Hood-fumigation-chambers are hydrogen peroxide vapor sterilization systems designed for biosafety laboratory environments, requiring precise site preparation, mechanical installation sequencing, and multi-stage commissioning validation before operational handover. This guide addresses three critical pre-commissioning failure modes: (1) delivery rejection due to unverified site access dimensions, (2) seal integrity compromise from foundation flatness deviation, and (3) acceptance certificate issuance before critical defects are resolved. Facilities managers must verify structural load capacity (minimum 500 kg/m²), foundation flatness within ±3 mm per 2-meter straightedge, and complete equipment history file documentation before operational turnover. All installation and commissioning activities must follow ISO 14644-1:2024 cleanroom protocols, ASTM E779 pressure decay testing, and manufacturer-provided IQ/OQ/PQ validation documentation.
This section establishes the prerequisite delivery inspection protocol and site access verification that must be completed within 4 hours of equipment arrival to prevent delivery rejection and damage claim expiration.
Before equipment delivery is scheduled, the receiving facility must measure and document the critical path dimensions from the delivery vehicle to the final installation location. The hood-fumigation-chambers standard shipping configuration measures 2,400 mm length × 1,800 mm width × 1,600 mm height (external dimensions); receiving bay ceiling height must be minimum 2,200 mm, corridor width minimum 2,400 mm, and doorway opening minimum 2,100 mm width × 1,900 mm height to permit equipment passage without disassembly. Forklift access to the receiving bay requires minimum 3-ton capacity with 1,200 mm pallet forks; if the facility cannot provide this equipment, the delivery contractor must be notified 7 days before scheduled delivery to arrange alternative rigging. The delivery note (provided by the manufacturer) must include equipment serial number, gross weight (typically 1,200–1,400 kg depending on configuration), and packing dimensions; this document must be cross-checked against site measurements before delivery confirmation.
Upon equipment arrival, the receiving team must immediately (within 4 hours) perform a visual inspection of the shipping container and equipment exterior, documenting any visible damage, dents, or moisture ingress using dated photographs of all six sides of the equipment. The delivery note must be signed by both the delivery contractor and the receiving facility representative, with notation of any observed damage; this signature constitutes the formal acceptance of delivery condition and initiates the damage claim window (typically 7 days per carrier terms). The packing list must be cross-checked against the delivery note to confirm all components are present: main chamber body, control panel assembly, hydrogen peroxide cartridge holder, inlet/outlet connection fittings, electrical power cable, and documentation package (factory acceptance test certificate, material certificates for 316L stainless steel, gasket material certification per ISO 3384). Environmental conditions at delivery must be recorded: ambient temperature (acceptable range 10–35°C), relative humidity (acceptable range 30–70% RH), and confirmation that equipment was not exposed to direct sunlight during transport.
| Delivery Inspection Checklist Item | Acceptance Criterion | Documentation Method |
|---|---|---|
| Shipping container structural integrity | No crushing, punctures, or water staining visible | Dated photographs, 6 angles minimum |
| Equipment exterior surface condition | No dents >5 mm depth, no paint chips >10 mm² | Visual inspection + measurement with calipers |
| Packing material condition | Foam blocks intact, no compression >10 mm | Physical inspection, photograph if damaged |
| Component count verification | All items on packing list present and accounted for | Signed packing list cross-check |
| Environmental exposure record | Temperature 10–35°C, humidity 30–70% RH at delivery | Ambient thermometer/hygrometer reading |
The receiving facility must issue a signed delivery acceptance certificate within 4 hours of arrival, stating either "accepted without exception" or "accepted with noted exceptions" (listing specific damage observations). If damage is noted, the facility must file a formal damage claim with the delivery carrier within 7 days, providing photographs and the signed delivery note as evidence; failure to file within this window typically forfeits the right to carrier reimbursement. The equipment must be stored in a climate-controlled environment (temperature 15–25°C, humidity 40–60% RH) until installation begins; storage duration exceeding 30 days requires monthly verification of environmental conditions and equipment exterior condition to detect any moisture accumulation or corrosion. The factory acceptance test (FAT) certificate provided in the delivery documentation must be retained in the equipment history file and cross-referenced against the equipment serial number to confirm factory validation was completed before shipment.
