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The Bureau of Safety Supervision of Special Equipment of the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China (hereinafter referred to as "AQSIQ") issued an assignment of drafting Supervision Regulation on Safety Technology for Hyperbaric Oxygen Chamber to China Special Equipment Inspection and Research Institute (hereinafter referred to as "CSEI") in April, 2010. In May 2010, the CSEI organized relevant experts to establish a drafting group and held the first meeting of the drafting team meeting in Beijing, discussing the drafting principles, key contents and main problems as well as structure (chapter) framework, making specific division of drafting and preparing a complete drafting schedule. The drafting team has convened multiple team meetings in Beijing, Wuhan and Yantai, and worked out Supervision Regulation on Safety Technology for Hyperbaric Oxygen Chamber (Exposure Draft) in November 2012 through discussion and modification. On July 23, 2013, the Bureau of Special Equipment solicited opinions from the grass-roots departments, units concerned, experts and citizens with No. 38 Document, ZHIJIANTEHAN [2013]. The drafting team studied and discussed the opinions solicited and finalized a draft for examination. In November 2013, the Bureau of Special Equipment submitted the draft for examination to the Special Equipment Safety Technical Committee, AQSIQ for deliberation, and the drafting team worked out the draft for approval after modification according to the deliberations. In November 2014, AQSIQ announced the Regulation to the World Trade Organization. On November 20, 2015, the Regulation is approved and issued by AQSIQ.
Basic principles for drafting of Supervision Regulation on Safety Technology for Hyperbaric Oxygen Chamber are:
(1) Unify the classification and adjust the application scope of hyperbaric oxygen chambers according to the requirements of Catalogue of Special Equipment;
(2) Establish the comprehensive code for hyperbaric oxygen chambers according to the thought of formulating "large code", in combination with the safety supervision and management experience and technical development over the years, based on normative documents and safety specifications such as Pressure Vessels Periodical Inspection Regulation and Pressure Vessel Service Administration Regulation and through integrating the basic safety requirements for procedures such as materials, design, manufacturing, installation, supervision and inspection, use, transformation, repair and periodic inspection of hyperbaric oxygen chambers involved in safety supervision and management;
(3) Adjust the administrative licensing requirements relevant to each procedure according to the reform of administrative licensing;
(4) Refer to the requirements of foreign relevant specifications and standards for hyperbaric oxygen chambers and learn lessons from hyperbaric oxygen chamber accidents;
(5) Define the classification, composition, hyperbaric oxygen chamber group, transformation and repair, etc. of hyperbaric oxygen chambers;
(6) Add basic safety requirements for the design service life, rated number of people in chamber, working medium quality as well as design, transformation and repair, safe use management, annual inspection and periodic inspection, etc. of hyperbaric oxygen chambers.
Contents
Foreword i
1 General Provisions 1
2 Materials 5
3 Design 7
4 Manufacturing 22
5 Installation 30
6 Transformation and Repair 35
7 Supervision and Inspection 38
8 Use Management 61
9 Periodic Inspection 71
10 Safety Accessories, Safety Protection Devices and Instruments 78
11 Supplementary Provisions 80
Annex A Application for Design Document Appraisal of Hyperbaric Oxygen Chamber 82
Annex B Design Document Appraisal Report of Hyperbaric Oxygen Chamber 84
Annex C Product Qualification Certificate of Hyperbaric Oxygen Chamber 87
Annex D Supervision and Inspection Certificate for Manufacturing Special Equipment (Hyperbaric Oxygen Chamber) 90
Annex E Installation and Debugging Data Sheet of Hyperbaric Oxygen Chamber 91
Annex F Supervision and Inspection Certificate for Installation of Special Equipment (Hyperbaric Oxygen Chamber) 93
Annex G Annual Inspection Report of Hyperbaric Oxygen Chamber 95
Annex H Periodic Inspection Report of Hyperbaric Oxygen Chamber 99
Supervision Regulation on Safety Technology for Hyperbaric Oxygen Chambers
1 General Provisions
1.1 Purpose
With a view to ensuring the safe operation of hyperbaric oxygen chamber, preventing and reducing accidents, protecting the people's life and property safety and promoting the economic and social development, the Regulation is formulated according to the relevant requirements of Special Equipment Safety Law of the People's Republic of China and Regulation on Safety Supervision of Special Equipment.
