Discussion on How to get a CE Mark for a Rebreather

***schford*** · 3rd March 2007, 08:44

This Thread to discuss Alex's article - http://www.rebreatherworld.com/gener...ebreather.html My response below.

((**************************************))

Alex an interesting and very informative article from a potential competitor to our existing manufacturers. Though I do not agree with it all, I thank you for pulling it together....

My research leads me to believe that you do not need external certification for EN 61508 to achieve the EN 14143 CE mark for Rebreathers for 2 main reasons:

1 - EN 14143 clearly specifies what is required in terms of testing for IEC 61508 wihch does not include additional certificaiton.
2 - EN 61508 is not actually an adopted harmonised European standard.

Let's look at my research - First up what EN 14143 actually says about 61508

Quote:

5.13 Electrical systems
5.13.1 Functional safety
Any electrical, electronic or programmable electronic part of the apparatus shall satisfy the requirements of IEC
61508, Parts 1-7.

Testing shall be done in accordance with 6.2.

Which says that yes indeed the rig shall satisfy the requirement's of 61508 and it also spells out clearly what testing is needed to prove it.

Let's go look at that testing section then...

Quote:

6.2 Visual Inspection
Visual inspection shall be conducted at normal visual acuity by the responsible expert(s) appointed by the
accredited test station to test the apparatus.
The visual inspection shall verify that the apparatus has been produced in accordance with the manufacturer’s

technical file and include marking and information supplied by the manufacturer.

So that for me says very clearly what testing needs to happen and it does not mention any external additional tester or requirement for additional certification.

Which kinda makes sense as 61508 was explained to me as being really a methodology or set of methodologies around designing safety systems - incidentally if any readers are interested and want more info see Embedded.com - Software safety by the numbers

So all they are checking is the manufacturer has proof of their development methadology and declares that it is 61508 conformant.

Just to double check this though I headed over to the IECs website which is the body responsible for 61508 and this is what they say about it.....(From IEC - IEC in action | Functional safety zone > C) Regional issues and technical interpretation)

Quote:

Is application of IEC 61508 compulsory under any EC Directive?

No. EN 61508 does not have the status of a harmonized European standard, and is not referred to by any EC Directive.

However, this does not prevent compliance with relevant parts of EN 61508 being used to support a declaration of conformity with an EC product directive, if that is appropriate. But because EN 61508 is not a harmonised European standard, there is no presumption of conformity with any directive. Therefore it would be necessary to explain in the technical file how compliance with EN 61508 is being used to support compliance with specific essential requirements of the particular directive.

Which ties in exactly with the visual inspection of the technical file, which is there to prove the manufacturers statement that they have developed to 61508.

The key thing though is it is used to support a declaration of conformity for another standard. eg the manufacturer is saying I declare I have conformed to this and here is my technical file as proof.

That leads me to believe that my interpretation is correct which is I believe a view that the current Competent Notified Bodies most definately share.

As if my interpretation of this is incorrect I believe that the liability would fall on the Competent Notified Body(accredited test station) for failing to correctly apply the standards - the manufacturers responsibility is to ensure their equipment is CE certified from a Competent Notified Body (which by it's very definition makes it valid) which they have done.

I can understand where you are coming from both from making our sport safer as well as being a potential competing manufacturer wanting to differentiate future products but I think the only thing that would validate your intepretation compared to the rest of the industry would be some case law or the EN 14143 standard being re written to specifically require testing against 61508 rather than a statement of conformity.

I would like to caveate my viewpoint by saying I am not as nor do I believe any one here is a legal expert on CE norm's or standards!

divetheworld · 3rd March 2007, 12:02

Quote: (Originally Posted by schford)

My research leads me to believe that you do not need external certification for EN 61508 to achieve the EN 14143 CE mark for Rebreathers for 2 main reasons:

1 - EN 14143 clearly specifies what is required in terms of testing for IEC 61508 wihch does not include additional certificaiton.
2 - EN 61508 is not actually an adopted harmonised European standard.

Let's look at my research - First up what EN 14143 actually says about 61508

Quote:

5.13 Electrical systems
5.13.1 Functional safety
Any electrical, electronic or programmable electronic part of the apparatus shall satisfy the requirements of IEC
61508, Parts 1-7.

Testing shall be done in accordance with 6.2.
Which says that yes indeed the rig shall satisfy the requirement's of 61508 and it also spells out clearly what testing is needed to prove it.

Let's go look at that testing section then...

Quote:

6.2 Visual Inspection
Visual inspection shall be conducted at normal visual acuity by the responsible expert(s) appointed by the
accredited test station to test the apparatus.
The visual inspection shall verify that the apparatus has been produced in accordance with the manufacturer’s

technical file and include marking and information supplied by the manufacturer.

