CE Testing/Approval of Component Parts??

***diverklondike*** · 18th April 2008, 13:16

I know that we have had lots of threads on the CE testing/approval of complete rebreather. Based on the comments that I have seen in several other threads, I was wondering if it's possible to get an aftermarket "component" CE tested and approved for use on a rebreather? Maybe on a specific rebreather??

Dive Safe

Mark

**nigelh** · 18th April 2008, 13:31

Quote: (Originally Posted by diverklondike)

I know that we have had lots of threads on the CE testing/approval of complete rebreather. Based on the comments that I have seen in several other threads, I was wondering if it's possible to get an aftermarket "component" CE tested and approved for use on a rebreather? Maybe on a specific rebreather??

If there isn't a spec for an item there is provision in the 'blue book' to self certify if it meets all the generic stuff like no unintended sharp bits and no EM emissions.

**jmurba** · 18th April 2008, 14:43

Quote: (Originally Posted by nigelh)

If there isn't a spec for an item there is provision in the 'blue book' to self certify if it meets all the generic stuff like no unintended sharp bits and no EM emissions.

During the short time I have used the draeger oxymeter I had a look to the manual provided with the gauge, and there was no trace of any EC PPI certification.

as far as I know no oxymeter solded without rebreather in europe as passed the test.

a rebreather itself is a personal protection equippement subjected to the ec certification when solded in europe, but a rebreather itself is not listed as a ppI as far as I know.

a rebreather is certified with all his components and ccr with their oxymeters and controllers.

regards

jean mi

**jmurba** · 18th April 2008, 14:44

Quote: (Originally Posted by nigelh)

If there isn't a spec for an item there is provision in the 'blue book' to self certify if it meets all the generic stuff like no unintended sharp bits and no EM emissions.

Hi just to know what is the blue book ?

AD_ward9 · 18th April 2008, 17:10

Components for rebreathers are covered by EN14143:2003. One can get components certified easily: one just applies the relevant sections, and go to the Notified Body with the Technical File, compliance matrix and test data to support that. You will need an ISO 9002 certified production facility, as well, generally.

It is not possible to self certify that part, as it is PPE or part of PPE, and is Complex Equipment as it does not fall into any of the simpler 2 PPE categories.

On jmurba's question, the only Blue Book I am aware of is a Blue Book in DL's QA system, i.e. an equipment specification prior to full engineering implementation. Experienced development groups normally apply "Phase Control" to the development process, with gates comprising reviews of key spec documents before a project is allowed to move from one phase to the next. Phases in DL are Clear Book (Marketing wish), White Book (Engineering reality check of the Clear Book), Blue Book (detailed engineering specification, including architecture, etc so anyone can go and implement it), Green Book (full engineering implementation description, ie. after it has been designed, built and tested), Violet Book (Mods after it is production: a book of Engineering Change Orders). The books are supported by other documents, including Feasibility Studies needed before a White Book can be approved, or Design Verification Reports on initial production samples before a Green Book is allowed to be approved for production, similarly the Safety Case documents (Accident Study, HAZOPS, FMECA, Compliance Documents, further Design Verification reports), etc.

Alex

divetheworld · 18th April 2008, 17:13

Okies,

Here we go.

PPE Directive.

This definition has proved readily understandable to equipment manufacturers and users alike, although some borderline cases still raise questions. Every term in the definition is important:
− PPE is “worn” in the sense that clothing, glasses, hearing protectors or fall arrest harnesses are worn. Indeed much PPE is clothing, be it garments, headgear, gloves or footwear. Other PPE is to be “held” in the hand, such as screens to protect the eyes and face during welding. The protection provided by PPE thus depends on an action by the person exposed to the hazard: the donning or holding of the equipment.
Portable equipment which is neither worn nor held during use is not considered as PPE.
So, for example, insulating mats or stools used by electricians for live working, or protective screens placed in the work stations are not regarded as PPE.
− PPE is worn or held “by an individual”. This is what distinguishes personal equipment from collective protective equipment. Significantly, the terms of the definition of PPE place it within the broad field of the protection of persons.
− PPE is used “for protection” of the individual. Generally the equipment forms a shield between part of the body and the hazard for the protection of the individual against any type of risk.
On the other hand, equipment used by individuals to help to prevent risks, but which do not have a protective function, such as alarm devices e.g., gas detectors or oxygen depletion detectors, are not classed as PPE.

Any system placed on the market in conjunction with PPE for its connection to another external, additional device shall be regarded as an integral part of that equipment even if the system is not intended to be worn or held permanently by the user for the entire period of risk exposure.

UKSteve · 18th April 2008, 17:16

Quote: (Originally Posted by AD_ward9)

Components for rebreathers are covered by EN14143:2003. One can get components certified easily: one just applies the relevant sections, and go to the Notified Body with the Technical File and test data.

