Description SILBIONE MM 書師SERIES 71791 U are si計線licone rubbers which cure

after addition of a vulcanising age能裡nt (chosen as a 放子function of the

production process).

This series includes four products 能睡which differ by their har海習dness

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

Once processed SILBIONE M姐快M SERIES 71791 U , &qu飛房ot;Food contact

and biomedical grade" are intended水刀 for:

· biomedical appl門知ications

· applications requiring a material 船工that is non-toxic under no謝姐rmal

conditions of use and inert 要裡to food products.

SILBIONE MM SERIES 71791 道學U , are elastomers comp電近rising

polymethylvinylsiloxane gu公但ms and silica. They 學國heat cure after

addition of an organic peroxide紙志 compound. This vulcanisation must

be followed by post curi視風ng at 200°C.

Special properties · Easy proces生音sing

· Highly transparent

· Excellent mechanical properties, 裡睡including high te農很ar strength

and a good compromise bet微風ween tear stren中高gth and

compression set

· Very good resistanc一開e to oxidising agents (oxygen, ozo子相ne, UV)

· Very good behaviour for all 站靜sterilisation modes

· Very good release 可著properties

· Chemically inert

Regulations The com雪什position of SILBIONE MM S地拍ERIES 71791 U enables them to

be used in conformity with the def票時initions in the following European a如我nd

American regulations.

Food contact:

France : Journal Officiel 和雜– Brochure 1227– order dated 喝時25 November

1992.

Germany : BGVV XVA and兵問 LIIA.

United States : : US- FDA- CFR 2明個1- part 177. 2600.

Italy : Gazetta U坐分fficiale – law dated 1973 and addend去能um.

Moreover, samples of SILBIONE MM SE視懂RIES 71791 U, catalysed街時

with dichloro- 2,時制 4 benzoyle peroxide, have been su校海bject to

migration tests in accordance with Euro空這pean regulations: Directives

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

21- part 177. 2600.

Regulations Drinking w遠吃ater contact

SILBIONE MM SERIES 71791 U 說舞of hardnesses 50 and暗煙 60 ShA, have

been successfully proven to b文下e in conformity with German KTZ

regulation part 資黃1.3.13.

Medical devices.

Basic biological stu黃南dies; cytotoxicity, irritation, s答上ensitisation and

hemocompatibility, required by directi北上ve 93/42 CE dated時為 June 14

1993, relative t光上o medical device的服s and USP Class VI費工 of US, have

been carried out on samples of SI他花LBIONE MM SERIES 71791 U雪高 ,

catalysed using dichloro 2,4 b從司enzoyle peroxide.

The summaries of the biologica快信l studies are available on requ員都est.

In all cases it is th空知e finished article manufacture她就r’s

responsibility to 姐場check conformity with the tests imp少呢osed by

the appropriate regulations.

For medical applications, 做來Rhodia Silicones SAS forbids th月工e

commercialisation of these elastomers 拿票for the production of

medical devices:

· implanted for more than訊線 29 days

· in contact for more than 29 days廠對 with blood and the

mucous membranes (c爸銀ontraception, o雜線bstetrics)

· for plastic surg木歌ery

Applications SILBIONE MM SERIES 717了火91 U , once cataly信章sed and processed is

recommended for the manufacture of民站 the following articles:

Those which enter in contact笑市 with food such as :

· Tubes for drink distribution, i兵頻ncluding potable water

· Baby’s bottle錢近 tops

· Various technical parts.

· Sections, sleeves, calen的老dered sheets, belts and conve低和yor belts

Those used in pharmacy su畫但ch as:

· Tubes and pipi和做ng for the circ樹師ulation of liquid o水南r soluble

medicines

· Medicine conveyor belts, etc.

Those used for medical applicat月你ions such as:

· Tubes and piping for extra-cor草還poral circulation笑和

· Oxygenotherapy tubes

· Self-injectable syringe seals

· Breathing masks

Quality Assurance 1- Manuf多得acture

Rhodia Silicone我讀s takes particular car我車e in manufactur兵如ing and quality

control in order to guarantee u物司sers with the supply of文自 an elastomer

whose quality level is in conformity w木人ith the special requirements in樹能

these types of application:

· lack of cross-pollution.

· high level filtration.

· Specific controls.

All of these operations are part o體和f Rhodia Silicones’ quality control

policy, certified to ISO 900他輛1.

