What is meant by Use of COMPONENTS WITH HIGH-INTEGRITY CHARACTERISTICS in ME EQUIPMENT (clause no 4.9)

#1
What is mean by Use of COMPONENTS WITH HIGH-INTEGRITY CHARACTERISTICS in ME EQUIPMENT (clause no 4.9)?
Which type of component we consider as a HIGH-INTEGRITY CHARACTERISTICS?
Any Examples...
 
Elsmar Forum Sponsor

Ronen E

Problem Solver
Staff member
Moderator
#2
3.17
* COMPONENT WITH HIGH-INTEGRITY CHARACTERISTICS
component where one or more characteristics ensure that its function is fault-free in relation to the safety requirements of this standard during the EXPECTED SERVICE LIFE of the ME EQUIPMENT in NORMAL USE and reasonably foreseeable misuse
 

Benjamin Weber

Trusted Information Resource
#3
I don't think posting the standard's definition will help.

Think of an opto-coupler, that is used a means of patient protection against mains voltage by double insulation. If the optocoupler's insulation fails, this might not be obvoius and your device will operate as expected. But in the case of an overvoltage, untintedned earthing-sutiation or similar this might result in an unacceptable risk. You rely upon the octocoupler's insulation and you cannot test every single optocoupler with 4kV, this would harm the optpcouplers. You have to rely upon the proper design and manufcturing of the components.

I know, others may not see this as an example for a CHiC - but I am interested in other (maybe better) examples.

There is another general example where you cannot properly perform 100% production testing: You are a manufacturer of matchesticks. How can you be sure, that the produced matchestcks will really work when needed? Of course you can try to ignite every single one that is produced. BUt eventually you will have no matchstrikes to sell. What can you do? You have to validate your manufcturing rocess and perform tests on a given amount of produced matchsticks. If the matchstick would be used for any safety relavent function, where a failure of a matchstick could directly lead to an unacceptable risk I would consider it as CHiC.
 

Peter Selvey

Staff member
Moderator
#4
CHiC (components with high integrity characteristics) are components that have been deliberately over-designed so as to be fault free. So for example a normal (non-CHiC) X-type mains capacitor might have a 0.2mm dielectric thickness which already 99.99% reliable over the lifetime of the device even at maximum stress. For a CHiC component the manufacturer would double the dielectric thickness to 0.4mm, and do the same approach to all other critical parameters such as lead spacing, temperature margins and so on. This makes a component that is >99.9999% reliable. It's not that hard to do but as you can see it takes roughly twice the materials and size of a normal part, so it would be a waste to do this for every part.

Capacitors (Y2 type), special resistors, optocouplers are examples, but it can be done with anything as long as you have a good understanding of the physics and the "2 x normal" approach. These parameters can then be controlled in production in addition to sampling tests. Note that sampling tests are just to pick up mistakes (e.g. wrong material), it is not possible guarantee CHiC reliability based on tests alone. It has to be driven by an understanding of the physics involved, failure statistics, and then implementing margins that statistically guarantee >99.9999% reliability.

Note that this would not work with run of the mill electronic parts many of which have extremely low failure rates. For example, a typical unstressed SMD resistor would be >99.9999% reliable. The problem here is that the high reliability is unlikely to be guaranteed by design and production test, it's more likely to be a by-product of the commercial side. The manufacturers of these parts do not guarantee the super low failure rates and many even include such disclaimers against in high risk product in their datasheets (where failure of a part can lead to serious harm).

To understand more, consider for example a Y2 capacitor (specified as a CHiC), where the manufacturer moves production from one factory in country X to a new factory in country Y. Since the manufacturer is claiming CHiC characteristics, it is required to check the materials, dielectric thickness, lead spacing and all other ChiC related parameters in the new factory before releasing to market. If the manufacturer fails to do this, they can be held legally liable for any injury caused, including negligence and possible criminal charges. Of course, a medical device manufacturer that used that part in a device where the part failure led to harm would initially be held liable, but they can then transfer that liability on to the capacitor manufacturer.

In contrast, if SMD resistor manufacturer moves production from one factory to another, the new factory might experience teething problems associated with the local suppliers that drop the reliability rate to 99.98% in the first six months of operation, not enough for CHiC. That product could still be released to market, as the manufacturer never guaranteed the reliability to be CHiC levels. That manufacturer cannot be held liable if a failed resistor caused injury. In this case, medical device manufacturer would liable for the incident, without being able to transfer responsibility. They could also be found negligent, especially if the part manufacturer clearly stated not to use such parts in way that failure could lead to serious harm.

So, it is not just a matter of having a super low failure rate, but also knowing and controlling the parameters that ensure a super low failure rate. These parameters are the "characteristics" in the term "components with high integrity characteristics".
 