1.2 Hyperbaric oxygen chamber definition
Hyperbaric oxygen chamber refers to the pressure vessel for human occupancy with breathable gas (e.g. air, oxygen or mixed gas (Note 1-1), etc.) as pressure medium and used for treatment and acclimatization training (hereinafter referred to as in-chamber activities) of personnel in chamber.
Note 1-1: mixed gas refers to the breathable gas prepared with oxygen and other gas in proportion.
1.3 Application scope
The Regulation is applicable to medical hyperbaric oxygen chamber and high-pressure chamber within the range specified in Catalogue of Special Equipment.
1.3.1 Medical hyperbaric oxygen chamber
Medical hyperbaric oxygen chamber includes medical hyperbaric oxygen chamber pressurized with air and medical hyperbaric oxygen chamber pressurized with oxygen, which are defined as follows:
(1) Medical hyperbaric oxygen chamber pressurized with air is a pressure vessel for human occupancy with air as pressure medium and used for treatment, for which, the working pressure is not greater than 0.3MPa (gauge pressure, the same below);
(2) Medical hyperbaric oxygen chamber pressurized with oxygen is a pressure vessel for human occupancy with oxygen as pressure medium and used for treatment, for which, the rated number of people in chamber is 1, and the working pressure is not greater than 0.2MPa.
1.3.2 High-pressure chamber
High-pressure chamber refers to the pressure vessel for human occupancy with air or mixed gas as pressure medium and used for in-chamber activities, for which, the working pressure shall comply with product standard.
1.4 Special requirements for application scope
1.4.1 Movable medical hyperbaric oxygen chamber
Movable medical hyperbaric oxygen chamber refers to the pressure vessel for human occupancy used for treatment where the running gear is under operation or static state, for which, the hyperbaric oxygen chamber is permanently installed on running gear.
Movable medical hyperbaric oxygen chamber shall meet the requirements of general provisions, design and manufacturing in the Regulation; moreover, its chamber and connection between components and running parts shall also meet the relevant requirements of Supervision Regulation on Safety Technology for Transportable Pressure Vessel.
1.4.2 Hyperbaric oxygen chamber group
Hyperbaric oxygen chamber groups within the application scope of the Regulation are as follows:
(1) 2 or more hyperbaric oxygen chambers are installed in the same room, sharing the same pressure regulating system and breathing gas system and under the control and operation by the same control console;
(2) 2 or more hyperbaric oxygen chambers are connected with transfer chamber, forming independent operation of one chamber or simultaneous operation of multiple chambers.
The safety management during design, manufacturing, installation, transformation and repair, supervision and inspection, application management, periodic inspection, etc. of hyperbaric oxygen chamber group shall not be carried out by hyperbaric oxygen chambers while shall be carried out on the whole hyperbaric oxygen chamber group.
1.5 Inapplicable scope
(1) Vessels for human occupancy used for military equipment, nuclear facilities, aerospace vehicles, offshore facilities and ships, underwater equipment, diving equipment as well as underground facilities in mine;
(2) Vessels for human occupancy used for health care purpose (including for household use);
(3) Transfer chamber for human occupancy.
1.6 Hyperbaric oxygen chamber scope definition
Hyperbaric oxygen chamber includes chamber, pressure regulating system, breathing gas system, electrical system, in-chamber environment conditioning system, fire-fighting system, safety accessories, safety protection devices and instruments.
1.6.1 Chamber
Chamber includes pressure elements (components) such as cylinder, end enclosure, chamber door, compartment end enclosure, medical lock, inspection (lighting) window and in-chamber pipeline as well as in-chamber materials such as decorative material, textile, seat (bed) and floor.
1.6.2 Pressure regulating system
Pressure regulating system includes gas compression equipment, matching pressure vessel, gas purifying device, matching pipeline, etc.
1.6.3 Breathing gas system
Breathing gas system includes breathing gas supply device, breathing device (including discharge device, the same below), humidifying device, matching pipeline, etc.
1.6.4 Electrical system
Electrical system includes power switch, overcurrent protection device, isolation transformer, power supply cable (wire), emergency power supply device, relay, contactor, distribution cabinet (panel), communication intercom device, emergency call device, video monitoring device, lighting device (including emergency lighting device, the same below), electrical connector (including bioelectrical device, the same below), control console, etc.
1.6.5 In-chamber environment conditioning system
In-chamber environment conditioning system includes air conditioning device, cooling (heating) device, temperature control device, fan-driven motor, radiator, humidifying device, matching pipeline, etc.
1.6.6 Fire-fighting system
Fire-fighting system includes water spraying fire-fighting system (including start gas supply, water storage tank, matching pipeline, control valve, sprayer, etc.; the same below) and other fire-fighting equipment.
