Laws and standards
Johan NilssonInstitutionen för elektrisk mätteknik
Laws and standards
Why?
• Safety and health aspects - establish a reasonable level of
product safety
• The requirements should be regarded as minimum
• Quality - the manufacturer may (with respect to
customers) establish a higher level of safety)
Laws and standardsThe CE-mark
The CE (Conformité Europeenne) mark:
Signals that the product fulfills all applicable safety and health
requirements
Products with the CE-mark can be sold freely within the
EU/EES area.
Laws and standardsThe CE-mark - who is responsible?
• The manufacturer
• or, the representative within EU/EES
• or, the company that puts the product on the market within
EU/EES
• or, the company that assembles the machinery for internal
use
• Ex: The S-mark used in Sweden is no longer mandatory.
The S-mark was certified by an independant third-part
(SEMKO).
Laws and standardsEU/EES member states
EU:
Austria, Belgium, Cypru,s Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Ireland, Italy,
Latvia, Lithuania, Luxembourg, Malta, Poland, Portugal,
Slovakia, Slovenia, Spain, Sweden, The Netherlands, United
Kingdom
EES:
Iceland and Norway
Laws and standardsThe New Approach Directives
The problem of creating uniformity in the European Union was
addressed by the creation of “New Approach Directives” in
1985. Each of these directives covers a range of products and sets
out the essential safety requirements that products -- including
imports – must satisfy before they may be sold anywhere in the
EU. Products covered by one or more directives must meet the
requirements set out in the directive(s). They bear the CE mark,
which is affixed by the manufacturer or exporter as proof of their
compliance.
Laws and standardsExamples of New Approach Directives
issuedLow voltage (73/23/EEC
Industrial Trucks (74/150/EEC)
Motor Vehicles trailers (70/50/56 EEC)
Products labeling directive (83/374 EEC)
Simple Pressure Vessels (87/404/EEC)
Safety of Toys (87/378/EEC)
Construction Products (89/106/EEC)
Electromagnetic Compatibility (89/336/EEC)
Machinery Safety (98/37/EC)
Personal Protective Equipment (89/686/EEC)
Non-automatic Weighing Instruments
(90/384/EEC)
Active Implantable Medical Devices (90/385/EEC)
Gas Appliances (90/396/EEC)
Telecommunications Terminal Equipment
(91/263/EEC)
Mobile Machinery (91/368 EEC
Hot Water Boilers (92/42/EEC)
Medical Devices (93/42/EEC)
Lift Machinery (93/44 EEC)
Explosive for Civil Uses Directive (93/5/EEC)
Satellite Earth Station Equipment (94/9/EEC)
Recreational Craft (94/25/EEC)
Packaging & packaging waste (94/62EEC)
Lift Safety (95/16 EEC)
Energy Labeling (97/75 EEC)
Pressure Equipment (97/23/EEC)
Harmonized Standards
• The directives contain fundamental health and safety
requirements on products
• Detailed requirements and technical solutions are found in
standards that are developed e.g. by European Standards
Organisations, ex: EN 292 Safety of machinery.
• The European standards are transferred to national standards
in each country in EU/EES, ex: SS-EN 292.
• The standards that are considered to meet the requirements
of the directives are called Harmonized Standards.
• Harmonized standards are published in the EU Official
Journal
• A product that is developed according to Harmonized
Standards will thus meet the requirements of the directives.
Standards Organisations
•World standards•IEC - International Electrotechnical Commission•ISO - International organization for Standardization
•European standards•CEN - European Committee for Standardization•CENELEC - European Committe for ElectrotechnicalStandardization•ETSI - European Telecommunications Standards Institute
•Swedish standards•BST - Byggstandardiseringen•HSS - Hälso- och sjukvårdsstandardiseringen•IKH - Kran- och Hisstandardiseringen•ITS - Informationstekniska standardiseringen•SEK - Svenska Elektriska Kommissionen•SIS - Standardisering I Sverige•SMS - Svensk Material- & Mekanstandard•STG - Allmänna Standardiseringsgruppen•TKS - Tryckkärlsstandardiseringen
Ref: www.sp.se
Technical Construction FileTCF
• Must be compiled before the CE mark can be affixed, and the product is sold in the
EU. The TCF must be produced in one of the official languages of the European
Union and be made available to the responsible authorities in any EU country.
The main parts are:
• Declaration of Conformity
• A general description of the product
• Design and production drawing and diagrams
• Detailed technical data for essential aspects of the product
• List of standards and/or solutions applied
• Report of calculations and tests that have been carried out
• Certificate and inspection reports
• In the case of series production, the internal conditions that have been observed to
safeguard compliance with the directive
• CE user manual
Declaration of Conformity
It should contain the following:
• Name and address of the manufacturer or his authorized representative established
within the Community
• A description of the product
• Reference to the harmonized standards
• Where appropriate, reference to the specifications on which conformity is declared
• Identification of the signatory who has been empowered to enter into commitments
on behalf of the manufacturer or his authorized representative established within the
community
• The last two digits of the year in which the CE marking was affixed (for the first
time)
• The declaration of Conformity must be drawn up at least in one of the official
languages of the community. !
