08.11.2007 Ed.

17

Polypropylene

Bormed RF825MO
Description
Bormed RF825MO is a specially modified transparent polypropylene random copolymer with high meltflow. This
polymer grade is intended for production of medical and medical-related articles. It is characterized by easy
processability, high transparency, high gloss and good stiffness-impact balance. In addition it can be sterilized with
ethylene oxide or steam and has an excellent chemical resistance.
In addition to its good physical properties and excellent transparency, this grade also yields products with good
printability.

Applications
Needle hubs
Blood tubes
Urine tubes

Catheter connections
Caps and closures
Laboratory disposable

Special features
Easy processability
Improved gloss and excellent transparency
Very good stiffness and impact balance

High gloss
High chemical resistance
Good printability

Physical Properties
Property

Typical Value

Test Method

Data should not be used for specification work

Density
Melt Flow Rate (230 C/2,16 kg)
Tensile Modulus (1 mm/min)
Tensile Strain at Yield (50 mm/min)
Tensile Stress at Yield (50 mm/min)
1
Heat Deflection Temperature (0,45 MPa)
Charpy Impact Strength, notched (23 C)
Hardness, Rockwell (R-scale)
1

905 kg/m3
20 g/10min
1.150 MPa
12 %
28 MPa
80 C
6 kJ/m
90

ISO 1183
ISO 1133
ISO 527-2
ISO 527-2
ISO 527-2
ISO 75-2
ISO 179/1eA
ISO 2039-2

Measured on injection moulded specimens acc. to ISO 1873-2

Processing Techniques
Bormed RF825MO is easy to process with standard injection moulding machines.

Following parameters should be used as guidelines:

Melt temperature
Holding pressure
Mould temperature
Injection speed

220 - 250 C
200 - 500 bar
30 - 40 C
Medium to high

Bormed is a trademark of Borealis A/S, Denmark.

Borealis AG | Wagramerstrasse 17-19 | 1220 Vienna | Austria

Telephone +43 1 224 00 0 | Fax +43 1 22 400 333
FN 269858a | CCC Commercial Court of Vienna | Website www.borealisgroup.com

Page 1 of 3

Minimum to avoid sink marks.

08.11.2007 Ed.17

Polypropylene

Bormed RF825MO
Shrinkage 1 - 2 %, depending on wall thickness and moulding parameters

Storage
Bormed RF825MO should be stored in dry conditions at temperatures below 50C and protected from UV-light.
Improper storage can initiate degradation, which results in odour generation and colour changes and can have
negative effects on the physical properties of this product.

Safety
The product is not classified as a dangerous preparation.

Recycling
The product is suitable for recycling using modern methods of shredding and cleaning. In-house production waste
should be kept clean to facilitate direct recycling.
Please see our Safety Data Sheet for details on various aspects of safety, recovery and disposal of the product, for
more information contact your Borealis representative.

Related Documents
The following related documents are available on request, and represent various aspects on the usability, safety,
recovery and disposal of the product.
Safety Data Sheet
Recovery and disposal of polyolefins
Information on emissions from processing and fires
Statement on compliance to regulations on medical use
Statement on polymer additives and BSE
Statement on chemicals, regulations and standards

Borealis AG | Wagramerstrasse 17-19 | 1220 Vienna | Austria

Telephone +43 1 224 00 0 | Fax +43 1 22 400 333
FN 269858a | CCC Commercial Court of Vienna | Website www.borealisgroup.com

Page 2 of 3

08.11.2007 Ed.17

Polypropylene

Bormed RF825MO
Disclaimer
The product(s) mentioned herein are not intended for use as medical implant material or implantable
medical devices and we do not support their use for such applications.
To the best of our knowledge, the information contained herein is accurate and reliable as of the date of publication,
however we do not assume any liability whatsoever for the accuracy and completeness of such information.
Borealis makes no warranties which extend beyond the description contained herein. Nothing herein shall
constitute any warranty of merchantability or fitness for a particular purpose.
It is the customer's responsibility to inspect and test our products in order to satisfy itself as to the
suitability of the products for the customer's particular purpose. The customer is responsible for the
appropriate, safe and legal use, processing and handling of our products.
No liability can be accepted in respect of the use of Borealis' products in conjunction with other materials. The
information contained herein relates exclusively to our products when not used in conjunction with any third party
materials.

