Regulatory Open Forum

Background

We are currently developing a class IIb active device and are trying to source a suitable plastic for the enclosure, but are struggling to find/clarify all the requirements in terms of flammability, ball-pressure tests, and UL-rated materials.

In our case, there is no patient contact (disposable accessory devices make contact) and the device is intended for European and American markets (via MDR & 510k respectively). It is a class II appliance (not earthed) and the plastic housing will be one of the two means of protection required under IEC 60601. The device is not intended for use with oxygen or flammable anesthetics, so the housing is not intended to be a fire enclosure. 

Questions

In short, I need to present some clear evidence to justify the costs (or savings) for going with (or against) an FR-rated material. This has turned into two questions:

1. I've found the ball-pressure test in IEC 60601, under [8.8.4.1], which doesn't need to be carried out if satisfactory evidence can be provided. In the first annex, [subclause 8.8.4.1] states 'tests concerning flammability of materials will be found in IEC 60695-11-10' – does this mean that a UL94-V0 rated material is an example of such satisfactory evidence, via a UL listing number for that material or by providing all the details of the test, including calibration certificates etc.
   
   
2. I've also found an article by Leo Eisner from back in 2004, stating that US national deviations to 60601 require fixed or stationary equipment to be V-0. I think this clears up my confusion on having an FR material, but am surprised that this is still a deviation in the latest edition and that this article is still at the very top of my search results (I know you're on RAPS, so well written Leo!?); unless Leo's article is still up-to-date, can anyone suggest any good resources that clearly differentiate national deviations, particularly for 60601-1 in the US?

Many thanks in advance, and apologies for the wall of text!

Background

We are currently developing a class IIb active device and are trying to source a suitable plastic for the enclosure, but are struggling to find/clarify all the requirements in terms of flammability, ball-pressure tests, and UL-rated materials.

In our case, there is no patient contact (disposable accessory devices make contact) and the device is intended for European and American markets (via MDR & 510k respectively). It is a class II appliance (not earthed) and the plastic housing will be one of the two means of protection required under IEC 60601. The device is not intended for use with oxygen or flammable anesthetics, so the housing is not intended to be a fire enclosure. 

Questions

In short, I need to present some clear evidence to justify the costs (or savings) for going with (or against) an FR-rated material. This has turned into two questions:

1. I've found the ball-pressure test in IEC 60601, under [8.8.4.1], which doesn't need to be carried out if satisfactory evidence can be provided. In the first annex, [subclause 8.8.4.1] states 'tests concerning flammability of materials will be found in IEC 60695-11-10' – does this mean that a UL94-V0 rated material is an example of such satisfactory evidence, via a UL listing number for that material or by providing all the details of the test, including calibration certificates etc.
   
   
2. I've also found an article by Leo Eisner from back in 2004, stating that US national deviations to 60601 require fixed or stationary equipment to be V-0. I think this clears up my confusion on having an FR material, but am surprised that this is still a deviation in the latest edition and that this article is still at the very top of my search results (I know you're on RAPS, so well written Leo!?); unless Leo's article is still up-to-date, can anyone suggest any good resources that clearly differentiate national deviations, particularly for 60601-1 in the US?

Many thanks in advance, and apologies for the wall of text!

