Description SILBIONE MM SE愛微RIES 71791 U are silicone r舞場ubbers which cure

after addition 森黑of a vulcanising agent (chosen as a車自 function of the

production process區西).

This series includes fou算機r products which dif弟化fer by their hardness

once cured : 40-慢黑50-60 and 70 Shore A坐民.

Once processed SILBIONE MM答窗 SERIES 71791 U ,對輛 "Food contact

and biomedical g體姐rade" are intended有書 for:

· biomedical ap北那plications

· applications requiring拍高 a material that is non-toxic u雪為nder normal

conditions of use and inert 機謝to food products.

SILBIONE MM SERI歌山ES 71791 U , are ela技能stomers comprisin紅中g

polymethylvinylsiloxane gums an冷水d silica. They 中地heat cure after

addition of an organic p妹紙eroxide compound. This vulca務匠nisation must

be followed by p書飛ost curing at 200°C.

Special properties · Easy proce爸通ssing

· Highly transparent

· Excellent mechanical propert西店ies, including high tear strength

and a good compromise between tear st件服rength and

compression set

· Very good resistance to 不會oxidising agents (oxygen, ozone, UV)能靜

· Very good behavi什時our for all sterili雪一sation modes

· Very good release properties

· Chemically inert國學

Regulations The composi姐事tion of SILBIONE志他 MM SERIES 71791 U enables them to

be used in confo話歌rmity with the defi唱地nitions in the following Europea很業n and

American regulations.

Food contact:

France : Journal Officiel – Brochure 1些低227– order dated 25科跳 November

1992.

Germany : BGVV XVA and LIIA.

United States : : US- FD光森A- CFR 21- part 177. 2600.

Italy : Gazetta Uff花水iciale – law dated路笑 1973 and addendum.

Moreover, samples of SILBIONE M到高M SERIES 71791 U, catalysed

with dichloro- 2, 4 benzoyle peroxid草請e, have been subject to

migration tests in accorda頻愛nce with European regulation著請s: Directives

82/ 711/ EEC and 93/ 8 EEC and American你呢 regulations: US- FDACFR

21- part 177. 2600.

Regulations Drinking wate鄉雨r contact

SILBIONE MM SERIES 71791 U of hardness商錢es 50 and 60 ShA, have

been successfully p身冷roven to be in conformity wit用事h German KTZ

regulation part 商友1.3.13.

Medical devices.

Basic biological studies; cytotoxici厭科ty, irritation, sensi生線tisation and

hemocompatibility, req事河uired by directive 93/42 CE dated Ju見費ne 14

1993, relative 朋高to medical device房年s and USP Class VI of US, ha街他ve

been carried out on samples of SILBI如頻ONE MM SERIES 71791 U ,

catalysed using dichloro購樂 2,4 benzoyle peroxide.厭雜

The summaries of the biological studi為老es are available on request.

In all cases it is the 很紙finished article m熱器anufacturer’s

responsibility to check conformity wi工計th the tests imposed by藍問

the appropriate regula鐵東tions.

For medical applicat都們ions, Rhodia Silicones SA兵購S forbids the

commercialisation of these elastomers 了要for the production of

medical devices:

· implanted for more than 29 days妹好

· in contact for more than 29 days w不好ith blood and the去日

mucous membranes (co弟冷ntraception, obstetrics)

· for plastic surgery

Applications SILBIONE MM SERIES 7是哥1791 U , once catalysed and通章 processed is

recommended for the manufacture of the會人 following artic去什les:

Those which enter in con校多tact with food such as作森 :

· Tubes for drink 來和distribution, includin亮笑g potable water

· Baby’s bottle tops

· Various technical parts.

· Sections, sleeves, calendered sheets,吃能 belts and conveyor bel子討ts

Those used in ph電頻armacy such as:

· Tubes and piping for the circula多樹tion of liquid or soluble

medicines

· Medicine conveyor belt一子s, etc.

Those used for medical ap冷裡plications such as:

· Tubes and piping for extra-藍好corporal circula物湖tion

· Oxygenotherapy tubes

· Self-injectable sy很器ringe seals

· Breathing masks

Quality Assuran城雨ce 1- Manufactur光區e

Rhodia Silicones ta土水kes particular care i草和n manufacturing and著去 quality

control in order to guarante山時e users with the supply of an elastome購區r

whose quality lev對也el is in conformity with the 什綠special requireme刀靜nts in

these types of applicat小從ion:

· lack of cross-pollution.

· high level filtr愛生ation.

· Specific controls.

All of these operations are遠男 part of Rhodia Silicones’ q房錢uality control

policy, certified t志公o ISO 9001.

Quality Assurance 2- 秒綠Control

Specific controls are carried out on e土自ach batch of SILBIONE MM

SERIES 71791 U to meet the variou習師s regulations.

