test methods for these
`properties, but an example of a test method for de·
`termining the production of fragments from rubber
`closures is given in annex B.
`
`Table 1 - Tolerances on length of needle tube
`Dimensions in millimetres
`
`13 Performance
`
`Nominal length of needle
`tube
`
`Tolerance
`
`13.1 Bond between hub and needle tube
`
`< 25
`
`25 to 39
`
`40
`
`>40
`
`+1
`-2
`
`+1,5
`- 2,5
`
`Q
`-4
`
`+1,5
`-t5
`
`The union of the hub and needle tube shall not be
`broken by the minimum force given in table 2 ap(cid:173)
`plied as push or pull in 1he direction of the needle
`axis.
`
`Table 2 - Force to test bond between hub and
`needle tube
`
`11.3 Freedom from defects
`
`When examined by normal or corrected vision, the
`needle tube shall appear straight and of regular
`cross-section and wall thickness.
`
`11 .4 Lubricant
`
`If the hypoderm ic need le tube is lubricated, the
`lubricant shall not be visible, under normal or cor(cid:173)
`rected vision, as droplets of fluid on the outside or
`inside surfaces of the needle tube.
`
`NOTE 1 An acceptable lubricant, applied undiluted, is
`polydimethylsiloxane complying with a national or the
`European pharmacopoeia,. The quantily of lubricant used
`should not exceed 0,25 mg per square centimetre of the
`surface area of the needle tut)e,
`
`12 Needle point
`
`When examined under x 2,5 magnification , the nee(cid:173)
`dle point sha ll appear sharp and free from feather
`edges, burrs and hooks.
`
`NOTE 2 The needle point usually has a bevel with a
`(11 ± 2) 0
`primary bevel angle of
`in
`(as
`illustrated
`figure 2). but a ''short" bevel with other angle, e,g.
`(17 ± 2)°, may be provided.
`
`The designation of needle point dimensions and the
`nomenclature used to describe the dimensions and
`features is shown for information In figure 2. The
`
`4
`
`Nominal outside diameter
`of needle
`
`mm
`
`0,3
`0,33
`0,36
`0,4
`0,45
`0,5
`0,55
`0,6
`0,7
`0,8
`0,9
`1,1
`1,2
`
`Force
`
`min.
`
`N
`
`22
`22
`22
`22
`22
`22
`34
`34
`40
`44
`54
`69
`69
`
`13.2 Patency of lumen
`
`The patency of the lumen shall be such that either
`
`a) a stainless steel stylet of the appropri ate diam(cid:173)
`eter se lected from the diameters given in table 3
`sha ll pass through the needle; or
`
`b) the rate of flow of water through the needle Un·
`der a hydrostatic pressure not exceeding
`
`Regeneron Exhibit 1042.008
`
`

