Draft ISO Standard:
Respiratory protective devices – Selection, use and maintenance Part 2: Condensed guide to establishing and implementing a respiratory protective device programme
1. DRAFT
SC15/WG1/PG2/N143
ISO DTR 16975-2
April 2012
Respiratory protective devices – Selection, use and
maintenance Part 2: Condensed guide to establishing and
implementing a respiratory protective device programme
2. 1. Introduction
When RPD is required to control exposure, then the RPD must be correctly selected,
used and maintained.
This standard provides a condensed guide for establishing and implementing a
complete respiratory protective device programme for respiratory protective devices
(RPD) that meet the requirements of ISO 17420. It is designed for employers
especially in small and medium sized enterprises.
This standard provides basic information on risk assessment, selection procedure,
training, use and maintenance. Assistance from the RPD supplier /manufacturer or
Health and Safety professional to establish and implement the programme may be
required.
It provides guidance on how to do this together with a table to assist in the selection
process. It follows a simple step-by-step approach to deciding the minimum level of
protection required from the RPD and the most suited to the wearers, the task and
workplace conditions.
It is the responsibility of the employer, to correctly select adequate and suitable RPD
based on a risk assessment.
2. Scope
This standard provides brief and simple guidance to assist persons responsible for
establishing and implementing a programme for respiratory protective devices that
meet the performance requirements of ISO 17420.
There are special applications where the selection of suitable RPD using this guide is
not appropriate. For more detailed information and information relating to the special
applications listed below refer to ISO 16975-1.
− Escape
− Fire Fighting
− Rescue
− CBRN (Chemical, Biological, Radiological and Nuclear agents)
− Marine
− Mining
− Abnormal Pressure Work Environment
This standard does not apply to RPD programmes for RPD used exclusively under
water, in aircraft, and medical life support respirators and resuscitators.
This standard is an international guideline and does not replace national or local
regulations.
3. Terms and Definitions
RPD programme: process of selecting, using and maintaining RPD to ensure
adequate protection to the wearer.
Hazardous substance: Any substance that presents a potential to cause injury or ill
health if it is inhaled, ingested or come into contact with or absorbed through the skin.
3. A hazardous substance may be a pure substance or generated as by-products
during work activities, for example, wood dust, stone dust and welding fume.
Hazardous substances can be present in the atmosphere in a number of physical
states:
• Gases – such as ammonia and chlorine
• Vapours - such as from solvents,
• Particles – such as dusts, mists, smoke, fumes, fibres, fog and micro-
organisms.
Hazardous atmospheres: Any atmosphere that is oxygen-deficient and/or the level
of substances in the atmosphere is at a concentration deemed to be hazardous.
Adequate RPD: RPD capable of reducing the inhalation exposure to an acceptable
level.
Suitable RPD: RPD that is adequate and is matched to the requirements of the
wearer, the task and the working environment.
Protection Level: The degree of respiratory protection allocated to an RPD for the
purposes of selection and use that is expected to be provided to wearers when used
within an effective RPD programme as described in ISO 16975.
4. Table 1. RPD Programme steps
Apply control measures
RPD should only be used after all other
Conduct risk assessment Clause 4
reasonably practicable control
measures have been taken
Consider the requirements of the task,
Gather information on when, where and who Clause 7
the workplace environment and the
will use the RPD Steps 1-2
wearer(s)
Consider its concentration and its form
Gather information on the hazardous in the air – particulate, gas, vapour Clause 7
substances Step 3
Potential for Oxygen-deficiency
Measurement of the concentration Clause 7
Determine the protection level required
Step 4
Use the information gathered in the
assessment
Clause 7
Select adequate and suitable RPD Include fit testing where appropriate
Steps 5-9
Involve the RPD wearers and employee
representatives
Provide training in the use, checking
Provide training Clause 9
and maintenance of the RPD
Including a filter change routine, battery
Implement use of the RPD in the workplace charging, cleaning, compressed air Clause 10
checking as appropriate
Including regular supervision and
Manage the use of RPD Clause 10
regular reminders to wearers
Maintain the RPD Maintain reusable RPD. Replace parts
as recommended by the manufacturer Clause 10
Correct any faults promptly
Review the suitable intervals to ensure
that any change in conditions,
Review Clause 10
hazardous substance, wearers etc. are
adequately addressed
Fit testing Ensure tight-fitting RPD are fit tested Clause 12
Keep records of the risk assessment
Records Clause 13
and the RPD selection process
5. 4. How to use this guide
To select adequate and suitable RPD you need to have completed a risk assessment
which must have considered the hazardous substance(s) being used or generated,
the task(s) being undertaken and the person performing the task(s) (the wearer). In
addition you will need information on the hazardous substance(s), which can be
found in their Safety Data Sheets (SDS) or Material Safety Data Sheets (MSDS).