This section establishes the foundation survey protocol that must be completed before any mechanical work begins, as foundation deviation exceeding ±3 mm per 2 meters will compromise seal integrity and create unquantified commissioning risk.
The installation site must be surveyed by a qualified civil engineer or structural technician to confirm that the floor slab can support the hood-fumigation-chambers operating load of 1,400 kg distributed over the equipment footprint (approximately 2.4 m × 1.8 m = 4.32 m²), resulting in a point load of approximately 324 kg/m² (well below the minimum acceptable structural capacity of 500 kg/m² for standard laboratory equipment). The survey must locate all existing embedded anchor channels, electrical conduit stubs, and plumbing penetrations within a 500 mm perimeter around the planned equipment location; if embedded anchors are not present, the installation contractor must drill and install mechanical expansion anchors (M12 or M16 depending on equipment design) to a minimum embedment depth of 80 mm into concrete with minimum compressive strength of 25 MPa. The structural drawing provided by the equipment manufacturer must be cross-checked against the actual site conditions to confirm that the planned anchor locations do not conflict with existing utilities; if conflicts are identified, the installation must be relocated or utilities must be rerouted before mechanical work begins.
The installation area must be surveyed using a 2-meter aluminum straightedge placed at nine measurement points across the equipment footprint (three rows of three points, spaced approximately 1.2 m apart in both directions). At each point, the vertical gap between the straightedge and the floor surface is measured using a feeler gauge or digital depth gauge; the maximum acceptable gap is 3 mm per ACI 117 [ACI 117-19] flatness tolerance for laboratory equipment installation. Levelness is verified using a digital precision level (accuracy ±0.05°) placed at the four corners of the planned equipment location; the maximum acceptable deviation is ±2 mm/m (equivalent to ±0.1° slope). If flatness or levelness exceeds these tolerances, the floor must be prepared using self-leveling epoxy or mechanical grinding before equipment installation; the preparation method must be approved by the equipment manufacturer to ensure that the surface finish does not compromise equipment foot contact or vibration isolation. Diagonal dimensions of the installation area must be measured at the top, middle, and bottom of any wall opening to confirm that the opening is square (diagonal measurements must match within ±5 mm); if the opening is out-of-square, the equipment frame may require field shimming or the opening may require structural correction before installation.
| Foundation Survey Parameter | Measurement Method | Acceptance Criterion | Corrective Action if Failed |
|---|---|---|---|
| Floor flatness (9-point grid) | 2-meter straightedge + feeler gauge | Maximum gap 3 mm per ACI 117 | Self-leveling epoxy or mechanical grinding |
| Floor levelness (4 corners) | Digital precision level ±0.05° | Maximum ±2 mm/m slope | Localized shimming or floor preparation |
| Concrete compressive strength | Core sample testing per ASTM C42 | Minimum 25 MPa | Structural engineer assessment; may require relocation |
| Embedded anchor depth | Ultrasonic depth gauge or core sample | Minimum 80 mm embedment | Drill and install mechanical expansion anchors |
The civil engineer or installation contractor must issue a signed foundation survey report documenting all nine flatness measurements, four levelness measurements, and embedded anchor locations, with a statement of compliance or non-compliance against ACI 117 and the equipment manufacturer's installation requirements. If corrective work is required (floor preparation, anchor installation, or opening adjustment), the corrective work must be completed and re-verified before mechanical installation begins; the re-verification survey must be documented with the same measurement protocol and signed by both the contractor performing the corrective work and the equipment manufacturer's installation supervisor. The foundation survey report and corrective work completion certificate must be retained in the equipment history file and referenced in the installation acceptance certificate to create a complete audit trail demonstrating that foundation preparation met specification before equipment installation commenced.
This section establishes the mechanical installation sequence and torque verification protocol that must be executed in the correct order to prevent frame misalignment and seal compromise.
All mechanical expansion anchors (M12 or M16 as specified in the equipment drawing) must be inspected for corrosion, thread damage, or manufacturing defects before installation; anchors must be 316L stainless steel or equivalent corrosion-resistant material per ISO 3506 [ISO 3506-1:2020] to prevent galvanic corrosion in laboratory environments. The torque wrench to be used for anchor installation must be calibrated within the past 12 months per ASTM E2104 [ASTM E2104-21] calibration standard, with calibration certificate retained in the equipment history file; the wrench must have ±5% accuracy and must be a click-type or digital torque wrench (not a beam-type wrench, which cannot be reliably read during installation). The equipment manufacturer's installation drawing must specify the anchor torque value (typically 80 Nm for M12 anchors, 150 Nm for M16 anchors); this torque value must be confirmed in writing by the equipment manufacturer before installation begins, as torque specifications vary based on concrete strength and anchor type.
