Technical Regulation for Simple Pressure Vessels

Preamble

In line with the Kingdom of Saudi Arabia's accession to the World Trade Organization in accordance with Council of Ministers Decision No. (244) dated 21/9/1426 AH, regarding the approval of the documents for the Kingdom's accession to the World Trade Organization,
and the requirement for the Kingdom to align its relevant systems with the principles of the organization's agreements, especially the Agreement on Technical Barriers to Trade (TBT), which stipulates that unnecessary technical requirements should not be imposed on the flow of goods between member states, and that there should be no discrimination between products of different origins in terms of technical requirements and conformity assessment methods, through the issuance of technical regulations that include legitimate basic requirements and unify work procedures.
Based on Article Three (Paragraph - 1) of the Organization of the Saudi Standards, Metrology and Quality Organization issued by Council of Ministers Decision No. (216) dated 17/6/1431 AH, corresponding to 31/5/2010 AD, which states that the organization shall "issue Saudi standard specifications, quality systems, and guidelines for conformity that comply with the standard specifications and international guidelines, meet the requirements of the World Trade Organization Agreement in this field, and be compatible with Islamic Sharia and serve the interests of the Kingdom".
And based on Article Four (Paragraph - 2) of the Organization of the Saudi Standards, Metrology and Quality Organization issued by Council of Ministers Decision No. (216) dated 17/6/1431 AH, corresponding to 31/5/2010 AD, which states that the organization shall "issue regulations for the conformity assessment of goods, products, and services according to the standard specifications it adopts".
And based on Article Four (Paragraph - 14) of the Organization of the Saudi Standards, Metrology and Quality Organization issued by Council of Ministers Decision No. (216) dated 17/6/1431 AH, corresponding to 31/5/2010 AD, which states that the organization shall "review the regulatory systems and regulations related to the fields of the organization's work, develop them, and propose the necessary amendments to keep pace with quality and safety requirements, and refer them to the competent authorities for study and issuance according to legal procedures".
And based on Article Six (Paragraph - 1) of the Organization of the Saudi Standards, Metrology and Quality Organization issued by Council of Ministers Decision No. (216) dated 17/6/1431 AH, corresponding to 31/5/2010 AD, which states that
"Without prejudice to what is stated in Article (Four) of this organization, the organization is the reference in the Kingdom for everything related to standard specifications, conformity assessment procedures, and granting quality and measurement and calibration marks. All government and private sectors must comply with Saudi standard specifications in all their purchases and operations".
Since the standard specifications for products covered by one of the regulations are considered the basis for the conformity of those products with the basic safety requirements in the specified regulation, the organization has prepared this technical regulation.
Note: This introduction and all annexes to this regulation are an integral part of it.
 

