United Kingdom Statutory Instruments

(i) are to apply upon or following termination of the designation;

(ii) require the use of test equipment for the purpose of conformity assessment appropriate to the exhaust gas analyser being assessed; and

(iii) limit the description of any exhaust gas analyser for which the person is designated;

(c) subject to regulation 10, may last for such period as may be specified in the designation;

(d) shall specify the conformity assessment procedures and specific tasks (which may be framed by reference to any circumstances) which the person has been designated to carry out; and

(e) may include a requirement to publish from time to time the scale of fees which the person charges pursuant to regulation 11 or such information about the basis of calculation of such fees as may be specified.

(i) in the United Kingdom by the Secretary of State; or

(ii) in another member State by the competent authority pursuant to Article 11.2.

(i) give notice in writing to the United Kingdom notified body of his reasons; and

(ii) give that notified body the opportunity to make representations within a period of 21 days from the date of that notice and consider any representations made to him within that period.

(i) the character and extent of the work done or to be done by that notified body on behalf of the applicant; and

(ii) the commercial rate normally charged on account of profit for that work or similar work.

(i) that the exhaust gas analyser is compliant with the requirements of these Regulations; or

(ii) that the manufacturer or his authorised representative acts as required under sub-paragraph (a) or (b),

any certificate or notification, issued by a notified body in accordance with the relevant conformity assessment procedure applicable to the exhaust gas analyser that the instrument satisfies the essential requirements, may be withdrawn by that notified body.

(i) an authorised mark affixed otherwise than in accordance with these Regulations;

(ii) an authorised mark that has been altered or defaced otherwise than in the circumstances referred to in paragraph (2); or

(iii) any marking which is likely to deceive any person as to the meaning or form, or both, of an authorised mark; or

(b) from which, to his knowledge, an authorised mark has been removed.

(i) admission to the premises has been or is likely to be refused, and that notice of intention to apply for a warrant has been given to the occupier; or

(ii) an application for admission, or the giving of such a notice would defeat the object of the entry, or that the case is one of urgency, or that the premises are unoccupied or the occupier is temporarily absent,

(a) the person from whom the information was received has consented to its disclosure; or

(b) the information is disclosed more than 50 years after it was received.

(a) by delivering it to him or by leaving it at his proper address or by sending it by post to him at that address;

(b) if the person is a body corporate, by serving it in accordance with sub-paragraph (a) on the secretary or clerk of that body corporate; or

(c) if the person is a partnership, by serving it in accordance with sub-paragraph (a) on a partner or on a person having control or management of the partnership business.

"climatic environments" means the conditions in which exhaust gas analysers may be used;

"critical change value" means the value at which the change in the measurement result is considered undesirable;

"disturbance" means an influence quantity having a value within the limits specified in the appropriate requirement but outside the specified rating conditions of the exhaust gas analyser. An influence quantity is a disturbance if for that influence quantity the rated operating conditions are not specified.

"exhaust gas components" means the components determined by an exhaust gas analyser, namely—

(a) carbon monoxide (CO);

(b) carbon dioxide (CO₂);

(c) oxygen (O₂); and

(d) hydrocarbons (HC) of which the content has to be expressed as concentration of n-hexane (C₆H₁₄), measured with near-infrared absorption techniques, and

the volume fractions of the gas components are expressed as a percentage (% vol) for CO, CO₂ and O₂ and in parts per million (ppm vol);

"influence quantity" means a quantity that is not the measurand but that affects the result of measurement;

"lambda" means a dimensionless value representative of the burning efficiency of an engine in terms of air/fuel ratio in the exhaust gases;

"measurand" means the particular quantity subject to measurement; and

"rated operating conditions" mean the values for the measurand and influence quantities making up the normal working conditions of an exhaust gas analyser.

Allowable Errors
     3. —(1) Under rated operating conditions and in the absence of a disturbance, the error of measurement shall not exceed the maximum permissible error (MPE) value as set out in paragraph 17.

    (2) Unless stated otherwise, MPE is expressed as a bilateral value of the deviation from the true measurement value.

    (3) Under rated operating conditions and in the presence of a disturbance, the performance requirement shall be as set out in paragraph 18(2).

    (4) Where the exhaust gas analyser is intended to be used in a specified permanent continuous electromagnetic field the permitted performance during the radiated electromagnetic field-amplitude modulated test shall be within MPE.