`

`ISO 7864:1993(E)
`
`1 x 105 Pa 2J shall be not less than 80 % of that of
`a needle of equ ivalent outside dfameter and
`length having a minimum inside diameter in ac(cid:173)
`cordance with ISO 9626 when tested under the
`same pressure.
`
`d) that once opened , the container cannot be easily
`resealed, and it should be obvious that the con(cid:173)
`ta iner has been opened.
`
`14.2 Secondary container
`
`Table 3 - Size of slylet to test patency of lumen
`Dimensions In milllrnetres
`
`One or more pri mary containers shall be packaged
`in a secondary container.
`
`Nominal
`outside
`diameter of
`needle
`
`Diameter of stylet
`0
`-D,01
`
`for needle
`of normal-
`walled
`tubing
`
`for needle
`of
`thin-walled
`tubing
`
`for needle
`of
`extra-thin-
`walled
`tubing
`
`The secondary container should be sufficiently ro(cid:173)
`bust to protect the contents during handlftig, transit
`and storage.
`
`One or more secondary containers may be pack(cid:173)
`aged in a storage and/or a transit container.
`
`0,3
`0,33
`0,36
`0,4
`0,45
`0,5
`0,55
`0,6
`0.7
`0,8
`0,9
`1, 1
`1,2
`
`0,11
`0, 11
`0,11
`0,15
`0,18
`0,18
`0,22.
`0,25
`0,30
`0,40
`0,48
`0,58
`0,70
`
`0,13
`0,15
`0,15
`0,19
`0,23
`0,23
`0,27
`0,29
`0,35
`0,42
`0,49
`0,60
`0,73
`
`-
`
`-
`-
`-
`-
`-
`-
`0,30
`0,37
`0,44
`0,50
`0,68
`0,83
`
`14 Packaging
`
`14.1 Primary container
`
`Each hypodermic needle shall be sealed in a pri(cid:173)
`mary container. ihe material and design of this
`container shall be such as to ensure that the colour
`coding of the contents is visible.
`
`The materials of the container should not have det(cid:173)
`rimental elfects on the contents. The materlals and
`design of this container should be such as to ensure
`
`a) the maintenance or sterility of the contents under
`dry, clean and adequately ventilated storage
`conditions;
`
`b) the minimum risk of contamination of the con(cid:173)
`tents during removal from the container;
`
`c) adequate protection of the contents during
`normal handling. transit and storage;
`
`2) 1 standard atmosphere (aim) = 101 325 Pa
`1 technical atmosphere (all = 98 066 ,5 Pa
`
`15 Labelling
`
`15.1 Primary container
`
`The primary container shall be marked with at least
`the following inrormation:
`
`a) a description of the contents, including the des-
`ignated metric size in accordance with ciause 7;
`
`b)
`
`the word "STERILE";
`
`c)
`
`the lot number, prefixed by the word " LOT";
`
`d) the name or trade-mark or trade-name or logo
`or the manufacturer or supplier.
`
`15.2 Secondary container
`
`The secondary container shall be marked with at
`least the following informat ion:
`
`a) a description of the contents, including the des(cid:173)
`ignated metric size in accordance with clause 7,
`the number, the type or angle or bevel (see
`clause 12) and, if appropriate, the words ''thtn(cid:173)
`walled" or "extra-thin-walled " or equivalent or
`an abbreviation;
`
`b) the word "STERILE" ;
`
`c)
`
`the words "FOR SINGLE USE" or equivalent (ex(cid:173)
`cepting the term "disposable '');
`
`NOTE 3 The symbol given In annex C may ad-
`ditionally be given.
`
`d) a warning to check th e integrity of each primary
`container before use;
`
`e) the lot number. prefixed by the word "LOT" :
`
`5
`
`Regeneron Exhibit 1042.009
`
`

`

`ISO 7864:1993(E)
`
`f)
`
`the date (year and month expressed as specified
`subdause 5.2.1.1 of
`ISO 8601: 1988) of
`in
`sterilization ;
`
`b) the lot number, prefixed by the word "LOT":
`
`c)
`
`the word "STERILE":
`
`NOTE 4 The date or sterilization may be incorpor(cid:173)
`ated in the first several digits of the lot number.
`
`d) the date of sterilization as specified in 15.2 f) :
`
`g) the name and address of the manufacturer or
`supplier,
`
`h) information for handling, storage and transpor·
`talion .
`
`15.3 Storage container
`
`If secondary containers are packaged in a storage
`- container, the storage container sha ll be marked
`with at least t.he following information:
`
`a) a description of the contents as specified in
`15.2 a);
`
`e) the name and address of the manufacturer or
`supplier;
`
`f)
`
`information for handling, storage and transpor(cid:173)
`tation of the contents.
`
`15.4 Transport wrapping
`
`If a storage container is not used but the secondary
`containe rs are wrapped for transportation, the in·
`formation required by 15.3 shall either be marked
`on the wrapping or shall be visible through the
`wrapping .
`
`6
`
`Regeneron Exhibit 1042.010
`
`

`

`ISO 7864:1993(E)
`
`Annex A
`(normative)
`
`Method for preparation of extracts
`
`A.1 Principle
`
`A.3 Procedure
`
`The needle, including the inside of the needle tube ,
`is immersed in water In order to extract soluble
`components.
`
`A.2 Apparatus and reagents
`
`A.2.1 Freshly distilled or deionized water, of grade
`3 in accordance with ISO 3696.
`
`Immerse 25 needles in 250 ml or water
`A.3.1
`from
`containet made
`(A.2.1)
`in
`a
`suitable
`boros ilicate glass (A.2.2) . Ensure that all surfaces of
`the needles, including the inside of the needle tube ,
`are in contact with the water. Maintain the water at
`a temperature of (37 +~) •c for (60 ± 2) min . Re(cid:173)
`move the needles and ensure that all water from the
`inside and outside su rfaces of the needles is re(cid:173)
`turned to !he container.
`
`A.2.2 Selection of laboratory borosilicate glass(cid:173)
`ware.
`
`A.3.2 Prepare the conlrol fluid by following the
`procedure given in A.3.1 but omitling the needles.
`
`7
`
`Regeneron Exhibit 1042.011
`
`

