The ionising radiations regulations 1985 (IRR85) type approval of radiation generators and apparatus and smoke detectors and gas filled self-luminous devices
OC 563/43
This 2-part OC describes HSE's type approval scheme and the action to be taken by inspectors on receipt of an application for type approval. This OC replaces HSEMs 1988/4, 1989/8 and OC 563/37. The attached information document (ID) may be given to interested persons outside HSE.
Introduction
1 The Ionising Radiations Regulations 1985 (IRR85) reg.5(2) requires employers intending to undertake work with ionising radiation to notify HSE 28 days before commencing the work. Regulation 5(1)(a) provides an exception to this general requirement where the work falls into one of the categories given in IRR85 Schedule 3.
2 Categories (f) and (g) of Schedule 3 specify the conditions under which work with radiation generators and apparatus containing radioactive substances need not be notified: the generator or apparatus should be of a type approved by HSE and the dose rate at 100 mm from any accessible surface should not exceed one Sv h-1.
3 Where work with ionising radiations is limited to one of the categories in Schedule 3, the employer is also relieved of the duty to appoint a radiation protection adviser (RPA) (reg.10(6)) and a radiation protection supervisor (reg.11(3)) in relation to that work. However, the exception does not extend to other requirements of the regulations, such as the duty to prepare local rules under reg.11(1) or to account for radioactive substances under reg.19.
4 The Health and Safety Executive Statement on type approval of radiation generators and apparatus under IRR85(file 563) (see ID Appendix 1) is intended to assist manufacturers, importers and suppliers who wish to obtain type approval by HSE under IRR85 Schedule 3. The HSE Statement also gives details of the criteria and legal requirements to be taken into account when considering such applications. Guidance is also given on the procedures that HSE will adopt in developing detailed criteria for each class of article.
5 All approvals granted under previous regulations were revoked by the introduction of IRR85.
Action on receipt of an application for type approval
6 All applications for type approval should be sent, via the usual channels, to HD B6, 6 North Wing, Rose Court, 2 Southwark Bridge, London, SE1 9HS. HD B6 will consult interested parties within HSE.
7 If an employer requests information on the procedures and criteria of the type approval scheme, a copy of the HSE Statement should be sent to them.
8 The overall costs to an employer of applying for type approval can be significant. Therefore, in most cases employers are unlikely to receive any significant benefits or advantages from gaining HSE approval unless large numbers of the devices are involved.
Enquiries from users and others
9 Users making enquiries about type approval should be referred to the relevant certificate of approval. All known suppliers, manufacturers and relevant trade associations have been provided with copies of the certificates. HSE has asked manufacturers and suppliers to be helpful to employers, advising them whether or not existing devices satisfy the conditions set out in the certificates.
10 The ID gives details of type approvals granted to date, including copies of the certificates at Appendices 2-4.
Devices not covered by type approval
11 HSE is not suggesting that devices should be replaced simply because they do not satisfy the conditions for type approval. If a user is unable to obtain confirmation from the supplier of a device that it satisfies the conditions of the relevant certificate, the inspector should advise notification under IRR85 reg.5(2) and the appointment of a radiation protection supervisor under IRR85 reg.11.
Cancellation of instructions
12 OC 563/37 - cancel and destroy .
13 OC 563/37 Supplement 1 - cancel and destroy .
18 September 1998
(220/FOD/1003/1998)
Disc ref:\J:\Editors\CA1\ocfiles\563_43.sam
ASI headings
Americium: devices: gaseous tritium light: ionising radiations: Ionising Radiations Regulations 1985: radiation(s): radioactive substances (isotopes): self-luminous devices: smoke detectors: tritium.
Health and safety executive
Information document
HSE 563/43
The ionising radiations regulations 1985 (IRR85): Type approval of radiation generators and apparatus and smoke detectors and gas filled self-luminous devices
Introduction
1 This document contains internal guidance which has been made available to the public. The guidance is considered good practice (rather than compulsory) but you may find it useful in deciding what you need to do to comply with the law. However, the guidance may not be applicable in all circumstances and any queries should be directed to the appropriate enforcing authority.
2 The information on type approvals certificates issued to date may be helpful to those organisations who are considering applying for type approval for ionisation chamber smoke detectors (ICSDs) and gas filled self-luminous devices.
3 Type approval is given under the Ionising Radiations Regulations 1985 (IRR85) Schedule 3 and removes the requirements on the user to:
1) notify HSE of use of the type approved articles;
2) appoint a radiation protection adviser in relation to work with those articles; or
3) appoint any radiation protection supervisors in relation to work with those articles.
