SBS - The best value in QMS software

Is Compliance Testing of IEC 60601-2-63 mandatory for Europe - Dental X-Ray machine

Kuldeep Singh

Involved In Discussions
#1
Hi,

As we are manufacture of medical products Class IIB and manufacture dental X-Ray machine. I am new to this product and during testing i have a query for testing of IEC 60601-2-63. when i saw the predicate devices and i found IEC 60601-2-63 in their compliance table which Is Medical electrical equipment - Part 2-63: Particular requirements for the basic safety and essential performance of dental extra-oral X-ray equipment .

And i found there is no reference of this standard in EU list of harmonized standards. whereas in FDA certification it is mandatory. Please give your opinions for registration in Europe.
 
Elsmar Forum Sponsor

Kuldeep Singh

Involved In Discussions
#3
but still there is question for testing of that particular standard i.e IEC 60601-2-63 ( Not harmonized standard as per EU Harmonized list updated on 17.11.17 on EU Website) .We have to testing with it also or EN 60601-2-54 & EN 60601-1-3 radiation related testing is sufficient.
 

Attachments

Marcelo

Inactive Registered Visitor
#4
For Europe, you can use any technical solution you want, any standard, anything, to comply with the essential requirements. The only drawback is that you do get presumption of conformity, if you do not use a harmonized standard.
 
Thread starter Similar threads Forum Replies Date
D USFDA vs NRTL/IEC 17025 Differences - Compliance testing lab ISO 17025 related Discussions 0
D USFDA vs NRTL/IEC 17025 Differences - Compliance testing lab US Food and Drug Administration (FDA) 6
L IEC 60601-1-11 IP22 Compliance - Ingress protection testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
W Is IEC 60601-1-2 compliance/testing required for battery powered Class I Device IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
J Transformer Compliance Testing, overheat then humidity treat, then dielectric test? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
A Testing Process Audit - Defining a Process Compliance Mechanism Software Quality Assurance 2
J Meeting 100% compliance in wrist strap testing - ESD (Elecro-Static Discharge) Misc. Quality Assurance and Business Systems Related Topics 27
M FULFILMENT of compliance obligation versus COMPLY with compliance obligations ISO 14001:2015 Specific Discussions 2
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
L Medical device HIPAA compliance in encryption Medical Information Technology, Medical Software and Health Informatics 1
J Strategy for MDR Regulatory Compliance Procedure ISO 13485:2016 - Medical Device Quality Management Systems 4
G Adopting old product - compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 9
M Advice needed for SEH Compliance Software and ISNETWord Compatabiliy Occupational Health & Safety Management Standards 2
D HIPAA, HITECH and Interoperability compliance route Medical Device and FDA Regulations and Standards News 2
N Quality Compliance Officer - ISO 13485, London Job Openings, Consulting and Employment Opportunities 1
A Environmental Compliance obligations and risks (ISO 14001:2015 6.1.3) ISO 14001:2015 Specific Discussions 3
M Tracking Expiration dates on compliance certifications REACH and RoHS Conversations 2
T Training recommendations? Bringing our RoHS and REACH compliance efforts in-house REACH and RoHS Conversations 2
optomist1 Informational Training IMDS - Management of Product Chemical Regulatory Compliance RoHS, REACH, ELV, IMDS and Restricted Substances 2
G ISO 14001 - 6.1.3 Compliance Obligations ISO 14001:2015 Specific Discussions 1
Ed Panek Compliance with Standards? When a standard is updated/revised CE Marking (Conformité Européene) / CB Scheme 3
K IEC 62304 compliance - Code reviews as part of verification strategy IEC 62304 - Medical Device Software Life Cycle Processes 5
N Which EN ISO 17664 version compliance to EU MDR? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 3
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 8
C Compliance with ISO 17025 requirement 8.4.2 - Controls - Records recovery ISO 17025 related Discussions 4
J Management Representative and PRRC (Person Responsible for Regulatory Compliance) ISO 13485:2016 - Medical Device Quality Management Systems 5
N Audit non-compliance - API Spec Q1 9th Ed 5.6.1.2 b Oil and Gas Industry Standards and Regulations 10
J Interesting Discussion Compliance with regulations in exceptional circumstances EU Medical Device Regulations 5
L Wearables 21 CFR Part 11 compliance Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
V Preparing the IFU in compliance with MDR 745, Chapter III EU Medical Device Regulations 2
L AS9146 Implementation and Compliance AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
P MDR PRRC (person responsible for regulatory compliance) and personal liability EU Medical Device Regulations 2
R Foam mattresses used in hospitals - compliance with MDR requirements? EU Medical Device Regulations 6
E Machines in Europe not in compliance with the EC directive CE Marking (Conformité Européene) / CB Scheme 0
N EUDAMED postponement and compliance with Article 120 (3) MDR for Legacy Devices EU Medical Device Regulations 8
R Role of quality compliance in SAP Software Quality Assurance 2
E Part 11 Compliance, Excel living documents (i.e. document master list, equipment list, approved supplier list) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 3
M MDR Legacy Medical Device Labeling compliance timeline EU Medical Device Regulations 3
D Required Checklist Showing Compliance to IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 11
D What is the best software used for the pharma compliance management? Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
T Rumours that class 1 NS, NM, NR devices will have a new deadline for MDR compliance EU Medical Device Regulations 3
M Informational From RAPS: Danish Regulators Seek to Help Smaller Companies With EU MDR Compliance Medical Device and FDA Regulations and Standards News 0
G ISO 9001 Legal Compliance and Legal Register Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Ed Panek Do Cloud services require 21 CFR Part 11 compliance? Qualification and Validation (including 21 CFR Part 11) 7
R Certificate of compliance to RoHS/REACH/WEEE - any such animal? REACH and RoHS Conversations 18
Sidney Vianna Interesting Discussion Legal compliance as part of ISO 45001 accredited certification. Major OSHA penalties in the USA. Occupational Health & Safety Management Standards 15
D Control chart applicable? Percentage of compliance with a standard Statistical Analysis Tools, Techniques and SPC 2
J Business Intelligence and 21 CFR Part 11 Compliance Qualification and Validation (including 21 CFR Part 11) 1
M Informational US FDA issued the first warning letter for UDI violations to help ensure compliance Medical Device and FDA Regulations and Standards News 0
I CAP/CLIA Environment - Part 11 Compliance Qualification and Validation (including 21 CFR Part 11) 3

Similar threads

Top Bottom