放射治疗卫生防护与质量保证管理规定
卫生部
放射治疗卫生防护与质量保证管理规定
1995年5月15日,卫生部
第一章 总 则
第一条 为加强放射治疗卫生防护,提高放射治疗质量,保障患者、工作人员和公众的健康与安全,根据《放射性同位素与射线装置放射防护条例》制定本规定。
第二条 中华人民共和国境内与放射治疗有关的单位和个人,都必须遵守本规定。
第三条 国务院卫生行政部门对全国放射治疗卫生防护与质量保证工作实施统一监督管理。
省级人民政府卫生行政部门根据国家有关规定,组织实施辖区内放射治疗卫生防护与质量保证工作的监督管理。
第二章 放射治疗工作场所
第四条 放射治疗工作场所的选址及其放射卫生防护设施,必须符合国家卫生标准。
第五条 新建、改建、扩建和续建的放射治疗工作场所建设项目(下称放射治疗工作场所建设项目),必须按照国家的规定,经省级人民政府卫生行政部门对其选址、设计进行放射卫生防护审核。
第六条 放射治疗工作场所建设项目竣工后,必须按照国家有关规定,经省级人民政府卫生行政部门指定的放射卫生防护机构(下简称省级放射卫生防护机构)实施放射卫生防护监测,并由省级人民政府卫生行政部门进行验收,合格后发给放射工作许可证件。
第三章 放射治疗装置
第七条 放射治疗装置的防护性能及与治疗质量有关的技术指标,必须符合国家卫生标准。禁止生产、经营、转让、订购、使用不符合国家卫生标准的放射治疗装置。
第八条 凡新研制和进口的放射治疗装置在临床试用、投产前,必须经国务院卫生行政部门组织的放射治疗与放射防护检测、评价,并经国务院卫生行政部门预防性监督合格后,由省级人民政府卫生行政部门发给许可证件,方可临床试用、投产。
第九条 放射治疗装置生产单位必须持有放射工作许可证件,并接受省级以上人民政府卫生行政部门的放射防护监督。
第十条 购买、订购、无偿接受放射治疗装置的单位,必须向出售单位或者转让单位提交放射工作许可证件,任何单位不得向无有效许可证件的单位出售或者转让放射治疗装置。
第十一条 放射治疗装置经调试安装完成后,使用单位必须向省级以上放射卫生防护机构提交安装调试报告,并接受验收监测,经省级人民政府卫生行政部门核准后,方可投入使用。
第十二条 放射治疗工作单位,应当按照国家标准的规定,对放射治疗场所和运行中的放射治疗装置进行定期放射防护检测,确保放射防护设施完好与放射治疗装置性能的稳定,并依照国家有关规定,申请省级以上放射卫生防护机构实施放射防护监测。
第十三条 放射治疗工作单位对经重大维修或更换重要部件的放射治疗装置,必须按照国家卫生标准的规定进行检测验收,并经省级放射卫生防护机构确认符合规定指标后,方可继续使用。
第十四条 放射治疗装置的订购合同、产品说明书、安装调试报告和维修、检测记录,应当至少保存至该装置报废后五年。
第四章 工作人员
第十五条 从事放射治疗工作的医疗、物理和其他技术人员,必须具备国家规定的资格条件,并经省级人民政府卫生行政部门组织实施的专业及防护知识考核合格,取得放射工作人员证后,方可从事放射治疗工作。
从事放射治疗装置安装、维修和剂量测试工作的人员,必须经省级以上人民政府卫生行政部门组织实施的有关防护知识及专业培训,取得考核合格证书后,方可从事限定范围内的工作。
第十六条 放射治疗工作单位,必须按照国家有关规定,对放射治疗工作人员进行个人剂量监测、健康监护以及专业技术和防护知识培训,并建立相应的档案管理制度。
第五章 放射治疗的实施
第十七条 对患者实施放射治疗前,应当符合下列要求:
(一)经病理学、细胞学明确诊断并经医生诊断确属放射治疗的疾患;
(二)放射治疗医师提出治疗方案,经物理人员核定照射剂量,或由放射治疗医师会同物理剂量人员、临床医师共同制订有效的放射治疗计划;
(三)放射治疗计划应当以高效治疗、减少正常组织损伤为目的,并应准确确定靶区位置与范围、照射剂量和时间。
第十八条 对患者实施首次放射治疗前,必须由放射治疗医师临场指导摆位和实施其他有关检查、处理。
第十九条 放射治疗应当对准靶区部位,确保靶区剂量达到预定治疗剂量,使患者治疗部位的正常组织、器官的照射剂量尽可能低,并对患者的非治疗部位采取有效的屏蔽防护措施。
第二十条 放射治疗工作单位必须采取有效措施,避免实施放射治疗过程中无关人员进入放射治疗室。
第二十一条 放射治疗工作单位的放射治疗档案和治疗记录应当长期保存,并建立保管、借阅制度。
第二十二条 放射治疗工作单位必须在放射治疗室和候诊室内张贴放射治疗安全防护知识等有关注意事项。
第二十三条 凡有放射治疗装置的单位,都必须配置技术性能合格的剂量检测仪器和其他必要的质量保证设备,按照国家规定的检测项目、方法和频度对放射治疗装置和其他有关设备的射线能量、输出量、治疗线束和其他有关性能分别进行检测,并依照国家规定接受放射卫生防护机构的监测。