You may also need to refer to substance specific regulations (e.g. asbestos) that may
direct you to a specify class or type of RPD.
Once you have completed your risk assessment and gathered the information
required, work through the selection table.
Depending upon your knowledge of RPD, your workplace circumstances and the
information you are able to gather from your risk assessment, the output of the table
may be either the classification of RPD suitable for your needs or sufficient
information to enable your RPD supplier to recommend suitable RPD.
The table should be retained as a record of RPD selection.
Where the table recommends seeking professional advice RPD manufacturers /
suppliers and safety consultants are a good source of information.
5. What is RPD?
RPD is a type of personal protective equipment (PPE) designed to protect the wearer
against inhalation of hazardous atmospheres.
RPD operate in one of two modes:
− Filtering devices: RPD in which air passes through a filter(s) before being
inhaled
− Supplied breathable gas devices: RPD that supplies the wearer with
breathable gas from a source independent of the ambient atmosphere either
individually carried or from a remote source.
− Class Sxxxx devices are commonly known as self-contained breathing
apparatus (SCBA) where the xxxx represents the available breathing gas
in litres.
− Class SY devices are commonly known as airline RPD, usually not having
a finite capacity.
6. Within each of these two operating modes there are different devices based on the
protection level class and the work rate class. Filtering devices also have differences
based on the type and class of filter used
RPD are available with a range of respiratory interfaces. They are categorised by
areas of coverage of the wearer’s body and by fitting characteristics.
The areas of coverage include:
o mouth only, e.g., a mouthpiece
o nose and mouth, e.g., half mask, filtering facepiece
o entire face, e.g., full facepiece, visor
o entire head, e.g., hood, helmet
o parts of or complete body, e.g., blouse, suit.
Respiratory interfaces can be tight fitting, those that have a complete seal with the
skin, or loose fitting, those that do not have a complete seal to the wearer’s skin.
Tight fitting interfaces require a good seal and therefore cannot be used if any deep
scars, hair or objects interfere with the seal. Tight fitting interfaces also require an
individual fit test on the wearer to ensure fit in accordance with national regulations or
guidance.
6. When should RPD be used?
After all practicable control measures have been taken or while they are being
implemented, and the risk assessment indicates the presence or potential presence
of a hazardous atmosphere, then RPD should be used.
7. The selection procedure
Follow the steps below and complete the selection table. Information on the
hazardous substances, the working environment including the potential for oxygen-
deficiency, the task and the wearer(s) is required.
Step 1: Organisation information
Fill in the details of the organisation and location of where the task is to be
undertaken, and the details and position of the person completing the selection
procedure.
Step 2: Description of the task
Describe the task and the environment in which the task will be conducted. Not all
RPD are suitable for wearing for long periods of time or suitable for cold or hot
environments.
Step 3: Define the hazards
The contaminant(s) should be identified and its airborne concentration(s) measured
or estimated. The potential for oxygen deficiency in the working area should be
considered.
The information on the occupational exposure limits (OEL) and the immediately
dangerous to life or health (IDLH) concentrations (if applicable) can be found by
reference to SDS, MSDS or established exposure limits
For each of the contaminants enter:
7. o the concentration in Box A
o the IDLH level in Box B
o the OEL in Box C
o the calculated hazard ratio in Box D; and
o the highest hazard ratio in Box E
If the contaminant is not known and/or the concentration not known or it is uncertain
whether there is the potential for oxygen-deficiency then seek professional advice or
follow national, local or industry guidance.