    (5) The manufacturer shall specify the climatic, mechanical and electromagnetic environments in which the exhaust gas analyser is intended to be used, power supply and other influence quantities likely to affect its accuracy, taking account of the requirements in this Schedule.

(a) Climatic environments—


     The manufacturer shall the temperature range. The minimum temperature range is 30°C and shall be within the upper temperature limit of 70°C and the lower temperature limit of -40°C. The manufacturer shall indicate whether the exhaust gas analyser is designed for condensing or non-condensing humidity as well as the intended location for the instrument, that is open or closed.



(b) Mechanical environments—



(i) M1: This class applies to exhaust gas analysers used in locations with vibration and shocks of low significance, for example for instruments fastened to light supporting structures subject to negligible vibrations and shocks transmitted from local blasting or pile-driving activities and slamming doors.

(ii) The following influence quantities shall be considered in relation with mechanical environments—


(aa) vibration;

(bb) mechanical shock.



(c) Electromagnetic environments—



(i) Electromagnetic environments are classified into classes E1 and E2, as follows—

     E1: This class applies to exhaust gas analysers used in locations with electromagnetic disturbances corresponding to those likely to be found in residential, commercial and light industrial buildings.

     E2: This class applies to exhaust gas analysers used in locations with electromagnetic disturbances corresponding to those likely to be found in other industrial buildings.

(ii) The following influence quantities shall be considered in relation with electromagnetic environments—


(aa) voltage interruptions;

(bb) short voltage reductions;

(cc) voltage transients on supply lines and/or signal lines;

(dd) electrostatic discharges;

(ee) radio frequency electromagnetic fields;

(ff) conducted radio frequency electromagnetic fields on supply lines and/or signal lines;

(gg) surges on supply lines or signal lines or both.

    (6) Other influence quantities to be considered, where appropriate, are—

(a) voltage variation;

(b) mains frequency variation;

(c) power frequency magnetic fields;

(d) any other quantity likely to influence in a significant way the accuracy of the exhaust gas analyser.

    (7) When carrying out the tests as envisaged in these Regulations, the following paragraphs apply—

(a) The basic rules for testing and the determination of errors are—


(i) the essential requirements specified in sub-paragraphs (1) to (4) shall be verified for each relevant influence quantity. These essential requirements apply when each influence quantity is applied and its effect evaluated separately, all other influence quantities being kept relatively constant at their reference value; and

(ii) the metrological tests shall be carried out during or after the application of the influence quantity, whichever condition corresponds to the normal operational status of the exhaust gas analyser when that influence quantity is likely to occur.



(b) In relation to ambient humidity—



(i) according to the climatic operating environment in which the exhaust gas analyser is intended to be used either the damp heat-steady state (non-condensing) or damp heat cyclic (condensing) test may be appropriate; and

(ii) the damp heat cyclic test is appropriate where condensation is important or when penetration of vapour will be accelerated by the effect of breathing. In conditions where non-condensing humidity is a factor the damp-heat steady state is appropriate.

Reproducibility
     4. The application of the same measurand in a different location or by a different user, all other conditions being the same, shall result in the close agreement of successive measurements. The difference between the measurement results shall be small when compared with the MPE.

Repeatability
     5. The application of the same measurand under the same conditions of measurement shall result in the close agreement of successive measurements. The difference between the measurement results shall be small when compared with the MPE.

Discrimination and Sensitivity
     6. An exhaust gas analyser shall be sufficiently sensitive and the discrimination threshold shall be sufficiently low for the intended measurement task.

Durability
     7. An exhaust gas analyser shall be designed to maintain an adequate stability of its metrological characteristics over a period of time estimated by the manufacturer, provided that it is properly installed, maintained and used according to the manufacturer's instruction when in the environmental conditions for which it is intended.

Reliability
     8. An exhaust gas analyser shall be designed to reduce as far as possible the effect of a defect that would lead to an inaccurate measurement result, unless the presence of such a defect is obvious.

Suitability
     9. —(1) An exhaust gas analyser shall have no feature likely to facilitate fraudulent use, whereas possibilities for unintentional misuse shall be minimal.

    (2) An exhaust gas analyser shall be suitable for its intended use taking account of the practical working conditions and shall not require unreasonable demands of the user in order to obtain a correct measurement result.

