In addition to implementing the Construction Standard for Hospital Clean Operating Department and the Architectural Technical Code for Hospital Clean Operating Department, the construction of the clean operating department must also abide by the national laws and regulations concerning economic construction and public health undertakings, and should in addition conform to relevant technical standards and codes.

2.3.1 Engineering Construction Aspects

(1) Laws related to the construction of hospital clean operating departments.

Laws related to hospital clean operating department construction projects refer to the various laws concerning construction projects that are deliberated by the National People's Congress and its Standing Committee and signed and promulgated by the President of the People's Republic of China in the form of presidential orders. The main ones include the Urban Planning Law of the People's Republic of China, the Construction Law of the People's Republic of China, the Tendering and Bidding Law of the People's Republic of China, the Contract Law of the People's Republic of China, the Environmental Protection Law of the People's Republic of China, the Land Administration Law of the People's Republic of China, the Product Quality Law of the People's Republic of China, the Energy Conservation Law of the People's Republic of China, and so on.

(2) Administrative regulations related to the construction of hospital clean operating departments.

Administrative regulations related to hospital clean operating department construction projects refer to the various regulations concerning construction projects that are formulated by the State Council in accordance with the law and signed and promulgated by the Premier of the State Council in the form of State Council orders. The main ones include the Interim Provisions of the State Council on the Procedures for the Investigation of Particularly Serious Accidents (State Council Decree No. 34), the Regulations on the Quality Management of Construction Projects (State Council Decree No. 279), the Regulations on the Administration of Survey and Design of Construction Projects (State Council Decree No. 293), and so on.

(3) Rules of the construction administrative department.

Rules of the construction administrative department refer to the rules formulated by the Ministry of Construction in accordance with the law within the scope of administrative duties prescribed by the State Council and signed and promulgated by the Minister of Construction in the form of ministerial orders. The main ones include the Provisions on the Reporting and Investigation Procedures for Major Accidents in Engineering Construction (Ministry of Construction Decree No. 3), the Provisions on the Supervision and Administration of Building Production Safety (Ministry of Construction Decree No. 13), the Provisions on the Administration of Building Construction Sites (Ministry of Construction Decree No. 15), the Measures for the Administration of Tendering and Bidding for Engineering Construction (Ministry of Construction Decree No. 23), the Measures for the Administration of Construction Permits for Building Projects (Ministry of Construction Decree No. 71), the Provisions on the Supervision of the Implementation of Mandatory Standards in Engineering Construction (Ministry of Construction Decree No. 81), the Provisions on the Scope and Scale Standards for the Supervision of Construction Projects (Ministry of Construction Decree No. 86), and so on.

(4) Mandatory standards for engineering construction.

Mandatory standards for engineering construction refer to those provisions of standards that directly concern engineering quality, safety, hygiene, and environmental protection in construction activities, which are designated as mandatory provisions by the construction administrative department in accordance with the Standardization Law of the People's Republic of China and the Regulations on the Quality Management of Construction Projects (State Council Decree No. 279). The Provisions on the Supervision of the Implementation of Mandatory Standards in Engineering Construction (Ministry of Construction Decree No. 81) issued by the Ministry of Construction stipulates: "Construction activities such as new construction, expansion, and reconstruction carried out within the territory of the People's Republic of China must implement the mandatory standards for engineering construction." The full text of these Provisions, which came into force on August 25, 2000, is as follows.

Provisions on the Supervision of the Implementation of Mandatory Standards in Engineering Construction

Article 1　In order to strengthen the supervision of the implementation of mandatory standards in engineering construction, ensure the quality of construction projects, safeguard the safety of people's lives and property, and protect the public interest, these Provisions are formulated in accordance with the Standardization Law of the People's Republic of China, the Regulations for the Implementation of the Standardization Law of the People's Republic of China, and the Regulations on the Quality Management of Construction Projects. Article 2 Whoever engages in engineering construction activities such as new construction, expansion, or reconstruction within the territory of the People's Republic of China must implement the mandatory standards for engineering construction.

Article 3 The mandatory standards for engineering construction referred to in these Provisions mean the mandatory provisions of engineering construction standards that directly concern project quality, safety, hygiene, and environmental protection.

The mandatory provisions of the national engineering construction standards shall be determined by the construction administrative department under the State Council in conjunction with the relevant administrative departments under the State Council.

Article 4 The construction administrative department under the State Council shall be responsible for the supervision and administration of the implementation of the mandatory standards for engineering construction nationwide.

