Glossary of Directives & Standards
|Low Voltage Directive||EU|
|Medical Device Directive||EU|
|RCM Mark, formerly C-Tick||Australia/New Zealand|
|US and Canada Safety||North America and Canada|
|ISED Canada (formerly Industry Canada, or IC)||Canada|
The EMC Directive 2014/30/EU was adopted in 2004. The EMC Directive applies to apparatus, systems, equipment, and installations containing electrical or electronic components.
Definitions as per the EMC Directive, Article 2
‘equipment’ means any apparatus or fixed installation
‘apparatus’ means any finished appliance or combination thereof made available on the market as a single functional unit, intended for the end-user and liable to generate electromagnetic disturbance, or the performance of which is liable to be affected by such disturbance
- Fixed Installation
‘fixed installation’ means a particular combination of several types of apparatus and, where applicable, other devices, which are assembled, installed and intended to be used permanently at a predefined location
- Electromagnetic Compatibility
‘electromagnetic compatibility’ means the ability of equipment to function satisfactorily in its electromagnetic environment without introducing intolerable electromagnetic disturbances to other equipment in that environment
- Electromagnetic Disturbance
‘electromagnetic disturbance’ means any electromagnetic phenomenon which may degrade the performance of equipment; an electromagnetic disturbance may be electromagnetic noise, an unwanted signal or a change in the propagation medium itself
‘immunity’ means the ability of equipment to perform as intended without degradation in the presence of an electromagnetic disturbance
- Safety Purposes
‘safety purposes’ means the purposes of safeguarding human life or property
- Electromagnetic Environment
‘electromagnetic environment’ means all electromagnetic phenomena observable in a given location
Low Voltage Directive 2014/35/EU was adopted in 2006
For the purposes of the Directive, ‘electrical equipment’ means any equipment designed for use with a voltage rating of between 50 and 1,000 VAC and between 75 and 1,500 VDC, other than the equipment and phenomena listed in Annex II
ANNEX II per the Low Voltage Directive (2006/95/EC) Equipment and Phenomena outside the Scope of this Directive
- Electrical equipment for use in an explosive atmosphere
- Electrical equipment for radiology and medical purposes
- Electrical parts for goods and passenger lifts
- Electricity meters
- Plugs and socket outlets for domestic use
- Electric fence controllers
- Radio-electrical interference
- Specialized electrical equipment, for use on ships, aircraft or railways, which complies with the safety provisions drawn up by international bodies in which the Member States participate
- Custom built evaluation kits destined for professionals to be used solely at research and development facilities for such purposes
1. This Directive applies to the following products:
(b) interchangeable equipment;
(c) safety components;
(d) lifting accessories;
(e) chains, ropes and webbing;
(f) removable mechanical transmission devices;
(g) partly completed machinery.
2. The following are excluded from the scope of this Directive:
(a) safety components intended to be used as spare parts to replace identical components and supplied by the manufacturer of the original machinery;
(b) specific equipment for use in fairgrounds and/or amusement parks;
(c) machinery specially designed or put into service for nuclear purposes which, in the event of failure, may result in an emission of radioactivity;
(d) weapons, including firearms;
(e) the following means of transport:
– agricultural and forestry tractors for the risks covered by Directive 2003/37/EC, with the exclusion of machinery mounted on these vehicles,
– motor vehicles and their trailers covered by Council Directive 70/156/EEC of 6 February 1970 on the approximation of the laws of the Member States relating to the type-approval of motor vehicles and their trailers, with the exclusion of machinery mounted on these vehicles,
– vehicles covered by Directive 2002/24/EC of the European Parliament and of the Council of 18 March 2002 relating to the type-approval of two or three-wheel motor vehicles, with the exclusion of machinery mounted on these vehicles,
– motor vehicles exclusively intended for competition, and
– means of transport by air, on water and on rail networks with the exclusion of machinery mounted on these means of transport;
(f) seagoing vessels and mobile offshore units and machinery installed on board such vessels and/or units;
(g) machinery specially designed and constructed for military or police purposes;
(h) machinery specially designed and constructed for research purposes for temporary use in laboratories;
(i) mine winding gear;
(j) machinery intended to move performers during artistic performances;
(k) electrical and electronic products falling within the following areas, insofar as they are covered by Council Directive 73/23/EEC of 19 February 1973 on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits:
– household appliances intended for domestic use,
– audio and video equipment,
– information technology equipment,
– ordinary office machinery,
– electric motors;
(l) the following types of high-voltage electrical equipment:
– switch gear and control gear,
Definitions as per the Machinery Directive, Article 1.
