Except as follows, this clause of IEC 61010-1 applies. This clause is replaced by the following: This standard applies to autoclaves, including those with automatic loading and unloading systems, which are equipped with pressure vessels using steam with an absolute pressure range of 0 to 500 kPa, which are intended for processing medical materials and laboratory processes, such as sterilization. When the autoclave is assembled in the same housing with a steam generator with its own pressure vessel, the relevant safety requirements for the autoclave pressure vessel also apply to the steam generator (see 14.105). The following is added to this clause: - Pressurized environmental chamber. This clause is replaced by the following: The first clause is replaced by the following: - Indoor use, or outdoor use according to the manufacturer's instructions (see 11.6 in IEC 61010-1); the fourth clause is replaced by the following: - Maximum relative humidity 85% within the temperature range 5℃ to 40℃. GB 4793.4-2001 Safety of electrical equipment for measurement, control and laboratory use Particular requirements for autoclaves for handling medical materials in laboratories GB4793.4-2001 Standard download decompression password: www.bzxz.net

GB4793.4—2001
All technical contents of this standard are mandatory. Foreword
This standard is formulated based on IEC 61010-2-041 Special requirements for autoclaves for handling medical materials in laboratories, which was formulated by the 66th Technical Committee of the International Electrotechnical Commission IEC "Safety of electrical equipment for measurement, control and laboratory use". This standard is equivalent to IEC61010-2-041:1995. This standard should be used in conjunction with IEC61010-1. GB4793.1—1995 has equivalently adopted the 1990 edition of IEC61010-1 and the first amendment of 1991, but has not adopted the second amendment of 1995. In order to ensure the coordination and consistency between the standards, this standard is used in conjunction with IEC61010-1. The content of IEC61010-1 can refer to GB4793.1-1995. The safety standard for electrical equipment for measurement, control and laboratory use consists of two parts. Part 1 is general requirements and Part 2 is the specific safety requirements for each product.
This part is necessary because special precautions for equipment that uses steam above or below atmospheric pressure to achieve functions need to be given to describe the characteristics of the equipment. These equipment have many potentially hazardous parts in their structure and have different safety requirements to supplement or modify the content in Part 1 of this standard.
It should be noted that there are also standards and regulations from other countries or international organizations. They should be noted because they may supplement this standard. Parts of this standard written as "applicable" indicate that the corresponding text in IEC61010-1 applies to this standard. Parts of this standard written as "replace" or "modify" are subject to the provisions of this standard; parts of this standard written as "added" indicate that in addition to complying with the corresponding provisions of IEC61010-1, the provisions added in this standard must also be complied with. This standard is proposed by the China Machinery Industry Federation. This standard is under the jurisdiction of the Comprehensive Technical and Economic Research Institute of Machinery Industry Instruments. This standard was drafted by: Mechanical Industry Instrumentation Comprehensive Technology and Economic Research Institute. The main drafter of this standard: Wang Li.
GB 4793.4—2001
IEC Foreword
1) The formal resolutions or agreements of IEC on technical issues, which are formulated by technical committees with the participation of all national committees with special concerns, express the international consensus on the issues involved as closely as possible. 2) These resolutions or agreements are for international use in the form of recommendations and are accepted by national committees in this sense. 3) In order to promote international unification, IEC hopes that all national committees will adopt the contents of IEC standards as the provisions of their national committees to the extent permitted by their domestic conditions. Any differences between the standards recommended by EC and the corresponding national standards should be clearly stated in the national standards as far as possible.
This standard was prepared by FC. Technical Committee No. 66 (Safety of Electrical Equipment for Measurement, Control and Laboratory Use). This standard has the status of a safety publication in accordance with IEC Guide 104. The text of this standard is based on the following documents: FDIS
66/109/DIS
Voting Report
66/129/RVD
Full details of the voting for the approval of this standard can be found in the voting report shown in the table above. This standard should be used in conjunction with IEC 61010-1. IEC 61010-1 consists of the first edition in 1990, the static amendment No. 1 in 1991 and the amendment No. 2 in 1995. Future editions or revisions of IEC 61010-1 are under study. This standard supplements or modifies the corresponding clauses of IEC 61010-1 in order to become an IEC standard: Particular requirements for laboratory centrifuges.