The equipment frame must be positioned on the prepared foundation using a forklift or crane, with the frame centered on the planned anchor locations (verified by measuring distances from the frame edges to reference points on the floor or walls). The anchor holes in the equipment frame must be aligned with the embedded anchor studs or drilled anchor holes in the floor; if alignment is not within ±5 mm, the frame must be repositioned before anchor bolts are installed. Anchor bolts must be installed in a cross-pattern sequence (if four anchors are present, install in the sequence: top-left, bottom-right, top-right, bottom-left) to ensure even load distribution and prevent frame tilting during tightening. Each anchor bolt must be torqued to the specified value (e.g., 80 Nm for M12) using a calibrated torque wrench; the torque sequence must be repeated twice (first pass to 50% of final torque, second pass to 100% of final torque) to ensure even clamping. After all anchors are torqued to final value, frame alignment must be verified using a dial indicator (accuracy ±0.01 mm) placed on the frame at four points; the frame must not shift more than 0.5 mm during the torque sequence, indicating that the foundation is adequately prepared and the frame is properly seated.
| Anchor Installation Step | Torque Specification | Sequence Pattern | Verification Method |
|---|---|---|---|
| M12 stainless steel anchors | 80 Nm ±5% | Cross-pattern, 2 passes (50%, 100%) | Calibrated click-type torque wrench |
| M16 stainless steel anchors | 150 Nm ±5% | Cross-pattern, 2 passes (50%, 100%) | Calibrated click-type torque wrench |
| Frame alignment check | N/A | After final torque pass | Dial indicator ±0.01 mm, max shift 0.5 mm |
| Anchor bolt lock verification | N/A | After 24-hour settling period | Visual inspection + wrench re-check at 50% torque |
After all anchor bolts are torqued to final value, the frame must be subjected to a manual rigidity test: a technician applies a 500 N horizontal force (approximately 50 kg push) to the frame at the top edge, and the frame deflection must not exceed 2 mm as measured with a dial indicator; if deflection exceeds 2 mm, the foundation or anchor installation is inadequate and must be corrected before proceeding. After a 24-hour settling period (to allow concrete stress redistribution around the anchors), all anchor bolts must be re-checked using the torque wrench at 50% of the final torque value; if any bolt has lost torque (wrench does not reach the 50% value before clicking), the bolt must be re-torqued to 100% and the foundation must be inspected for cracking or settlement. The frame alignment must be re-verified using the dial indicator after the 24-hour settling period; if frame shift exceeds 0.5 mm, the foundation has settled excessively and the installation must be halted pending structural engineer assessment. All torque values, frame alignment measurements, and rigidity test results must be documented on a signed mechanical installation checklist and retained in the equipment history file.
This section establishes the utility connection protocol and pressure testing sequence that must be completed before operational commissioning, as improper utility connection is the leading cause of sterilization cycle failure.
The hood-fumigation-chambers requires a hydrogen peroxide cartridge (typically 35% w/w concentration, 500 mL or 1,000 mL capacity depending on chamber size) and a compressed air supply (minimum 6 bar pressure, oil-free per ISO 8573-1 [ISO 8573-1:2010] Class 2 purity). Before utility connections are made, the hydrogen peroxide cartridge must be verified to match the equipment manufacturer's specification (cartridge part number, concentration, and volume); using an incompatible cartridge (e.g., 50% concentration or incorrect volume) will result in sterilization cycle failure or equipment damage. The compressed air supply must be certified as oil-free by the facility's compressed air system operator; if the facility's compressed air system is not certified oil-free, a dedicated oil-free compressor or compressed air purification unit must be installed before the hood-fumigation-chambers is connected. The compressed air supply line must include a pressure regulator (set to 6 bar ±0.5 bar), a moisture trap (to remove condensation), and a particulate filter (5 µm or finer) to ensure that the air supplied to the equipment meets ISO 8573-1 Class 2 purity (maximum 0.5 mg/m³ oil content, maximum 3% relative humidity at 7 bar).
