General Product Safety Directive

Firstly, it would be unusual for an 'aerospace IT product' to fall within the scope of the General Product Safety Directive as it only applies to consumer products, i.e. those which will not be used in the course making financial gain (for want of a better definition).

So before I start to discuss the GPSD, I'd need to confirm whether it's applicable. If not, it raises the question - what safety related regulations are applicable? Well, there may be several, but none which give prescriptive requirements affecting the design, documentation and attestation, like the CE marking directives do. A revision of the Low Voltage Directives in the future will probably reduce the lower voltage level to zero, which will close this gap, but until then, it remains.

Irrespective of what regulations are applicable or not, none of them would give prescriptive requirements concerning the electrical safety related design; you will only get this from standards. So, if you want to ensure and demonstrate the product is safe, the best option would be to identify a suitable electrical safety related standard and comply with that. It may well be EN 60950-1, but to confirm this, we'd need to get details of the product and perform a proper standards search.

First, it would be unusual for an 'aerospace IT product' to fall within the scope of the General Product Safety Directive (GPSD) as it only applies to consumer products. A ‘consumer’ is not actually defined in the GPSD but it does state that there is a difference between ‘consumer’ and ‘professional’ usage. In addition, the Directive does not apply to products used in the workplace by workers. Products that are used in the provision of a service, even if they are used for (but not by) consumers are also outside the scope of the GPSD.

Without yet fully understanding the make-up of your product, you do state however that it uses/generates 28VDC. Therefore, we can say that, at the very least, both EMC and RoHS should apply to this product. They themselves address particular safety issues rather than all of the safety matters derived by the device as a whole. One part of the GPSD would cover this gap as it states that, and in broad terms, where other Directives are implemented and they cover specific requirements – any other requirements not addressed by that specific Directive will be met by the GPSD. That should then cover all the remaining issues but, as we have already made clear, the GPSD only applies to consumer products.

There are, however, two other platforms that will ensure that due diligence is performed on the product. The first are the Regulations relating to the Market Surveillance Authorities. In the UK, under Regulation 765, an MSA will remove dangerous products from (or prevent them from being placed on) the market. (There are more stringent MSA requirements in the EU under Regulation 2019/1020). How an MSA deems a product to be safe is that any safety control measure that has been implement must achieve, at the minimum, the level of protection that is stated within a standard. The second platform are the ‘in-service’ regulations, which will again identify any substandard, professional product and prevent its use.

Furthermore, irrespective of what regulations are applicable or not, none of them give prescriptive requirements concerning the safety of the design (i.e. what are the ‘levels’ of safety to be achieved); you will only achieve this from standards.

So, if you want to ensure and demonstrate that the product is safe – so that it can be both sold and used - the best option would be to identify a suitable standard (in this case, an electrical standard) and comply with that. It may well be EN 60950-1 but, to confirm this, we would need the details of the product and perform a search for the appropriate standard(s).

Last updated: 2021-07-08 14:57

Posted 11 months ago
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Castors and wheels covered under EN 12531, EN 12527 and EN 12528 are covered by which directive? Do they require Notified body involvement?

You mentioned the following standards in your enquiry, as applicable to castors and wheels; BS EN 12531 - Castors and…

You mentioned the following standards in your enquiry, as applicable to castors and wheels;

BS EN 12531 - Castors and wheels. Hospital bed castors.
BS EN 12527 - Castors and wheels. Test methods and apparatus.
BS EN 12528 - Castors and wheels. Castors for furniture.

These products do not fall under the scope of any CE marking directives. Also, as they are not consumer products, I would not consider that the General Product Safety Directive applies either. Notified Body involvement is, therefore, also not required.

However, the products may be incorporated into a final product which does fall under the scope of a CE marking directive (e.g. a hospital bed). In this case the manufacturer of the final product will need to ensure that the final product meets the essential requirements of the applicable directive(s), which includes collating data sheets, test reports etc for component parts. Although this is generally only done for safety components (of which castors and wheels are probably not), in your case you would demonstrate the safety compliance of the castors and wheels by demonstrating that they are manufactured in accordance with the relevant standards mentioned above. You may wish to use a Notified Body to perform such testing on your behalf, but there is no requirement to do so.

Last updated: 2021-07-08 14:58

Posted 11 months ago
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You will need to meet ‘The Furniture and Furnishings (Fire) (Safety) Regulations’ but there is no requirement for CE marking through this regulation. (However, if it is children’s furniture that has play features or play value, then it is considered to be a toy and you will need to meet the requirements of the Toy Safety Directive 2009/48/EC and CE mark the final product).