All other relevant provisions of IRR85 apply.
4 The Health and Safety Executive Statement on type approval of radiation generators and apparatus under IRR85 is intended to assist manufacturers, importers and suppliers who wish to obtain type approval by HSE under IRR85 Schedule 3. The HSE Statement gives details of the criteria and legal requirements that HSE will take into account when considering such applications. Guidance is also given on HSE's procedures in developing detailed criteria for each class of article. A copy of the HSE Statement is reproduced at Appendix 1. Further copies of the HSE Statement are available from HSE, HD B6, 6th Floor, North Wing, Rose Court, 2 Southwark Bridge, London, SE1 9HS.
Certificates of approval
5 Three type approvals under IRR85 have been granted to date and copies are reproduced at Appendices 2-4:
1) Ionisation chamber smoke detectors (Approval Certificate TA1 of 1989);
2) Ionisation chamber smoke detectors (Approval Certificate TA1 of 1990); and
3) Gas filled self-luminous devices (Approval Certificate TA2 of 1990).
Type approval given by certificate ta1 of 1989
6 This certificate covers any ionisation chamber smoke detector containing not more than 40 kBq Americium-241 that is kept in any building or premises and conforming to all of the requirements for that detector specified in the Recommendations for ionisation chamber smoke detectors in implementation of radiation protection standards published by the Nuclear Energy Agency of the Organisation for Economic Co-operation and Development (OECD) 1977.
7 Employers, such as DIY stores, who are considered to be working with ionising radiations solely because they store such detectors in any building or premises need not notify HSE that they are working with ionising radiation if the total number kept in the building or premises does not exceed 500.
Type approval given by certificate ta1 of 1990
8 This certificate covers any ionisation chamber smoke detector containing Americium-241 that is installed in premises or workplaces and conforms to all of the requirements for that detector specified in Recommendations for ionisation chamber smoke detectors in implementation of radiation protection standards published by OECD in 1977. The certificate limits the activity per detector (740 kBq Americium-241 for devices that are not single station detectors) and limits the dose rate to less than one Sv h-1at 100mm from any accessible surface.
9 Employers who have such apparatus installed in their premises but do no other work with ionising radiation need not notify HSE that they are working with ionising radiation.
Type approval given by certificate ta2 of 1990
10 This certificate covers any self-luminous fire safety sign or other device containing gaseous tritium light sources, which is supplied to, or installed in, premises or workplaces, provided that the sources are not directly accessible, the sign or device gives rise to a dose rate of less than one Sv h-1at 100mm from any accessible surface and the device is constructed so as to withstand normal use without breaking.
11 Employers who have such apparatus installed in their premises but do no other work with ionising radiation need not notify HSE that they are working with ionising radiation. This certificate does not apply to bulk storage of signs or devices for wholesale or retail use.
APPENDIX 1: HSE statement on the type approval of radiation generators and apparatus under irr85
(para 4)
Type approval by the Health and Safety Executive (HSE) will relieve the user of the approved articles of 3 duties under the Ionising Radiations Regulations 1985 (IRR85). This means that the user will not be required to:
(a) notify HSE of use of the approved articles;
(b) appoint a radiation protection adviser; or
(c) appoint any radiation protection supervisors.
However, all other relevant provisions of the Regulations will continue to apply. Background notes on the legal requirements are at Annex 1.
This guidance is intended to assist manufacturers, importers and suppliers who wish to obtain type approval by HSE under IRR85 Schedule 3. Details of the general criteria that will be used by HSE in considering applications for type approval are given below. Guidance is also given on the procedures that HSE will adopt in developing detailed criteria for each class of article.
HSE policy on type approval
1 In principle, HSE will consider applications for type approval of any class of article which meets the basic criteria set out in Schedule 3, paragraphs (f) and (g) to the Regulations. In each case HSE will require evidence that the article concerned meets both the general criteria detailed below and also meets any detailed criteria that have been developed by HSE. HSE will consult with manufacturers, importers and suppliers, their representative associations and other interested bodies in drawing up detailed criteria. In view of the constraints of time and money available to HSE it is intended to give priority to applications for articles which are widely used. Reference will be made to existing national, or international standards where these are applicable. In principle, it is intended that goods approved for the purposes of the voluntary scheme of assessment of products to appropriate international standards, operated by the National Radiological Protection Board, will be granted type approval under IRR85.
