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# BIS Certification Consultant for Diagnostic Medical X-Ray Equipment | IS 7620 (Part 1) | Qualitance India **SEO Title:** BIS Certification for Diagnostic Medical X-Ray Equipment | IS 7620 Part 1 **Meta Description:** Need BIS certification for diagnostic medical X-ray equipment? Understand IS 7620 Part 1, electrical and mechanical safety testing, sample requirements, documentation and regulatory compliance with Qualitance India. **URL Slug:** `bis-certification-diagnostic-medical-x-ray-equipment-is-7620-part-1` **Primary Keyword:** BIS Certification for Diagnostic Medical X-Ray Equipment — ## Introduction Diagnostic medical X-ray equipment is used in hospitals, diagnostic centres, clinics and other healthcare facilities to produce medical images for diagnosis and patient assessment. Because these machines operate at high voltages and generate ionising radiation, their design and manufacture require careful attention to electrical safety, mechanical safety, performance and radiation protection. **IS 7620 (Part 1):1986 – Specification for Diagnostic Medical X-ray Equipment: Part 1, General and Safety Requirements** is an Indian Standard historically used for the mechanical and electrical safety requirements of diagnostic X-ray machines. BIS has published a product manual for certification under this standard, covering sampling, testing equipment, inspection and testing arrangements, and the scope of the licence. However, manufacturers must pay particular attention to the standard’s revision history. A BIS circular dated July 2016 stated that the earlier X-ray equipment standards were revised and replaced by corresponding IEC-based Indian Standards. BIS’s current Scheme-I listing continues to show IS 7620 (Part 1), so applicants should obtain confirmation from BIS regarding the applicable standard and certification route for their specific equipment before applying. Qualitance India provides consultancy support to manufacturers seeking guidance on BIS product certification, technical documentation, testing arrangements and applicable compliance requirements. ## What Is IS 7620 (Part 1)? IS 7620 (Part 1):1986 addresses general, mechanical and electrical safety requirements for diagnostic medical X-ray equipment. The standard historically covered equipment such as stationary and mobile diagnostic X-ray machines. Its scope and technical requirements must be interpreted with reference to the standard itself, applicable amendments and the relevant BIS certification instructions. The July 2020 BIS product manual identifies the product as **Medical Electrical Equipment – Diagnostic X-ray Machine – Part 1: Mechanical and Electrical Safety**. It records three amendments to IS 7620 (Part 1):1986. Before proceeding with certification, manufacturers should establish whether their equipment falls under the legacy standard or a relevant revised standard for the particular X-ray application. ## Important: Confirm the Applicable X-Ray Standard Before Applying The standards applicable to medical X-ray equipment depend on the equipment type and intended use. In its July 2016 circular, BIS identified revised standards based on the IEC 60601 series, including: – **IS 13450 (Part 1):2008 / IEC 60601-1:** General requirements for basic safety and essential performance of medical electrical equipment. – **IS 13450 (Part 1/Sec 3):2014 / IEC 60601-3:** Radiation protection in diagnostic X-ray equipment. – **IS 13450 (Part 2/Sec 43):2016:** X-ray equipment for interventional procedures. – **IS 13450 (Part 2/Sec 44):2016:** Computed tomography (CT) equipment. – **IS 13450 (Part 2/Sec 45):2016:** Mammographic X-ray equipment and mammographic stereotactic devices. – **IS 13450 (Part 2/Sec 54):2016:** X-ray equipment for radiography and radioscopy. – **IS 13450 (Part 2/Sec 63):2016:** Dental extra-oral X-ray equipment. – **IS 13450 (Part 2/Sec 65):2016:** Dental intra-oral X-ray equipment. The BIS circular explains that the revised standards address general safety and performance requirements, while radiation safety is to be verified by the Atomic Energy Regulatory Board (AERB). This distinction is important: **IS 7620 (Part 1) should not automatically be assumed to be the current or correct standard for every type of diagnostic X-ray machine.** Manufacturers should confirm the applicable standard, product category and BIS certification route before preparing the application. ## Is BIS Certification Required for Diagnostic Medical X-Ray Equipment? BIS lists diagnostic medical X-ray equipment under its **Scheme-I (ISI Mark Scheme)** product listing. The listing refers to the regulatory background for diagnostic medical X-ray equipment. However, applicants must distinguish between: – The applicable Indian Standard for their specific X-ray equipment. – BIS product certification and the conditions for use of the Standard Mark. – AERB requirements relating to radiation safety and the applicable medical-radiation regulatory framework. Because the standards have undergone revision, manufacturers should confirm the applicable certification route with BIS and verify current AERB requirements for the product and intended use. A BIS licence does not, by itself, replace any separate radiation-safety approval, registration or authorisation required under applicable regulations. ## BIS Certification Process for Diagnostic Medical X-Ray Equipment The process depends on the applicable standard, equipment type and current BIS instructions. For applications being assessed under IS 7620 (Part 1):1986, the July 2020 BIS product manual provides the following guidance. ### 1. Identify the Equipment Category Identify whether the equipment is stationary or mobile and determine its intended diagnostic application. Record the machine type, generator configuration, rated voltage, current, frequency, phase, rated peak output voltage and output power. ### 2. Confirm the Applicable Indian Standard Review the applicable Indian Standard and its amendments. If the machine falls under a revised