1. An isolation or sometimes called insulation diagram of the whole product/system showing where all the insulation of the system/product relied on to meet the 60601 series of applicable standards are applied to meet the requirements.  This will show where this disposable accessory is located in terms of the rest of the insulated items and where there is any energy or not.  The insulation diagram shows the spacing (creepage and air-clearance requirements and also the Dielectric requirements for each insulation within the system).
2. Is the product/system a home-use device/system? Or used in an Emergency Medical Services environment?  There are specific collateral standards that may additionally apply.
3. Are there any Particular (i.e. IEC 60601-2-XX or IEC/ISO 80601-2-XX or other related IEC or ISO standards) standards that apply to the device/system that are 60601 based? (All 60601 based standards mentioned in items 2 & 3 can impact the requirements you are asking about).
4. Many test houses will accept UL 94 V materials but I can't guarantee all will even though the IEC60695 series is based on UL 94.  Per clause 11.3 of IEC 60601-1 the fire ENCLOSURE  requirements are FV-1 or better (which is per IEC 60695 series) but can be interpreted to mean UL 94V-1 or better is for FIXED or STATIONARY ME EQUIPMENT per the definitions in IEC 60601-1, ed. 3.1 (60601-1:2005 + A1:2012).  And are FV-2 or better (UL 94V-2 or better for TRANSPORTABLE ME EQUIPMENT.  I don't know the type of classification of your equipment so that will impact what type of material and flame rating you need.  Also, color, thickness all have an impact on meeting flame rating for plastic so you need to review the UL recognition of the plastic closely.  Also, important to understand that the mould release can have an impact on the flammability of the plastic as well.
5. Most labs still conduct the ball pressure test from what I have found unless you have really good evidence so I would check with your test lab before assuming anything about clause 8.8.4.1.  They also need a specific size sample typically so they are able to use the ball pressure device easily.
6. Since your enclosure is a polymeric material (plastic) I would recommend you also consider the Mechanical Strength tests that apply per the IEC 60601-1, clause 15.3 & related clauses and any applicable other 60601 other standards that may apply to your device as they may modify the general standard (IEC 60601-1) and so need to be considered closely before just testing separately.  You should refer to Table 28 based on the type of ME EQUIPMENT, such as HAND-HELD, BODY WORN, PORTABLE, MOBILE, FIXED or STATIONARY so you know what tests apply from clause 15.3.  Please also make sure to read the details in clause 15.3.1 as there are some critical items that all these tests shall not result in loss of BASIC SAFETY or ESSENTIAL PERFORMANCE.

Background

We are currently developing a class IIb active device and are trying to source a suitable plastic for the enclosure, but are struggling to find/clarify all the requirements in terms of flammability, ball-pressure tests, and UL-rated materials.

In our case, there is no patient contact (disposable accessory devices make contact) and the device is intended for European and American markets (via MDR & 510k respectively). It is a class II appliance (not earthed) and the plastic housing will be one of the two means of protection required under IEC 60601. The device is not intended for use with oxygen or flammable anesthetics, so the housing is not intended to be a fire enclosure. 

Questions

In short, I need to present some clear evidence to justify the costs (or savings) for going with (or against) an FR-rated material. This has turned into two questions:

1. I've found the ball-pressure test in IEC 60601, under [8.8.4.1], which doesn't need to be carried out if satisfactory evidence can be provided. In the first annex, [subclause 8.8.4.1] states 'tests concerning flammability of materials will be found in IEC 60695-11-10' – does this mean that a UL94-V0 rated material is an example of such satisfactory evidence, via a UL listing number for that material or by providing all the details of the test, including calibration certificates etc.
   
   
2. I've also found an article by Leo Eisner from back in 2004, stating that US national deviations to 60601 require fixed or stationary equipment to be V-0. I think this clears up my confusion on having an FR material, but am surprised that this is still a deviation in the latest edition and that this article is still at the very top of my search results (I know you're on RAPS, so well written Leo!?); unless Leo's article is still up-to-date, can anyone suggest any good resources that clearly differentiate national deviations, particularly for 60601-1 in the US?

Many thanks in advance, and apologies for the wall of text!

Thanks for the detailed answers Leo and I hope you're feeling better.

I'll definitely be referring  back to your responses in the future. My current queries closely relate to your 4^th point, we've already spoken with a plastics supplier and they suggested a medical grade plastic which, unfortunately, isn't UL listed. The 'medical' naming was (although still important) from a quality perspective in guaranteeing no changes to the material.

If we are selling in the US and EU, could we simply get this material (once molded into shape) tested to UL94?

I would like to use the same test house as for 60601-1 to simplify any questions on accreditation, test details, certifications, calibrations etc. We have asked our usual test house but they weren't very clear on whether a UL94 test alone was sufficient and steered the conversation towards UL-listing, which is substantially more expensive and I just don't think it's necessary?