The relevant administrative departments under the State Council shall be responsible for the supervision and administration of the implementation of the mandatory standards for engineering construction in accordance with the division of functions assigned by the State Council.

The construction administrative departments of the local people's governments at or above the county level shall be responsible for the supervision and administration of the implementation of the mandatory standards for engineering construction within their respective administrative regions.

Article 5 Where new technologies, new processes, or new materials to be adopted in engineering construction do not conform to the provisions of the mandatory standards in force, the unit intending to adopt them shall request the project owner to organize a special technical demonstration, and submit the matter to the construction administrative department that approved the standard or the relevant competent department under the State Council for examination and approval.

Where international standards or foreign standards are adopted in engineering construction and the mandatory standards in force contain no provisions in this regard, the project owner shall file the matter for the record with the construction administrative department under the State Council or the relevant competent department under the State Council.

Article 6 Planning review institutions for construction projects shall supervise the implementation of the mandatory standards at the planning stage of engineering construction.

Construction drawing design document review units shall supervise the implementation of the mandatory standards at the survey and design stages of engineering construction.

Construction safety supervision and administration institutions shall supervise the implementation of the mandatory standards for construction safety at the construction stage of engineering construction.

Project quality supervision institutions shall supervise the implementation of the mandatory standards at the construction, supervision, acceptance, and other stages of engineering construction.

Article 7 The technical personnel of the planning review authorities for construction projects, the construction design drawing design document review units, the construction safety supervision and administration institutions, and the project quality supervision institutions must be familiar with and have a good command of the mandatory standards for engineering construction.

Article 8 The department that approves engineering construction standards shall regularly inspect the supervision over the implementation of the mandatory standards conducted by the planning review authorities for construction projects, the construction drawing design document review units, the construction safety supervision and administration institutions, and the project quality supervision institutions; units and individuals that fail to supervise effectively shall be given circulated criticism, and the relevant departments shall be advised to deal with them.

Article 9 The department that approves engineering construction standards shall conduct supervision and inspection of the implementation of the mandatory standards for engineering projects. Such supervision and inspection may be conducted by means of key inspections, spot checks, and special inspections.

Article 10 The supervision and inspection of the mandatory standards shall cover the following:

(1) whether the relevant engineering and technical personnel are familiar with and have a good command of the mandatory standards;

(2) whether the planning, survey, design, construction, and acceptance of the engineering project conform to the provisions of the mandatory standards;

(3) whether the materials and equipment used in the engineering project conform to the provisions of the mandatory standards;

(4) whether the safety and quality of the engineering project conform to the provisions of the mandatory standards;

(5) whether the contents of the guides, guidelines, manuals, and computer software used in the project conform to the provisions of the mandatory standards.

Article 11 The department that approves engineering construction standards shall announce the results of the supervision and inspection of the mandatory standards within a certain scope.

Article 12 The department that approves engineering construction standards shall be responsible for the interpretation of the mandatory standards for engineering construction.

The interpretation of the specific technical contents of a standard may be delegated by the department that approves engineering construction standards to the unit responsible for the compilation and administration of that standard.

Article 13 Engineering and technical personnel shall participate in training on the mandatory standards for engineering construction, and such training may be counted toward continuing education credit hours.

Article 14 When handling major engineering accidents, the construction administrative department or the relevant administrative department shall have experts in the field of engineering construction standards participate; the engineering accident report shall include opinions on whether the mandatory standards for engineering construction have been complied with.

Article 15 Any unit or individual shall have the right to report, bring charges against, or lodge complaints with the construction administrative department or the relevant departments against acts that violate the mandatory standards for engineering construction.

Article 16 Where a project owner commits any of the following acts, it shall be ordered to make corrections and fined not less than 200,000 yuan but not more than 500,000 yuan:

(1) explicitly or implicitly instructing the construction contractor to use substandard building materials, building components and fittings, and equipment;

(2) explicitly or implicitly instructing the design unit or the construction contractor to violate the mandatory standards for engineering construction, thereby lowering project quality.

Article 17 Where a survey or design unit conducts survey or design work in violation of the mandatory standards for engineering construction, it shall be ordered to make corrections and fined not less than 100,000 yuan but not more than 300,000 yuan.

Where the act specified in the preceding paragraph causes a project quality accident, the unit shall be ordered to suspend business for rectification and have its qualification grade lowered; where the circumstances are serious, its qualification certificate shall be revoked; causing loss ...losses, shall bear compensation liability in accordance with the law.

