TÜV SÜD Product Service Slide 1 Customer Day 2015 15-07-21

Wearable Technology Richard Poate TÜV SÜD Product Service

Who am I?

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Name Richard Poate

Title: Senior Manager

Employer: TÜV SÜD Product Service

Experience: 21 Years experience in product testing and approval

History: Worked for MoD, NHS, Industry, TÜV SÜD Product Service

Telephone: +44 (0)1489 558 215

E-mail: richard.poate@tuv-sud.co.uk

Content

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1 What is wearable technology

2 Compliance

3 Wearables with wireless

4 Other considerations

5 What might apply and gaining consumer trust

What is wearable technology?

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Wearable technology (also called wearable gadgets) is a category of technology devices that can be worn by a consumer and often include tracking information related to health and fitness Other wearable tech gadgets include devices that have small motion sensors to take photos and sync with your mobile devices Definition courtesy of www.webopedia.com

Examples of types of wearable technology?

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In the body: - Artificial limbs - Smart pills - Bionic eyes - Smart implants

Worn on the body: - 3D motion sensors - Hearing aids - EEG/EMG devices - Electronic glasses - Sensor patches - Insulin pump patches

Worn close to the body: - Smart phone accessories - Sleep monitors - Glasses - GPS - Alarms - Brain controlled devices - Clothes & shoes - Emotion monitors - Cameras - Activity trackers - Watches

Recent media headlines…

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“Five of the best smartwatches for 2015”

“Barclays expands contactless wearables”

“Wearable fitness gadget maker Fitbit valued at more than £2.5bn”

“Hospitals and GPs to start providing free Wi-Fi”

“Beware a future where health monitoring by wearables is the norm”

“Google Atap: touch-sensitive jeans, tiny radar and the death of the password”

“Get yourself connected: is the internet of things the future of fashion?”

Content

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1 What is wearable technology

2 Compliance

3 Wearables with wireless

4 Other considerations

5 What might apply and gaining consumer trust

So what about compliance for wearable tech...?

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Let’s consider a pair of battery powered flashing socks Usual softlines testing requirements apply - toxicology, care label verification, colourfastness, physical testing etc… But what else…? - General Product Safety Directive (GPSD) - EMC - Ingress protection - LEDs - Toy safety and “play value” - Battery Directive - Restriction of Hazardous Substances (RoHS) - Waste Electrical and Electronic Equipment (WEEE) - Etc…

Let’s consider compliance in a more detail:

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GENERAL PRODUCT SAFETY DIRECTIVE (2001/95/EC)

• Applies in the absence of specific European regulations on safety of certain product categories and complements the provisions of sector legislation, which do not cover certain matters, for instance in relation to producers’ obligations and the authorities’ powers and tasks

GPSD seems to be the world’s best kept secret! You can think of it as a “catch all” Directive for consumer safety

Let’s consider compliance in a more detail:

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EMC

• EN 55014-1 and EN 55014-2 would cover emissions & immunity

• Top tip: adopt a risk management approach for simple devices

i.e. if there are no active electronics that maybe affected by immunity testing then no need to conduct this element

• Note: EMC is a CE marking Directive which means CE marking must be applied!

Let’s consider compliance in a more detail:

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INGRESS PROTECTION

• Difficult to correlate ingress protection ratings in accordance with EN 60529 (degrees of protection afforded by enclosures) to real life scenarios

• Probably no safety hazard posed by water / washing (depending on the battery chemistry used – Note: Lithium and water don’t mix!)

• Top tip: more appropriate testing would be washing machine cycles to replicate the real world

Let’s consider compliance in a more detail:

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LEDs

• Testing to EN 60825 not generally required.

• LEDs must comply with EN 62471 - photobiological safety of lamps and lamp systems (note: EN 60825 ONLY required if called up by EN 62471)

• Top tip: In reality there shouldn’t be any need to test to EN 62471 as LED suppliers should provide suitable evidence of compliance

Note: Photobiology is the study of the interaction of optical radiation with living organisms

Let’s consider compliance in a more detail:

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TOY SAFETY & “PLAY VALUE”

• If socks intended for adults and sold through adult retail stores then this type of garment would not be a toy and would have limited play value

• In this case the General Product Safety Directive (GPSD) applies.

Top tip: You could apply toy standards such as EN 62115 (safety of electric toys) and EN 71-3 (migration of certain elements) as a means to demonstrate "due diligence" with the GPSD but these socks should not be identified as or labelled as a toy

Let’s consider compliance in a more detail:

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CHEMICAL LABELLING (BATTERY DIRECTIVE) • Requirement: certain chemical content has to be included on the garment • Top tip: In our opinion, chemical content should not be stated on the

garment packaging, instead label the electronics part. Rationale: chemical composition / labelling relates to end of life recycling specifically relating to the electronics part.

We think it’s better to declare chemical composition on the electronics part so the information can't be discarded prior to end of life (i.e. garment packaging maybe (probably!) thrown away). Also avoids misleading consumers, e.g. implying socks contain lead, cadmium and the like!

Let’s consider compliance in a more detail:

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RESTRICTION OF HAZARDOUS SUBSTANCES / WEEE

• Crossed wheelie bin symbol recommended on sock packaging to advise consumers not to dispose of as household waste

• Top tip: suggest RoHS be applied now for due diligence as it will apply after July 2019 anyway: New category 11 (other electrical and electronic equipment not covered by any other categories) comes into scope from July 2019

Note: Phthalates now included!