第二十四条 放射治疗工作单位的放射治疗剂量测量仪,必须按照国家规定定期送请省级以上人民政府卫生行政部门指定或者法定的标准剂量实验室检定。
第二十五条 放射治疗工作单位应当对患者进行定期随访,及时发现、处理放射治疗所致的放射损伤。
第六章 监督与管理
第二十六条 放射治疗工作单位应当设置放射治疗卫生防护与质量保证工作负责人,建立、健全放射治疗卫生防护与质量保证管理规定制度,制订与组织实施本单位放射治疗卫生防护与质量保证方案,并将实施放射治疗卫生防护与治疗质量保证的情况,作为考核业绩的重要内容。
第二十七条 省级以上放射卫生防护机构,根据其职责负责管理辖区内的放射治疗卫生防护与质量保证计划实施中的监测、评价。
第二十八条 对违反本规定的单位或者个人,省级以上人民政府卫生行政部门根据《放射性同位素与射线装置放射防护条例》和《医疗事故处理办法》,给予处罚。
第七章 附 则
第二十九条 本规定所称的“放射治疗”装置是指由放射治疗专用的射线装置(如医用电子加速器、中子治疗仪、深、浅部X射线治疗机等)或者由装(配)有密封型放射源的放射治疗专用的装置(如钴—60治疗机、后装机等)所发生的电离辐射装置,对人体的疾患部位进行照射治疗的过程;它包括密封型放射源在人体外的远距离治疗和在人体腔内组织间的近距离治疗,不包括核医学实践中的非密封型放射性同位素治疗和放射性敷贴治疗。
第三十条 本规定由国务院卫生行政部门负责解释。
第三十一条 本规定自1995年6月1日起施行。
CONSUMER COUNCIL ORDINANCE ——附加英文版
Hong Kong
CONSUMER COUNCIL ORDINANCE
(CHAPTER 216)
CONTENTS
ion
I PRELIMINARY
hort title
nterpretation
II INCORPORATION AND POWERS
ncorporation of Consumer Council
unctions of Council
owers of Council
embership of Council
eetings of Council
ommittees
isclosure of member's interest
Appointment of staff and advisers
Documents of Council
III FINANCIAL
Resources of Council
Borrowing powers
Investment of funds
Estimates
Accounts, audit and annual report
IV GENERAL
Council not servant or agent of Crown
Governor may give directions
Protection of members of Council and committees
Prohibition of exploitation of the Council's name for
advertisement
oses
Transitional provisions
dule
Whole document
ncorporate the Consumer Council, to define its functions and
powers,
egative personal liability of members and employees for the
Council's
ts committees' acts or omissions, and for connected purposes.
July 1977] L. N. 167 of 1977
PART I PRELIMINARY
hort title
Ordinance may be cited as the Consumer Council Ordinance.
nterpretation
his Ordinance, unless the context otherwise requires--
ncil" means the Consumer Council incorporated by section 3 (1);
ancial year" means each period of 12 months ending with 31 March;
ber" means a member of the Council.
