Knowledge of laws and regulations

Explanation of various laws and regulations concerning ESTERI products

Knowledge of laws and regulations (Table of Contents)

Autoclave/Retort Sterilizer

Our autoclave/retort sterilizers, with the exception of some models, are subject to the following regulations:

Occupational Safety and Health Act
https://laws.e-gov.go.jp/law/347AC0000000057
Enforcement Order of the Industrial Safety and Health Act
https://laws.e-gov.go.jp/law/347CO0000000318#Mp-At_1
Boiler and pressure vessel safety regulations
https://laws.e-gov.go.jp/law/347M50002000033

Classification of pressure vessels
If the container has a large internal volume (V) or a high pressure (P), the risk of the container bursting is very high.
Based on the cumulative value of these two elements, internal product (V) and pressure (P), they are classified into the following three types, and the inspection and inspection obligations vary depending on the level of danger.
ESTERI corresponds to "small pressure vessel" and "simple vessel."

Item/Classification Duty Target model Applicable laws and regulations
Type 1 pressure vessel Installation notification and inspection by the prefectural labor bureau are mandatory at the time of installation, and performance inspection by a registered performance inspection agency is mandatory once a year after use. Not applicable Enforcement Order of the Industrial Safety and Health Act, Article 1, Item 5
Small pressure vessel Regular self-inspections are required once a year, and inspection records are kept for three years. ESS, ESS-D, EFN, EFV, EET-62, ETV, ENS-37, ENS-50, ERD-37, ERM-96 Enforcement Order of the Industrial Safety and Health Act, Article 1, Item 6
Article 45 of the Industrial Safety and Health Act 
Boiler and Pressure Vessel Safety Regulations Article 94  
Simple container Inspections and checks are not specifically mandated. EAS-12, ENS-12, ENS-22 Enforcement Order of the Industrial Safety and Health Act, Article 13, Item 26

Incubator (warm-blooded device)

The equipment equipped with the refrigerator uses fluorocarbon gas. Due to its large environmental impact, fluorocarbon gases are strictly regulated under the "Fluorocarbon Emissions Control Act" from their manufacture to their use and disposal.

Act on the Rationalization and Management of the Use of Fronts (commonly known as the Fron Emission Control Act)
https://laws.e-gov.go.jp/law/347AC0000000057
Target models: ELI-900
Information necessary for management
・Compressor rated output: Listed on the refrigerator body
・Refrigerant gas type: Listed in the rated name plate
・Refrigerant gas filling amount: as stated in the rated name plate
Item/Classification Duty Target model Applicable laws and regulations
Simple inspection
and record keeping
Conducting an in-house visual inspection at least once every three months. ( Presence or absence of strange sounds, vibrations, oil bleeding, etc.)
Records of inspections will be retained for a minimum of three years after the equipment is discarded.
ELI-900 Act on the Rationalization and Proper Management of the Use of Fronts
Conducting regular inspections Regular inspections at least once a year
(This applies to equipment equipped with a refrigerator with a compressor rated output of 7.5kW or more, but the ELI-900 is not applicable because it is rated at 7.5kW or less.)
Not applicable Act on the Rationalization and Proper Management of the Use of Fronts
What to do in case of a leak If a flon leak is detected, it must be repaired promptly. It is illegal to continue using the gas by refilling it while it is leaking. Furthermore, if there is a certain amount or more leakage, there is an obligation to report it to the government.
During repairs, the fluorocarbon will be collected and filled by a registered "Type 1 fluorocarbon filling and recovery company."
ELI-900 Act on the Rationalization and Proper Management of the Use of Fronts
Proper disposal When disposing of or replacing equipment, CFCs must be collected. In doing so, there is an obligation to issue and preserve a "scheduled management slip" that proves that proper collection has taken place.
When disposing of the materials, we will request a registered "Type 1 CFCs Filling and Recovery Company" to collect the CFCs.
ELI-900 Act on the Rationalization and Proper Management of the Use of Fronts

Large dryer

To prevent serious workplace accidents such as fires and explosions, large dryers that meet certain standards are regulated under the category of 『drying equipment』.

Occupational Safety and Health Act
https://laws.e-gov.go.jp/law/347AC0000000057
Occupational Safety and Health Regulations
https://laws.e-gov.go.jp/law/347CO0000000318
Target models: EID-1296 , EID-2250 , ECO-600
The above products have a rated power consumption of more than 10 kW and therefore fall under the category of "drying equipment" under Article 6 of the Enforcement Order of the Occupational Safety and Health Regulations.
Due to the large equipment that generates high temperatures, the following measures are necessary to prevent explosions and burns caused by incorrect use:
Item/Classification Duty Target model Applicable laws and regulations
Notification of establishment to the Minister of Health, Labour and Welfare When installing or relocating drying equipment or changing major structural parts, businesses must notify the Minister of Health, Labour and Welfare at least 30 days before the start of construction. EID-1296, EID-2250, ECO-600 Article 88 of the Industrial Safety and Health Act
Occupational Safety and Health Regulations Article 293~Article 296
Appointment of Drying Equipment Work Supervisor A drying equipment work chief will be appointed to carry out matters stipulated by Ministry of Labor ordinance in order to prevent industrial accidents. EID-1296, EID-2250, ECO-600 Article 14 of the Industrial Safety and Health Act
Articles 297 and 298 of the Industrial Safety and Health Regulations
Conducting and preserving regular self-inspections A regular self-inspection is conducted once a year, and the results are stored for three years. EID-1296, EID-2250, ECO-600 Article 45 of the Industrial Safety and Health Act
Articles 299 and 300 of the Industrial Safety and Health Regulations