equipment-specific standard, determine the relevant requirements before starting the application. ### 3. Review Product Design and Safety Features Prepare the technical information needed to demonstrate compliance with the applicable mechanical and electrical safety requirements. This may include electrical schematics, earthing arrangements, enclosure design, insulation details, protective devices and the relevant safety-related components. ### 4. Prepare the Manufacturing and Quality-Control Documents Compile the manufacturing process, inspection procedures, testing arrangements, equipment details and records needed to demonstrate consistent production. ### 5. Arrange Product Testing Identify the tests required under the applicable standard and product manual. For the legacy IS 7620 (Part 1):1986 route, the July 2020 product manual specifies a sample size of **one** and states that each variety is to be tested for grant of licence or change in scope of licence. It also specifies that complete testing of a sample is to be performed at the factory. These provisions should not be applied automatically to a revised standard without checking its current product manual. ### 6. Submit the Application and Address Observations Submit the applicable application and supporting documents through the relevant BIS process. Respond to any technical or documentary observations and provide additional evidence when required. ### 7. Complete Applicable Assessment and Obtain the Licence Meet the applicable product-testing, factory-assessment and documentation requirements. The Standard Mark may be used only after the relevant licence has been granted and within its approved scope. ### 8. Maintain Compliance Maintain the required routine testing, calibration, production records, product marking and controls for non-conforming products according to the applicable product manual and licence conditions. ## Testing Requirements for Diagnostic Medical X-Ray Equipment The July 2020 BIS product manual for IS 7620 (Part 1):1986 identifies several important mechanical and electrical safety tests and the equipment used for them. ### 1. General Requirements and Construction The machine’s construction, wiring, enclosures and mechanical arrangements must meet the applicable requirements of the standard. Relevant components must be installed and protected as required. ### 2. Enclosure Protection Enclosure protection testing checks whether the equipment provides the required protection against access to hazardous parts. The product manual identifies a steel probe for the relevant test. ### 3. Insulation Resistance Test Insulation resistance testing assesses the electrical insulation of the equipment under the specified conditions. The manual identifies a humidity chamber and megger among the relevant equipment. ### 4. High-Voltage Test The high-voltage test evaluates electrical insulation under the specified test conditions. The product manual identifies a high-voltage tester for this purpose. ### 5. Leakage Current Test Leakage current testing checks compliance with the applicable electrical safety limits. The manual identifies a leakage-current tester. ### 6. Earth Resistance Test The earth resistance test evaluates the protective earthing arrangement. The product manual identifies an earth resistance tester with the associated current source, ammeter and voltmeter. ### 7. Over-Current Protective Devices The equipment’s over-current protective devices and meters must meet the applicable requirements. The manual identifies a dummy load and multimeter for relevant tests. ### 8. Temperature Rise Test Temperature rise testing evaluates temperature changes under specified operating conditions. The product manual identifies a temperature indicator with thermocouples. ### 9. Mechanical and Dimensional Checks The product manual also identifies checks involving sheet-metal thickness, metal-plate thickness, clearances, barrier thickness and X-ray table drift. Vernier callipers and a scale are listed for relevant measurements. The complete list of tests, test methods, acceptance criteria and frequencies must be established from the applicable Indian Standard and current BIS product manual. ## Sample Requirements and Scope of Licence The July 2020 BIS product manual for IS 7620 (Part 1):1986 specifies **one sample** and states that each variety must be tested for grant of licence or change in scope of licence. It also states that the licence is operated on a factory-testing basis, with complete testing of a sample carried out at the factory. The manual identifies the following information for describing the scope of the licence: – Stationary or mobile diagnostic X-ray machine – Machine type – Frequency-generator details – Rated line voltage – Frequency in hertz – Number of phases – Rated current in amperes – Rated peak output voltage in kilovolts peak (kVp) – Output power in watts Other relevant aspects may also be included in the scope. These details are specific to the legacy product manual. Applicants following a revised equipment-specific standard should verify the corresponding product manual and scope requirements. ## Factory Testing Facilities and Quality Control The July 2020 BIS product manual specifies that a suitably equipped and staffed laboratory should be maintained for tests required by the specification. It also requires the manufacturer to prepare a calibration plan and maintain test records. Important preparation activities include: – Maintaining suitable testing facilities and trained personnel. – Preparing a calibration plan for relevant equipment. – Maintaining records of inspections and tests. – Ensuring product marking complies with the applicable requirements. – Establishing control-unit identification and production-testing arrangements. – Managing non-conforming products to prevent improper release or marking. The manual identifies several tests as routine controls and others at specified periodic intervals. The applicable testing frequency must be confirmed from the relevant standard and product manual rather