PART II INCORPORATION AND POWERS
ncorporation of Consumer Council
The Consumer Council existing at the commencement of this
Ordinance is
by created a body corporate consisting of the persons who from
time to
hold office as members of the Council.
The Council shall have perpetual succession and a common
seal and
l be capable of suing and being sued and of doing and suffering
all
other acts and things as bodies corporate may lawfully do and
suffer.
The Council shall continue to be known in the Chinese language
as.
unctions of Council
The functions of the Council are to protect and promote the
interests
onsumers of goods and services and purchasers, mortgagors and
lessees
mmovable property by--
collecting, receiving and disseminating
rmation concerning goods, services and immovable property;
receiving and examining complaints by and giving advice to
consumers
oods and services and purchasers, mortgagors and lessees of
immovable
erty;
taking such action as it thinks justified by information
in its
ession, including tendering advice to the Government or to any
public
cer;
encouraging business and professional associations to
blish codes of practice to regulate the activities of their
members;
undertaking such other functions as the Council may adopt
with the
r approval of the Governor in Council.
The Governor may be notice in writing to the Council
declare any
s, services or immovable property or class of goods,
services or
vable property to be outside the scope of the Council's
functions
r subsection (1).
In subsection (1) and in section 5 (2) (c) "goods and services"
does
include goods and services which are--
supplied by--
the Government, the Urban Council or the Regional Council; or
(Amended
f 1985 s. 60)
a body mentioned in the Schedule; or
made the subject of a declaration under subsection (2).
The Governor in Council may, by order published in the Gazette,
amend
Schedule. (Amended 5 of 1992 s. 2)
owers of Council
The Council may do such things as are reasonably necessary to
enable
o carry out its functions.
Without restricting the generality of subsection (1), the Council
may
arrying out its functions--
acquire, hold and dispose of all kinds of property
movable and
vable and in any manner which it thinks fit;
enter into any contract;
undertake the testing and examination of goods and
services and
ection of immovable property; (Amended 5 of 1992s. 3)
produce or distribute, by way of sale or otherwise, any
publication
h is of interest to consumers;
do any thing which it may do under this ordinance in
association or
peration with any other person or sponsor any other person to do
that
g;
charge for the use of any facility or service provided by the
Council;
with the prior approval of the Governor, become a member
of or
liate to any international body concerned with consumer matters.
embership of Council
The Council shall consist of the following members--
a Chairman who shall be appointed by the Governor for a
term not
eding 2 years;
a Vice-Chairman who shall be appointed by the Governor for a term
not
eding 2 years; and (Replaced 28 of 1985 s. 2)
not more than 20 other persons each of whom shall be appointed
by the
rnor for a term not exceeding 2 years. (Replaced 28 of 1989 s.
2)
The Chairman, Vice-Chairman and any other member
appointed under
ection (1) (c) may be reappointed upon expiry of their
respective
s of office. (Amended 28 of 1985 s. 2)
The Chairman, Vice-Chairman and any other member
appointed under
ection (1) (c) may at any time-- (Amended 28 of 1985 s. 2)
resign his office by notice to the Governor; or
be removed therefrom by the Governor for permanent incapacity or
other
icient cause, and upon such resignation or removal the term for
which
as appointed shall be deemed to have expired.
Where the Chairman, Vice-Chairman or any other member appointed
under
ection (1) (c) is precluded by temporary incapacity or other
cause
exercising his functions as such for any period the
Governor may
int another person to act in place of the Chairman Vice-
Chairman or
r member during such period with all such rights, powers,
duties or
ilities as if he had been appointed under subsection (1). (Amended
28
985s. 2)
(Replaced 28 of 1985s. 2)
Where any question arises under subsection (3) or (4) as to
whether
incapacity or cause exists or whether any incapacity is
temporary or
anent or any cause sufficient, the decision of the Governor
thereon
l be final.
eetings of Council
Meetings of the Council shall be held at such times and places
as the
cil, the Chairman or in his absence, the Vice-Chairman may from
time
ime appoint.
