INTERNATIONAL
`
`STANDARD
`
`ISO
`
`7864
`
`Third edition
`1993-05-15
`
`
`
`Sterile hypodermic needles for single use
`
`Aiguiiies hypodermiques sfériies, nan réuriiisabies
`
`ii
`E¥
`E
`H1
`=7
`3
`E
`a
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`
`1F”‘Illlliilm
`
`Reference number
`ISO 7864:1993(E‘,
`
`Regeneron Exhibit 1042.001
`
`

`

`ISO 7864:1993{E)
`
`Contents
`
`Page
`
`1
`
`Scope .................................................................................................
`
`2 Normative references .......................................................................
`
`3 Nomenclature
`
`..............................................................................
`
`4 Cleanliness
`
`..................................................................................
`
`5
`
`6
`
`1
`
`Limits for acidity or alkalinity
`
`....................................................
`
`Limits for extractable metals
`
`...................................................
`
`Size designation
`
`..........................................................................
`
`8 Colour coding
`
`.................................................... :......................
`
`9 Needle hub
`
`..................................................................................
`
`10
`
`Sheath
`
`........................................................................................
`
`11 Needle tube
`
`...............................................................................
`
`12 Needle point
`
`..............................................................................
`
`13
`
`Performance
`
`..............................................................................
`
`14
`
`15
`
`Packaging
`
`..................................................................................
`
`Labelling
`
`....................................................................................
`
`1
`
`1
`
`1
`
`1
`
`1
`
`1
`
`2
`
`2
`
`2
`
`2
`
`3
`
`4
`
`4
`
`5
`
`5
`
`Annexes
`
`A Method for preparation of extracts
`
`..........................................
`
`T
`
`B
`
`c
`
`D
`
`Example of method for determination of fragment production from
`rubber closures
`..........................................................................
`B
`
`Symbol for "do not re—use"
`
`.....................................................
`
`10
`
`Bibliography
`
`..............................................................................
`
`11
`
`1993
`to use
`All rights reserved. No part of this publication mayr be reproduced or utilized in any form
`or by any means, electronic or mechanical. including photocopylng and microfilm, without
`permission In writing from the publisher.
`International Organization for Standardization
`Case Postale 56 0 CH-1211 Geneva 20 4' Switzerland
`Printed In Switzerland
`
`Regeneron Exhibit 1042.002
`
`

`

`ISO 7854:1993lE)
`
`Foreword
`
`ISO {the international 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 technical committee has been established has the right to be
`represented on that committee.
`International organizations. govern-
`mental and non-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 for voting. Publication as an Inter-
`national Standard requires approval by at least 'r'5 “/9 of the member
`bodies casting a vote.
`
`International Standard ISO 7864 was prepared by Technical Committee
`ISOITC 84. Medical devices
`for
`injections, Sub-Committee SC 1.
`Syringes. needles and intravascular catheters for single use.
`
`second
`the
`replaces
`and
`cancels
`edition
`third
`This
`(ISO Y354:1983], of which it constitutes a technical revision.
`
`edition
`
`The major dilferences betwaen this edition and the 1988 edition are as
`follows.
`
`a) This international Standard specifies the use of needle tubing com-
`plying with lSO 9525. As
`requirements
`for metallic materials.
`stillness, resistance to breakage and resistance to corrosion are
`given in ISO 9626,
`they have been deleted from this International
`Standard. The preparation of ISO 9826 has also allowed the intro-
`duction of new, smaller outside diameters of needle tubing and of
`tubing of thin- and extra-thIn-walled types into this international
`Standard.
`In order to avoid inhibiting innovation, 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 fragmentation properties. and the limited num-
`ber of tests for toxicity given in the 1988 edition has been replaced
`by an informative annex that lists a significantly greater number of
`relevant biological tests.
`
`c} This International Standard permits the use on package labelling of
`the ISO symbol for “do not re—use". but continues to require the
`written word. Manufacturers are encouraged to use the symbol so
`as to increase familiarity with it among purchasers and users.
`
`Annex A forms an integral part of this International Standard. Annexes
`B, C and D are for information only.
`
`Regeneron Exhibit 1042.003
`
`