GPSD and REACH also apply to your product, although, and again, their application does not involve placing the CE mark on the furniture.

You probably also ought to take account of the strength and durability requirements from, for example, EN 12520 and EN 13759 but these are more of a benchmark against which the adequacy of your products will be measured than a mandatory requirement that you have to meet.

Last updated: 2021-07-08 14:59

Posted 11 months ago
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The GPSD applies to "products used by consumers". What is meant by that? If we sell electrical components and subsystems to engineering companies, do we fall under this category?

A consumer product is one which the user purchases for something other than their business. Typical examples are things like…

A consumer product is one which the user purchases for something other than their business. Typical examples are things like domestic appliances or IT equipment purchased by home users, although a microwave oven, purchased by a company for use by its staff in a rest area, would also qualify (the ‘consumer’ being the user of the microwave, rather than the company which purchased it). Electrical components supplied to a company which then incorporates them into products to be sold on would not be considered as consumer products. Those types of components will, more than likely, require compliance with LVD, EMC and RoHS – all of which are CE marking Directives / Regulations.

Last updated: 2021-07-08 15:00

Posted 11 months ago
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Would children's bibs and bedding need to be CE certified?

Ordinary bibs and bedding will not require CE marking as they will not be classed as a toy under the…

Ordinary bibs and bedding will not require CE marking as they will not be classed as a toy under the Toy Safety Directive and there is no other applicable CE marking Directive. You will need to comply with any local requirements such as the Furniture and Furnishings (Fire) (Safety) Regulations and the Nightwear (Safety) Regulations.

Last updated: 2021-07-08 15:02

Posted 11 months ago
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What is a 'consumer' product?

A ‘consumer’ is someone who is not using the equipment in the course of their professional activities. A ‘consumer’ is…

A ‘consumer’ is someone who is not using the equipment in the course of their professional activities. A ‘consumer’ is not actually defined in the GPSD but it does state that there is a difference between ‘consumer’ and ‘professional’ usage. Typical examples would be products used in the home such as white or brown goods etc. The definition also applies to products used in the workplace but which are incidental to the professional activities of the user. An example would be a kettle or a microwave provided by a company for employees to prepare their lunch are products which would be ‘consumer’ products. On the other hand, a kettle used by someone to boil water for drinks which they are serving in a cafe would not be ‘consumer’ equipment. This is because products that are used in the provision of a service, even if they are used for (but not by) consumers, are outside the scope of the GPSD; the Directive does not apply to products used in the workplace by workers.

Last updated: 2021-07-08 15:03

Posted 11 months ago
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Would sheepskin require fire retardant treatment before upholstering a stool?

Upholstered furniture sold in the UK must meet the Furniture and Furnishings (Fire) (Safety) Regulations 1988. This sets out requirements…

Upholstered furniture sold in the UK must meet the Furniture and Furnishings (Fire) (Safety) Regulations 1988. This sets out requirements for complete items of furniture, not for the materials from which they are made.

It is possible that you will need to apply fire retardant treatment to the fur in order for the finished item of furniture to meet the Regulations. You will need to get the tests defined in the Regulations done on a sample to determine this.

Last updated: 2021-07-08 15:03

Posted 11 months ago
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I want to make wheat / heat bags that you put in the microwave and use for aches and pains. I want to sell at craft markets and online. Do I need to CE mark these products?

The main point to consider is how you are intending to market these items; what is their intended purpose? Where…

The main point to consider is how you are intending to market these items; what is their intended purpose? Where such items are sold with claims as to be ‘therapeutic’, alleviate’, ‘is a treatment for’, then they may well be considered to be a Medical Device. If they are and they are also ‘passive’ (i.e. they are not powered while being in contact with the body), then they are Class I Medical Devices, which you will need to CE mark but, as Class I, this can be done by self-certification. Once a product becomes ‘active’ (connected to a source of power whilst at the same time being used) then that will increase the classification, resulting in the need for testing and inspection by a Notified Body and then, once approved, CE marked.

EN 80601-2-35 addresses heating pads that are classed as ‘medical electrical equipment’.

The best way to fully understand whether you have a Medical Device or not is to contact the MHRA (via their website) and describe the product to them. Retain their written reply in your product’s Technical File as evidence of their classification.

If you are making no such medical claims (i.e. it is just a warming device like heating pads to go inside gloves on cold mornings) then you will not need to CE mark it but you will need to comply with the GPSD. Therefore, you should consider using EN 60335-2-17 and EN 80601-2-35 which addresses heating pads.

Last updated: 2021-07-08 15:04

Posted 11 months ago
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