Description SILBIONE MM SERIES 7179讀錯1 U are silicon些師e rubbers which cure

after addition of a vulcanising agent (樂木chosen as a function of the

production process).

This series includes four produc鄉術ts which differ by t現又heir hardness

once cured : 40-50-60 and 7看體0 Shore A.

Once processed SILBIONE MM 的山SERIES 71791 U , "Food contact

and biomedical grade" are 校船intended for:

· biomedical appli機些cations

· applications requiring a material t時裡hat is non-toxic un分習der normal

conditions of use and inert to 秒理food products.

SILBIONE MM SERIE車著S 71791 U , are elastomers compris舊見ing

polymethylvinylsiloxane g為媽ums and silica. They he森也at cure after

addition of an organic p術個eroxide compound. This vulcanis上放ation must

be followed by post curing a輛錢t 200°C.

Special properties · Easy proce村看ssing

· Highly transparent

· Excellent mechanical properti暗唱es, including high tear strength跳知

and a good compromise between人體 tear strength and

compression set

· Very good resistanc船有e to oxidising agents (oxygen兵請, ozone, UV)

· Very good behaviour for得請 all sterilisation modes

· Very good releas海如e properties

· Chemically inert

Regulations The composition of窗爸 SILBIONE MM SERIES 71791 U enabl林業es them to

be used in conformity with the defini書拍tions in the following Eur木睡opean and

American regulations.

Food contact:

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

1992.

Germany : BGVV XVA and LIIA.

United States : : US- FDA- CFR 21- pa現妹rt 177. 2600.

Italy : Gazetta Ufficial爸見e – law dated 1973 and addendum.

Moreover, samples o聽湖f SILBIONE MM SERIES 71791 U, c兵腦atalysed

with dichloro- 2, 4 benzoyle per去銀oxide, have been 現西subject to

migration tests in accordance with Euro得友pean regulations: 知看Directives

82/ 711/ EEC and 93/ 8 EEC and Americ地北an regulations: US- FDACFR

21- part 177. 2600.

Regulations Dri公習nking water contact

SILBIONE MM SERIES 71791 U of har懂下dnesses 50 and 60 ShA, hav文行e

been successfully proven to be 工道in conformity wi舞請th German KTZ

regulation part 1.3.13.

Medical devices.

Basic biological studies; cyto什我toxicity, irritation, sensitisa在為tion and

hemocompatibilit間跳y, required by directive 喝黑93/42 CE dated June 朋美14

1993, relative t身物o medical devices and USP Class VI of U海為S, have

been carried out 朋市on samples of SILB麗場IONE MM SERIES 71791 U ,

catalysed using dichloro 2,你會4 benzoyle peroxid匠美e.

The summaries of the b南村iological studies a風兵re available on request.

In all cases it船離 is the finished article m美關anufacturer’s

responsibility 通舞to check conformity with the tests i用朋mposed by

the appropriate regulations.

For medical applications, Rhodia Sili公腦cones SAS forbids the

commercialisation of these elastome從通rs for the prod照個uction of

medical devices:

· implanted for more than 29 days

· in contact for more than 29 days wi算房th blood and the

mucous membranes (cont中長raception, obstetrics)

· for plastic surgery

Applications SILBIONE MM SERIES 中新71791 U , once ca年謝talysed and processed is

recommended for the m路月anufacture of th街樂e following articl機在es:

Those which enter in contact with fo國到od such as :

· Tubes for drink distribution,美的 including potable water

· Baby’s bottle to兵熱ps

· Various technical parts.

· Sections, sleeves, cale內用ndered sheets, be照拍lts and conveyor belts

Those used in pharmacy such as:

· Tubes and piping for the員裡 circulation of liquid or soluble

medicines

· Medicine conveyor belts, etc.

Those used for medical applications 有她such as:

· Tubes and piping弟業 for extra-corporal她開 circulation

· Oxygenotherapy明討 tubes

· Self-injectable syrin下紙ge seals

· Breathing masks

Quality Assurance 1- Manufactur理綠e

Rhodia Silicones舞美 takes particular care in 上件manufacturing and quali紅區ty

control in orde明房r to guarantee users with the supp土著ly of an elastomer

whose quality level 學男is in conformity with the special re作唱quirements in

these types of appli音低cation:

· lack of cross-pollution.明我

· high level filtrati亮對on.

· Specific controls.

All of these operations火服 are part of Rhodia Silicones’她嗎 quality control

policy, certified to ISO 9001.

Quality Assurance 2- 吧民Control

Specific controls are carried out 鐵著on each batch of SILBIONE 森這MM

SERIES 71791 U t體聽o meet the various r微哥egulations.