For the purposes of this Directive, ‘machinery’ designates the products listed in Article 1(1)(a) to (f).
The following definitions shall apply:
- (a) Machinery
‘machinery’ means: – an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, at least one of which moves, and which are joined together for a specific application,
– an assembly referred to in the first indent, missing only the components to connect it on site or to sources of energy and motion,
– an assembly referred to in the first and second indents, ready to be installed and able to function as it stands only if mounted on a means of transport, or installed in a building or a structure,
– assemblies of machinery referred to in the first, second and third indents or partly completed machinery referred to in point (g) which, in order to achieve the same end, are arranged and controlled so that they function as an integral whole,
– an assembly of linked parts or components, at least one of which moves and which are joined together, intended for lifting loads and whose only power source is directly applied human effort;
- (b) Interchangeable Equipment
‘interchangeable equipment’ means a device which, after the putting into service of machinery or of a tractor, is assembled with that machinery or tractor by the operator himself in order to change its function or attribute a new function, in so far as this equipment is not a tool;
- (c) Safety Component
‘safety component’ means a component: – which serves to fulfill a safety function,
– which is independently placed on the market,
– the failure and/or malfunction of which endangers the safety of persons, and
– which is not necessary in order for the machinery to function, or for which normal components may be substituted in order for the machinery to function.An indicative list of safety components is set out in Annex V, which may be updated in accordance with Article 8(1)(a);
- (d) Lifting Accessory
‘lifting accessory’ means a component or equipment not attached to the lifting machinery, allowing the load to be held, which is placed between the machinery and the load or on the load itself, or which is intended to constitute an integral part of the load and which is independently placed on the market; slings and their components are also regarded as lifting accessories;
- (e) Chains, Ropes and Webbing
‘chains, ropes and webbing’ means chains, ropes and webbing designed and constructed for lifting purposes as part of lifting machinery or lifting accessories;
- (f) Removable Mechanical Transmission Device
‘removable mechanical transmission device’ means a removable component for transmitting power between self-propelled machinery or a tractor and another machine by joining them at the first fixed bearing. When it is placed on the market with the guard it shall be regarded as one product;
- (g) Partly Completed Machinery
‘partly completed machinery’ means an assembly which is almost machinery but which cannot in itself perform a specific application. A drive system is partly completed machinery. Partly completed machinery is only intended to be incorporated into or assembled with other machinery or other partly completed machinery or equipment, thereby forming machinery to which this Directive applies;
- (h) Placing on the Market
‘placing on the market’ means making available for the first time in the Community machinery or partly completed machinery with a view to distribution or use, whether for reward or free of charge;
- (i) Manufacturer
‘manufacturer’ means any natural or legal person who designs and/or manufactures machinery or partly completed machinery covered by this Directive and is responsible for the conformity of the machinery or the partly completed machinery with this Directive with a view to its being placed on the market, under his own name or trademark or for his own use. In the absence of a manufacturer as defined above, any natural or legal person who places on the market or puts into service machinery or partly completed machinery covered by this Directive shall be considered a manufacturer;
- (j) Authorized Representative
‘authorized representative’ means any natural or legal person established in the Community who has received a written mandate from the manufacturer to perform on his behalf all or part of the obligations and formalities connected with this Directive;
- (k) Putting Into Service
‘putting into service’ means the first use, for its intended purpose, in the Community, of machinery covered by this Directive;
- (l) Harmonized Standard
‘harmonized standard’ means a non-binding technical specification adopted by a standardization body, namely the European Committee for Standardization (CEN), the European Committee for Electrotechnical Standardization (CENELEC) or the European Telecommunications Standards Institute (ETSI), on the basis of a remit issued by the Commission in accordance with the procedures laid down in Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services.
Scope: This Directive shall apply to medical devices and their accessories. For the purposes of this Directive, accessories shall be treated as medical devices in their own right. Both medical devices and accessories shall hereinafter be termed devices.
