Self-test minimum requirements

FrancoisA

Starting to get Involved
#1
Dear all

Are you aware of any normative requirements for the minimum content of medical devices self-tests?

I know that IEC 60335 has such requirements for class B or C household applications, but I couldn't find anything similar is either the IEC 60601-1 serie, nor in IEC 62304.
If the absence of such normative requirements for the medical domain, could a notify body consider that the requirements set by IEC 60335 should be applied, considering it as a part of prior art ?

Thanks
 
Elsmar Forum Sponsor

Peter Selvey

Leader
Super Moderator
#3
Some standards like IEC 60601-2-16 and IEC 60601-2-24 (dialysis and infusion respectively) require either automated self testing or user testing, but user testing is cumbersome so it's always done by software at power on, and in special cases higher frequency, for example the air detector sensor. This is all related to protection systems with fairly high risk if they fail.

If a device has a similar kind of risk, it could be possible for NBs to use those standards or "functional safety" as a guide.

As Yodon points out though, it depends on the risk analysis. With every protection system it should be asked if it is sufficiently reliable over the lifetime of the device, noting that the combined probability of two independent events (two faults, or a user miss + fault, or a low battery + fault etc etc) increases with time squared. This means that probabilities which are acceptable over short periods of time (e.g. 1 year) may not be over a lifetime (e.g. 10 years). Close attention is required for protection against direct high severity harm (e.g. infant incubator overtemp protection) and also protection against user mistakes for medium and high severity harm (an interlock to prevent mechanical harm).

If the risk analysis judges it is not acceptable, automated periodic testing of a protection system is probably the most cost effective solution, and is frequently used in medical devices. You don't need to go to household applications to see it is state of the art. Note there are other options such as additional redundancy, proof of high reliability by testing, asking the user to perform tests, annual maintenance with varying effectiveness and costs.
 

ECHO

Involved In Discussions
#4
Looks like @Peter Selvey pretty much addressed everything.

The only thing that I would add is, "what should the user do when a self-test fails?". Are some self-test failures "fixable" by the user? If so, don't forget to provide those instructions.
 

VinceTech

Involved In Discussions
#5
Just forget what is protection/self te
Looks like @Peter Selvey pretty much addressed everything.

The only thing that I would add is, "what should the user do when a self-test fails?". Are some self-test failures "fixable" by the user? If so, don't forget to provide those instructions.
Maybe try to forget what is protection/self-test and what is control. These words have been defined clearly. Use two means. You will consider the failure of a means in risk analysis.
So if self-test fails, it shall be detectable in your system before another means fails.
 