The results are wr讀懂itten on the analytical tes生錯t certificate in add時林ition to

the mechanical cha章暗racteristics.

SPECIFICATION FOOD GRADE MEDIC和車AL GRADE

ON POST CURED VULCANISED PRODUCT

Identity : IR Spectrum In Conformity店冷 m m

Volatile content (%):

(200°C-10g-4h)

0.5 maxi. m

Residual peroxides (%) 0.08 maxi地吧. m

Mineral oils (fluorescence) I紙影n Conformity m

ON AQUEOUS EXTRACT

Turbidity (NTU) 4 maxi. m

Alkalinity (ml 0.01 M HCl) 1 maxi. m

Acidity (ml 0.01M NaOH) 1.5 maxi. m

Reducing substances

(ml 0.01 M Na2 SO3)

1 maxi m

ON HEXANE EXTRACT

Hexane soluble (%) 3 maxi 歌時m m

Phenyl compounds (DO/UV) 0.4 maxi. m

Heavy metals (ppm) (other tha件外n

aqueous extract)

10 maxi m

Processing methods The choi女輛ce of vulcanising agent (peroxide)行影 to add to the SILBI小視ONE

MM SERIES 71791 U depends on the proces錯有sing method and the

conformity with vari愛從ous “Food contact grade” regulatio做南ns.

The various proc拍影essing methods are sum說但marised in the tabl議現e

below:

SILBIONE

MM SERIES 71791 U

Dichloro- 2, 4 benzoyle

Peroxide at 50 %

(E)

Dicumyl Peroxide

at 95 %

(D)

2, 5 dimethyl-

2, 5- di (tertio女中- butylperoxy)

hexane at 72 %

(L)

compression

Moulding injection

0.6 parts per 100

master batch

0.6 parts per 100

master batch

hot air vulcanisation 0.9空農 to 1.25 parts 票能per 100

master batch

6 to

12 bar

0.6 parts per 100

Extrusion pressurised master ba玩文tch

steam

vulcanisation

12 to

20 bar

0.6 parts per 100

master batch

Calandering hot air vul開老canisation

0.9 to 1.25 parts per 100

master batch

Characteristics 身去1- Physical properties

Type (according to AFNOR T現懂 40002)....... .....厭要......................是女......MVQ

Hardness Specific gravity at 2用吧5 ° C, approx.

40 ShA 1.10

50 ShA 1.13

60 ShA 1.15

70 ShA 1.18

Characteristics Nat東身ural colour......................秒家... ............白店............................T費知ransparent

2- Mechanical properties

Below we give an example of th妹件e characteristics obtained人自 using

dichloro- 2, 4 benz冷東oyle peroxide (at 50%) as a 志離vulcanising agent.

Measurements are made on a 2 mm土紙 thick moulded sheet, cur風煙ed for

8 min at 115°C and post cured雪很 for 4 hours at 200°C.

SILBIONE MM SERIES 學學71791 U 71 791/40 U 71河慢 791/50 U 71 791/60 U 71 厭關791/70 U

Peroxide dose in parts per姐從 100 of master batch 0.9 1 1.25 1.2來化5

ShA hardness , points們小, approx

(Standard ASTM D 對書2240)

43 53 62 72

Tensile strength, MPa, a我劇pprox,

(Standard AFNOR 時城NF T 46- 002)

9.0 9.5 10 9.5

Elongation at break, %, approx,

(Standard AFNOR大都 NF T 46- 002)

600 640 500 410

Tear strength, kN/m, approx,

(Standard ASTM D 624 A)

31 38 38 34

Compression set ( 2開銀2h/ 177°C/ 25%), %, approx,

(Standard ASTM D 39朋習5 B)

27 34 40 40

Rebound resilience (thicknes西月s 8 mm), %, approx,

(Standard DIN 53 512)

50 45 42 37

Linear shrinkage %,一訊 approx, 3.5 3.7 3.7 4.0

SILBIONE MM SERIES年員 71791 U must be post cured at 2信裡00°C

after vulcanisation (it is recom章請mended not to excee長了d this

temperature).

Post curing is ess不去ential in order to :

· Ensure conform新人ity with the legislation and regul花熱ations currently

in force

· Stabilise the mechanical 小相properties of the elastomer as 些報well as

its dimensions

· Ensure the heat sta遠大bility of the elastomer

· Improve its c朋國hemical resistance懂女, especially with respect 靜高to

solvents, fats and steam

Processing 1- Adding peroxide to 工視SILBIONE MM SERIE書紅S 71791 U

This operation is perfor她街med on a two-roll mixing 務腦mill.

Operating procedure :

à Check that th月習e equipment is scrupulously cl讀章ean in order to 內海avoid

including impurities that文但 would detract from t場低he quality and properti體慢es of

the SILBIONE MASTER BATCH.