So that for me says very clearly what testing needs to happen and it does not mention any external additional tester or requirement for additional certification.

Which kinda makes sense as 61508 was explained to me as being really a methodology or set of methodologies around designing safety systems - incidentally if any readers are interested and want more info see Embedded.com - Software safety by the numbers

So all they are checking is the manufacturer has proof of their development methadology and declares that it is 61508 conformant.

Just to double check this though I headed over to the IECs website which is the body responsible for 61508 and this is what they say about it.....(From IEC - IEC in action | Functional safety zone > C) Regional issues and technical interpretation)

Quote:
Is application of IEC 61508 compulsory under any EC Directive?

No. EN 61508 does not have the status of a harmonized European standard, and is not referred to by any EC Directive.

However, this does not prevent compliance with relevant parts of EN 61508 being used to support a declaration of conformity with an EC product directive, if that is appropriate. But because EN 61508 is not a harmonised European standard, there is no presumption of conformity with any directive. Therefore it would be necessary to explain in the technical file how compliance with EN 61508 is being used to support compliance with specific essential requirements of the particular directive.
Which ties in exactly with the visual inspection of the technical file, which is there to prove the manufacturers statement that they have developed to 61508.

The key thing though is it is used to support a declaration of conformity for another standard. eg the manufacturer is saying I declare I have conformed to this and here is my technical file as proof.

That leads me to believe that my interpretation is correct which is I believe a view that the current Competent Notified Bodies most definately share.

As if my interpretation of this is incorrect I believe that the liability would fall on the Competent Notified Body(accredited test station) for failing to correctly apply the standards - the manufacturers responsibility is to ensure their equipment is CE certified from a Competent Notified Body (which by it's very definition makes it valid) which they have done.

I can understand where you are coming from both from making our sport safer as well as being a potential competing manufacturer wanting to differentiate future products but I think the only thing that would validate your intepretation compared to the rest of the industry would be some case law or the EN 14143 standard being re written to specifically require testing against 61508 rather than a statement of conformity.

I would like to caveate my viewpoint by saying I am not as nor do I believe any one here is a legal expert on CE norm's or standards!
__________________

Here is your first snag.
The standard EN14143 states that 61508 is only to be applied to the electrical, electronic or programmable electronic part of the apparatus. As 61508 is for a system the statement in the standard EN14143 is, as quoted by Ron Bell (Chairman of IEC SC65A/Working Group 10 that developed EN61508) as being "of insufficient precision to render it meaningless".

The clauses in the standard can be used in defence as due dilligence, having a design approved by a Notified Body in itself can be used as indication of due dilligence but does not prevent a succesful prosecution.
There are a number of views, that of SIRA is still a veiw and not a legal definition regardless what rhetoric may be spurned from this.

Above all, standards are NOT law. You do not have to comply with a single standard, whether it be Harmonised or not. However, if you comply with the specified Harmonised Euro Norms, then it is presumed that you comply with the Essential Safety requirments in the Directive.

Where interpretations exist, it is up to the manufacturer to demonstrate compliance or obtain a definition from the Horizontal or Technical Committee as to a definition.

The above does not represent my opinion which may differ fromn the facts posted.

Brent Hudson
Senior Engineer in a Notified body.
EU Commission appointed representative.

N.B.
I've just read Alex' article and it is quite informative. There are a few bits I dont necasarily agree with in some parts but nothing that detracts from the spirit of what he is trying to say. If they come up as parts of the discussion, I will try to address them but not worth pointing out at this time as it would be plainly "nit picking" by someone who is anal about this topic. In summary, its quite accurate as to the current position relating to the certification of rebreathers.
Well done.

***schford*** · 3rd March 2007, 12:08

So I think what you are saying it that the wording in EN14143 is such that 61058 can never fully apply - so could not possibly be certified to apply?

divetheworld · 3rd March 2007, 12:44

Quote: (Originally Posted by schford)

So I think what you are saying it that the wording in EN14143 is such that 61058 can never fully apply - so could not possibly be certified to apply?

Personal opinion.
Lets take a simple example of the scrubber. If you apply 61508 to the whole system as has been suggested, then how can a granule based single scrubber comply? In short, it can not. Ever. Remember that stuff about failure rates, SIL levels and MTTF that Alex talked about? Try applying that in mathematical form to a granule scrubber with repeatable results. Turns to faecies real quick. Hence the design of the DL rebreather.

So in order to certify, we have to take our own interpretation, document this and make it comply with what we can demonstrate is safe enough. Then be prepared to justify this in court should we need to. If a part of the Standard is impossible to comply with, then dont comply with it. Use due dilligence and risk assessments in the Technical Construction File but then you can not declare compliance with that Standard on the Declaration of Conformity. In essence, you can not pick and choose parts you want to comply with, then put the Standard number on your Declaration.

