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EN 529 – The European BGR 190
General
It is a well-known fact that the European Union (EU) is the highest-level legislative body in the area of occupational safety and health. The EU issues directives which are then transposed into national law. The European Council Directive of 30 November 1989 on the minimum health and safety requirements for the use by workers of personal protective equipment at the workplace (89/656/EC) was transposed into German law many years ago, the contents of the Directive having been firmly anchored in the German Occupational Safety and Health Act.

As early as 1992, the Technical Committee (CEN/TC 79 "Respiratory Protective Devices") compiled on the basis of the a forementioned Directive its Report CR 529 "Guide to the selection and use of respiratory protective devices". The report is targeted at European users of respiratory protective devices, and provides guideline information on how to select and use respiratory protective devices commensurate with the level of risk. Nonetheless, this guideline does not release users from their obligation to precisely determine, analyse and evaluate the actual conditions prevailing at the workplace and the protection requirements, and to select the appropriate device for these conditions. Report CR 529 formed the basis for a number of national regulations within the EU. In Germany, the regulation was issued by the professional associations – ZH1/701 "Regulations for the use of respiratory protective devices“.
CEN report CR 529 was periodically revised, regulation ZH1/701 following suit and being reissued under the name BGR 190. The contents of this regulation have already been outlined in a previous edition of the Dräger Review. At the time of the revision of CR 529, a general description of the report was featured in Dräger Review 85 (April 2000). The report was intended to be a practical document which would provide the user with the information needed to establish and practice efficient respiratory protection management. It aimed to explain all relevant aspects, from risk analysis to cost situation. Was this goal reached by the current version? To judge this, we need to take a look at its contents.

Main focus of the contents
To give the document greater weight, the revised version will be published as European Standard EN 529 "Respiratory protective devices – Recommendations for selection, use, care and maintenance – Guidance document“. At the present time, it is undergoing a formal European vote at CEN in Brussels. Since a positive outcome is likely, we will talk hereinafter of the EN 529 standard. The contents of this Standard are divided into the following main sections:
  • Terms and definitions
  • Classification
  • Programme process
  • Risk assessment process
  • Criteria for using respiratory protective devices
  • Risk assessment for respiratory protective devices use
  • Adequacy and suitability
  • Use
  • Operating information, instruction and training
  • Maintenance
  • Storage
  • Record keeping
  • Annexes A to F
The annexes deal with the following topics:
  • Annex A: Types and components of respiratory protective devices
  • Annex B: Atmospheres immediately dangerous to life or health
  • Annex C: Protection factors
  • Annex D: Suitability factors
  • Annex E: Assessing the fit of tight fitting facepieces
  • Annex E: Assessing the fit of tight fitting facepieces
  • Annex F: Respiratory protection passport
These main sections are preceded by a foreword, a brief introduction, information about the scope, and normative references. The Standard ends with a short bibliography. The introduction contains a reference to the hazard potential of the contaminants in the ambient atmosphere, and the order of priority of protective measures. Respiratory protective devices are only to be used in situations where other protective measures are not effective. Respiratory protective devices must be carefully selected, and adapted to the wearer in line with the task to performed, the ambient atmosphere, and the risk situation. All associated problems should be avoided by introducing suitable respiratory protective device programme. The Scope section states that EN 529 is intended as a practical guideline to the creation and implementation of a suitable respiratory protective device programme. It is designed to form the Europewide basis for the selection, use, care and maintenance of respiratory protective devices. The section "Normative References" lists currently relevant European standards relating to respiratory protection. The list starts with EN 132 "Respiratory protective devices – Definitions of terms and pictograms“ ends with EN 14387 "Respiratory protective devices – Gas filter(s) and combined filter(s) – Requirements, testing, marking“. In addition to the terms mentioned in EN 132 and EN 134 "Respiratory protective devices – Nomenclature of components", EN 529 contains a further 12. These range from the definition of an "atmosphere posing a direct threat to life or health" to an explanation of the term "work intensity". The wide range of different respiratory protective devices is classified into two main types:
– Filtering devices: these clean the ambient air to be inhaled using filters which remove any airborne contaminants.
– Breathing apparatus: these supply the device wearer with breathing air or gas (e.g. oxygen) from a non-contaminated source.
Annex A of EN 529 contains a detailed description of the respiratory protective devices. The aforementioned device types comprise two main components: a facepiece with filter(s) or with a device providing a supply of clean breathing air or gas. Facepieces can be any of the following:
– tightly fitting facepieces such as half and full face masks,
– non-tightly fitting facepieces such as hoods and helmets. These are only suitable for respiratory protective devices with obligatory breathing air/gas supply, e.g. power-assisted filtering devices.
– Mouthpieces with nose clip. These are preferably to be used for self-rescuers. Filters should be selected to match the type and concentration of the contaminant. The respiratory protective device wearer should be supplied with pure breathing air/gas from a container (e.g. O2 generator) or a source such as a compressed air line. The supply type is explained in the device description in Annex A.