# BIS Certification Consultant for Diagnostic Medical X-Ray Equipment | IS 7620 (Part 1) | Qualitance India **SEO Title:** BIS Certification for Diagnostic Medical X-Ray Equipment | IS 7620 Part 1 **Meta Description:** Need BIS certification for diagnostic medical X-ray equipment? Understand IS 7620 Part 1, electrical and mechanical safety testing, sample requirements, documentation and regulatory compliance with Qualitance India. **URL Slug:** `bis-certification-diagnostic-medical-x-ray-equipment-is-7620-part-1` **Primary Keyword:** BIS Certification for Diagnostic Medical X-Ray Equipment — ## Introduction Diagnostic medical X-ray equipment is used in hospitals, diagnostic centres, clinics and other healthcare facilities to produce medical images for diagnosis and patient assessment. Because these machines operate at high voltages and generate ionising radiation, their design and manufacture require careful attention to electrical safety, mechanical safety, performance and radiation protection. **IS 7620 (Part 1):1986 – Specification for Diagnostic Medical X-ray Equipment: Part 1, General and Safety Requirements** is an Indian Standard historically used for the mechanical and electrical safety requirements of diagnostic X-ray machines. BIS has published a product manual for certification under this standard, covering sampling, testing equipment, inspection and testing arrangements, and the scope of the licence. However, manufacturers must pay particular attention to the standard’s revision history. A BIS circular dated July 2016 stated that the earlier X-ray equipment standards were revised and replaced by corresponding IEC-based Indian Standards. BIS’s current Scheme-I listing continues to show IS 7620 (Part 1), so applicants should obtain confirmation from BIS regarding the applicable standard and certification route for their specific equipment before applying. Qualitance India provides consultancy support to manufacturers seeking guidance on BIS product certification, technical documentation, testing arrangements and applicable compliance requirements. ## What Is IS 7620 (Part 1)? IS 7620 (Part 1):1986 addresses general, mechanical and electrical safety requirements for diagnostic medical X-ray equipment. The standard historically covered equipment such as stationary and mobile diagnostic X-ray machines. Its scope and technical requirements must be interpreted with reference to the standard itself, applicable amendments and the relevant BIS certification instructions. The July 2020 BIS product manual identifies the product as **Medical Electrical Equipment – Diagnostic X-ray Machine – Part 1: Mechanical and Electrical Safety**. It records three amendments to IS 7620 (Part 1):1986. Before proceeding with certification, manufacturers should establish whether their equipment falls under the legacy standard or a relevant revised standard for the particular X-ray application. ## Important: Confirm the Applicable X-Ray Standard Before Applying The standards applicable to medical X-ray equipment depend on the equipment type and intended use. In its July 2016 circular, BIS identified revised standards based on the IEC 60601 series, including: – **IS 13450 (Part 1):2008 / IEC 60601-1:** General requirements for basic safety and essential performance of medical electrical equipment. – **IS 13450 (Part 1/Sec 3):2014 / IEC 60601-3:** Radiation protection in diagnostic X-ray equipment. – **IS 13450 (Part 2/Sec 43):2016:** X-ray equipment for interventional procedures. – **IS 13450 (Part 2/Sec 44):2016:** Computed tomography (CT) equipment. – **IS 13450 (Part 2/Sec 45):2016:** Mammographic X-ray equipment and mammographic stereotactic devices. – **IS 13450 (Part 2/Sec 54):2016:** X-ray equipment for radiography and radioscopy. – **IS 13450 (Part 2/Sec 63):2016:** Dental extra-oral X-ray equipment. – **IS 13450 (Part 2/Sec 65):2016:** Dental intra-oral X-ray equipment. The BIS circular explains that the revised standards address general safety and performance requirements, while radiation safety is to be verified by the Atomic Energy Regulatory Board (AERB). This distinction is important: **IS 7620 (Part 1) should not automatically be assumed to be the current or correct standard for every type of diagnostic X-ray machine.** Manufacturers should confirm the applicable standard, product category and BIS certification route before preparing the application. ## Is BIS Certification Required for Diagnostic Medical X-Ray Equipment? BIS lists diagnostic medical X-ray equipment under its **Scheme-I (ISI Mark Scheme)** product listing. The listing refers to the regulatory background for diagnostic medical X-ray equipment. However, applicants must distinguish between: – The applicable Indian Standard for their specific X-ray equipment. – BIS product certification and the conditions for use of the Standard Mark. – AERB requirements relating to radiation safety and the applicable medical-radiation regulatory framework. Because the standards have undergone revision, manufacturers should confirm the applicable certification route with BIS and verify current AERB requirements for the product and intended use. A BIS licence does not, by itself, replace any separate radiation-safety approval, registration or authorisation required under applicable regulations. ## BIS Certification Process for Diagnostic Medical X-Ray Equipment The process depends on the applicable standard, equipment type and current BIS instructions. For applications being assessed under IS 7620 (Part 1):1986, the July 2020 BIS product manual provides the following guidance. ### 1. Identify the Equipment Category Identify whether the equipment is stationary or mobile and determine its intended diagnostic application. Record the machine type, generator configuration, rated voltage, current, frequency, phase, rated peak output voltage and output power. ### 2. Confirm the Applicable Indian Standard Review the applicable Indian Standard and its amendments. If the machine falls under a revised equipment-specific standard, determine