Article (1): Terms and Definitions


1/1 The terms and phrases below and other phrases mentioned in this Regulation - when applying its provisions - shall have the meanings and connotations indicated before them, or those stated in the laws, regulations, and decisions in force at the Organization, unless the context of the text requires otherwise.
The Kingdom: The Kingdom of Saudi Arabia.
The Council: The Board of Directors of the Organization.
The Organization: The Saudi Standards, Metrology and Quality Organization.
Regulatory Authorities: The governmental authority/authorities with regulatory tasks according to their jurisdiction, responsible for implementing or monitoring the implementation of technical regulations, whether at customs points, markets, or factories.
Market Surveillance Authorities: The governmental entities specialized in monitoring markets and the measures taken to ensure that products comply with the requirements of the regulations issued by the Board of Directors.
Technical Regulation: An approved document from the Board of Directors that sets out the characteristics of products and the processes associated with them and their production methods, including the applicable administrative provisions that must be adhered to. It may specifically include or address terms, definitions, packaging, requirements for labeling or marking products, services, processes, or production methods.
The Product: Simple pressure vessels.
Standard Specification: A document that defines the attributes of a commodity, material, or service, or anything subject to measurement, or its descriptions, characteristics, quality level, dimensions, and measures, or safety and security requirements, including terms, symbols, testing methods, sampling, packaging, data sheets, and labels.
Essential Requirements: Requirements specific to products that may affect safety, health, and the environment, which must be adhered to.
Hazard: A potential source of harm.
Risks: The likelihood of a hazard causing harm; related to the severity of the harm.
Market Surveillance: The activities and measures taken by Market Surveillance Authorities to verify that products meet the requirements stipulated in the relevant technical regulations and do not pose a risk to health, safety, and the environment, or any other aspect related to protecting the public interest.
The Supplier: Refers to the following:
– The manufacturer of the product, if established in the Kingdom, or any person who presents their identity as the manufacturer of the product by naming the product in their name or any relevant trade description, as well as any person who renews the product.
– The manufacturer's agent in the Kingdom if the manufacturer is located outside the Kingdom, or the importer in the absence of an agent for the manufacturer in the Kingdom.
– Any person in the supply chain whose activity may affect the characteristics of the product.
Conformity Assessment Procedures: An approved document from the Board of Directors that outlines the procedure used directly or indirectly for assessing conformity.
Accepted Entities: Entities for conformity assessment accepted by the Organization according to the Regulation for Accepting Conformity Assessment Entities.
Certificate of Conformity: The certificate issued by the Organization or one of the accepted entities, confirming that the product or any batch of it complies with the requirements of the relevant standard specifications.
Supplier's Declaration of Conformity: A declaration from the supplier themselves that their product complies with the requirements of the applicable legislation, without any mandatory intervention from a third party - at all stages of the manufacturing process - and the declaration may rely on tests on the product according to the relevant legislation.
Saudi Quality Mark: A mark approved by the Organization indicating that the establishment has an effective management system that ensures the production of a commodity compliant with the Regulation and the granting procedures and the relevant Saudi standard specifications.
Market Placement: The first placement of the product in the market of the Kingdom, for which either the manufacturer or the importer is responsible.
Market Offering: Means any supply of the product for distribution, consumption, or use in the Kingdom within a commercial activity, whether for monetary compensation or without compensation.
Withdrawal: Any action aimed at preventing the offering of products in the market and in the supply chain.
Recall: Any action aimed at retrieving products that have been previously provided to the end user.
Simple Pressure Vessels: Containers designed and manufactured to contain air or nitrogen under pressure, including direct appurtenances connecting them to other devices and equipment, which may consist of one or more chambers.
Appurtenances: Parts and assemblies that contribute to the resistance of the pressure vessel (bolts, nuts, etc.).
1/2 The words and other phrases mentioned in this technical regulation shall have the meanings stated in the laws, regulations, and decisions in force in the Kingdom.
 

Article 2: Scope

  • 2/1 This Regulation applies to simple pressure vessels and their appurtenances, which have the following characteristics:

    • A- Welded vessels, designed to withstand an internal pressure exceeding (0.5 bar), intended to contain air or nitrogen, and not designated for combustion.

    • B- Vessels whose parts or fittings contributing to the reinforcement of the vessel are made either of high-quality non-cast steel, or non-cast aluminum, or non-heat-treated aluminum alloys.

    • C- Vessels that consist of:

      • – A cylindrical part with a circular cross-section closed at the ends with concave outward curved ends or flat bottoms having the same axis as the cylindrical part.

      • – Two concave bottoms having the same axis of rotation.

      • D- Vessels where the maximum operating pressure in the vessel is less than or equal to (30 bars) and the product of the maximum allowable operating pressure and the capacity of the vessel (PS × V) does not exceed (10000) bar*liters.

      • E- Vessels that do not have a minimum operating temperature lower than (-50) degrees Celsius and a maximum operating temperature not exceeding (300) degrees Celsius for steel vessels or 100 degrees Celsius for aluminum vessels or non-heat-treated aluminum alloys.

    • This is in accordance with the definitions and terms contained in Article (1) and the relevant standard specifications included in Appendix (1).

  • 2/2 The following are exempt from the application of this Regulation:

    • − Devices specifically designed for nuclear use, the failure of which could result in radioactive emissions.

    • − Devices specifically prepared for propelling boats or aircraft.

    • − Products subject to the requirements of the Saudi Food and Drug Authority.
       

Article 3: Objectives

This regulation aims to define the basic requirements for simple pressure vessels covered by the scope of this regulation, and to specify the conformity assessment procedures that suppliers must adhere to, in order to ensure that these products comply with the basic requirements aimed at preserving the environment and the health and safety of their users, as well as facilitating market surveillance procedures.
 