`

`ISO 7864:1993(E)
`
`Anne>< B
`(informative)
`
`Example of method for determinatioh of fragment production from rubber closures
`
`B.1 Principle
`
`=
`
`Penetration or ISO rubber closures for injection vials
`by the needle, and collection and counting or t he
`fragments generated by t he penetrations. Because
`the number of fragments generated is affected by
`variables of needle desig n, each type of needle to
`be tested is compared with the performance of a
`reference needle.
`
`B.2.8 Distilled or deionized water, of grade 3 in ac(cid:173)
`cordance with ISO 3696 .
`
`8.3 Procedure
`
`8 .3.1 Place n m I of water (B.2 .8)
`into th e vial
`(B .2.1), where n is 50 % of the nominal capacity of
`the vial .
`
`B.2 Apparatus and reagents
`
`Injection vials , in accordance Wi1h ISO 8362·1
`B.2.1
`or ISO 8362-4.
`
`B.3.2 Place a closure (B.2.2) on the via l and seal
`with an aluminium cap (B.2.3) us ing the hand(cid:173)
`operaled ca pping device (B.2.4). Inspect the vial by
`normal or corrected-to-normal vision for the pres(cid:173)
`ence or fragments , and discard any vial in which
`rubber fragments are vis ible.
`
`closures,
`B.2.2 Rubber
`ISO 8362-2, as .follows:
`
`in
`
`accordance with
`
`B.3.3 Fill the syringe (B.2.6) with water (B .2.8) . At(cid:173)
`tach a reference needle to the syringe and remove
`any water from the outside of the needle tube.
`
`Type A, nom inal size 20
`
`Hardness; 40 IRHD
`
`Base elastome r: Halogenated butyl.
`
`caps 1
`8 .2.3 Alumlnlmn
`accordance with
`in
`1SO 8362-3, having a central hole , to fit the injection
`vials (8.2.1 ).
`
`B.2.4 Hand-operated capping device, suitable for
`vials (B.2.1) and caps (B.2.3).
`
`B.2.5 Membrane filter, of pore size 5 µm, and filter
`holder.
`
`8.3.4 Place the via l vertically and , holding lhe
`syringe vertically , pierce the closure.
`
`8.3.5
`Inject 2 rnl of water into the vial , and with(cid:173)
`draw the needle from the vial Remove the needle
`from ttie syringe and replace It with a fresh refer(cid:173)
`ence need le. Remove any water from the outside of
`the needle tu be.
`
`B.3.6 Repeat B.3.4 and B.3.5 for a total of five
`penetrations, choosing a different area of the clo(cid:173)
`sure each time.
`
`8.2.6 Hypodermic ,yringe, of 10 ml nominal ca·
`pacity In accordance with ISO 7886-1 .
`
`B.3.7 Repeal 8.3.3 to B.3.6 on a total of five vials,
`i.e. 25 reference needles and 25 penetrations In all.
`
`B.2.7 Rererence needles1 of the same nominal out(cid:173)
`side diameter of the type of needle to be tested, and
`having a nom inal value of ix (see figure 2) of 13° .
`
`8 .3.8 Repeat 8 .3.3 to 8 .3 7, using 25 needles of the
`type to be tested.
`
`8
`
`Regeneron Exhibit 1042.012
`
`

`

`ISO 7864:1993(E)
`
`8.3.9 Remove the closure from the five vials from
`B.3.7 and fi lter the contents through the membrane
`fllter (B.2.5) . Ensure that no fragments remain in the
`vial.
`
`a) th.e numbe r of fragments generated by the refer(cid:173)
`ence needles, as counted in 8.3 .11;
`
`b) the number of fragments generated by the type
`of needle tested, as counted in 8.3.11 ;
`
`B.3.10 Repeat B.3.9 on the five vials from B.3.8,
`using a second membrane filter.
`
`c)
`
`the date of testing.
`
`B.3.11 Count and record the number or fragments
`on each filter visible with norma l or corrected vision
`without magnification, the distance between the eye
`and the filter being (250 ± 5) mrn.
`
`8.5 Validity
`
`B.4 Test report
`
`The test report shall contain a1
`information:
`
`least the following
`
`Consider the resu lts obtained from the test needles
`to be invalid if the results from the reference nee(cid:173)
`dles lack consistency with previous results. Deter(cid:173)
`mine the reasons for the Inconsistency.
`
`9
`
`Regeneron Exhibit 1042.013
`
`