the relevant requirements before starting the application. ### 3. Review Product Design and Safety Features Prepare the technical information needed to demonstrate compliance with the applicable mechanical and electrical safety requirements. This may include electrical schematics, earthing arrangements, enclosure design, insulation details, protective devices and the relevant safety-related components. ### 4. Prepare the Manufacturing and Quality-Control Documents Compile the manufacturing process, inspection procedures, testing arrangements, equipment details and records needed to demonstrate consistent production. ### 5. Arrange Product Testing Identify the tests required under the applicable standard and product manual. For the legacy IS 7620 (Part 1):1986 route, the July 2020 product manual specifies a sample size of **one** and states that each variety is to be tested for grant of licence or change in scope of licence. It also specifies that complete testing of a sample is to be performed at the factory. These provisions should not be applied automatically to a revised standard without checking its current product manual. ### 6. Submit the Application and Address Observations Submit the applicable application and supporting documents through the relevant BIS process. Respond to any technical or documentary observations and provide additional evidence when required. ### 7. Complete Applicable Assessment and Obtain the Licence Meet the applicable product-testing, factory-assessment and documentation requirements. The Standard Mark may be used only after the relevant licence has been granted and within its approved scope. ### 8. Maintain Compliance Maintain the required routine testing, calibration, production records, product marking and controls for non-conforming products according to the applicable product manual and licence conditions. ## Testing Requirements for Diagnostic Medical X-Ray Equipment The July 2020 BIS product manual for IS 7620 (Part 1):1986 identifies several important mechanical and electrical safety tests and the equipment used for them. ### 1. General Requirements and Construction The machine’s construction, wiring, enclosures and mechanical arrangements must meet the applicable requirements of the standard. Relevant components must be installed and protected as required. ### 2. Enclosure Protection Enclosure protection testing checks whether the equipment provides the required protection against access to hazardous parts. The product manual identifies a steel probe for the relevant test. ### 3. Insulation Resistance Test Insulation resistance testing assesses the electrical insulation of the equipment under the specified conditions. The manual identifies a humidity chamber and megger among the relevant equipment. ### 4. High-Voltage Test The high-voltage test evaluates electrical insulation under the specified test conditions. The product manual identifies a high-voltage tester for this purpose. ### 5. Leakage Current Test Leakage current testing checks compliance with the applicable electrical safety limits. The manual identifies a leakage-current tester. ### 6. Earth Resistance Test The earth resistance test evaluates the protective earthing arrangement. The product manual identifies an earth resistance tester with the associated current source, ammeter and voltmeter. ### 7. Over-Current Protective Devices The equipment’s over-current protective devices and meters must meet the applicable requirements. The manual identifies a dummy load and multimeter for relevant tests. ### 8. Temperature Rise Test Temperature rise testing evaluates temperature changes under specified operating conditions. The product manual identifies a temperature indicator with thermocouples. ### 9. Mechanical and Dimensional Checks The product manual also identifies checks involving sheet-metal thickness, metal-plate thickness, clearances, barrier thickness and X-ray table drift. Vernier callipers and a scale are listed for relevant measurements. The complete list of tests, test methods, acceptance criteria and frequencies must be established from the applicable Indian Standard and current BIS product manual. ## Sample Requirements and Scope of Licence The July 2020 BIS product manual for IS 7620 (Part 1):1986 specifies **one sample** and states that each variety must be tested for grant of licence or change in scope of licence. It also states that the licence is operated on a factory-testing basis, with complete testing of a sample carried out at the factory. The manual identifies the following information for describing the scope of the licence: – Stationary or mobile diagnostic X-ray machine – Machine type – Frequency-generator details – Rated line voltage – Frequency in hertz – Number of phases – Rated current in amperes – Rated peak output voltage in kilovolts peak (kVp) – Output power in watts Other relevant aspects may also be included in the scope. These details are specific to the legacy product manual. Applicants following a revised equipment-specific standard should verify the corresponding product manual and scope requirements. ## Factory Testing Facilities and Quality Control The July 2020 BIS product manual specifies that a suitably equipped and staffed laboratory should be maintained for tests required by the specification. It also requires the manufacturer to prepare a calibration plan and maintain test records. Important preparation activities include: – Maintaining suitable testing facilities and trained personnel. – Preparing a calibration plan for relevant equipment. – Maintaining records of inspections and tests. – Ensuring product marking complies with the applicable requirements. – Establishing control-unit identification and production-testing arrangements. – Managing non-conforming products to prevent improper release or marking. The manual identifies several tests as routine controls and others at specified periodic intervals. The applicable testing frequency must be confirmed from the relevant standard and product manual rather