Article 4: Obligations of the Supplier

  • The supplier must comply with the following requirements:

  • 4 /1 Technical Requirements

  • The supplier must meet the following requirements:

    • 4 /1/1 Compliance of simple pressure vessels with the technical requirements specified in the standard specifications outlined in Appurtenance (1) of this Regulation.

    • 4 /1 /2 Compliance with the required conformity assessment as specified in Article (6).

    • 4 /1 /3 Ensure that vessels with a product of the maximum allowable operating pressure and capacity (PS × V) exceeding (50) bar*liters, are designed and manufactured in accordance with the essential safety requirements stipulated in Appurtenance (2).

    • 4/ 1/ 4 Ensure that the vessels covered by this Regulation bear the markings specified in Appurtenance (3).

    • 4 /1/ 5 Retain technical documentation and the supplier's declaration of conformity after the vessels are placed on the market for a period determined by the relevant specifications.

    • 4 /1/ 6 Ensure that there are procedures in place to maintain the production chain's compliance with this Regulation, taking into account all changes in the design or technical characteristics of the vessels, as well as changes in the standard specifications.

    • 4 /1/ 7 Ensure that the vessels have a type or serial number or batch number that allows for their identification.

    • 4 /1/ 8 Notify regulatory authorities and market surveillance authorities immediately, providing details, particularly if the vessels pose a hazard.

  • 4/ 2 Metrological Requirements

  • International System Units (SI Units) or their multiples or subdivisions must be used for simple pressure vessels during design, manufacturing, or trading.

  • 4/ 3 Environmental Requirements

  • Compliance with the following is required:

    • 4/ 3/ 1 The product must be free from toxic or environmentally hazardous materials.

    • 4/ 3/ 2 Compliance with environmental regulations and their executive systems issued by the relevant authorities.

    • 4/ 3/ 3 Availability of an effective environmental management system at the factory in accordance with the requirements of the competent authorities.

    • 4/ 3/ 4 Design and manufacture products in a manner that ensures the sustainability of the use of natural materials, taking into account the reuse or recycling of these materials and their components, and avoiding the use of primary or secondary raw materials that are not environmentally compliant.

  • 4/4 Packaging Requirements

    • 4/ 4/ 1 Ensure that simple pressure vessels are assembled and arranged safely and correctly during storage and transport, in accordance with the packaging requirements specified in the relevant standard specification.

    • 4/ 4/ 2 Ensure that the packaging materials for simple pressure vessels are free from lead or any heavy metals.
       

Article (5) Explanatory Data


The labeling information for simple pressure vessels, prepared for placement and display in the market, must meet the following requirements:
5/1 The labeling information on the product must comply with the technical requirements set forth in this regulation and the relevant standard specifications, as outlined in Appendix (1) of this regulation.
5/2 The labeling information must include safety information, instructions, definitions, and symbols contained in Appendix (3) of this regulation, and must be in a clear font and in a manner that is difficult to remove.
5/3 The name of the supplier or their registered trademark must be included.
5/4 The information must be in Arabic, and it may be written in another language in addition to Arabic, with the Arabic text taking precedence.
5/5 All information used in the labeling must be accurate and substantiated.
5/6 The images and phrases used on the product packaging must not violate public order, public morals, or the prevailing Islamic values in the Kingdom.
 

Article 6: Procedures for Conformity Assessment

  • 6/ 1 The supplier - responsible for placing simple pressure vessels on the market - where the product of the maximum allowable operating pressure multiplied by the vessel capacity (PS × V) is less than or equal to (50) bar * liter - must obtain a certificate of conformity issued by an entity accepted by the authority, according to the conformity assessment model (Type 1 a) according to the standard 17067 ISO/IEC as shown in annex (4).

  • 6/ 2 The supplier - responsible for placing simple pressure vessels on the market - where the product of the maximum allowable operating pressure multiplied by the vessel capacity (PS × V) is greater than (50) bar * liter - must obtain a certificate of conformity issued by an entity accepted by the authority, according to the conformity assessment model (3 Type) according to the standard 17067 ISO/IEC as shown in annex (5).