Borealis AG | Wagramerstrasse 17-19 | 1220 Vienna | Austria

Telephone +43 1 224 00 0 | Fax +43 1 22 400 333
FN 269858a | CCC Commercial Court of Vienna | Website www.borealisgroup.com

Page 3 of 3

08.01.2008 Ed.17

Polypropylene

Bormed RF825MO
STATEMENT ON COMPLIANCE TO REGULATIONS ON MEDICAL USE
We confirm that this product fulfils the requirements on materials used for articles or components of articles
intended for medical use as described in:

Council of Europe

European Pharmacopoeia, 6th edition (2008)

Monograph 3.2.2. Plastic containers and closures for pharmaceutical use

USA

The product has passed the United States Pharmacopeia testing including
Class VI tests and has been assigned the FDA Drug Master File.: DMF
12123.

Additional information

Material has succesfully passed the biological tests according to ISO 10993 external communicating devices for indirect blood contact for a prolonged
period.

Prepared by

Borealis Group Product Stewardship / Hanneli Seppnen

Disclaimer
The product(s) mentioned herein are not intended for use as medical implant material or implantable
medical devices and we do not support their use for such applications.
To the best of our knowledge, the information contained herein is accurate and reliable as of the date of publication,
however we do not assume any liability whatsoever for the accuracy and completeness of such information.
Borealis makes no warranties which extend beyond the description contained herein. Nothing herein shall
constitute any warranty of merchantability or fitness for a particular purpose.
It is the customer's responsibility to inspect and test our products in order to satisfy itself as to the
suitability of the products for the customer's particular purpose. The customer is responsible for the
appropriate, safe and legal use, processing and handling of our products.
No liability can be accepted in respect of the use of Borealis' products in conjunction with other materials. The
information contained herein relates exclusively to our products when not used in conjunction with any third party
materials.

Bormed is a trademark of Borealis A/S, Denmark.

Borealis AG | Wagramerstrasse 17-19 | 1220 Vienna | Austria

Telephone +43 1 224 00 0 | Fax +43 1 22 400 333
FN 269858a | CCC Commercial Court of Vienna | Website www.borealisgroup.com

Page 1 of 1

26.09.2007 Ed.6

Polypropylene

Bormed RF825MO
STATEMENT ON CHEMICALS, REGULATIONS AND STANDARDS
We certify, that during manufacturing of this product, we do not use or intentionally incorporate into it, any of the
chemicals as restricted by the following regulations and their subsequent amendments in amounts which exceed
the applicable limits.

Directive 76/768/EEC (cosmetic products)

Directive 76/769/EEC (to be superseeded from 01.06.09 by REACH Regulation 1907/2006/EC - Annex
XVII) - Marketing and use of certain dangerous substances and preparations

CONEG "Toxics in Packaging" Model Legislation, rev. 2004

Directive 94/62/EC (Packaging and packaging waste - PPW) and related EN13428 and CR13695
- Sum of Cd, Cr, Hg and Pb < 100 ppm

Directive 2000/53/EC (End of life vehicles - ELV) - Cr(VI), Hg and Pb < 0.1 wt%, Cd < 0.01 wt%)

Directive 2002/95/EC (Restriction of the use of certain Hazardous Substances in electrical and electronic
equipment - RoHS) - Cr(VI), Hg, Pb, PBB and PBDE < 0.1 wt%, Cd < 0.01 wt%

Directive 2002/96/EC (Waste Electrical & Electronic Equipment - WEEE) - Annex II - No ingredients used
which require selective waste treatment (As, Hg, PCB, PCT, CFC, HCFC, HFC, brominated FR)

Regulation 2005/1895/EC on the restriction of use of certain epoxy derivatives

- specific migration limits for BADGE, prohibition to use NOGE or BFDGE

Chemicals List of Proposition 65 of the State of California and subsequent amendments, as known to the
State of California to cause cancer

Regulation 2037/2000/EC (Marketing and use of Ozone layer depleting substances)

- Prohibition of CFC's, HCFC's, Halons, CCl4, Trichloroethane, HBFC's

US Clean Air Act, Title VI, Classes I and II (EPA Final Rule; Federal Register 8136, 11.2.1993) on
substances that deplete the ozone layer