    (3) Where an exhaust gas analyser is designed for the measurement of values of the measurand that are constant over time, the instrument shall be insensitive to small fluctuations of the value of the measurand, or shall take appropriate action.

    (4) An exhaust gas analyser shall be robust and its materials of construction shall be suitable for the conditions in which it is intended to be used.

    (5) An exhaust gas analyser shall be designed so as to allow the control of the measuring tasks after the instrument has been placed on the market and put into use. If necessary, special equipment or software for this control shall be part of the instrument. The test procedure shall be described in the operation manual.

    (6) When an exhaust gas analyser has associated software which provides other functions besides the measuring function, the software that is critical for the metrological characteristics shall be identifiable and shall not be inadmissibly influenced by the associated software.

Protection against corruption
     10. —(1) The metrological characteristics of an exhaust gas analyser shall not be influenced in any inadmissible way by the connection to it of another device, by any feature of the connected device itself or by any remote device that communicates with the instrument.

    (2) A hardware component that is critical for metrological characteristics shall be designed so that it can be secured. Security measures foreseen shall provide for evidence of an intervention.

    (3) Software that is critical for metrological characteristics shall be identified as such and shall be secured.

    (4) Software identification shall be easily provided by the exhaust gas analyser.

    (5) Evidence of a software intervention shall be available for a reasonable period of time.

    (6) Measurement data, software that is critical for measurement characteristics and metrologically important parameters stored or transmitted shall be adequately protected against accidental or intentional corruption.

Information to be borne by and to accompany the exhaust gas analyser
     11. —(1) An exhaust gas analyser shall bear the following inscriptions—

(a) manufacturer's mark or name;

(b) information in respect of its accuracy,

plus, when applicable:

(c) information in respect of the conditions of use;

(d) measuring capacity;

(e) measuring range;

(f) identity marking;

(g) number of the EC-type examination certificate or the EC design examination certificate;

(h) information whether or not additional devices providing metrological results comply with these Regulations.

    (2) The exhaust gas analyser shall be accompanied by information on its operation, unless the simplicity of the instrument makes this unnecessary. Information shall be easily understandable and shall include where relevant—

(a) rated operating conditions;

(b) mechanical and electromagnetic environment classes;

(c) the upper and lower temperature limit, whether condensation is possible or not, open or closed location;

(d) instructions by installation, maintenance, repairs, permissible adjustments;

(e) instructions for correct operation and any special conditions of use;

(f) conditions for compatibility with interfaces or other measuring instrument.

    (3) Groups of identical exhaust gas analysers used in the same location do not necessarily require individual instruction manuals.

    (4) The scale interval for a measured value shall be in the form 1 x 10ⁿ, 2 x 10ⁿor 5 x 10ⁿ, where n is any integer or zero. The unit of measurement or its symbol shall be shown close to the numerical value.

    (5) The units of measurement used and their symbols shall be in accordance with the provisions of Community legislation on units of measurement and their symbols.

    (6) All marks and inscriptions required under any requirement shall be clear, non-erasable, unambiguous and non-transferable.

Indication of result
     12. —(1) Indication of the result shall be by means of a display or hard copy.

    (2) The indication of any result shall be clear and unambiguous and accompanied by such marks and inscriptions necessary to inform the user of the significance of the result. Easy reading of the presented result shall be permitted under normal conditions of use. Additional indications may be shown provided they cannot be confused with the metrologically controlled indications.

    (3) In the case of hard copy the print or record shall also be easily legible and non-erasable.

Further processing of data to conclude the trading transaction
     13. —(1) An exhaust gas analyser shall record by a durable means the measurement result accompanied by information to identify the particular transaction, when—

(a) the measurement is non-repeatable; and

(b) the exhaust gas analyser is normally intended for use in the absence of one of the trading parties.

    (2) Additionally, a durable proof of the measurement result and the information to identify the transaction shall be available on request at the time the measurement is concluded.

Conformity evaluation
     14. An exhaust gas analyser shall be designed so as to allow ready evaluation of its conformity with the appropriate requirements of these Regulations.

Instrument Classes
     15. There are two classes (0 and 1) being defined for exhaust gas analysers and the relevant minimum measuring ranges for these classes are shown in Table 1.