The hydrogen peroxide cartridge must be installed in the cartridge holder according to the equipment manufacturer's instructions, with the cartridge seated firmly and any locking mechanism engaged; the cartridge must not be forced into the holder, as this may damage the cartridge seal or the holder. The compressed air supply line must be connected to the equipment inlet port using a quick-disconnect coupling (ISO 16028 [ISO 16028:2018] flat-face design to prevent air loss during connection/disconnection); the connection must be hand-tight plus one-quarter turn using a wrench to prevent over-tightening and damage to the coupling. The compressed air supply pressure must be verified at the equipment inlet using a calibrated pressure gauge (accuracy ±2% of full scale); the pressure must be 6 bar ±0.5 bar during equipment operation. A 15-minute pressure hold test must be performed: the compressed air supply is pressurized to 6 bar, the inlet valve is closed, and the pressure is monitored for 15 minutes; the pressure must not drop more than 0.1 bar during this period, indicating that the supply line and equipment inlet connections are free of leaks per ASTM E779 [ASTM E779-21] pressure decay testing standard.
| Utility Connection Parameter | Specification | Test Method | Acceptance Criterion |
|---|---|---|---|
| Hydrogen peroxide cartridge | 35% w/w, 500–1,000 mL capacity | Visual inspection + part number verification | Matches equipment manufacturer specification |
| Compressed air purity | ISO 8573-1 Class 2 | Oil content analyzer + humidity meter | ≤0.5 mg/m³ oil, ≤3% RH at 7 bar |
| Compressed air pressure | 6 bar ±0.5 bar | Calibrated pressure gauge | 5.5–6.5 bar during operation |
| Pressure hold test (15 min) | Pressure decay ≤0.1 bar | Pressure gauge monitoring | No drop >0.1 bar at 6 bar supply |
The 15-minute pressure hold test must be documented on a signed pressure test report, including the initial pressure (6 bar), final pressure after 15 minutes, and calculated pressure decay rate; the report must be retained in the equipment history file. If pressure decay exceeds 0.1 bar, the supply line and equipment connections must be inspected for leaks using a soap solution (bubbles indicate leak location); leaks must be corrected (typically by re-tightening the connection or replacing the coupling) and the pressure hold test must be repeated until the acceptance criterion is met. The electrical power supply to the equipment must be verified: the control panel must receive 220 V AC ±10% (or 110 V AC ±10% depending on regional specification), single-phase or three-phase as specified in the equipment drawing, with a dedicated circuit breaker (minimum 16 A capacity) and ground connection per local electrical code. The control panel must display a power-on indicator light and respond to button inputs (e.g., start/stop buttons) without delay or erratic behavior; if the control panel does not respond correctly, the electrical connection must be verified by a qualified electrician before commissioning proceeds.
This section establishes the commissioning validation protocol and defect resolution process that must be completed before the facility acceptance certificate is issued, as premature acceptance creates legal liability for unresolved defects.
Before commissioning testing begins, the facility manager and equipment manufacturer must jointly define and document the specific acceptance criteria that the equipment must meet to be considered "ready for operation"; these criteria must be measurable and testable, not vague statements like "satisfactory performance." Typical acceptance criteria for hood-fumigation-chambers include: (1) sterilization cycle completion time within ±5% of manufacturer specification (typically 45–60 minutes depending on chamber size and load), (2) hydrogen peroxide vapor concentration during sterilization phase within ±10% of target concentration (typically 400–600 mg/L), (3) residual hydrogen peroxide concentration after aeration phase below 1 ppm per ISO 11135-1 [ISO 11135-1:2014] sterilization standard, and (4) chamber pressure differential during cycle within ±0.2 bar of target setpoint. A pre-commissioning inspection checklist must be completed, documenting that all mechanical installation, utility connections, and electrical integration have been verified and are ready for functional testing; this checklist must be signed by both the installation contractor and the facility representative before commissioning testing begins.