Certain clauses of IEC 61010-1 are not restated in this standard but still apply to this standard. Where there is an "addition", "modification" or "replacement" in this standard, the relevant requirements, test requirements or notes in IEC 61010-1 shall also apply. Annex AA forms part of IEC 61010. Annex B is for reference only.
In this publication, the following typographical fonts are used: - Requirement itself · Roman
- Note: Small Roman;
- Test specification: Italic:
Terms used in this standard defined in Chapter 3: Small Roman. National Standard of the People's Republic of China
Safety requirements for electrical equipment for measurement, control and laboratory use - Particular requirements for autoclaves using stean for thetreatinent of medical materials and for laboratory process 1 Scope and purpose
Except as follows, IEC 61010-1 This clause is replaced by the following:
GB 4793.4—2001
idt IEC 61010-2-041: 1995
This standard applies to autoclaves, including those with automatic loading and unloading systems, which are equipped with pressure vessels for steam with an absolute pressure range of 0 to 500 kPa, and are intended for use in processing medical materials and laboratory processes, such as sterilization.
1 State and other regulations and rules apply to the safety of automatic loading and unloading systems. 2 All pressures are expressed in absolute values, 1 atmosphere (1 bat) α100 kPa. When the autoclave is assembled in the same shell as a steam generator with its own pressure vessel, the relevant safety requirements for the autoclave pressure vessel also apply to the steam generator (see 14.105). 1.1.2 The following content is added to this clause;
Pressurized environmental chamber.
1 The autoclaves covered by this standard all use steam and do not include other types that use dry heat, inert gas or radioactive sources. 2 This standard does not involve special protection requirements for chemical and microbiological hazards related to the installation of autoclaves, nor does it involve requirements related to the design of the pressure vessel itself.
1.4 This clause is replaced by the following content:
Replace the first clause with the following content:
For indoor use, or outdoor use according to the manufacturer's instructions (see 11.6 in IEC61010-1); replace the fourth clause with the following content:
In the temperature range of 5 to 40°C, it is 85% of the relative humidity. 2 Reference standards
Except for the following content, IEC 61010-1 This chapter in IEC61010-1 is applicable. 2.2 The following content is added to this clause:
ISO 3585:1991 Borosilicate glass 3.3 Characteristics Approved by the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China on November 2, 2001 and implemented on June 1, 2002
GB4793.4—2001
ISO 6718:1991
Explosion-proof partition Private explosion-proof partition device
3 Specification
Except for the following content, this chapter in IEC61010-1 is applicable. 3.1 The following two definitions are added:
3.1.101 Autoclave
Equipment installed with a pressure vessel or vacuum vessel for processing a load to a certain condition (for example, for sterilization). 3.1.102 Operating cycle operating cycle A complete operating process performed in a specific sequence. 3.2 Add the following four definitions:
3.2.101 Chamber
The part of the autoclave that receives the load and performs the treatment process. 3.2.102 Load
Equipment or material placed in the autoclave for treatment during the operating period. 3.2.103 Pressure vessel includes the autoclave pressure chamber, jacket (if installed) door and all related parts permanently connected to the autoclave pressure chamber. Note: Pressure vessels do not include independent parts such as steam generators, piping and fittings. 3.2.104 Sterilizer
A device designed to process the load to reduce its viable microorganisms to a certain level. Note: In practice, absolute conditions cannot be obtained, so sterilization is only an indication of possibility. 4 Test
Except for the following contents, this chapter of IEC61010-1 is applicable. 4.3.5 This clause is replaced by the following:
Replace the second paragraph with the following:
For covers that can be removed without tools, if they have an interlock that automatically prevents the movement of parts that could cause a hazard (see 1.2) when the cover is opened, they do not need to be removed.