New Approach Directives
Low voltage (73/23/EEC)
Industrial Trucks (74/150/EEC)
Motor Vehicles trailers (70/50/56 EEC)
Products labeling directive (83/374 EEC)
Simple Pressure Vessels (87/404/EEC)
Safety of Toys (87/378/EEC)
Construction Products (89/106/EEC)
Electromagnetic Compatibility (89/336/EEC)
Machinery Safety (98/37/EC)
Personal Protective Equipment (89/686/EEC)
Non-automatic Weighing Instruments
(90/384/EEC)
Active Implantable Medical Devices (90/385/EEC)
Gas Appliances (90/396/EEC)
Telecommunications Terminal Equipment
(91/263/EEC)
Mobile Machinery (91/368 EEC
Hot Water Boilers (92/42/EEC)
Medical Devices (93/42/EEC)
Lift Machinery (93/44 EEC)
Explosive for Civil Uses Directive (93/5/EEC)
Satellite Earth Station Equipment (94/9/EEC)
Recreational Craft (94/25/EEC)
Packaging & packaging waste (94/62EEC)
Lift Safety (95/16 EEC)
Energy Labeling (97/75 EEC)
Pressure Equipment (97/23/EEC)
Most valid for this course
Ex: Risk assessment of a device
Menotreat
Control
unit
PumpDisplay
Power supply
Heater
Tubing Treatment balloon
Keyboard
Pressure sensor
Ex: Risk assessment of a device
Menotreat
• Patient safety!
• LVD - electrical aspects, shock, leakage currents.
• MSD - machinery safety aspects, get jammed, (kläm),
heat,
• EMC - immunity, emissions
• Material, Silicone-other
• Software-validation, fault tolerant.
Machinery Safety Directive
98/37/EEG
• Contains Fundamental Safety and Health Requirements
for design and construction of machines
• Implemented in Swedish legislation through AFS 1994:48
(Maskindirektivet)
Machinery Safety Directive
What is machinery?(a)
• an assembly of linked parts or components, at least one of which moves, with
the appropriate actuators, control and power circuits, etc., joined together for a
specific application, in particular for the processing, treatment, moving or
packaging of a material,
• an assembly of machines which, in order to achieve the same end, are
arranged and controlled so that they function as an integral whole,
• interchangeable equipment modifying the function of a machine, which is
placed on the market for the purpose of being assembled with a machine or a
series of different machines or with a tractor by the operator himself in so far
as this equipment is not a spare part or a tool;
(b) 'safety components` means a component, provided that it is not
interchangeable equipment, which the manufacturer or his authorised
representative established in the Community places on the market to fulfil a
safety function when in use and the failure or malfunctioning of which
endangers the safety or health of exposed persons.
Example of topics covered by the
Machinery Safety Directive• Risk assessment
• Emergency stops
• Machine control units - single fault tolerant
• Safety components - Ex: Logic for Emergency stop
• Protective devices
• Safety distances and minimum distances
• Hydraulics and pneumatics
• Ergonomics
• Noise
• Vibrations
• Hot and cold parts
• Electrical risks
Machinery Safety Directive
How to reach safe machinery?
1. Remove hazards in the machine design step
2. Protect hazardous parts from contact
3. Warn for the remaining hazards
The producer must consider both normal use and expected
abnormal use of the products
Machinery Safety Directive
Examples
• Transmission parts like axes or gear-wheels may cause
jamming or crushing - protection by cover
• If the consequence of a yet very unlikely accident is
serious, it is not enough to warn!
Risk assessment
Standard SS-EN 1050:1996
• Risk
• Seriousness of the injury
• Probability for the injury to occur
• Frequency and durability of exposure
• Probability that a risky event will occur
• Technical and human possibilities to avoid or
limit injury
Risk assessment process
• Start
• Determining the boundries of the machine
• Identifying the sources of risk
• Estimation of risk
• Evaluation of risk
• Is the machine safe?Yes
END
Reduction of risk
No
Risk assessment
Risk assessmentCategories for protection functions of
control systems
Risk assessment
Safety strategy
I. Reduce risks through construction
II. Remove working tasks from risk area
III. Design protective covers for remaining
work tasks
IV. Inform about remaining risks,
surveillance, personal protection
equipment
V. Warn for still remaining risks
Machine control unit
Standard SS-ISO 11 161:1994
• The construction and installation of the system must
protect from sources of interference:
• Electromagnetic (EMI)
• Electrostatic (ESD)
• Radiofrequency (RFI)
• Vibrations
• Noise
• Light
• Radiation
Machine control unit
Standard SS-ISO 11 161:1994
• The construction of the system must be fault tolerant:
• A single fault must not lead to increased risk
• A single fault that is not discovered must not lead
to increased risk if a second fault occures.