Thread starter Similar threads Forum Replies Date
Z COVID-19 Antigen Test Kit (Self-test) Registration in Peru Other Medical Device Regulations World-Wide 0
S User evaluation for self monitoring blood glucose test systems US Food and Drug Administration (FDA) 4
J Good Documentation Practices Self Test? ISO 13485:2016 - Medical Device Quality Management Systems 6
A Selling CE marked self-test in Malta - any additional requirements? EU Medical Device Regulations 0
Z IVD Self Test Pregnancy - Assessment Route? EU Medical Device Regulations 5
B Own Brand Labelling and Distributors - Self Test IVD's EU Medical Device Regulations 3
H Wavetek 9100 fails self-test - Need Service Manual source General Measurement Device and Calibration Topics 18
S 17025 Flexible Scopes of Accreditation - Laboratory to 'self-assess' new test method ISO 17025 related Discussions 2
F Self Evident Inspection Method ISO 13485:2016 - Medical Device Quality Management Systems 11
D Question and advice for a supplier self audit questionnaire ISO 13485:2016 - Medical Device Quality Management Systems 6
F Medical cart self certification EU Medical Device Regulations 1
M IATF 16949 SI # 10: Integrated self-calibration of measurement equipment- Needs for explanation IATF 16949 - Automotive Quality Systems Standard 2
K Technical file for MHRA - looking for assistance with self declaration Class I device CE Marking (Conformité Européene) / CB Scheme 8
A Self-training or Self-studying ISO 13485:2016 - Medical Device Quality Management Systems 8
K MDR Class 1 Self Certification - Competent Authority or Notified Body? EU Medical Device Regulations 6
M Control-self assessment Internal Auditing 5
Q Self-assessment audit information Quality Management System (QMS) Manuals 6
S Supplier Management ISO 13485: 2016- Which supplier needs to fill in a self assessment form? ISO 13485:2016 - Medical Device Quality Management Systems 6
E HONDA HAA QAV-1 Self Assessment General Auditing Discussions 4
T Formal Q Self Assessment - Problem with assigning Product and Process Customer and Company Specific Requirements 1
G Self Assessment Audit from a new potential customer General Auditing Discussions 3
M CE self-certification for Class I device (face mask) EU Medical Device Regulations 9
M Informational US FDA – Ear, Nose, and Throat Devices; Classification of the Self-Fitting Air-Conduction Hearing Aid Medical Device and FDA Regulations and Standards News 0
K Intended Use-Class I Self Certified - Intended Use and Indications for Use statements EU Medical Device Regulations 1
Ed Panek Part 11 Self Certify Memo - What else should it cover? Qualification and Validation (including 21 CFR Part 11) 5
M Informational TGA Consultation: Review of the regulation of certain self-testing IVDs in Australia Medical Device and FDA Regulations and Standards News 0
C CE marking for general IVD (self-certified) & ISO 13485 QMS requirements - auditing EU Medical Device Regulations 6
MichaelDRoach Oganization's Self Declaration of Conformance to ISO 28000 wording example wanted Supply Chain Security Management Systems 1
M Medical Device News TGA – Regulator Performance Framework: Self-assessment Report, July 2017 to June 2018 Medical Device and FDA Regulations and Standards News 0
M CE self-certify, or needs testing by 3rd party? CE Marking (Conformité Européene) / CB Scheme 12
M Notified Body Involvement with Self Declared Products EU Medical Device Regulations 7
S Help: Need Control Self Assessment Questionnaire for HR Departmental Functions Process Audits and Layered Process Audits 0
T IVD - Self Declaration - Technical File - Template wanted Various Other Specifications, Standards, and related Requirements 12
R Documenting Self-Training and Effectiveness - ISO 13485:2016 Training - Internal, External, Online and Distance Learning 4
K ISO 13485:2016 Self Certification for Class I (annex 9) Stand-Alone Software? ISO 13485:2016 - Medical Device Quality Management Systems 3
S ISO9001:2015 and ISO14001:2015 Readiness/Self Evaluation Checklists wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
N MDD Class I Medical Device Self Declaration Articles/Supplementary Documents EU Medical Device Regulations 1
A Self-study plan to improve fluency in English speaking, writing After Work and Weekend Discussion Topics 3
Crusader Interval for Self-Calibrating Measurement Device? Calibration Frequency (Interval) 15
T Transition Time for Self Declared IVDs EU Medical Device Regulations 3
S Anyone know the self-selection study for home use medical device Other US Medical Device Regulations 2
D Off-Label Self Promotion - What to do EU Medical Device Regulations 3
S Creating goals and objectives with targets and measurables for self-evaluations Management Review Meetings and related Processes 2
C Help with Risk/Benefit Analysis Self-help Device for Diabetics ISO 14971 - Medical Device Risk Management 3
B Self Contained Biological Indicators as internal PCD Other Medical Device Related Standards 2
T Self Declaration for CE Class I, Non-Invasive Medical Device EU Medical Device Regulations 10
R Self-Certification Is Not a Real Thing - an IAF article Registrars and Notified Bodies 13
T Should a supplier self assessment form be a controlled document? Document Control Systems, Procedures, Forms and Templates 9
C Vendor Self-Survey to Qualify Vendors/Suppliers - AVL Question ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Annex III self declared IVD to be in use with Annex II List B IVD EU Medical Device Regulations 1

Similar threads

Top Bottom