4.4.2.4 This clause is added with the following:
Add the following new paragraph:
In cases where the motor cannot be quickly braked, a separate phase motor should be tested. 4.4.2.10 This clause is added with the following:
Add the following clause;
-Except when the overpressure safety device meets the requirements of 11.7.4, the pressure controller should be overcut to continuously start the heating device or circuit;
The loss of supply water should be simulated.bZxz.net
4.4.2.12 This clause is added with the following:
Add the following after the first paragraph:
Mechanical interlocks should fail in sequence.
Add the following clauses:
4.4.2.101 Failure or partial failure of the main power supply First reduce the voltage obtained from the power supply to 89% of the rated voltage within 5 min, and then cut off the power supply. 4.4.2.102-Failure of other supplies
Sequentially interrupt or partially interrupt each non-electrical supply or service, such as air, fluid, steam, drainage channel and exhaust system, taking them under the more unfavorable conditions.
5 Marking and documents
GB 4793. 4—2001
Except for the following contents, this chapter in IEC61010-1 is applicable. 5.1.1 Add the following to this clause:
Add new Note 1 and change the existing Note to Note 2: Note
1EC 60073 gives instructions for the color of indicator lights and non-illuminated buttons. 5.1.2 Add the following to this clause:
Add the following content and paragraph after the first paragraph: Pressure vessel marking (see 5.1.102).
Where the pressure vessel has a jacket and the pressure conditions in the jacket are different from those in the pressure chamber, the relevant information required above shall be marked on the pressure chamber and the jacket respectively, and the combined information shall also be marked on the outside of the pressure vessel. For small autoclaves with a pressure-volume product of less than 50 bar·L (5 000 kPa·L), the above marking may be permanently marked anywhere on the equipment.
5.1.3 Replace with the following:
Replace d) with the following:
d) For equipment that can be set to different rated supply voltages, an indication of the voltage to which the equipment is set shall be provided. For portable equipment, the indication shall be visible from the outside. If the equipment allows the supply voltage setting to be changed without the use of tools, the indication shall also be changed when the voltage setting is changed.
6 Add the following content to this clause:
Add aa) after e):
a) In normal use, if changing the setting of the control may cause a hazard (see 1.2), control-related indication devices, such as instruments, dials, LED lights, etc., shall be provided.
Note: Controllers, instruments and lights for a single function shall be grouped together. The following clause is added to this chapter:
5. 1.101 Overpressure safety device
The device (see 11.7.4) shall be identified by engraved numbers, names or other means, and marked with the pressure value it is set. There is a release indicator plate between the pressure chamber and the overpressure safety device, which shall be marked with its specified release pressure and related temperature. 5.1.102 The marking of pressure vessels shall indicate the following: a) the manufacturer of the pressure vessel; b) the number of the pressure vessel; e) the identification number of the door (which may be the same as the serial number of the pressure vessel); d) the maximum working pressure, e) the maximum working temperature; f) the minimum working pressure (lower than atmospheric pressure); g) the test pressure 1 h) the construction standard of the pressure vessel; i) the volume of the pressure chamber (in liters).
5.2 Add the following content to this clause:
Add the following two paragraphs:
According to 7.103, if the autoclave has a lockable door locking device, a warning sign should be provided to the operator to lock the device and hold the key before entering the pressure chamber, or other means to lock the device when the operator is in the pressure chamber. When the autoclave is used with a load that is not designed for use and may cause danger (see 1.2), there should be an appropriate warning sign indicating the type of load that can be used. For small instruments that do not have sufficient space to mark the warning sign, symbol 14 in Table 1 should be used.5.4.1 Add the following content to this clause:
Add the following two paragraphs:
-Instructions for compliance with the requirements for pressure vessels in 14.101;-Instructions for warning signs in accordance with national regulations. 5.4.3 The following shall be replaced by the following:
The documentation shall include the following details of installation, training and special commissioning requirements: a) Positioning and installation instructions, including space requirements for safe and effective servicing; b) Weights of major components and total weight of all equipment: c) Floor loading requirements: d) Assembly instructions: e) Main power requirements and connections f) Instructions for ground protection; g) Sound pressure data and requirements (see 12.5.1). 5.4.4 This clause shall be replaced by the following:
The instructions for use shall include:
Identification and use of operating controls in all operating modes; - If the location of the equipment would make it difficult to operate the disconnect device, it shall be specified (see 6.12). - instructions for connection to accessories and other equipment, including identification of applicable accessories, removable parts and any special materials; - provisions for limit values ​​for intermittent operation
Instructions on the markings required by IEC 61010-1 and used on the equipment, - cleaning instructions (see 11.2):
- instructions on the correct use of the locking device (see 7.103) for closing the door before entering the pressure chamber, including instructions for the operator to hold the key or other means of locking the device when inside the pressure chamber; - "In the event of a fault, instructions for the responsible person to safely use the spare key or other relevant methods of approaching the pressure chamber, - operating instructions in the event of a functional error.