1.6.7 Safety accessories, safety protection devices and instruments
Safety accessories, safety protection devices and instruments include safety valve, emergency discharge device, safety protection interlocking device, earthing device as well as automatic measurement, display, record and alarm devices and instruments of operation parameters such as concentration and pressure of breathing gas and working pressure, humidity and temperature of hyperbaric oxygen chamber.
1.7 Relationship with technical standards and management systems
The Regulation specifies basic safety requirements for procedures such as design, manufacturing, installation, transformation and repair, use and inspection of hyperbaric oxygen chamber; technical standards and management systems of units and organizations concerned with hyperbaric oxygen chamber shall not be lower than those specified in the Regulation.
1.8 Treatment of inconsistency with the Regulation
For hyperbaric oxygen chamber adopting new material, technology and process and provided with special service requirements, in case that any inconsistency with the requirements of the Regulation is available or the Regulation fails to specify relevant requirement, and thereby significantly affecting the safety performance of hyperbaric oxygen chamber, relevant units shall submit relevant product standards as well as technical information such as basis, data and result of design, research and test and their inspection and test reports to the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China (hereinafter referred to as AQSIQ, the same below). AQSIQ will entrust the safety technology consulting agency or relevant professional organization to perform technical evaluation, and such pressure vessels shall not be put into production and service until the evaluation result is approved by AQSIQ.
1.9 Imported hyperbaric oxygen chamber
(1) The product safety performance of imported hyperbaric oxygen chamber shall meet the basic safety requirements of the Regulation;
(2) The overseas manufacturer shall obtain special equipment manufacturing license according to the requirements of relevant regulations and safety specifications;
(3) Where the overseas manufacturer fails to adopt Chinese standards for manufacturing of hyperbaric oxygen chamber, mature standards adopted extensively in the world may be adopted for design and manufacturing; meanwhile, declaration and comparison table indicating that its product conforms to the basic safety requirements in the Regulation shall be submitted to AQSIQ;
(4) Generally, overseas manufacturing supervision and inspection is adopted for the imported hyperbaric oxygen chamber; where the manufacturing supervision and inspection is not completed overseas, the unit importing hyperbaric oxygen chamber or the overseas manufacturer of hyperbaric oxygen chamber shall make declaration to and obtain approval of the special equipment safety supervision management department of the provincial or municipal (hereinafter referred to as provincial) people's government; arrival inspection may be carried out according to the requirements of 7.10.6 when arriving at port or use place, and use registration formalities may only be transacted after conforming to the basic safety requirements of the Regulation;
(5) The installation, use and maintenance instruction, product nameplate, safety warning mark and its description for the imported hyperbaric oxygen chamber shall be in Chinese.
1.10 Supervision and management
The units in charge of the design, manufacturing, installation, transformation, repair, and operation as well as the organizations in charge of inspection and testing of hyperbaric oxygen chamber shall strictly enforce the Regulation and accept the supervision and management of the special equipment supervision and management department of the people's governments at all levels; they shall also timely input the data required into the special equipment information management system according to the requirements of special equipment information management.