Operation of the type approval scheme
2 If detailed criteria for the class of article concerned have been developed then the approval procedure will be as follows:
a) application to HSE with payment of the current fee plus VAT;
b) production of documentary evidence, by the applicant, to show that the equipment has been tested to the detailed criteria;
c) consideration of the application and the test report by HSE; and
d) if the application is successful the applicant will be issued with a certificate by HSE which will state the limits of the approval.
3 In cases where detailed criteria have not been developed, HSE will consider the establishment of criteria. The procedure for developing detailed type approval criteria is set out in paragraphs 5-8 below.
General criteria for type of approval
4 In addition to the requirements of Schedule 3 (f) and (g) the following conditions should be met:
(i) the user should not have access or need access to any area that is required to be designated as a controlled or supervised area under Schedule 6 of IRR85 and is therefore required to be designated as a controlled or supervised area under IRR85 regulation 8;
(ii) the article should be sufficiently robust so that foreseeable mistreatment or accidental damage does not result in a dose of ionising radiation to persons nearby greater than the annual dose limit for a member of the public (ie the limit for any other person as listed in Part 1, Schedule 1 of IRR85);
(iii) any routine modification, eg source changing, should only be carried out by the supplier or other competent person who has notified HSE of an intention to carry out work with ionising radiations;
(iv) in the case of apparatus containing radioactive substances the radioactive substance should be in the form of a sealed source. The sealed source should ensure effective protection against any leakage of radioactive material; and
(v) the article should be marked with the maximum design activity of radioactive sources. If the article is too small to carry information then adequate supporting documentation should be provided.
Development of detailed criteria
5 Before contacting HSE the applicant should check that the class of articles concerned is likely to meet the requirements of categories (f) and (g) Schedule 3 IRR85 and also the general criteria listed in paragraph 4.
6 Applicants or their trade associations should send the following details to HD B6, 6th Floor, North Wing, Rose Court, 2 Southwark Bridge, SE1 9HS:
(a) general description of class of article for which type approval is required;
(b) estimate of the number of articles likely to be supplied annually for use at work;
(c) reports of tests carried out to show that the requirements of Schedule 3 of IRR85 will be met (see Annex 2 to this paper) and that the articles will comply with the general HSE criteria; and
(d) if the article has been approved under the voluntary scheme of assessment of products to appropriate international standards, operated by the National Radiological Protection Board, this should be stated.
7 When this information is received HSE will consult both internally and with other organisations. If there are no outstanding difficulties HSE will make arrangements with the applicant to draft detailed criteria.
8 The draft criteria will be circulated to other Government Departments, CBI, TUC, NRPB and other interested parties for comment. Once the criteria have been finalised applications for approval can be processed as described in paragraph 2.
ANNEX 1
(Appendix 1 introductory paragraph)
Background notes on legal requirements
1 Where the only work with ionising radiations falls into one or more of the categories listed in Schedule 3 to IRR85, the employer undertaking that work is relieved of 3 separate duties under the Regulations as follows:
(a) the need to notify HSE at least 28 days before commencing work for the first time with ionising radiations (Reg 5(2)):
(b) the need to consider appointment of a radiation protection adviser. Regulation 10(1) specifies conditions which require such an appointment to be made. Under Regulation 10(6), where the only work is work specified in Schedule 3, no appointment is required regardless of whether such conditions do exist; and
(c) the need to appoint any radiation protection supervisors (Reg 11(3)).
2 Two categories of work in Schedule 3 namely (f) and (g), specify the criteria applicable to radiation generators and apparatus containing a radioactive substance. In each case there is a requirement for the article concerned to be of a type approved by HSE.
3 Exemptions granted under the Ionising Radiations (Unsealed Radioactive Substances) Regulations 1968 or the Ionising Radiations (Sealed Sources) Regulations 1969 are revoked by operation of Regulation 41(1) of the Ionising Radiations Regulations 1985.
4 Statutory exemption from some of the provisions of the Radioactive Substances Act 1960 is separate from the operation of the type approval scheme. Notification to HSE will still be required unless the exempt article is also type approved.
ANNEX 2: Testing to criteria
(Appendix 1 para 6(3))
1 Manufacturers, suppliers or importers of articles for which type approval is sought should contact a reputable independent testing body to make arrangements for testing. The testing organisation will carry out the tests required to determine whether the article meets the criteria specified.
2 If some of these tests have been carried out by a reputable independent body on a previous occasion it will not be necessary to repeat them provided the design and specification of the article remains unchanged.