Step 4: Determination of the protection level
Determine the protection level class required by comparing the highest hazard ratio
calculated in step 3 with the protection levels. Always select the protection level class
which is higher than the highest hazard ratio calculated.
Step 5: Work rate assessment
In order to select RPD that is suitable for the work rate at which the wearer will be
working during the task, compare the task demands with the descriptions in the table
for W1, W2, W3 and W4.
• If the task only requires light to moderate manual work then select W1, e.g.
light manual work to sustained hand and arm work
• if the task requires heavy to very heavy work then select W2, e.g. intense arm
and trunk work to intensive shovelling or digging
• if the task requires very, very heavy to extremely heavy manual work then
select W3, e.g. walking quickly or running with protective equipment and/or
heavy tools and goods to crawling under and climbing over obstacles
• if the task requires maximal work then select W4 , e.g. Climbing stairs and
ladders at high speed.
Step 6: Filter identification
If filtering RPD is selected then the correct type and class of filter must be used.
Selecting the correct filter type and class requires knowledge of the task, the hazard
and the work rate. Using this information seek professional advice to identify the
correct filter.
Step 7: Supplied breathable gas RPD capacity
Class Sxxxx supplied breathable gas RPD usually include a cylinder(s) of
compressed breathable gas. These cylinders are available in a number of volumes
and working pressures leading to a number of usable durations. Calculate the
minimum volume in litres required to ensure that the capacity of the RPD is adequate
for the task duration and work rate.
If the calculated capacity for the task duration is greater than any available Sxxxx
RPD capacity then class ‘SY’ RPD should be selected.
Step 8: Task related factors
The RPD selected must be suitable for the task that the wearer will be undertaking
while wearing the RPD. Certain task requirements may restrict the range of suitable
RPD. This step asks a number of questions relating to the task and gives advice as
to the most suitable types of RPD.
Step 9: Wearer related factors
The RPD selected must be suitable for the wearer. Some wearer related factors such
as hair, the need to wearer corrective lenses and medical conditions might restrict
8. the range of suitable RPD. This step asks a number of questions relating to the
wearer and gives advice as to the most suitable types of RPD.
− Fit of RPD: As people come in different shapes and sizes facial differences
will mean one type of respiratory interface is unlikely to fit all wearers. It is
essential that where an RPD includes a tight fitting respiratory interface then
the wearer should be fit tested to ensure that the selected RPD is capable of
fitting them.
− Hair: Any beard, stubble, thick sideburns, hair or moustache where a
respiratory interface is intended to seal will most likely cause leakage. Where
there is facial hair select a loose-fitting respiratory interface.
Step 10: Final selection
Using the information gathered in the earlier steps and the advice given relating to
task and wearer related factors write down the minimum class of RPD suitable.
Using the minimum classification and the other information gathered, identify suitable
RPD in discussion with RPD manufacturer, RPD supplier or relevant authorities.
Select a specific RPD from the suitable RPD identified.
The selection may have to be changed depending on the result of a fit test.
In some situations both filtering and supplied breathable gas RPD may be suitable.
Table 2 provides additional guidance that in deciding between filtering or supplied
breathable gas RPD.
9. Table 2
Supplied breathable gas RPD
Filtering RPD
Class Sxxxx Class SY
− Filtering RPD can − Can be used in − Can be used in
only be used where oxygen-deficient and oxygen-deficient
there is sufficient IDLH atmospheres atmospheres
oxygen in the − Requires an external − Mobility may be
atmosphere supply of high restricted due to
− Suitable filters may pressure breathable supply hoses
not be available for gas − Requires an
the identified − There will be a time external supply of
contaminant(s) duration restriction medium pressure
− Filters have limited due to the capacity breathable gas
capacity and have to of the breathable gas − Requires
be changed cylinder(s) breathable quality
periodically − Requires breathable gas and regular
− A filter change quality gas and measurements
schedule must be regular
established to suit measurements
the task and work
environment
10. 8. Using RPD
8.1 General
RPD must be inspected, used, maintained and stored as described in the user
instructions supplied by the RPD manufacturer and in accordance with local or
national regulations.
