Basic Standards on Radiation Protection and Safety

May 4, 2004

DOH ADMINISTRATIVE ORDER NO. 2004-0149

 

I. Rationale

The Basic Standards on Radiation Protection and Safety are issued pursuant to the enactment of Presidential Decree 480, otherwise known as the "Creation of Radiation Health Office" in 1974 as amended by Presidential Decree 1372 in 1978 and Executive Order 119, otherwise known as the "Reorganization Act of the Ministry of Health" in 1987, as revised by Executive Order 102, otherwise known as "Redirecting the Functions and Operations of the Department of Health (DOH)" in 1999.

These standards on radiation protection and safety are promulgated to establish the basic requirements for the protection against the risks associated with exposure to x-ray radiation and for the safety of x-ray devices that may deliver such exposures. In consonance with the global and international efforts towards harmonization of standards for radiation protection and safety for x-ray devices and facilities, these standards are based on the International Basic Safety Standards for Protection against Ionizing Radiation and for the Safety of Radiation Sources (IBSS) published as International Atomic Energy Agency (IAEA) Safety Series No. 115 report.

II. Scope and Limitation

These Standards shall apply to all entities or facilities operating x-ray devices for medical and non-medical purposes and to all establishments introducing electrical/electronic devices that emit x-ray radiation intentionally or as a by-product of its operation.

Radiation generators, of a type approved by the BHDT/DOH, and any electronic tube, such as a cathode ray tube for the display of visual images are automatically exempted without further consideration from the requirements of the Standards, including those for notification, registration or licensing provided that: DTIcSH

• they do not cause in normal operating conditions an ambient dose equivalent rate or a directional dose equivalent rate, as appropriate, exceeding 1 mSv-h1 at a distance of 0.1 m from any accessible surface of the apparatus; or

• the maximum energy of the radiation produced is no greater than 5 keV

III. Definition of Terms

Authorization — a permission, embodied in a document, granted in a document by the DOH through the BHDT to a legal person who has submitted an application to carry out a practice. The authorization can take the form of a registration or a license.

Defence in depth — the application of more than a single protective measure for a given safety objective such that the objective is achieved even if one of the protective measures fails.

Dose — a measure of the radiation received or 'absorbed' by a target.

Dose constraint — a prospective and source related restriction on the individual dose delivered by the x-ray source which serves as a bound in the optimization of protection and safety of the source.

Dose limit — the value of the effective dose or the equivalent dose to individuals from controlled practices that shall not be exceeded.

Establishment — pertains to structures or installations that are involved in the introduction of x-ray sources in the country.

Exposure — the act or condition of being subject to irradiation.

Facility — pertains to structures or installations that houses an x-ray source used for medical or non-medical purposes.

Guidance level — a level of a specified quantity above which appropriate actions should be considered. In some circumstances, actions may need to be considered when the specified quantity is substantially below the guidance level.

Intervention — any action intended to reduce or avert exposure or the likelihood of exposure to x-ray sources which are not part of a controlled practice or which are out of control as a consequence of an accident.

Intervention level — the level of avertable dose at which a specific protective action or remedial action is taken in an emergency exposure situation or a chronic exposure situation.

Introduction — the selling, importing, exporting, manufacturing, refurbishing, lending, assembling, distributing, commissioning, decommissioning and servicing electrical/electronic devices that emit x-ray radiation intentionally or as a by-product of its operation.

Ionizing radiation — for the purposes of radiation protection, radiation capable of producing ion pairs in biological material(s).

License — the permission granted by the DOH thru the BHDT on the basis of a safety assessment and accompanied by specific requirements and conditions to be complied with by a person, firm or corporation to carry on a practice subject to regulation.

Licensee — the holder of a current license granted for a practice or source who has recognized rights and duties for the practice or source, particularly in relation to protection and safety.

Limit — the value of a quantity used in certain specified activities or circumstances that must not be exceeded.

