Health and Safety Executive statement on the type approval of apparatus under the Ionising Radiations Regulations 1999

Contents:

• Introduction
• HSE Policy on Type Approval
• Operation of the Type Approval Scheme
• General Criteria for Type Approval
• Development of Detailed Criteria
• APPENDIX 1 - Background notes on legal requirements
• APPENDIX 2 - Testing to criteria

Introduction

Type approval by the Health and Safety Executive (HSE) will relieve the user of the approved articles of two duties under the Ionising Radiations Regulations 1999. This means that the user will not be required to:

1. notify HSE of use of the approved articles; or
2. consult a radiation protection adviser.

However all other provisions of the Regulations will continue to apply. Background notes on the legal requirements are at Appendix 1.

This guidance is intended to assist manufacturers, importers and suppliers who wish to obtain type approval by HSE under Schedule 1 of the Ionising Radiations Regulations 1999. 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.

1. HSE Policy on Type Approval

In principle HSE will consider applications for type approval of any class of article which meets the basic criteria set out in Schedule 1, paragraphs (c) and (d) to the Regulations. In each case HSE will require evidence that the article concerned meets both the general criteria detailed below and 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 initially for applications for articles which are widely used. Reference will be made to existing national or international standards where these are applicable.

2 Operation of the Type Approval Scheme

If detailed criteria for the class of article concerned have been developed then the approval procedure will be as follows:

1. application to HSE and payment of the current fee and VAT;
2. production by the applicant of documentary evidence to show that the equipment has been tested to the detailed criteria;
3. consideration of the application and the test report by HSE;
4. if the application is successful the applicant will be issued with a certificate by HSE which will state the limits of the approval.

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 section 4.

3 General Criteria for Type Approval

In addition to the requirements of Schedule 1 (c) and (d) the following conditions should be met:

1. 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, any other person as listed in Part 1, Schedule 4 of the Ionising Radiations Regulations 1999);
2. 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 radiation;
3. in the case of apparatus containing radioactive substances the radioactive substance should be in the form of a sealed source, as defined in the Ionising Radiations Regulations 1999;
4. the article should be marked with the maximum design activity of radioactive substances. If the article is too small to carry information then adequate supporting documentation should be provided.

4 Development of Detailed Criteria

Before contacting the HSE the applicant should check that the class of articles concerned is likely to meet the requirements of Schedule 1 (c) and (d) to the Regulations and also the general criteria listed in paragraph 3. Applicants or their trade associations should send the following details to HSE, Radiation Protection Policy, 6 NW, Rose Court, 2 Southwark Bridge, London SE1 9HS:

1. general description of class of article for which type approval is required;
2. estimate of the number of articles likely to be supplied annually for use at work;
3. reports of tests carried out to show that the requirements of Schedule 1 (c) and (d) of the Ionising Radiations Regulations 1999 will be met (see Appendix 2 to this paper) and that the articles will comply with the general HSE criteria.

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. 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.

APPENDIX 1 - Background notes on legal requirements

Where the only work with ionising radiation falls into one or more of the categories listed in Schedule 1 (c) and (d) to the Ionising Radiations Regulations 1999, the employer undertaking that work is relieved of two separate duties under the Regulations as follows:

1. the need to notify HSE at least 28 days before commencing work for the first time with ionising radiation (Reg 6(2)).
2. the need to consult a radiation protection adviser. Regulation 13(1) specifies conditions which require such consultation. Regulation 13(3) removes this requirement where the only work is work specified in Schedule 1.

Two categories of work in Schedule 1, namely those described in sub-paragraph (c) and (d), specify the criteria applicable to apparatus containing a radioactive substance and electrical apparatus to which the Regulations apply. In each case there is a requirement for the article concerned to be of a type approved by HSE.

Exemptions granted under the Ionising Radiations Regulations 1985 are revoked by operation of Regulation 41(2)(a) of the Ionising Radiations Regulations 1999.

The Radioactive Substances Act 1993 (RSA) contains requirements for registration of radioactive substances: it also deals with radioactive waste. There are statutory exemptions under RSA but they do not exempt employers from notification to HSE. The type approval scheme described in this statement is not linked to RSA.

APPENDIX 2 - Testing to criteria

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.

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 that the design and specification of the article remain unchanged.

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.