This is an overly simplified example to which you can argue for months over technicalities should someone wish to, but the spirit of what I am saying should get through.

Brent
normal guy, dives quite often

Up front note to all.
There are many aspects of this thread that I will not be able to make comment upon due to my profession and various Non Disclosure agreements that I am bound to, including those to Deep Life.
I also will not engage in bun fights either.

AD_ward9 · 3rd March 2007, 15:30

Quote: (Originally Posted by schford)

So I think what you are saying it that the wording in EN14143 is such that 61058 can never fully apply - so could not possibly be certified to apply?

There are two sets of wording on EN61508 in EN14143.

The first is the list of normative standards. It lists EN61508. That is explicit. If the equipment falls within the scope any of the normative standards, then it needs to be tested to those standards.

There is a second clause refering to EN61508 in Section 5 of the standard. I raised Brent's interpretation of this and the comment he had received with a member of the CEN-SC7 Committee who are responsible for EN14143. They do not concur: they intend that the equipment must comply with EN61508. I have sent a copy of Brent's note to the Committee and it is being raised at the next meeting. I understand there is a revision for EN14143 due out sometime, probably not very soon, and the wording will not doubt be even more explicit.

Alex

AD_ward9 · 3rd March 2007, 15:33

Quote: (Originally Posted by divetheworld)

Personal opinion.
Lets take a simple example of the scrubber. If you apply 61508 to the whole system as has been suggested, then how can a granule based single scrubber comply? In short, it can not. Ever. Remember that stuff about failure rates, SIL levels and MTTF that Alex talked about? Try applying that in mathematical form to a granule scrubber with repeatable results. Turns to faecies real quick. Hence the design of the DL rebreather.

Thanks. Your personal opinion on this is endorsed by the directors of the CASS scheme we contacted to check this very point (and also on the international EN61508 committee, BSI etc).

Granular scrubbers do not come up to the safety standard required for any of the EN61508 Safety Integrity levels, at least when the user packs them.

It is possible for pre-packaged canisters with hydrophobic seals to pass, such as a prepack for a Cis-Lunar Mk 5. The other thing that passes is the Micropore EACs.

On the second part of your opinion, on "own interpretation", the member of the SC7 committee we checked this with, indicated this would not be sufficient. The ALARP principle applies, and in the case of PPE equipment where it also falls into the scope of EN61508, one would have to justify that in a EN61508 audit. From personal experience, ALARP can be a tough one to prove unless one has changed the last P from Practical to Possible.

Where there is a matter of interpretation or any ambiguity, we have sent that to an SC7 committee member. The ensuing discussion can reveal safety hazards one had not considered, but were considered by the committee when writing the standard.

Alex

AD_ward9 · 3rd March 2007, 15:44

Quote: (Originally Posted by divetheworld)

electrical, electronic or programmable electronic part of the apparatus. As 61508 is for a system the statement in the standard EN14143 is, as quoted by Ron Bell (Chairman of IEC SC65A/Working Group 10 that developed EN61508) as being "of insufficient precision to render it meaningless".

I think you have the quote not quite right.

I will raise it with Ron Bell at the 61508 Association meeting this Wednesday and report back.

Alex

divetheworld · 3rd March 2007, 15:53

Quote: (Originally Posted by AD_ward9)

I think you have the quote not quite right.

I will raise it with Ron Bell at the 61508 Association meeting this Wednesday and report back.

Alex

To copy the correspondance verbatim;

"I think it could be argued that the clause is of sufficient imprecision to render it meaningless."
Is there a point to that or are we nit picking?

So when facing a court of law in the event of an accident and basing your entire structured arguments on one interpretation of this clause, it I doubt it will be possible to conclude beyond reasonable doubt that reasonably practicable means was not employed if the clause was followed in any reasonable interpretation.
It would end up one appointed experts opinion over anothers, and I have had much experience with courts as appointed expert to know thats a dead end.
The only constructive route would be in clarifying the standard in such a way that it is not open to interpretation and is still commercially viable. Without both, there is no point to it.

AD_ward9 · 3rd March 2007, 16:21

Thanks for correcting the quote.

Quote: (Originally Posted by divetheworld)

The only constructive route would be in clarifying the standard in such a way that it is not open to interpretation and is still commercially viable. Without both, there is no point to it.

That is very good advice. If any company finds and ambiguity in any standard they should comply with, and especially any Notified Body, they should advise the Committee responsible for the standard and get something in writing.

For example, we had an issue with our hose stretch being more than the standard specifies, so we raised it with the CEN-SC7 Committee in their last meeting in Delft, and they were very accommodating. Not only did they reveal the valid safety reason for that clause that we had not considered, but minuted a statement giving us a dispensation as the hose stretch was more than the standard required but did not trigger the safety issue that caused the clause to be written. Committees do seem to be very receptive to a safety case that is properly forumated.