NOTE: These instructions include any special methods for analysing the recorded data during the operating cycle, such as the use of a chart recorder to detect failures or causes Tendency to failure.
5.4.5 Replace with the following:
Replace the first paragraph with the following:
Instructions shall be given including special protections concerning maintenance and observation required for the safety of the qualified person. These instructions shall include details of the maintenance of components (see 7.1.101) that may cause hazards (see 1.2) after failure and of installed safety devices, as well as their installation and replacement procedures.
6 Protection against electric shock
Except as follows, this chapter of IEC61010-1 is applicable. 6.1 Add the following content to this clause:
Add the following paragraph after the note:
Asbestos products shall not be used.
6.10.2.2 Add the following content to this clause:
Add the following content in the second paragraph:
GB 4793. 4—2001
Wire fixing devices shall not be used to fix any other parts. The following content shall be added to this competition:
6.11.101 Non-detachable connection between power cord and terminal At the connection between flexible wires or cables and terminal sockets, the wire or cable terminals do not require special treatment of the conductors. They should be designed and installed so that the conductors will not be damaged or slip out when tightening the screws or nuts. NOTE
1 The term "special treatment of conductors" includes welding seals on cables, using cable torches, installing small holes, etc., but the shape of the conductors cannot be changed or the wires cannot be twisted into bundles to strengthen the ends before they are inserted into the terminals. 2 The equipment installation instructions may explain the use of commonly used cables that require special treatment. 6.12.101 Disconnection caused by power interruption or partial interruption shall not cause any electric shock or non-electric shock safety system to fail and cause hazards (see 1.2). Compliance is passed by 4.4.2.101 and check to make sure that no hazard occurs. 7 Protection against mechanical hazards
This clause of IEC 61010-1 applies except as follows. 7.1 This clause is amended with the following:
The following is added after the first paragraph:
See also 6.12.101 and 11.102. This clause is added with the following:
7.1.101 Locking and braking mechanisms for doors
A single fault condition in the locking and braking mechanisms for doors shall not cause a hazard (see 1.2). Wear of the threaded parts of the locking and braking mechanisms for doors shall not lead to failure. NOTE: I50 2901, 2902, 2903,2904 specifies threads. Compliance is checked by failure mode analysis of the door closing mechanism. 7.2.101 Powered doors
7.2.101.1 Circuit breakers
Each door of the autoclave shall be equipped with at least one circuit breaker which is easily accessible and in a prominent position. These devices are non-automatic reset. When any of these devices is activated: a) any residual movement of the door shall not cause a hazard (see 1.2); b) all other safety-related parts used for the control of compressed gases, steam, fluids and sealed substances shall return to a safe condition, such as valve seals, etc.;
c) a key, code or other relevant method is required to reset the circuit breaker to restore normal control system. This resetting process shall not cause a hazard (see 1.2).
Compliance is checked by visual inspection and by operation and reset of the circuit breakers. 7.2.101.2 Reverse movement and blocking of doors
If a power-operated door can exert a force greater than 150N on an obstruction, or there is no baffle in front of the power-operated door that is interlocked with the control system, the power-operated door shall have a device that reverses the movement of the door when it encounters an obstruction during closing, and reverse movement shall begin when the pressure exerted on the obstruction is greater than 150N.