Table 1
Classes and measuring ranges

Parameter	Classes 0 and 1
CO fraction	from 0 to 5 % vol
CO2 fraction	from 0 to 16 % vol
HC fraction	from 0 to 2 000 ppm vol
O2 fraction	from 0 to 21 % vol
λ	From 0.8 to 1.2

Rated operating conditions
     16. —(1) The values of the operating conditions shall be specified by the manufacturer, as follows.

    (2) For the electrical power influence quantities, the limits of the DC voltage supply.

    (3) For the ambient pressure, the minimum and the maximum values of the ambient pressure are for both classes: _Pmin ≤ 860 hPa, _Pmax ≥ 1 060 hPa.

MPE
     17. The MPEs are defined as follows—

(a) for each of the fractions measured, the maximum error value permitted under rated operating conditions according to paragraph 3(1) and (2) of this Schedule is the greater of the two values for the relevant class shown in Table 2, with absolute values being expressed in % vol or ppm vol, percentage values are percent of the true value;

(a) sound technical and vocational training, covering all conformity assessment tasks for which the body was designated;

(b) satisfactory knowledge of the rules governing the tasks which it carries out, and adequate experience of such tasks; and

(c) the requisite ability to draw up the certificates, records and reports demonstrating that the tasks have been carried out.

     6. The impartiality of the body, its director and staff shall be guaranteed. The remuneration of the body shall not depend on the results of the tasks it carries out. The remuneration of the body's director and staff shall not depend on the number of tasks carried out or on the results of such tasks.

     7. The body shall satisfy the Secretary of State that it has adequate civil liability insurance.

     8. The body's director and staff shall be bound to observe professional secrecy with regard to all information obtained in the performance of their duties pursuant to these Regulations, except vis-à-vis the Secretary of State.

(a) a certificate of conformity;

(b) a design or type examination certificate; or

(c) a notification of approval of the manufacturer's quality system,

in accordance with the Annex applicable to the relevant conformity assessment procedure in respect of an exhaust gas analyser.

    (2) In determining such an application, the notified body—

(a) shall have regard to the actual or usual environment of the exhaust gas analyser; and

(b) may have regard to any other standard or other technical criteria appearing to it to be relevant.

    (3) Where, in the opinion of the notified body, the exhaust gas analyser to which an application relates is compliant with the essential requirements, it shall issue a certificate or notification in accordance with paragraph 12.

    (4) Where, in the opinion of the notified body, the exhaust gas analyser to which an application relates is not compliant with the essential requirements, it shall issue a notice to the applicant in accordance with paragraph 15.

    (5) Where a certificate or notification under sub-paragraph (3) is issued by a United Kingdom notified body, it shall send a copy to the Secretary of State.

Limitations on duties to exercise functions
     10. —(1) A notified body shall not accept an application for a certificate or notification in respect of an exhaust gas analyser unless the application—

(a) is in writing, in English or another language acceptable to that notified body;

(b) is accompanied by all relevant documentation, in which all writing is in English or another language acceptable to that notified body; and

(c) includes particulars of which applicable standards the manufacturer has applied or proposes to apply in respect of the instrument.

    (2) A notified body shall not be required to determine an application for a certificate or notification where the manufacturer has not—

(a) granted the notified body access to an exhaust gas analyser to which the application relates or the production facilities for the instrument (including, where applicable, the production facilities envisaged in relation to a representative instrument) to the extent that the notified body reasonably requests; and

(b) made available to the notified body such information as it may reasonably require to determine the application.

    (3) A notified body shall not be required to carry out the functions referred to in regulation 7(4)(d) if—

(a) the person making the application has not submitted with the application the amount of the fee which the notified body requires to be submitted with the application pursuant to regulation 11; or

(b) the notified body reasonably believes that, having regard to the number of applications made to it pursuant to its designation which are outstanding, it will be unable to commence the required work within three months of receiving the application.

Contractors
     11. —(1) A notified body may, in exercising its functions—

(a) arrange for some other person to carry out any test, assessment or inspection on its behalf; or

(b) require the applicant to satisfy another person with respect to any matter at the applicant's expense.

    (2) But nothing in sub-paragraph (1) authorises a notified body to rely on the opinion of another person with regard to whether an exhaust gas analyser is compliant with any of the essential requirements.