3 When the tests are complete the testing organisation will provide the applicant with a report of type testing. This will contain details of both the model and specification of the article and the results of testing. Any fee for testing work undertaken is a matter between the parties concerned and will be in addition to the fee mentioned in paragraph 2(a) which covers HSE costs.
APPENDIX 2
(para 5)
Health and safety at work etc act 1974
Ionising radiations regulations 1985
CERTIFICATE OF APPROVAL NO TA1 OF 1990
1 By virtue of the powers conferred on it by sub-paragraph (g) of Schedule 3 to the Ionising Radiations Regulations 1985 ("the Regulations"), the Health and Safety Executive approves the type of apparatus specified in Schedule 1 to this certificate, subject to the conditions specified in Schedule 2.
2 This Certificate shall remain in force until it is revoked in writing by the Health and Safety Executive.
Signed by P b woods
(A person duly authorised by the Health and Safety Executive to act in that behalf)
Dated this 26th day of November 1990.
SCHEDULE 1
1 Ionisation chamber smoke detectors containing Americium-241 installed in premises or a workplace.
SCHEDULE 2
1 This type approval shall only apply to ionisation chamber smoke detectors (specified in Schedule 1) that have been shown to conform to all of the requirements for that detector specified in "Recommendations for ionisation chamber smoke detectors in implementation of radiation protection standards" published by the Nuclear Energy Agency of the Organisation for Economic Co-operation and Development (OECD) 1977.
EXPLANATORY NOTES FOR CERTIFICATE OF APPROVAL No TA1 of 1990
1 This does not form part of the Certificate of Approval.
2 Apparatus specified in the Certificate is type approved for the purposes of Schedule 3 to the Regulations. This means that employers who have such apparatus installed in their premises but carry out no other work with ionising radiation need not notify the Health and Safety Executive and need not appoint a Radiation Protection Supervisor.
3 The approval does not exempt employers from all other requirements of the Regulations.
4 This approval does not relate to the functional ability of the apparatus.
5 The Nuclear Energy Agency publication referred to in the Certificate of Approval (Schedule 2) limits the activity per detector (eg 740 kBq Americium-241 for devices that are not single station detectors) and limits the dose equivalent rate at 100mm from the surface of the detector to 1 Sv per hour. In addition, the detector must pass certain tests with respect to radioactive contamination on accessible surfaces and the effects of temperature, impact, drop, vibration and fire.
6 This Certificate of Approval is general in application and applies to any type of appliance specified in Schedules 1 and 2. Thus, individual certificates of approval will not be required for each type of ionisation chamber smoke detector.
7 An employer can satisfy the conditions in Schedule 2 to the Certificate of Approval if he can show that his appliance is:
(a) one of a type that was tested on behalf of the manufacturer or supplier by a reputable independent testing body and found to conform to the requirements specified in Schedule 2; or
(b) one of a type approved under the Radioactive Products (Safety) Regulations l99- .
It is expected that the manufacturer or supplier will make available to employers at the time of supply/installation and in the case of existing installations, on reasonable request, written information which shows whether or not this type of ionisation chamber smoke detector satisfied (a) or (b) above.
8 This Certificate of Approval replaces Certificate of Approval No TA1 which expires on 31 December 1990. There may be some existing detectors which do not meet the requirements of this Certificate. In such cases employers should notify the Health and Safety Executive under Regulation 5 of the Ionising Radiations Regulations 1985.
9 Ionisation chamber smoke detectors stored in premises or a workplace are covered by Certificate of Approval No TA1 of 1989 subject to certain conditions.
10 In the case of apparatus installed on offshore installations (premises referred to in Article 4 of the Health and Safety at Work etc Act 1974 (Application outside Great Britain) Order 1989) a separate Certificate of Approval has been issued on behalf of the Secretary of State for Energy.
APPENDIX 3
(para 5)
Health and safety at work etc act 1974
Ionising radiations regulations 1985
CERTIFICATE OF APPROVAL NO TA2 OF 1990
1 By virtue of the powers conferred on it by sub-paragraph (g) of Schedule 3 to the Ionising Radiations Regulations 1985 ("the Regulations"), the Health and Safety Executive approves the type of apparatus specified in Schedule 1 to this Certificate, subject to the conditions specified in Schedule 2.
2 Schedule 3 defines the terms used.
3 This Certificate shall remain in force until it is revoked in writing by the Health and Safety Executive.
Signed by P B WOODS
(A person duly authorised by the Health and Safety Executive to act in that behalf)
Dated this 26th day of November 1990.