à Plasticise the SILBIONE MASTER BA店子TCH.

Use of a back / front roller 畫快speed ratio of between快鄉 1.25 and 1.4 ensures鐵在

sufficient friction to giv什去e good plasticising身藍.

à Add the peroxide, th來秒en mix by cutting and crossing.

à Cool the cylinders throu高影ghout the operation in 工雜order to maintain the

SILBIONE MASTER BATCH at a temperature森大 below 30°C;

In the case of catal鄉件ysis using crystalised市朋 dicumyl peroxide, 也山after

dispersion it is recommended to heat th兒費e elastomer to 50°C to ensure農學 the

fusion of the peroxide, then to cool t工理o 30° once fully inc視員orporated.

2- Processing

SILBIONE MM SERIES 71791 U ob文明tained in this way can be

processed using all c水得onventional methods通厭 in the rubber proce秒雨ssing

industry used for tr影女aditional materia個拿ls.

Processing In this way公睡, using SILBIONE MASTER BATCH plastic子子ised on a

two-roll mixing mill, w城弟e could:

à Either roll a she秒購et to the required 技看thickness from whi飛雜ch we will cut

preforms for moulding.

à or cut bands that will 我街be used for example to feed an inje會嗎ction press or

to prepare sheets for calendering.物算

3- Vulcanisation and post curing

Vulcanisation of SILBIONE MM SERIE聽呢S 71791 U is carrie可我d out at

temperatures accordin對書g to the type of perox雨數ide used.

Once cured we remind you t紙頻hat SILBIONE MM SERIES 71791 U

must be post cured at 200°C in forced a兵熱ir ovens with protecte公視d

heating elements.

The post cure durati睡雜on depends on the thickness of the pa訊靜rts

obtained (moulded, e湖南xtruded or calendered).

Post curing gives the elast坐得omer its optimum characteri飛飛stics and ensures

its conformity wit要水h the requirements of西男 the regulation唱舞s currently in force.

Important comments :

Post curing at a temperatu民音re above 200°C or市志 any accidental increase in

temperature (e.g. t場新o around 250-300°C) can damage 跳議parts causing

stiffening, cracking or formation of a 樹車surface glaze. It is therefore

important to use 農來good temperature control to了線gether with forced air

ventilation.

Non-ventilated ovens or those with ins員老ufficient ventilation can cause

"reversion"森農; to occur : a reduction in ha我報rdness due to the onset of

depolymerisation.

Important notice RHODIA SILICON讀門ES SAS guarantees the properti店作es given for

SILBIONE MM SERIES 71791 U .

However, our compan身我y cannot guarantee站影 the behaviour of 得筆this master

batch and the application that is made錯信 of it by the user, since雜道 it has no

control over the兵我 conditions of application nor the 拿可process under w好林hich a

study has been conduc城筆ted.

Packaging SILBIONE MM SERIES 花在71791 U are available in 25 kg re離都inforced

cardboard cartons. Each master bat雨玩ch is enclosed in a release

coated sheet.

Storage and

shelf life

SILBIONE MM SERIES 71791 U may 線現be stored in its original

unopened packaging at a temper制個ature below +40°問子C for up to 18

months from the date of manufactur我日e marked clearly on the

packaging.

Past this date, Rhodia Silicones no 場做longer guarantees that 視校the

product meets the sales specific明紙ations.When kept i通弟n its original

unopened packaging,

According to the hardness, it is re術場commended to sli術不ghtly refreshen

SILBIONE MM SERIES 717船懂91 U before using.

Comment : Prolonged storag著鐘e beyond the recommended expiry dat快鐘e

generally means a 森開reduction in hardness and an in唱話crease in refreshening

time

Safety Please refer to the 文了Safety Data Sheets for SILBIONE MM SE明行RIES

71791 U .

Warning to users The information con請跳tained in this document新北 is given in good faith

based on our current knowledge.站內 It is only an indication and is in很紙 no

way binding, particularly as reg頻議ards infringeme化裡nt of or prejudice to

third party rights 山我through the use of our produc西拍ts.

RHODIA SILICONES GUARANTEES THAT 紙視ITS PRODUCTS

COMPLY WITH ITS SAL跳學ES SPECIFICATIONS.

This information must 黃雨on no account be us中吧ed as a substitute for

necessary prior tests whic得好h alone can ensu讀麗re that a product 還木is

suitable for a given use.

Users are responsi機中ble for ensuring黑廠 compliance with local legis銀村lation

and for obtaining 農綠the necessary certifications and 木他authorisations.

Users are requested to ch大美eck that they are in possess金了ion of the

latest version of this d動雪ocument and RHODIA SILICONES i技離s at their

disposal to supply any additional in刀腦formation.