Introduction

Diagnostic medical X-ray equipment is used in hospitals, diagnostic centres, clinics and other healthcare facilities to produce medical images for diagnosis and patient assessment. Because these machines operate at high voltages and generate ionising radiation, their design and manufacture require careful attention to electrical safety, mechanical safety, performance and radiation protection. IS 7620 (Part 1):1986 – Specification for Diagnostic Medical X-ray Equipment: Part 1, General and Safety Requirements is an Indian Standard historically used for the mechanical and electrical safety requirements of diagnostic X-ray machines. BIS has published a product manual for certification under this standard, covering sampling, testing equipment, inspection and testing arrangements, and the scope of the licence. <Cite refs={["turn916989view0"]}/> However, manufacturers must pay particular attention to the standard's revision history. A BIS circular dated July 2016 stated that the earlier X-ray equipment standards were revised and replaced by corresponding IEC-based Indian Standards. BIS's current Scheme-I listing continues to show IS 7620 (Part 1), so applicants should obtain confirmation from BIS regarding the applicable standard and certification route for their specific equipment before applying. <Cite refs={["turn916989view1","turn353572search0"]}/> Qualitance India provides consultancy support to manufacturers seeking guidance on BIS product certification, technical documentation, testing arrangements and applicable compliance requirements.

What Is IS 7620 (Part 1)?

IS 7620 (Part 1):1986 addresses general, mechanical and electrical safety requirements for diagnostic medical X-ray equipment. The standard historically covered equipment such as stationary and mobile diagnostic X-ray machines. Its scope and technical requirements must be interpreted with reference to the standard itself, applicable amendments and the relevant BIS certification instructions. The July 2020 BIS product manual identifies the product as Medical Electrical Equipment – Diagnostic X-ray Machine – Part 1: Mechanical and Electrical Safety. It records three amendments to IS 7620 (Part 1):1986. <Cite refs={["turn916989view0"]}/> Before proceeding with certification, manufacturers should establish whether their equipment falls under the legacy standard or a relevant revised standard for the particular X-ray application.

Important: Confirm the Applicable X-Ray Standard Before Applying

The standards applicable to medical X-ray equipment depend on the equipment type and intended use. In its July 2016 circular, BIS identified revised standards based on the IEC 60601 series, including: <Cite refs={["turn916989view1"]}/>
  • IS 13450 (Part 1):2008 / IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment.
  • IS 13450 (Part 1/Sec 3):2014 / IEC 60601-3: Radiation protection in diagnostic X-ray equipment.
  • IS 13450 (Part 2/Sec 43):2016: X-ray equipment for interventional procedures.
  • IS 13450 (Part 2/Sec 44):2016: Computed tomography (CT) equipment.
  • IS 13450 (Part 2/Sec 45):2016: Mammographic X-ray equipment and mammographic stereotactic devices.
  • IS 13450 (Part 2/Sec 54):2016: X-ray equipment for radiography and radioscopy.
  • IS 13450 (Part 2/Sec 63):2016: Dental extra-oral X-ray equipment.
  • IS 13450 (Part 2/Sec 65):2016: Dental intra-oral X-ray equipment.
The BIS circular explains that the revised standards address general safety and performance requirements, while radiation safety is to be verified by the Atomic Energy Regulatory Board (AERB). <Cite refs={["turn916989view1"]}/> This distinction is important: IS 7620 (Part 1) should not automatically be assumed to be the current or correct standard for every type of diagnostic X-ray machine. Manufacturers should confirm the applicable standard, product category and BIS certification route before preparing the application.