On the issue of Ron's advice, I will raise it with the 61508 Association and CASS Scheme Directors as well as bring it to the attention of SC7. Ron's advice opinion falls down in that EN14143 defines EN61508 to be a normative standard, therefore applicable to anything falling into its scope.

Alex

divetheworld · 3rd March 2007, 17:04

Quote: (Originally Posted by AD_ward9)

Thanks for correcting the quote.
That is very good advice. If any company finds and ambiguity in any standard they should comply with, and especially any Notified Body, they should advise the Committee responsible for the standard and get something in writing.

For example, we had an issue with our hose stretch being more than the standard specifies, so we raised it with the CEN-SC7 Committee in their last meeting in Delft, and they were very accommodating. Not only did they reveal the valid safety reason for that clause that we had not considered, but minuted a statement giving us a dispensation as the hose stretch was more than the standard required but did not trigger the safety issue that caused the clause to be written. Committees do seem to be very receptive to a safety case that is properly forumated.

On the issue of Ron's advice, I will raise it with the 61508 Association and CASS Scheme Directors as well as bring it to the attention of SC7. Ron's advice opinion falls down in that EN14143 defines EN61508 to be a normative standard, therefore applicable to anything falling into its scope.

Alex

I honestly think any further discussion on this particular subject would be flogging a dead horse until the market surveillance authorities give a definitive ruling. It is only the MSA's opinion that counts in EU law (But they can be influenced by the 'experts' ;-)).
As always, you hope for a balanced and objective veiw when appealing for rulings and arguments based upon a number of opinions.

Generally the notified body does not go to the committee responsible. The system setup for these particular problems are the Horizontal committee and the vertical technical and sub committees of which the NB or his representative will be a member. The ruling comes from there, even then I would hesitate to call it a ruling.

Brent

As a foot note to those quietly watching the banter between the likes of Alex and I that this is a refreshing change for someone in my position. I almost invariably find myself in a position where I must explain the law to clients to make them put in extra effort, systems or components to ensure the safety requirements are met. Rarely do I find myself in a position where I would suggest a lesser level of effort is required in support of compliance. As such I would not dissuade or disrespect Alex' tenacious campain.

3rd March 2007, 08:44	#1 (permalink)
*schford* Despotic Overlord Current Rebreather/s: Megalodon Sport Kiss Other Rebreather/s: Join Date: Jan 2005 Location: London, UK Posts: 3,687	Re: How to get a CE Mark for a Rebreather This Thread to discuss Alex's article - http://www.rebreatherworld.com/gener...ebreather.html My response below. ((************************************)) Alex an interesting and very informative article from a potential competitor to our existing manufacturers. Though I do not agree with it all, I thank you for pulling it together.... My research leads me to believe that you do not need external certification for EN 61508 to achieve the EN 14143 CE mark for Rebreathers for 2 main reasons: 1 - EN 14143 clearly specifies what is required in terms of testing for IEC 61508 wihch does not include additional certificaiton. 2 - EN 61508 is not actually an adopted harmonised European standard. Let's look at my research - First up what EN 14143 actually says about 61508 Quote: 5.13 Electrical systems 5.13.1 Functional safety Any electrical, electronic or programmable electronic part of the apparatus shall satisfy the requirements of IEC 61508, Parts 1-7. Testing shall be done in accordance with 6.2. Which says that yes indeed the rig shall satisfy the requirement's of 61508 and it also spells out clearly what testing is needed to prove it. Let's go look at that testing section then... Quote: 6.2 Visual Inspection Visual inspection shall be conducted at normal visual acuity by the responsible expert(s) appointed by the accredited test station to test the apparatus. The visual inspection shall verify that the apparatus has been produced in accordance with the manufacturer’s technical file and include marking and information supplied by the manufacturer. So that for me says very clearly what testing needs to happen and it does not mention any external additional tester or requirement for additional certification. Which kinda makes sense as 61508 was explained to me as being really a methodology or set of methodologies around designing safety systems - incidentally if any readers are interested and want more info see Embedded.com - Software safety by the numbers So all they are checking is the manufacturer has proof of their development methadology and declares that it is 61508 conformant. Just to double check this though I headed over to the IECs website which is the body responsible for 61508 and this is what they say about it.....(From IEC - IEC in action \| Functional safety zone > C) Regional issues and technical interpretation) Quote: Is application of IEC 61508 compulsory under any EC Directive? No. EN 61508 does not have the status of a harmonized European standard, and is not referred to by any EC Directive. However, this does not prevent compliance with relevant parts of EN 61508 being used to support a declaration of conformity with an EC product directive, if that is appropriate. But because EN 61508 is not a harmonised European standard, there is no presumption of conformity with any directive. Therefore it would be necessary to explain in the technical file how compliance with EN 61508 is being used to support compliance with specific essential requirements of the particular directive. Which ties in exactly with the visual inspection of the technical file, which is there to prove the manufacturers statement that they have developed to 61508. The key thing though is it is used to support a declaration of conformity for another standard. eg the manufacturer is saying I declare I have conformed to this and here is my technical file as proof. That leads me to believe that my interpretation is correct which is I believe a view that the current Competent Notified Bodies most definately share. As if my interpretation of this is incorrect I believe that the liability would fall on the Competent Notified Body(accredited test station) for failing to correctly apply the standards - the manufacturers responsibility is to ensure their equipment is CE certified from a Competent Notified Body (which by it's very definition makes it valid) which they have done. I can understand where you are coming from both from making our sport safer as well as being a potential competing manufacturer wanting to differentiate future products but I think the only thing that would validate your intepretation compared to the rest of the industry would be some case law or the EN 14143 standard being re written to specifically require testing against 61508 rather than a statement of conformity. I would like to caveate my viewpoint by saying I am not as nor do I believe any one here is a legal expert on CE norm's or standards! __________________ Bailout and Kit Management account for Murphy's Law The only** bad question is one you did not ask and later wish you had. Use of Rebreather World is subject to the Rebreather World Terms & Conditions of Use Last edited by schford : 3rd March 2007 at 11:10.
(Offline)