2 Materials
2.1 Basic requirements
(1) Metal materials adopted for chamber and pressure element (component) shall meet the requirements of Supervision Regulation on Safety Technology for Stationary Pressure Vessel;
(2) Where manufacturing license requirements for pressure pipeline components (including pipe, elbow, tee, valve, flange, etc.) are specified in relevant safety specifications, product manufactured by the unit with corresponding manufacturing license qualification shall be adopted;
(3) The maximum and minimum wall thickness difference of organic glass pipes and the thickness difference of plates shall not be greater than 10% of the nominal wall thickness and nominal thickness, and their physical and mechanical performances shall meet the requirements of Tables 2-1 and 2-2;
Table 2-1 Physical and Mechanical Performance Indexes of Organic Glass Pipes
Item Performance index
Tensile strength (MPa) ≥53
Solvent craze resistance Free of crazing after being soaked for 1h
Table 2-2 Physical and Mechanical Performance Indexes of Organic Glass Plates
Item Performance index
Non-notch impact strength of simply supported beam (kJ/m2) ≥17
Tensile strength (MPa) ≥70
Tensile failure strain (%) ≥3
Vicat softening temperature (℃) ≥100
Solvent craze resistance Free of crazing after being soaked for 4h
(4) Pressure elements (components) made of organic glass materials such as cylinder and inspection (lighting) window shall meet the first-class product requirements in product standards of cast organic glass pipes and plates;
(5) Non-metal material adopted for pipeline shall be non-toxic and provided with oxidation resistance;
(6) In-chamber materials, under working conditions (concentration, pressure, humidity, temperature and etc. of breathing gas, the same below) of hyperbaric oxygen chamber, shall meet the requirements of uninflammable, flame-retardant and antistatic performance, and shall be provided with product quality certificate documents of such performance;
(7) Antirust paint sprayed on inner wall of chamber and matching pressure vessel shall be fire-proof and non-toxic paint complying with the requirements of relevant medical treatment and health care specifications;
(8) Lubricating material and hydraulic medium adopted for hyperbaric oxygen chamber shall be provided with favorable flame-retardant and oxidation resistance;
(9) Sealing materials (including sealing ring and pad, etc.) shall be those with strong oxidation resistance and favorable sealing performance; oxidizable, non-fire-resistant and harmful materials, e.g. aluminum, nylon and asbestos product, shall not be adopted;
(10) The device, equipment, apparatus, instrument, electrical element and device, etc. of electrical system shall meet the requirements of GB 9706.1 Medical Electrical Equipment - Part 1: General Requirements for Safety and relevant product standards;
(11) Wires (cables) adopted for medical hyperbaric oxygen chamber shall meet the requirements of GB/T 5023 Polyvinyl Chloride Insulated Cables of Rated Voltages up to and Including 450/750V; single-core shielded wire and twin-core shielded wire shall meet the requirements of JB/T 8734 Polyvinyl Chloride Insulated Cables and Wires and Cords of the Rated Voltages up to and Including 450/750V; wires (cables) adopted in high-pressure chamber shall also meet the requirements of GB/T 19666 Flame Retardant and Fire Resistant Wires and Cables General;
(12) Where independent earthing device is arranged, the embedded materials of earthing device shall be copper or stainless steel material;
(13) As for hyperbaric oxygen chamber, the carbon steel seamless steel pipe adopted shall meet the requirements of GB/T 8163 Seamless Steel Tubes for Liquid Service; the stainless steel seamless pipe shall meet the requirements of GB/T 14976 Seamless Stainless Steel Pipes for Fluid Transport; the copper pipe shall meet the requirements of GB/T 1527 Drawn Tube of Copper and Copper Alloys;
(14) Stainless steel materials shall be adopted for pipes and penetration pieces of water spraying fire-fighting system.
2.2 Material substitution
During the manufacturing, installation and transformation of hyperbaric oxygen chamber, the material substitution of pressure elements (components) affecting the safety performance of hyperbaric oxygen chamber and that of electrical devices, equipment, apparatus, instrument, element and component, wire (cable), etc. shall be confirmed by the design personnel and approved by the technical director of the manufacturer and construction unit (i.e. the unit undertaking installation and transformation, the same below) in advance, and shall be recorded in detail in the manufacturing completion drawing, installation and transformation technical information and document. In case of transformation for hyperbaric oxygen chamber not manufactured by this unit, the material substitution may be confirmed by the design personnel and approved by the technical director of the unit undertaking hyperbaric oxygen chamber transformation.
3 Design
3.1 Design unit and its personnel
Hyperbaric oxygen chamber design is undertaken by the manufacturer complying with those specified in 4.1.1.1 (hereinafter referred to as "the design unit"), which is responsible for the design quality of the designed hyperbaric oxygen chamber. Personnel engaged in design, review and approval of hyperbaric oxygen chamber shall have corresponding design capability and be responsible for the quality of design, review and approval of hyperbaric oxygen chamber.
3.2 General requirements for design
(1) The design of medical hyperbaric oxygen chamber shall meet the requirements of GB/T 12130 Medical Hyperbaric Chamber Pressurized with Air or GB/T 19284 Hyperbaric Chamber Pressurized with Medical Oxygen;
(2) The design of chamber and pressure element (component) of metal hyperbaric oxygen chamber shall meet the requirements of Supervision Regulation on Safety Technology for Stationary Pressure Vessel and GB 150 Pressure Vessels; thereof, the design of pipeline shall meet the relevant requirements of GB 50751 Technical Code for Medical Gases Engineering;
(3) The design of pressure regulating system and breathing gas system of hyperbaric oxygen chamber shall meet the relevant requirements of medical treatment and health care, fire regulation and GB 50751;
(4) The design of electrical system of medical hyperbaric oxygen chamber shall meet the relevant requirements of GB 9706.1;
(5) For the design of penetration pieces (elements or components connecting the interior/exterior of chamber) of hyperbaric oxygen chamber, factors such as sealing performance and insulation performance shall be considered;
(6) Safety warning mark and its description shall be arranged in visible positions, e.g. the entrance and exit, chamber interior and control console;
(7) Conditions such as thermal expansion and contraction, vibration, external force impact during the operation process shall be considered for the design of movable medical hyperbaric oxygen chamber; meanwhile, the effect of inertia on personnel and in-chamber materials during the operation process shall also be considered.