  • 6/ 3 The accepted entity must implement conformity assessment procedures according to the specified model, ensuring compliance with the requirements of this technical regulation and the relevant Saudi standards; as indicated in annex (1).

  • 6/ 4 A technical file must accompany the product, including the following:

    • A) Supplier's (manufacturer/supplier) declaration of conformity according to the model attached in annex (6).

    • B) Risk assessment document.

  • 6/ 5 The supplier must cooperate with regulatory bodies and market surveillance authorities, such as providing technical file documents and certificates of conformity, and any other documented information proving the product's compliance with the requirements of this technical regulation, whenever requested.

  • 6/ 6 Simple pressure vessels and related appurtenances that contribute to strengthening the vessel, which have obtained the Saudi quality mark or its equivalent, are considered compliant with the requirements stipulated in this technical regulation.

Article (7) Responsibilities of Regulatory Authorities

The regulatory authorities, within their jurisdiction and powers, shall carry out the following:
7/1 Verify the compliance of simple pressure vessels with the specified conformity assessment procedures and the technical documents attached to the shipments.
7/2 The regulatory authorities have the right to randomly withdraw samples from simple pressure vessels and refer them to specialized laboratories to ensure their compliance with the requirements stated in this technical regulation.
7/3 The regulatory authorities have the right to charge suppliers (manufacturers and importers) the costs of conducting tests and related matters.
7/4 In the event of a non-compliance issue with the product, the regulatory authority shall withdraw the concerned products from the warehouses and take legal action against them.
 

Article 8 Responsibilities of Market Survey Authorities

The market surveillance authorities, within their jurisdiction and powers, shall carry out the following:
8/1 Implement market surveillance procedures on products displayed in the markets, as well as products stored in the warehouses of traders and manufacturers, to verify the safety of the products and their compliance with the essential requirements outlined in this regulation and the relevant standard specifications.
8/2 Withdraw samples of the product, whether from the market or the warehouses of suppliers (manufacturers and importers), in order to conduct the necessary tests and ensure their compliance with the requirements stipulated in this regulation.
3/8 In the event of detecting a non-compliance of the product - whether displayed or stored - with the requirements of this regulation, the market surveillance authorities shall take all administrative actions for the withdrawal and recall of the concerned product, and the procedures and penalties stated in Article (9) shall be applied, after taking the necessary actions.
 

Article 9: Violations and Penalties

  • 9/1 It is prohibited to manufacture and import products that do not comply with the provisions of this technical regulation, as well as to place and display them in the market, or even advertise them.

  • 9/2 The failure of a product to meet the requirements of this technical regulation is considered sufficient reason for market surveillance authorities and regulatory bodies to judge that this product is non-compliant; which may pose a risk to consumer health and safety and the environment, in the following cases:

    • A) Incorrect or improper affixing of conformity marks or the Saudi quality mark or their equivalent.

    • B) Failure to issue a certificate of conformity or the supplier's declaration of conformity, or their issuance in an incorrect manner.

    • C) Lack of or incomplete technical documentation.

    • D) Lack of or incomplete explanatory data or usage instructions.

  • 9/3 Upon detecting any violation of the provisions of this technical regulation, market surveillance authorities must - depending on the case - take all necessary measures to remove the violation and its effects from the market, and for this purpose, they may:

    • A) Instruct the violating entity - responsible for placing and displaying the non-compliant product - to withdraw it from warehouses or the market to correct the violation, if possible, or to export or destroy it (depending on the nature of the product) within the timeframe specified by market surveillance authorities.

    • B) Withdraw, seize, or destroy the products, or take any other action to recall them from the markets. Market surveillance authorities may - depending on the case - announce the recall of the product from the markets, with the violating entity bearing all costs incurred as a result.

  • 9/4 Upon detecting a violation, the authority takes the necessary actions against these products that violate the requirements of this technical regulation, including canceling the related certificate of conformity, and taking necessary measures with the accepted entity issuing the certificate in accordance with the regulation for accepting conformity assessment bodies.

  • 9/5 Without prejudice to any harsher penalty in the applicable laws, anyone who violates the requirements of the approved standard specifications for products covered by this technical regulation shall be punished with the penalties stipulated in the Anti-Commercial Fraud Law.

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