Quality Assurance 2- 藍近Control

Specific controls 年友are carried out on eac喝遠h batch of SILBIONE MM

SERIES 71791 U to meet the various r少機egulations.

The results are written美水 on the analytical test ce又黃rtificate in addition to

the mechanical characteristics.

SPECIFICATION FOOD GRADE ME水就DICAL GRADE

ON POST CURED VULCANISED PRODUC匠視T

Identity : IR Spectrum In Conformity m還但 m

Volatile content (%):

(200°C-10g-4h)

0.5 maxi. m

Residual peroxides (%) 唱輛0.08 maxi. m

Mineral oils (fluorescence) In Co電村nformity m

ON AQUEOUS EXTRACT

Turbidity (NTU) 4快山 maxi. m

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

Acidity (ml 0.01M NaOH) 1.畫要5 maxi. m

Reducing substances

(ml 0.01 M Na2 SO3)

1 maxi m

ON HEXANE EXTRACT

Hexane soluble (%) 3 max不場i m m

Phenyl compounds (DO/UV) 0.家外4 maxi. m

Heavy metals (ppm) (other than

aqueous extract)

10 maxi m

Processing methods The choic見著e of vulcanisin離鐵g agent (peroxide) to add to the員長 SILBIONE

MM SERIES 71791村雨 U depends on the proc厭綠essing method and the

conformity with va能都rious “Food contact grade” regul影山ations.

The various processing methods are su兵窗mmarised in the table

below:

SILBIONE

MM SERIES 71791 U

Dichloro- 2, 4 benzoyle我討

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 10懂飛0

master batch

0.6 parts per 100

master batch

hot air vulcanisation 0.9 t影短o 1.25 parts per 100

master batch

6 to

12 bar

0.6 parts per 100

Extrusion pressurised ma文街ster batch

steam

vulcanisation

12 to

20 bar

0.6 parts per 100

master batch

Calandering hot ai子離r vulcanisation

0.9 to 1.25 part妹好s per 100

master batch

Characteristics 1- Physical properti用友es

Type (according to AFN關農OR T 40002)....... ................音農.................MVQ

Hardness Specific gravity at 25 ° C機離, approx.

40 ShA 1.10

50 ShA 1.13

60 ShA 1.15

70 ShA 1.18

Characteristics Natural co機生lour............錢文............. .........................媽算...............Transparent

2- Mechanical pr司家operties

Below we give an example of the c我拿haracteristics obtain一視ed using

dichloro- 2, 4 benzoyle pe懂路roxide (at 50%) as a vu刀為lcanising agent.

Measurements are made on a可微 2 mm thick moulded sheet, 子用cured for

8 min at 115°C and po那著st cured for 4 hours at 200°C.

SILBIONE MM SERIES 71791 U 71 791/40他習 U 71 791/50 U 71 做知791/60 U 71 791/70分麗 U

Peroxide dose in parts 能學per 100 of master batch 0煙見.9 1 1.25 1.25

ShA hardness , points, approx

(Standard ASTM D 2240)

43 53 62 72

Tensile strength, MPa, appro暗林x,

(Standard AFNOR NF T 46- 002)

9.0 9.5 10 9.5

Elongation at break, %, appro體麗x,

(Standard AFNOR NF T 46- 00還朋2)

600 640 500 410

Tear strength, k和司N/m, approx,

(Standard ASTM D 624 A)

31 38 38 34

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

(Standard ASTM D 395 B)

27 34 40 40

Rebound resilience (thickness票間 8 mm), %, approx,

(Standard DIN 53 5弟海12)

50 45 42 37

Linear shrinkage %, appro年都x, 3.5 3.7 3.7 4.0

SILBIONE MM SERIES 71791 U must be po拍裡st cured at 200樂業°C

after vulcanisation (it is recommended間白 not to exceed this

temperature).

Post curing is essential i體志n order to :

· Ensure conformity with the你明 legislation and regulati音雜ons currently

in force

· Stabilise the m器如echanical properties o可弟f the elastomer as well a制書s

its dimensions

· Ensure the hea媽銀t stability of the elastome城還r

· Improve its chemical resistance, es年視pecially with respect to

solvents, fats and steam

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

This operation is performed on a two-ro廠熱ll mixing mill.

Operating procedure :

à Check that the equipmen南大t is scrupulously 河飛clean in order to avoi風麗d

including impuritie老那s that would detract from the quality a票器nd properties of

the SILBIONE MASTER BATCH.

à Plasticise the SILBIONE MASTE科學R BATCH.

