Industrial machines / domestic appliances / lighting Folie 14 Manufacturer A Manufacturer B Radio module Washing machine becomes radio Intentional change of radio properties What does

Industrial machines / domestic appliances / lighting

Conformity assessment of smart equipment

- Safety and radio aspects

Dr. Alexandra Schleier

Combined equipment =

combination of non-radio and radio products

Folie 2

ETSI EG 203 367 v1.1.0

Guide to the application of harmonized standards covering articles 3.1b and 3.2 of the

Directive 2014/53/EU to multi-radio and combined radio and non-radio equipment

Product A and B are products in their own

right

At least one is a radio product

Each could have been placed on the

market individually

Product C is a new product falling in the

scope of the RED as a result of the

combination

Sofia Antipolis, 1 December 2016

Combined equipment:

radio part can be easily detached

Folie 3

What does „can be easily detached“ mean?

Definition still unclear

But:

if easily detachable

= two individual products

= conformity assessment independent of

each other

according to the respective CE-directives

applying

Here:

Conformity assessment for combined equipment with non-detachable radio part

?


How could combined equipment look like in

reality?

Folie 4Sofia Antipolis, 1 December 2016

Which directives apply?

2014/35/EU Low voltage

2014/30/EU

Electromagnetic compatibility

2011/65/EU

Hazardous Substances

2009/125/EC

Ecodesign directive

Folie 5

2006/42/EC

Machinery

2014/30/EU


Transeuropean or national

approval

2014/30/EU


+ Radio


Conformity assessment of combined equipment?

2014/35 EU

Low voltage

2014/30/EU

Electromagnetic

compatability

2011/65/EU

Hazardous

Substances

2009/125/EC

Ecodesign directive

Folie 6

2006/42/EC

Machinery

2014/30/EU

Electromagnetic

compatability

Transeuropean or

national approval

2014/30/EU

Electromagnetic

compatability

+ Radio

What does that mean for conformity

assessment ?

Which directives apply now ?



Folie 7

2014/35/EU Low voltage

2014/30/EU


before

2014/53/EU RED

= essential requirements LVD

= essential requirements EMC

+ efficient use of spectrum

after

Link to

previously

relevant

directives

remains


Safety requirements

Complete conformity assessment and documentation

for safety aspects already exists

Main risks are electrical and mechanical risks

Does the implementation of the radio module lead to

new risks (e.g. functional safety?)

Folie 8

Proposal:

Manufacturer relies on existing conformity assessment

Manufacturer conducts risk analysis on the combined equipment:

impact of incorporating a radio module on safety

Manufacturer includes results of this analysis into the technical

documentationSofia Antipolis, 1 December 2016

Safety standards and presumption of conformity

Safety standards for non-radio equipment listed

under LVD

Safety standards for non-radio equipment not yet

listed under RED

Folie 9

No presumption of conformity for safety !

„burden of proof“-ping-pong

Legal certainty and equal treatment throughout the internal market?

Timely solution would be highly appreciated


Use of radio spectrum –

Case I: No intentional change of radio properties

Conformity assessment

Documentation

DoC

Folie 10

Manufacturer A Manufacturer B

Radio

module

Washing machine becomes radio

No intentional change of radio properties,

no own development

What does the manufacturer need to do?



Case I: No intentional change of radio properties

Folie 11

Proposal:

Manufacturer relies on conformity assessment of radio

module manufacturer

Manufacturer conducts risk analysis on the combined

equipment:

impact of incorporating a radio module on radio properties

Manufacturer includes results of this analysis into the

technical documentation

Agreement would be highly appreciated


Components already placed on the market

“… different compliant pieces of equipment as defined by Directive

… previously placed on the market by different manufacturers

… have to conform with the Directive …

… Manufacturer of the assembly may presume conformity of these

pieces of equipment

… may restrict his own risk assessment … to additional … hazards

… which become relevant because of the final combination.

If there are additional … hazards, a further conformity assessment

… necessary.”

Folie 12

What are the hazards addressed in this quote?


Components already placed on the market

Folie 13

What are the hazards addressed in this quote?

Exploding FacTory Sites!

Despite high risk products

ATEX Directive works sufficiently with reliability of

previous conformity assessment results

in the supply chain



Case II: Intentional change of radio properties

Conformity assessment

Documentation

DoC

Folie 14

Manufacturer A Manufacturer B

Radio

module

Washing machine becomes radio

Intentional change of radio properties

What does the manufacturer need to do?


Use of radio spectrum

Case II: Intentional change of radio properties

Folie 15

Consequence

New conformity assessment and documentation



Folie 16

2006/42/EC Machinery

2014/30/EU


before

2006/42/EC - Machinery

2014/53/EU RED

= essential requirements LVD

= essential requirements EMC

+ efficient use of spectrum

after

Link to EMC

remains

Double

regulation

safety


Relation LVD – Machinery Directive

Years of debate to clarify the scopes and relation of LVD and

machinery directives ( relevant also for other directives)

LVD:

- mechanical hazards

- electrical hazards

Machinery:

- electrical hazards according to LVD

- specific mechanical hazards according to MD

(30 pages essential requirements)

Folie 17


Harmonized standards

No harmonized safety standards for machinery under RED

No presumption of conformity for article 3.1 a)

Even more uncertainty and questioning of free circulation in

the internal market = equal treatment in all member states?


Solution

Lex specialis – Blue Guide 2016 (chapter 2.6, page 23)

- High dynamics in the development of combined equipment

- Spread of radio applications to be expected in epidemic

proportions

Individual solutions not feasible

General solution required

= lex specialis principle in the RED Guide


Efficient use of spectrum

Proposal:

- Manufacturers B and C rely on conformity assessment of manufacturer A

- Risk analysis of the combined equipment

- No involvement of Notified Bodies in the second and third stepFolie 20

Manufacturer A Manufacturer B Manufacturer C

NB A NB C?NB B?


Summary

Conformity assessment:

clarification which safety requirements apply

Supply chain:

no unnecessary double assessment

Regulation:

there are no regulatory gaps but inconsistent double

regulation

Timely and practical solutions are required


Documents

Industrial machines / domestic appliances / lighting Folie 14 Manufacturer A Manufacturer B Radio module Washing machine becomes radio Intentional change of radio properties What does