Is testing according to IEC 60601-1 & IEC 60601-1-2 mandatory for a device being registered under MDR?

Harsh

Involved In Discussions
#1
Hello Everyone,

I am working in a lab device manufacturing firm. We are going to register our one centrifuge as a class IIa Medical Device (as an accessory). This is the first project for us under MDR & I was wondering about the EMC & Safety test requirements for the product.

During my research, I have found that there are two standards according to which the product should have been tested for CE declaration. The first one is EN 60601-1 & second one is EN 60601-1-2. But for the CE declaration of the product, it should have been tested according to the mentioned edition of the harmonized standard.

According to the current scenario, we do have to fulfill the requirements of MDR & when I referred to the current list of harmonized standards under MDR there is no mention of these standards. Also, these standards are not available in the list under EMC & LVD directive. Does that mean that there is no need to test the products according to these standards?

In the past when MDD was applicable these standards were available in the list. So this is confusing as I have to opt for testing according to the 60601 series of standards or there are new & different provisions according to MDR which I am missing. Because there is no reference for the current harmonized edition of the standards.

If I am missing something please let me know.

Thanks in advance.
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Moderator
#3
As I wrote in the thread @indubioush linked to, the MDR harmonized standards initial list is still WIP. This is a complicated process, but I have no doubt that in due course both these standards will be included (this is scheduled to happen by 2024 latest, AFAIK).

More generally, under the MDR your technical compliance requirements are as detailed in the GSPR (Annex I). Even if those 2 standards were already harmonized, you wouldn't be obliged to follow them or get certified to either. However, this is by far the most straightforward and predictable path to compliance, considering your interaction with the NB. But from a regulatory aspect you are free to demonstrate how you meet the relevant GSPRs through other standards / methods, including some in-house developed methods and testing, as long as you have a solid technical rationale documented, explaining why and how these methods indeed satisfy the GSPRs.

For devices within the scope of 60601 I recommend testing and certification to the latest versions, i.e. EN 60601-1 Ed. 3.2 (including A2 from 2020) and EN 60601-1-2:2015+A1:2020.
 

Peter Selvey

Leader
Super Moderator
#4
Just to add to Ronen's post, in modern regulations compliance is voluntary but in practice this should be read as mandatory with justified exceptions, especially for standards with highly prescriptive requirements for common areas like electrical safety and EMC. The reason is that the average manufacturer will not have the resources (time, experience, expertise, experimental data, access to equipment etc.) to develop their own criteria for these common aspects, it's not economically feasible, and there is a high chance that a manufacturer going it alone will make a really bad design decision at some point.

Although the MDR is yet to formally recognise 601 series standards, a similar case exists.

So the idea is to apply the standards in general but when a road block is hit, you have the option to create your own method to meet the GSPRs rather than follow the standard. These days standards have some flexibility built in anyway, so you can still "comply" without using this "go it alone" option.

The catch is that unfortunately the modern 601 series is not well written and are prone to overkill, and messy handling of subjects like essential performance and risk management that have created a huge unnecessary expense in dealing with these standards for third party testing. But, I'd still say better to use them than go it alone. In the future we may see a simpler objective standards that are designed for efficient third party testing (where they can provide value due to their expertise, equipment etc), and leave the messy stuff purely on the manufacturer side. That could be decades away though.
 