Article 18 Where a construction unit violates mandatory standards for engineering construction, it shall be ordered to make corrections and shall be fined between 2% and 4% of the project contract price; where the quality of the construction project fails to meet the prescribed quality standards, it shall be responsible for rework and repair, and shall compensate for the losses caused thereby; in serious cases, it shall be ordered to suspend business for rectification, have its qualification grade lowered, or have its qualification certificate revoked.

Article 19 Where a project supervision unit, in violation of mandatory standards, signs off unqualified construction projects as well as building materials, building components and fittings, and equipment as qualified, it shall be ordered to make corrections and shall be fined between RMB 500,000 and RMB 1,000,000, and its qualification grade shall be lowered or its qualification certificate revoked; any illegal gains shall be confiscated; where losses are caused, it shall bear joint and several liability for compensation.

Article 20 Where violations of mandatory standards for engineering construction cause project quality or safety hazards or project accidents, the units and persons responsible for the accidents shall be punished in accordance with the relevant provisions of the Regulations on Quality Management of Construction Projects.

Article 21 Administrative penalties involving orders to suspend business for rectification, lowering of qualification grades, and revocation of qualification certificates shall be decided by the authority that issued the qualification certificates; other administrative penalties shall be decided by the construction administrative department or the relevant departments in accordance with their statutory powers.

Article 22 Staff members of construction administrative departments and relevant administrative departments who neglect their duties, abuse their powers, or engage in malpractice for personal gain shall be given administrative sanctions; where a crime is constituted, criminal liability shall be pursued in accordance with the law.

Article 23 These Provisions shall be interpreted by the construction administrative department of the State Council.

Article 24 These Provisions shall come into force on the date of promulgation.

The mandatory provisions for engineering construction are an important guarantee of project quality, the basis for imposing penalties under the Regulations on Quality Management of Construction Projects, and the code of conduct regulating the behavior of all parties participating in construction activities. A complete understanding and correct grasp of the Architectural Technical Code for Hospital Clean Operating Departments is the prerequisite, and strict implementation of the mandatory provisions in the Architectural Technical Code for Hospital Clean Operating Departments is the safeguard. Any partial implementation of the Code or the mandatory provisions will result in hospital clean operating department projects failing to meet the expected requirements; in particular, violations of the mandatory provisions will lead to corresponding administrative penalties. The Architectural Technical Code for Hospital Clean Operating Departments contains a total of 14 mandatory provisions (clauses), specifically Article 3.0.3, Article 5.2.1, Article 5.2.5, Article 5.3.6, Paragraph 1 of Article 7.1.3, Article 7.1.4, Paragraph 4 of Article 7.1.9, Article 7.3.7, Paragraphs 1 and 2 of Article 8.3.1, Paragraph 4 of Article 8.3.2, Paragraph 2 of Article 8.3.4, Article 9.0.1, and Article 9.0.9, which must be strictly implemented.

The following regulations pertain to related technical aspects:

  • Air Filters (GB/T14295—93)
  • High-Efficiency Air Filters (GB/13554—92)
  • Hygienic Standard for Disinfection in Hospitals (GB15982—1995)
  • Code for Fire Protection Design of High-Rise Civil Buildings (2001 Edition) (GB50045—95)
  • Code for Construction and Acceptance of Ventilation and Air Conditioning Works (GB50243—2002)
  • Design Code for Clean Rooms (GB50073—2001)
  • Architectural Technical Code for Hospital Clean Operating Departments (GB50333—2002)
  • 1996 Construction Standards for General Hospitals
  • 2000 Construction Standards for Hospital Clean Operating Departments
  • Code for Fire Protection Design of Buildings (GBJ16—87)
  • Design Code for Heating, Ventilation and Air Conditioning (GBJ19—2001)
  • Code for Compressed Air Stations (GBJ29—90)
  • Design Code for Automatic Fire Alarm Systems (GBJ116—88)
  • Code for Construction and Acceptance of Decoration Works (GBJ210—83)
  • Standard for Quality Inspection and Assessment of Ventilation and Air Conditioning Works (GBJ304—88)
  • Design Code for General Hospital Buildings (GBJ49—88) "Code for Construction and Acceptance of Cleanrooms" (GBJ71—90)

"Code for Electrical Design of Civil Buildings" (GBJ/T16—19)

"Code for Design of Automatic Sprinkler Fire Extinguishing Systems" (JP50084—2001)

"General Technical Specification for Medical Central Suction Systems" (YY/T0186—94)

"General Technical Requirements for Medical Central Oxygen Supply Systems" (YY/T0187—94)