Is BIS Certification Required for Diagnostic Medical X-Ray Equipment?

BIS lists diagnostic medical X-ray equipment under its Scheme-I (ISI Mark Scheme) product listing. The listing refers to the regulatory background for diagnostic medical X-ray equipment. <Cite refs={["turn353572search0"]}/> However, applicants must distinguish between:
  • The applicable Indian Standard for their specific X-ray equipment.
  • BIS product certification and the conditions for use of the Standard Mark.
  • AERB requirements relating to radiation safety and the applicable medical-radiation regulatory framework.
Because the standards have undergone revision, manufacturers should confirm the applicable certification route with BIS and verify current AERB requirements for the product and intended use. A BIS licence does not, by itself, replace any separate radiation-safety approval, registration or authorisation required under applicable regulations.

BIS Certification Process for Diagnostic Medical X-Ray Equipment

The process depends on the applicable standard, equipment type and current BIS instructions. For applications being assessed under IS 7620 (Part 1):1986, the July 2020 BIS product manual provides the following guidance. <Cite refs={["turn916989view0"]}/>

1. Identify the Equipment Category

Identify whether the equipment is stationary or mobile and determine its intended diagnostic application. Record the machine type, generator configuration, rated voltage, current, frequency, phase, rated peak output voltage and output power.

2. Confirm the Applicable Indian Standard

Review the applicable Indian Standard and its amendments. If the machine falls under a revised equipment-specific standard, determine the relevant requirements before starting the application.

3. Review Product Design and Safety Features

Prepare the technical information needed to demonstrate compliance with the applicable mechanical and electrical safety requirements. This may include electrical schematics, earthing arrangements, enclosure design, insulation details, protective devices and the relevant safety-related components.

4. Prepare the Manufacturing and Quality-Control Documents

Compile the manufacturing process, inspection procedures, testing arrangements, equipment details and records needed to demonstrate consistent production.

5. Arrange Product Testing

Identify the tests required under the applicable standard and product manual. For the legacy IS 7620 (Part 1):1986 route, the July 2020 product manual specifies a sample size of one and states that each variety is to be tested for grant of licence or change in scope of licence. It also specifies that complete testing of a sample is to be performed at the factory. <Cite refs={["turn916989view0"]}/> These provisions should not be applied automatically to a revised standard without checking its current product manual.

6. Submit the Application and Address Observations

Submit the applicable application and supporting documents through the relevant BIS process. Respond to any technical or documentary observations and provide additional evidence when required.

7. Complete Applicable Assessment and Obtain the Licence

Meet the applicable product-testing, factory-assessment and documentation requirements. The Standard Mark may be used only after the relevant licence has been granted and within its approved scope.

8. Maintain Compliance

Maintain the required routine testing, calibration, production records, product marking and controls for non-conforming products according to the applicable product manual and licence conditions.

Testing Requirements for Diagnostic Medical X-Ray Equipment

The July 2020 BIS product manual for IS 7620 (Part 1):1986 identifies several important mechanical and electrical safety tests and the equipment used for them. <Cite refs={["turn916989view0"]}/>

1. General Requirements and Construction

The machine's construction, wiring, enclosures and mechanical arrangements must meet the applicable requirements of the standard. Relevant components must be installed and protected as required.

2. Enclosure Protection

Enclosure protection testing checks whether the equipment provides the required protection against access to hazardous parts. The product manual identifies a steel probe for the relevant test.

3. Insulation Resistance Test

Insulation resistance testing assesses the electrical insulation of the equipment under the specified conditions. The manual identifies a humidity chamber and megger among the relevant equipment.

4. High-Voltage Test

The high-voltage test evaluates electrical insulation under the specified test conditions. The product manual identifies a high-voltage tester for this purpose.

5. Leakage Current Test

Leakage current testing checks compliance with the applicable electrical safety limits. The manual identifies a leakage-current tester.

6. Earth Resistance Test

The earth resistance test evaluates the protective earthing arrangement. The product manual identifies an earth resistance tester with the associated current source, ammeter and voltmeter.

