Natural Rubber / Latex Product CE Marking - Requirements

mpfizer

Involved In Discussions
#1
Natural rubber / latex products being cytotoxic can be they be CE marked and if yes how does one mitigate the risk.

Thanks

Regards

michelle
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
Natural rubber / latex products being cytotoxic can be they be CE marked and if yes how does one mitigate the risk.

Thanks

Regards

michelle
There are no current EU limitations posed specifically on devices containing latex / natural rubber. The risk is mitigated through biological evaluation (eg ISO 10993) and general risk management - refer to the MDD ERs.

The upcoming EU MDR will require manufacturers to notify the (future) UDI database whether a device contains latex or not.

According to the FDA, "Contact with devices containing natural rubber has been associated with anaphylaxis in individuals allergic to natural rubber latex proteins" (https://www.fda.gov/downloads/medic...onandguidance/guidancedocuments/ucm342872.pdf). Did you encounter cytotoxicity issues during actual testing?
 
Last edited:

mpfizer

Involved In Discussions
#3
YES, we did encounter cytotoxicity issues during biocompatibility testing.

we have been informed that natural rubber latex is cytotoxic in nature
 
Thread starter Similar threads Forum Replies Date
S Recurring Natural Disasters in Contingency Plans - What's the point? IATF 16949 - Automotive Quality Systems Standard 7
V Query on PA66+GF15% - Color variation (Natural to Yellowish) problem Manufacturing and Related Processes 20
M Definition Recurring Natural Disasters - IATF 16949 Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
Moncia Definition Natural, Synthetic definitions needed as in ISO 9235 Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 1
M Is it possible to get Natural Tolerance (Tn) with Non Normal Distribution? Statistical Analysis Tools, Techniques and SPC 9
S Natural Gas Power Plant - Aspects & Impacts Miscellaneous Environmental Standards and EMS Related Discussions 8
D ISO TS 29001 (Petroleum Petrochemical Natural Gas) - Internal Audit Checklist example Other ISO and International Standards and European Regulations 3
S How to control aspects related to natural resource depletion? Miscellaneous Environmental Standards and EMS Related Discussions 14
R Improving our ISO 9004 score with respect to Natural Resources ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
K Any adhesive needed for PVC and PC natural bond? ISO 13485:2016 - Medical Device Quality Management Systems 1
Marc Is the cost of energy (gasoline, electricity, natural gas, etc) affecting you? Coffee Break and Water Cooler Discussions 24
K Contingency Plans - Does TS16949 require natural disasters be included? IATF 16949 - Automotive Quality Systems Standard 11
Q Natural process limits for quality metrics. Do you use them? Quality Tools, Improvement and Analysis 3
R ISO/TS 29001:2003 - Petroleum, Petrochemical and Natural Gas Industries Other ISO and International Standards and European Regulations 22
Claes Gefvenberg Your description of a natural born auditor? General Auditing Discussions 14
J ISO 14001 - What Data to Use to Set Targets for Natural Resources Use Miscellaneous Environmental Standards and EMS Related Discussions 14
J ISO 9001:2000 - 6.7 Natural resources - Resource costs?? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
V MVT(Multivariable Transmitter) accuracy- AGA3 and AGA8 calculations for Natural Gas General Measurement Device and Calibration Topics 1
E Does CQI-23 (Molding Sys. Asses.) apply to RUBBER molding? IATF 16949 - Automotive Quality Systems Standard 2
A Tensile Strength Testing of Rubber Underwear Manufacturing and Related Processes 2
V Query on Rubber products (EPDM, Silicone, BR, NBR, Neoprene, TPE) Manufacturing and Related Processes 5
S Cell Rubber Stamping PPM for Scrap Analysis Quality Tools, Improvement and Analysis 1
M Genuine Signatures vs. Rubber Stamp (Approval) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
AnaMariaVR2 DIY Fixes Don't Meet CGMP: FDA Slams Manufacturer for Fixes Involving Tape, Rubber Ba Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
QMMike Cross sectioning (wafering?) saw for rubber and plastics Manufacturing and Related Processes 3
triathlonx13 Rubber - Tear and Adhesion Strength Peel Cross Head Speed Design and Development of Products and Processes 3
J Sourcing Rubber or Silicone Electrodes for Medical Device Other ISO and International Standards and European Regulations 2
N Why Would Produced Rubber Product Smell Like Diesel? Manufacturing and Related Processes 13
J AS9100 C - Is Molding of Rubber Parts a Special Process (7.5.2)? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
J Related Websites for Rubber Information, Rubber Products, Rubber Industries Book, Video, Blog and Web Site Reviews and Recommendations 3
T ISO 2230 (Guidelines for Storage of Rubber Products) - Temperature, Humidity & Light Other ISO and International Standards and European Regulations 8
J ISO 48 - Rubber: Vulcanized or Thermoplastic Other ISO and International Standards and European Regulations 1
O Product Audit for Rubber Parts for Automotive Industry IATF 16949 - Automotive Quality Systems Standard 3
Rameshwar25 Who has Design Responsibility in this Scenario - Rubber Parts Manufacturer IATF 16949 - Automotive Quality Systems Standard 23
P Visual Inspection Device for Tiny Rubber Parts General Measurement Device and Calibration Topics 10
D ISO 594-1 Female Conical Fitting Mount or Rubber Bung" Qualification in ISO 8537:2007 Other Medical Device Related Standards 6
P Capability Study for a Specific Thickness of Rubber Sheeting Capability, Accuracy and Stability - Processes, Machines, etc. 6
S Calibration Laboratory Technician and QA Rubber Stamps: Pro or con? General Measurement Device and Calibration Topics 5
N ISO 34: Rubber, vulcanized or thermoplastic - Determination of tear strength Other ISO and International Standards and European Regulations 1
F Inspection Companies in China - Rubber and Welding Manufacturing Process Inspection, Prints (Drawings), Testing, Sampling and Related Topics 2
A Cause and Effect Analysis - Hardness of Rubber (i.e., durometer) Quality Tools, Improvement and Analysis 11
V 'SCORCHING' and Under Cure in Extruded Rubber Products (Seals) Manufacturing and Related Processes 4
A I need some quality manuals for quality system - Tire or polymer and rubber industry Quality Management System (QMS) Manuals 1
G Definition ASTM D624 - Test Method for Tear Strength of Vulc. Rubber & Thermo. Elastomers Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 1
ScottK Customer requiring that we "rubber stamp" our C of C's for them... Records and Data - Quality, Legal and Other Evidence 10
S RUBBER PART has a special strong smell - Over-moulding with NBR rubber Manufacturing and Related Processes 4
ScottK Rubber O-Ring Inspection Standard - SAE J515? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
H Quality Control for Rubber Mixing and/or link to related forum Inspection, Prints (Drawings), Testing, Sampling and Related Topics 27
P ASTM D 380 Clause 16.1 - Methods of Burst Testing Rubber and Plastic Hoses Various Other Specifications, Standards, and related Requirements 3
R Source of 1/2" - 9/16" Round Rubber Inspection Stamps Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5

Similar threads

Top Bottom