Ansell EX2003
`Reckitt Benckiser LLC v. Ansell Healthcare Products LLC
`IPR2017-00063
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`Contents
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`1
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`Scope ............................................................................... ..
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`E Normative references ..........................................................................................................__
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`3 Terms and definitions .............
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`.............................................................................................................. .
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`4 Quality verification ........................................................................................................................__
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`5 Design . ..................................................................................................................................................... ..
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`E Elurst volume and pressure ................................................................................................................. _
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`? Tesis for stability and shelf iiie ........................................................................................................................__
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`a Freedom lrom holes ........................................................................................................................................ ..
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`5
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`‘v'isible detects ..................................................................................................................................................
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`t D Package integrityr .......................................................................................................................................... ..
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`I
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`1 1
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`Packaging and labelling ............................................................................................................................... __
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`12 Test report
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`.................................................................................................................................................... ..
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`finnexes
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`iii Sampling plans intended tor assessing compliance of a continuing series of lots of sulficienl number to allow
`me SWIIUHIHQ rules to be applied ...........................................................................................................
`___________ ._
`
`B Sampling plans intended lor assessing compliance of isolated lots ............................................................. ..
`t:
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`fietermination of total tubricentfer condoms in individual containers
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`Determination ol lengl‘o ................................................................................................................................. __
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`Determination of width
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`Determination of thickness ............................................................................................................................ ..
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`Determination of bursting volume and pressure .......................................................................................... __
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`Dven treatment ior condoms......................................................................................................................... ..
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`Determination ol lorce and elongation at breai: ol test pieces of condoms .................................................... ..
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`F]
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`E F G
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`H
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`J Determination otsheli life by real-time slahilltv sluoles. . ................................................................................
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`K Guidance on conducting and analysing accelerated ageing studies .......................
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`..............
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`............... ..
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`L Testing ior holes ............................................................................................................................................ ._
`tI.I1
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`Testsforpeoitage Integrity__..........-....................
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`Ci Calibration ot sir infletion equipment for determination of bursi volume and pressure ................................. ..
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`P Flationaie ......................................................................................................................................
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`............... ..
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`Bibliography ........................................................................................................................................................
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`JED 4|]?4:2El[i2{E}
`
`Foreword
`
`standards bodies (iSCr
`preparing Internationai Standards is normally carried out
`through [SCI 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
`liaison with tan. also taire part
`in the work.
`Commission {EU} on all matters oi electrotochnical standardization.
`
`international Standards are dratted in accordance with the rules given in the iSCiiIEC Directives, Part 3.
`Brett international Standards adopted by the technical committees are circulated
`to the member bodies for yoting.
`Publication as an International St
`andard requires approval by at least 3’5 tire of the member bodies casting a vote.
`Attention is drawn to the possibility that some oi the etements of this interns
`tional Standard may be the subject or
`patent rights. ISD shall not be held responsible
`ter identityth any or all such patent rights.
`International Standard ISO 40M was prepared by Technical Committee iSDiTG 15?. Mechanicai contraceptives.
`This first edition cancels and replaces the first editions of ISO 401M, Parts 1‘1 t1
`Annexes A. G. D. E, F. G. H. l. J. L. M and N form a normatiye part ot this international Standard. Annexes B. it, D
`and F“ are tor information only.
`
`Iy
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`Introduction
`
`iso 4DT4:2DDE{E)
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`External
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`Document No.
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`The intact latex film has been shown to be
`a barrier to human immunod
`oficiency virus {Hill}. other Infectious agents
`responsible for the transmission of sexually
`transmitted infections {STls}
`and to spermatozoa. In order to help ensure
`n the prevention of transmission of STis. it is
`that condorns are effective for contra
`cepilve purposes and for assisting |
`essential that condoms lit the penis
`.
`adequate physical strength so as not to break
`during use. are correctly packaged to protect them during storage and are correctly labelled to facilitate their use. All
`these Issues are addressed in this international Standard.
`
`The condom and any lubricant. additive, dressing.
`neither contain nor liberate substances in amounts I
`under normal conditions of storage or use. Fteterenc
`safety of condoms particularly in respect of the risk
`
`powder applied to It should
`rriiating or othenvise harmful
`
`Condoms are medical devices. Therefore
`Fieference should be made. for example to
`IStIII 13455 or fat! 13438.
`
`they should be produced under
`the ISO sued-series. iECt 149M
`
`a good quality management system.