`

`ISO 7364:1993isi
`
`Introduction
`
`This International Standard covers sterile hypodermic needles intended
`for single use primarily In humans.
`
`This international Standard does not give requirements or test methods
`for freedom from biological hazard because international agreement
`upon the methodology and the passffail criteria is incomplete. Guidance
`on biological
`tests relevant
`to hypodermic needles
`is given in
`ISO 10993-1, and it is suggested that manufacturers 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 ISO 10993-1.
`
`Plastics materials 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 pharmacopoeiae.
`
`Hypoderrnic needles specified in this International Standard are in-
`tended for use with hypodermic syringes specified in ISO 595 and
`ISO 7386-1. They will also fit syringes of types 1 and 2 specified in
`ISO 3537.
`
`In some countries, national pharmacopoeiae or government regulations
`are legally binding and their requirements may take precedence over
`this International Standards
`
`iv
`
`Regeneron Exhibit 1042.004
`
`

`

`
`
`INTERNATIONAL STANDARD
`ISO 7864:1993(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.
`
`It does not apply to dental needles.
`
`2 Normative references
`
`The following standards contain provisions which,
`through reference in this text, 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 editions of the standards in~
`dicated below. Members oi [EC and ISO maintain
`registers of currently valid International Standards.
`
`ISO 5944:1986, Conical fittings with a 6 ”/3 {Liter} ta-
`per lor syringes, needles and certain other medical
`equipment -— Part
`t: General requirements.
`
`150 594-21991, Conical fittings with a 6 9-6 (Luerl ta-
`per for syringes, needles and certain other medical
`equipment — Part 2: Lock fillings.
`
`ISO 3696:1987, Water for analytical laboratory use —
`Specification and test methods.
`
`iSO 8801:1988, Data elements and interchange lor-
`mats — information interchange — Representation of
`dates and times.
`
`ISO 9626:1991, Stainless steel needle tubing for the
`manufacture or medical devices.
`
`3 Nomenclature
`
`The nomenclature for components of hypodermic
`needles for single use is shown in figuret together
`with the designation for length l; nomenclature for
`needle points is shown in Figure 2.
`
`4 Cleanliness
`
`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 3:: 2.5 magnification, the hub
`socket shall appear free from 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.
`
`lSC} 6009:1992, Hypodermic needles for single use a-
`Colour coding for identification.
`
`6 Limits for extractable metals
`
`ISO 7886-1:-—". Sterile hypodermic syringes for single
`use — Part 1: Syringes for manual use.
`
`recognized microanalytical
`a
`When tested by
`method.
`[or example by an atomic absorption
`
`I) To be published.
`
`Regeneron Exhibit 1042.005
`
`

`

`ISO recanssats)
`
`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 mgll of lead. tin, zinc and iron. The
`cadmium content of the extract shall. when cor-
`rected for the cadmium content of the control fluid,
`be lower than 0.1 mgll.
`
`7 Slze designation
`
`ance with ISO 3009 applied to the unit container
`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:
`
`The conical socket oi the hypodermic needle hub
`shall be in accordance with ISO 594-1.
`
`a)
`
`the nominal outside diameter of the needle tube,
`expressed in millimetres;
`
`If the hub has a locking fitting,
`ance with ISO 594-2.
`
`it shall be in accord
`
`b} the nominal length ofthe needle tube, expressed
`in millimetres.
`
`9.2 Colour of hub
`
`The size shall be referred to as “the designated
`metric size" and shall be expressed in millimetres.
`
`The hub shall be made either of pigmented or of
`unpigmented material. prigmented, the colour shall
`be in accordance with ISO 8009.
`
`EXAMPLE
`
`0.8x40
`
`8 Colour coding
`
`The nominal outside diameter or hypodermic nee-
`dles shall be identified by colour coding in accord-
`
`10 Sheath
`
`it shall be
`If a separate needle sheath is provided,
`made either of pigmenied or of unpigmented ma-
`terial.
`If pigmented the colour shall be in accord-
`ance with lSO 6009.
`
`
`
`Key
`
`1
`2
`3
`4
`
`Hub
`Jolntlng medium
`Needle tube
`Sheath
`
`Figure 1 — Example at typical hypodermic needle and sheath for single use
`
`2
`
`Regeneron Exhibit 1042.006
`
`