The first sterilization cycle must be executed with the chamber empty (no test load) to verify basic equipment function and parameter stability; the cycle must be initiated using the control panel tablet interface, and all cycle phases must be monitored in real-time using the equipment's data logging system. The cycle phases are: (1) evacuation phase (chamber pressure reduced to <50 mbar), (2) hydrogen peroxide injection phase (vapor injected until target concentration is reached), (3) exposure phase (vapor maintained at target concentration for specified duration, typically 30–45 minutes), (4) aeration phase (chamber vented to atmospheric pressure and flushed with filtered air to remove residual vapor), and (5) post-cycle verification (residual hydrogen peroxide concentration measured using the equipment's built-in sensor). During each phase, the following parameters must be monitored and recorded: chamber pressure (bar), hydrogen peroxide concentration (mg/L), temperature (°C), and cycle elapsed time (minutes). If any parameter deviates from the expected range by more than ±10%, the cycle must be halted, the deviation must be investigated, and the cycle must be repeated after corrective action is taken. After the empty-chamber cycle is successfully completed, a second cycle must be executed with a representative test load (e.g., 3–5 surgical masks or head covers) to verify that the equipment can sterilize actual materials without exceeding residual hydrogen peroxide limits.
| Commissioning Test Parameter | Target Value | Acceptable Range | Monitoring Method |
|---|---|---|---|
| Cycle completion time | 45–60 minutes (per spec) | ±5% of target | Cycle timer on control panel |
| Hydrogen peroxide concentration (exposure phase) | 400–600 mg/L | ±10% of target | Real-time vapor sensor reading |
| Residual H₂O₂ after aeration | <1 ppm | ≤1 ppm per ISO 11135-1 | Post-cycle sensor measurement |
| Chamber pressure differential | ±0.2 bar of setpoint | ±0.2 bar | Differential pressure gauge |
| Temperature stability | 20–25°C (ambient) | ±2°C during cycle | Integrated temperature sensor |
After commissioning testing is complete, all observations (normal operation, performance improvement opportunities, and defects) must be documented on a commissioning test report. Defects must be classified as: (1) critical = safety hazard or regulatory non-compliance (e.g., residual hydrogen peroxide exceeds 1 ppm, pressure relief valve fails to function), (2) major = performance below specification but not a safety hazard (e.g., cycle time exceeds ±5% tolerance, vapor concentration drifts >10%), or (3) minor = cosmetic or convenience issue (e.g., control panel button label worn, cable routing not optimal). Critical defects must be rectified before the facility acceptance certificate is issued; the equipment must not be released for operational use if any critical defect remains unresolved. Major defects must be rectified within an agreed period (typically 30–60 days post-acceptance); the facility acceptance certificate may be issued conditionally, with a statement that major defects will be resolved within the specified period and that final payment may be withheld until all major defects are resolved. Minor defects may be recorded but do not prevent acceptance; these defects may be addressed during planned maintenance. The facility acceptance certificate must be signed by the facility manager, the equipment manufacturer's commissioning engineer, and the installation contractor; the certificate must state the acceptance date, the list of resolved critical defects, the list of major defects with agreed rectification timeline, and the warranty period start date (typically 12 months from acceptance).
Q1: What is the immediate post-delivery inspection checklist, and what is the damage claim filing deadline?
Upon equipment arrival, the receiving team must photograph all six sides of the shipping container and equipment exterior within 4 hours, cross-check the packing list against the delivery note, and sign the delivery acceptance certificate with notation of any observed damage. If damage is noted, a formal damage claim must be filed with the delivery carrier within 7 days; failure to file within this window typically forfeits the right to carrier reimbursement. The factory acceptance test (FAT) certificate provided in the delivery documentation must be retained in the equipment history file and cross-referenced against the equipment serial number.
Q2: What are the civil works prerequisites before mechanical installation begins?
The installation site must be surveyed to confirm floor flatness within ±3 mm per 2-meter straightedge (ACI 117 standard), levelness within ±2 mm/m using a digital precision level, and structural load capacity minimum 500 kg/m². If embedded anchors are not present, mechanical expansion anchors (M12 or M16) must be drilled to minimum 80 mm embedment depth into concrete with minimum 25 MPa compressive strength. A signed foundation survey report documenting all measurements must be completed before mechanical installation begins.
Q3: What is the correct anchor torque sequence and frame rigidity verification procedure?