Note: If the device is activated, an alarm shall be triggered. When a hinged door is opened, movement shall stop before the edge of the door farthest from the hinge exerts a force greater than 150N on the obstruction. Compliance is checked by measuring the force exerted by the panel door on the obstruction. The movement of the door shall be appropriately blocked or the door shall be reversed before 150N is reached.
7.2.101.3 Sliding doors
GB 4793.4—2001
When power failure or failure of any part of the sliding door system would cause a hazard (see 1.2), the speed of movement of the door before it is stopped by the restraining system shall not be greater than 1 cm/s and the distance moved shall not be greater than 10 cm. Compliance is checked by disconnecting the power supply and simulating the failure of each part of the door's motion system in turn. In each case, the speed and distance of the door movement shall be measured.
7.2.101.4 Power disconnection
If the power supply is disconnected during operation, the emergency disconnect device shall be activated in the manner required by 7.2.101.1. Compliance is checked by disconnecting the power supply to the door during the operating cycle and then restoring the power supply to check whether 7.2.101.1 is met. 7.2.102 Bell-shaped pressure vessels
If the autoclave consists of a bell-shaped pressure vessel or similar pressure vessel whose surface tightness decreases with the horizontal plane, two means shall be provided to prevent operators from approaching the pressure vessel when it is being raised or lowered: - a stopper placed before the pressure vessel movement control is activated; - a motion control system that requires two hands to be used safely at least 1 m from the start of the movement. The requirements for power doors in 7.2.101 also apply to bell-shaped or similar pressure vessels. Compliance is checked by visual inspection and by tests to determine whether the motion control system meets the requirements. 7.4.101 Guarding of loads entering and leaving the autoclave Guarding against mechanical hazards (see 1.2) that may occur to operators during the entry and exit of loads into and out of the autoclave shall be provided. Means shall be provided to position and restrain the load and its container (if any) in the correct position when the load is placed into or removed from the pressure chamber. When it is necessary to push a sliding frame in the pressure chamber to place or remove the load, means shall be provided to prevent it from tilting or accidentally falling out when the frame is pushed.
Compliance is checked by visual inspection and by test. 7.101 Door interlocks
7.101.1 General requirements
a) Where access to the pressure chamber would cause a hazard (see 1.2), protection shall be provided by interlocks (see 11.5.101, 13.102 and 15). During the operating cycle, the pressure chamber shall be inaccessible by applying (without the use of a tool) a force of 1000N ± 100N to the door locking mechanism. Compliance is checked by starting the operating cycle and applying a force of 1000N ± 100N to the door or door locking mechanism. b) For autoclaves with a pressure and volume product greater than or equal to 50 bel·L (5 000 kPa·L), there shall be an interlock system to prevent the entry of steam or compressed gas into or the generation of steam or compressed gas in the pressure chamber until the door of the autoclave is closed and all pressure-confining parts are in the conditions specified by the manufacturer.
Compliance is checked by visual inspection and test that steam or compressed gas will not enter the pressure chamber or be produced in the pressure chamber until the door is closed and all pressure-confining parts are in place (see 4.4.2.12). c) Means shall be provided to prevent the simultaneous commencement of a new operation following the failure of any part of the door interlock system. Compliance is checked by visual inspection and by checking that a new operating cycle cannot be initiated by failing the various parts of the interlock system in sequence. d) The interlock shall prevent the complete release of the pressure-confining part of the door before atmospheric air enters the pressure chamber. Compliance is checked by operating the autoclave through an operating cycle producing maximum internal pressure, measuring the internal pressure and determining that the interlock prevents the door from opening before atmospheric air enters.
c) Autoclaves with a pressure and volume product greater than or equal to 50 bar■L (5 000 kPa-L) shall have an interlock system that prevents partial release of the pressure-confining part of the door from causing a breach of the seal until the pressure in the pressure chamber is less than 0.2 bar (20 kPa). Compliance is checked by determining the product of the pressure generated and the volume of the pressure chamber. (If practicable) Apply different internal pressures of 0.2 bar (20 kPa), allow the pressure to drop and measure the pressure value that can be released first. f) Autoclaves with a product of pressure and volume less than 50 ber·L (5000 kPa·L) shall also have an interlock system as described above or a device that allows the pressure chamber to be connected to the atmosphere before access to the door release mechanism is allowed. Compliance is checked by visual inspection.