Machine control unit
Standard SS-ISO 11 161:1994
• Fault tolerance can be achieved by:
• Partly or full redundance
• Use of diversity
• Reduced speed or force for risky movements
• Supervision of control functions used for safety
purposes
• Acceptance systems
Ex: Motor drive circuit
Low Voltage Directive
73/23/EEC with amendment 93/68/EEC
• Applicable for electrical equipment with voltage ratings
between 50 and 1000 VAC or 75 - 1500 VDC.
Low Voltage Directive
What is electrical equipment?
• Every product that is used for purposes like generation,
transformation, transmission, distribution or use of electric
energy, e.g. motors, transformers, apparatus, instruments,
protective equipment, cables and house-hold equipment.
(IEC)
Low Voltage Directive
Why safety requirements?
• Accidents involving electricity - Electric shock
• Fire caused by electricity
Low Voltage Directive
Impedance hand - foot or hand - hand
• Typically in the range of 1kohm - 5 kohm
• Effect on skin from electric current:
< 10 mA/mm2 No harm
10 - 20 mA/mm2 Redness
20 - 50 mA/mm2 Blisters
> 50 mA/mm2 Gets charred (förkolnas)
Low Voltage Directive
Safety strategy for faults
0 fault Normal function, no hazard
1 fault ? Function, no hazard
>1 fault ? Function, hazard
Low Voltage Directive
• Effect on human body from electric current:
No reaction
0.5 mA unlimited time
Notable, no injury
10 mA, 2s / 200 mA, 10 ms
Muscles out of control, cramp
40 mA, 3s / 500 mA, 10 ms
Risk for auricular fibrillation
80 mA, 3s / 1.5 A, 10 ms (flimmer)
50% auricular fibrillation
Low Voltage Directive
Examples of solutions
• Protective earth (Class I equipment)
• Double isolation - 230 V cables, standard equipment with
no protective earth (Class II equipment)
Low Voltage Directive
Safety against fire
• Eliminate inflammable materials
• Encapsulate a possible fire
• Remove source of ignition
Low Voltage Directive
Examples of solutions against fire
• Fuses
• Transistor in own metal housing
• Thin bond wires in components
EMC Directive
89/336/EEG
• Applicable for electrical apparatus
• Component (does not serve a purpose on its own for the end
used) - not included in the directive
• System - two or more separate pieces of apparatus installed
and operating together - the complete system should meet the
directive, ex: PC (CPU-Monitor-keyboard)
• Installation - not sold as a unit - the different parts should
meet the directive, ex: telephone exchanges, factory
installations.
EMC Directive
Essential requirements
• The electromagnetic disturbance generated must not exceed a
level not allowing radio and telecommunications equipment
and other apparatus to operate as intended (emission)
• The apparatus must have an adequate level of intrinsic
immunity to electromagnetic disturbance to enable it to
operate as intended (immunity)
EMC Standards
Emissions test
• 150 kHz - 30 MHz: Conducted
• 30 MHz - 1 GHz: Radiated
EMC Standards
Ex of immunity tests
• Radiated RF field 80 MHz - 1 GHz
• Electrostatic discharge
• Electrical fast transients on power and I/O ports
• Surge
• AC power voltage dips
EMC Standards
Proposed performance criteria
• The apparatus continuous to operate as intended with no
degradation below a performace level specified by the
manufacturer
• The apparatus continues to operate as intended after the test,
but during the test some degradation of performance is
allowed
• Temporary loss of function is allowed, provided that it is
self- or operator-recoverable
Medical Devices Directive
93/42/EEC
• Contains all fundamental health and safety requirements
relevant for medical devices
• The different aspects of the Machinery, Low Voltage and
EMC directives are included in the medical Devices
Directive.
• Medical Devices do therefore ”only” need to meet the
requirements of MDD
Software
• Currently no requirements on development process except
for Medical Devices
• Consequences of software faults must be taken into
account
Unused program memory areasWatchdog
IP-klassning
Quality control of production
The manufacturer must assure that each produced piece of
equipment fullfils the requirements
Responsible for implementation of
the directives in Sweden• Machinery Safety Directive - Arbetsmiljöverket (www.av.se)
• Low Voltage Directive - Elsäkerhetsverket (www.elsak.se)
• EMC Directive - Elsäkerhetsverket
• Medical Device Directive - Socialstyrelsen
Responsible for co-ordination of the
market control and certification of
third-part test laboratories
• SWEDAC - Styrelsen för ackreditering och teknisk
kontroll
Useful links
• www.sp.se - Sveriges provnings och forskningsinstitut
• www.swedac.se - SWEDAC
• europa.eu.int/comm/enterprise/newapproach/legislation/gui
de/legislation.htm - EU hemsida för the New Approach
• www.newapproach.org/directiveList.asp
• /www.euroinfo.se/ - svensk EU-information
The end