Thread starter Similar threads Forum Replies Date
A Do HF accessories require EMC testing according to IEC 60601-1-2? IEC 60601 - Medical Electrical Equipment Safety Standards Series 14
N Insulation Barrier Testing - According IEC 60601-1 IEC 60601 - Medical Electrical Equipment Safety Standards Series 22
M In Vitro irritation testing according to ISO 10993-23 ISO 13485:2016 - Medical Device Quality Management Systems 2
T Biocompatibility Testing for Implantable Medical Devices according to ISO 10993 ISO 13485:2016 - Medical Device Quality Management Systems 4
Ajit Basrur Setting up a new laboratory for testing our samples according to RoHS RoHS, REACH, ELV, IMDS and Restricted Substances 1
E Usability for Near Patient Testing Test Kit Human Factors and Ergonomics in Engineering 2
J Single Fault Testing for Secondary Circuits (60601-1 section 13.1) IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
P Medical device testing lab/service standard Other Medical Device Related Standards 1
T Cytoxtoxicity Testing Dilution Other Medical Device Related Standards 1
M Altitude testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
H IEC 62368-1 Scope of Testing CE Marking (Conformité Européene) / CB Scheme 3
H EMC & Safety Testing of the product with the same Sr. No. for EC Declaration CE Marking (Conformité Européene) / CB Scheme 3
A Non-medical device testing in the medical system IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
W CQI-9 Testing Fluids Manufacturing and Related Processes 0
XRAY_3121 Class II heating pad - does the power supply have to have IEC 60601-1 testing?? US Medical Device Regulations 5
T Testing for proving food safety on USP class vi material RoHS, REACH, ELV, IMDS and Restricted Substances 0
J Risk Analysis for Proficiency Testing Reliability Analysis - Predictions, Testing and Standards 1
Rene Minassian Control of (TMME) Testing and Measurement Equipment Oil and Gas Industry Standards and Regulations 2
M Is complete testing required as per ISO 10993 for materials used in orthopedic implants or is literature review route possible Other Medical Device Related Standards 3
B A testing lab within an organization ISO 17025 related Discussions 10
B Package integrity Testing failure ISO 13485:2016 - Medical Device Quality Management Systems 7
R Basic Lab Practices - related to ISO 17025 testing labs ISO 17025 related Discussions 1
N Microbial testing on food packaging materials Food Safety - ISO 22000, HACCP (21 CFR 120) 3
A Stability Testing of a device with sterile fluid pathway claim Other Medical Device and Orthopedic Related Topics 1
M Cosmetic Shelf Life Testing Misc. Quality Assurance and Business Systems Related Topics 10
S Safety testing IEC 60601 series Medical Device and FDA Regulations and Standards News 2
M EE's - Laptops/Printer Change and Emissions Testing IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
keya1tos EU to UK plug adapter correct testing standard CE Marking (Conformité Européene) / CB Scheme 9
D IEC 60601-1-2: Is EMC immunity testing required for a device without essential performance? IEC 60601 - Medical Electrical Equipment Safety Standards Series 25
M Oral irritation testing Medical Information Technology, Medical Software and Health Informatics 0
A Fire Testing - EN 50339 Not 20 minutes ISO 17025 related Discussions 0
M Biological testing at the end of the real time of MD Other Medical Device Related Standards 3
R SaMD Performance Testing US Medical Device Regulations 5
J 'Failure rate leading to false-negatives and repeat testing' - MDCG and Common Tech Specs Other Medical Device Regulations World-Wide 0
M Extractables testing replicates - Chemical Characterization ISO 10993-18 EU Medical Device Regulations 2
C Strategies to Mitigate Fails in DV Testing Design and Development of Products and Processes 3
E 17025 Accredited Microbiological Testing Laboratory ISO 17025 related Discussions 3
X Looking for 17025 auditor to perform internal audit on IT software testing laboratory ISO 17025 related Discussions 3
J Design Verification Testing and Statistics Reliability Analysis - Predictions, Testing and Standards 3
W External PSU Providing a MOOP -- Will This Necessitate Conducted Emissions Testing? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
G How to Record Informal Testing (Not Verification/Validation) Other Medical Device and Orthopedic Related Topics 15
J Medical Device Component Change - Testing, Sampling Criteria ISO 14971 - Medical Device Risk Management 3
R Microbiological test (USP61, USP62, USP71, ISO 11137.1, ISO11137.2) --- Testing flow chart Other Medical Device Related Standards 0
R GB9706.1:2020 - in-country testing China Medical Device Regulations 1
A Bench Testing US Food and Drug Administration (FDA) 2
R Validation of Software used in Verification Testing ISO 13485:2016 - Medical Device Quality Management Systems 2
M Do i need to have equipment validation if 100% testing is completed? Qualification and Validation (including 21 CFR Part 11) 6
E Biocompatibility testing of our applied part seems redundant Other Medical Device Related Standards 2
A Recommended testing methods for weather stripping Manufacturing and Related Processes 6
T Shrinkage Testing for EPDM Material Various Other Specifications, Standards, and related Requirements 5

Similar threads

Top Bottom