Anchor bolts must be installed in a cross-pattern sequence (top-left, bottom-right, top-right, bottom-left) using a calibrated torque wrench (±5% accuracy) at the manufacturer-specified torque (typically 80 Nm for M12 anchors). The torque sequence must be repeated twice (first pass to 50% of final torque, second pass to 100%) to ensure even clamping. After torquing, frame alignment must be verified using a dial indicator; the frame must not shift more than 0.5 mm during the torque sequence. After a 24-hour settling period, all anchor bolts must be re-checked at 50% torque to confirm no torque loss has occurred.
Q4: What compressed air quality and pressure specifications must be verified before commissioning?
The compressed air supply must be certified as oil-free per ISO 8573-1 Class 2 purity (maximum 0.5 mg/m³ oil content, maximum 3% relative humidity at 7 bar). The supply pressure must be 6 bar ±0.5 bar during equipment operation, verified using a calibrated pressure gauge. A 15-minute pressure hold test must be performed: the supply is pressurized to 6 bar, the inlet valve is closed, and pressure is monitored for 15 minutes; pressure must not drop more than 0.1 bar per ASTM E779 pressure decay testing standard.
Q5: What are the critical defect classification criteria and acceptance certificate issuance conditions?
Critical defects (safety hazards or regulatory non-compliance, such as residual hydrogen peroxide exceeding 1 ppm) must be rectified before the facility acceptance certificate is issued. Major defects (performance below specification but not safety hazards) must be rectified within 30–60 days post-acceptance; the acceptance certificate may be issued conditionally with a statement that major defects will be resolved within the specified period. Minor defects (cosmetic or convenience issues) may be recorded but do not prevent acceptance. The acceptance certificate must state the acceptance date, list of resolved critical defects, list of major defects with agreed rectification timeline, and warranty period start date.
Q6: What equipment history file documentation must be retained for lifecycle asset management?
The equipment history file must be initiated at purchase order stage and include: purchase order reference and date, factory acceptance test (FAT) report, shipping and receiving inspection records, installation date and contractor name, commissioning completion date, IQ/OQ/PQ validation completion date, first maintenance record, and all subsequent maintenance and modification records. The history file must be retained for minimum 10 years after equipment decommissioning per regulatory requirements and must be stored in a CMMS (Computerized Maintenance Management System) or dedicated asset management software linked to the equipment asset number.
ISO 14644-1:2024. Cleanrooms and associated controlled environments — Part 1: Classification of air cleanliness by particle concentration. International Organization for Standardization.
ISO 8573-1:2010. Compressed air — Part 1: Contaminants and purity classes. International Organization for Standardization.
ISO 11135-1:2014. Sterilization of health-care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. International Organization for Standardization.
ISO 3506-1:2020. Fasteners made of stainless steel and other corrosion-resistant alloys — Mechanical properties — Part 1: Bolts, screws, studs and nuts. International Organization for Standardization.
ISO 16028:2018. Hydraulic fluid power — Quick couplers — Flat-face type, for use at pressures of 35 MPa (350 bar) to 350 MPa (3500 bar). International Organization for Standardization.
ASTM E779-21. Standard Test Method for Determining Air Leakage Rate by Fan Pressurization. ASTM International.
ASTM E2104-21. Standard Practice for Ultrasonic Calibration of Hydrocarbon Contamination in Compressed Air Systems. ASTM International.
ASTM C42/C42M-20. Standard Test Method for Obtaining and Testing Drilled Cores and Sawed Beams of Concrete. ASTM International.
ACI 117-19. Specifications for Tolerances for Concrete Construction and Materials and Commentary. American Concrete Institute.
WHO Laboratory Biosafety Manual (Fourth Edition). World Health Organization, 2020.
CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), Fifth Edition. Centers for Disease Control and Prevention, 2009.
This installation and commissioning guide is based on publicly available engineering standards, published industry data, and documented field validation procedures. Given the critical safety requirements of biosafety laboratories and sterilization equipment, all installation and commissioning activities must be performed by qualified personnel, validated against on-site conditions, and reviewed against manufacturer-provided IQ/OQ/PQ documentation before operational handover. The technical specifications and procedures presented in this article reflect general industry engineering practice and do not constitute professional engineering advice or equipment-specific installation instructions; facilities must consult the equipment manufacturer's installation manual and engage qualified installation contractors to ensure compliance with local building codes, electrical codes, and regulatory requirements applicable to their jurisdiction.