The reason for picking a simple pair of socks…

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Easy… wearable tech requires a new mind set

Even the simplest of wearable products needs careful consideration of the risks and application of the rules and regulations

Common sense is key

Content

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1 What is wearable technology

2 Compliance

3 Wearables with wireless

4 Other considerations

5 What might apply and gaining consumer trust

Wearables with wireless…

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And now, from low tech to high tech:

Many wearable devices incorporate wireless technology… - Smart glasses - Smart watches - Fitness devices - Bluetooth headsets and so on…

And not just for communication and data transfer but also for wireless battery charging

This adds another level of complexity and calls up the R&TTE Directive (Radio & Telecommunication Terminal Equipment Directive (transitioning to the RED Directive (Radio Equipment Directive)

Wearables with wireless…

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Popular frequency bands:

• 2.4GHz ISM Band (Worldwide band – very commonly used) – Bluetooth – 802.11 b/g/n (Wi-Fi)

• 5GHz ISM Band (Worldwide band – very commonly used) – WLAN 802.11 a/n/ac (Wi-Fi)

• Licensed Cellular – GSM (2G), WCDMA (3G), LTE (4G)

• GPS for tracking and positioning purposes

Wearables with wireless…

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R&TTE Directive (1999/5/EC) (Radio Equipment Directive 2014/53/EU will apply from June 2016)

Compliance is against generic “Essential Requirements” (Article 3); covering: - Health and safety - EMC - Spectrum usage

R&TTE / RED Essential Requirements

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R&TTE / RED essential requirements are very similar: • Article 3.1(a) – Health and safety of the user and others

(RED includes domestic animals) • Article 3.1(b) – EMC

• Article 3.2 – Effective spectrum usage

(RED covers “efficient” spectrum usage as well) Mandatory that the essential requirements are met If Harmonised Standards are used, Notified Body use is voluntary

Essential requirement - Article 3.1(a)

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Article 3.1(a) – “protection of the health and the safety of user and any other person”

The “health” aspect of this essential requirement requires that any “RF exposure” hazards are taken into account

Standards which have been applied should be listed on the Declaration of Conformity

SAR or RF exposure standard applied

Essential requirement - Article 3.1(a)

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SAR (Specific Absorption Rate) is heating effect on human tissue

Generally, devices used within 20cm of the head or body are subject to “SAR”, if the transmitted power output is above a certain threshold

Wrist and ankle worn devices have much lower compliance limits than those worn on head or body

The global picture

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• In the EU, R&TTE Directive compliance is primarily “self-declaration” Other regions in the world (e.g. USA and Canada) have a much stricter regime in place and formal certification of wireless devices is required

• SAR in the US is highly regulated FCC rules can be complex Most devices subject to SAR, which have been authorised by TCBs, are subject to 100% audit by the FCC

• Other countries tend to base their certification on either what goes on in Europe OR on what goes on in North America

• Top tip: know your intended markets, upfront planning will reduce tests, save cost and eliminate problems down the line

Content

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1 What is wearable technology

2 Compliance

3 Wearables with wireless

4 Other considerations

5 What might apply and gaining consumer trust

It’s not all about safety and compliance with regulations…

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DEVICE PERFORMANCE 1. Battery Typically wearable devices are small and lightweight (for obvious reasons) Battery life is critical for both user experience and for device functionality Of course, you can design a device with predicted battery life, but to be sure you need to replicate real world conditions and test 2. Mechanical Strength and Robustness Dropping is another easily foreseeable event, again how can you be sure that the device is safe under this (and similar) misuse conditions? Not only that your customers will expect that the device is durable and will withstand expected “wear and tear”

Medical vs. wellbeing devices

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Currently we see a mix of wearable devices available. Some of these are what we would call wellness/wellbeing devices, e.g. fitness trackers

But others may well be medical devices, it all depends on the claims made about the devices

So, you could have two devices for monitoring and recording heart rate BUT for one, the manufacturer claims that the data may be used by clinical professionals for diagnosis purposes

That may well make it a medical device which needs to comply with the Medical Devices Directive!

In which case IEC 60601-1 + collaterals + part 2 standards will apply + Medical Device Directive(s) requirements

Potential issues with wearables…

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Testing isn’t a magic bullet but independent, verifiable tests will help to counter negative claims and will bolster consumer confidence There has already one major (voluntary) recall involving wearable tech

“claimed it had caused skin rashes”

“users posting photos of skin rashes allegedly caused by the device”

“report comparing accuracy of fitness trackers”

Content

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1 What is wearable technology

2 Compliance

3 Wearables with wireless

4 Other considerations

5 What might apply and gaining consumer trust

Selection of EU Directives/Legislation that may apply to wearables

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• General Product Safety • Low Voltage Directive (primarily for charging devices) • EMC • R&TTE (RED) • Medical Devices • WEEE • RoHS • Batteries • REACh • Toys • Regulation on persistent organic pollutants

Other considerations

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• Water ingress

• Mechanical strength / general robustness

• Battery life

• Battery charging time

• Operating life

• Skin irritation

• Shipping / transport

• Usability and ergonomics

• Etc…

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And how can you ensure all this…?

Gaining consumer trust

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Increased confidence for end users through an independent and reliable brand

Demonstrate your quality

management process Benefit from years of expertise

in the safety & compliance area

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Thank you for listening Richard Poate Senior Manager TÜV SÜD Product Service +44 (0)1489 558215 richard.poate@tuv-sud.co.uk