Alex

Alex,

Thats interesting. But how would you get approval for something like a BOV? Especially compliance with the WOB as it seems in the EN standard that they refer to the breathing loop as a whole, not specific components. Therefore, how could you, for example, CE stamp a BOV intended for more than one model of rebreather? Especially a R/B that is not CE stamped itself?

Steve

AD_ward9 · 18th April 2008, 17:31

Quote: (Originally Posted by UKSteve)

Alex,

Thats interesting. But how would you get approval for something like a BOV? Especially compliance with the WOB as it seems in the EN standard that they refer to the breathing loop as a whole, not specific components. Therefore, how could you, for example, CE stamp a BOV intended for more than one model of rebreather? Especially a R/B that is not CE stamped itself?

Steve

Hi Steve,
Simple. You just apply the EN14143:2003 tests that relate to the BOV.

WOB, CO2 retention, FMECA, and put into a PPE technical file, as well as the EN250 tests (though most are migrated into the EN14143 requirements). The Notified Body should not have a problem certifying you if your figures are right. EN14143:2003 specifically covers rebreathers and rebreather components.

In your safety case for a BOV, you may find the WOB figures and curves we published on the ISC figures thread very useful, as you can then measure your BOV and refer to our figures to show that your BOV does not cause an increased WOB in any units listed so long as your WOB of your mouthpiece is less than those we list. This means you can get a CE approval for the BOV, even though the rest of the unit is not approved. You can then sell your BOV anywhere you like, and if you do it diligently, then you have the data to support you when an accident occurs.

In the safety case, you would need to consider the stability of the mushroom valves, ensure mushroom valves pass sick (easy, I can give you the safety clearances to you or anyone else who needs them free of charge), and a few other factors. Basically, make sure it is safe under all plausible operating conditions.

Of course, if someone then fits it to a non CE approved unit that is their problem. If they have an accident on it, then you are most unlikely to have any bother with lawyers, as your product complied and theirs did not. If you fit your CE BOV to a CE rebreather, such that it's relevant characteristics (dead volume, resistance and WOB) is not worse than the manufacturers, then again you are clear. If someone is selling components, and does not have the part CE approved, they are putting their neck out for any lawyer to chop it off as soon as the inevitable happens: it might take years, but trust me, it is not worth the hassle - it will make any profits you make vanish, and could cost you a lot more as well as the problem sleeping. Much better to do it properly, get it tested, fix the issues and retest, then certify a product that you now prove to be safe: you can then sleep easy, and any profits you make are yours and the taxmans.

Alex

***diverklondike*** · 18th April 2008, 17:45

Ok... Lets follow the BOV example... What happens if you have a "CCR" that is CE approved and of course meets WOB requirements. Someone then takes an aftermarket BOV that is also CE approved and replaces the OEM BOV. The compination of the two due to hose sizes etc results in a rig that no longer meets CE WOB requirements. Are there any ramifications to that example?

M

UKSteve · 18th April 2008, 17:46

Quote: (Originally Posted by AD_ward9)

Hi Steve,
Simple. You just apply the EN14143:2003 tests that relate to the BOV.....<snip>

Alex

Alex,

Yikes.. should have said "hypothetically".. I make my living (thankfully) making deep holes in the ground or these day teaching others how to do it instead!!

A much more simple form of engineering.

Thanks for explaining how you would go about it though.. makes sense now... Managed to get hold of a copy of the standard recently and it made interesting reading.

From your description it is hard to see how the intent (if not always the result) of CE regs is not to make our lifes a little safer.

Cheers

Steve

18th April 2008, 13:16	#1 (permalink)
*diverklondike* Moderator Current Rebreather/s: Inspiration Classic Other CCR Other Rebreather/s: Inspiration Classic Other CCR Join Date: Oct 2005 Location: Delaware, USA Posts: 1,563	CE Testing/Approval of Component Parts?? I know that we have had lots of threads on the CE testing/approval of complete rebreather. Based on the comments that I have seen in several other threads, I was wondering if it's possible to get an aftermarket "component" CE tested and approved for use on a rebreather? Maybe on a specific rebreather?? Dive Safe Mark
(Online)

18th April 2008, 13:31	#2 (permalink)
nigelh New Member Current Rebreather/s: Inspiration Vision Other CCR Other Rebreather/s: Inspiration Classic Other CCR Join Date: Mar 2005 Location: Brighton, Sussex, UK Posts: 825	Re: CE Testing/Approval of Component Parts?? Quote: (Originally Posted by diverklondike) I know that we have had lots of threads on the CE testing/approval of complete rebreather. Based on the comments that I have seen in several other threads, I was wondering if it's possible to get an aftermarket "component" CE tested and approved for use on a rebreather? Maybe on a specific rebreather?? If there isn't a spec for an item there is provision in the 'blue book' to self certify if it meets all the generic stuff like no unintended sharp bits and no EM emissions. __________________ nigelh
(Offline)