`vt and one of the relevant standards:
`
`tSondoms are non-sterile medical devices but
`microbiological contamination of the product duri
`
`manufacturers should latte appropriate precautions to minimize
`ng manufacture and packaging.
`This first edition ot ISIS}I 4W4 requires manufacturers to conduct stability tests to estimate the shelf life of any new or
`modified condom before the product is placed on the market
`and to initiate real-time stability studies. These
`requirements are described in clause 3'. The real-time stability tes
`‘
`requirement to conduct post-marketing surveillance on their prod
`that manufacturers have adequate data to support shelf-life claims before produots are placed on the market and that
`these data are avallabie for review by regulatory authorities. third-party test laboratories and purchasers. They are
`also Intended to limit the need for third parties to conduct long-term stability studies.
`A guideline
`{ISDIEGSBJ
`IECtr'Tf3157NIiG 14.
`
`for
`
`the application of
`
`this
`
`International Standard
`
`is under development
`
`by
`
`This International Standard contains requirements for tettsile
`properties [force at break} when a manufacturer makes
`a claim for "extra strength". Annett I contains the test
`method for determination of force and elongation at break. as it
`may be useful in the quality system of a manufacture
`r and in very special cases in a purchaser’s contract.
`
`to certain otauses or this International Standard is
`'
`given in annex P. Iil'Iihere this is relevant. the appropriate clause in annex F' is referenced In the rain.
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`INTERNATIONAL STANDARE
`
`ISO 40?4:2UDHE}
`
`Natural latex rubber condoms —- Requirements and test methods
`
`1 Scope
`
`This International Standard specifies the mi
`irom natural rubber later: which or
`of sexually transmitted inlections.
`
`'
`
`2 Normative references
`
`The toltowing normative docume
`in this text. constitute provisions of
`this International Standard. For dated references. subsequent amendments to. or revisions of. any of
`these
`publications do not apply. However. parties to agreements based on this international Standard are encouraged to
`investigate the possibility oi applying the most recent editions oi the normative documents Indicated below. For
`undated references.
`the latest edition of the normative document referred to applies. Members at tact and IEC
`maintain registers of currently valid International Standards.
`
`IStZlI tBB. Ftubber. vulcanized or thermoplastic — Accelerated ageing and heat resistance tests
`ISO 2859411999. Sampling procedures for inspection by attributes— Part t: Sampling schemes indexed by
`acceptance duality limit {AOL} tor lot-by-iot inspection
`
`iSD 15223. Medical devices— Symbols to be used with medical device labels,
`supplied
`
`labelling and information to be
`
`EN 930. Graphical symbols for use in the labelling at medical devices
`
`3 Terms and definitions
`
`For the purposes ct this International Standard, the terms and detinitions given in ISO 2859-1 and the following
`apply.
`3.1
`
`acceptable dualityr limit
`AOL
`
`When a continuous series of lots is considered. the quality level which for the purposes of sampling inspection is the
`limit of a satisfactory process mean {according to JED 2359-1}:
`3.2
`condom
`
`medical device used by consumers. which is intended to be retained on
`ot contraception and prevention of sexually transmitted inledticns
`
`the penis during sexual activity. for purposes
`
`NOTE It a consumer could responsiny consider a device to be a condom {due to its shape, packaging. etc}. it Is considered a
`condom tor the purpose of this International Standard.
`
`3.3
`
`consumer package
`package. intended for distribution to a consumer. containing one or more individual containers
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`.iso someones}
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`an
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`expiry date
`stated date after which a condom should not be used
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`3.5
`identification number
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`number, or combination of numeralsr symbols or letters used by a manufacturer on consumer packages to identity
`uniquely the lot numbers oi individual condoms contained in that package. and from which it is possible to trace those
`lots through all stages of packaging and distn‘oulion
`
`NOTE When the consumer package contains onty one kind at condom, then the identification number may be the same as the
`lot number. Eat if the consumer package contains saveral ditterent types at condom. tor instance condoms ct ditferent shapes or
`cutouts, then the identification number will be diiietent from the lot number.
`
`3.5
`individual container
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`immediate wrapping at a single condom
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`3.?
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`inspection level
`relationship between lot size and sample size.
`
`NOTE For description. see 150 ease-in see. tut.