The legal regulations require employers and the self-employed to define and document a suitable policy for designing a respiratory protective device programme. This encompasses the correct selection, maintenance and issue of equipment, as well as monitoring of the correct use of the respiratory protective devices. These goals can be achieved by
  • an effective organization involving persons with the relevant expert knowledge,
  • making available the necessary resources,
  • periodically reviewing the programme,
  • giving all persons involved in the programme suitable instruction,
  • constantly monitoring use of the equipment and checking the effectiveness of the respiratory protective device programme.
It goes without saying that employees likewise have obligations to meet. If they are involved in the respiratory protective device programme, they must act in accordance with the applicable procedures and systems, and take responsibility for the duties assigned to them. The devices must be worn, used in accordance with the manufacturer's instructions, and checked prior to use. In accordance with the information given during the employer's instruction, any problems during wearing must be reported. In order to be able to perform all the duties associated with the respiratory protective devices, experts should work together with the employer to ensure that they are provided with the necessary knowledge, experience and instruction. Manufacturers of respiratory protective devices are responsible for CE marking their devices. The information supplied with the devices must be correct, conform to the latest state of knowledge, and contain details of the correct device selection by the employer/ user. Responsibility for the appropriate selection and use of suitable respiratory protective devices lies with the employer. Before resorting to the use of respiratory protective devices, the exposure to hazardous substances at the workplace should be eliminated or, if this is not possible, minimized by undertaking suitable measures. Before initiating such measures, a risk assessment should be carried out to establish the type and extent of the dangers, the work environment, the work duties to be performed and the persons performing them, the preventive measures taken and the consequences of failure of the protective measures. If protective measures are required, the steps listed in Table 1 of EN 529 should be followed – these range from the "use of alternative substances which are less hazardous" to the "use of appropriate and suitable personal protective equipment, including respiratory protective devices". These steps should be supported by organizational and monitoring systems and the hazard risk should be periodically reviewed. The following conditions need to be met to necessitate the use of respiratory protective devices:
  • Although other protective measures are in force, there is still a risk of hazardous substances being inhaled.
  • The limit values for hazardous substances have been exceeded and the implementation of protective measures is imminent.
  • Emergency work can be undertaken even without protective measures being in force.
  • There is no point in implementing protective measures because the hazardous substances occur only rarely and for brief periods.
  • Respiratory protective devices are used in the case of work emergencies by instructed persons for the purposes of self-rescue.