18th April 2008, 14:43	#3 (permalink)
jmurba wet bear Current Rebreather/s: Home Build Other Rebreather/s: Home Build Join Date: May 2006 Location: cannes france Posts: 720	Re: CE Testing/Approval of Component Parts?? Quote: (Originally Posted by nigelh) If there isn't a spec for an item there is provision in the 'blue book' to self certify if it meets all the generic stuff like no unintended sharp bits and no EM emissions. During the short time I have used the draeger oxymeter I had a look to the manual provided with the gauge, and there was no trace of any EC PPI certification. as far as I know no oxymeter solded without rebreather in europe as passed the test. a rebreather itself is a personal protection equippement subjected to the ec certification when solded in europe, but a rebreather itself is not listed as a ppI as far as I know. a rebreather is certified with all his components and ccr with their oxymeters and controllers. regards jean mi __________________ when will I be able to think about something else then spending hours underwater, when will I be normal ? http://web.mac.com/jmurba/Site_2/home.html http://web.mac.com/jmurba/Site_3/home.html
(Online)

18th April 2008, 14:44	#4 (permalink)
jmurba wet bear Current Rebreather/s: Home Build Other Rebreather/s: Home Build Join Date: May 2006 Location: cannes france Posts: 720	Re: CE Testing/Approval of Component Parts?? Quote: (Originally Posted by nigelh) If there isn't a spec for an item there is provision in the 'blue book' to self certify if it meets all the generic stuff like no unintended sharp bits and no EM emissions. Hi just to know what is the blue book ? __________________ when will I be able to think about something else then spending hours underwater, when will I be normal ? http://web.mac.com/jmurba/Site_2/home.html http://web.mac.com/jmurba/Site_3/home.html
(Online)

18th April 2008, 17:10	#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: 1,736	Re: CE Testing/Approval of Component Parts?? Components for rebreathers are covered by EN14143:2003. One can get components certified easily: one just applies the relevant sections, and go to the Notified Body with the Technical File, compliance matrix and test data to support that. You will need an ISO 9002 certified production facility, as well, generally. It is not possible to self certify that part, as it is PPE or part of PPE, and is Complex Equipment as it does not fall into any of the simpler 2 PPE categories. On jmurba's question, the only Blue Book I am aware of is a Blue Book in DL's QA system, i.e. an equipment specification prior to full engineering implementation. Experienced development groups normally apply "Phase Control" to the development process, with gates comprising reviews of key spec documents before a project is allowed to move from one phase to the next. Phases in DL are Clear Book (Marketing wish), White Book (Engineering reality check of the Clear Book), Blue Book (detailed engineering specification, including architecture, etc so anyone can go and implement it), Green Book (full engineering implementation description, ie. after it has been designed, built and tested), Violet Book (Mods after it is production: a book of Engineering Change Orders). The books are supported by other documents, including Feasibility Studies needed before a White Book can be approved, or Design Verification Reports on initial production samples before a Green Book is allowed to be approved for production, similarly the Safety Case documents (Accident Study, HAZOPS, FMECA, Compliance Documents, further Design Verification reports), etc. Alex Last edited by AD_ward9 : 18th April 2008 at 17:21.
(Offline)

18th April 2008, 17:13	#6 (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: 1,562	Re: CE Testing/Approval of Component Parts?? Okies, Here we go. PPE Directive. This definition has proved readily understandable to equipment manufacturers and users alike, although some borderline cases still raise questions. Every term in the definition is important: − PPE is “worn” in the sense that clothing, glasses, hearing protectors or fall arrest harnesses are worn. Indeed much PPE is clothing, be it garments, headgear, gloves or footwear. Other PPE is to be “held” in the hand, such as screens to protect the eyes and face during welding. The protection provided by PPE thus depends on an action by the person exposed to the hazard: the donning or holding of the equipment. Portable equipment which is neither worn nor held during use is not considered as PPE. So, for example, insulating mats or stools used by electricians for live working, or protective screens placed in the work stations are not regarded as PPE. − PPE is worn or held “by an individual”. This is what distinguishes personal equipment from collective protective equipment. Significantly, the terms of the definition of PPE place it within the broad field of the protection of persons. − PPE is used “for protection” of the individual. Generally the equipment forms a shield between part of the body and the hazard for the protection of the individual against any type of risk. On the other hand, equipment used by individuals to help to prevent risks, but which do not have a protective function, such as alarm devices e.g., gas detectors or oxygen depletion detectors, are not classed as PPE. Any system placed on the market in conjunction with PPE for its connection to another external, additional device shall be regarded as an integral part of that equipment even if the system is not intended to be worn or held permanently by the user for the entire period of risk exposure. __________________ 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
(Offline)