The results are writt錯生en on the analytical test certifi車爸cate in addition to

the mechanical character化吧istics.

SPECIFICATION FOOD GRADE MED謝算ICAL GRADE

ON POST CURED VU白西LCANISED PRODUCT

Identity : IR Spectrum In 還雪Conformity m m

Volatile content (%):

(200°C-10g-4h)

0.5 maxi. m

Residual peroxides (子快%) 0.08 maxi. m

Mineral oils (fluorescence嗎都) In Conformity m

ON AQUEOUS EXTRACT

Turbidity (NTU) 4 maxi. m

Alkalinity (ml 0.01 M HCl) 民紙1 maxi. m

Acidity (ml 0.01M NaOH) 1.5 maxi山裡. m

Reducing substa電弟nces

(ml 0.01 M Na2 SO3)

1 maxi m

ON HEXANE EXTRACT

Hexane soluble 近術(%) 3 maxi m m

Phenyl compounds 年離(DO/UV) 0.4 maxi. m

Heavy metals (ppm) (other公計 than

aqueous extract)

10 maxi m

Processing methods The choice of vulc機家anising agent (p件嗎eroxide) to add to the SIL謝雨BIONE

MM SERIES 71791 U depend樂上s on the processing method and the作舊

conformity with various “Food contact水師 grade” regulations.

The various processing met道明hods are summarised in the煙問 table

below:

SILBIONE

MM SERIES 71791 U

Dichloro- 2, 4 看村benzoyle

Peroxide at 50 %

(E)

Dicumyl Peroxide

at 95 %

(D)

2, 5 dimethyl-

2, 5- di (tertio- 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 to 1.25 電事parts per 100

master batch

6 to

12 bar

0.6 parts per 100

Extrusion pressurise道人d master batch

steam

vulcanisation

12 to

20 bar

0.6 parts per 100

master batch

Calandering hot air vulcanisation

0.9 to 1.25 parts per 100

master batch

Characteristics 1- Physica金體l properties

Type (according to AFNOR T 40002).....就術.. .................................M哥靜VQ

Hardness Specific 國費gravity at 25 ° C, approx.

40 ShA 1.10

50 ShA 1.13

60 ShA 1.15

70 ShA 1.18

Characteristics Na愛白tural colour............看有............. .........................我小...............Transparent

2- Mechanical properties

Below we give an example of the char習要acteristics obt視下ained using

dichloro- 2, 4 benzoyle peroxide 草票(at 50%) as a vulcanising agent通去.

Measurements are mad拍遠e on a 2 mm thick moulded sheet, c內資ured for

8 min at 115°C and post cured f身妹or 4 hours at 200°C.

SILBIONE MM SERIES 71791 U通家 71 791/40 U 71 791/50 U 71 草上791/60 U 71 791/70愛懂 U

Peroxide dose in parts per 100 of mast暗紅er batch 0.9 1 1.25 1.25

ShA hardness , points, approx

(Standard ASTM D 2240)

43 53 62 72

Tensile strength資年, MPa, approx,

(Standard AFNOR NF T 46- 002)影商

9.0 9.5 10 9.5

Elongation at break, %, approx,

(Standard AFNOR NF T 46- 0紅的02)

600 640 500 410

Tear strength, kN/m, approx,

(Standard ASTM D 624 A)

31 38 38 34

Compression set ( 22h/ 177°C/ 25%), %車少, approx,

(Standard ASTM D 395 B)

27 34 40 40

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

(Standard DIN 53 512)農師

50 45 42 37

Linear shrinkage %, approx, 3.5 3.7日知 3.7 4.0

SILBIONE MM SERIES 7179照銀1 U must be post cured at 200°C

after vulcanisation聽但 (it is recommen答熱ded not to exceed票了 this

temperature).

Post curing is essential in 理化order to :

· Ensure conformity wi站北th the legislation and regulations cur錢做rently

in force

· Stabilise the mec妹學hanical properties of the elastomer a能時s well as

its dimensions

· Ensure the heat stability o雜爸f the elastomer

· Improve its che聽窗mical resistance, 友雪especially with re低學spect to

solvents, fats and steam

Processing 1- Adding peroxide to 友信SILBIONE MM SERIES 71791 U

This operation is performed身銀 on a two-roll mixing mill.

Operating procedure :

à Check that the equipment 雪話is scrupulously clean in ord和民er to avoid

including impuri場可ties that would detract from the qu票離ality and properties of

the SILBIONE MASTE坐也R BATCH.

à Plasticise the SILBIONE MASTER BA玩的TCH.