3rd March 2007, 12:02	#2 (permalink)
divetheworld Dive porn pimp Current Rebreather/s: Inspiration Classic Other CCR Other Rebreather/s: Not Bought Yet Inspiration Classic Inspiration Vision Classic Kiss Other CCR Join Date: Mar 2005 Location: Leeds, England Posts: 1,585	Re: How to get a CE Mark for a Rebreather Quote: (Originally Posted by schford) My research leads me to believe that you do not need external certification for EN 61508 to achieve the EN 14143 CE mark for Rebreathers for 2 main reasons: 1 - EN 14143 clearly specifies what is required in terms of testing for IEC 61508 wihch does not include additional certificaiton. 2 - EN 61508 is not actually an adopted harmonised European standard. Let's look at my research - First up what EN 14143 actually says about 61508 Quote: 5.13 Electrical systems 5.13.1 Functional safety Any electrical, electronic or programmable electronic part of the apparatus shall satisfy the requirements of IEC 61508, Parts 1-7. Testing shall be done in accordance with 6.2. Which says that yes indeed the rig shall satisfy the requirement's of 61508 and it also spells out clearly what testing is needed to prove it. Let's go look at that testing section then... Quote: 6.2 Visual Inspection Visual inspection shall be conducted at normal visual acuity by the responsible expert(s) appointed by the accredited test station to test the apparatus. The visual inspection shall verify that the apparatus has been produced in accordance with the manufacturer’s technical file and include marking and information supplied by the manufacturer. So that for me says very clearly what testing needs to happen and it does not mention any external additional tester or requirement for additional certification. Which kinda makes sense as 61508 was explained to me as being really a methodology or set of methodologies around designing safety systems - incidentally if any readers are interested and want more info see Embedded.com - Software safety by the numbers So all they are checking is the manufacturer has proof of their development methadology and declares that it is 61508 conformant. Just to double check this though I headed over to the IECs website which is the body responsible for 61508 and this is what they say about it.....(From IEC - IEC in action \| Functional safety zone > C) Regional issues and technical interpretation) Quote: Is application of IEC 61508 compulsory under any EC Directive? No. EN 61508 does not have the status of a harmonized European standard, and is not referred to by any EC Directive. However, this does not prevent compliance with relevant parts of EN 61508 being used to support a declaration of conformity with an EC product directive, if that is appropriate. But because EN 61508 is not a harmonised European standard, there is no presumption of conformity with any directive. Therefore it would be necessary to explain in the technical file how compliance with EN 61508 is being used to support compliance with specific essential requirements of the particular directive. Which ties in exactly with the visual inspection of the technical file, which is there to prove the manufacturers statement that they have developed to 61508. The key thing though is it is used to support a declaration of conformity for another standard. eg the manufacturer is saying I declare I have conformed to this and here is my technical file as proof. That leads me to believe that my interpretation is correct which is I believe a view that the current Competent Notified Bodies most definately share. As if my interpretation of this is incorrect I believe that the liability would fall on the Competent Notified Body(accredited test station) for failing to correctly apply the standards - the manufacturers responsibility is to ensure their equipment is CE certified from a Competent Notified Body (which by it's very definition makes it valid) which they have done. I can understand where you are coming from both from making our sport safer as well as being a potential competing manufacturer wanting to differentiate future products but I think the only thing that would validate your intepretation compared to the rest of the industry would be some case law or the EN 14143 standard being re written to specifically require testing against 61508 rather than a statement of conformity. I would like to caveate my viewpoint by saying I am not as nor do I believe any one here is a legal expert on CE norm's or standards! __________________ Here is your first snag. The standard EN14143 states that 61508 is only to be applied to the electrical, electronic or programmable electronic part of the apparatus. As 61508 is for a system the statement in the standard EN14143 is, as quoted by Ron Bell (Chairman of IEC SC65A/Working Group 10 that developed EN61508) as being "of insufficient precision to render it meaningless". The clauses in the standard can be used in defence as due dilligence, having a design approved by a Notified Body in itself can be used as indication of due dilligence but does not prevent a succesful prosecution. There are a number of views, that of SIRA is still a veiw and not a legal definition regardless what rhetoric may be spurned from this. Above all, standards are NOT law. You do not have to comply with a single standard, whether it be Harmonised or not. However, if you comply with the specified Harmonised Euro Norms, then it is presumed that you comply with the Essential Safety requirments in the Directive. Where interpretations exist, it is up to the manufacturer to demonstrate compliance or obtain a definition from the Horizontal or Technical Committee as to a definition. The above does not represent my opinion which may differ fromn the facts posted. Brent Hudson Senior Engineer in a Notified body. EU Commission appointed representative. N.B. I've just read Alex' article and it is quite informative. There are a few bits I dont necasarily agree with in some parts but nothing that detracts from the spirit of what he is trying to say. If they come up as parts of the discussion, I will try to address them but not worth pointing out at this time as it would be plainly "nit picking" by someone who is anal about this topic. In summary, its quite accurate as to the current position relating to the certification of rebreathers. Well done. __________________ Attitude and self praise is no reccomendation. Dont try to be a great man, just be a man and let history be the judge of you. CHECK OUT OUR INTERWEBS FOR CUSTOM REBREATHER UPGRADES *WWW.NARKEDAT90.CO.UK* *http://www.grpservices.com/pursuit/* Supporting Shearwater Research Products in Europe Last edited by divetheworld : 3rd March 2007 at 13:36. Reason: fixed quote not coming across properly (words out of order) due to sub quotes
(Offline)