Definitions as per the Medical Devices Directive 93/42/EEC
- (a) Medical Device
‘medical device’ means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of: – diagnosis, prevention, monitoring, treatment or alleviation of disease,
– diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
– investigation, replacement or modification of the anatomy or of a physiological process,
– control of conception,and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means;
- (b) Accessory
‘accessory’ means an article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device;
- (c) Device Used for In Vitro Diagnosis
‘device used for in vitro diagnosis’ means any device which is a reagent, reagent product, kit, instrument, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of samples derived from the human body with a view to providing information on the physiological state, state of health or disease, or congenital abnormality thereof;
- (d) Custom-Made Device
‘custom-made device’ means any device specifically made in accordance with a duly qualified medical practitioner’s written prescription which gives, under his responsibility, specific design characteristics and is intended for the sole use of a particular patient.The abovementioned prescription may also be made out by any other person authorized by virtue of his professional qualifications to do so.Mass-produced devices which need to be adapted to meet the specific requirements of the medical practitioner or any other professional user are not considered to be custom-made devices;
- (e) Device Intended for Clinical Investigation
‘device intended for clinical investigation’ means any device intended for use by a duly qualified medical practitioner when conducting investigations as referred to in Section 2.1 of Annex X in an adequate human clinical environment.For the purpose of conducting clinical investigation, any other person who, by virtue of his professional qualifications, is authorized to carry out such investigation shall be accepted as equivalent to a duly qualified medical practitioner;
- (f) Manufacturer
‘manufacturer’ means the natural or legal person with responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person himself or on his behalf by a third party.The obligations of this Directive to be met by manufacturers also apply to the natural or legal person who assembles, packages, processes, fully refurbishes and/or labels one or more ready-made products and/or assigns to them their intended purpose as a device with a view to their being placed on the market under his own name. This subparagraph does not apply to the person who, while not a manufacturer within the meaning of the first subparagraph, assembles or adapts devices already on the market to their intended purpose for an individual patient;
- (g) Intended Purpose
‘intended purpose’ means the use for which the device is intended according to the data supplied by the manufacturer on the labeling, in the instructions and/or in promotional materials;
- (h) Placing on the Market
‘placing on the market’ means the first making available in return for payment or free of charge of a device other than a device intended for clinical investigation, with a view to distribution and/or use on the Community market, regardless of whether it is new or fully refurbished;
- (i) Putting Into Service
‘putting into service’ means the stage at which a device is ready for use on the Community market for the first time for its intended purpose.
3. Where a device is intended to administer a medicinal product within the meaning of Article 1 of Directive 65/65/EEC, that device shall be governed by the present Directive, without prejudice to the provisions of Directive 65/65/EEC with regard to the medicinal product.
If, however, such a device is placed on the market in such a way that the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, that single product shall be governed by Directive 65/65/EEC. The relevant essential requirements of Annex I to the present Directive shall apply as far as safety and performance related device features are concerned.
4. Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of Article 1 of Directive 65/65/EEC and which is liable to act upon the body with action ancillary to that of the device, that device must be assessed and authorized in accordance with this Directive.
5. This Directive does not apply to:
(a) in vitro diagnostic devices;
(b) active implantable devices covered by Directive 90/385/EEC;
(c) medicinal products covered by Directive 65/65/EEC;
(d) cosmetic products covered by Directive 76/768/EEC (18);
(e) human blood, human blood products, human plasma or blood cells of human origin or to devices which incorporate at the time of placing on the market such blood products, plasma or cells;
(f) transplants or tissues or cells of human origin nor to products incorporating or derived from tissues or cells of human origin;
(g) transplants or tissues or cells of animal origin, unless a device is manufactured utilizing animal tissue which is rendered non-viable or non-viable products derived from animal tissue.
6. This Directive does not apply to personal protective equipment covered by Directive 89/686/EEC. In deciding whether a product falls under that Directive or the present Directive, particular account shall be taken of the principal intended purpose of the product.
7. This Directive is a specific Directive within the meaning of Article 2 (2) of Directive 89/336/EEC.
8. This Directive does not affect the application of Directive 80/836/Euratom, nor of Directive 84/466/Euratom.
1. This Directive applies to equipment and protective systems intended for use in potentially explosive atmospheres.
2. Safety devices, controlling devices and regulating devices intended for use outside potentially explosive atmospheres but required for or contributing to the safe functioning of equipment and protective systems with respect to the risks of explosion are also covered by the scope of this Directive.
3. For the purposes of this Directive, the following definitions shall apply:
Equipment and protective systems intended for use in potentially explosive atmospheres
(a) ‘Equipment’ means machines, apparatus, fixed or mobile devices, control components and instrumentation thereof and detection or prevention systems which, separately or jointly, are intended for the generation, transfer, storage, measurement, control and conversion of energy for the processing of material and which are capable of causing an explosion through their own potential sources of ignition.
(b) ‘Protective systems’ means design units which are intended to halt incipient explosions immediately and/or to limit the effective range of explosion flames and explosion pressures. Protective systems may be integrated into equipment or separately placed on the market for use as autonomous systems.
(c) ‘Components’ means any item essential to the safe functioning of equipment and protective systems but with no autonomous function.
Explosive atmospheres – Mixture with air, under atmospheric conditions, of flammable substances in the form of gases, vapors, mists or dusts in which, after ignition has occurred, combustion spreads to the entire unburned mixture.