Medical exposure — exposure incurred by patients as part of their own medical or dental diagnosis or treatment; by persons, other than those occupationally exposed, knowingly while voluntarily helping in the support and comfort of patients; and by volunteers in a program of biomedical research involving their exposure.

Medical radiation practitioner — an individual who has been authorized through appropriate national procedures to practice as a health professional and fulfills the national requirements on training and experience for conducting procedures involving medical exposure.

Monitoring — the measurement of dose for reasons related to the assessment or control of exposure to x-ray, and the interpretation of results.

Notification — a document submitted by a legal person to inform the BHDT/DOH of an intention to carry out a practice. IDCHTE

Practice — any human activity that increases x-ray exposure.

Protection and Safety — to safeguard the people against exposure to x-ray and the security and care of x-ray sources, including the means for achieving such measures, such as the various procedures and devices for keeping people's doses and risks as low as can reasonably be achieved and below prescribed dose constraints, as well as the means for preventing accidents and for mitigating the consequences of accidents should they occur.

Qualified expert — an individual who, by virtue of certification by regulatory authorities; appropriate boards or societies, professional licenses or academic qualifications and experience, is duly recognized as having expertise in a relevant field of specialization, e.g., medical physics, radiation protection, quality assurance or any relevant engineering or safety specialty.

Quality assurance — the organized effort of a facility to ensure the high standard of quality of its product.

Radiation protection officer — an individual technically competent in radiation protection matters relevant for a given type of practice who is designated by the registrant or licensee to oversee the application of the requirements of the Standards.

Registrant — an applicant who is granted registration of a practice or x-ray source and has recognized rights and duties for such a practice or x-ray source, particularly in relation to protection and safety.

Registration — a form of authorization for practices of low or moderate risks whereby the legal person responsible for the practice has, as appropriate, prepared and submitted a safety assessment of the facilities and equipment to the BHDT/DOH. The practice or use is authorized with conditions or limitations as appropriate. The requirements for safety assessment and the conditions or limitations applied to the practice should be less severe than those for licensing.

Risk — a multiattribute quantity expressing hazard, danger or chance of harmful or injurious consequences associated with actual or potential exposures.

Safety assessment — a review of the aspects of design and operation of an x-ray source which are relevant to the protection of persons or the safety of the source, including the analysis of the provisions for safety and protection established in the design and operation of the source and the analysis of risks associated with normal conditions and accident situations.

Safety culture — the assembly of characteristics and attitudes in organizations and individuals which establishes that, as an overriding priority, protection and safety issues receive the attention warranted by their significance.

Servicing — maintaining, repairing, transferring and disassembling electrical/electronic devices that emit x-ray radiation intentionally or as a by-product of its operation.

Source — anything that emits x-ray radiation intentionally or as a by-product of its operation.

Supplier — any legal person to whom a registrant or licensee delegates duties, totally or partially, in relation to the design, manufacture, production, construction or installation of an x-ray source.

X-ray — an ionizing radiation produced by bombardment of a substance by high-speed electrons.

IV. General Guidelines

A. Requirements for Practices

1. Radiation Protection Requirements

1.1. Justification of Practices

No practice involving exposure to x-ray sources within a practice should be adopted and authorized unless the practice produces sufficient benefit to the exposed individual or society to offset the radiation harm that it might cause; that is: unless the practice is justified, taking into account social, economic and other relevant factors.

1.2. Dose Limitation

The normal exposure of individuals shall be restricted so that neither the total effective dose nor the total equivalent dose to relevant organ or tissues, caused by the possible combination of exposures from authorized practices, exceeds any relevant dose limit specified. Dose Limits shall not apply to medical exposures from authorized practices. aDICET

1.3. Optimization of protection and safety

In relation to exposures from any particular source within a practice, except for therapeutic medical exposures, protection and safety shall be optimized in order that the magnitude of individual doses, the number of people exposed and the likelihood of incurring exposures shall be kept as low as reasonably achievable, economic and social factors being taken into account, within the restriction that the doses to individuals delivered by the source be subject to dose constraints.