The following procedural provisions shall apply to
y meeting of the Council and subject thereto the Council may
regulate
own procedure--
at meetings of the Council 11 members shall form a quorum;
(Replaced
f 1989 s. 3. Amended 5 of 1992 s. 4)
the Chairman or in his absence, the Vice-Chairman shall preside
or, if
are absent or disqualified under section 9 (c), the members
present
l appoint one of their number to preside;
every question shall be determined by a majority of votes
of the
ers present and voting thereon;
in the event of an equality of votes the member presiding shall
have a
ing vote in addition to his ordinary vote.
nded 28 of 1985 s. 3)
ommittees
The Council may appoint committees and may delegate to
them the
cise and performance of any of its powers and functions except
this
r of delegation.
Persons who are not members of the Council are
ible for appointment to committees.
Subject to the terms of any delegation by the
Council, every
ittee--
may exercise and perform the delegated powers and functions
the same effect as if it were the Council itself;
shall be presumed to be acting in accordance with the terms of
the
gation in the absence of proof to the contrary;
may regulate its own procedure.
isclosure of member's interest
member of the Council, or of any committee of the Council,
has a
ct or indirect commercial interest in any matter under discussion
at a
ing of the Council or of the committee, being an interest greater
than
which he has as a member of the general public, the
following
isions shall apply--
he shall disclose the nature of his interest at the meeting;
the disclosure shall be recorded in the minutes;
where the disclosure is made by the member presiding, he shall
vacate
chair during the discussion;
the member (including one who has vacated the chair under
paragraph
shall, if so required by the member presiding, withdraw
from the
ing during the discussion and shall not in any case,
except as
rwise determined by the member presiding, vote on any
resolution
erning the matter or be counted for the purpose of establishing
the
tence of a quorum.
Appointment of staff and advisers
Subject to subsection (4), the Council shall appoint a person to
hold
office of Chief Executive. (Amended 28 of 1985 s. 4)
The Council may appoint such other employees as it thinks
fit and
ect to subsection (4), determine all matters relating
to their
neratior and terms and conditions of appointment or employment.
The Council may engage the services of technical and
professional
sers in such manner and on such terms and conditions as it thinks
fit.
The Council shall obtain the prior approval of the Governor to--
any appointment proposed to be made under subsection (1) and the
terms
conditions thereof;
the suspension or dismissal of the Chief Executive;
the salary or salary scale (including allowances and other
pecuniary
fits) and conditions of employment applicable to the Chief
Executive
every other employee or class employee, and any variation
thereof.
nded 28 of 1985 s. 4)
No person shall be employed by the Council otherwise than on the
salar
alary scale or on the conditions of employment applicable to that
pers
oved by the Governor under subsection (4).
Documents of Council
The Council may make and execute all such documents as may
expedient
or conducive to the exercise and performance of its power
functions
duties.
The fixing of the seal of the Council to any document
l--
be authorized by resolution of the Council; and
be authenticated by the signatures of any 2 members
authorize by
lution of the Council, either generally or specially, to ao for
that
ose.
Any document purporting to be duly executed under the seal
of the
cil shall, unless the contrary is proved, be considered to be
duly
uted.
Any contract or instrument which if entered into or executed
by a
on not being a body corporate would not be required to be in the
form
deed may be entered into or executed on behalf of the Council by
any
on generally or specially authorized by the Council for that
purpose.
PART III FINANCIAL
Resources of Council
The Governor may, out of money appropriated for the purpose
by the
slative Council, authorize payment to the Consumer Council
of such
nts as he thinks fit.
The resources of the Council shall consist
all money received by the Council pursuant to subsection (1);
money paid to the Council by way of donations, fees,
subscriptions,
and interest;
all other money and property, including accumulations of
income,
ived by the Council for its purposes.
Borrowing powers
Council may, with the approval of the Financial Secretary,
borrow or
rwise raise money and charge all or any part of its
property as
rity therefor.
Investment of funds
money of the Council that is not immediately required
shall be
sted--
on fixed deposit in any bank or savings bank approved by the
ncial Secretary, either generally or in any particular case, for
the
ose; or
in such other forms of investment as the Financial
Secretary may
ove.