Thread starter Similar threads Forum Replies Date
S What's meant by ISO9001 clause 8.7 non conforming output? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
P Validation of Processes - What is meant by 7.5.6 (a) - Defined Criteria for Review ISO 13485:2016 - Medical Device Quality Management Systems 7
J APQP Requirements - What is meant by "among other items" IATF 16949 - Automotive Quality Systems Standard 2
M "Value", A product that really meant something to you Coffee Break and Water Cooler Discussions 15
T Are Control Plans "Summary Documents" not meant to replace Work Instructions? IATF 16949 - Automotive Quality Systems Standard 3
T What is meant by a Characteristic Classification within GR&R? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
G What is meant by FAI (First Article Inspection) and how do we comply? AS9102 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 26
G AS9100 - Clarify what is meant by Statutory & Regulatory Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
A DMR (Device Master Record): What is meant by these words - Software Specifications? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
P Non EASA Aircraft - What is meant by Non EASA Aircraft? EASA and JAA Aviation Standards and Requirements 4
K Subgroup Size - Understanding what is meant by Subgroup Size Six Sigma 13
S Does 7.4 apply to products or services meant for Environment or OHS management? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
B What is meant by "Configuration Management"? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 36
H AS9102A - What is meant by 5.2.5, "... approved Special Process sources..." AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
Chennaiite What is meant by 'Lesson Learned' in the context of Problem Solving Quality Tools, Improvement and Analysis 6
C What is meant by two throws, three throws etc, when applied to Compressors? Manufacturing and Related Processes 4
W What is meant by Process Approach Auditing and What questions should be asked? Process Audits and Layered Process Audits 11
J What is meant by number of "items"? Chrysler Layered Process Audit Question Process Audits and Layered Process Audits 10
G What is meant when a datum (feature) is called a "6 way"? GD&T help Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
R What is meant by "Test Specimens" per AS9100 Clause 7.4.2 f) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
R Purchasing Information - Trouble understanding what is meant by a), b),and c) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
A TS 16949 Clause 7.4.3.2 Promotion of supplier monitoring - What is meant by promote? Supplier Quality Assurance and other Supplier Issues 6
F Scheduling Internal Audits - What is meant by 'based on status and importance'? Internal Auditing 35
M Para 4.6.3c - What is meant by the last part; ...number and issue of...? QS-9000 - American Automotive Manufacturers Standard 4
J Process FMEA Template with examples - Cold and Hot Forged components FMEA and Control Plans 4
F Biocompatibility evaluation for Hardware/Interface Components? Other Medical Device Related Standards 4
K 510K new manufacturer but same components Other US Medical Device Regulations 6
D Using non-conforming components even though the final assembly is conforming? Manufacturing and Related Processes 5
R DHR question: Traceability of components ISO 13485:2016 - Medical Device Quality Management Systems 2
J Medical Device Components US to EU commercialization EU Medical Device Regulations 7
B IATF 16949 - Is a Deviation required for sample components in a prototype build? IATF 16949 - Automotive Quality Systems Standard 13
A Components of a medical device - Hardware robotic hand EU Medical Device Regulations 3
D IMDS for Like Components (Interior Plastic, Leather/vinyl Armrest, etc.)other than Color APQP and PPAP 1
JoshuaFroud Serial numbers and labelling when sharing device components ISO 13485:2016 - Medical Device Quality Management Systems 1
A How to deal with changed shared components in 510k 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Nicole Desouza Plastic Extrusion of Medical Device Components - No ISO or AS 9100 Certifications Other Medical Device and Orthopedic Related Topics 7
Q Handling Off-the-Shelf Components 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
I PPAP Assembly and Components Manufacturing and Related Processes 3
D CB Certificate - Distributor for a product with electrical components CE Marking (Conformité Européene) / CB Scheme 4
K Selling Medical Device Components to US hospitals and doctors US Food and Drug Administration (FDA) 4
S Need Assistance in Visual Inspection - Tiny electronic components AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
R FDA - How to discontinue/obsolete medical devices that share sub-components with others that will still be distributed Other US Medical Device Regulations 5
F Mig Welded Components - IMDS International Material Data System RoHS, REACH, ELV, IMDS and Restricted Substances 1
D Software Validation - Contract manufacturer of Components (PCBA's) Qualification and Validation (including 21 CFR Part 11) 7
G Audit finding - Components being transferred inter-plant Internal Auditing 3
J Referencing Medical Device in FDA records - Package contains several other components Other Medical Device Regulations World-Wide 1
K Article 23 (Parts and components) - Economic Operator EU Medical Device Regulations 1
S How are Medical Device Components and Subassemblies defined? ISO 13485:2016 - Medical Device Quality Management Systems 1
H Classification of a Class IIb Medical Device with 3 Components CE Marking (Conformité Européene) / CB Scheme 1
P REACH - A few of the hundreds components in my product no longer meet requirement REACH and RoHS Conversations 2

Similar threads

Top Bottom