In addition, ensure:
The RPD is clean, not damaged and is in good working order before putting it
on, even when new
The RPD is worn all the time, and until the wearer is away from the
contaminated area
If filters are used a replacement policy should be determined
Wearers of tight fitting respiratory interfaces are clean-shaven
That wearer-seal checks are performed each time tight fitting respiratory
interfaces are used
That the RPD wearers leave the contaminated area immediately if they smell,
taste or sense irritation or the RPD becomes damaged.
That the RPD wearers leave the contaminated area immediately if a warning
alarm on the RPD operates
That filtering RPD are never used in oxygen-deficient or IDLH atmospheres
8.2 Using Filtering RPD
A filtering device will not provide protection unless:
It is equipped with the correct filter(s) for the hazardous substances
8.2.1 Replacing filters
You should ensure:
Filters are replaced before they become ineffective and affect the protection.
Filters may have to be changed mid-shift.
Filters are replaced with the same type and class
A replacement schedule is established to meet your work situation by getting
help from the filter supplier
Particle filter(s) are replaced when breathing becomes more difficult
Filters are replaced if damaged
Gas filters are replaced as directed by the end-of-service-life-indicator (if
present)
8.3 Using supplied breathable gas RPD
You should ensure:
The breathable gas supplied is of a quality required by national or local
regulations.
That the supply of breathable gas is sufficient for the intended duration of
your task and for all wearers. The source of breathable gas may be limited
11. e.g. from a compressed air cylinder
9. RPD wearer Training
Every RPD wearer should be trained in correct use, storage and where necessary
maintenance.
The training should include:
The manufacturer’s instructions for use
The reasons for wearing RPD
Which RPD should be used
How to check the right RPD is provided
When to wear the RPD
How to correctly use the RPD
When to change the filters
What types of user maintenance should be carried out and how
How to clean the RPD after use
How to store the RPD
10. Management of the RPD programme
It is essential that the selection, use and maintenance of RPD is correctly managed
to ensure that the RPD will continue to provide the protection required.
RPD wearers should be supervised to ensure they are using the RPD in
accordance to manufacturer’s instruction and training provided
Reusable RPD should be maintained in accordance with the user instructions
supplied by the RPD manufacturer
The RPD programme should be reassessed at suitable intervals to ensure
that any change in conditions, hazardous substance, wearers etc. are
adequately addressed
11. Face fit testing
Many things can interfere with the fit of a tight fitting RPD and can seriously affect its
performance. These include, but are not limited to:
• Any beard, stubble, thick sideburns, long hair or moustache coming into
contact with the face seal area of a respiratory interface
• Deep cuts or scars, heavy wrinkles, moles, warts etc.
• Other types of PPE such as spectacles and goggles
Therefore, all wearers of tight-fitting respiratory interfaces should be fit tested as
required by national or local regulations.
12. Records
12. The following records are to be kept for a time period appropriate to the toxicity and
latency of diseases associated with the contaminants concerned and at least for the
minimum period required by any national or local regulations or standards.
Risk assessment
RPD selection process
Fit testing
Wearer training
RPD Maintenance and defects
Quality checks on the breathable gas supply
13. Annex 1
Respiratory Protective Device (RPD) Selection Record
This form summarises and records the risk assessment and selection of respiratory protective devices. If you are unsure about any of
the questions in this table seek professional advice
Step 1 Organisation information
Organisation: Location:
Details of the person completing the form Name of wearer(s)
Name:
Job title:
Step 2 Description of the task
Is the task any of the following?
Escape, firefighting, CBRN, marine, mining, abnormal pressure working – Use the selection procedure in ISO 16975-1
If the task is not any of the above, describe the task and the working environment (e.g. motor vehicle paint spraying inside a spray booth,
kerb stone cutting outdoors, welding in a shop)
(a) How long does the task take? (b) What are the working conditions? (Include the range)
(e.g. spraying a motor vehicle - 20 minutes, sanding a wood panel -
10 minutes, cutting stone - 5 minutes) Temperature: …….. oC
…………….hrs ……….Mins Humidity: ……………….%RH
How many times a shift? ………..times a shift
Step 3 Define the hazards
Is the work Follow national regulations if they exist.