Directive 2003/89/EC - Annex IIIa (Allergenes)

Swedish National Chemical Inspectorate's Observation List (1996) and List of Restricted Chemical
Substances in Sweden (1996), as amended in their PRIO Database

Global Automotive Declarable Substance List (GADSL) rev.3 (2007) and VDA232-101
- No use of prohibited or declarable substances above threshold limits

Swiss SR 814.018 (Verordnung ber die Lenkungsabgabe auf flchtigen organischen Verbindungen VOCV) - VOC's according to Annexes 1 & 2 < 3 wt%

"European Standard EN 71 "Safety of Toys", Part 3 (1994): "Migration of certain elements" - (Sb< 60;
As<50; Ba<1000; Cd< 75; Cr< 60; Pb< 90; Hg< 60; Se< 500 mg/kg toy material) and Part 9 (2005)
"Organic chemical compounds - Requirements" (none of the substances listed in Tables 2 A-I are
intentionally added).

Bormed is a trademark of Borealis A/S, Denmark.

Borealis AG | Wagramerstrasse 17-19 | 1220 Vienna | Austria

Telephone +43 1 224 00 0 | Fax +43 1 22 400 333
FN 269858a | CCC Commercial Court of Vienna | Website www.borealisgroup.com

Page 1of 3

26.09.2007 Ed.6

Polypropylene

Bormed RF825MO
Regarding classification of the above product according to the EU Directive 99/45/EC, which refers to Directive
67/548/EEC and subsequent amendments, reference is made in the SDS for the above product.

We also certify, that during the manufacturing of the above product, we do not use or intentionally incorporate into it
any of the following materials:

Acrylamide
Alkyltin compounds
Antimony, Arsenic, Beryllium, Bismuth
Aromatic Amines
Artificial Musks
Asbestos
Azocolorants (restricted)
BHA or BHT
Biocides (Pesticides, Herbicides, Insecticides)
Brominated flame retardants (e.g. PBB, PBDE)
Cadmium, Chromium (VI), Lead, Mercury
CFC, HCFC
Chlorinated hydrocarbons
Dioxines and furanes
2-EHA, Ethoxyquin, ITX, Thiuram
Formaldehyde
Genetically modified materials (GMO)
Gold, Indium, Nickel, Palladium

Natural rubbers, Latex

Octyl- or Nonylphenols or -phenolethoxylates;
TNPP
Pentachlorophenol (PCP)
Perfluorinated tensides - PFT (e.g. PFOA, PFOS)
Plasticisers (e.g. Adipates, ESBO, Phthalates)
Polychlorinated Bi- or Terphenyls (PCB/PCT)
Polycyclic aromatic hydrocarbons (PAH)
Radioactive substances
Recycled materials
Selenium, Silver, Tellurium, Thorium
Substances dangerous for the environment,
marked with "N" in Directive 67/548/EEC
UV-hardeners (e.g. ITX, Titanyl-acetylacetone)
Vinylchloride, Vinylidenechloride, PVC or PVDC

The use of DEP, DEHP or DIBP in the catalyst system may result in traces of these phthalates in the product,
typically in concentrations below 1 ppm.
The substances used in the manufacturing of the above product, and - so far covered - the basic polymer(s), are
listed in the following chemical inventories:
Australia/AICS
Canada/DSL and NDSL
China/IECSC
Korea/KECL

Prepared by

Borealis Group Product Stewardship / Barbara Splechtna

Borealis AG | Wagramerstrasse 17-19 | 1220 Vienna | Austria

Telephone +43 1 224 00 0 | Fax +43 1 22 400 333
FN 269858a | CCC Commercial Court of Vienna | Website www.borealisgroup.com

Page 2of 3

26.09.2007 Ed.6

Polypropylene

Bormed RF825MO
Disclaimer
To the best of our knowledge, the information contained herein is accurate and reliable as of the date of publication,
however we do not assume any liability whatsoever for the accuracy and completeness of such information.
Borealis makes no warranties which extend beyond the description contained herein. Nothing herein shall
constitute any warranty of merchantability or fitness for a particular purpose.
It is the customer's responsibility to inspect and test our products in order to satisfy itself as to the
suitability of the products for the customer's particular purpose. The customer is responsible for the
appropriate, safe and legal use, processing and handling of our products.
No liability can be accepted in respect of the use of Borealis' products in conjunction with other materials. The
information contained herein relates exclusively to our products when not used in conjunction with any third party
materials.