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`3.3
`lot
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`collection of condoms of the same design, colour, shape, size and tormulaiionI manufactured at essentially the same
`time. using the same process, raw materials at the same specifications. common equipment and packed with the
`same lubricant and any other additive or dressing in the same type of individual container
`
`NOTE This International Standard does not specify the size at a lot, but it is possibie for a purchaser to do so as part at the
`purchasing contract. Attention is drawn to the d'rrticutties that can be associated with the distribution and control of very large lots.
`The recommended maximum individual lot size for production is SUD IDEIU.
`
`3.9
`lot number
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`number or combination oi numerals, symbols or letters used by the manufacturer to identity a lot at Individually
`packaged condoms. and from which it is possibia to trace that lot through all stages at manufacture up to packaging
`
`NOTE For testing purposes, sampling is manducted by lot numberI not identification number. See requirements in clause 4.
`
`3.1 El
`lot test
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`test to assess the compliance of a lot
`
`NOTE a lot test may be limited to include only those parameters which may change Irorn lot to lot.
`
`3.11
`non-visible hole
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`hole in the condom that is not vislbte under normal or corrected vision but is detected by leakage when rotting on
`absorbent paper
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`3.12
`
`sampling plan
`specific plan which indicates the number of units of product from each tot which are to be inspected {sample size or
`series at sample sizes} and the associated criteria tor determining the acceptability oi the lot [acceptance and
`rejection numbers}
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`Iso surrenders}
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`3.13
`shelf life
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`time from date of manufacture to the claimed expiry date
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`3.14
`visible hole
`hole or tear in the condom that is visible under normal or corrected vision
`
`
`
`4 Duality verification
`
`Condoms are mass-produced articles manufactured in very large quantities. Inevitava there will be some variation
`betwoen Individual condoms. and a small proportion of condoms in each production run mag,r not meet
`the
`requirements In this International Standard. FurtherI the majority of the test methods described in this International
`standard are destructive. For
`these reasons the only practicable method ot assessing compliance with this
`International Standard is bv testing a representative sample from a lot or sories of lots. Etaslc sampling plans are
`given in ISO 2559-1. Fteterence should be made to ISUHFt 855D for guidance on the selection of an acceptance
`sampling system. scheme or plan for the inspection ol discrete Items in a lot.
`
`When on-gcing verification is required of the quality otccndoms. it is suggested thatr instead of concentrating soleiv
`on evaluation of the final product. the part}.I concerned also directs his attention to the manufacturers quality svstarn.
`In this connection it should be noted that the ISO SIZHthZi series {see Bibliography} covers the provision of an integrated
`qualitv system.
`
`Samptlng plans shall be selected to provide an acceptable level of consumer protection. Suitable sampling plans are
`given in annexes A and B.
`
`at Annex A. describes sampling pians based on tSD 2359—1 and is most appiicable to manufacturers or purchasers
`assessing the compliance of a continuing series of lots. The toll level of consumer protection available depends
`upon the switch to tightened inspection it a deterioration in guatitv is detected. The switching rutes cannot oils:-
`full protection for the first two lots tested. but become progressivetv more effective as the number ot tots in a
`series increases. The sampling plans in annex A are recommended when five or more lots are being tested.
`
`b} Annex E describes sampling plansr based on ISO 23555-1. that are recommended for the assessment of Isolated
`lots. The sampling plans in annex E'- provide approximatetv the same level of consumer protection as those given
`in annex .Ft when used with the switching rules. It is recommended that these sampling ptsns be used tor the
`easessmont of lower than live lots. for example in cases of dispute. for retaree purposes. tor tvpe testing. for
`qualification porposes or for short mns of continuing tots.
`
`c} Handling and storage conditions shall be documented before drawing the samples.
`
`It is necessarv to l-tnow the lot size in order to derive trom ISO 2859-1 the number at condoms to be tested. The lot
`size will var"...I between manulacturere and Is regarded as part of the process and quality controls used by the
`manufacturer.
`
`5 Design
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`5.1
`
`Integral head
`
`The open end of the condom shall terminate in an integral bead and shall complv with clause 9.
`
`5.2 Lubrication
`
`if the amount of lubricant in the package is specified. then this amount shall be determined by the method described
`in annex G.
`
`The method in annexG also recovers part of the dressing powder on the condom. {See rationale.
`atlowsnce should be made for this when manulacturere or purchasers specify lubricant levels.
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`5.3 Dimensions
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`5.3.1 Length
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`DocunwntNo.
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`Ute-ni-Uaor
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`Iii't'hen tested by the method given in annex D. taking 13 condoms trem each lot. no individual length measurement
`ehatt be below 150 mm.