7. Over-Current Protective Devices

The equipment's over-current protective devices and meters must meet the applicable requirements. The manual identifies a dummy load and multimeter for relevant tests.

8. Temperature Rise Test

Temperature rise testing evaluates temperature changes under specified operating conditions. The product manual identifies a temperature indicator with thermocouples.

9. Mechanical and Dimensional Checks

The product manual also identifies checks involving sheet-metal thickness, metal-plate thickness, clearances, barrier thickness and X-ray table drift. Vernier callipers and a scale are listed for relevant measurements. <Cite refs={["turn916989view0"]}/> The complete list of tests, test methods, acceptance criteria and frequencies must be established from the applicable Indian Standard and current BIS product manual.

Sample Requirements and Scope of Licence

The July 2020 BIS product manual for IS 7620 (Part 1):1986 specifies one sample and states that each variety must be tested for grant of licence or change in scope of licence. It also states that the licence is operated on a factory-testing basis, with complete testing of a sample carried out at the factory. <Cite refs={["turn916989view0"]}/> The manual identifies the following information for describing the scope of the licence:
  • Stationary or mobile diagnostic X-ray machine
  • Machine type
  • Frequency-generator details
  • Rated line voltage
  • Frequency in hertz
  • Number of phases
  • Rated current in amperes
  • Rated peak output voltage in kilovolts peak (kVp)
  • Output power in watts
Other relevant aspects may also be included in the scope. <Cite refs={["turn916989view0"]}/> These details are specific to the legacy product manual. Applicants following a revised equipment-specific standard should verify the corresponding product manual and scope requirements.

Factory Testing Facilities and Quality Control

The July 2020 BIS product manual specifies that a suitably equipped and staffed laboratory should be maintained for tests required by the specification. It also requires the manufacturer to prepare a calibration plan and maintain test records. <Cite refs={["turn916989view0"]}/> Important preparation activities include:
  • Maintaining suitable testing facilities and trained personnel.
  • Preparing a calibration plan for relevant equipment.
  • Maintaining records of inspections and tests.
  • Ensuring product marking complies with the applicable requirements.
  • Establishing control-unit identification and production-testing arrangements.
  • Managing non-conforming products to prevent improper release or marking.
The manual identifies several tests as routine controls and others at specified periodic intervals. The applicable testing frequency must be confirmed from the relevant standard and product manual rather than assumed from a general checklist. <Cite refs={["turn916989view0"]}/> Manufacturers should also assess whether their equipment and testing capabilities meet the requirements of any revised standard applicable to their particular X-ray machine.

Documents Required for BIS Certification

The final document checklist depends on the applicable standard, product category and BIS application procedure. Documents commonly relevant to a certification application may include:
  • Business registration and legal-entity details
  • Manufacturing-facility address and details
  • Product description and model information
  • Technical specifications and rated electrical parameters
  • Product drawings and electrical circuit diagrams
  • Bill of materials and component specifications
  • Details of earthing and electrical protection arrangements
  • Manufacturing process flow chart
  • Quality-control procedures and inspection records
  • Details of testing equipment and calibration records
  • Relevant test reports and in-house test records
  • Details of technical and quality-control personnel
  • Product labels, markings and instruction manuals
  • Supplier conformity documents for relevant components
  • Declarations and undertakings required by BIS
  • Other documents specified in the current application checklist
This is an indicative list. The final checklist should be confirmed against the applicable standard, current product manual and BIS instructions.

BIS Certification and AERB Radiation Safety: What Is the Difference?

BIS product certification and radiation-safety compliance are related but distinct aspects of medical X-ray equipment regulation. BIS certification addresses the requirements specified under the applicable Indian Standard and the relevant certification scheme. Depending on the applicable standard, these may include general, mechanical, electrical safety and performance requirements. AERB compliance concerns radiation safety and the regulatory requirements applicable to the X-ray equipment, its installation, operation and use. The July 2016 BIS circular specifically stated that radiation-safety requirements were to be verified by AERB, while BIS certification addressed the applicable electrical, mechanical, general safety and performance requirements. <Cite refs={["turn916989view1"]}/> Manufacturers and importers should independently verify current AERB requirements and determine which approvals or registrations apply to their equipment. Obtaining a BIS licence should not be treated as proof that every AERB obligation has been met.