Borealis AG | Wagramerstrasse 17-19 | 1220 Vienna | Austria

Telephone +43 1 224 00 0 | Fax +43 1 22 400 333
FN 269858a | CCC Commercial Court of Vienna | Website www.borealisgroup.com

Page 3of 3

PC

05.07.2007 Ed.19

Polypropylene

Bormed RF825MO
STATEMENT ON COMPLIANCE TO FOOD CONTACT REGULATIONS
We confirm that this product fulfils the requirements on materials used for articles or components of articles
intended to come into contact with food as described in:

Austria
Belgium
The Czech Republic
Denmark
EU
Finland
France
Germany

Great Britain

Italy
The Netherlands
Norway
Portugal
Spain
Sweden
Switzerland
USA

Kunststoffverordnung Nr. 476/2003 und nderungen 242/2005 und

452/2006
Koninlijk Besluit - Arrt Royal du 3 juillet 2005 (M.B. 29.07.2005)
Vyhlaska Ministerstva zdravotnictvi c. 38/2001 Sb, c. 186/2003 Sb, c.
207/2006 Sb
Fdevaredirektoratets Bekentgrelse nr. 1102 (09.11.2006)
Regulation (EC) No 1935/2004 and Commission Directive 2002/72/EC
amendmend by 2004/1/EC, 2004/19/EC, 2005/79/EC and 2007/19/EC
KTM Asetukset 953/2002, 141/2005, 181/2005 ja 762/2006
Repression des Fraudes (2002), No 1227, et Arrt du 2 janvier 2003, Arrt
du 29 mars 2005, Arrt du 9 aout 2005 et Arrt du 19 octobre 2006
Bedarfgegenstndeverordnung 23.12.1997 und nderungen vom 21.
Dezember 2000, 7. April 2003, 13. Juli 2005, 30. November 2006 und 20.
Dezember 2006 sowie BfR-Empfehlungen
A VII, Polypropylen, Stand. 1.4.2006
England: Statutory Instrument 2006 No. 2687; Northern-Ireland: Statutory
Rule 2006 No. 420; Scotland: Statutory Instrument 2006 No. 517; Wales:
Statutory Instrument 2006 No.2982 and BPF-BIBRA (1995),
Polymer Specification 5, Polypropylene
Decreto Ministeriale n.220, 26.04.1993 and subsequent amendmends (last
update: D.M. n.227 of 04.05.2006) and D.M. n.34, 21.03.1973
Warenwet (2006), Hoofdstuk 1, Kunststoffen
Sosial- og helsedepartementets forskrift 1993-12-21-1381
Decreto-Lei n. 4/2003 de 10 de Janeiro de 2003
Real Decreto 118/2003, R.D.1262/2005, SCO/3508/2006 y ANAIP (1982),
Anexo 1, Anexo 4
Statens Livsmedelsverks kungrelse LIVSFS 2003:2 och ndr. LIVSFS
2004:31, 2005:14, 2005:28, 2006:6, 2006:20
Verordnung der EDI ber Bedarfsgegenstnde 23.11.2005 und nderung
vom 15.11.2006, 3. Abschnitt Bedarfsgegenstnde aus Kunststoff
FDA, CFR, Title 21 (2007),
177.1520 (a)(3)(i)(c)(1), (b) and (c)3.1a Olefin polymers

Bormed is a trademark of Borealis A/S, Denmark.

Borealis AG | Wagramerstrasse 17-19 | 1220 Vienna | Austria

Telephone +43 1 224 00 0 | Fax +43 1 22 400 333
FN 269858a | CCC Commercial Court of Vienna | Website www.borealisgroup.com

Page 1

PC

05.07.2007 Ed.19

Polypropylene

Bormed RF825MO
Migration limits

Used monomers and additives are not regulated with specific migration limits.
Substances authorised as food additives are not present in the end product in
such quantities that migration to foodstuffs could exceed the limits set in the
relevant food legislation or have a technological function in the final food.