`
`5.3.2 Width
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`IIi'ii'hen tested bv the method given in annex E, talting 1 3 condoms from each lotr no width measurement shall deviate
`from the nominal width stated by the manufacturer by more than i- 2 mm.
`
`The width shall be measured at the narrowest part of the condom within 35 mm from the open end. or at a point
`specified by the manufacturer within the same area.
`
`NOTE The width for dotonninetiefi of The requirements tor burst volume as In 6.1 ma].r be measured at the same time.
`
`5.3.3 Thickness
`
`if the thickness of the condom is specified. then it shall be determined by the method in annex F.
`
`E Burst volume and pressure
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`5.1 Untreated condoms
`
`When tested in accordance with annex G. the bursting press-ere shall be not less than 1.0 I-tF'Et and the bursting
`volume (rounded to the nearest D,5 de} shall be net less than:
`
`— 1E.D dma tor condoms with a width less than Sill) mm, or
`
`— 131i drrrz" tor condoms with a width greater than or equal to HELD mm and up to 55.0 mm. or
`
`"r 22.0 Elma tor condoms with a width greater than or equal to 56.0 mm
`
`The width ls defined as the mean flat width of 13 condoms measured in accordance with annex E at a point
`[3’5 :l: 5} mm lrom the closed end. {See rationale in annex Ft]
`
`The compliance level tor each lot shall be an AOL ot 1.5 for non-conforming condoms.
`._.-—'—'—-—"‘—-—-—__
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`-—.—.-
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`A non—contorming condom Is detined as a condom that tells the requirement for volumer pressure, or bothr or any
`________._.—-—-—.____
`condom that exhibits an; leakage.
`L'___'_""-—-__..
`"‘
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`6.2 Let testing for oven-treated condoms
`
`The purpose of this test is to check for major tormulatlon or vulcanization errors. When ovenvtreated as described in
`annex H for [183 :l: 2} h at {re -_i: 2) “G and tested according to annex G. the condoms shall meet the requirements
`of 5.1. This test does not provide information about the shelf lite of the product.
`
`This test is applicable only to condoms that are tess than one year old [rem the date oi manufacture.
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`6.3 Extra strength
`
`5.3.1 Ge nerai
`
`If a manutacturer makes a claim that a particular brand of condoms Is stronger or implies
`that a particular brand of
`condoms provides extra protection or safety in use because the condoms are stro
`nger than regular condoms. then
`the additional requirements for "Extra Strength" condoms defined
`in this section shall apply. [See annex P.}
`
`5.3.2 Requirements for mechanical properties
`
`I-"Il'hen tested according to annex t3. the minimum bursting pressure shall be not less than 2.0 kFa and the bursting
`volume shall conform to the requirements of 6.1.
`
`the minimum mean force at break shalt be ititihl based on the mean of
`1Illlhen tested according to annex l.
`13 condoms selected at random from each lot of ccndorns.
`
`5.3.3 Requirements for clinical data
`
`tv'fanuiactu rers shalt substantiate the extraaslrength claims with clinical data or prominently display on the pack the
`statement given in ‘1 1.2.3.2.
`
`The clinical data shall substantiate a statistically significant reduction in breakage rate tor the extra strong condom
`when compared in a random. double blind trial to a reference. marketed condom from normal production produced
`by the same manufacturer. The reference condom shall comply with the requirements of ISO son and shall exceed
`ubfid mm single wall thickness at the mid body.
`
`Useful references are ISO 14155 or EN 540 and ISO 15%? {in preparation}.
`
`T Tests for stability and shelf life
`
`?.1 General
`
`Manufacturers shall verify that the condoms comply with the requirements of 6.1 of this International Standard until
`the end of thelabelled shelf life. Shelf—fife claims shall not exceed five years [see annex F'}.
`
`Data supporting the shetf~llfe claims made by the manufacturer shalt be made available to the appropriate regulatory
`authorities and direct pumhasers upon request.
`
`Before a new or modified condom design is placed on the market. the following requirements shall be met.
`— The condom shall be tested for the minimum stability requirements as described In T2.
`— A real-time study as described In its to determine shelf life shall have commenced.
`
`— Pending completion of the real-time study. shelf life shall be estimated as described in 14.
`
`NOTE I A modified condom design is one to which there have been significant changes to the formulation
`process or individual sealed contalners.
`
`NOTE 2 Compliance with me requirements oi T.1 does not Imply that the shelf life of the product has been determined.