`

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`
`Figure 2 — Designation oi dimensions and nomenclature of needle paint geometry (see clause 12}
`
`Regeneron Exhibit 1042.007
`
`
`

`

`Iso 1364:1993(E)
`
`1 1 Needle tube
`
`11.1 General
`
`The needle shall he made of tubing in accordance
`with ISO 9626.
`
`11.2 Tolerances on length
`
`The actual length ofthe needle tube (see dimension
`{in figure 1) shall equal the nominal length within the
`tolerances given in table 1.
`
`needle points shovm are of configurations com-
`monly manufactured: other configurations may be
`equally satisfactory. it may not be necessary to use
`all the dimensions when describing the point con-
`figurafion.
`
`The needle point should be designed so as to mini-
`mize coming and fragmentation when penetrating
`vial closures. This International Standard does not
`
`these
`specify requirements or test methods for
`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
`
`1 3 Performance
`
`Tolerance
`
`Nominal length of 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
`
`the
`if the hypodermic needle tube is lubricated,
`lubricant shall not be visible. under normal or cor-
`rected vision. as droplets of fluid on the outside or
`inside surfaces of the needle tube.
`
`is
`An acceptable lubricant, applied undiluted,
`NOTEl
`polydimelhyisiloxane complying with a national or the
`European pharmacopoeia. The quantity of lubricant used
`should not exceed 0.25 mg per square centimetre of the
`surface area of the needle tube.
`
`12 Needle point
`
`When examined under N 2,5 magnification. the nee-
`dle point shall appear sharp and free from feather
`edges, burrs and hooks.
`
`The needle point usually has a bevel with a
`NOTE2
`primary bevel angle of
`(11 $3" (as
`illustrated in
`figure2}. but a “short" bevel with other angle, eg.
`(1? :l_- 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
`
`13.1 Bond between hub and needle tube
`
`The union of the hub and needle tube shall not be
`broken by the minimum force given in table2 ap—
`plied as push or pull
`in the direction of the needle
`axis.
`
`Table 2 - Force to test bond between hub and
`needle tube
`
`Nominal outside diameter
`of needle
`
`
`
`13.2 Patency of lumen
`
`The patency of the lumen shall be such that either
`
`a) a stainless steel stylet of the appropriate diam-
`eter selected from the diameters given in table3
`shall pass through the needle; or
`
`b} the rate of flow of water throUQh the needle un-
`der
`a
`hydrostatic pressure
`not
`exceeding
`
`Regeneron Exhibit 1042.008
`
`