Use of a back / front roller spee說很d ratio of between 1.25 and 1.4 ens了內ures

sufficient friction to giv雜船e good plasticising.

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

à Cool the cylinders th相城roughout the operat友到ion in order to 快友maintain the

SILBIONE MASTER BATCH at a temper會女ature below 30°上黑C;

In the case of catalysis using 多海crystalised dicumyl peroxide,請但 after

dispersion it is recommended to heat兒影 the elastomer to 50為東°C to ensure the

fusion of the peroxide,上下 then to cool to 30° once full時和y incorporated.

2- Processing

SILBIONE MM SERIES 71791 U obtai見花ned in this way can be

processed using all conventional 東工methods in the rubber proces票火sing

industry used for tr書放aditional materials.

Processing In this way, using 窗討SILBIONE MASTER BATCH plasticise視聽d on a

two-roll mixing mill, we could:

à Either roll a sheet t問離o the required thickness他務 from which we will cut

preforms for mo暗站ulding.

à or cut bands tha雜弟t will be used for example to feed 厭生an injection pre她家ss or

to prepare sheet開訊s for calendering.

3- Vulcanisation 老計and post curing

Vulcanisation o站公f SILBIONE MM SERIES 71791 U is carri風生ed out at

temperatures accord年能ing to the type of per志見oxide used.

Once cured we remi還間nd you that SILBIONE還影 MM SERIES 71791 U術跳

must be post cured at 200°C in forced a又市ir ovens with protect開熱ed

heating elements.

The post cure duration depends 化不on the thickness of the parts

obtained (mould飛我ed, extruded or calen拿票dered).

Post curing gives the elastomer its o老子ptimum characteristics and ens短店ures

its conformity with the r短東equirements of the regulations curr理錯ently in force.

Important comments :

Post curing at a temperature above風朋 200°C or any acc和國idental increase in

temperature (e.g. to 金數around 250-300°C) can damage par務煙ts causing

stiffening, cracking or f車文ormation of a surface glaze. It學錢 is therefore

important to use good temperature contr你們ol together with forced a訊作ir

ventilation.

Non-ventilated ovens or those with 業知insufficient ventilat下子ion can cause

"reversion" to occur : a 日黃reduction in hardnes數是s due to the onset of

depolymerisation.

Important notice R劇他HODIA SILICONES SAS guaran人村tees the properties given for到喝

SILBIONE MM SERIES 71雜多791 U .

However, our company cannot guarantee 技冷the behaviour of this master

batch and the application th的讀at is made of it by姐兵 the user, since it has no

control over the conditions of applica爸友tion nor the process under which a

study has been conducted.

Packaging SILBIONE MM SERIES 71791 U a雨視re available in 25 kg reinfor雪少ced

cardboard cartons. Each master batch綠舊 is enclosed in a release

coated sheet.

Storage and

shelf life

SILBIONE MM SER一些IES 71791 U may b大很e stored in its o你服riginal

unopened packaging at a temp用腦erature below +40°C for up to 1什媽8

months from the date of manufacture很村 marked clearly on the

packaging.

Past this date, Rhodia Silicones 務學no longer guarantees that th道黑e

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

unopened packaging,

According to the hardness, it is recom高河mended to slightly refreshen

SILBIONE MM SERIES 7音東1791 U before using.

Comment : Prolonged st的章orage beyond the但音 recommended expiry date

generally means下舊 a reduction in hardness an數秒d an increase in refreshening

time

Safety Please refer to the Safety Data吃時 Sheets for SILBIONE MM SERIES

71791 U .

Warning to users The 答志information contained in this documen學醫t is given in good faith

based on our current knowledg風美e. It is only an indication an快這d is in no

way binding, particularly as regards動雪 infringement of 靜關or prejudice to

third party rights 間哥through the use of空對 our products.

RHODIA SILICONES GUARANT個廠EES THAT ITS PRODUCTS

COMPLY WITH ITS SALES 內西SPECIFICATIONS.

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

necessary prior tests whi刀小ch alone can ensure that a produ中道ct is

suitable for a given北輛 use.

Users are responsible for ensuring 湖章compliance with lo照務cal legislation

and for obtaining the necessary ce輛體rtifications and authorisatio些子ns.

Users are requested to check that 司了they are in poss腦作ession of the

latest version of th弟是is document and RHODIA 愛白SILICONES is at their

disposal to supply a術看ny additional info多做rmation.