Potentially explosive atmosphere – An atmosphere which could become explosive due to local and operational conditions.
Equipment groups and categories –
– Equipment group I applies to equipment intended for use in underground parts of mines, and to those parts of surface installations of such mines, liable to be endangered by firedamp and/or combustible dust.
– Equipment group II applies to equipment intended for use in other places liable to be endangered by explosive atmospheres.
The categories of equipment defining the required levels of protection are described in Annex I.
Equipment and protective systems may be designed for a particular explosive atmosphere. In this case, they must be marked accordingly.
Intended use The use of equipment, protective systems, and devices referred to in Article 1 (2) in accordance with the equipment group and category and with all the information supplied by the manufacturer which is required for the safe functioning of equipment, protective systems and devices.
**Equipment covered by the ATEX Directive must also meet the requirements of other relevant directives such as the EMC Directive, Low Voltage Directive, and Machinery Directive.
Australia/New Zealand (RCM Mark)
Effective March 1, 2013, the RCM Mark is the only mark that will indicate compliance with the Australian Communications and Media Authority’s (ACMA) regulatory requirements for telecommunications, radio, EMC and electromagnetic energy (EME).
Any new product that is physically labeled for the first time beginning on March 1, 2013 will need to be labeled with the RCM mark. The use of the C-Tick mark on all legacy products will be phased out by March 1, 2016.
Federal Communications Commission
The Federal Communications Commission (FCC) requires that all digital devices (including Information Technology, Industrial, Scientific, and Medical Equipment) that operate with internal clock rates over 9 kHz be tested under one or more of the sections outlined in CFR Title 47, Parts 15 or 18. F2 Labs has filed our test site with the FCC and has been accredited by A2LA in order to provide these services to our customers.
FCC Certification – Excerpts from www.fcc.gov
CERTIFICATION (47 CFR Section 2.907)ONE OR BOTH PROCEDURES
The procedure that is applicable for equipment authorization, depends on the applicable FCC rule part(s) that apply to the radio frequency functions. Except when otherwise stated in a rule, an intentional radiator (transmitter) is required to be approved using the certification procedure. Unintentional radiators (digital circuitry) are approved using the SDoC procedure. Today for example, devices such as mobile phones; wireless local area networking equipment, notebook computers, and tablet computers are a combination of radio transmitters requiring approval using the certification procedure and unintentional digital circuity requiring use of the SDoC procedure.
Equipment that consists of only a radio transmitter (not a transceiver) – such as remote control transmitters; land mobile radio transmitters and wireless medical telemetry transmitters – are required to be approved using the certification procedure.
Equipment that only contains digital circuitry (does not contain a radio transmitter) – such as computer peripherals, microwave ovens consumer ISM equipment, switching power supplies, LED light bulbs, radio receivers and TV interface devices – are subject to approval using the SDoC procedure or may optionally use the certification procedure.
Radio frequency devices that would have been considered eligible for authorization under either the verification or Declaration of Conformity procedures that were in effect prior to November 2, 2017 may continue to be authorized until November 2, 2018 under the appropriate procedure in accordance with the requirements that were in effect immediately prior to November 2, 2017. For a copy of the 2016 rules that specified the verification and Declaration of Conformity procedures see: https://www.govinfo.gov/app/collection/cfr/2016/title47/chapterI
U.S. and Canadian Safety Certification to UL and CSA standards
F2 Labs is a full service testing organization. If your products need U.S. and/or Canadian safety approvals to the UL and/or CSA standards, we can help. We partner with SGS, who is a Nationally Recognized Test Lab (NRTL) in order to provide our clients with product certification.
The Occupational Health and Safety Administration (OSHA) regulates products that are used in the workplace by stipulating that these products be suitably third-party safety approved by a Nationally Recognized Testing Laboratory (NRTL). A manufacturer has the option to select the NRTL of its choice for the testing and certification of their products. Additionally, they can expect that customers/retailers will accept products that have been Listed by any NRTL.
In April of 1988 a final rule was published in the Code of Federal Regulations that created the NRTL Program and ended the monopoly that Underwriter’s Laboratories had on the testing market. Under the responsibility of OSHA, labs meeting the requirements set forth in these laws would be accredited by OSHA and accepted into the NRTL Program.
The misconception that products can only be certified by Underwriter’s Laboratories (UL) or CSA Group (CSA) is false.
Likewise, when you sell your product in Canada, the law requires that you have it approved by a Certification Organization (CO) accredited by the Standards Council of Canada (SCC). Once your product is evaluated against the applicable Canadian requirements, it will bear a mark specifically designated for Canada.