3rd March 2007, 12:08	#3 (permalink)
*schford* Despotic Overlord Current Rebreather/s: Megalodon Sport Kiss Other Rebreather/s: Join Date: Jan 2005 Location: London, UK Posts: 3,687	Re: Discussion on How to get a CE Mark for a Rebreather So I think what you are saying it that the wording in EN14143 is such that 61058 can never fully apply - so could not possibly be certified to apply? __________________ Bailout and Kit Management account for Murphy's Law The only bad question is one you did not ask and later wish you had. Use of Rebreather World is subject to the Rebreather World Terms & Conditions of Use
(Offline)

3rd March 2007, 12:44	#4 (permalink)
divetheworld Dive porn pimp Current Rebreather/s: Inspiration Classic Other CCR Other Rebreather/s: Not Bought Yet Inspiration Classic Inspiration Vision Classic Kiss Other CCR Join Date: Mar 2005 Location: Leeds, England Posts: 1,585	Re: Discussion on How to get a CE Mark for a Rebreather Quote: (Originally Posted by schford) So I think what you are saying it that the wording in EN14143 is such that 61058 can never fully apply - so could not possibly be certified to apply? Personal opinion. Lets take a simple example of the scrubber. If you apply 61508 to the whole system as has been suggested, then how can a granule based single scrubber comply? In short, it can not. Ever. Remember that stuff about failure rates, SIL levels and MTTF that Alex talked about? Try applying that in mathematical form to a granule scrubber with repeatable results. Turns to faecies real quick. Hence the design of the DL rebreather. So in order to certify, we have to take our own interpretation, document this and make it comply with what we can demonstrate is safe enough. Then be prepared to justify this in court should we need to. If a part of the Standard is impossible to comply with, then dont comply with it. Use due dilligence and risk assessments in the Technical Construction File but then you can not declare compliance with that Standard on the Declaration of Conformity. In essence, you can not pick and choose parts you want to comply with, then put the Standard number on your Declaration. This is an overly simplified example to which you can argue for months over technicalities should someone wish to, but the spirit of what I am saying should get through. Brent normal guy, dives quite often Up front note to all. There are many aspects of this thread that I will not be able to make comment upon due to my profession and various Non Disclosure agreements that I am bound to, including those to Deep Life. I also will not engage in bun fights either. __________________ Attitude and self praise is no reccomendation. Dont try to be a great man, just be a man and let history be the judge of you. CHECK OUT OUR INTERWEBS FOR CUSTOM REBREATHER UPGRADES *WWW.NARKEDAT90.CO.UK* *http://www.grpservices.com/pursuit/* Supporting Shearwater Research Products in Europe Last edited by divetheworld : 3rd March 2007 at 12:52.
(Offline)