1. An isolation or sometimes called insulation diagram of the whole product/system showing where all the insulation of the system/product relied on to meet the 60601 series of applicable standards are applied to meet the requirements.  This will show where this disposable accessory is located in terms of the rest of the insulated items and where there is any energy or not.  The insulation diagram shows the spacing (creepage and air-clearance requirements and also the Dielectric requirements for each insulation within the system).
2. Is the product/system a home-use device/system? Or used in an Emergency Medical Services environment?  There are specific collateral standards that may additionally apply.
3. Are there any Particular (i.e. IEC 60601-2-XX or IEC/ISO 80601-2-XX or other related IEC or ISO standards) standards that apply to the device/system that are 60601 based? (All 60601 based standards mentioned in items 2 & 3 can impact the requirements you are asking about).
4. Many test houses will accept UL 94 V materials but I can't guarantee all will even though the IEC60695 series is based on UL 94.  Per clause 11.3 of IEC 60601-1 the fire ENCLOSURE  requirements are FV-1 or better (which is per IEC 60695 series) but can be interpreted to mean UL 94V-1 or better is for FIXED or STATIONARY ME EQUIPMENT per the definitions in IEC 60601-1, ed. 3.1 (60601-1:2005 + A1:2012).  And are FV-2 or better (UL 94V-2 or better for TRANSPORTABLE ME EQUIPMENT.  I don't know the type of classification of your equipment so that will impact what type of material and flame rating you need.  Also, color, thickness all have an impact on meeting flame rating for plastic so you need to review the UL recognition of the plastic closely.  Also, important to understand that the mould release can have an impact on the flammability of the plastic as well.
5. Most labs still conduct the ball pressure test from what I have found unless you have really good evidence so I would check with your test lab before assuming anything about clause 8.8.4.1.  They also need a specific size sample typically so they are able to use the ball pressure device easily.
6. Since your enclosure is a polymeric material (plastic) I would recommend you also consider the Mechanical Strength tests that apply per the IEC 60601-1, clause 15.3 & related clauses and any applicable other 60601 other standards that may apply to your device as they may modify the general standard (IEC 60601-1) and so need to be considered closely before just testing separately.  You should refer to Table 28 based on the type of ME EQUIPMENT, such as HAND-HELD, BODY WORN, PORTABLE, MOBILE, FIXED or STATIONARY so you know what tests apply from clause 15.3.  Please also make sure to read the details in clause 15.3.1 as there are some critical items that all these tests shall not result in loss of BASIC SAFETY or ESSENTIAL PERFORMANCE.

Background

We are currently developing a class IIb active device and are trying to source a suitable plastic for the enclosure, but are struggling to find/clarify all the requirements in terms of flammability, ball-pressure tests, and UL-rated materials.

In our case, there is no patient contact (disposable accessory devices make contact) and the device is intended for European and American markets (via MDR & 510k respectively). It is a class II appliance (not earthed) and the plastic housing will be one of the two means of protection required under IEC 60601. The device is not intended for use with oxygen or flammable anesthetics, so the housing is not intended to be a fire enclosure. 

Questions

In short, I need to present some clear evidence to justify the costs (or savings) for going with (or against) an FR-rated material. This has turned into two questions:

1. I've found the ball-pressure test in IEC 60601, under [8.8.4.1], which doesn't need to be carried out if satisfactory evidence can be provided. In the first annex, [subclause 8.8.4.1] states 'tests concerning flammability of materials will be found in IEC 60695-11-10' – does this mean that a UL94-V0 rated material is an example of such satisfactory evidence, via a UL listing number for that material or by providing all the details of the test, including calibration certificates etc.
   
   
2. I've also found an article by Leo Eisner from back in 2004, stating that US national deviations to 60601 require fixed or stationary equipment to be V-0. I think this clears up my confusion on having an FR material, but am surprised that this is still a deviation in the latest edition and that this article is still at the very top of my search results (I know you're on RAPS, so well written Leo!?); unless Leo's article is still up-to-date, can anyone suggest any good resources that clearly differentiate national deviations, particularly for 60601-1 in the US?

Many thanks in advance, and apologies for the wall of text!

Thanks for the detailed answers Leo and I hope you're feeling better.

I'll definitely be referring  back to your responses in the future. My current queries closely relate to your 4^th point, we've already spoken with a plastics supplier and they suggested a medical grade plastic which, unfortunately, isn't UL listed. The 'medical' naming was (although still important) from a quality perspective in guaranteeing no changes to the material.

If we are selling in the US and EU, could we simply get this material (once molded into shape) tested to UL94?

I would like to use the same test house as for 60601-1 to simplify any questions on accreditation, test details, certifications, calibrations etc. We have asked our usual test house but they weren't very clear on whether a UL94 test alone was sufficient and steered the conversation towards UL-listing, which is substantially more expensive and I just don't think it's necessary?

