Licensing and notification for trade, installation and maintenance involving ionising radiation

1. Fill in and submit the form Application for licence to conduct activities involving ionising radiation. The form must be signed by an authorised signatory.

General description of the activity

2. Describe the activity and its purpose for using the specified radiation sources.

For installation and maintenance, the description must also include:

a) Type of equipment to be installed or serviced;

b) Type of facilities where the equipment will be installed or serviced;

c) Whether contract workers may perform any tasks.

For HASS, the description must also include:

a) Location of the source within the facility;

b) Whether contract workers may perform any tasks.

Organisation and management system

3. Describe which tasks may lead to radiation doses to workers or others during normal use. Also identify tasks or incidents posing an increased risk of exposure. (Chapter 2, Section 1 of SSMFS 2018:1)

4. Attach an organisational chart. (Chapter 3, Section 1 of SSMFS 2018:1)

5. Specify the person or function responsible for radiation protection tasks in the following areas: organisation and management system; competence; protection of workers and the public; premises and protective equipment; radiation sources. If responsibilities are shared, describe the division of duties and how cooperation is arranged.

Competence

6. Describe the radiation protection expert function, including:

a) Documentation proving an approved expert function, or documentation for an application for approval of a new or modified function;

b) Contracts or equivalent showing the inclusion of external persons;

c) Documentation of the expert function’s authority and reporting lines to senior management. (Chapter 3, Section 12 of SSMFS 2018:1)

7. Describe how it is ensured that workers have adequate competence before beginning work with radiation sources. (Chapter 3, Section 10 & Chapter 4, Section 13 of SSMFS 2018:1)

Protection of workers and the public

8. Explain how radiation protection instructions are made available at every workplace where radiation sources are used. (Chapter 4, Section 2 of SSMFS 2018:1)

9. Describe how workers are classified by exposure category. (Chapter 4, Section 15 of SSMFS 2018:1)

The time it takes to process an application varies depending on factors such as complexity, type of licence and the authority’s workload at the time in question. We will begin dealing with the matter when we receive a completed application. If the application is incomplete and supplementation is required, the processing time will be extended accordingly. If the requested information is not forthcoming, we may need to reach a decision based on the information we have to hand, or we may dismiss the application entirely.

A decision regarding a permit, or licence, under the Radiation Protection Act (2018:396) may be appealed to the Administrative Court in Stockholm. The decision includes instructions on how to lodge an appeal.

According to the Ordinance (2008:463) on certain fees to the Swedish Radiation Safety Authority, the application fee for installation and maintenance of radiation sources is SEK 11 400.

The following laws, ordinances and regulations govern activities requiring a licence:

Pursuant to Section 1 of Chapter 6 of the Swedish Radiation Protection Act (2018:396), it is prohibited to conduct unlicenced activities involving ionising radiation. Pursuant to point 1 in Section 2 of Chapter 9 of the same act, anyone intentionally or negligently breaching this prohibition may be sentenced to a fine or imprisonment for up to two years.

If you cease activities involving ionising radiation, you need to be able to demonstrate that all registered radioactive substances and x-ray equipment have been dealt with in accordance with Swedish Radiation Safety Authority regulations and report to us accordingly. We can then write-off your activity and annual fee. You are also required to decontaminate premises in which you have used radioactive substances as radioactive sources, so that the premises can be given clearance.

Deregistering radioactive substances

Contact the company from which you purchased the radioactive substance for assistance with safe handling and report the changes to us by completing and submitting the form for deregistering equipment.

Deregistering x-ray tubes

Deposit the x-ray equipment with a radioactive waste company and report the changes to us by completing and submitting the form for deregistering equipment. You also need to send us an original certificate in which you or the waste firm certifies that the x-ray tube is been rendered unusable.

Clearance of premises

Clearance is required for premises no longer used for work involving radioactive substances in the form of open radioactive sources. Obtaining clearance involves:

• the decontamination of all surfaces that may have been contaminated by the radioactive source;
• dealing with radioactively contaminated equipment and other inventory in a safe manner; and
• reporting the implementation of certain decontamination measures and the results of control measurements to the Swedish Radiation Safety Authority, which will then decide whether to grant clearance.

Clearance is regulated in Swedish Radiation Safety Authority Regulations (SSMFS 2018:3) concerning Exceptions from the Radiation Protection Act and the Clearance of Materials, Buildings and Areas.

1. Log in to our e-service using your Freja eID or BankID.
2. Select the type of activity you wish to register.
3. Provide the following details:
1. Invoicing address
2. Invoice reference
3. Preferred means of invoicing
4. Contact details for someone who can answer any questions
5. The make, model and serial number of the equipment (the serial number can be registered at a later date)
6. Any supplier information
7. Address where the practice is located
4. You also need to supply details of the equipment to which your application relates.

When you have signed your notification, a confirmation will be sent to your email address. This means that your notification has been approved. Save this confirmation as it is only generated once when you register.

Your notification is valid for five years. You can renew it no earlier than six months before it expires. The renewal must be submitted via our e-service.

You have automatic authorisation to log in to the e-service if you are an authorised signatory, CEO or director of the company. If the signatures of multiple directors are required, you will need power of attorney to log in. Power of attorney is also required if someone other than an authorised signatory or CEO is representing the organisation. Power of attorney is also required for sole traders, limited partnerships, economic associations, publicly owned companies and public authorities.

You can apply for power of attorney in two ways:

1. The authorised signatory or CEO can log in and delegate authority to represent the organisation. The representative must then log in and approve the information in the e-service.
2. The representative can log in directly to the e-service and enter and send their details.

In both cases, documentation of delegation must be attached and signed and approved by the authorised signatory or CEO. This must state the name and job title of the delegator and the name and personal identity number of the delegatee.

The Swedish Radiation Safety Authority will check the information and a case officer from the authority must approve power of attorney. A confirmation document will be emailed to the representative once power of attorney has been approved.

According to the Ordinance (2008:463) on certain fees to the Swedish Radiation Safety Authority, the fee for notifiable activities is SEK 1,850.

The obligation to notify is regulated by the following acts, ordinances and regulations:

If you no longer conduct an operation registered with the Swedish Radiation Safety Authority, you can deregister by emailing us at Tillstandsprovning-stralskydd@ssm.se. Please state the registration number.