GB 4793.42001
7.101.2 Interlocks for doors of autoclaves containing fluids a) The door shall not be opened until the temperature of the fluid in the pressure chamber and the load is 5 K below its boiling point at the ambient atmospheric pressure. NOTE To compensate for the decrease in boiling point with increasing altitude (see 1.4), the manufacturer shall provide means for adjusting the temperature to below the temperature at which the interlock system is activated. Compliance is checked by loading the pressure chamber with the maximum load for which it is designed, completing an operating cycle and measuring the temperature of the fluid and load in the pressure chamber immediately after the door interlock is released. b) Autoclaves designed to process fluids in sealed containers should be fitted with additional controls to ensure that the door interlock is not released before the temperature of the fluid in the container has dropped to a safe value. The safe temperatures for glass containers and flexible containers (such as PVC bags) are 20 K and 10 K below the boiling point of water at ambient atmospheric pressure, respectively.
1 To compensate for the decrease in boiling point with increasing altitude (see 1.4), the manufacturer should provide means to adjust the temperature to below the temperature of the automatic interlock system.
2 The expansion of flexible containers reduces the possibility of rupture and temperatures close to the boiling point are desirable because below 20 K below the boiling point, their outer surfaces may rust.
3 When controlled by a fluid temperature sensor in the container, it is not possible to rely solely on a sensor in a single container that may rupture and allow the fluid to be lost. Compliance is checked by loading the pressure chamber with the maximum design load of the autoclave for each type of container. The glass sealed container is the first type of silica glass in IS03585, and the load is water. The load of the flexible container is water. At the end of each operating cycle, the fluid temperature in the container should be measured immediately after the door is opened. Note: Usually the glass container only carries 90% of the total capacity. 7.101.3 Interlocking of double-ended autoclave doors
The operator is not allowed to open or close the door on the end of the pressure chamber away from the operator. The operator does not participate in the door opening process, except for autoclaves with automatic transmission loading.
Qualification is checked by daily test method and inspection of door interlocks and door release mechanisms. 7.102 Doors with inflatable or pressure-actuated gaskets Doors in autoclaves sealed by inflatable or pressure-actuated gaskets shall be fitted with a device which ensures that, if the sealing pressure of the door drops below the minimum pressure specified by the manufacturer: a) the operating cycle is interrupted; h) a visual or audible alarm is given to indicate a fault; c) the door remains closed; d) steam, water or air are prevented from entering the pressure chamber; e) no hazard is created (see 1.2). Compliance is checked by visual inspection, by inspection of documentation and by simulating a door seal failure to cause a pressure drop. 7.103 Preventing the closing of doors If a pressure chamber is large enough for one person to enter, even if this is difficult, for example if the person has to move part of a load in the chamber, the autoclave shall be fitted with a device which prevents the door from closing. If the autoclave has an emergency cut-out control that can be operated from within the pressure chamber, or the pressure chamber is less than 1 Ⅱ deep and has a capacity of less than 0.65 m2,The above requirements are not applicable. A special key or other relevant means shall be provided for the operator to lock and brake the device when the operator is in the pressure chamber (see 5.2 and 5.4.4).
Compliance is checked by visual inspection and test to determine that the device can prevent the door from closing and that a key or relevant means has been provided. 8 Resistance to mechanical shock and impact
This clause of IEC 61010-1 applies except as follows. 8.4.1 Add the following content to this clause:
Add the following new paragraph:
This test is not applicable to equipment that is unlikely to move accidentally due to its size and weight and does not move in normal use. 9 Temperature limits of equipment and prevention of the spread of fire GB 4793. 4—2001
This clause of IEC 61010-1 applies except as follows. 9.1 Add the following content to this clause:
Add after the first paragraph:
See also 6.12.101.
Add the following new paragraph:
Asbestos products shall not be used for thermal insulation.
