IEC Certification requirement for external WLAN Adapter

K

kunal shah

#1
I'm interested in defining IEC Certification requirement for a new system.
We are planning to Certify our system with the following certifications,
EN/IEC/UL 61010-1
EN/IEC 61326-1
EN/IEC 61000-6-3
EN 55022 / CISPR 22
EN/IEC 61326-1
EN/IEC 61000-6-2
EN/IEC 61000-4-2
EN/IEC 61000-4-3
EN/IEC 61000-4-4
EN/IEC 61000-4-5
EN/IEC 61000-4-6
EN/IEC 61000-4-11
EN/IEC 61000-4-14

We plan to have a WLAN 802.11 b/g/n adapter on USB 2.0 as an external interface and not as a part of our system

So should we include the WLAN Adapter to the current system and then certify the product as a whole?
OR
Are we allowed to exclude the WLAN adapter from our system and certify only the system in isolation.?

If we have to include the WLAN adapter to our existing system, then kindly suggest what all additional standard should the system be complied to.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3
T ISO/IEC 17065 certification scheme Help Other ISO and International Standards and European Regulations 7
F IEC 62133 cell vs. Battery Pack - Certification on the cell only IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
E IEC 60601 Main requirements for the certification of a device with a Li-ion batt IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
K IEC 62133 Test Report for Lithium Battery Certification IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
A Dental Laser Certification IEC 62304 for a Firmware IEC 62304 - Medical Device Software Life Cycle Processes 1
B IEC 61010-1 Certification Requirements, and External Supply/ELV questions CE Marking (Conformité Européene) / CB Scheme 4
R Medical Device IDE - IEC 60601-1 Certification 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
D ISO and IEC Certification for 510K Approval 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
H IEC 60601-1 3rd Edition Certification - New Products Only? IEC 60601 - Medical Electrical Equipment Safety Standards Series 25
I Is ISO 14971 certification required for IEC 62304? IEC 62304 - Medical Device Software Life Cycle Processes 11
Hershal For accredited labs that expect more - Certification of ISO/IEC 17025 assessors ISO 17025 related Discussions 4
T IEC 62304 : Risk control for SaMD IEC 62304 - Medical Device Software Life Cycle Processes 8
G IEC 60601 Compliance IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
W IEC 60601-1 clause 8.8.3 - Dielectric Strength IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
L ISO/IEC 20000-6 Technical Areas IT (Information Technology) Service Management 0
B IEC 60601-1 Clause 14.8 - Architecture IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
T Infusion pump and IEC 62353 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
F IEC 62304 agile development EU Medical Device Regulations 1
R IEC 60601-2-57 light source classification IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
shimonv Working with a software developer who is not setup for IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 9
P Examples of quality plans in IEC 62304 US Food and Drug Administration (FDA) 2
L Top opening of enclsoure against fire in IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
S ISO/IEC 15408 - Is this is Certifiable Standard? Other ISO and International Standards and European Regulations 2
C EN 45502 vs IEC 60601-1-8 Other Medical Device Related Standards 0
Richard Regalado Informational ISO/IEC DIS 27001:2021, to be published soon. IEC 27001 - Information Security Management Systems (ISMS) 0
E Test report to certify compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 5
B 3-phase supply, overvoltage catogory, line-to-neutral and working voltage (IEC 61010-1) IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
B European Harmonized vs IEC standard IEC 62366 - Medical Device Usability Engineering 2
E Software maintenance Process Software maintenance Process to IEC 6204? IEC 62304 - Medical Device Software Life Cycle Processes 3
A ISO/DIS 15223-1:2020 - Country of manufacture label (IEC 60417 No. 6049) - Which national law requires this symbol? Other Medical Device Related Standards 0
JoCam IEC 60601-1 and 60601-1-2 retest after PCBA change IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
K IEC 60601-1:2005/AMD2:2020, Why this standard version is 3.0? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
B Reference to IEC 60950-1 in Amendment 2 IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
C IEC 60601 - 8.8.3 Dielectric Strength test. 4kv being applied to the ground conductor?! IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
R IEC 60601-1 Clause 15.3.2, Push test IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
E Any sample of a full software life cycle IEC 62304 report ( any class )? IEC 62304 - Medical Device Software Life Cycle Processes 4
A Defining a lower ESD test level in IEC 60601 safety test IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
J IEC 60601-1-11 Home Class II With Ballasts IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
T Relationship between ISO 9001 and ISO – IEC BS EN 870079- 34 2020 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
T Help with BS EN ISO - IEC 80079-34 2020 (Explosive atmospheres QMS) Other ISO and International Standards and European Regulations 0
A Coverage and differences: EN 60601-1:2006+A12:2014 Vs AAMI/IEC 60601-1:2005+AMD1:2012 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
E IEC 62353 normalization IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
T IEC 60601-1-8:2020 Is it necessary to change the alarm melody? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
G Adopting old product - compliance with IEC 62304 IEC 62304 - Medical Device Software Life Cycle Processes 12
M Is it normal / sufficient to have only the IEC 60601-1-2 test report without indicating IEC 60601-1? IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
S IEC 60601-2-30 - Is it mandatory to claim alarms? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Y Auditory alarm standard IEC 60601-1-8 Reliability Analysis - Predictions, Testing and Standards 0
M IEC 61010-1 requirements for motors Other Medical Device Related Standards 0
R IEC 60601-1 - Power Supply Cords (Section 8.11.3.1) IEC 60601 - Medical Electrical Equipment Safety Standards Series 2

Similar threads

Top Bottom