1. An isolation or sometimes called insulation diagram of the whole product/system showing where all the insulation of the system/product relied on to meet the 60601 series of applicable standards are applied to meet the requirements.  This will show where this disposable accessory is located in terms of the rest of the insulated items and where there is any energy or not.  The insulation diagram shows the spacing (creepage and air-clearance requirements and also the Dielectric requirements for each insulation within the system).
2. Is the product/system a home-use device/system? Or used in an Emergency Medical Services environment?  There are specific collateral standards that may additionally apply.
3. Are there any Particular (i.e. IEC 60601-2-XX or IEC/ISO 80601-2-XX or other related IEC or ISO standards) standards that apply to the device/system that are 60601 based? (All 60601 based standards mentioned in items 2 & 3 can impact the requirements you are asking about).
4. Many test houses will accept UL 94 V materials but I can't guarantee all will even though the IEC60695 series is based on UL 94.  Per clause 11.3 of IEC 60601-1 the fire ENCLOSURE  requirements are FV-1 or better (which is per IEC 60695 series) but can be interpreted to mean UL 94V-1 or better is for FIXED or STATIONARY ME EQUIPMENT per the definitions in IEC 60601-1, ed. 3.1 (60601-1:2005 + A1:2012).  And are FV-2 or better (UL 94V-2 or better for TRANSPORTABLE ME EQUIPMENT.  I don't know the type of classification of your equipment so that will impact what type of material and flame rating you need.  Also, color, thickness all have an impact on meeting flame rating for plastic so you need to review the UL recognition of the plastic closely.  Also, important to understand that the mould release can have an impact on the flammability of the plastic as well.
5. Most labs still conduct the ball pressure test from what I have found unless you have really good evidence so I would check with your test lab before assuming anything about clause 8.8.4.1.  They also need a specific size sample typically so they are able to use the ball pressure device easily.
6. Since your enclosure is a polymeric material (plastic) I would recommend you also consider the Mechanical Strength tests that apply per the IEC 60601-1, clause 15.3 & related clauses and any applicable other 60601 other standards that may apply to your device as they may modify the general standard (IEC 60601-1) and so need to be considered closely before just testing separately.  You should refer to Table 28 based on the type of ME EQUIPMENT, such as HAND-HELD, BODY WORN, PORTABLE, MOBILE, FIXED or STATIONARY so you know what tests apply from clause 15.3.  Please also make sure to read the details in clause 15.3.1 as there are some critical items that all these tests shall not result in loss of BASIC SAFETY or ESSENTIAL PERFORMANCE.

Background

We are currently developing a class IIb active device and are trying to source a suitable plastic for the enclosure, but are struggling to find/clarify all the requirements in terms of flammability, ball-pressure tests, and UL-rated materials.

In our case, there is no patient contact (disposable accessory devices make contact) and the device is intended for European and American markets (via MDR & 510k respectively). It is a class II appliance (not earthed) and the plastic housing will be one of the two means of protection required under IEC 60601. The device is not intended for use with oxygen or flammable anesthetics, so the housing is not intended to be a fire enclosure. 

Questions

In short, I need to present some clear evidence to justify the costs (or savings) for going with (or against) an FR-rated material. This has turned into two questions:

1. I've found the ball-pressure test in IEC 60601, under [8.8.4.1], which doesn't need to be carried out if satisfactory evidence can be provided. In the first annex, [subclause 8.8.4.1] states 'tests concerning flammability of materials will be found in IEC 60695-11-10' – does this mean that a UL94-V0 rated material is an example of such satisfactory evidence, via a UL listing number for that material or by providing all the details of the test, including calibration certificates etc.
   
   
2. I've also found an article by Leo Eisner from back in 2004, stating that US national deviations to 60601 require fixed or stationary equipment to be V-0. I think this clears up my confusion on having an FR material, but am surprised that this is still a deviation in the latest edition and that this article is still at the very top of my search results (I know you're on RAPS, so well written Leo!?); unless Leo's article is still up-to-date, can anyone suggest any good resources that clearly differentiate national deviations, particularly for 60601-1 in the US?

Many thanks in advance, and apologies for the wall of text!

1. OTS UL-94 material
2. Somehow convince/pay the plastics manufacturer to gain UL-94 rating for our specific colour at vast cost (~£6k) and yearly auditing (£?)
3. Fire test the molded plastic (~£100's) and account for the costs of potentially repeating this on every FDA factory inspection

Thanks for the detailed answers Leo and I hope you're feeling better.

I'll definitely be referring  back to your responses in the future. My current queries closely relate to your 4^th point, we've already spoken with a plastics supplier and they suggested a medical grade plastic which, unfortunately, isn't UL listed. The 'medical' naming was (although still important) from a quality perspective in guaranteeing no changes to the material.

If we are selling in the US and EU, could we simply get this material (once molded into shape) tested to UL94?