Yes
area deficient If there are no national regulations use the selection procedure in ISO 16975-1
in Oxygen or
the potential to
become No Continue to next question
oxygen
deficient?
Yes Continue to next question
Is the i) Seek professional advice to identify the contaminant, or refer to national regulations or industry
contaminant guidance related to the task
known?
No
ii) If the contaminant cannot be identified then select supplied breathable gas RPD with the highest
Protection Level (PL) class Go to step 5
Yes Continue - complete the table below
i) Refer to national regulations or industry guidance to establish the required PL - Go to step 5, or
Is the ii) Refer to national regulations or industry guidance to establish the specific RPD type and
concentration classification - Go to step 6, or
known by iii) Refer to ISO 16975-1 or seek professional advice to measure or estimate the concentration
measurement No
or estimation? -Continue - complete the table below, or
iv) Use the control banding method (see form X) to establish the required PL - Go to step 5, or
v) Select supplied breathable gas RPD with the highest Protection Level class - Go to step 5
Complete the boxes below for particulate contaminants (dust, fibre, fume, smoke, mist, fog, micro-organisms)
Contaminant (A) Concentration (B) IDLH Level (if (C) OEL (D) Calculate the
Name / CAS number (if applicable) Measured or estimated applicable) Occupational Exposure Hazard ratio
concentration in air (mg/ Immediately Limit value should be the
m3 or fibres/ml) dangerous to life or same unit as in a). If no = Concentration (A)
health OEL what is the safe
OEL (C)
(mg/m3 or fibres/ml) exposure value?
(i)
14. (ii)
(iii)
(iv)
If more than four contaminants are
present continue on a separate sheet.
Complete the boxes below for gas/vapour contaminants
Contaminant (A) Concentration (B) IDLH Level (if (C) OEL (D) Calculate the
Name / CAS number (if applicable) Measured or estimated applicable) Occupational Exposure Hazard ratio
concentration in air (ppm Immediately Limit value should be the
or mg/m3) dangerous to life or same unit as in a). If no = Concentration (A)
health OEL what is the safe
OEL (C)
(ppm or mg/m3) exposure value?
(i)
(ii)
(iii)
(iv)
If more than four contaminants are
present continue on a separate sheet.
Result of step 3
Which one of the contaminant(s) from the above tables (and separate sheet) requires the highest Hazard E) Highest hazard
Ratio in (D)? Record it in (E). ratio:
If the hazard ratio is <1 then RPD is not required UNLESS national or local regulations apply to the contaminant
Are any of the
Select supplied breathable gas RPD with an appropriate PL as determined in step 4
contaminant Yes
(When class SY RPD is selected it shall be combined with an ES or S class RPD)
concentrations in
(A) higher than the
IDLH value (B)? No Continue to step 4
(if applicable)
Step 4 Determination of the Protection Level Class (PL)
Circle the number that is greater than or equal to the
number given in (E)
4 10 30 250 2000 10000
RPD PL Class determined from the Hazard Ratio
Chose the PL class associated with the number circled PL1 PL2 PL3 PL4 PL5 PL6
Minimum Protection Level class required PL
Step 5 Work rate assessment
From light manual work to sustained hand and
W1 You will need an RPD with at least work rate class W1
arm work
There are four work rate
classes - W1, W2, W3 and From Intense arm and trunk work to intensive
W2 You will need an RPD with at least work rate class W2
W4. shovelling or digging
From walking quickly or running with protective
Choose the work rate
W3 equipment and/or heavy tools and goods to You will need an RPD with at least work rate class W3
class that best matches
crawling under and climbing over obstacles
the task to be undertaken.
W4 Climbing stairs and ladders at high speed. You will need an RPD with at least work rate class W4
Minimum Work rate class required W
Step 6 Filter Identification
Using the information in Step 2 (a & b), step 4 and step 5, seek professional advice to identify the type and class of filter(s) suitable for
the hazard including their relevant service life(s) applicable to your task.
Alternatively if you wish to use a supplied breathable gas RPD, go to step 7.