3rd March 2007, 15:30	#5 (permalink)
AD_ward9 So much more to learn Current Rebreather/s: Other CCR Other Rebreather/s: Other CCR Join Date: Jun 2005 Location: Scotland Posts: 1,856	Re: Discussion on How to get a CE Mark for a Rebreather Quote: (Originally Posted by schford) So I think what you are saying it that the wording in EN14143 is such that 61058 can never fully apply - so could not possibly be certified to apply? There are two sets of wording on EN61508 in EN14143. The first is the list of normative standards. It lists EN61508. That is explicit. If the equipment falls within the scope any of the normative standards, then it needs to be tested to those standards. There is a second clause refering to EN61508 in Section 5 of the standard. I raised Brent's interpretation of this and the comment he had received with a member of the CEN-SC7 Committee who are responsible for EN14143. They do not concur: they intend that the equipment must comply with EN61508. I have sent a copy of Brent's note to the Committee and it is being raised at the next meeting. I understand there is a revision for EN14143 due out sometime, probably not very soon, and the wording will not doubt be even more explicit. Alex
(Offline)

3rd March 2007, 15:33	#6 (permalink)
AD_ward9 So much more to learn Current Rebreather/s: Other CCR Other Rebreather/s: Other CCR Join Date: Jun 2005 Location: Scotland Posts: 1,856	Re: Discussion on How to get a CE Mark for a Rebreather Quote: (Originally Posted by divetheworld) Personal opinion. Lets take a simple example of the scrubber. If you apply 61508 to the whole system as has been suggested, then how can a granule based single scrubber comply? In short, it can not. Ever. Remember that stuff about failure rates, SIL levels and MTTF that Alex talked about? Try applying that in mathematical form to a granule scrubber with repeatable results. Turns to faecies real quick. Hence the design of the DL rebreather. Thanks. Your personal opinion on this is endorsed by the directors of the CASS scheme we contacted to check this very point (and also on the international EN61508 committee, BSI etc). Granular scrubbers do not come up to the safety standard required for any of the EN61508 Safety Integrity levels, at least when the user packs them. It is possible for pre-packaged canisters with hydrophobic seals to pass, such as a prepack for a Cis-Lunar Mk 5. The other thing that passes is the Micropore EACs. On the second part of your opinion, on "own interpretation", the member of the SC7 committee we checked this with, indicated this would not be sufficient. The ALARP principle applies, and in the case of PPE equipment where it also falls into the scope of EN61508, one would have to justify that in a EN61508 audit. From personal experience, ALARP can be a tough one to prove unless one has changed the last P from Practical to Possible. Where there is a matter of interpretation or any ambiguity, we have sent that to an SC7 committee member. The ensuing discussion can reveal safety hazards one had not considered, but were considered by the committee when writing the standard. Alex Last edited by AD_ward9 : 3rd March 2007 at 15:38.
(Offline)

3rd March 2007, 15:44	#7 (permalink)
AD_ward9 So much more to learn Current Rebreather/s: Other CCR Other Rebreather/s: Other CCR Join Date: Jun 2005 Location: Scotland Posts: 1,856	Re: How to get a CE Mark for a Rebreather Quote: (Originally Posted by divetheworld) electrical, electronic or programmable electronic part of the apparatus. As 61508 is for a system the statement in the standard EN14143 is, as quoted by Ron Bell (Chairman of IEC SC65A/Working Group 10 that developed EN61508) as being "of insufficient precision to render it meaningless". I think you have the quote not quite right. I will raise it with Ron Bell at the 61508 Association meeting this Wednesday and report back. Alex
(Offline)

3rd March 2007, 15:53	#8 (permalink)
divetheworld Dive porn pimp Current Rebreather/s: Inspiration Classic Other CCR Other Rebreather/s: Not Bought Yet Inspiration Classic Inspiration Vision Classic Kiss Other CCR Join Date: Mar 2005 Location: Leeds, England Posts: 1,585	Re: How to get a CE Mark for a Rebreather Quote: (Originally Posted by AD_ward9) I think you have the quote not quite right. I will raise it with Ron Bell at the 61508 Association meeting this Wednesday and report back. Alex To copy the correspondance verbatim; "I think it could be argued that the clause is of sufficient imprecision to render it meaningless." Is there a point to that or are we nit picking? So when facing a court of law in the event of an accident and basing your entire structured arguments on one interpretation of this clause, it I doubt it will be possible to conclude beyond reasonable doubt that reasonably practicable means was not employed if the clause was followed in any reasonable interpretation. It would end up one appointed experts opinion over anothers, and I have had much experience with courts as appointed expert to know thats a dead end. The only constructive route would be in clarifying the standard in such a way that it is not open to interpretation and is still commercially viable. Without both, there is no point to it. __________________ Attitude and self praise is no reccomendation. Dont try to be a great man, just be a man and let history be the judge of you. CHECK OUT OUR INTERWEBS FOR CUSTOM REBREATHER UPGRADES *WWW.NARKEDAT90.CO.UK* *http://www.grpservices.com/pursuit/* Supporting Shearwater Research Products in Europe Last edited by divetheworld : 3rd March 2007 at 15:57.
(Offline)