3.3 Design documents
3.3.1 Contents of design documents
Design documents of hyperbaric oxygen chamber mainly include design instruction, chamber design calculation sheet, general design drawing, pressure element (component) drawing, in-chamber layout, pressure regulating system drawing, breathing gas system drawing, electrical system design document, in-chamber environment conditioning system drawing, water spraying fire-fighting system drawing, installation, use and maintenance instruction as well as other design documents.
3.3.2 Design instruction
The design instruction at least includes design basis, design service life, model and specification of hyperbaric oxygen chamber, etc.
3.3.3 Chamber design calculation sheet
Chamber design calculation sheet includes design basis, design parameters, design service life as well as calculation of cylinder thickness, end enclosure (including compartment end enclosure) thickness, other pressure element (component), support, safety valve type selection and relieving (discharge) capacity calculation, etc.
3.3.4 Design drawings
(1) General design drawing, at least including material list, list of technical characteristics, interface list, technical requirements, chamber volume per capita, rated number of people in chamber, non-destructive testing requirements, heat treatment requirements, pressure test requirements and special inspection requirements, etc.;
(2) Pressure element (component) drawing, at least including drawings for pressure elements (components) such as chamber door, compartment end enclosure, medical lock, inspection (lighting) window and in-chamber pipeline;
(3) In-chamber layout, including layout of in-chamber material, fire-fighting equipment, device and component;
(4) Pressure regulating system drawing, including working principle of system; type selection of gas compression equipment, capacity calculation of air tank, safety accessories and safety protection devices as well as instruments, pressure display and recording devices; pressure test parameters and installation requirements of each pipeline section, etc.;
(5) Breathing gas system drawing, including working principle of system; type selection of equipment, pipeline, safety accessories and safety protection devices as well as instruments, breathing devices, humidifying devices, pressure and humidity display and recording device and breathing gas concentration measuring device; pressure test parameters and installation requirements of each pipeline section, etc.;
(6) Electrical system design documents, including electrical system drawing, power supply type, power equipment and control console power, isolating transformer capacity, distribution circuit model and sectional area specification, insulation design (including relevant electrical equipment layout), technical requirements of wire (cable) laying and installation wiring, capacity calculation or technical requirement specification of emergency power supply, communication intercom device, emergency call device, video monitoring device, lighting device and electrical connector as well as the requirements of automatic measurement, display and recording devices of hyperbaric oxygen chambers, etc.;
(7) In-chamber environment conditioning system drawing, including system working principle; the requirements of equipment, pipeline, cooling (heating) device, temperature control device, humidifying device as well as temperature and humidity display devices, etc.;
(8) Water spraying fire-fighting system drawing, including system working principle; water flow calculation (water spraying amount calculation); type selection of water storage tank, water pipeline, pressure display device, control valve, etc.; system test parameters as well as installation requirements, etc.
Foreword i
1 General Provisions
2 Materials
3 Design
4 Manufacturing
5 Installation
6 Transformation and Repair
7 Supervision and Inspection
8 Use Management
9 Periodic Inspection
10 Safety Accessories, Safety Protection Devices and Instruments
11 Supplementary Provisions
Annex A Application for Design Document Appraisal of Hyperbaric Oxygen Chamber
Annex B Design Document Appraisal Report of Hyperbaric Oxygen Chamber
Annex C Product Qualification Certificate of Hyperbaric Oxygen Chamber
Annex D Supervision and Inspection Certificate for Manufacturing Special Equipment (Hyperbaric Oxygen Chamber)
Annex E Installation and Debugging Data Sheet of Hyperbaric Oxygen Chamber
Annex F Supervision and Inspection Certificate for Installation of Special Equipment (Hyperbaric Oxygen Chamber)
Annex G Annual Inspection Report of Hyperbaric Oxygen Chamber
Annex H Periodic Inspection Report of Hyperbaric Oxygen Chamber