Estimates
Council shall in each financial year adopt estimates of
income and
nditure for the ensuing financial year and, before a date
to be
inted by the Financial Secretary, send them to the Governor for
his
oval together with a programme of its proposed activities
for the
ing financial year.
Accounts, audit and annual report
The Council shall keep proper accounts and proper records in
relation
eto and shall within 3 months after the expiry of a financial year,
or
further period as the Financial Secretary may allow,
prepare a
ement of the accounts of the Council, which statement shall
include an
me and expenditure account and a balance sheet.
The Council
l, subject to subsection (3), appoint an auditor, who
shall be
tled to have access at any time to all books of account, vouchers
and
r financial records of the Council and to require such information
and
anations relating thereto as he thinks fit.
The Council shall obtain the prior approval of the Financial
Secretary
ny appointment proposed to be made under subsection (2).
The auditor shall, as soon as is practicable, audit the
accounts
ired by subsection (1) and shall submit a report thereon
to the
cil.
The Council shall within 3 months after the receipt by it
of the
tor's report in respect of its accounts for a financial
year, or
in such further period as the Financial Secretary may allow,
furnish--
a report on the affairs of the Council for that year;
a copy of its accounts therefor; and
the auditor's report on the accounts, to the Governor who shall
cause
same to be tabled in the Legislative Council.
PART IV GENERAL
Council not servant or agent of Crown
Council is not a servant or agent of the Crown and does not enjoy
any
us, immunity or privilege of the Crown.
Governor may give directions
The Governor may, if he considers that the public
interest so
ires, give to the Council such directions as he thinks
fit with
ect to the exercise and performance by the Council of its
powers,
tions and duties under this Ordinance, either generally or
in any
icular case.
The Council shall comply with any direction given to
it under
ection (1).
Protection of members of Council and committees
No member or employee of the Council or of any committee
of the
cil shall be personally liable for any act done or default made--
by the Council; or
by any committee of the Council, acting in good faith in the course
of
operations of the Council or of the committee.
The protection hereby conferred on members and employees
of the
cil or of a committee in respect of any act or default shall not
in
way affect any liability of the Council for that act or default.
Prohibition of exploitation of the Council's name for
advertisement
oses
No person shall, with a view to promoting or disparaging any
s, services or immovable property or promoting the image
of any
on, publish or cause to be published any advertisement which
either
essly or by implication makes reference to--
the Council;
any committee, member, agent or employee of the Council;
the Council's publication or finding of tests or surveys
conducted by
n behalf of the Council; or
any other information published by the Council, without
written
ent of the Council.
Any person who contravenes subsection (1) commits an offence
and is
le to a fine of $ 100,000.
For the purpose of subsection (1) "advertisement" may be
constituted
ny words, whether written or spoken, or any picture, drawing,
visual
e, figure or article--
appearing in any publication; or
brought to the notice of the public or any section of the public
in
other way. (Replaced 5 of 1992 s. 5)
Transitional provisions
All property of whatever kind and whether movable or immovable
vested
r belonging to the Consumer Council existing at the
commencement of
Ordinance shall as from that date vest in or belong to that
Council
ts corporate capacity without any further assurance.
All obligations and liabilities of the said Consumer Council
are as
the commencement of this Ordinance the obligations and
liabilities of
Council in its corporate capacity.
Where anything has been commenced by or under the authority
of the
Consumer Council before the commencement of this Ordinance such
thing
be carried on any completed by the Council in its corporate
capacity.
Every person who immediately before the commencement of this
Ordinance
s an appointment as Chairman, Executive Director or a member of
the
Consumer Council is, as from such commencement but subject to
the
s of his appointment, the Chairman, Executive Director, or a
member of
Council, as the case may be, for the purposes of this Ordinance.
Notwithstanding the definition of "financial year" in section
2 the
od between the commencement of this Ordinance and 31 March 1978
shall
eemed to be a financial year.
No stamp duty shall be payable in respect of any transfer of
property
r this section.
SCHEDULE
Television Limited
a Light and Power Company, Limited
a Motor Bus Company, Limited
Cross-Harbour Tunnel Company, Limited
Marketing Organization
Kong Air Cargo Terminals Limited
Hong Kong and Yaumati Ferry Company Limited
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