Use of a back / front roller speed rat友技io of between 1.25 and 1.高體4 ensures

sufficient frictio用票n to give good plasticis遠通ing.

à Add the peroxide, then mix 少如by cutting and crossing.

à Cool the cylinders throug志窗hout the operation in order 聽森to maintain the

SILBIONE MASTER BAT紙海CH at a temperature bel路跳ow 30°C;

In the case of 湖線catalysis using crystalised d店他icumyl peroxide, after

dispersion it is recomm內飛ended to heat the elastomer時知 to 50°C to ensure the

fusion of the peroxide, then to笑錢 cool to 30° once fully incorporat請物ed.

2- Processing

SILBIONE MM SERIES 71791 U obtained 森房in this way can be

processed using all c看問onventional methods in the rubber pr個麗ocessing

industry used for traditional materials章輛.

Processing In this way, using SILBIONE 們雨MASTER BATCH plasticised on a

two-roll mixing mil麗友l, we could:

à Either roll a sheet to the required 視間thickness from which we will動睡 cut

preforms for mould照家ing.

à or cut bands that will be used for飛公 example to feed an injection制員 press or

to prepare sheets for calender鐘船ing.

3- Vulcanisation 去雨and post curing

Vulcanisation of SILBIONE 我水MM SERIES 71791 U is ca冷外rried out at

temperatures according 刀船to the type of peroxide used.雨如

Once cured we remind you tha校朋t SILBIONE MM SER跳得IES 71791 U

must be post cured at 200°C in forced相吃 air ovens with 高章protected

heating elements.銀花

The post cure duratio文請n depends on the thickne弟術ss of the parts

obtained (moulded, extruded or c雨錯alendered).

Post curing gives the elas低姐tomer its optimum charact愛會eristics and ensu多南res

its conformity with the requiremen美日ts of the regulations current我司ly in force.

Important comments :

Post curing at a temperatur水件e above 200°C or any謝件 accidental increase in見資

temperature (e.g. to around 250東姐-300°C) can damage parts校北 causing

stiffening, cracking or f水通ormation of a surface glaze. I服什t is therefore

important to use good舊藍 temperature control toget紅子her with forced air

ventilation.

Non-ventilated 門學ovens or those with insuffici了農ent ventilation can c火吧ause

"reversion" t間器o occur : a reduction in hardness due t多和o the onset of

depolymerisation.

Important notice RHODIA SILICONES S議村AS guarantees t金好he properties give呢熱n for

SILBIONE MM SERIES 71791 U .

However, our compan看金y cannot guarantee t中多he behaviour of th鄉可is master

batch and the app些舊lication that is made 妹能of it by the user, since it has 人外no

control over the conditions of appli地行cation nor the proc計畫ess under which a

study has been conducted.

Packaging SILBIONE MM SER拍有IES 71791 U are 街有available in 25 kg reinforced

cardboard cartons. Each ma技農ster batch is enclosed in業黃 a release

coated sheet.

Storage and

shelf life

SILBIONE MM SERIES 71791 U may be stor通和ed in its original通器

unopened packagi也歌ng at a temperature below +40°C f她拍or up to 18

months from the date of manu水讀facture marked clearl歌雪y on the

packaging.

Past this date, Rhodia Silic慢那ones no longer g哥我uarantees that 議又the

product meets the sales specification坐女s.When kept in its original

unopened packaging,

According to the hard好業ness, it is rec制刀ommended to slightly refreshen

SILBIONE MM SERIES 71791拿資 U before using.

Comment : Prolonged storage beyond the在討 recommended expiry date

generally means a reduction in ha飛的rdness and an increase in refre日好shening

time

Safety Please refer to the 些照Safety Data She計如ets for SILBIONE MM SERI票自ES

71791 U .

Warning to users The informat民金ion contained in t我行his document is given in good f煙暗aith

based on our current knowledg他吃e. It is only an indication and is 街冷in no

way binding, parti服術cularly as regards infringement 愛家of or prejudice to

third party rights through the use 報得of our products.

RHODIA SILICONES GUARANTEES THAT ITS PR又冷ODUCTS

COMPLY WITH ITS SA信話LES SPECIFICATIONS.

This information 見劇must on no account be used 好樂as a substitute for

necessary prior 大地tests which alone 新資can ensure that a product is

suitable for a given u司現se.

Users are responsibl老對e for ensuring compliance with local le說外gislation

and for obtaining the nece些到ssary certifications and a身厭uthorisations.

Users are requeste紅南d to check that they are 拿算in possession of the

latest version of喝劇 this document and RHODIA SILICON車動ES is at their

disposal to supply 要哥any additional inform吧花ation.