18th April 2008, 17:16	#7 (permalink)
UKSteve Still a novice... Current Rebreather/s: Inspiration Vision Other Rebreather/s: Join Date: Jul 2005 Location: Weymouth, UK Posts: 577	Re: CE Testing/Approval of Component Parts?? Quote: (Originally Posted by AD_ward9) Components for rebreathers are covered by EN14143:2003. One can get components certified easily: one just applies the relevant sections, and go to the Notified Body with the Technical File and test data. Alex Alex, Thats interesting. But how would you get approval for something like a BOV? Especially compliance with the WOB as it seems in the EN standard that they refer to the breathing loop as a whole, not specific components. Therefore, how could you, for example, CE stamp a BOV intended for more than one model of rebreather? Especially a R/B that is not CE stamped itself? Steve Last edited by UKSteve : 18th April 2008 at 17:20.
(Offline)

18th April 2008, 17:31	#8 (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: 1,736	Re: CE Testing/Approval of Component Parts?? Quote: (Originally Posted by UKSteve) Alex, Thats interesting. But how would you get approval for something like a BOV? Especially compliance with the WOB as it seems in the EN standard that they refer to the breathing loop as a whole, not specific components. Therefore, how could you, for example, CE stamp a BOV intended for more than one model of rebreather? Especially a R/B that is not CE stamped itself? Steve Hi Steve, Simple. You just apply the EN14143:2003 tests that relate to the BOV. WOB, CO2 retention, FMECA, and put into a PPE technical file, as well as the EN250 tests (though most are migrated into the EN14143 requirements). The Notified Body should not have a problem certifying you if your figures are right. EN14143:2003 specifically covers rebreathers and rebreather components. In your safety case for a BOV, you may find the WOB figures and curves we published on the ISC figures thread very useful, as you can then measure your BOV and refer to our figures to show that your BOV does not cause an increased WOB in any units listed so long as your WOB of your mouthpiece is less than those we list. This means you can get a CE approval for the BOV, even though the rest of the unit is not approved. You can then sell your BOV anywhere you like, and if you do it diligently, then you have the data to support you when an accident occurs. In the safety case, you would need to consider the stability of the mushroom valves, ensure mushroom valves pass sick (easy, I can give you the safety clearances to you or anyone else who needs them free of charge), and a few other factors. Basically, make sure it is safe under all plausible operating conditions. Of course, if someone then fits it to a non CE approved unit that is their problem. If they have an accident on it, then you are most unlikely to have any bother with lawyers, as your product complied and theirs did not. If you fit your CE BOV to a CE rebreather, such that it's relevant characteristics (dead volume, resistance and WOB) is not worse than the manufacturers, then again you are clear. If someone is selling components, and does not have the part CE approved, they are putting their neck out for any lawyer to chop it off as soon as the inevitable happens: it might take years, but trust me, it is not worth the hassle - it will make any profits you make vanish, and could cost you a lot more as well as the problem sleeping. Much better to do it properly, get it tested, fix the issues and retest, then certify a product that you now prove to be safe: you can then sleep easy, and any profits you make are yours and the taxmans. Alex Last edited by AD_ward9 : 18th April 2008 at 17:40.
(Offline)

18th April 2008, 17:45	#9 (permalink)
*diverklondike* Moderator Current Rebreather/s: Inspiration Classic Other CCR Other Rebreather/s: Inspiration Classic Other CCR Join Date: Oct 2005 Location: Delaware, USA Posts: 1,563	Re: CE Testing/Approval of Component Parts?? Ok... Lets follow the BOV example... What happens if you have a "CCR" that is CE approved and of course meets WOB requirements. Someone then takes an aftermarket BOV that is also CE approved and replaces the OEM BOV. The compination of the two due to hose sizes etc results in a rig that no longer meets CE WOB requirements. Are there any ramifications to that example? M
(Online)

18th April 2008, 17:46	#10 (permalink)
UKSteve Still a novice... Current Rebreather/s: Inspiration Vision Other Rebreather/s: Join Date: Jul 2005 Location: Weymouth, UK Posts: 577	Re: CE Testing/Approval of Component Parts?? Quote: (Originally Posted by AD_ward9) Hi Steve, Simple. You just apply the EN14143:2003 tests that relate to the BOV.....<snip> Alex Alex, Yikes.. should have said "hypothetically".. I make my living (thankfully) making deep holes in the ground or these day teaching others how to do it instead!! A much more simple form of engineering. Thanks for explaining how you would go about it though.. makes sense now... Managed to get hold of a copy of the standard recently and it made interesting reading. From your description it is hard to see how the intent (if not always the result) of CE regs is not to make our lifes a little safer. Cheers Steve
(Offline)

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