Applicable standards for CE marking of Spinal Intervertebral Body Fixation Devices

#1
Can anybody help me to identify applicable harmonized standards CE marking of "Spinal Intervertebral Body Fixation" device , there are not much standards related to spine implants are available in the harmonized standard list.
 
Elsmar Forum Sponsor

bio_subbu

Super Moderator
#2
Re: Applicable standards for CE marking of Spinal Intervertebral Body Fixation Device

Can anybody help me to identify applicable harmonized standards CE marking of "Spinal Intervertebral Body Fixation" device , there are not much standards related to spine implants are available in the harmonized standard list.
The use of European Harmonized Standards application is voluntary, if you do not found any relevant standards in the EU harmonized standards list, you may want to choose an alternative route to use applicable International Standards such as EN, CEN, ISO or IEC standards to justify the relevant ERs are satisfied in order to meet the mandatory essential health and safety requirements. Notified Bodies verify the appropriateness of the standards used when conducting evaluation.
 

somashekar

Staff member
Super Moderator
#3
Re: Applicable standards for CE marking of Spinal Intervertebral Body Fixation Device

ASTM F565-04 (Reapproved 2013) Standard Practice for Care and Handling of Orthopedic Implants and Instruments
ASTM F2193-02 (Reapproved 2007) Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
ASTM F1798-13 Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants
ASTM F1717-14 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
ASTM F983-86 (Reapproved 2013) Standard Practice for Permanent Marking of Orthopaedic Implant Components
>
>>
>>>
These may be helpful to you
 
#4
Re: Applicable standards for CE marking of Spinal Intervertebral Body Fixation Device

thanks a lot subbu & somashekar.

I also found these ASTM standards in FDA Recognized Consensus Standards, but was not sure whether i can use this for the CE Marking purpose. so now i believe that we can use this o justify the relevant ERs.
 
Thread starter Similar threads Forum Replies Date
C Does a CE mark infer meeting all applicable standards? CE Marking (Conformité Européene) / CB Scheme 4
DuncanGibbons To what extent are NASA standards applicable to commercial aviation? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
N Class I 510(k) exempt - Applicable Standards 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
B Standards Needed In House - Determining what standards are applicable Various Other Specifications, Standards, and related Requirements 3
C Gynecology Chair - Applicable EU Standards EU Medical Device Regulations 10
R Applicable Medical Device Standards for Home Use Blood Pressure Devices IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
B IVD Laboratory Blood Processor - Applicable standards? IEC61010-1, -2-101? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
N ISO Standards Applicable to Our Kind of Work? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Searching for applicable Standards for a Medical Device using electronics, software Other Medical Device Related Standards 11
J Aviation Safety Standards applicable to operation and maintenance Federal Aviation Administration (FAA) Standards and Requirements 2
K Review of applicable standards - How to make sure new rev is only a reaffirmation? Quality Manager and Management Related Issues 4
D Suppliers and all applicable standards - Supplier Surveys Supplier Quality Assurance and other Supplier Issues 8
J ISO 13485:2003 Clause 1.3 - Applicable Standards and Regulations ISO 13485:2016 - Medical Device Quality Management Systems 8
Q Matrix of Standards Clauses to applicable System and Process Hierarchy General Auditing Discussions 1
C Applicable standards EC type examination - Sterile plastic nebulizers ISO 13485:2016 - Medical Device Quality Management Systems 1
A Interpretation of GMP Requirements for class 1 medical device manufacturer (device GMP exempt, only General controls applicable) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
R Machine directory (2006/42/EEC) is applicable or not Other Medical Device Related Standards 0
R An indication that the device is a medical device (MDR, Annex 23.2q) - applicable for accessories? EU Medical Device Regulations 5
N Is capability applicable for a destructive test? Capability, Accuracy and Stability - Processes, Machines, etc. 9
DuncanGibbons Are the IQ OQ & PQ procedures applicable to the aerospace industry? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
G App - Local regulations applicable EU Medical Device Regulations 2
M Do you need an Applicable general safety and performance requirements Checklist? EU Medical Device Regulations 2
S SOPs applicable for Regulatory Affairs department Other ISO and International Standards and European Regulations 1
DuncanGibbons Who are ISO/IEC 17065 and 17025 applicable to? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
G Is impact test according to IEC 60601-1 applicable for HAND-HELD equipment if also classified as BODY-WORN? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
B EU MDR Quality System Requirements - Applicable to Class I? EU Medical Device Regulations 5
R CQI-15 for ultrasonic welding splices on wiring harness, is applicable? Customer and Company Specific Requirements 2
C Is IEC 60601 applicable to our smart bed? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
D Applicable MDR Annex's for Class IIa Medical Devices EU Medical Device Regulations 0
M Dilemma about choosing the most applicable clause related to Risk ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
B Does EMC Directive 2014/30/EU cease to apply when the Machine Directive 2006/42/EC is applicable? CE Marking (Conformité Européene) / CB Scheme 4
D Control chart applicable? Percentage of compliance with a standard Statistical Analysis Tools, Techniques and SPC 2
M Accelerated Ageing Test for Orthopedic Implants -- ASTM F 1980 or ISO 11607 or both are applicable ? Other Medical Device and Orthopedic Related Topics 2
Z CQI-15 Welding System Assessment - Robotic Ultrasonic Foam onto Plastic "Weld" applicable? Various Other Specifications, Standards, and related Requirements 3
M CEP requirements in MEDDEV 2.7/1, rev 4 and MDR - Are all MEDDEV requirements still applicable? EU Medical Device Regulations 7
MrTetris GDPR - General Data Protection Regulation - Only applicable to EU data? Other ISO and International Standards and European Regulations 6
qualprod Only manufacturing, non applicable - ISO 9001 Clause 8.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
K Assigning the Correct Procedures Applicable to Job Titles General Auditing Discussions 15
L Pneumatic powertool (Drill) - Is IEC 60601-1 applicable? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Q Applicable Medical Device Wifi regulations for various Countries Other Medical Device Regulations World-Wide 7
pcoltsqe AS9100 - The statement 'applicable statutory and regulatory requirements' AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
qualprod Is it a NC, if a clause is not declared as non applicable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A ISO 13485:2016 Applicable regulatory requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
R ISO 9001:2015 Clause 7.1.5.2 - Is Measurement traceability applicable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
T To Identify the Applicable MDD Directive - Prepared blood smear EU Medical Device Regulations 13
qualprod Non applicable clauses in a reseller? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
T IATF16949:2016 8.7.1.4 Control of non-applicable reworked product IATF 16949 - Automotive Quality Systems Standard 3
M ISO13485:2016 - Exemption vs. Not Applicable ISO 13485:2016 - Medical Device Quality Management Systems 16
Y ISO 9001 Cl. 8.3 - Design and Development of Products and Services not applicable ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
1 Applicable ISO 9001:2015 Clauses for Remote Site(s) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1

Similar threads

Top Bottom