`

`ISO 7864:1993(E)
`
`1 x 105 Pa” shall be not less than 80 % of that of
`a needle of equivalent outside diameter and
`length having a minimum inside diameter in ac-
`cordance with ISO 9528 when tested under the
`same pressure.
`
`d} that once opened. the container cannot be easily
`rescaled. and it should be obvious that the con-
`tainer has been opened.
`
`14.2 Secondary container
`
`Table 3 — Size of style! to test patency of lumen
`Dimensions in millimetres
`
`One or more primary containers shalt be packaged
`in a secondary container.
`
`Diameter of stylet
`a
`"’4"
`
`for needle
`oi normal-
`walled
`tubing
`
`for needle
`of
`thin-walled
`
`for needle
`of
`extra-thin-
`walled
`tubing
`
`Nominal
`outside
`diameter of
`needle
`
`‘
`
`tubing
`
`The secondary container should be sufficiently ro-
`bust to protect the contents during handling, transit
`and storage.
`
`One or more secondary containers may be pack-
`aged in a storage andfor a transit container.
`
`15 Labelling
`
`15.1 Primary container
`
`The primary container shall be marked with at least
`the following information:
`
`a) a description of the contents, including the des-
`ignated metric size in accordance with clause 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
`of the manufacturer or supplier.
`
`15.2 Secondary container
`
`The secondary container shall be marked with at
`least the following information:
`
`a) a description of the contents. including the des-
`ignated metric size in accordance with clause 7,
`the number,
`the type or angle of bevel (see
`clause 12) and.
`if appropriate, the words "thin-
`walied" or “extra—thin-wailed" or equivalent or
`an abbreviation:
`
`b)
`
`the word “STERiLE";
`
`c)
`
`the words "FOR SINGLE USE“ or equivalent {ex-
`cepting the term ”disposable");
`
`The symbol given in annex C may ad-
`NOTES
`ditionally be given.
`
`d) a warning to check the integrity of each primary
`container before use;
`
`14 Packaging
`
`14.1 Primary container
`
`Each hypodermic needle shall be sealed in a pri-
`mary container. The 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-
`rimental effects on the contents. The materials and
`design of this container should be such as to ensure
`
`a} the maintenance oi sterility oi the contents under
`dry, clean and adequately ventilated storage
`conditions;
`
`b} the minimum risk of contamination of the con-
`tents during removal from the container;
`
`the contents during
`c) adequate protection of
`normal handling. transit and storage;
`
`9)
`
`the lot number. prefixed by the word "LOT":
`
`2]
`
`1 standard atmosphere (aim) = 101 325 Pa
`
`1 technical atmosphere (an = 98 066.5 Pa
`
`Regeneron Exhibit 1042.009
`
`

`

`ISO 7354:1993(E)
`
`i}
`
`the date (year and month expressed as specified
`in
`sot-clause
`5231.1
`of
`ISO 8601:1933)
`of
`sterilization;
`
`b} the lot number, prefixed by the word "LOT“;
`
`c)
`
`the word "STERILE":
`
`The date of sterilization may be incorpor-
`NOTE4
`ated in the first several digits of the lot number.
`
`d} the date of sterilization as specified in 15.2 f);
`
`9}
`
`the name and address of the manufacturer or
`suppflen
`
`h)
`
`information for handling. storage and transpor-
`tation.
`
`e} the name and address of the manutacturer or
`supplier:
`
`f}
`
`information for handling. storage and transpor-
`tation of the contents.
`
`15.3 Storage container
`
`If secondary containers are packaged in a storage
`container,
`the storage container shall be marked
`with at least the following information:
`
`a) a description of the contents as specified in
`15.2 a};
`
`15.4 Transport wrapping
`
`If a storage container is not used but the secondary
`containers 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.
`
`Regeneron Exhibit 1042.010
`
`

`

`lSO 1364:1993(E)
`
`Annex A
`
`(normative)
`
`Method tor preparation of extracts
`
`A.1
`
`Principle
`
`131.3 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 of water
`A.3.1
`in
`a
`suitable
`container made
`from
`(9.2.1)
`borosilicate glass {A22}. 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 oi {37 *3] “C for (60¢ 2) min. Re-
`move the needles and ensure that all water from the
`inside and outside surfaces of the needles is re-
`turned to the container.
`
`A.2.2 Selectinn of
`ware.
`
`laboratory boroslllcate glass-
`
`fluid by following the
`A.3.2 Prepare the control
`procedure given in A.3,1 but omitting the needles.
`
`Regeneron Exhibit 1042.011
`
`