However, despite control measures being in force, situations can occur which necessitate the use of respiratory protective devices as an additional form of protection. Respiratory protective devices should only be used if a functional respiratory protective device programme is in place which covers the following aspects:
  • recognition and identification of hazards,
  • risk assessment to meet legal requirements,
  • instruction of all persons involved in the programme,
  • device maintenance in accordance with manufacturer's instructions,
  • documentation of all relevant programme ponts,
  • programme auditing and management systems.
As regards the risk assessment, the following factors should be given consideration:
  • Is sufficient oxygen available during the work?
  • Which hazardous substances occur and what are their physical and chemical characteristics?
  • Which form do the hazardous substances occur in, e.g. dust or gas, and what effects do they have on the human body?
  • Which maximum concentrations, realistic workplace limit values and other hazards, e.g. fire, can be expected?
The careful evaluation of the above questions ensures the correct selection and use of respiratory protective devices. A respiratory protective device is suitable for use at a workplace if it is able to reduce the contaminant concentration to non-harmful levels.
If work has to be performed in atmospheres which pose a direct threat to life or health, breathing apparatus should be used – preferably with a positive pressure design and equipped with a self-rescuer. In such cases it should be borne in mind that the protection factors (tight fit of facepiece, e.g. full face mask) which the respiratory protective device is able to provide result in the necessary level of protection. A respiratory protective device is suitable for use if it
  • provides protection for the entire duration of the work,
  • is CE marked and appropriate,
  • is compatible with the environment, the wearer and the other personal protective equipment being used, and is in a fully functional condition,
  • is able to withstand the physical, chemical and mechanical ambient conditions,
  • is ergonomic in design, offers good visibility, freedom of movement and communication and poses little strain on the user,
  • does not have a negative impact on the wearer's physical fitness, facial contours, physique or other physical characteristics.
If all these factors are taken into account and fulfilled, there is no reason not to use the device. It should be used in accordance with the manufacturer's instructions for use, and should not be modified in any way. Immediately prior to use, the device wearer should check
  • the condition of any sensitive parts, e.g. the straps,
  • the suitability of the filter (in filtering devices) and its connection to the facepiece,
  • the supply of breathing gas and the leak tightness of the facepiece.
Optimum use and handling of the respiratory protective device by device wearers will only be possible if they receive the necessary information, instruction and practice from their employers. During instruction, all relevant information should be provided, e.g.
  • reference to the hazards the respiratory protective device affords protection against and their effects on health,
  • why and when should the device be used?
  • scope of responsibility of the device wearer,
  • action to be taken in the event of device errors,
  • device function, limits to use, recognition of defects, inspections and checks,
  • donning of device, leak tightness testing, emergency measures,
  • removal of device, cleaning and disinfection, maintenance and proper storage,
  • reporting.
After instruction has been given, it makes sense to perform practical exercises on and with the device for the purposes of familiarizing the wearer with the equipment. Yearly refresher instruction courses are also essential.
Supervisory staff should likewise receive instruction so as to be able to monitor use of the equipment and all activities connected with the respiratory protective device programme and, if necessary, initiate the necessary measures. A respiratory protective device can only function properly if it is maintained by experts in accordance with the manufacturer's instructions. This includes, among other things, cleaning and disinfection, troubleshooting, replacement of components, performance checks and proper storage. To maintain full proof of their activities, employers should carefully document all elements of their respiratory protective device programme and archive the documents. Importance of the annexes Although they are more informative in nature, the contents of Annexes A to F are extremely important as regards designing the respiratory protective device programme. Annex A contains a detailed description of the types and components of respiratory protective devices and provides information about particular features, properties, areas of application etc. Interested readers will find information about
  • facepieces
  • full face, half and quarter masks
  • filters
  • particle, gas and combined filters
  • filter retention times
  • filtering devices
  • positive pressure devices, e.g. filtering half masks
  • air-supplied devices, e.g. power-assisted filtering devices with full face mask
  • breathing apparatus
  • fresh air hose breathing apparatus
  • compressed air line breathing apparatus
  • independent breathing apparatus, e.g. compressed air breathing apparatus and closed-circuit breathing apparatus
  • ventilated protective suits
  • compressed air for respiratory protective devices
  • devices for self-rescue, e.g. oxygen self-rescuers and filtering escape apparatus (filtering self-rescuers).
Annex B deals with atmospheres which pose an immediately danger to life or health. These are atmospheres which have direct and acute effects on health and make it impossible for a person to escape to safety unaided in the event of failure of their respiratory protective device. Such situations arise in confined spaces where there is a shortage of oxygen, or when there is a build-up of hazardous substances. Annex C provides information about protection factors, their use and how they are assigned to the individual respiratory protective devices. Generally speaking, the protection factor is associated with the "leak tight" fit of the facepiece, and in the European Standards is defined as the maximum total inward leakage. It is assumed that the "nominal protection factor" which is determined in this manner represents a level of protection which is achieved by all wearers of respiratory protective equipment. The nominal protection factor determined in the laboratory does not take into account the conditions prevailing at the workplace, which in most cases reduce the protection factor. For this reason, reductions need to be made to the nominal protection factor to ensure safe use of respiratory protective devices. These reductions have resulted in the definition of Assigned Protection Factors (APF) which vary from country to country for one and the same respiratory protective device. The list provided with this Annex gives an overview of the nominal and assigned protection factors for the individual respiratory protective devices. Annex D provides information on how to assess the suitability of a respiratory protective device for coping with the circumstances of the intended use. The following points need to be considered in this context:
  • Ambient factors such as
  • oxygen shortage / surplus,
  • substances with a suffocating effect,
  • contaminants of all types,
  • corrosive and potentially explosive atmospheres,
  • extreme climatic conditions.
  • Task-/work-related factors which affect the device wearer, for instance:
  • work intensity,
  • visibility,
  • mobility,
  • communication possibilities,
  • exposure to heat,
  • duration of wear and
  • tools needed to perform duties.
  • Device wearer-related factors such as
  • medical aptitude,
  • facial characteristics,
  • visual aids, e.g. glasses, and
  • compatibility with other protective equipment and general items such as mobile phones, jewellery.
  • Legal factors as stipulated by European Directives and Standards, e.g. the use of CE-marked respiratory protective devices.
Annex E describes how to check that facepieces fit tightly enough. To avoid damage to health, the facepiece connected to the respiratory protective device must fit the device wearer snugly and it must be possible to check it for leak tightness. Annex E explains how to perform this check using positive and negative pressure. Generally speaking, this involves covering over the breathing air inlet/outlet of the facepiece and using the power of the lungs to generate a positive or negative pressure which, assuming the facepiece is sufficiently leak tight, will remain constant for a short period of time.

Qualitative and quantitative methods are also suitable for checking leak tightness. The qualitative method primarily uses tasteor odour-intensive substances which become noticeable if the facepiece is not leak tight.

Quantitative methods use gases or aerosols, particle counting or pressure techniques to test for leak tightness. Such methods are not suitable for use with all facepieces. Although they are a good way to determine protection factors, they are of hardly any use when it comes to practical applications.

Annex F describes the contents of a respiratory protection passport which certifies that the holder – the user of the respiratory protective device – has knowledge of how to use and maintain the equipment correctly.

Dr Adalbert Pasternack

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