15. Recommendation received from:
Filter
Yes type & class
Has a suitable filter been
identified? Go to step 8
No You will have to use supplied breathable gas RPD Go to Step 7
16. Step 7 Supplied Breathable Gas RPD capacity
Calculate the volume of the breathable gas needed for the duration of the task, including entry and exit, by using the information in
step 3 and step 5, using the calculations below.
Changing the work rate will change the useable duration of the breathable gas volume
Calculation Minimum capacity
Duration of task (min) x 30 L/min for W1 (e.g. 20 min x 30 L/min = 600 L)
Duration of task (min) x 40 L/min for W2
Duration of task (min) x 50 L/min for W3
Duration of task (min) x 65 L/min for W4 Litres (L)
Classification options for class S RPD: The minimum classification in litres is the calculated capacity, rounded up in increments of 50 litres, if less
than 1000 litres, and in increments of 100 litres if above 1000 litres.
Minimum S classification S
Step 8 Task related Factors
Answer the following questions for each wearer (circle Yes / No)
Requires special considerations for entry inline with national
Is the task carried out in a confined space? (e.g. vat, pit, Yes
regulations. Seek professional advice.
chambers, tanks, trenches, pipes, sewers, flues or wells)
No Continue
Do not select type SY RPD
Does the task require mobility such that the use of air Yes
supply hoses is impractical?
No Continue
Select RPD that are fitted with a speech diaphragm or additional
Is precise communication needed to give safety critical Yes
communication means
instructions when RPD is worn?
No Continue
Yes Consider assisted filtering RPD or supplied breathable gas RPD
Is the duration of RPD continuous wear >2 hour before it is
taken off?
No Continue
Seek RPD manufacturer/supplier advice as specialised RPD may be
Does the task create sparks, molten metals or UV Yes
required
radiation?
No Continue
Seek RPD manufacturer/supplier advice as specialised RPD may be
Yes
Is the work area atmosphere explosive or flammable? required
No Continue
Seek RPD manufacturer/supplier advice as specialised RPD may be
Yes
Is the work area atmosphere corrosive? required
No Continue
Yes Consider selecting RPD which covers the entire face or head
Is the contaminant an eye irritant?
No Continue
17. Step 9 Wearer related Factors
Answer the following questions for each wearer (circle Yes / No)
Select RPD that do not rely on a tight fit to the wearer’s
Are any of these present in the sealing area of the respiratory interface - Yes
face
beards, moustache, side burns, deep facial marking or facial jewellery?
No Continue
Select RPD that do not interfere with the corrective lenses
Yes
Are corrective lenses worn? or RPD that have facilities for wearing corrective lenses
No Continue
Ensure that the selected RPD and other PPE required for
the task do not interfere with each other.
Yes
Are other types of personal protective equipment (PPE) worn (e.g. head,
Consider RPD that provide integrated head and/or face
eye and hearing protection, protective clothing etc),
and eye and hearing protection.
No Continue
Medical conditions: Important: Some pre-existing medical conditions (examples include breathing disorders such as asthma, or skin allergies or
heart problems) may restrict or prevent some workers wearing any RPD or certain types of RPD. Ensure that workers are medically able to wear
the selected and required RPD. Seek medical advice.
Where national or local regulations exist these should be followed.
Step 10 Final Selection
Minimum Class of Filtering RPD
Fill in the boxes below with the information gathered
Protection level Work rate class Filter type and class Suitable RPD
required required required Identify examples of suitable RPD
(See step 4) (See step 5) (See step 6)
PL W
Minimum Class of Supplied breathable gas RPD
Fill in the boxes below with the information gathered
Protection level Work rate class Breathable Gas
required required capacity Suitable RPD
(See step 4) (See step 5) (Sxxxx or SY) Identify examples of suitable RPD
(See step 7)
PL W S
Selected RPD:
Employer statement
I understand that It is ultimately the responsibility of the employer, to select adequate and suitable RPD based on a risk assessment, to ensure
that fit testing has been carried out where applicable and that each wearer has been medically cleared.
Name of the person providing the information in this form:
Signature: Date:
Company Name:
This table can be used as record of RPD selection