1.4. Dose Constraints

Except for medical exposure, the optimization of the protection and safety measures associated with any particular source within a practice shall be subject to dose constraints which do not exceed either the appropriate values established or agreed to by the BHDT/DOH for such a source or values which can cause the dose limits to be exceeded.

1.5. Guidance Levels for Medical Exposure

Guidance levels for medical exposure shall be established for use by medical radiation practitioners.

2. Management Requirements

2.1. Safety Culture

A management system to maintain a safety culture shall be established.

2.2. Quality Assurance

A quality assurance program shall be established.

2.3. Human Factors

Provision shall be made for reducing as far as practicable the contribution of human error to accidents and other events that could give rise to exposures.

2.4. Qualified Experts

Qualified experts shall be made available for providing advice on the observance of the Standards.

3. Technical Requirements

Relevant principal parties shall ensure that the protection and safety measures for practices for which they have responsibilities are governed by the technical requirements specified in the Manual on Basic Radiation Protection and Safety.

3.1. Defence in Depth

A multilayer (defence in depth) system of provisions for protection and safety commensurate with the magnitude and likelihood of the potential exposures involved shall be applied to sources such that a failure at one layer is compensated for or corrected by subsequent layers.

3.2. Good Engineering Practice

The introduction of x-ray sources shall be based on sound engineering.

4. Verification of Safety

4.1. Safety Assessments

Safety assessments related to protection and safety measures for sources within practices shall be made at different stages.

4.2. Monitoring and Verification of Compliance

Monitoring and verification of compliance with the requirements of the Standards shall be conducted.

4.3. Records

Records shall be maintained of the results of monitoring and verification of compliance, including records of the tests and calibrations carried out in accordance with the Standards.

B. Requirements for Intervention

1. Radiation Protection Requirements

1.1. Intervention is justified only if it is expected to achieve more good than harm, with due regard to health, social and economic factors.

1.2. Optimized intervention levels and action levels shall be specified in plans for intervention situations, on the basis of the guidelines given in the Manual on Basic Radiation Protection and Safety. EICSDT

2. Administrative Requirements

Applicable responsibilities set forth in the Manual shall be discharged by the registrant or licensee, the employer and the Intervening Organizations, as required by the BHDT/DOH.

V. Roles and Responsibilities

A. The BHDT/DOH shall be responsible for the enforcement of the appropriate Regulatory Standards pertaining to x-ray facilities and establishments that introduce x-ray sources in the Philippines.

B. The registrants or licensees and employers are the principal parties that are mainly responsible for the application of the Regulatory Standards.

1. The general responsibilities of principal parties within the requirements specified by the BHDT/DOH are:

1.1. To establish protection and safety objectives in conformity with the requirements specific to the x-ray device.

1.2. To develop, implement and document a radiation protection program commensurate with the nature and extent of the risks associated with the practices and interventions under their responsibility that is sufficient to ensure compliance with the requirements of the Standards.

2. The principal parties shall permit duly authorized representatives of the BHDT/DOH and other appropriate boards or societies when applicable, to inspect their protection and safety records and to carry out appropriate inspections of their authorized activities.

C. Other parties that shall have subsidiary responsibilities for the application of the Regulatory Standards include the:

1. suppliers

2. workers

3. radiation protection officers

4. medical radiation practitioners

5. health professionals

6. qualified experts

7. radiation protection committees (if applicable)

8. medical radiation committees (if applicable)

9. any other party to whom a principal party has delegated specific responsibilities

VI. Miscellaneous Provisions

A. Except as specifically authorized by the DOH Secretary in writing, no interpretation of the meaning of these Standards by any officer or employee of the BHDT or other DOH officials will be recognized to be binding.

B. The Manual on Basic Radiation Protection and Safety of X-ray Sources shall be distributed to all DOH offices through a Department Circular for information and guidance of all concerned.

VII. Effectivity

This Order shall take effect 15 days after publication in the Official Gazette or in a newspaper of general circulation and shall supersede all issuances inconsistent therewith.

(SGD.) MANUEL M. DAYRIT, MD, MSc.Secretary of Health