`

`ISO 7864:1993(E)
`
`Annex B
`
`(informative)
`
`Example of method for determination of fragment production from rubber closures
`
`3.1
`
`Principle
`
`3.2.8 Distilled or deionized water. of grade 3 in ac~
`cordance with ISO 3596.
`
`Penetration of ISO rubber closures for injection vials
`by the needle. and collection and counting of the
`fragments generated by the penetrations. Because
`the number of fragments generated is affected by
`variables of needle design. each type of needle to
`be tested is compared with the performance of a
`reference needle.
`
`3.3 Procedure
`
`into the vial
`Place a ml of water (3.2.3)
`3.3.1
`{3.2.1}. where n is 50 % of the nominal capacity of
`the vial.
`
`3.2 Apparatus and reagents
`
`Injection vials, in accordance with ISO 8362-1
`3.2.1
`or ISO 8362-4.
`
`5.3.2 Place a closure (3.2.2) on the vial and seal
`with an aluminium cap {32.3) using the hand-
`operated capping device (3.2.4). Inspect the vial by
`normal or corrected-to-normal vision for the pres-
`ence of fragments. and discard any vial
`in which
`rubber fragments are visible.
`
`closures,
`3.2.2 Rubber
`[30 3382-2, as follows:
`
`in
`
`accordance with
`
`3.3.3 Fill the syringe {3.2.5} with water (3.2.8). At-
`tach a reference needle to the syringe and remove
`any water from the outside of the needle tube.
`
`Type A, nominal size 20
`
`Hardness: 40 IRHD
`
`Base elastomer. Halogenated butyl.
`
`3.3.4 Place the vial vertically and, holding the
`syringe vertically, pierce the closure.
`
`with
`accordance
`in
`3.2.3 Aluminium caps,
`lSO 8362—3, having a central hole. to fit the injection
`vials (3.2.1).
`
`3.3.5 Inject 2 ml of water into the vial; and with-
`draw the needle from the vial. Remove the needle
`from the syringe and replace it with a fresh refer-
`ence needle. Remove any water irorn the outside of
`the needle tube.
`
`3.2.4 Hand-operated capping device. suitable for
`vials {3.2.1} and caps (3.2.3).
`
`3.2.5 Membrane filter. of pore size 5 pm. and filter
`holder.
`
`3.3.6 Repeat 3.3.4 and 3.3.5 for a total of five
`penetrations. choosing a ditterent area of the clo-
`sure each time.
`
`3.2.6 Hypoderrnlc syringe, of 10 ml nominal ca~
`pacity in accordance with ISO 7336-1.
`
`5.3.? Repeat 3.3.3 to 3.3.6 on a total of five vials.
`is. 25 reference needles and 25 penetrations in all
`
`3.2.? Relerence needles. of the same nominal out-
`side diameter or the type 0t needle to be tested, and
`having a nominal veins of (it. {see figure 2) of 13°.
`
`3.3.8 Repeat 3.3.3 to 3.3.7. using 25 needles ofthe
`type to be tested.
`
`Regeneron Exhibit 1042.012
`
`

`

`lSO 7854:1993(E)
`
`3.3.9 Remove the closure from the five vials from
`3.3.? and filter the contents through the membrane
`filter (3.2.5). Ensure that no fragments remain in the
`vial.
`
`a)
`
`b)
`
`the number of fragments generated by the refer-
`ence needles, as counted in 33.11;
`
`the number of fragments generated by the type
`of needle tested. as counted in 3.3.11;
`
`3.3.10 Repeat 8.3.9 on the live vials trom B.3.B.
`using a second membrane filter.
`
`c]
`
`the date of testing.
`
`3.3.11 Count and record the number of fragments
`on each filter visible with normal or corrected vision
`without magnification. the distance between the eye
`and the filter being (250 i 5) mm.
`
`5.5 Validity
`
`3.4 Test report
`
`The test report shall contain at least the following
`information:
`
`Consider the results obtained from the test needles
`to be invalid if the results from the reference nee-
`
`dles lack consistency with previous results. Deter-
`mine the reasons for the inconsistency.
`
`Regeneron Exhibit 1042.013
`
`