Common Challenges During BIS Certification

Manufacturers may face delays when the applicable standard, product scope or testing arrangements are not clearly established. Common challenges include:
  1. Using an outdated standard: Applying IS 7620 (Part 1):1986 without confirming whether a revised standard applies to the equipment.
  2. Incorrect product classification: Failing to identify whether the machine is intended for radiography, radioscopy, CT, mammography, dental imaging or another application.
  3. Incomplete technical specifications: Omitting rated voltage, frequency, current, phase, kVp or output power.
  4. Insufficient testing facilities: Not providing the facilities required by the applicable standard or product manual.
  5. Incomplete test records: Missing calibration plans, inspection records or product-testing evidence.
  6. Confusion between BIS and AERB: Treating BIS certification as a substitute for separate radiation-safety obligations.
  7. Incorrect licence scope: Assuming one product variety or machine configuration automatically covers all other varieties.
A preliminary compliance review can help identify these issues before an application is submitted.

How Qualitance India Can Help

Qualitance India provides consultancy support for manufacturers seeking BIS certification and product-compliance guidance. Our support may include:
  • Preliminary review of product applicability and the relevant Indian Standard
  • Guidance on identifying the applicable BIS certification route
  • Assistance with technical documentation and application preparation
  • Review of product specifications and proposed licence scope
  • Guidance on testing requirements and factory testing arrangements
  • Review of quality-control procedures and testing records
  • Guidance on calibration and documentation requirements
  • Support in addressing documentary gaps and certification observations
  • Guidance on distinguishing BIS product certification from other applicable regulatory obligations
The scope, professional fees and timeline depend on the equipment type, applicable standard, factory readiness, testing requirements and current regulatory procedure. Certification decisions remain with BIS, and radiation-safety approvals remain subject to the applicable regulatory authority.

Why Choose Qualitance India?

Qualitance India helps manufacturers understand Indian Standards, prepare certification documentation and plan product-compliance activities. Our approach focuses on practical guidance, accurate technical documentation and identifying the applicable requirements before the certification process progresses. Qualitance India – Improving Quality & Competence We support businesses with BIS product certification consultancy, NABL ISO/IEC 17025 consultancy and related quality-management services.

Frequently Asked Questions (FAQs)

1. Which standard applies to diagnostic medical X-ray equipment?

IS 7620 (Part 1):1986 is the legacy standard for general and safety requirements. BIS issued a circular in July 2016 describing revised IEC-based standards for different types of X-ray equipment. The applicable standard should be confirmed for the specific equipment before applying. <Cite refs={["turn916989view1"]}/>

2. Is IS 7620 (Part 1) still listed by BIS?

Yes. BIS's Scheme-I product listing continues to show diagnostic medical X-ray equipment under IS 7620 (Part 1). However, BIS has also published guidance about revised standards. Applicants should confirm the current certification route with BIS for their particular product. <Cite refs={["turn353572search0","turn916989view1"]}/>

3. How many samples are specified in the IS 7620 (Part 1) product manual?

The July 2020 product manual specifies one sample and states that each variety must be tested for grant of licence or change in scope. Complete testing of the sample is to be performed at the factory under that manual. <Cite refs={["turn916989view0"]}/>

4. What tests are identified in the product manual?

The manual identifies insulation resistance, high voltage, leakage current, earth resistance, over-current protection, temperature rise, enclosure protection and relevant mechanical or dimensional checks. The complete requirements depend on the applicable standard. <Cite refs={["turn916989view0"]}/>

5. Does BIS certification replace AERB compliance?

No. BIS certification and AERB radiation-safety requirements are separate regulatory considerations. The applicable AERB requirements must be checked for the equipment and its intended use. <Cite refs={["turn916989view1"]}/>

6. Can Qualitance India guarantee the grant of a BIS licence?

No consultant can guarantee a certification decision. Qualitance India can provide consultancy support with requirement review, documentation, testing preparation and process guidance, while BIS retains authority over the licence decision.

Official References

Consult these official resources to review the applicable standard, certification process and regulatory guidance:
  1. BIS Product Manual for IS 7620 (Part 1):1986 – July 2020: View the official product manual
  2. BIS Circular on Revised Standards for X-Ray Equipment – July 2016: View the official circular
  3. BIS Scheme-I Product Listing: View products under compulsory certification
  4. BIS Product Manuals Directory: Search official product manuals
  5. BIS Standard Information: Search the official BIS standards portal
Always confirm the latest standard status, amendments, applicable product manual, BIS instructions and AERB requirements before making a compliance decision.

Contact Qualitance India for BIS Certification Consultancy

Are you a manufacturer or supplier of diagnostic medical X-ray equipment seeking guidance on BIS certification? Contact Qualitance India to discuss your equipment category, applicable Indian Standard, technical documentation and testing requirements. Qualitance India – Improving Quality & Competence Contact us to discuss your BIS certification consultancy requirements.

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