9.5Add the following content to this clause:
Over-temperature protection devices shall be used to prevent the temperature of the pressure chamber wall from exceeding the temperature that will damage the material. NOTE
1 The strength of some materials (particularly aluminum) will be rapidly destroyed at temperatures slightly exceeding the maximum working temperature of the material. 2 For pressure chambers heated by external steam, overpressure safety valves can be regarded as over-temperature protection devices. Over-temperature protection devices required for safety shall be completely isolated from any temperature control system and shall not be self-resetting. Over-temperature protection devices are not required to be reset by welding operations. NOTE: It is necessary not to use welding to reset over-temperature protection devices because it is impossible to ensure that the correct solder is used when the protection device is reset. 10 Heat resistance
This clause of IEC 61010-1 applies.
11 Protection against hazards of fluids
This clause of IEC 61010-1 applies except as follows. 11.1 The following is added to this clause:
After the first paragraph, add the following:
See also 6.12.101.
The following is added to this clause:
11.5.101 Drainage of residual water in pressure chambers The drainage of residual water at the end of an operating cycle shall not cause a hazard (see 1.2), for example water formed by condensation of steam between the water outlet and the interior of a horizontal autoclave shall not cause a hazard. Compliance is checked by determining that, after a period of operation, water generated in the door of the autoclave does not cause a hazard due to the drainage of water when the door is opened.
11.5.102 Indication and interlocks for residual water
If water in the door of a pressure chamber could cause a hazard when the door is opened (see 1.2), means shall be provided to indicate the presence of water (e.g. due to obstruction of drainage) and to prevent the door from opening in this case. The interlocks for the door shall satisfy the requirements of 7.101.1. Compliance is checked by introducing sufficient water (in excess of that required to provide a means of detecting potential hazards due to residual water) and closing the door. When this occurs, an indication shall be given and the door shall not be able to be opened. 11.7.4 The following is added to this clause:
Add the following before the first paragraph:
When the pressure generated by the pressure source may exceed the maximum working pressure of the pressure chamber, an overpressure safety device shall be installed and set to activate at a pressure value not exceeding the maximum working pressure. The overpressure safety device and its piping arrangement shall ensure that the pressure in the sterile pressure chamber shall not exceed 10% of the maximum working pressure. In normal use, the safety device shall not be used to relieve excessive pressure during the operating cycle, and precautions shall be taken to make it unlikely that water will accumulate in the seal of the safety door.
GB 4793.4—2001
Note: The possibility of damage due to the eventual blockage of the device by scale resistant to salt precipitation in the water should be avoided. The safety device should have a drain connected to the lowest point where water accumulates, unless other drainage facilities are provided. This drain should drain the water to a safe place.
Compliance is checked by the following methods:
a) Daily test of the type of device used and the manufacturer's information; b) Test to determine that in normal use, the device is not used to discharge excess pressure during the operating cycle; c) Using a pressure source and a rate not less than the maximum recommended by the autoclave manufacturer, prove that the pressure in the pressure chamber does not exceed 110% of the maximum working pressure specified by the manufacturer.
Add to "An overpressure safety device (see also 14.8) should not be activated under normal operating conditions and meet all of the following requirements:"
The overpressure safety device should be installed in accordance with the valve manufacturer's instructions and connected directly to the pressure chamber by the shortest possible pipe. 11.7.101 Display and indicating devices
If necessary for safety reasons, the following display and indicating devices for the autoclave shall be provided: 8) Pressure indicator for the pressure chamber:
h) Alternative pressure indicator (if the pressure chamber is fitted with a sleeve): c) Operating cycle counter.
Compliance is checked by visual inspection.
11.101 Exhaust from pressure relief valves and overpressure safety devices a) Exhaust in this manner shall not cause a hazard (see 1.2). Unless an automatic condensate drain is provided at the lowest point of any dip in the pipe connected to the exhaust side of the pressure relief valve, the pipe shall descend continuously to its discharge end so that no condensate can accumulate (see 7.2.101.1). If the pipe is provided as part of the building service, this shall be stated in the manufacturer's installation instructions b) If exhaust takes place inside the pressure chamber of the autoclave, the sleeve shall be able to exhaust so that no pressure increase occurs in the pressure chamber and that the exhaust gas does not reach the operating personnel.