Prepared by

Borealis Group Product Stewardship / Jrgen Emig

Disclaimer
To the best of our knowledge, the information contained herein is accurate and reliable as of the date of publication,
however we do not assume any liability whatsoever for the accuracy and completeness of such information.
Borealis makes no warranties which extend beyond the description contained herein. Nothing herein shall
constitute any warranty of merchantability or fitness for a particular purpose.
It is the customer's responsibility to inspect and test our products in order to satisfy itself as to the
suitability of the products for the customer's particular purpose. The customer is responsible for the
appropriate, safe and legal use, processing and handling of our products.
No liability can be accepted in respect of the use of Borealis' products in conjunction with other materials. The
information contained herein relates exclusively to our products when not used in conjunction with any third party
materials.

Borealis AG | Wagramerstrasse 17-19 | 1220 Vienna | Austria

Telephone +43 1 224 00 0 | Fax +43 1 22 400 333
FN 269858a | CCC Commercial Court of Vienna | Website www.borealisgroup.com

Page 2 of 2

09.07.2007 Ed.9

Polypropylene

Bormed RF825MO
STATEMENT ON POLYMER ADDITIVES AND BSE
In this product we incorporate small amounts of stearates or other materials derived from fatty acids.
These are derived from fat, mainly from animal origin. The following can be stated about the fat delivery
chain:
Our suppliers guarantee that their fat supply comes from countries with no BSE and that specific risk
materials are not used. Thus the requirements of the Commission Decisions 2000/418/EC and
2001/2/EC regulating the use of materials presenting risks as regards transmissible spongiform
encephalophathies (TSE) are fulfilled.
The process of making stearates include hydrolysis, esterification and hydrogenation steps in
different variations depending on the supplier. The common features are that these steps include
processing conditions with temperatures above 235 oC, pressures above 30 bars with retention
times up to several hours. The final product is obtained through fractionation, neutralisation and
purification.
The subsequent extrusions at our factory granulator and when producing the product take place at
200 oC for several minutes.
The production chain of stearates thus far exceeds the stringent requirements of 200 oC for 20 minutes
in Annex II of the EU Directive 99/534/EC, in EU Directives 2000/6/EC and 1999/82/EC (referring to
Document EMEA/410/01-Final, latest version: Rev. 2 October 2003) and in the Report
WHO/CDS/VPH/95.145, meaning that any virus, bacteria or substance causing immunological diseases
(TSE; BSE, CJD) is destroyed.
In the FDA document FR Doc 04-15881 (14.07.2004) on Use of materials derived from cattle in human
food and cosmetics tallow derivatives are excluded from Prohibited cattle materials
We therefore state that these materials and our product are to be considered safe to use in food,
pharmaceutical and cosmetic contact applications with respect to BSE and TSE transmissions.

Prepared by

Borealis Group Product Stewardship / Jrgen Emig

Bormed is a trademark of Borealis A/S, Denmark.

Borealis AG | Wagramerstrasse 17-19 | 1220 Vienna | Austria

Telephone +43 1 224 00 0 | Fax +43 1 22 400 333
FN 269858a | CCC Commercial Court of Vienna | Website www.borealisgroup.com

Page 1 of 2

09.07.2007 Ed.9

Polypropylene

Bormed RF825MO
Disclaimer
To the best of our knowledge, the information contained herein is accurate and reliable as of the date of
publication, however we do not assume any liability whatsoever for the accuracy and completeness of
such information.
Borealis makes no warranties which extend beyond the description contained herein. Nothing
herein shall constitute any warranty of merchantability or fitness for a particular purpose.
It is the customer's responsibility to inspect and test our products in order to satisfy itself as to
the suitability of the products for the customer's particular purpose. The customer is
responsible for the appropriate, safe and legal use, processing and handling of our products.
No liability can be accepted in respect of the use of Borealis' products in conjunction with other
materials. The information contained herein relates exclusively to our products when not used in
conjunction with any third party materials.

Borealis AG | Wagramerstrasse 17-19 | 1220 Vienna | Austria

Telephone +43 1 224 00 0 | Fax +43 1 22 400 333
FN 269858a | CCC Commercial Court of Vienna | Website www.borealisgroup.com

Page 2 of 2