`

`[so 7864:1993(E)
`
`Annex C
`
`(informative)
`
`Symbol for “do not re-use”
`
`0.1 General
`
`The ISO symbol to denote equipment intended for
`single use is
`ISO symbol
`registration number
`lSO 7000;1051, giVen in lSO 7000:1989.
`
`Further information on design dimensions and
`NOTE 5
`application of ISO symbols is given in ISO 3461.
`
`(2.2 Original design
`
`Symbol ISO ?000}1051 is shown in figure C1.
`
`The thickness of the lines is 2 mm. Dimension :1 is
`
`tSD
`the nominal size of the original design of all
`symbols and is normally made equal to 50 mm.
`In
`many cases, including ISO MOO/1051, the actual di-
`mension differs slightly, and the outside diameter oi
`
`the circle (dimension h) of the original design is
`1.16 a, Le. 58 mm.
`
`No colour is specified in ISO 7000 or in this Inter-
`national Standard for symbol 1051.
`
`(2.3 Reduction and enlargement of
`original design
`
`it may be neces—
`For the application of the symbol
`sary to reduce or enlarge the size of the original to
`a suitable size at which it will 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 symbol losing its legibility. However, the
`Iegibility of the symbol when reduced in size should
`be checked.
`
`|_
`
`h =1.16 a
`
`i
`
`_l
`
`NOTE - The visual centring lines do not form part of the symbol.
`
`Figure C.1 — ISO symbol for “do not re—use”, number ISO 7000i1051
`
`1U
`
`Regeneron Exhibit 1042.014
`
`

`

`ISO 7354:1593(E)
`
`Annex D
`
`(informative)
`
`Bibliography
`
`[1]
`
`ISO 5954:1936. Reusabie aii—giass or metat-
`and—giass syringes for medicai use — Part 1:
`Dimensions.
`
`E2]
`
`[3]
`
`[4]
`
`iSO 595-211987. Reusabie aii-giass or metair
`and-glass syringes for medicai use — Part 2:
`Design, performance requirements and rests.
`
`the
`{or
`ISO 3451-1z1988. General principles
`creation of graphicai
`symbols — Part 1:
`Graphicai symbois for use on equipment.
`
`the
`ISO 3461—2:1937, Generai principles for
`creation of graphicai
`symbois — Part 2:
`Graphicai symbols for use in technicai product
`documentation.
`
`[5]
`
`ISO 7000:1939, Grapiiicai symbois for use on
`equipment — index and synopsis.
`
`[5]
`
`[7]
`
`[a]
`
`[9]
`
`for
`containers
`injection
`[80 8362421989.
`injeciabies and accessories - Part 1: injection
`vials made of giass tubing.
`
`for
`containers
`injection
`ISO 3362421988.
`injectabies and accessories — Part 2: Ciosures
`for injection viais.
`
`for
`containers
`injection
`ISO 3352-31989,
`injectabies and accessories — Part 3: Aiu—
`miniutn caps for injection viais.
`
`for
`containers
`injection
`ISO 8352-41939.
`injectabies and accessories - Part 4: injection
`w‘ais made of mouided giass.
`
`[10]
`
`ISO 3537:1991, Sic-rite singie-use syringes, with
`or without needie, for insuiin.
`
`[11]
`
`of
`evaiuation
`|SD10993-1:1992. Biotogicai
`medicai devices — Part
`1': Guidance on se-
`iection of tests.
`
`11
`
`Regeneron Exhibit 1042.015
`
`

`

`Iso 7864:1993(E)
`
`
`
`UDC 615.473.2.014.45
`
`Descrlplors: medical equipment, hypodermic needles,
`labelling.
`
`Price based on 11 pages
`
`specifications, dimensions,
`
`tests, designation, colour marking, packaging,
`
`Regeneron Exhibit 1042.016
`
`