`
`Shelf-life estimates {14] shall be based on a mean kinetic temperature of SCI “It: for all climatic conditions and may
`be carried out on condoms fmm the same production lots as used for real-time determination of shelf life {is}.
`
`For existing designs on the market at the date of publication of this International Standard, real—time data in a form
`consistent with annex .l. and at temperatures consistent with local regulatory requirements prevalllng at the time me
`product 1.vas Introduced. shalt be acceptable. to verify the shelf-life claims.
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`12 Minimum stability requirements
`
`Test three lots of condoms for compliance with ISO 4cm. except 11.2 and 11.3. using the sampling plans given in
`annex E.
`
`Unly tots meeting all of the requirements of ISO 4D?4. except 11.2 and 11.3. shall be used for this test.
`
`Incubate samples in their individual sealed containers according to annex H. one set for HEB :I: 5] h {1 Week} at
`[to :I: 2] "C and the other set tor {Elli i 1] days at {SCI :I: 2} “C. At the end of the incubation periods, I.I.'ithdravtr the
`condoms and test for airburst properties according to annex G and the requirements of 6.1.
`
`The test report shall Include the requirements of annexes G and hi.
`
`NOTE Data to verily compliance with T2 can be extracted from studies for estimates of shelf life t?.4i.
`
`13 Procedure for determining shelf life by real—time stability studies
`
`After testing according to annex d the condoms shall meet the requirements In 6.1.
`
`If the real-time data indicate a shorter shelf life than that claimed on the basis of accelerated ageing {1-1}. the
`manufacturer shall notify the relevant regulatory authorities and direct purchasers. The manutacturer shatt change
`the shelf-life claim for the product to one based upon the real-time study. In no case shall shelf life exceed five years.
`For condoms placed on the market. real-time stainitlty studies shalt be completed for the full period at the shelf-fife
`Claim.
`
`Tat Estimating shelf life based upon accelerated stability studies
`
`Pending the completion of real-time studies, accelerated stability studies shalt be used to estimate the shelf life.
`
`at the date of publication. no single method of analysis was sufficiently validated or widely used to Justify its
`designation as a standard method. Several approaches to the analysis of accelerated-ageing data have been
`explored. It is anticipated that as manufacturers and regulatory agencies accumulate real—time data. a consensus
`method for the next revision of this International Standard will be developed. Meanwhile. the results of accelerated-
`ageing data may be analysed by a number of methods or as stipulated by the manulacturer‘s regutatory authority.
`
`Examples of methods for accelerated studies and data analysis are provided in annex K. Data generated from such
`studies shall support the claim that the condoms fulfil the requirements in 5.1 for the duration of the tabelled sheii life
`at 30 all}.
`
`3 Freedom from notes
`
`IIi'Iihen tested by either method described in annex L. the compliance level for each totI for the sum of condoms with
`visible and non-visible holes and tears, shalt be an eat. of fl.25.
`
`5t
`
`‘v'isihte defects
`
`For visible defects as described in annex L “.233. L.3.3.rt]. the compliance level for each lot shall be an AOL of flit.
`
`1t] Package integrity
`
`When requested by a customer or a regutatory body. the manufacturer or supplier shall provide information on
`package integrity based upon the test method given in annex M. The compliance level for each tot shall be an AOL of
`2.5.
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`E
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`tso trimesters}
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`11 Packaging and labelling
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`11.1 Packaging Each condom shall be packed in an Individual container. One or more indiyi ua con a n
`
`- packed In other
`packaging such as a consumer package. The individual container. or consumer package or both. shall be opaque to
`light. However packagedr the packaging shall protect the condom from light even if only the individual package is
`provided to the consumer.
`
`If a marking medium. such as ink. ls used on a condom or on any part of a package directly In contact with a condom.
`it shall not have any deleterious effect on the condom or be harmful to the user.
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`Individual containers and any other packaging shall protect the condom from damage during transport and storage.
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`Individual containers and any other packaging shall be designed in such a way that the pack can be opened without
`damaging the condom. The design of the individual container should facilitate easy opening. {See rationale in
`annex F.}
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`11.2 Labelling
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`11.2.1 Symbols
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`If symbols are used on packaging. Information and marketing materials. the symbols shall meet the requirements In
`ISO 1 5223 or EN RBI}.