3rd March 2007, 16:21	#9 (permalink)
AD_ward9 So much more to learn Current Rebreather/s: Other CCR Other Rebreather/s: Other CCR Join Date: Jun 2005 Location: Scotland Posts: 1,856	Re: How to get a CE Mark for a Rebreather Thanks for correcting the quote. Quote: (Originally Posted by divetheworld) The only constructive route would be in clarifying the standard in such a way that it is not open to interpretation and is still commercially viable. Without both, there is no point to it. That is very good advice. If any company finds and ambiguity in any standard they should comply with, and especially any Notified Body, they should advise the Committee responsible for the standard and get something in writing. For example, we had an issue with our hose stretch being more than the standard specifies, so we raised it with the CEN-SC7 Committee in their last meeting in Delft, and they were very accommodating. Not only did they reveal the valid safety reason for that clause that we had not considered, but minuted a statement giving us a dispensation as the hose stretch was more than the standard required but did not trigger the safety issue that caused the clause to be written. Committees do seem to be very receptive to a safety case that is properly forumated. On the issue of Ron's advice, I will raise it with the 61508 Association and CASS Scheme Directors as well as bring it to the attention of SC7. Ron's advice opinion falls down in that EN14143 defines EN61508 to be a normative standard, therefore applicable to anything falling into its scope. Alex Last edited by AD_ward9 : 3rd March 2007 at 16:24.
(Offline)

3rd March 2007, 17:04	#10 (permalink)
divetheworld Dive porn pimp Current Rebreather/s: Inspiration Classic Other CCR Other Rebreather/s: Not Bought Yet Inspiration Classic Inspiration Vision Classic Kiss Other CCR Join Date: Mar 2005 Location: Leeds, England Posts: 1,585	Re: How to get a CE Mark for a Rebreather Quote: (Originally Posted by AD_ward9) Thanks for correcting the quote. That is very good advice. If any company finds and ambiguity in any standard they should comply with, and especially any Notified Body, they should advise the Committee responsible for the standard and get something in writing. For example, we had an issue with our hose stretch being more than the standard specifies, so we raised it with the CEN-SC7 Committee in their last meeting in Delft, and they were very accommodating. Not only did they reveal the valid safety reason for that clause that we had not considered, but minuted a statement giving us a dispensation as the hose stretch was more than the standard required but did not trigger the safety issue that caused the clause to be written. Committees do seem to be very receptive to a safety case that is properly forumated. On the issue of Ron's advice, I will raise it with the 61508 Association and CASS Scheme Directors as well as bring it to the attention of SC7. Ron's advice opinion falls down in that EN14143 defines EN61508 to be a normative standard, therefore applicable to anything falling into its scope. Alex I honestly think any further discussion on this particular subject would be flogging a dead horse until the market surveillance authorities give a definitive ruling. It is only the MSA's opinion that counts in EU law (But they can be influenced by the 'experts' ;-)). As always, you hope for a balanced and objective veiw when appealing for rulings and arguments based upon a number of opinions. Generally the notified body does not go to the committee responsible. The system setup for these particular problems are the Horizontal committee and the vertical technical and sub committees of which the NB or his representative will be a member. The ruling comes from there, even then I would hesitate to call it a ruling. Brent As a foot note to those quietly watching the banter between the likes of Alex and I that this is a refreshing change for someone in my position. I almost invariably find myself in a position where I must explain the law to clients to make them put in extra effort, systems or components to ensure the safety requirements are met. Rarely do I find myself in a position where I would suggest a lesser level of effort is required in support of compliance. As such I would not dissuade or disrespect Alex' tenacious campain. __________________ Attitude and self praise is no reccomendation. Dont try to be a great man, just be a man and let history be the judge of you. CHECK OUT OUR INTERWEBS FOR CUSTOM REBREATHER UPGRADES *WWW.NARKEDAT90.CO.UK* *http://www.grpservices.com/pursuit/* Supporting Shearwater Research Products in Europe Last edited by divetheworld : 3rd March 2007 at 17:37.
(Offline)

Thread Tools
Show Printable Version Email this Page
Display Modes
Linear Mode Switch to Hybrid Mode Switch to Threaded Mode