    (3) Nothing in these Regulations shall preclude a person referred to in sub-paragraph (1)(a) or (1)(b) from charging any fee in respect of any work undertaken by him in pursuance of those sub-paragraphs.

Form of certificates and notifications
     12. A certificate or notification issued by a notified body shall be in writing and, in addition to the requirements provided for in the relevant conformity assessment procedure, shall—

(a) be in English;

(b) give the name and address—


(i) of the applicant;

(ii) where the applicant is not the manufacturer, of the manufacturer;



(c) be signed by or on behalf of the notified body and give the identification number of the notified body;

(d) bear—



(i) the date of issue; and

(ii) the number of the certificate or notification;



(e) give particulars of the relevant exhaust gas analyser (where applicable, in relation to each variant) to which it relates sufficient to identify it, and shall state whether the instrument to which it relates is a single item or a representative, or if it covers a number of variants of that instrument; and

(f) certify that the exhaust gas analyser to which it relates is compliant with the essential requirements.

Conditions in certificates or notifications
     13. —(1) A certificate or notification may be unconditional or may be subject to such conditions as the notified body considers appropriate.

    (2) Such conditions may include—

(a) a limitation on the environment for which the exhaust gas analyser is stated to be suitable; or

(b) a requirement that the exhaust gas analyser is only to be installed at a specific site.

    (3) The conditions imposed pursuant to sub-paragraph (1) may be varied in accordance with paragraph 15 by the notified body which issued the certificate or notification and such variation may include the imposition of new conditions or the removal of conditions.

Withdrawal of certificates or notifications
     14. The notified body which issued the certificate or notification shall withdraw that certificate or notification in accordance with paragraph 15, if it appears that the exhaust gas analyser to which it relates is not compliant with the essential requirements.

Procedure where a notified body is minded to refuse to give, or to vary or withdraw a certificate or notification
     15. —(1) Where a notified body is minded to—

(a) refuse to issue a certificate or notification;

(b) vary a certificate or notification (other than at the request of the person to whom it was given); or

(c) withdraw a certificate or notification,

it shall give to the applicant, or the person to whom the certificate or notification was given, a notice in writing—

(i) giving reasons for the refusal, variation or withdrawal;

(ii) specifying the date on which the refusal, variation or withdrawal is to take effect; and

(iii) giving the applicant or person the opportunity to make representations within 21 days from the date of the notice and stating that the notified body shall consider any representations made to it within that period by that applicant or person.

    (2) Where a notified body, having considered representations made to it under sub-paragraph (1), remains of the opinion that—

(a) an application for a certificate or notification should be refused; or

(b) a certificate or notification should be varied or withdrawn,

it shall inform the applicant, or the person to whom the certificate or notification was given, of that decision in writing and give that applicant or person information about the judicial remedies available to him.

    (3) Where a notice is given under sub-paragraph (1) by a United Kingdom notified body, it shall send a copy to the Secretary of State.

(a) the definition of the metrological characteristics;

(b) the reproducibility of the metrological performances of produced exhaust gas analysers when properly adjusted using appropriate intended means; and

(c) the integrity of the exhaust gas analyser.

     3. The technical documentation shall include insofar as relevant for assessment and identification of the type and/or exhaust gas analyser—

(a) a general description of the instrument;

(b) conceptual design and manufacturing drawings and plans of components and circuits;

(c) manufacturing procedures to ensure consistent production;

(d) if applicable, a description of the electronic devices with drawings, diagrams, flow diagrams of the logic and general software information explaining their characteristics and operation;

(e) descriptions and explanations necessary for the understanding of sub-paragraphs (b), (c) and (d), including the operation of the instrument;

(f) a list of the relevant national standards and/or relevant normative documents, applied in full or in part;

(g) descriptions of the solutions adopted to meet the essential requirements where the relevant national standards and/or relevant normative documents have not been applied;

(h) results of design calculations and examinations;

(i) the appropriate test results, where necessary, to demonstrate that the type and/or instrument is compliant with the requirements of these Regulations under declared rated operating conditions and under specified environmental disturbances; and

(j) the EC-type examination certificates or EC design examination certificates in respect of instruments containing parts identical to those in the design.

     4. The manufacturer shall specify where seals and markings have been applied.

     5. The manufacturer shall indicate the conditions for compatibility with interfaces and sub-assemblies, where relevant.