Compliance is checked by self-test.
17.102 Interruption of supply or service
An interruption or partial interruption of any non-electrical supply or service shall not result in the violation of the safety system and shall not cause a hazard (see 1.2). Compliance is checked by checking in accordance with 4.4.2.102 that no hazard occurs. 12 Protection against radiation (including laser sources), sound pressure and ultrasonic pressure This clause of IEC 61010-1 applies except as follows. 12.1 To this clause the following is added:
Add after the first paragraph:
See also 6. 12.101 and 11, 102.
13 Protection against gas release, explosion and implosion
This clause of IEC 61010-1 applies except as follows. 13.1 Add the following to this clause:
Add after the first paragraph:
See 6.12.101 and 11.102.
Add the following clause to this clause:
13.101 Exhaust system for pressure chambers
Exhaust from the pressure chamber shall not cause a hazard (see 1.2). Compliance is checked by visual inspection and by checking the installation instructions. 13.102 Access to loads after a fault
GB 4793.4—2001
If access to the loads after a fault in the operating cycle is possible, such as by the use of a key or coding, all safety devices shall not be disabled and access to the loads shall not be permitted until the conditions in the pressure chamber do not present any hazard (see 1.2). Compliance is checked by analysing the control system and (if necessary) interrupting the operating cycle in turn at each stage of the operating cycle to determine that it is not possible to access the loads when a hazard exists. 13.103 Interruption of supplies or services
The interruption or partial interruption of any supply or service (e.g. non-electrical supplies and services such as air, water, steam, drainage and exhaust systems) shall not result in a breach of the safety system and cause a hazard (see 1.2). After the interrupted supply or service has been restored, the hazard shall not reappear (see 1.2). Compliance is checked by visual inspection and by tests interrupting each supply or service in turn. 14: Components
This clause of IEC 61010-1 applies except as follows. 14.2.1 Add the following to this clause:
Add the following second paragraph:
When the motor is fully energized, the current delay after stopping shall not cause a hazard (see 1.2). High load currents caused by one-phase spikes in three-phase motors shall not cause a hazard even if the motor is not started (see 1.2). 14.B This article is replaced by the following:
Replace the first paragraph with the following:
Overpressure safety capacity shall meet the requirements of [SO4126-1, except for small autoclaves outside the scope. The following article is added to this chapter:
14.101 Pressure vessels
Pressure vessels shall comply with the regulations and standards of the country of use for pressure vessels. If there are no national regulations and national standards, the purchaser shall specify other applicable regulations and standards.
Qualification is checked by inspecting the pressure vessel and referring to national regulations and standards. 14.102 Visibility and readability of display and indicating devices Measuring instruments, instruments and indicating devices, whether analogue or digital, which are functionally relevant to safety, shall be located where they are easily visible to the operator.
Except operating cycle counters, such equipment shall be readable (by normal vision or calibrated force) at a distance of 1 m under ambient lighting conditions of 2151x ± 151x.
Compliance is checked by visual inspection under the specified conditions. 14.103 Access ports
Autoclaves, including steam hot culture preselectors, shall be provided with one or more access ports through which the operator can access the pressure interior without the need for tools. These access ports and their locking mechanisms shall be considered as part of the door or cover and shall be of sufficient strength to withstand the design pressure and temperature.
Unless such a locking mechanism is covered in normal use by a barrier interlocked in accordance with 7.101, it shall itself be actuated by a corresponding interlocking mechanism.
Compliance is checked by visual inspection and by checking the design specifications of the materials used. 14.104 Control System
The operational controls provided shall restrict the operator from placing the autoclave in any condition that would create a hazard (see 1.2). The following functions shall be ensured by an enhanced strict control system. Examples of possible control levels are shown in "": a) the initiation of an operating alarm [which may be controlled by the operator; b) the selection of a specific operating period [controlled by a supervisor or higher level]
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