`

`ISO 7864:1993(E)
`
`Annex C
`(informative)
`
`Symbol for "do not re-use"
`
`C.1 General
`
`=
`
`The ISO symbol to denote equi pment Intended for
`single use
`is
`ISO symbol registration number
`ISO 7000/1051 , given in ISO 7000:1989.
`
`Further information on design, dimensions and
`NOTE 5
`application of ISO symbols is given in ISO 3461 .
`
`C.2 Original design
`
`Symbol ISO 7000/1051 is shown in figure C.1 .
`
`The thickness or the lines is 2 mm . Dirnensioh a is
`the nominal size of the original design of all ISO
`symbols and is normally made equal to 50 mm. In
`many cases, including ISO 7000/1051 , the actua l di(cid:173)
`:me-nsi'on differs slightly, and the outside diameter of
`
`the circle (dimension It) of the original design Is
`1,1 6 a, i.e. 58 mm.
`
`No colour is specified in ISO 7000 or in this Inter(cid:173)
`national Standard for symbol 1051 .
`
`C.3 Reduction and enlargement of
`original design
`
`For the app lication of the symbol it may be neces(cid:173)
`sary to reduce or enlarge the srze of the orig inal to
`a suitable size at wh ich it w ill actually appear. The
`nominal dimension a should be used as a gauge .
`Practice has shown that a may be reduced to 3 mm
`without the sym bol losing its legibility . However, the
`legibility of the symbol when reduced In size shou ld
`be checked.
`
`L
`
`_J
`
`NOTE - The visual centring lines do nol form part of the syrnbol.
`
`Figure C.1 -
`
`ISO symbol for "do not re-use'', number ISO 7000/1051
`
`10
`
`Regeneron Exhibit 1042.014
`
`

`

`ISO 7864:1993(E)
`
`Annex D
`(informative)
`
`Bibliography
`
`[1] ISO 595-1:1986, Reusable all-glass or metal(cid:173)
`and-gfass syringes for medical use - Part f:
`Dimensions.
`
`for
`containers
`Injection
`[6 ] ISO 8362-1:1 989,
`in]ectables and accessories - Part 1: Injection
`vials made of glass tubing.
`
`[2] ISO 595-2: 1987, Reusable all-glass or meta/(cid:173)
`and-glass syringes for medical use - Part 2:
`Design, performance requirements and tests.
`
`[7] ISO 8362-2:1988 ,
`for
`containers
`Injection
`injec!ab/es and accessories - Part 2: Closures
`for injection vials ,
`
`the
`for
`[3] ISO 3461-1:1988, General principles
`Part 1:
`-
`creation of graphical symbols
`Graphical symbols for use on equipment.
`
`[8] ISO 8362-3:1989 ,
`Injection
`injeclables and accessories
`minium caps for injection vials.
`
`for
`containers
`Part 3: Alu-
`
`[4] ISO 3461 -2:1987, General principles for the
`creation of graphical symbols
`-
`Part 2:
`Graphical symbols for use in technical product
`documentation.
`
`[5] ISO 7000:1989, Graphical symbols for use on
`equipment -
`Index and synopsis.
`
`[9] ISO 8362-4:1 989,
`for
`containers
`Injection
`injectab/es and accessories - Part 4: Injection
`vials made of moulded glass.
`
`[ 1 OJ ISO 8537:1991, Sterile single-use syringes, with
`or without needle, for insulin .
`
`[ 11] ISO 10993-1.: 1992, Biological evaluation of
`medical devices - Part 1: Guidance on se(cid:173)
`lection of tests.
`
`11
`
`Regeneron Exhibit 1042.015
`
`

`

`ISO 7864:1993(E)
`
`UDC 615.473.2.014.45
`De$Crlplor$: medica l equipment, hypodermic needles, specifications, di mensions,
`labelling.
`
`Price based on 11 pages
`
`tes ts, designation, colour marking, packaging,
`
`Regeneron Exhibit 1042.016
`
`