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`11.2.2 Indiyfdu at container
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`Each individual container shall hear at least the following information:
`
`all
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`oi
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`oi
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`the identity of the manufacturer or distributor. fSee rationale in annex P};
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`the manutacturer‘s Identifying reference for traceability leg. the lot number};
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`the expiry date {year. month}. The format of the year shall be in four digits; the format of the month shall he in
`fedora or two digits. {See rationale in annex F'.}
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`11.2.3 Consumer package
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`11.2.3.1 General
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`The outside of the consumer package shall hear at least the following information in at least one of the official
`languagets‘i of the country of destination or as stipulated differently by that country:
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`at
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`12:]
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`c}
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`d}
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`at
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`a description of the condom. including whether or not it has a reservoir. if the condom is coloured or textured this
`shall be stated:
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`the number of condoms contained;
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`the nominal width of the condom;
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`the name or trade name and address of the manufacturer andrer distributor. depending on national and regional
`requirements. {See rationale in annex P}:
`
`the expiry date [year and month]. The format of the year shall be in four digits and the format of the month shall
`be in letters or two digits. It a consumer package includes condoms hem different lots. the earliest expiry date
`shall apply to ail condoms;
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`I)
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`a statement to store the condom in a cool dry place away from direct sunlight:
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`tso 4D?4:2flii2[E]
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`gt a statement that individual containers. if not opaque to light. should not be stored outside the opaque consumer
`package;
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`h} whether the condom is lubricated or dry. lI.I'I.fhen a medicinal ingredient is added. it shall be identified and its
`purpose Indicated leg. spermicidall. If the condom or lubricant is fragrancsd or flavoured. this shall be stated:
`
`it
`
`lf different
`the manufacturer's identifying reference for traceability log. the identification numberl'lot number}.
`types of condoms. e.g. different colours. are packaged together in the same consumer package. the identification
`nontber on the consumer package shall ailctltr
`the manufacturer to identify uniquely the lot numbers of the
`individual condoms contained in that package. so that it is possible to trace those lots through all stages of
`manufacture up to packaging;
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`it
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`a statement that the condom is made of natural rubber latex.
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`11.2.3.2 Labelling of extra-strong condoms
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`A claim such as "extra strong" implies that the condoms have a lower level of breakage than a "regular" condom.
`Such claims shall be supported by clinical investigations. {See 6.3.3}
`
`if the manufacturer wishes to use the claim “extra strong“ pending the completion of a clinical study. the labelling shall
`state:
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`This extra-strong condom has not been shown to be safer in use than regular condoms."
`
`11.2.4 Additional information on the consumer package
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`The outside or the inside of the consumer package. or a leaflet contained within the consumer package. shall bear at
`least the following information expressed in simple terms, and In at least one of the official languagefs} ot the country
`of destination.
`it possible supplemented by pictorial representations of the major steps involved or as stipulated
`differently by that country.
`
`a]
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`Instructions for use of the condom. including
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`1}
`
`the need to handle the condom carefully. including removal from the package so as to avoid damage to the
`condom by fingernails. iswellsry etc:
`
`2} how and when to put on the condom; mention should be made that the condom should be placed on the erect
`penis before any contact occurs between the penis and the partner's body to assist in the prevention of
`sexually transmitted infections and pregnancy:
`
`3}
`
`if]
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`the need to withdraw the penis soon after ejaculation. while holding the condom firmly in place at the base of
`the penis;
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`the need. if an additional lubricant is desired. to use the correct type of lubricant which is recommended for
`use with condoms and the need to avoid the use of oil-based lubricants such as petroleum jelly. baby oil.
`body lotions. massage oils. butler. margarine etc. as these are deleterious to the integrity of the condom:
`
`5}
`
`the need to consult a doctor or pharmacist about the compatibility of topical medicines that may come In
`contact with the condom.
`
`b]
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`Instructions on how to dispose of the used condom.
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`c} A statement that the condom is for single use.
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`d] The number of this International Standard. is. £50 4W4. [See rationals in annex P.)
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`1 1.3 Inspection
`
`From each lot. 13 consumer packages and 13 individual containers shall be inspected for compliance. All inspected
`containers shall comply with the requirements.
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`Under certain conditions It may be permissible for the manufacturerfdistributor to correct faults associated with
`packaging and labelling requirements and resubmit the lot for further conformity testing. Examples include insertion
`
`External
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`Document No.
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`gag-flt-UBUT
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`ISC‘lI 4074:2flt12lEl
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`oi missing Instruction leaflets or repackaging oi individual containers into new complete consumer padcages before
`placing on the