GB 16353-1996Radiological protection standards for consumer products containing radioactive substances (English PDF)

3.1 Consumer product

A product purchased and used to meet the living needs of members of society and their families, or to provide them with corresponding services.

3.2 Consumer product containing radioactive substances

A consumer product to which, because of the requirements of the product function or of the manufacturing process, radioactive substances have been added as a raw material, or in which a sealed radioactive source has been assembled, or which has been made radioactive by technical means. It is hereinafter referred to as a radioactive consumer product or the product. It does not include medical and pharmaceutical products.

4.1

The total exposure of the public arising from the application of all radioactive consumer products shall be kept within acceptable limits.

4.2

Before a radioactive consumer product is put on the market, all stages after its manufacture - transport, storage, sale, use, disposal and accidents - shall be subjected to a radiological protection assessment as one complete practice. The assessment shall be carried out according to the three principles of radiation protection laid down in GB 4792.

4.3

The design and manufacture of radioactive consumer products shall comply with the relevant technical standards, so as to guarantee the quality of the product and its protective performance.

4.4

The instructions for use of a radioactive consumer product shall include the structure, characteristics and performance of the product, the correct method of use, emergency handling in the event of an accident and the appropriate method of disposal.

5.1

Whether the use of a radioactive consumer product and the exposure it causes are justified shall be confirmed by assessing the following points:

5.1.1

The benefit obtained by the user from using the product, and the benefit obtained by the persons concerned from the production and distribution of the product.

5.1.2

The cost of the detriment that may be suffered by the above persons and other possibly exposed persons, first of all the doses received by users and other persons after the product has been sold.

a. When assessing the individual doses received by users of the product, assumptions erring on the side of safety shall be adopted;

b. When assessing the collective dose commitment caused by the product, models as close to reality as possible shall be adopted;

c. When assessing individual doses and collective dose commitment, not only the normal use of the product shall be considered, but also the doses caused by misuse, accidents and disposal.

5.1.3

The cost of the management and protection applied to the product.

5.1.4

Whether a non-radioactive substitute could be used. The absence of a substitute is not the sole basis for the justification assessment; it shall also be considered whether the function of the radioactive consumer product is exactly the same as that of the substitute, and the two shall be compared in terms of cost, safety, reliability and possible detriment.

5.2

The use of a product shall be considered unjustified if it falls under any of the following:

a. a radioactive source sold separately to the public as a commodity, rather than as part of a complete product;

b. a product designed to irradiate the human body (medical products excepted), or a children's toy;

c. a product of no legitimate benefit to the user, such as gambling devices;

d. other products confirmed as unacceptable by the health administration department of the government.

6.1

The optimisation assessment may be based on previous assessment experience with other products, especially similar products, and it is normally only necessary to assess qualitatively whether the product meets the following requirements:

a. provided that the functional requirements and service life of the product are met, the radionuclide with the lowest toxicity, the shortest half-life and the weakest energy is selected;

b. provided that the effective function of the product is ensured, the lowest radioactive activity or specific activity is selected;

c. the most appropriate physical and chemical form of the radioactive substance is selected, so that it has the best safety performance in normal use and in the event of accidents;

d. the radioactive substance in the product can be directly accessed only with special tools.

6.2

If the product falls under any of the following, its optimisation assessment shall be carried out on the basis of a quantitative (or semi-quantitative) cost-benefit analysis:

a. the individual dose received by the public from the product approaches any of the limits for the different conditions given in Clause 7 or 8.2;

b. the collective dose commitment caused by the product is relatively high;

c. the investment required to further improve the protective performance of the product is very large.

7.1

For products designed and manufactured specifically to prevent loss of life or damage to property, the dose equivalents received by the individual user under normal conditions of use shall not exceed the following limits:

Effective dose equivalent: 0.05 mSv/a

Skin dose equivalent (see note 1 to 8.2): 5 mSv/a

Lens of the eye dose equivalent: 1.5 mSv/a

7.2

For other products, the dose equivalents received by the individual user under normal conditions of use shall not exceed the following limits:

Effective dose equivalent: 0.005 mSv/a

Skin dose equivalent (see note 1 to 8.2): 5 mSv/a

Lens of the eye dose equivalent: 1.5 mSv/a

8.1

When assessing misuse of the product and accidents, both their frequency of occurrence and the exposure doses they cause shall be considered together.

8.2

The limits on the individual dose equivalent received by members of the public as a result of misuse and accidents are:

Effective dose equivalent: 1 mSv/a

Skin dose equivalent (1): 50 mSv/a

Lens of the eye dose equivalent: 15 mSv/a

Note 1: The skin dose equivalent is the dose received per square centimetre, averaged over the area of local skin (<= 100 cm2) receiving the highest dose.

8.3

If the frequency of misuse and accidents of the product is not expected to be very low, the production and marketing of the product shall be regarded as unjustified.

8.4

If the individual dose equivalent caused by misuse and accidents of the product is expected to approach one of the limits of 8.2, the production and marketing of the product shall have fully sufficient justification.

8.5

When assessing the disposal of the product, the effects on public health that may result from the various methods of disposal shall be considered.

8.6

Users shall use and dispose of the product in accordance with the product instructions; sealed radioactive sources in the product shall not be dismantled or discarded at will.