SCHEDULE 1
1 Self-luminous fire safety signs or other devices containing gaseous tritium light sources, supplied to or installed in premises or a workplace.
SCHEDULE 2
1 The gaseous tritium light sources inside the sign or device shall not be directly accessible.
2 The dose rate at 100 mm from any accessible surface shall be less than 1Sv h-1.
SCHEDULE 3
1 In this Certificate: "gaseous tritium light source" means a sealed glass container filled with gaseous tritium and coated internally with a phosphor.
2 In this Certificate: "device containing gaseous tritium light sources" means an instrument, piece of equipment, article of sub-assembly containing one or more such sources and so constructed as to withstand normal use without breaking.
EXPLANATORY NOTE FOR CERTIFICATE OF APPROVAL NO TA2 OF 1990
1 This does not form part of the Certificate of Approval.
2 Apparatus specified in the Certificate is type approved for the purposes of Schedule 3 to the Regulations. This means that employers who have such apparatus installed in their premises but carry out no other work with ionising radiations need not notify the Health and Safety Executive and need not appoint a radiation protection supervisor.
3 The approval does not exempt employers from all other requirements of the Regulations.
4 This approval does not relate to the functional ability of the apparatus.
5 This Certificate concerns fire safety signs or other devices containing one or more of these sources and provided with mechanical protection to prevent direct access to the source(s).
6 This Certificate does not apply to self-luminous fire safety signs or other devices kept in any premises or workplace for purposes other than the installation of the sign or device in those premises or workplace. Thus, bulk storage of signs or devices for wholesale or retail will not be exempted.
7 This Certificate replaces Certificate of Approval No TA2 which expires on 31 December 1990. Gaseous tritium light sources which are not installed in a fire safety sign or other device are no longer covered by an exemption from notification. In such cases employers should notify the Health and Safety Executive under Regulation 5 of the Ionising Radiations Regulations 1985.
8 In the case of apparatus installed on offshore installations (premises referred to in Article 4 of the Health and Safety at Work etc Act 1974 (Application outside Great Britain) Order 1989) a separate Certificate of Approval has been issued on behalf of the Secretary of State for Energy.
APPENDIX 4
(para 5)
Health and safety at work etc act 1974
Ionising radiations regulations 1985
CERTIFICATE OF APPROVAL No TA1 OF 1989
1 By virtue of the powers conferred on it by sub-paragraph (g) of Schedule 3 to the Ionising Radiations Regulations 1985 ("the Regulations"), the Health and Safety Executive approves the type of apparatus specified in Schedule 1 to this Certificate, subject to the conditions specified in Schedule 2.
2 This Certificate shall remain in force until it is revoked in writing by the Health and Safety Executive.
Signed by P B WOODS
(A person duly authorised by the Health and Safety Executive to act in that behalf).
Dated this 11th day of December 1989.
SCHEDULE 1
1 Ionisation chamber smoke detectors containing not more than 40 kBq 241 -Americium in any detector and conforming to all of the requirements for single station ionisation chamber smoke detectors specified in "Recommendations for ionisation chamber smoke detectors in implementation of radiation protection standards" published by the Nuclear Energy Agency of the Organisation for Economic Co-operation and Development (OECD) 1977.
SCHEDULE 2
1 This type approval shall only apply when the number of such detectors present in any building or premises is less than 500.
2 This type approval shall only apply to ionisation chamber smoke detectors (specified in Schedule 1) kept in any building or premises where work with ionising radiations arises solely from the storage, handling or disposal of such detectors, provided that in no case shall any detector be dismantled.
EXPLANATORY NOTE FOR CERTIFICATE OF APPROVAL NO TA1 OF 1989
1 This does not form part of the Certificate of Approval.
2 Apparatus specified in the Certificate is type approved for the purposes of Schedule 3 to the Regulations. This means that employers who are working with ionising radiations solely due to the presence of less than 500 such detectors (specified in Schedule 1 to the Certificate) in any building or premises under their control, need not notify the Health and Safety Executive that they are working with ionising radiations.
3 This approval is not a general exemption from the application of the Regulations and most other substantive requirements will continue to apply.
4 This approval does not relate to the functional ability of the apparatus.
5 Ionisation chamber smoke detectors installed in premises or a workplace are covered by Certificate of Approval of TA1 of 1990.
6 At the date of this Certificate storage of more than 100 detectors requires a Certificate of Registration under the Radioactive Substances Act 1960 which is administered in England by the Department of the Environment, in Wales by the Welsh Office and in Scotland by the Scottish Development Department.