I would like to use the same test house as for 60601-1 to simplify any questions on accreditation, test details, certifications, calibrations etc. We have asked our usual test house but they weren't very clear on whether a UL94 test alone was sufficient and steered the conversation towards UL-listing, which is substantially more expensive and I just don't think it's necessary?

1. An isolation or sometimes called insulation diagram of the whole product/system showing where all the insulation of the system/product relied on to meet the 60601 series of applicable standards are applied to meet the requirements.  This will show where this disposable accessory is located in terms of the rest of the insulated items and where there is any energy or not.  The insulation diagram shows the spacing (creepage and air-clearance requirements and also the Dielectric requirements for each insulation within the system).
2. Is the product/system a home-use device/system? Or used in an Emergency Medical Services environment?  There are specific collateral standards that may additionally apply.
3. Are there any Particular (i.e. IEC 60601-2-XX or IEC/ISO 80601-2-XX or other related IEC or ISO standards) standards that apply to the device/system that are 60601 based? (All 60601 based standards mentioned in items 2 & 3 can impact the requirements you are asking about).
4. Many test houses will accept UL 94 V materials but I can't guarantee all will even though the IEC60695 series is based on UL 94.  Per clause 11.3 of IEC 60601-1 the fire ENCLOSURE  requirements are FV-1 or better (which is per IEC 60695 series) but can be interpreted to mean UL 94V-1 or better is for FIXED or STATIONARY ME EQUIPMENT per the definitions in IEC 60601-1, ed. 3.1 (60601-1:2005 + A1:2012).  And are FV-2 or better (UL 94V-2 or better for TRANSPORTABLE ME EQUIPMENT.  I don't know the type of classification of your equipment so that will impact what type of material and flame rating you need.  Also, color, thickness all have an impact on meeting flame rating for plastic so you need to review the UL recognition of the plastic closely.  Also, important to understand that the mould release can have an impact on the flammability of the plastic as well.
5. Most labs still conduct the ball pressure test from what I have found unless you have really good evidence so I would check with your test lab before assuming anything about clause 8.8.4.1.  They also need a specific size sample typically so they are able to use the ball pressure device easily.
6. Since your enclosure is a polymeric material (plastic) I would recommend you also consider the Mechanical Strength tests that apply per the IEC 60601-1, clause 15.3 & related clauses and any applicable other 60601 other standards that may apply to your device as they may modify the general standard (IEC 60601-1) and so need to be considered closely before just testing separately.  You should refer to Table 28 based on the type of ME EQUIPMENT, such as HAND-HELD, BODY WORN, PORTABLE, MOBILE, FIXED or STATIONARY so you know what tests apply from clause 15.3.  Please also make sure to read the details in clause 15.3.1 as there are some critical items that all these tests shall not result in loss of BASIC SAFETY or ESSENTIAL PERFORMANCE.

Background

We are currently developing a class IIb active device and are trying to source a suitable plastic for the enclosure, but are struggling to find/clarify all the requirements in terms of flammability, ball-pressure tests, and UL-rated materials.

In our case, there is no patient contact (disposable accessory devices make contact) and the device is intended for European and American markets (via MDR & 510k respectively). It is a class II appliance (not earthed) and the plastic housing will be one of the two means of protection required under IEC 60601. The device is not intended for use with oxygen or flammable anesthetics, so the housing is not intended to be a fire enclosure. 

Questions

In short, I need to present some clear evidence to justify the costs (or savings) for going with (or against) an FR-rated material. This has turned into two questions:

1. I've found the ball-pressure test in IEC 60601, under [8.8.4.1], which doesn't need to be carried out if satisfactory evidence can be provided. In the first annex, [subclause 8.8.4.1] states 'tests concerning flammability of materials will be found in IEC 60695-11-10' – does this mean that a UL94-V0 rated material is an example of such satisfactory evidence, via a UL listing number for that material or by providing all the details of the test, including calibration certificates etc.
   
   
2. I've also found an article by Leo Eisner from back in 2004, stating that US national deviations to 60601 require fixed or stationary equipment to be V-0. I think this clears up my confusion on having an FR material, but am surprised that this is still a deviation in the latest edition and that this article is still at the very top of my search results (I know you're on RAPS, so well written Leo!?); unless Leo's article is still up-to-date, can anyone suggest any good resources that clearly differentiate national deviations, particularly for 60601-1 in the US?

Many thanks in advance, and apologies for the wall of text!